BrainStorm Cell Therapeutics - press releases

BrainStorm Cell Therapeutics Announces Second Quarter 2026 Financial Results and Provides Corporate Update

Fri, 14 Aug 2026 12:00:00 GMT

NEW YORK, Aug. 14, 2026 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update.

"We continue to advance and complete the preparations necessary to initiate the Phase 3b ENDURANCE study of NurOwn in ALS, supported by an FDA-agreed protocol under a Special Protocol Assessment," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "The recent appointment of Peter Pitts as Executive Chairman represents an important enhancement to our leadership. Peter is joining the Company in an active executive capacity and will help lead the regulatory, operational, partnership and capital-markets initiatives surrounding the NurOwn program. His experience as a former senior FDA official brings an additional level of regulatory insight and strategic perspective as we prepare to enter this next phase. ALS imposes an enormous burden on patients, families and caregivers, and we remain resolute in our commitment to the ALS community and to advancing what we believe will be a valuable new therapeutic option."

Recent Highlights

NurOwn® (MSC-NTF) for ALS

Corporate and Leadership

Publications

Financial Results for the Second Quarter Ended June 30, 2026

U.S. dollars in thousands

(Except share and per share amounts)

June 30,

December 31,

2026

2025

Unaudited

Audited

U.S. $ in thousands

ASSETS

Current Assets:

Cash and cash equivalents

Other accounts receivable

162

Prepaid expenses and other current assets

132

192

Total current assets

316

307

Long-Term Assets:

Prepaid expenses and other long-term assets

Restricted Cash

187

247

Right of use asset (Note 3)

106

208

Property and equipment, net

152

235

Total Long-Term Assets

472

715

Total assets

788

1,022

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

Current Liabilities:

Accounts payable

7,488

7,067

Accrued expenses

454

396

Short-term loans (Note 6)

1,261

967

Operating lease liability (Note 3)

113

208

Employees related liability

3,069

2,369

Total current liabilities

12,385

11,007

Total liabilities

12,385

11,007

Stockholders' Deficit:

Stock capital: (Note 4)

Common stock $0.00005 par value; 250,000,000 shares authorized and 11,034,775 shares issued and outstanding

Additional paid-in-capital

231,428

227,058

Treasury stock

(116)

Accumulated deficit

(242,925)

(236,943)

Total stockholders' deficit

(11,597)

(9,985)

Total liabilities and stockholders' deficit

788

1,022

The accompanying notes are an integral part of the consolidated financial statements.

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands

(Except share and per share amounts)

Six months ended

Three months ended

June 30,

2026

2025

2026

2025

Unaudited

Operating expenses:

Research and development, net

1,725

2,424

963

1,120

General and administrative

3,934

3,238

2,650

1,453

Operating loss

(5,659)

(5,662)

(3,613)

(2,573)

Financial income (expense), net

(323)

(284)

(242)

(330)

Gain (loss) on change in fair value of Warrants liability

179

Net loss

(5,982)

(5,767)

(3,855)

(2,903)

Basic and diluted net loss per share from continuing operations

(0.54)

(0.77)

(0.35)

(0.34)

Weighted average number of shares outstanding used in computing basic and diluted net loss per share

11,034,775

7,487,495

11,034,775

8,620,400

The accompanying notes are an integral part of the consolidated financial statements.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect," a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), the Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will", "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. BrainStorm does not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although BrainStorm believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future results, levels of activity, performance, or achievements.

BrainStorm Appoints Former FDA Associate Commissioner Peter J. Pitts as Executive Chairman

Tue, 28 Jul 2026 12:00:00 GMT

Peter J. Pitts, co-founder of the Center for Medicine in the Public Interest and former FDA Associate Commissioner, has been named Executive Chairman and Chief Strategic Regulatory and Policy Officer. In his new capacity, Mr. Pitts will assume immediate leadership over BrainStorm's daily strategic operations, corporate partnerships, investor engagements, and clinical-regulatory pathways. His primary mandate is to drive the upcoming Phase 3b trial for NurOwn® under an active FDA Special Protocol Assessment (SPA) agreement. This is the first SPA ever granted for an ALS therapeutic candidate.

Professor Jacob Frenkel, who has anchored BrainStorm's leadership since joining its advisory board in 2007 alongside the late Harvey Krueger and served as Board Chairman since 2020, will transition into the role of Senior Advisor. Professor Frenkel initiated this succession plan to transition board leadership to an active, daily executive as the company enters its late-stage clinical execution phase.

"Securing a leader of Peter's global caliber and deep FDA experience to manage our daily operations transforms our strategic position," said Chaim Lebovits, President and CEO of BrainStorm. "As we enter high-stakes corporate partnership and institutional investor discussions, having a former senior FDA official directly overseeing our regulatory and financial strategy dramatically enhances our operational capabilities."

"BrainStorm is advancing a validated, significantly de-risked clinical asset with a clear regulatory blueprint," said Peter J. Pitts, incoming Executive Chairman. "I am coming 'all in' because the science behind NurOwn is compelling and the patient need in ALS is urgent."

Chaim Lebovits, President and CEO of BrainStorm, added: "On behalf of the entire Board of Directors, I want to express our deepest gratitude to Professor Frenkel for his vision, dedication, and steadfast leadership over these many years. His guidance has been instrumental in bringing BrainStorm to this pivotal moment, and we are delighted that he will continue to support the company as Senior Advisor."

Professor Jacob Frenkel added: "Having steered BrainStorm for two decades since its early advisory days to the launch preparation of this important late-stage trial, I am pleased to pass the torch of board leadership to Mr. Pitts. His willingness to step into an active executive role provides the ideal catalyst for my transition, and I look forward to supporting Mr. Lebovits and Mr. Pitts in this next exciting chapter for the company."

About BrainStorm Cell Therapeutics Inc.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis and has received Orphan Drug designation from both the U.S. Food and Drug Administration and the European Medicines Agency. A Phase 3 trial in ALS has been completed, and a Phase 3b trial is set to launch under a Special Protocol Assessment agreement with the FDA - the first SPA ever granted for an ALS therapeutic candidate. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration, the Special Protocol Assessment, the clinical development of NurOwn® as a therapy for ALS, the future availability of NurOwn® to patients, and the future success of BrainStorm Cell Therapeutics. All statements, other than statements of historical fact, are forward-looking statements. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Readers should not place undue reliance on forward-looking statements. BrainStorm does not assume any obligation to update forward-looking statements except as required by law.

Contacts

Investors:

Michael Wood

LifeSci Advisors

+1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka

Chief Business Officer

+1 917-284-2911

uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Announces Publication Calling for Updated FDA Approaches to ALS, Rare Diseases and Regenerative Medicine

Tue, 02 Jun 2026 12:00:00 GMT

As the ALS community marks Lou Gehrig Day and reflects on the courage and resilience of those living with the disease, the publication highlights the growing need for regulatory approaches that keep pace with advances in science and the urgent realities faced by patients and families.

The article, "Restoring Regulatory Fairness and Reclaiming Biomedical Leadership: ALS, Rare Disease Regulation, and the Future of Regenerative Medicine," was published in the Journal of the Academy of Public Health and co-authored by BrainStorm Board Member Peter J. Pitts, a former FDA Associate Commissioner, and BrainStorm President and CEO Chaim Lebovits.

The authors argue that advances in biomarkers, genomics, artificial intelligence, regenerative medicine and precision therapeutics are changing what is possible in drug development, while many regulatory approaches are reliant on older models of evidence generation. Amyotrophic lateral sclerosis (ALS) is used as a case study for a broader question: whether patients with serious, fast-moving diseases can benefit from modern science if regulatory tools do not evolve alongside it.

"We're asking regulators to evaluate 21st-century science with the most up to date tools," said Mr. Pitts. "The Agency now has these tools, including Accelerated Approval, adaptive trial design, Bayesian statistics, and biomarker qualification. In this paper we discuss how those tools can be applied more consistently in ALS and regenerative medicine."

The article examines how tools such as validated biomarkers, surrogate endpoints, adaptive trial designs, Bayesian statistics and earlier sponsor-regulator alignment can help improve the development of therapies for ALS and other rare diseases. These approaches, the authors write, may be especially important in diseases where patient populations are small, symptoms vary widely, and traditional clinical endpoints can take years to measure.

"When science advances, the system has to advance with it," said Lebovits. "Our Special Protocol Assessment, the first ever granted in ALS, is a good example of what is possible when a sponsor and regulator work together in good faith."

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration, the Special Protocol Assessment, the clinical development of NurOwn® as a therapy for ALS, the future availability of NurOwn® to patients, and the future success of BrainStorm Cell Therapeutics. All statements, other than statements of historical fact, are forward-looking statements. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Readers should not place undue reliance on forward-looking statements. BrainStorm does not assume any obligation to update forward-looking statements except as required by law.

Contacts

Investors

Michael Wood

LifeSci Advisors

+1 646-597-6983

mwood@lifesciadvisors.com

Media

Uri Yablonka

Chief Business Officer

+1 917-284-2911

uri@brainstorm-cell.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Appoints Former FDA Associate Commissioner Peter J. Pitts to Board of Directors

Thu, 28 May 2026 12:00:00 GMT

Mr. Pitts is a globally recognized expert in healthcare policy, regulatory science, and U.S. Food and Drug Administration (FDA) governance. He previously served as Associate Commissioner at the FDA and as a member of the U.S. Senior Executive Service. His appointment comes as BrainStorm prepares to, upon acquisition of necessary funding, initiate its Phase 3b ENDURANCE trial evaluating NurOwn® for ALS under a recently executed FDA Special Protocol Assessment (SPA), the first SPA ever granted for an ALS therapeutic candidate.

"BrainStorm is conducting some of the most important and scientifically rigorous work in neurodegenerative medicine today," said Pitts. "The FDA's Special Protocol Assessment for this Phase 3b trial is unprecedented in ALS and sends a powerful signal that the agency recognizes both the seriousness of the disease and the strength of the trial design."

"Just as importantly, the FDA is now under new management - and we believe that creates a far greater opportunity for smart regulatory innovation, serious scientific engagement, and patient-focused flexibility than we've seen in recent years. Patients with terminal ALS do not have the luxury of bureaucratic drift or ideological grandstanding. They need urgency, rigor, and leadership."

"For too long, portions of the FDA confused caution with paralysis. With new leadership now in place, there is renewed opportunity for regulatory creativity grounded in science rather than institutional defensiveness. ALS patients cannot afford performative skepticism from regulators sitting comfortably outside the blast radius of this disease."

"I look forward to working with Chaim Lebovits, the Board, and leading ALS centers around the country to help ensure that sound science, regulatory common sense, and a relentless focus on patients bring this promising therapy across the finish line."

Chaim Lebovits, President and Chief Executive Officer of BrainStorm, added, "We are honored to welcome Peter Pitts to the BrainStorm Board at this defining moment for our Company and for the ALS community. Peter's unparalleled regulatory expertise, credibility, and commitment to patients will be invaluable as we initiate the Phase 3b ENDURANCE trial under our Special Protocol Assessment granted by the FDA."

Mr. Pitts currently serves as President and co-founder of the Center for Medicine in the Public Interest (CMPI). His commentaries on regulatory science and healthcare reform have appeared in The Wall Street Journal, The New York Times, and The Washington Post, and his peer-reviewed work has been published in leading journals including The Lancet, JAMA, and NEJM Catalyst.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection. NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS:

Contacts

CONTACTS:

Investors

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media

Uri Yablonka

Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Announces Aggregate of $400,000 in Private Placements Priced at Premium to Market

Tue, 19 May 2026 12:00:00 GMT

Transaction Highlights and Premium Pricing:

The transactions were priced at $0.95 per share, representing a 37.6% premium over the previous day's closing price of $0.69. Investors will also receive 120% warrant coverage with an exercise price of $1.45 per share and a five-year term from the date of issuance. Two of the private placements for an aggregate of $200,000 in gross proceeds closed on May 11, 2026; the final May private placement closed on May 18, 2026.

This tactical financing builds upon BrainStorm's $2.0 million capital raise in February 2026 (priced at $0.60 per share with warrants at $1.00). The Company believes the sequential increase in both the share price ($0.60 to $0.95) and the warrant strike price ($1.00 to $1.45) reflects the market's growing recognition of the company's reduced risk profile and long-term trajectory.

Management Commentary

"The investor confidence reflected in this transaction speaks directly to the strength of our scientific foundation and future potential of NurOwn®," said Chaim Lebovits, President and CEO of BrainStorm. "While the total capital required for our Phase 3b Endurance trial is substantially larger, these high-premium placements serve the tactical purpose of extending our runway and supporting our regulatory momentum without subjecting shareholders to unnecessary dilution at current market levels."

Mr. Lebovits continued: "As we look ahead to the funds needed for the Endurance trial, we are actively pursuing a range of strategic options, including non-dilutive structures. By securing this bridging capital at a premium now, we protect our capital structure and strengthen our negotiating position with potential future investors."

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection. NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Announces First Quarter 2026 Financial Results and Provides Corporate Update

Fri, 15 May 2026 12:00:00 GMT

NEW YORK, May 15, 2026 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the three months ended March 31, 2026, and provided a corporate update.

“The team at BrainStorm is focused on completing the final steps required to initiate our planned Phase 3 ENDURANCE study of NurOwn in ALS,” said Chaim Lebovits, President and CEO. “Site activation, manufacturing readiness, and regulatory engagement are all progressing, and, subject to securing the necessary financing, we are well positioned to move into the enrollment phase. ENDURANCE is designed to enroll patients with earlier-stage disease, where NurOwn's mechanism has the greatest opportunity to demonstrate benefit. ALS is a devastating illness with limited therapeutic options, and we remain committed to the community to complete NurOwn's development and make it available to those who need it."

Recent Highlights

NurOwn® (MSC-NTF) for ALS

· BrainStorm continues its preparations for the Phase 3b ENDURANCE study of NurOwn, with clinical sites on standby and manufacturing and operational activities well underway. The planned study is expected to enroll approximately 200 participants across leading ALS centers and is designed as a two-part trial: a 24-week randomized, double-blind, placebo-controlled segment (Part A) followed by a 24-week open-label extension (Part B) to further characterize long-term safety and durability of effect. The primary efficacy endpoint will measure change from baseline to Week 24 on the ALSFRS-R scale.

· ENDURANCE Part A completion expected to support new BLA submission. Successful completion of Part A of the study is anticipated to generate the clinical data required to support a new Biologics License Application (BLA) submission for NurOwn. Further trial details are posted on ClinicalTrials.gov ID NCT06973629 .

Corporate

· In February 2026, the company entered into two strategic private placement agreements, each consisting of stock and warrants, securing a total of $2 million in funding. Together, these financings are expected to reinforce a stable valuation for the company and provide the resources to support near-term operational objectives and preparatory work for the planned Phase 3b ENDURANCE trial of NurOwn.

Financial Results for the Three Months Ended March 31, 2026

· Cash, cash equivalents, and restricted cash were approximately $0.2 million as of March 31, 2026, compared to approximately $0.3 million as of December 31, 2025.

· Research and development expenditures, net, for the three months ended March 31, 2026 were approximately $0.8 million, compared to approximately $1.3 million for the three months ended March 31, 2025.

· General and administrative expenses for the three months ended March 31, 2026 were approximately $1.3 million, compared to approximately $1.8 million for the three months ended March 31, 2025.

· Net loss for the three months ended March 31, 2026 was approximately $2.1 million, as compared to a net loss of approximately $2.9 million for the three months ended March 31, 2025.

· Net loss per share for the three months ended March 31, 2026 and 2025 was $(0.19) and $(0.45), respectively.

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share and per share amounts)

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

The accompanying notes are an integral part of the consolidated financial statements.

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands

(Except share and per share amounts)

The accompanying notes are an integral part of the consolidated financial statements.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company’s proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection.

NurOwn® is BrainStorm’s lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the “Floor Effect” - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm’s growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com .

Notice Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management’s ability to successfully achieve its goals, BrainStorm’s ability to raise additional capital, BrainStorm’s ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm’s future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm’s annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm’s forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management’s beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

BrainStorm Cell Therapeutics Announces Full Year 2025 Financial Results and Provides Corporate Update

Tue, 31 Mar 2026 12:00:00 GMT

Strategic $2.0 million post year-end financing and re-rating of BCLI shares underscore market confidence

Company highlights durable long-term survival in Expanded Access Program ( EAP) cohort supporting Phase 3b patient selection and inclusion criteria

NEW YORK, March 31, 2026 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the full year ended December 31, 2025, and provided a corporate update.

“Our main priority continues to be advancing NurOwn into a Phase 3b confirmatory study, having received clearance from the FDA in 2025 for the planned study,” said Chaim Lebovits, President and CEO. “This study is designed to generate confirmatory data to support a potential BLA submission. Having completed key regulatory steps, the SPA, CMC alignment, and the May 2025 FDA clearance, we believe we have addressed some of the primary hurdles in our development program and positioned the company for success. Our network of leading clinical sites are on standby, and we remain actively engaged with regulators. Further, we believe that the $2.0 million in strategic financing secured in early 2026 has served as the catalyst for our recovery, resulting in a significant re-rating of our shares and providing the cash runway to execute on key operational activities. ALS is a devastating disease with limited treatment options, and we remain committed to the ALS community as we work to complete development of NurOwn and make it available to patients.”

Recent Highlights

NurOwn (MSC-NTF) for ALS

· Company continues to execute on operational, clinical and manufacturing activities to support the Phase 3b ENDURANCE study of NurOwn. The planned study is expected to enroll approximately 200 participants at leading ALS centers and is designed as a two-part trial consisting of a 24-week randomized, double-blind, placebo-controlled portion (Part A), followed by a 24-week open-label extension (Part B) to further assess long-term safety and durability of effect. The primary efficacy endpoint for Part A will be change from baseline to Week 24 on the ALSFRS-R. If successful, the Company believes these data could support a potential BLA submission. Further trial details are posted on ClinicalTrials.gov ID NCT06973629.

· A Citizen Petition was filed with the FDA by representatives of the ALS community. The petition requests a renewed regulatory review of the data supporting NurOwn. BrainStorm acknowledges the petition as a constructive development that underscores the continued interest in NurOwn's potential therapeutic value. The Company did not participate in the drafting or submission of this petition.

· In the Expanded Access Program (EAP), 50% of patients (5/10) remain alive according to publicly available data. Estimated mean survival has reached approximately 84 months. At the time of the Citizen Petition filing (July 2025), all five surviving patients were tracheostomy-free, as documented in the petition. All 10 EAP patients exceeded 5-year survival versus ~20% historically. Notably, these patients entered into the Phase 3 trial with higher baseline function (mean ALSFRS-R of approximately 41), reinforcing the strategic focus of the Phase 3b trial on earlier-stage populations where the treatment effect may be most detectable.

Corporate

· In February 2026, the company entered into two strategic private placement agreements, each consisting of stock and warrants, securing a total of $2 million in funding. Together, the company hopes these financings will reinforce a stable valuation for the company and provide the resources to support near-term operational objectives and preparatory work for the planned Phase 3b ENDURANCE trial of NurOwn.

Financial Results for the full year Ended December 31, 2025

· Cash, cash equivalents, and restricted cash were approximately $0.3 million as of December 31, 2025. Subsequent to year-end, the company secured an additional $2 million in funding through two private placements, as described above.

· Research and development expenditures, net, for the year ended December 31, 2025 were $4.2 million, compared to $4.7 million for the year ended December 31, 2024.

· General and administrative expenses for the twelve months ended December 31, 2025, and 2024 were approximately $5.8 million and $7.0 million, respectively.

· Net loss for the twelve months ended December 31, 2025, was approximately $10.3 million, as compared to a net loss of approximately $11.6 million for the twelve months ended December 31, 2024.

· Net loss per share for the twelve months ended December 31, 2025, and 2024 was $1.11 and $2.31, respectively.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, the Phase 3b ENDURANCE study of NurOwn and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, whether Brainstorm can successfully fund and complete the Phase 3b ENDURANCE study of NurOwn and other factors detailed in BrainStorm's annual report on Form 10-K available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors: Michael Wood Phone: +1 646-597-6983 mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer Phone: +1 917-284-2911 uri@brainstorm-cell.com

Brainstorm Cell Therapeutics Secures Second $1 Million Strategic Placement; Total $2 Million Raised In February

Thu, 26 Feb 2026 12:00:00 GMT

The financing is expected to reinforce a stable valuation for the company and provides the near-term resources required to advance its immediate regulatory and clinical objectives.

Key Terms of the Second Placement:

"We believe that securing a cumulative $2 million in a single week establishes a floor for our valuation and reflects the market's growing confidence in our trajectory," said Chaim Lebovits, President and CEO of Brainstorm. "While the stock has shown positive momentum, our strategic investors are focused on the $1.00 warrant target. This latest capital influx, combined with our disciplined management of legacy liabilities, significantly extends our operational runway and allows us to focus on the preparatory work and strategic funding requirements for our Phase 3b clinical trial."

The company intends to use the proceeds for working capital and general corporate purposes, including the support of its ongoing regulatory and clinical development initiatives.

About NurOwn® The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statement This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka,

Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

Brainstorm Cell Therapeutics Announces $1 Million Strategic Financing at Premium to Market

Fri, 20 Feb 2026 12:00:00 GMT

The financing was structured to reflect the company's current operational momentum and the underlying value of its NurOwn® platform.

Key Terms of the Financing:

The financing follows a period of intense strategic activity for BrainStorm, as the company finalizes its Phase 3b trial design under a Special Protocol Assessment (SPA) and engages in high-level discussions regarding the pending Citizens Petition for Accelerated Approval.

"Securing this financing at a premium to the current market is a powerful vote of confidence in the trajectory of Brainstorm," said Chaim Lebovits, President and CEO of Brainstorm. "Our partners have recognized the immense potential of our regulatory and clinical path to advance NurOwn as an innovative treatment for ALS. The $1.00 warrant strike price, in particular, serves as a clear indicator of where we believe this company is headed as we make final preparations for our planned Phase 3b trial and continue our high-level engagement with regulatory authorities. We remain committed to the ALS patient community, the science and our targeted goal of commercializing NurOwn."

The company filed a Form 8-K regarding this transaction with the Securities and Exchange Commission on Friday, February 13, 2026.

Proceeds from the financing will be used to support ongoing regulatory initiatives, prepayments for the upcoming Phase 3b trial of NurOwn® in ALS, and general corporate purposes.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka,

Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

Photo:https://mma.prnewswire.com/media/1166536/5459259/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces Third Quarter 2025 Financial Results and Provides Corporate Update

Fri, 14 Nov 2025 12:00:00 GMT

NEW YORK, November 14, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update.

“We are making steady progress toward stabilizing our financial situation and initiating our Phase 3b study of NurOwn, designed to generate confirmatory data to support a potential BLA submission,” said Chaim Lebovits, President and CEO. “We have been working closely with our network of clinical sites and with our selected manufacturing partners to ensure operational readiness. We also continue to engage with regulatory authorities and are pleased that the FDA has cleared the planned clinical study. We are committed to working with the ALS community and believe that, if approved, NurOwn will be a valuable therapeutic approach that would slow disease progression and improve quality of life for people afflicted with ALS.”

Recent Highlights

NurOwn (MSC-NTF) for ALS

· With U.S. FDA clearance secured, the Company is advancing key pre-initiation activities for the Phase 3b clinical trial of NurOwn ® The upcoming Phase 3b ENDURANCE study, is expected to enroll approximately 200 participants at leading ALS centers. The trial will include a 24-week, randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension (Part B) to further assess long-term safety and durability of effect. The primary efficacy measure will be change from baseline to Week 24 on the ALSFRS-R. Data from Part A is expected to support a Biologics License Application (BLA). Further trial details are posted on ClinicalTrials.gov ID NCT06973629.

· A Citizen Petition was filed with the FDA by representatives of the ALS community . The petition requests a renewed regulatory review of the data supporting NurOwn. BrainStorm acknowledges the petition as a constructive development that underscores the continued interest in NurOwn’s potential therapeutic value. The Company did not participate in the drafting or submission of this petition.

BrainStorm is planning to host a conference call and webcast for the investment community later in Q4 2025 or early Q1 2026, to provide further updates on the NurOwn Phase 3 program.

Financial Results for the Third quarter Ended September 30, 2025

· Cash, cash equivalents, and restricted cash were approximately $0.23 million as of September 30, 2025.

· Research and development expenditures, net, for the quarter ended September 30, 2025 were $0.9 million, compared to $1 million for the quarter ended September 30, 2024.

· General and administrative expenses for the quarter ended September 30, 2025 were approximately $1.1 million, compared to approximately $2.0 million for the quarter ended September 30, 2024.

· Net loss for the quarter ended September 30, 2025, was approximately $2.1 million, as compared to a net loss of approximately $2.7 million for the quarter ended September 30, 2024.

· Net loss per share for the three months ended September 30, 2025, and 2024 was $0.19 and $0.51, respectively.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors:

Michael Wood Phone: +1 646-597-6983 mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer Phone: +1 917-284-2911 uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update

Thu, 14 Aug 2025 12:00:00 GMT

Conference call and webcast scheduled for 8:30 a.m. Eastern Time Today, Thursday, August 14, 2025

NEW YORK, Aug. 14, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update.

"BrainStorm remains focused on executing our clinical development plan for NurOwn ® . We reached an important milestone in Q2 with FDA clearance to initiate our Phase 3b trial, designed to generate confirmatory data to support a potential BLA submission," said Chaim Lebovits, President and CEO. "We are also advancing key operational activities, including discussions with clinical sites as well as ongoing engagement with our selected CDMO partners to ensure readiness for clinical drug supply. We are encouraged by the ongoing interest and support from clinicians and the ALS community, and we remain confident that, if approved, NurOwn has the potential to make a meaningful difference for patients and their families."

Mr. Lebovits continued, "We support the FDA's consideration of the Citizen Petition, which may provide a fresh opportunity for an objective evaluation of the scientific evidence. We continue to stand behind the integrity and rigor of our data and will continue to engage with clinicians and the ALS community."

Recent Highlights

NurOwn (MSC-NTF) for ALS

· FDA has cleared the company to initiate the Phase 3b clinical trial of NurOwn ® The Phase 3b trial, known as ENDURANCE, is expected to enroll approximately 200 participants at leading academic medical centers and will consist of a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension in which all participants will receive NurOwn. The primary endpoint is the change from baseline to week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R). Successful completion of the double blind portion of the study (Part A) is expected to generate the clinical data needed to support a new BLA submission. Details of the trial, including a list of anticipated participating clinical sites, are available on ClinicalTrials.gov ID NCT06973629 .

· A Citizens Petition submitted to the FDA by ALS Community requesting a new review of the NurOwn data The company acknowledges that the FDA's consideration of the petition provides a new opportunity to reaffirm NurOwn's potential as a therapy for ALS. BrainStorm was not involved in drafting or submitting this petition or its contents.

· New survival data from NurOwn Expanded Access Program show that 100% of participants (10/10) in the EAP survived more than 5 years from the onset of ALS symptoms, compared to published estimates indicating that approximately 10% of individuals with ALS would survive beyond 5 years. The single death in the cohort occurred following elective euthanasia. The median survival observed in the EAP cohort was 6.8 years (range: 6 to 7 years) from symptom onset. Although the EAP cohort included participants earlier in their disease course, these results are encouraging and support further study.

· Manufacturing Partnership with Minaris BrainStorm has signed a Letter of Intent (LOI) with Minaris Advanced Therapies , a global contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, to manufacture NurOwn for the upcoming Phase 3b clinical trial.

· NurOwn® data selected as Breakthrough Science for Presentation at ISCT 2025 Meeting The new pharmacogenomic data were delivered in an oral presentation at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting in May 2025, in New Orleans. The data highlight the impact of the UNC13A genotype on clinical outcomes for ALS patients treated with NurOwn. The presentation was featured in the ISCT public announcement regarding the meeting, which indicated that the data were "carefully reviewed and selected by the ISCT 2025 Planning Faculty, to explore the latest breakthroughs in the clinical translation of Mesenchymal Stem/Stromal Cells and how they will shape the future of cell therapies."

Financial Results for the Second quarter Ended June 30, 2025

· Cash, cash equivalents, and restricted cash were approximately $1.03 million as of June 30, 2025.

· Research and development expenditures, net, for the quarter ended June 30, 2025 were $1.1 million, compared to $0.9 million for the quarter ended June 30, 2024.

· General and administrative expenses for the quarter ended June 30, 2025 were approximately $1.4 million, compared to approximately $2.1 million for the quarter ended June 30, 2024.

· Net loss for the quarter ended June 30, 2025, was approximately $2.9 million, as compared to a net loss of approximately $2.5.4 million for the quarter ended June 30, 2024.

· Net loss per share for the three months ended June 30, 2025, and 2024 was $0.34 and $0.60, respectively.

Conference Call and Webcast

Participant Numbers:

Toll Free 877-545-0320

International 973-528-0002

Participant Access Code 601260

Webcast https://shorturl.at/xrBQQ

The replay of the conference call can be accessed by dialing the numbers below and will be available until August 28.

Replay Numbers:

Toll Free 877-481-4010

International 919-882-2331

Reply Passcode 52831

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com .

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors: Michael Wood Phone: +1 646-597-6983 mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer Phone: +1 917-284-2911 uri@brainstorm-cell.com

BrainStorm to Announce Second Quarter Financial Results and Provide a Corporate Update

Fri, 08 Aug 2025 12:00:00 GMT

NEW YORK, Aug. 8, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that it will hold a conference call and webcast to update shareholders on financial results for the second quarter of 2025, at 8.30 a.m. Eastern Time on August 14, 2025.

BrainStorm's President and Chief Executive Officer, Chaim Lebovits, will provide the update. Hartoun Hartounian, PhD, Chief Operating Officer, Bob Dagher, MD, Chief Medical Officer, and Alla Patlis, Interim Chief Financial Officer, will also participate in the call. Following the prepared remarks, there will be a Q&A session with the investment community.

Participants are encouraged to submit their questions in advance of the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 10:00 a.m. Eastern Time on August 12, 2025.

The investment community may participate in the conference call by dialing the following numbers:

Investor dial in:U.S. Toll Free: 877-545-0320 International: 973-528-0002

Participant Access Code: 601260 Webcast URL: https://shorturl.at/xrBQQ

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available until August 28, 2026.

Teleconference Replay Number:

Toll Free: 877-481-4010

International: 919-882-2331

Replay Passcode: 52831

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Announces Nasdaq Delisting and Transition to OTCQB

Thu, 17 Jul 2025 12:00:00 GMT

The delisting is a result of the company's non-compliance with Nasdaq Listing Rule 5550(b)(1), pertaining to its minimum shareholder equity requirement.

BrainStorm has already secured approval for its common stock to be quoted on the OTCQB Venture Market, a U.S. trading platform operated by OTC Markets Group. The company anticipates its shares will begin trading on the OTCQB under the same symbol, BCLI, beginning at the open of trading on July 18, 2025, or as soon as possible thereafter.

Chaim Lebovits, CEO of BrainStorm Cell Therapeutics, stated, "While this delisting from Nasdaq is a challenging outcome, we want to assure our shareholders and the patient community that it does not alter our core mission or our unwavering commitment to advancing NurOwn for ALS patients. Our pre-arranged transition to OTCQB ensures continuous trading for our shares and allows us to focus entirely on NurOwn's development. We remain fully dedicated to our ongoing scientific and clinical programs, including preparations for our pivotal Phase 3b trial under the Special Protocol Assessment (SPA) agreement with the FDA."

The company confirms that the delisting does not impact its business operations, its ongoing research and development efforts, or its commitment to its shareholders. BrainStorm will continue to provide updates on its progress and financial status in compliance with applicable SEC regulations.

About NurOwn® The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

FDA Review of Citizen Petition Offers a Fresh Look at NurOwn®'s Evidence of Treatment Effectiveness

Tue, 08 Jul 2025 12:00:00 GMT

BrainStorm has consistently supported the integrity and scientific validity of its data and believes a comprehensive review of all evidence is essential, especially as the regulatory landscape for rare diseases with unmet needs continues to evolve. Although BrainStorm was not involved in drafting or submitting this petition or its contents, the company welcomes the FDA's willingness to reevaluate existing data. It endorses any process that thoroughly assesses the scientific evidence related to potential treatment options for people living with ALS.

"We respect the FDA's independent review process and welcome its consideration of this request," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We continue to stand firmly behind the scientific integrity of BrainStorm's data and remain committed to working collaboratively with the FDA and the ALS community to advance the development of safe and effective therapies."

BrainStorm is committed to continuing alignment with FDA and will proceed with its Phase 3b ENDURANCE trial of NurOwn under an FDA Special Protocol Assessment (SPA), designed to generate additional robust data and confirm the product's efficacy and safety in early stage ALS patients. In parallel, the company supports exploration of potential regulatory pathways that may allow appropriate access to NurOwn for individuals living with ALS today.

Bob Dagher, M.D., Chief Medical Officer at BrainStorm, stated, "A new review of the NurOwn data offers an important chance to ensure all available evidence is fully considered. We remain dedicated to rigorous science and to increasing access for ALS patients in need."

Mary Kay Turner, Senior Vice President, Advocacy and Public Affairs at BrainStorm, added, "The ALS community has been a powerful voice in advocating for new approaches to treatment. We stand with advocates in supporting efforts that prioritize both data-driven decision-making and urgency for patients facing this devastating disease."

ALS is a rapidly progressive neurodegenerative disease that leads to the loss of motor neurons, severely impairing voluntary muscle movement. Despite recent advances in care, effective disease-modifying treatment options remain limited.

Peer-reviewed analyses have demonstrated clinically meaningful benefits in individuals with less-advanced ALS:

BrainStorm recently announced new survival data from 10 participants who had previously completed the Phase 3 clinical trial and subsequently entered its Expanded Access Program (EAP). Notably, participants survived more than five years from ALS symptom onset – well above published estimates suggesting that only 10% of people diagnosed with ALS reach that benchmark. The median survival in the group was 6.8 years.

These results strongly suggest that the observed survival outcomes in the EAP patients are unlikely to be due to chance alone and further underscore the need for continued scientific exploration.

BrainStorm will continue to engage transparently with the FDA, clinicians, advocacy groups, and the broader ALS community, and will provide updates as appropriate.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

BrainStorm Announces New Survival Data from Expanded Access Program Cohort: Remarkably 90% of ALS Patients Survived Over 5 Years with NurOwn®

Mon, 16 Jun 2025 12:00:00 GMT

The analysis reviewed survival from the time of first symptom onset through participation in the Phase 3 trial, EAP Periods 1 and 2, followed by additional survival data collected through publicly available records.

EAP participants presented at the start of the Phase 3 trial relatively early in their disease course, with Mean ALSFRS-R at Baseline of 35.8 (Range: 32 – 40), followed by Mean ALSFRS-R at the start of the EAP of 31.4 (Range: 27 – 38; with one outlier score of 13).

Key findings include:

"These survival data provide encouraging real-world insights into the long-term experience of ALS patients treated with NurOwn under expanded access," said Chaim Lebovits, President and CEO of BrainStorm Cell Therapeutics. "We believe these findings add further evidence to support the upcoming Phase 3b clinical trial of NurOwn, to be conducted under an FDA Special Protocol Assessment (SPA). Our goal remains to generate high quality and conclusive data to demonstrate the benefit of NurOwn in people living with ALS."

Bob Dagher, MD, Chief Medical Officer of BrainStorm Cell Therapeutics, stated: "The fact that 9 out of 10 EAP participants surpassed five years of survival from first symptom - in contrast with the very modest expected survival pattern typically seen in ALS - represents a clinically meaningful observation. Furthermore, 6 out of 10 patients are still alive, even post seven years from symptom onset. These data further strengthen the scientific rationale to pursue our pivotal Phase 3b trial of NurOwn in ALS, under full alignment with the FDA guidance."

The NurOwn EAP was designed to provide compassionate access to NurOwn for eligible ALS participants who completed the Phase 3 trial. The observed durability of survival in this cohort, as reflected in the publicly sourced survival data, underscores the importance of advancing the upcoming registrational Phase 3b controlled clinical trial.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTSInvestors:Michael WoodPhone: +1 646-597-6983 mwood@lifesciadvisors.com

[1] National Institute of Neurological Disorders and Stroke (NINDS), NIH. Amyotrophic Lateral Sclerosis (ALS) Fact Sheet. https://www.ninds.nih.gov/health-information/disorders/amyotrophic-lateral-sclerosis-als

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Secures Key Manufacturing Partnership with Minaris for Upcoming NurOwn® Phase 3b ALS Clinical Trials

Tue, 27 May 2025 12:00:00 GMT

The LOI marks the beginning of a strategic collaboration between BrainStorm and Minaris to initiate the technology transfer of NurOwn® in preparation for clinical trial manufacturing at Minaris' state-of-the-art facility in Allendale, New Jersey. This partnership supports BrainStorm's readiness for its planned Phase 3b clinical trial.

"We are excited to support BrainStorm in the next phase of NurOwn development," said Eytan Abraham, Ph.D., Chief Commercial and Technology Officer at Minaris Advanced Therapies. "Our team looks forward to applying our expertise in cell therapy manufacturing to enable BrainStorm to conduct its clinical trial to the highest standards and move efficiently to commercial manufacturing."

This partnership enhances BrainStorm's U.S. based manufacturing capabilities and supports its multicenter Phase 3b clinical trial in the United States. It complements BrainStorm's recently announced collaboration with Pluri Inc. (Nasdaq: PLUR) in Israel, which will also contribute to the production of clinical trial material. Together, these strategic relationships reinforce BrainStorm's commitment to building a robust and flexible manufacturing network to advance the clinical development of NurOwn®.

Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics, commented, "This partnership reflects our ongoing commitment to the ALS community and to advancing a therapy with the potential to meaningfully impact patients' lives. NurOwn® represents a scientifically advanced and differentiated approach to treating ALS, and by joining forces with Minaris Advanced Therapies, we are ensuring that our clinical and manufacturing strategies are tightly aligned to support a successful Phase 3b trial and beyond,"

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Receives FDA Clearance to Initiate Phase 3b Trial of NurOwn® for ALS

Mon, 19 May 2025 12:00:00 GMT

The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA), confirming the study's endpoints and statistical methodology are appropriate to support a future Biologics License Application (BLA) submission. This clearance allows the company to proceed with patient enrollment.

"This FDA clearance is a defining milestone for BrainStorm and the ALS community," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We are now positioned to swiftly activate clinical sites in a phased manner, diligently preparing to enroll the first patient in the Phase 3b trial. At the same time, we are actively working to secure funding through multiple avenues, including non-dilutive grants, to ensure the timely and successful launch of this critical study."

The Phase 3b trial will enroll approximately 200 participants at leading academic medical centers and will consist of a 24-week randomized, double-blind, placebo-controlled phase followed by a 24-week open-label extension where all participants will receive NurOwn®. The primary endpoint is the change from baseline to week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R). For more details on the trial, refer to ClinicalTrials.gov ID NCT06973629.

BrainStorm management will discuss this important development on its corporate update conference call and webcast, taking place today, May 19 at 8.30am ET. To access the call, refer to the events page on the company's website here. The company will provide further ongoing updates as the trial progresses and key milestones are achieved.

About BrainStorm Cell Therapeutics Inc.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces First Quarter 2025 Financial Results and Provides Corporate Update

Thu, 15 May 2025 12:00:00 GMT

Conference call and webcast rescheduled for 8:30 a.m. Eastern Time on Monday, May 19

NEW YORK, May 15, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the first quarter ended March 31, 2025, and provided a corporate update.

“BrainStorm continues to make meaningful progress in advancing our NurOwn® development program. Our priority continues to be initiation of a Phase 3b trial, designed to confirm the product’s efficacy in early stage ALS patients and support a new BLA,” said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. “We have a clear path forward and ongoing support from the ALS community. We recently submitted an amendment to our IND, which includes updated documentation that is essential for regulatory compliance and trial integrity. We are in the process of finalization clinical trial agreements with leading academic centers and completing other necessary steps on trial execution and manufacturing. We believe that NurOwn, if approved, has the potential to become a valuable treatment option for ALS patients. Our team is fully aligned and executing with discipline to position BrainStorm for success.”

Recent Highlights

NurOwn (MSC-NTF) for ALS

· IND amendment on NurOwn submitted to FDA BrainStorm submitted an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration for NurOwn. This important milestone sets the stage for the initiation of the planned Phase 3b clinical trial, which has been designed in collaboration with the FDA under a Special Protocol Assessment (SPA). The trial will have a primary efficacy endpoint assessing changes in ALSFRS-R scores from baseline to week 24, and is designed to enroll approximately 200 ALS participants with early stage disease. Successful completion of the double blind part of the study (Part A) is expected to generate the clinical data to support a new BLA submission.

· Phase 3b trial listed on Clinicaltrials.gov. Details of the trial, known as ENDURANCE, are now available on ClinicalTrials.gov ID NCT06973629. Included is a list of 15 clinical trial sites that are expected to participate in the trial.

· NurOwn® data selected as Breakthrough Science for Presentation at ISCT 2025 Meeting The new pharmacogenomic were delivered in a oral presentation at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting, in New Orleans. The data highlight the impact of the UNC13A genotype on clinical outcomes for ALS patients treated with NurOwn. The presentation was featured in the ISCT public announcement regarding the meeting, which indicated that the data were "carefully reviewed and selected by the ISCT 2025 Planning Faculty, to explore the latest breakthroughs in the clinical translation of Mesenchymal Stem/Stromal Cells and how they will shape the future of cell therapies."

· Biomarker insights supporting NurOwn's mechanism and clinical impact presented at the 2025 ALS Drug Development Summit BrainStorm’s senior leadership team (Dr. Bob Dagher, Dr. Netta Blondheim-Shraga and May Kay Turner) participated in sessions at the summit that highlighted insights and expertise gained throughout the NurOwn® development program. These sessions included a presentation on cerebrospinal fluid (CSF) biomarker pathways associated with NurOwn treatment, including their relationship to clinical outcomes and disease heterogeneity in ALS.

Financial Results for the First Quarter Ended March 31, 2025

· Cash, cash equivalents, and restricted cash were approximately $1.8 million as of March 31, 2025.

· Research and development expenditures, net, for the quarter ended March 31, 2025 were $1.3 million, compared to $1.0 million for the quarter ended March 31, 2024.

· General and administrative expenses for the quarter ended March 31, 2025 were approximately $1.8 million, compared to approximately $1.5 million for the quarter ended March 31, 2024.

· Net loss for the quarter ended March 31, 2025, was approximately $2.9 million, as compared to a net loss of approximately $3.4 million for the quarter ended March 31, 2024.

· Net loss per share for the three months ended March 31, 2025, and 2024 was $0.45 and $0.75, respectively.

Conference Call and Webcast

Monday, May 19, 2025, at 8:30 a.m. U.S. Eastern Time

Participant Numbers: Participant Numbers:

U.S. dial in: 888-506-0062

International: 973-528-0011

Participant Access Code: 621608

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/52457

The replay of the conference call can be accessed by dialing the numbers below and will be available for 14 days.

Teleconference Replay Number: Teleconference Replay Number:

Toll Free: 877-481-4010

International: 919-882-2331

Passcode: 52457

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company’s proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors: Michael Wood Phone: +1 646-597-6983 mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer Phone: +1 917-284-2911 uri@brainstorm-cell.com

BrainStorm Reschedules First Quarter 2025 Financial Results Release to Post-Market Close Today and Sets Investor Call for Monday, May 19

Thu, 15 May 2025 12:00:00 GMT

Conference call and webcast rescheduled for 8:30 a.m. Eastern Time on Monday, May 19

Recent Highlights

NurOwn (MSC-NTF) for ALS

Financial Results for the First Quarter Ended March 31, 2025

· Cash, cash equivalents, and restricted cash were approximately $1.8 million as of March 31, 2025.

· Research and development expenditures, net, for the quarter ended March 31, 2025 were $1.3 million, compared to $1.0 million for the quarter ended March 31, 2024.

· General and administrative expenses for the quarter ended March 31, 2025 were approximately $1.8 million, compared to approximately $1.5 million for the quarter ended March 31, 2024.

· Net loss for the quarter ended March 31, 2025, was approximately $2.9 million, as compared to a net loss of approximately $3.4 million for the quarter ended March 31, 2024.

· Net loss per share for the three months ended March 31, 2025, and 2024 was $0.45 and $0.75, respectively.

Conference Call and Webcast

Monday, May 19, 2025, at 8:30 a.m. U.S. Eastern Time

Participant Numbers: Participant Numbers:

U.S. dial in: 888-506-0062

International: 973-528-0011

Participant Access Code: 621608

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/52457

The replay of the conference call can be accessed by dialing the numbers below and will be available for 14 days.

Teleconference Replay Number: Teleconference Replay Number:

Toll Free: 877-481-4010

International: 919-882-2331

Passcode: 52457

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors: Michael Wood Phone: +1 646-597-6983 mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer Phone: +1 917-284-2911 uri@brainstorm-cell.com

BrainStorm Cell Therapeutics to Announce First Quarter Results and Provide a Corporate Update on May 15, 2025

Wed, 07 May 2025 12:00:00 GMT

BrainStorm's President & Chief Executive Officer, Chaim Lebovits, will present a corporate update to be followed by Q&A. Joining Mr. Lebovits to answer investment community questions will be Bob Dagher, M.D., Chief Medical Officer, and Alla Patlis, CPA, MBA, Interim Chief Financial Officer.

Participants are encouraged to submit their questions in advance of the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. Eastern Time on Monday, May 12, 2025.

Investors may access the conference call by dialing the following numbers:

Participant Numbers:

Toll Free

888-506-0062

International

973-528-0011

Participant Access Code

621608

Webcast

https://www.webcaster4.com/Webcast/Page/2354/52457

The replay of the conference call can be accessed by dialing the numbers below and will be available for 14 days.

Replay Numbers:

Toll Free

877-481-4010

International

919-882-2331

Reply Passcode

52457

About Brainstorm Cell Therapeutics Inc.

NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a confirmatory Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine.To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

Logo: https://mma.prnewswire.com/media/1166536/3310319/BrainStorm_Logo.jpg

BrainStorm to Present Biomarker Insights Supporting NurOwn's Mechanism of Action and Clinical Impact at the 2025 ALS Drug Development Summit

Tue, 06 May 2025 12:00:00 GMT

Netta Blondheim-Shraga, PhD, Senior Vice President of Research & Development at BrainStorm, will present new insights into cerebrospinal fluid (CSF) biomarker pathways associated with Debamestrocel (NurOwn), the company's investigational cell therapy, including their relationship to clinical outcomes and disease heterogeneity in ALS.

"Biomarker data from our prior Phase 3 study suggest a potential multimodal mechanism of action and deepen our understanding of how NurOwn may influence ALS disease pathways," said Blondheim-Shraga. "These insights are helping to refine the biomarkers that will be further evaluated in the upcoming Phase 3b trial of NurOwn, under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA)."

Dr. Bob Dagher, Executive Vice President and Chief Medical Officer, will moderate a workshop session focused on adaptive and decentralized clinical trial models that have the potential to improve enrollment, increase geographic reach, and reduce burden on people living with ALS.

Dr. Dagher commented, "There is a growing imperative to modernize ALS trial design to ensure both scientific rigor and real-world feasibility. Our upcoming Phase 3b trial reflects key learnings from our previous Phase 3 study, particularly in refining patient selection criteria and optimizing trial design to better evaluate the therapeutic benefit of our cell therapy platform."

Mary Kay Turner, Senior Vice President of Global Patient Advocacy & Public Affairs, will lead a panel discussion titled "ALS Clinical Trials and Access to Investigational Therapies Through Expanded Access Programs: Perspectives from Patients, Caregivers, Advocacy, and Biopharma - And How the Path to Diagnosis Shapes These Decisions." The conversation will explore how the diagnostic journey influences trial decision-making, the need for early patient involvement in shaping protocols, and strategies to improve accessibility and trust in clinical research.

BrainStorm's participation in this year's summit marks a critical juncture for the company as it prepares to launch its Phase 3b clinical trial of NurOwn, supported by a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA), which affirms that the trial's design and statistical analysis are adequate to support a future marketing application if successful.

About Brainstorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection.NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a confirmatory Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investors:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Media:

Uri Yablonka, Chief Business Officer

Phone: +1 917-284-2911

uri@brainstorm-cell.com

BrainStorm's NurOwn® Data Selected as Breakthrough Science for Presentation at ISCT 2025 Meeting

Tue, 29 Apr 2025 12:00:00 GMT

The presentation was featured in the ISCT public announcement, which indicated that the data were "carefully reviewed and selected by the ISCT 2025 Planning Faculty, to explore the latest breakthroughs in the clinical translation of Mesenchymal Stem/Stromal Cells and how they will shape the future of cell therapies."

"We look forward to sharing the latest scientific data on NurOwn at this year's ISCT meeting. These new results are particularly meaningful as they explore a genetic factor that may help predict treatment response. The feedback received from the ALS experts on these new data continues to be encouraging as we advance in our mission to address the unmet needs of patients with this devastating disease," said Chaim Lebovits, President and CEO of BrainStorm.

Mr. Lebovits added, "Our immediate priority is to launch the Phase 3b trial of NurOwn to build on our clinical data and demonstrate its potential in early ALS. We are enjoying positive communication with the FDA, have submitted an IND amendment, and are implementing the SPA exactly as agreed with the Agency. We're fully prepared to begin the study."

Dr. Bob Dagher, Executive Vice President & Chief Medical Officer at BrainStorm, commented, "These latest results offer additional scientific insights into our completed Phase 3 NurOwn trial and increase our understanding of treatment effects in patient subpopulations. These types of analysis provide important information for the development of future ALS treatments and add to the growing body of evidence supporting NurOwn®." Dr. Dagher added, "This represents a first-of-its-kind pharmacogenomic analysis from the Phase 3 trial in ALS and is among the first ALS studies to analyze how genetic differences, specifically the UNC13A genotype, affect patient response to therapy. Understanding how genetics can influence treatment response will help move us closer to truly personalized medicine for ALS."

Presentation details:

Title: Debamestrocel Effect on Clinical and Biomarker Endpoints by UNC13A Genotype in Phase 3 ALS TrialLead Author Bob Dagher, MDOral Session: Mesenchymal Stem/Stromal Cells #1Date and time: Date & Time: Thursday, May 8, 2025 | 9:00 – 10:00 a.m. U.S. Central Time.Location: Ernest N. Morial Convention Center, 900 Convention Center Boulevard, New Orleans, Louisiana 70130

A copy of the poster will be available on the BrainStorm corporate website, at the conclusion of the ISCT meeting.

About Brainstorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection. NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a confirmatory Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" - a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine.

To learn more, visit www.brainstorm-cell.com.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

CONTACT:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Submits IND Amendment to FDA, Paving the Way for Phase 3b Trial of NurOwn® in ALS

Thu, 10 Apr 2025 12:00:00 GMT

"The submission of this IND amendment, together with the FDA's agreement on our trial design under the SPA, represents a major step toward bringing NurOwn to ALS patients," said Chaim Lebovits, CEO of BrainStorm Cell Therapeutics. "We are optimistic about a rapid review and are eager to initiate our Phase 3b study, which we are undertaking to support regulatory approval."

The Phase 3b trial is expected to enroll approximately 200 ALS participants and will be conducted in two parts. In Part A, patients will receive three doses of either NurOwn or placebo over a 24-week double-blind period. Following this, all participants - including those initially in the placebo group - will have the opportunity to transition to an open-label extension (Part B), receiving three additional doses of NurOwn over another 24 weeks. The trial's primary efficacy endpoint will assess changes in ALSFRS-R scores from baseline to week 24, comparing disease progression between the NurOwn and placebo groups. The successful completion of Part A will position BrainStorm for a BLA submission, accelerating NurOwn's path to potential approval.

ALS remains a devastating disease with limited therapeutic options, and BrainStorm is committed to working closely with regulatory agencies, clinical investigators, and the ALS community to ensure the rapid and rigorous evaluation of NurOwn. The company will provide updates as the FDA review progresses.

About NurOwn® The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About Brainstorm Cell Therapeutics Inc. Brainstorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). Brainstorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). Brainstorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

BrainStorm Cell Therapeutics Announces Full Year 2024 Financial Results and Provides Corporate Update

Mon, 31 Mar 2025 12:00:00 GMT

Conference call and webcast at 8:30 a.m. Eastern Time today

NEW YORK, March 31, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the fiscal year ended December 31, 2024, and provided a corporate update.

"2024 was a year of resilience and progress for BrainStorm as the company remained focused on its mission to develop and commercialize innovative therapies for neurodegenerative diseases. We had important accomplishments that reinforced our goal to gain regulatory approval of NurOwn in ALS and we continue to work closely with the FDA to achieve this," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We are now in advanced preparations for the Phase 3b trial of NurOwn, to be conducted in approximately 200 participants with ALS. We have secured an agreement with the FDA on a Special Protocol Assessment (SPA), thereby significantly derisking the regulatory aspects of the program. We are also aligned with the FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of the trial. We believe that if approved, NurOwn has the potential to make a meaningful difference in the lives of ALS patients, and we are fully committed to executing on our clinical and corporate goals to realize that vision."

Fourth Quarter 2024 and Recent Highlights

· December 30, 2024: Issued a letter to shareholders summarizing key corporate achievements and strategic priorities for 2025.

NurOwn (MSC-NTF) for ALS

· December 11, 2024 : Hosted a key opinion leader (KOL) webinar featuring Dr. Terry Heiman-Patterson, from the Lewis Katz School of Medicine at Temple University. Dr. Heiman-Patterson discussed the current treatment landscape and advances for patients with ALS (ALS). The replay can be accessed on the corporate website here .

· November 11, 2024 : Announced a strategic partnership with Pluri to support manufacturing for the Phase 3b NurOwn trial, enhancing operational readiness and production capabilities.

· October 30, 2024 : Regained compliance with Nasdaq's minimum bid price requirement, maintaining continued listing on the Nasdaq Capital Market.

· October 28, 2024 : Presented two scientific posters at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis (NEALS) Meeting. The first poster highlighted findings from the Expanded Access Program (EAP) for NurOwn, showing a statistically significant survival benefit for treated patients. The second poster provided an overview of the planned Phase 3b trial design.

· October 7, 2024: Participated in the 2024 Maxim Healthcare Virtual Summit to provide a corporate update on the Phase 3b NurOwn trial .

Exosome Technology

· December 3, 2024 : Received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering exosome platform technology, further strengthening BrainStorm's IP portfolio.

Corporate

· March 31, 2025: The Company is announcing today that it has entered into a warrant inducement agreement pursuant to which it is expected to raise approximately $1.64 million, to close on or about April 1, 2025.

Financial Results for the Year Ended December 31, 2024

· Cash, cash equivalents, and short-term bank deposits were approximately $0.4 million as of December 31, 2024, compared to $1.5 million as of December 31, 2023. Subsequent to year-end, on March 31, 2025, the Company entered into a warrant inducement agreement pursuant to which it is expected to raise approximately $1.64 million, to close on or about April 1, 2025, as described above.

· Research and development expenditures, net, for the year ended December 31, 2024 were $4.7 million, compared to $10.7 million for the year ended December 31, 2023.

· General and administrative expenses for the twelve months ended December 31, 2024, and 2023 were approximately $7.0 million and $10.7 million, respectively.

· Net loss for the twelve months ended December 31, 2024, was approximately $11.6 million, as compared to a net loss of approximately $17.2 million for the twelve months ended December 31, 2023.

· Net loss per share for the twelve months ended December 31, 2024, and 2023 was $2.31 and $6.00, respectively.

Conference Call and Webcast

Monday March 31, 2025, at 8:30 a.m. U.S. Eastern Time

Investor dial in : Investor dial in :

U.S. dial in: 888-506-0062

International: 973-528-0011

Participant Access Code: 508970

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/52238

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available until April 14, 2025.

Teleconference Replay Number: Teleconference Replay Number:

Toll Free: 877-481-4010

International: 919-882-2331

Passcode: 52238

About NurOwn®

About Brainstorm Cell Therapeutics Inc.

Brainstorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). Brainstorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). Brainstorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Michael Wood Phone: +1 646-597-6983 mwood@lifesciadvisors.com

BrainStorm Cell Therapeutics Granted Compliance Extension from Nasdaq

Wed, 26 Mar 2025 12:00:00 GMT

BrainStorm presented its request for continued listing on The Nasdaq Capital Market and the relevant compliance plan to the Nasdaq Hearings Panel at the panel hearing held on February 25, 2025. As a result of the hearing, the Nasdaq Hearings Panel granted BrainStorm an extension until June 30, 2025 to regain compliance with certain continued listing standards. The grant of such exception reflects BrainStorm's commitment to executing its compliance plan to meet the applicable requirements within the specified time frame.

Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics, commented: "We take our compliance plan extremely seriously, and we are fully committed to implementing the necessary measures to meet the requirements within the given time frame. This effort is fully aligned with our ongoing work plan, which includes launching the Phase 3b ALS study for NurOwn®, reducing our overall debt balance, and actively pursuing strategic partnerships to enhance our pipeline. We remain focused on strengthening our financial position and advancing our clinical programs to deliver value to both patients and shareholders."

The company is actively pursuing a range of initiatives aimed at enhancing shareholder value and improving its financial standing. BrainStorm remains dedicated to maintaining transparency throughout this process and will continue to provide updates as warranted.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative therapies for debilitating neurodegenerative diseases, leveraging both autologous and allogeneic platforms. The Company holds exclusive worldwide licensing rights for the NurOwn® technology platform, which produces autologous MSC-NTF cells. These cells have received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for amyotrophic lateral sclerosis (ALS). BrainStorm is currently planning the launch of a confirmatory Phase 3b trial in ALS with NurOwn to further evaluate its safety and efficacy. BrainStorm's exosome technology, derived from MSC-NTF cells, represents an allogeneic therapeutic platform, providing customizable, nano-carrier-based solutions for targeted delivery of bioactive molecules. These exosomes exhibit unique immunomodulatory properties and are designed to address critical pathways in neurodegenerative and respiratory diseases. The Company has completed a Phase 3 trial assessing NurOwn in ALS and advanced clinical studies of NurOwn in progressive multiple sclerosis (MS), supported by grants from the California Institute for Regenerative Medicine (CIRM) and the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the expectation of continued listing of BrainStorm's common stock on The Nasdaq Capital Market, execution of its compliance plan, launch of the Phase 3b ALS study for NurOwn®, reduction of its overall debt balance, and active pursuit of strategic partnerships to enhance its pipeline. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, the factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm to Announce Fourth Quarter and Fiscal Year 2024 Financial Results and Provide a Corporate Update

Mon, 24 Mar 2025 12:00:00 GMT

NEW YORK, March 24, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that it will hold a conference call and webcast to update shareholders on financial results for the fourth quarter and year ended December 31, 2024, at 8.30 a.m. Eastern Time on March 31, 2025.

BrainStorm's President and Chief Executive Officer, Chaim Lebovits, will provide the update. Hartoun Hartounian, PhD, Chief Operating Officer, and Bob Dagher, MD, Chief Medical Officer, and Alla Patlis, interim Chief Financial Officer, will also participate in the call. Following the prepared remarks, there will be a Q&A session with the investment community.

Participants are encouraged to submit their questions in advance of the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 10:00 a.m. Eastern Time on March 28, 2025.

The investment community may participate in the conference call by dialing the following numbers:

Investor dial in:

U.S. dial in:

888-506-0062

International:

973-528-0011

Participant Access Code:

508970

Webcast URL:

https://www.webcaster4.com/Webcast/Page/2354/52238

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available until April 14, 2025.

Teleconference Replay Number:

Toll Free:

877-481-4010

International:

919-882-2331

Replay Passcode:

52238

Notice Regarding Forward-Looking StatementsThis press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the expectation of continued listing of BrainStorm's common stock on The Nasdaq Capital Market. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, the factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

BrainStorm Issues 2024 Letter to Shareholders

Mon, 30 Dec 2024 12:00:00 GMT

Dear Valued Shareholders,

2024 has been a very productive year for BrainStorm Cell Therapeutics, defined by remarkable milestones and achievements that have brought us closer to our mission of delivering groundbreaking therapies for neurodegenerative diseases. I am proud to share this summary of our accomplishments as we close the year with optimism and look forward to the promise of 2025.

2024: A Year of Strategic Milestones

This year, we achieved one of our most significant milestones to date - securing a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA) for our Phase 3b clinical trial of NurOwn®. An SPA agreement ensures that critical elements of a clinical trial's overall design and analysis plan are adequate to support regulatory approval of a drug, significantly de-risking the regulatory aspects of our clinical development pathway. Additionally, in June, we announced that we had reached alignment with the FDA on our Chemistry, Manufacturing, and Controls (CMC) plan for our Phase 3b clinical trial , laying the groundwork for a consistent and high-quality manufacturing process essential for clinical success.

Operationally, we fortified our capabilities by entering a Memorandum of Understanding (MOU) with Pluri Inc. for the clinical manufacturing of NurOwn. Pluri's expertise in GMP-compliant manufacturing will complement our already leased facility at the Sourasky Medical Senter in Tel Aviv (Ichilov) Manufacturing Center in Israel, enabling a fast startup for the Phase 3b study. Furthermore, an additional U.S.-based manufacturing center will be onboarded to support broader production needs as we advance.

On the research front, our advancements have been equally compelling. Data from our biomarker studies continue to demonstrate the potential of NurOwn to reduce neurofilament light (NfL) levels, an important marker of neurodegeneration in ALS patients. NfL is a well-established biomarker linked to axonal damage, and elevated levels are often associated with disease progression in neurodegenerative conditions. In our studies, patients treated with NurOwn have consistently exhibited reductions in NfL compared to baseline levels, suggesting that NurOwn may mitigate the ongoing neuronal damage typically seen in ALS.

These results are particularly meaningful because they provide a quantifiable measure of NurOwn's biological impact, complementing clinical assessments of patient function and quality of life. Beyond NfL, exploratory analyses have highlighted potential correlations between NurOwn treatment and other biomarkers associated with inflammation and neuroprotection, further emphasizing the potential multifaceted benefits of our therapy. Together, these findings validate our scientific approach and reinforce our confidence in NurOwn's ability to deliver meaningful and measurable outcomes for patients battling ALS.

Despite the challenges we faced, including the setback of a disappointing FDA Advisory Committee (ADCOM) meeting in 2023, we have been able to learn from these experiences to refine our strategies and strengthen our alignment with the FDA. These efforts have ultimately positioned us for greater success moving forward. We will continue to work closely with the FDA, as well as with ALS advocacy groups and leading ALS scientists and clinicians, to ensure we remain aligned with both regulatory guidelines and experts' expectations. We wish to thank the dedicated efforts of those in the Center for Biologics Evaluation and Research (CBER), and particularly those in its Office of Therapeutic Products (OTP) for their assistance during the past year toward advancing the program.

On the corporate front, our leadership team has also been strengthened with the addition of Dr. Haro Hartounian as Chief Operating Officer. Dr. Hartounian's extensive experience in cell and gene therapy, coupled with his operational acumen, will be instrumental in navigating the complexities of manufacturing and commercialization. Similarly, Bob Dagher, M.D., has been promoted to Chief Medical Officer. With a successful track record in the development and approval of treatments for challenging neurological and rare diseases, Dr. Dagher has played a pivotal role in advancing our clinical development plans and translating pre-clinical research into clinical applications, further expanding NurOwn into new therapeutic areas.

2025 and Beyond

As we enter 2025, our focus intensifies on executing the Phase 3b trial for NurOwn, a pivotal step that underscores our commitment to the ALS community. Results from our prior Phase 3 study demonstrated that NurOwn is more likely to have a treatment effect in early-stage ALS patients and this is the group we are targeting in Phase 3b. The Phase 3b trial seeks to provide robust evidence of the treatment's efficacy, offering hope to individuals and families affected by this devastating disease.

Simultaneously, we are accelerating the development of our exosome platform, a groundbreaking approach with significant potential to address critical pathways in neurodegenerative and respiratory diseases. With its customizable, nano-carrier-based solutions, we are pursuing strategic collaborations to expand its therapeutic applications and unlock further value. Advancing the exosome platform into clinical phases will mark a major milestone, reflecting our dedication to both pipeline innovation and stakeholder value. This progress is bolstered by a recent Notice of Allowance from the U.S. Patent and Trademark Office, strengthening our intellectual property portfolio and solidifying BrainStorm's leadership in cell-based therapies.

A Resilient Business and Operational Structures

Despite the inherent challenges of the biotechnology sector, including a difficult financing environment, BrainStorm has consistently achieved remarkable outcomes with limited resources. All the accomplishments highlighted this year reflect our ability to excel despite financial constraints, thanks to the dedication and ingenuity of our world class BrainStorm team. By achieving more with less, we have maintained financial discipline and operational excellence. Strategic partnerships, such as our collaboration with Pluri, and prudent capital management have further positioned us to execute on our ambitious goals. Since the ADCOM results, we have successfully raised approximately $8 million, and we are actively pursuing additional funding sources, including non-dilutive grants and potential partnerships, to fund Phase 3b trial for NurOwn, development of our exosome platform and our operations. Our team's sacrifices, including salary reductions and extended work hours, have been critical in keeping the company moving forward. We remain committed to exploring new opportunities for funding and collaboration to ensure our innovations reach their full potential.

Reflecting on Our Mission

As we look ahead, it is important to reaffirm the values that drive us. At BrainStorm, innovation is not just a goal - it is our ethos. Our commitment to patients remains steadfast, and our focus on scientific excellence guides every decision we make. Each milestone achieved brings us closer to transforming lives, and we are honored to have your support on this journey.

Closing Thoughts

2024 has been a year of progress, perseverance, and preparation. We are entering 2025 with a renewed sense of purpose and optimism. With the Phase 3b trial on track to launch and our exosome platform advancing, we are poised to deliver on the promise of innovation, and we see multiple opportunities to create value.

Ending the year on a high note, the FDA's approval of Ryoncil, the first mesenchymal stromal cell (MSC)-based therapy, has been a pivotal moment for the regenerative medicine field. This milestone highlights the FDA's commitment to fostering innovative treatments for unmet medical needs. It has given the cell therapy community a renewed sense of optimism for the future, inspiring confidence in our own MSC-based therapeutic approach with NurOwn. Together, we are entering 2025 with momentum and hope for progress that biotech can achieve to transform patient lives.

Thank you for your trust and belief in our vision. Your support is important to our mission to redefine what is possible in the treatment of neurodegenerative diseases. As we enter the next chapter, we invite you to stay engaged with our progress through regular updates, earnings calls, and strategic announcements. Together, we will continue to make progress toward a brighter future.

With gratitude and determination,

Chaim Lebovits President and Chief Executive Officer BrainStorm Cell Therapeutics Inc.

December 30, 2024

Notice Regarding Forward-Looking Statements

This letter to shareholders contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding cooperation with Pluri for the clinical manufacturing of NurOwn, potential partnership with an additional U.S.-based manufacturing center, clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, future strategies with respect to NurOwn and our exosome platform, exploration of new opportunities for funding and collaboration, and the future success of BrainStorm Cell Therapeutics. All statements, other than statements of historical fact, contained in this letter to shareholders are forward-looking statements. Forward-looking statements contained in this letter to shareholders may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, the factors detailed in BrainStorm's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this letter to shareholders are based on the beliefs, expectations, and opinions of management as of the date of this letter to shareholders. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics to Host Investor Call and Provide a Corporate Update

Mon, 09 Dec 2024 12:00:00 GMT

NEW YORK, Dec. 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that it will hold a conference call and webcast on December 30, 2024, at 8:30 a.m. Eastern Time.

BrainStorm's President and Chief Executive Officer, Chaim Lebovits, will provide the update. Hartoun Hartounian, PhD, Chief Operating Officer and EVP, and Bob Dagher, MD, Chief Development Officer, will also participate in the call. Following the prepared remarks, there will be a Q&A session with the investment community.

Participants are encouraged to submit their questions in advance of the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 10:00 a.m. Eastern Time on December 22, 2024.

The investment community may participate in the conference call by dialing the following numbers:

Investor dial in:U.S. dial in: 888-506-0062 International: 973-528-0011

Participant Access Code: 225269 Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/51756

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available until Monday, January 13, 2025.

Teleconference Replay Number:

Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 51756

As previously announced, BrainStorm will also host a Key Opinion Leader (KOL) Webinar "Current Developments in the Treatment of Amyotrophic Lateral Sclerosis (ALS)" on Wednesday, December 11, 2024, at 10:00 AM ET. The event will feature a presentation by Dr. Terry Heiman Patterson, Director of the Center for Neurodegenerative Disorders and Professor in the Department of Neurology at the Lewis Katz School of Medicine at Temple University. For more details and to register for the event, click here.

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the expectation of continued listing of BrainStorm's common stock on The Nasdaq Capital Market. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, the factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm Cell Therapeutics. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm Cell Therapeutic's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm Cell Therapeutic's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm Cell Therapeutic's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm Cell Therapeutic's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm Cell Therapeutic's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

BrainStorm Strengthens Exosome Patent Portfolio: Receives Notice of Allowance for U.S. Patent Covering Its Platform Technology

Tue, 03 Dec 2024 12:00:00 GMT

The patent describes the composition and method of BrainStorm's unique exosomes that are isolated from the secretome of MSC-NTF (mesenchymal stem cells that secrete neurotrophic factors). MSC-NTF -derived exosomes are produced in bioreactors and contain cargo (i.e. active biological molecules) that includes at least one of the following neurotrophic factors (LIF, VEGFA, GDF-15), and may contain additional proteins or microRNA molecules. The exosomes express characteristic exosomal and MSC markers and are isolated in a unique process developed by BrainStorm and comprise a proprietary product. This patent enhances BrainStorm's exosome intellectual property portfolio, further strengthening the company's position as a leader in developing cutting-edge cellular and exosome-based therapies. It is expected to provide protection until April 10, 2039, subject to standard term adjustments.

"This patent strengthens BrainStorm's intellectual property portfolio and highlights our commitment to advancing novel technologies for respiratory and neurodegenerative diseases," said Chaim Lebovits, BrainStorm's President and Chief Executive Officer. "Our primary focus continues to be development of NurOwn for ALS as we prepare to initiate a Phase 3b registrational trial. We are seeking additional ways to unlock value from our assets and are pursuing strategic collaborations for the exosome platform."

About BrainStorm's Exosome Technology

Exosomes are nano-sized (typically 30–120 nm), cell-derived extracellular vesicles, naturally released by cells, that play a role in intercellular communication and the transport of biological materials. Exosomal cargo provides important regulatory functions for many cell processes, including immunomodulation and neuroprotection. BrainStorm's proprietary exosomes are developed from MSC-NTF cells. They can serve as nano-carriers to effectively deliver bio-active molecules to target tissues and cells in a non-invasive manner. They have significant therapeutic potential in different therapeutic areas, including respiratory and neurodegenerative diseases, based on their unique biological characteristics, customizable cargo, intrinsic immunomodulatory properties and ability to target specific CNS pathways.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative therapies for debilitating neurodegenerative diseases, leveraging both autologous and allogeneic platforms. The Company holds exclusive worldwide licensing rights for the NurOwn® technology platform, which produces autologous MSC-NTF cells. These cells have received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for amyotrophic lateral sclerosis (ALS). BrainStorm is currently planning the launch of a confirmatory Phase 3b trial in ALS with NurOwn to further evaluate its safety and efficacy. BrainStorm's exosome technology, derived from MSC-NTF cells, represents an allogeneic therapeutic platform, providing customizable, nano-carrier-based solutions for targeted delivery of bioactive molecules. These exosomes exhibit unique immunomodulatory properties and are designed to address critical pathways in neurodegenerative and respiratory diseases. The Company has completed a Phase 3 trial assessing NurOwn in ALS and advanced clinical studies of NurOwn in progressive multiple sclerosis (MS), supported by grants from the California Institute for Regenerative Medicine (CIRM) and the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the expectation of continued listing of BrainStorm's common stock on The Nasdaq Capital Market. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, the factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics to Host KOL Webinar on Current Developments in the Treatment of Amyotrophic Lateral Sclerosis (ALS) on December 11, 2024

Mon, 02 Dec 2024 12:00:00 GMT

The webinar will feature Dr. Terry Heiman-Patterson, a KOL from the Lewis Katz School of Medicine at Temple University, who will discuss the current treatment landscape and advances for patients with amyotrophic lateral sclerosis (ALS). Dr. Heiman-Patterson will be joined by BrainStorm's management team, who will share updates on the company's planned Phase 3b registrational clinical trial, NurOwn® (autologous MSC-NTF cells), and future development plans.

Successful completion of the randomized portion (Part A) of the Phase 3b trial is expected to support a Biologic License Application (BLA) for NurOwn.

A live Q&A session will follow the formal presentations.

About Terry Heiman-Patterson, MD

Dr. Terry Heiman-Patterson is a pioneering figure in ALS care and research, with a career spanning decades of groundbreaking contributions to neurology. She is the Director of the Center for Neurodegenerative Disorders and a Professor in the Department of Neurology at the Lewis Katz School of Medicine at Temple University. Previously, she held esteemed roles as Vice Chair of the Department of Neurology, Director of the Division of Neuromuscular Disease, and Professor of Neurology at Drexel University College of Medicine in Philadelphia, PA.

For over 20 years, Dr. Heiman-Patterson directed the MDA/ALS Center of Hope at Drexel, and for more than 30 years, she led the outpatient Muscular Dystrophy Clinic at Good Shepherd Rehabilitation Center in Allentown. She co-founded and serves as President of the ALS Hope Foundation and has been a driving force as Co-chair of the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) Executive Committee.

Dr. Terry Heiman-Patterson has spearheaded 24 clinical trials, establishing key standards in ALS care. She has authored more than 50 groundbreaking papers on motor neuron diseases and published hundreds of papers, abstracts, and book chapters on ALS and related disorders. Her work has earned national and international acclaim, including the prestigious Forbes Norris Award for her dedication to improving ALS patient care and advancing research

Dr. Heiman-Patterson earned her medical degree at Albany Medical College in Albany, NY. She completed her Neurology Residency at Albany Medical College and specialized in Muscular Dystrophy through fellowships at the University of Pennsylvania in Philadelphia, PA. Her profound expertise and relentless dedication to advancing ALS research and care make her a cornerstone in the field of neurology.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association and I AM ALS. BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the probability of NurOwn demonstrating a treatment effect in ALS, the patient enrollment and dosing in the Phase 3b trial for NurOwn®, and the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update

Thu, 14 Nov 2024 12:00:00 GMT

Conference call planned for later in Q4 2024 to provide updates on NurOwn® program

NEW YORK, November 14, 2024 / PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2024 and provided a corporate update.

"BrainStorm’s primary focus continues to be preparing for the upcoming Phase 3b registration trial of NurOwn in ALS,” said Chaim Lebovits, President and CEO of Brainstorm. "We have carefully refined the trial design based on the learnings from our previous study, and we believe this will increase the probability of demonstrating a treatment effect. We are partnering with Pluri Inc., an established global leader in the development and manufacturing of cell-based therapeutics, to support the clinical supply needs. We have also selected a leading Clinical Research Organization and continue to work with investigators to establish multiple trial sites. We remain committed to the ALS community as we work to advance NurOwn and deliver a therapeutic option that we believe will make a difference for patients and their families."

Third Quarter 2024 and Recent Highlights

· In November 2024, BrainStorm entered into a Memorandum of Understanding (MOU) with Pluri Inc. (Pluri) to manufacture NurOwn® for use in the planned Phase 3b ALS trial. This MOU enables Brainstorm to begin the immediate transfer of its manufacturing technology and start producing NurOwn at Pluri’s facility while the binding definitive agreement is being finalized.

· In October 2024, Brainstorm announced further details of the Phase 3b trial at the Annual Northeastern Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting .

· Up to approximately 200 participants with ALS are expected to enroll in the two-part Phase 3b trial, to receive 3 doses of either NurOwn (debamestrocel) or placebo for 24 weeks (Part-A), followed by an open label period during which all patients will receive 3 doses of NurOwn for another 24 weeks (Part B). Successful completion of Part A is expected to support a Biologic License Application (BLA).

· The primary efficacy endpoint will be a comparison of change in ALSFRS-R from baseline to week-24 (i.e. at the end of Part A) for NurOwn vs. placebo. Other outcome assessments will include CAFS (Clinical Assessment of Function & Survival), SVC, HHD (Hand-Held Dynamometry), survival, ALSAQ-40 questionnaire, the ZBI (Zarit Burden Interview), and disease biomarkers.

· The entry criteria are specifically targeting people living with ALS in the early stage of their disease. Key entry criteria will include: age 18 to 75 years old, ALS diagnosis defined by the revised El Escorial criteria as laboratory-supported probable, clinically probable, or definite, symptom onset within 24 months of screening, ≥2 points on each item of the ALSFRS-R, ALSFRS-R total score ≤45, and upright Slow Vital Capacity (SVC) ≥65% of predicted.

· Participants in both treatment arms will be able to receive standard of care while on study.

· Also at the NEALS meeting, Brainstorm presented a poster “Debamestrocel Long-Term Benefits on Survival and Neurodegeneration in ALS Expanded Access Program” featuring the results from 10 participants (6 NurOwn, 4 placebo) from the company's prior Phase 3 clinical trial (BCT-002-US) who enrolled in an open label Expanded Access Program (EAP). The EAP spanned two 28-week periods, with a break in time between the periods. Participants received a dose of NurOwn every 8 weeks, for a maximum of 6 doses over the 2 periods.

· Promising long term survival benefits were observed in NurOwn treated patients compared to matched controls in the PRO-ACT database. The survival curves revealed a statistically significant difference in favor of NurOwn (LRT, p= 0.0379) with a median survival time of 46.6 months for the treated group compared to 41.1 months for the matched control.

· Consistent reductions in neurofilament light (NfL) were observed both during the randomized Phase 3 trial and in the subsequent EAP period, indicating that patients treated with NurOwn continued to see benefits from extended treatment. NfL is an important biomarker in ALS, measuring neurodegeneration and neural cell death. These data align with the understanding of NurOwn's mechanism of action.

Investor Conference Call and Webcast

BrainStorm is planning to host a conference call and webcast for the investment community later in Q4 2024 to provide further updates on the NurOwn Phase 3 program. Details will be provided in the near future.

Financial Results for the Third Quarter Ended September 30, 2024

· Cash, cash equivalents, and restricted cash amounted to approximately $0.35 million, as of September 30, 2024.

· Research and development expenses, net, in the third quarter ended September 30, 2024 were $1 million, compared to $3.3 million for the quarter ended September 30, 2023.

· General and administrative expenses for the third quarter ended September 30, 2024 and 2023 were $2 million and $2.7 million, respectively.

· Net loss for the third quarter ended September 30, 2024 was $2.7 million as compared to a net loss of $1.2 million for the quarter ended September 30, 2023.

· Net loss per share for the third quarter ended September 30, 2024 and September 30, 2023 was $0.51 and $0.45, respectively.

About BrainStorm Cell Therapeutics Inc .

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the probability of NurOwn demonstrating a treatment effect in ALS, the patient enrollment and dosing in the Phase 3b trial for NurOwn®, and the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Media : Lisa Guiterman Phone: +1 202-330-3431 lisa.guiterman@gmail.com

IR: Michael Wood Phone: +1 646-597-6983 mwood@lifesciadvisors.com

BrainStorm Cell Therapeutics and Pluri Partner to Support NurOwn® Phase 3b Trial Manufacturing

Mon, 11 Nov 2024 12:00:00 GMT

Under the terms of the proposed agreement, Pluri will provide GMP-compliant manufacturing of NurOwn at its facilities in Israel. This collaboration aims to fulfill essential supply requirements of NurOwn® as BrainStorm advances its Phase 3b clinical trial. Additionally, the two companies are exploring options for manufacturing to support potential future commercial distribution, pending approval of NurOwn.

"Pluri has become a recognized leader in GMP-compliant clinical manufacturing of cell-based products, known for their exceptional quality standards and strict regulatory compliance," said Haro Hartounian, PhD, Chief Operating Officer at BrainStorm. "Pluri will offer manufacturing capacity to support our Phase 3b clinical trials, in addition to our existing development and clinical manufacturing activities at The Center for Advanced Cellular Therapies (I-ACT) in Israel. We believe that having Pluri's clinical manufacturing facility near BrainStorm's manufacturing and R&D teams will strengthen communication and foster a highly productive collaboration."

Chaim Lebovits, President and CEO of Brainstorm, added, "The Phase 3b clinical trial marks a critical step toward potential regulatory approval of NurOwn, "This MOU with Pluri creates a strong foundation to meet the clinical supply requirements of NurOwn®. The proposed agreement also offers the prospect of establishing an attractive supply arrangement that aligns well with our strategic priorities as we prepare for the operational and financial commitments of the Phase 3b trial."

Yaky Yanay, CEO and President of Pluri commented, "We applaud BrainStorm for their commitment to developing a novel cell therapy for ALS. We are eager to utilize our proprietary knowledge, long years of experience and manufacturing capabilities to support their mission of bringing hope to patients and families impacted by this devastating disease."

The Phase 3b trial has been designed to enroll up to approximately 200 participants with ALS. It will be conducted in two parts: In Part A, participants will receive 3 doses of NurOwn or placebo for 24 weeks. This will be followed by an open label period, during which patients from both arms will receive 3 doses NurOwn for another 24 weeks (Part B). The primary efficacy endpoint will be a comparison of change in ALSFRS-R from baseline to week-24 (i.e. at the end of Part A) for NurOwn vs. placebo. Successful completion of Part A of the double-blind Phase 3b study will position BrainStorm to submit a Biologics License Application (BLA) for regulatory approval, potentially accelerating the path to market.

BrainStorm plans to hold a conference call for investors later in Q4 2024, during which it will provide further updates on the NurOwn Phase 3 clinical program.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process, to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

The NurOwn clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted, but never before explored in depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic analysis of clinical outcome, offering great promise for the development of future treatments for ALS.

About Pluri Inc.

Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company's technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges- from medicine and climate change to food scarcity, animal cruelty and beyond. PluriCDMO™ offers CDMO services to companies from early preclinical development, through late-stage clinical trials and commercialization, with a mission to deliver high-quality, essential therapies to patients. . Pluri establishes partnerships that leverage the Company's proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement

Wed, 30 Oct 2024 12:00:00 GMT

Accordingly, the Company's common stock will continue to trade on The Nasdaq Capital Market, subject to the Company's compliance with Nasdaq's continued listing requirements.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association and I AM ALS. BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the expectation of continued listing of BrainStorm's common stock on The Nasdaq Capital Market. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, the factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS:

Contacts

CONTACTS:

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Presented Positive Survival Data from NurOwn® Expanded Access Program at 2024 Annual NEALS Meeting

Mon, 28 Oct 2024 12:00:00 GMT

Debamestrocel Long-Term Benefits on Survival and Neurodegeneration in ALS Expanded Access Program (Bob Dagher et al)

"We were pleased to provide this important update from the NurOwn EAP with the ALS community at this year's NEALS meeting," said Bob Dagher, M.D., Executive VP and Chief Medical Officer at Brainstorm. "The encouraging findings suggest that among the 10 ALS participants who received NurOwn during the EAP, there was a long-term survival benefit when compared with the matched control group. As previously reported, we also observed reductions in neurofilament light (NfL) which is an important biomarker marker in ALS, measuring neurodegeneration and neural cell death. The consistent reductions in NfL observed both during the randomized Phase 3 trial and in the subsequent EAP periods, indicate that patients treated with NurOwn continued to see benefits from the extended treatment. These data align with our understanding of NurOwn's mechanism of action."

An Overview of The Phase 3b Clinical Trial of Debamestrocel in ALS (Bob Dagher et al)

Dr. Dagher added, "A key priority for BrainStorm is to confirm NurOwn's efficacy in the upcoming Phase 3b trial. Our goal is to conclusively demonstrate the treatment's benefits in early-stage ALS patients, hence, we have set the entry criteria to specifically target people living with ALS in the early stage of their disease. We have secured an agreement with the US FDA on a Special Protocol Assessment (SPA), thereby significantly derisking the regulatory aspects of this program. We have also aligned with the FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of the trial. We look forward to providing further updates as we advance our trial preparations."

Copies of the posters can be viewed online by registered attendees of the NEALS Meeting and will be available on the BrainStorm corporate website.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process, to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

Notice Regarding Forward-Looking StatementsThis press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics to Provide Corporate Update on Phase 3b NurOwn® Trial at the 2024 Maxim Healthcare Virtual Summit

Mon, 07 Oct 2024 12:00:00 GMT

The Maxim Healthcare Summit will take place from October 15 to 17 and will bring together biotechnology, diagnostic, medical device, and healthcare information technology companies. Senior analysts will lead presentations and discussions, while engaging industry panels will focus on critical healthcare trends shaping the future of the industry.

This conference will be live on M-Vest. To access, sign up to become an M-Vest member.

Click here to reserve your seat

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces Presentations on NurOwn® at 2024 Annual NEALS Meeting

Tue, 24 Sep 2024 12:00:00 GMT

"We look forward to sharing the latest update on NurOwn at this year's NEALS meeting. The insights and feedback that we gather from the ALS community are invaluable in advancing our mission to address the unmet needs of patients with this devastating disease," said Chaim Lebovits, President and CEO of BrainStorm. "Our top priority continues to be the initiation of a Phase 3b clinical trial, in order to confirm NurOwn's efficacy and conclusively demonstrate its efficacy in early stage ALS patients. Our team is energized by the progress to date and is working diligently to ensure the execution and success of this important study. As we make preparations, we anticipate multiple key milestones in the coming months that we believe will have potential to drive value. We remain committed to advancing our novel treatment option for ALS patients and achieving regulatory approval as quickly as possible."

Presentation details

Title: Debamestrocel Long-Term Benefits on Survival and Neurodegeneration in ALS Expanded Access Program Lead Author: Bob Dagher, MDSession: Poster Session 1Date and time: 4.30 – 6.30pm ET, Tuesday, Oct 22Location: Sea Salon & Sand Salon, Opal Sands Resort, FL

Title: An Overview of The Phase 3b Clinical Trial of Debamestrocel in ALSLead author: Bob Dagher MDSession: Poster Session 2Date and time: 4.00 – 6.00pm ET, Wednesday, Oct 23Location: Sea Salon & Sand Salon, Opal Sands Resort, FL

Copies of the posters will be available on the BrainStorm corporate website, at the conclusion of the NEALS meeting.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process, to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

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BrainStorm Cell Therapeutics Announces Second Quarter 2024 Financial Results and Provides Corporate Update

Wed, 14 Aug 2024 12:00:00 GMT

Company reached alignment with the U.S. FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of its planned Phase 3b clinical trial for NurOwn® in ALS

SPA in place for Phase 3b NurOwn® trial in ALS

Enhanced leadership team with appointment of Hartoun Hartounian Ph.D. as EVP and Chief Operating Officer, and promotion of Dr. Bob Dagher to EVP and Chief Medical Officer

Conference call and webcast at 8.30am ET today

NEW YORK, Aug 14, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the Second Quarter ended June 30, 2023 and provided a corporate update.

“We continue to make excellent progress in our preparations for the planned Phase 3b trial of NurOwn in ALS, with important recent developments on regulatory and operational fronts,” said Chaim Lebovits, President and CEO of BrainStorm. “We believe that the regulatory aspects of the program have been substantially derisked, having secured agreement with the FDA on a Special Protocol Assessment and also reached alignment on the CMC aspects. We have selected a leading Clinical Research Organization and are actively working to establish multiple trial sites. If successful, this trial has the potential to significantly improve the lives of ALS patients by providing a much-needed therapeutic option."

Second Quarter 2024 and Recent Highlights

Clinical and regulatory

· In June 2024, BrainStorm reached alignment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of its planned Phase 3b clinical trial for NurOwn®, its investigational therapy for amyotrophic lateral sclerosis (ALS). This followed the announcement, in April 2024, that the FDA had granted BrainStorm a Special Protocol Assessment (SPA) agreement for the Phase 3b trial. The SPA agreement validates the clinical trial protocol and statistical analysis of the trial, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS.

· The Company has selected a leading Clinical Research Organization (CRO) to support the initiation and execution of the Phase 3b trial. We are actively engaging with over 12 leading ALS centers of excellence to establish trial sites. Manufacturing processes are well-advanced and on track to meet production timelines.

· In May 2024, new biomarker data on NurOwn from the prior Phase 3 study and Expanded Access Program (EAP) were featured in a presentation at the 3rd Annual ALS Drug Development Summit, which took place in Boston MA. The data suggested that patients who received extended treatment with NurOwn continued to see benefits. The summit was attended by advocacy groups, physicians, research organizations, industry representatives, key thought leaders and decision makers dedicated to ALS research.

· In April 2024, Phase 3 biomarker data on NurOwn in ALS were published in Muscle and Nerve in a paper entitled "Debamestrocel multimodal effects on biomarker pathways in amyotrophic lateral sclerosis are linked to clinical outcomes".

Corporate

· In June 2024, BrainStorm completed a successful registered direct offering, with a single institutional investor, raising gross proceeds of $4.0 million.

· In June 2024, appointed Hartoun Hartounian Ph.D. as EVP and Chief Operating Officer. Dr. Hartounian brings a distinguished track record with over 32 years of experience in the biopharmaceutical industry, with a focus on cell and gene therapy.

· In April 2024, promoted Dr. Bob Dagher to Executive Vice President and Chief Medical Officer. Dr. Dagher has over 20 years' of experience in clinical research and development, with a proven track record of leading successful clinical trials and fostering innovation in drug development.

Financial Results for the Second Quarter Ended June 30, 2024

· Cash, cash equivalents, and restricted cash amounted to approximately $3.65 million, as of June 30, 2024.

· Research and development expenses, net, in the second quarter ended June 30, 2024 were $0.9 million, compared to $2.8 million for the quarter ended June 30, 2023.

· General and administrative expenses for the second quarter ended June 30, 2024 and 2023 were $2.0 million and $2.7 million, respectively.

· Net loss for the second quarter ended June 30, 2024 was $2.5 million as compared to a net loss of $5.3 million for the quarter ended June 30, 2023.

· Net loss per share for the second quarter ended June 30, 2024 and June 30, 2023 was $0.04 and $0.13, respectively.

Conference Call and Webcast

BrainStorm management will discuss the second quarter results and recent progress in a conference call and webcast for the investment community at 830am ET today. Investors may participate by dialing the following numbers:

Toll Free: 877-545-0523

International: 973-528-0016

Participant Access Code: 308245

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/51009

The replay of the conference call can be accessed by dialing the numbers below and will be available for 14 days.

Replay Numbers

Toll Free: 877-481-4010

International: 919-882-2331

Replay Passcode: 51009

About BrainStorm Cell Therapeutics Inc .

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Media : Lisa Guiterman Phone: +1 202-330-3431 lisa.guiterman@gmail.com

IR: Michael Wood Phone: +1 646-597-6983 mwood@lifesciadvisors.com

BrainStorm Cell Therapeutics to Announce Second Quarter Results and Provide a Corporate Update

Wed, 07 Aug 2024 12:00:00 GMT

BrainStorm's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Haro Hartounian, Ph.D., Chief Operating Officer, Bob Dagher, M.D., Chief Medical Officer, and Alla Patlis, CPA, MBA, Interim Chief Financial Officer.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:Toll Free: 877-545-0523International: 973-528-0016Participant Access Code: 308245

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/51009

The replay of the conference call can be accessed by dialing the numbers below and will be available for 14 days.

Replay Numbers:Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 51009

About BrainStorm Cell Therapeutics Inc.

Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm Cell Therapeutics has completed a Phase 3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association and I AM ALS. BrainStorm Cell Therapeutics completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements

Contacts

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

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BrainStorm Cell Therapeutics to Provide Corporate Mid-Year Update on NurOwn Program

Mon, 01 Jul 2024 12:00:00 GMT

BrainStorm's President and Chief Executive Officer, Chaim Lebovits, will present the update, together with recently appointed Chief Operating Officer and EVP, Hartoun Hartounian, PhD. Bob Dagher, MD, Chief Development Officer, will also be on the call for Q&A. The Q&A session with the investment community will follow the prepared remarks.

Participants are encouraged to submit their questions in advance of the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 10:00 a.m. Eastern Time on Friday, July 5, 2024.

The investment community may participate in the conference call by dialing the following numbers:

Investor dial in:Toll Free: 888-506-0062International: 973-528-0011Participant Access Code: 358402 Webcast: https://www.webcaster4.com/Webcast/Page/2354/50824

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available until Monday, July 22, 2024.

Teleconference Replay Number: Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 50824

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm Cell Therapeutics holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm Cell Therapeutics has completed a Phase 3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association and I AM ALS. BrainStorm Cell Therapeutics completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm Cell Therapeutics. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm Cell Therapeutic's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm Cell Therapeutic's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm Cell Therapeutic's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm Cell Therapeutic's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm Cell Therapeutic's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTSMedia: Lisa GuitermanPhone: +1 202-330-3431lisa.guiterman@gmail.com IR:Michael WoodPhone: +1 646-597-6983mwood@lifesciadvisors.com

Contacts

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

BrainStorm Cell Therapeutics Announces Pricing of $4.0 Million Registered Direct Offering

Thu, 27 Jun 2024 12:00:00 GMT

In a concurrent private placement, the Company has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 16,666,667 shares of its common stock. The warrants have an exercise price of $0.3912 per share, will be exercisable six months from the date of issuance and will expire five years from the date of issuance. The private placement will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder.

In connection with the offering, the Company will also reduce the exercise price of 4,054,055 common stock warrants previously issued on July 19, 2023 to and currently held by the Holder to $0.3912 per warrant share and will extend those warrant expiration dates into 2029.

The offering is expected to close on or about June 28, 2024, subject to satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent for the offering.

The securities in the registered direct offering are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-258640) filed with the U.S. Securities and Exchange Commission (the "SEC") on August 9, 2021 and declared effective by the SEC on August 19, 2021. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at syndicate@maximgrp.com or telephone at (212) 895-3745.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association and I AM ALS. BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements related to the completion of the offering. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including the satisfaction of customary closing conditions related to the offering, completion of the offering and various other factors. These and other risks and uncertainties are described more fully in the sections titled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the final prospectus related to the offering described herein, and the Company's Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn® Clinical Trial

Wed, 26 Jun 2024 12:00:00 GMT

This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a Special Protocol Assessment (SPA) agreement for its NurOwn Phase 3b trial. The SPA agreement provided clarity on the design and endpoints of the trial, significantly de-risking the regulatory aspects of the program.

"This in-person Type C meeting with the FDA was an important step as we finalize preparations for our pivotal Phase 3b trial of NurOwn. We are very pleased with the outcome and are now aligned with the FDA on resolving all previously outstanding CMC questions," said Chaim Lebovits, President & Chief Executive Officer of BrainStorm. "As with any cell therapy products, there are additional complexities in the manufacturing process, and it is important that we have alignment in advance with all the relevant groups within the FDA. We are committed to working closely with the FDA and to helping the ALS community, and are excited to move forward with the Phase 3b trial. Our ultimate goal is to achieve approval for NurOwn in order to address the unmet needs of patients."

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS:

Contacts

CONTACTS:

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

BrainStorm Cell Therapeutics Announces Appointment of Haro Hartounian Ph.D. as Chief Operating Officer

Thu, 20 Jun 2024 12:00:00 GMT

Dr. Hartounian brings a distinguished track record with over 32 years of experience in the biopharmaceutical industry, with a focus on cell and gene therapy. His career highlights include founding and leading BioCentriq, a state-of-the-art cell and gene therapy CDMO facility, which was successfully acquired for $73 million in 2022. Dr. Hartounian founded and managed the growth of four biotechnology companies. He has a track record of achieving aggressive goals at large pharmaceutical, contract development and manufacturing organizations, as well as at start-up biotechnology companies.

In his new role, Dr. Hartounian will oversee all operational aspects of BrainStorm Cell Therapeutics, including CMC and commercialization. He has the right skillset to enhance the company's operational efficiency and the strategic vision to support the commercial readiness of its therapeutic platforms including NurOwn® for amyotrophic lateral sclerosis (ALS).

Chaim Lebovits, President and CEO of Brainstorm Cell Therapeutics, commented, "We are pleased to welcome Dr. Hartounian to our team. His broad experience and proven track record will be invaluable as we continue to advance NurOwn, our investigational treatment for ALS. Dr. Hartounian brings the relevant expertise at this important time for the company to help us smoothly navigate CMC and commercialization complexities and to streamline logistics."

Dr. Hartounian stated, "I am eager to join BrainStorm Cell Therapeutics at this exciting juncture and envision a tremendous opportunity to leverage my expertise in advancing the company's innovative therapies. I am profoundly inspired by the groundbreaking work BrainStorm Cell Therapeutics has accomplished with NurOwn®, and I am impressed by the path forward set for the upcoming registrational Phase 3b study. The potential to transform the treatment landscape for neurodegenerative diseases is immense. I am pleased to join the talented team and to work with a robust technology platform. Together, I am confident in our ability to achieve our strategic objectives and deliver significant value to our patients and stakeholders."

Dr. Hartounian founded BioCentriq, a full-service, collaborative, revenue generating CDMO company for cell and gene therapy, focusing on all stages of process development and clinical manufacturing. He served initially as the company's General Manager (2015 to 2022) and then as its President, CEO and a member of the Board of Directors (2022 to 2023). He led BioCentriq from inception to its $73 million acquisition by GC Holdings (Korea). From 2013 to 2015, Dr. Hartounian was CEO, Co-Founder and a member of the Board of Directors at DiaVacs, a company specializing in cell therapy for type 1 diabetes. Prior to that, from 2011 to 2013 he was CEO and Co-Founder of Allied BioVentures. From 2008 to 2011, he was also President, CEO and a member of the Board of Directors of Vyteris Inc., where he led the company through a successful turnaround, reorganization, merger, and business transformation, positioning it for growth and success in the CRO industry. Dr. Hartounian has also been an affiliated faculty member at the New Jersey Institute of Technology in the Department of Chemistry and Environmental Sciences since 2020, as well as an adjunct faculty member in the Department of Chemical Engineering at Columbia University from 2015 to 2022.

Additionally, Dr. Hartounian holds a Ph.D. in chemical engineering with a minor in biochemistry from the University of Delaware, an M.S. in chemical engineering from the University of California and a B.S. in Chemical Engineering from Arya-Mehr University

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm Cell Therapeutics holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm Cell Therapeutics has completed a Phase 3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association and I AM ALS. BrainStorm Cell Therapeutics completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements

Contacts

Media:

Lisa Guiterman

+1 202-330-3431

lisa.guiterman@gmail.com

IR:

Michael Wood

+1 646-597-6983

mwood@lifesciadvisors.com

BrainStorm Cell Therapeutics to Present New Biomarker Data Suggesting ALS Patients May Benefit From Longer-Term Treatment with NurOwn

Mon, 20 May 2024 12:00:00 GMT

"We are very pleased to share these important outcome data from the NurOwn EAP with the ALS community," said Dr. Stacy Lindborg, Member of BrainStorm's Board of Directors. "The data demonstrate a consistent reduction of neurofilament light (NfL) from baseline among participants who were randomized to receive NurOwn in the Phase 3 study. This reduction in NfL observed during the randomized Phase 3 trial, as well as in the subsequent EAP periods, indicate that patients treated with NurOwn during the Phase 3 study see benefits from the extended treatment. Furthermore, participants initially randomized to placebo in Phase 3 and were later treated with NurOwn during the EAP showed stabilization in Period 1 of the EAP, followed by reductions in NfL in Period 2 over their Phase 3 baseline levels. We looked forward to confirming this finding in the planned Phase 3b study."

Presentation Title: Promising Longer-Term Biomarker Data from NurOwn Program in ALS: Spotlight on NfL in EAP Extension CohortSpeaker: Stacy Lindborg, PhDDate/ time: May 22, 9am ETLocation: Hyatt Regency, Boston MA

Highlights

Workshop and Panel

Antonio Trejo, VP of Regulatory Affairs at BrainStorm, will participate in a workshop Reinventing the Surrogate Landscape: Innovating Regulatory Acceptable Endpoints Most Meaningful to People Living with ALS at 2pm on May 21. The co-presenters in the workshop will be Christopher Ocampo, Senior Medical Director, AbbVie; Angela Genge, Director, ALS Centre of Excellence, McGill University; and Marjan Sepassi, Vice President, Medical Affairs, Clene Nanomedicine.

Mary Kay Turner, Senior Vice President, Global Patient Advocacy & Public Affairs and Kylan Morris Senior Manager, Patient Advocacy at Brainstorm, will participate in a panel discussion Leveraging Insight from Real-Life Experiences: How Do People Living with ALS Evaluate Which Trial They Want to be Enrolled in? at 4pm on May 22.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process, to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTSMedia: Lisa GuitermanPhone: +1 202-330-3431lisa.guiterman@gmail.com IR:Michael WoodPhone: +1 646-597-6983mwood@lifesciadvisors.com

Contacts

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update

Tue, 14 May 2024 12:00:00 GMT

"We recently achieved an important milestone on our Debamestrocel (NurOwn®) development program, reaching agreement with the US FDA on a Special Protocol Assessment for our planned Phase 3b trial of NurOwn. The SPA covers the design and planned analysis of the trial in order to adequately address the objectives necessary to support a regulatory submission," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We believe that the SPA will substantially derisk the regulatory aspects of our program. This moves us closer to initiating the trial and ensures our approach aligns with the FDA's current views, standards, and guidelines. We are committed to collaborating closely with the ALS community and are grateful for the continued support and collaboration of patients, caregivers, and advocacy groups as we work to bring this potentially valuable new treatment to those affected by this devastating disease."

First Quarter 2024 and Recent Highlights

Clinical and regulatory

Corporate

Upcoming Event – ALS Drug Development Summit

Financial Results for the First Quarter Ended March 31, 2024

Conference Call and Webcast

BrainStorm management will host a conference call for the investment community later in the second quarter to provide update on the NurOwn program. Details on the conference call will be provided when available.

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS

Michael Wood Phone: +1 646-597-6983 mwood@lifesciadvisors.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

March 31,

December 31,

Unaudited

Audited

U.S. $ in thousands

ASSETS

Current Assets:

Cash and cash equivalents

779

1,300

Other accounts receivable

Prepaid expenses and other current assets (Note 4)

454

548

Total current assets

1,259

1,899

Long-Term Assets:

Prepaid expenses and other long-term assets

Restricted Cash

182

185

Operating lease right of use asset (Note 5)

1,265

1,416

Property and Equipment, Net

622

686

Total Long-Term Assets

2,089

2,309

Total assets

3,348

4,208

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

Current Liabilities:

Accounts payables

4,690

4,954

Accrued expenses

636

1,240

Operating lease liability (Note 5)

588

603

Employees related liability

917

1,003

Total current liabilities

6,831

7,800

Long-Term Liabilities:

Operating lease liability (Note 5)

533

672

Warrants liability (Note 6)

1,534

594

Total long-term liabilities

2,067

1,266

Total liabilities

8,898

9,066

Stockholders' Deficit:

Stock capital: (Note 7)

Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at March 31, 2024 and December 31, 2023 respectively; Issued and outstanding: 68,447,193 and 60,489,208 shares at March 31, 2024 and December 31, 2023 respectively.

Additional paid-in-capital

212,967

210,258

Treasury stocks

(116)

Accumulated deficit

(218,414)

(215,013)

Total stockholders' deficit

(5,550)

(4,858)

Total liabilities and stockholders' deficit

3,348

4,208

The accompanying notes are an integral part of the consolidated financial statements.

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands

(Except share data)

Three months ended

March 31,

Unaudited

Operating expenses:

Research and development, net

961

2,924

General and administrative

1,513

2,227

Operating loss

(2,474)

(5,151)

Financial income, net

Loss on change in fair value of Warrants liability (Note 6)

(940)

Net loss

(3,401)

(5,059)

Basic and diluted net loss per share from continuing operations

(0.05)

(0.14)

Weighted average number of shares outstanding used in computing basic and diluted net loss per share

64,738,544

36,735,435

The accompanying notes are an integral part of the consolidated financial statements.

Contacts

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

March 31,

December 31,

2024

2023

Unaudited

Audited

U.S. $ in thousands

ASSETS

Current Assets:

Cash and cash equivalents

779

1,300

Other accounts receivable

Prepaid expenses and other current assets (Note 4)

BrainStorm Cell Therapeutics Announces Management Changes as Company Plans Registrational Phase 3b Trial of NurOwn

Tue, 16 Apr 2024 12:00:00 GMT

Dr. Dagher has served as our Chief Development Officer since July 2023. In his new role as Executive Vice President and Chief Medical Officer, Dr. Dagher's responsibilities will include overseeing the planned Phase 3b registration trial of NurOwn. The Company recently announced that it has reached agreement with the U.S. Food & Drug Administration (FDA) for a Special Protocol Assessment (SPA) for this trial.

"With Bob's promotion as CMO and Stacy's addition to our Board, BrainStorm is well positioned for a smooth transition into a pivotal phase for the company and continued commitment to ALS," said Chaim Lebovits, President and CEO of Brainstorm. "Bob's capabilities, which include expertise in neurology, psychiatry, and rare diseases, make him exceptionally qualified as we launch the Phase 3b trial of NurOwn and prepare for success. We are fortunate to have someone of his caliber at the helm of our clinical efforts."

Dr. Dagher commented, "I am honored to step into the role of Chief Medical Officer at such an important moment for BrainStorm. The opportunity to lead our talented clinical team through the upcoming Phase 3b trial is incredibly exciting. I am deeply committed to our mission and look forward to contributing to our success in bringing new treatments to patients and families affected by ALS."

Dr. Dagher has over 20 years' of experience in clinical research and development, with a proven track record of leading successful clinical trials and fostering innovation in drug development. Prior to joining Brainstorm he was Chief Medical Officer at Enveric Biosciences where he was responsible for defining the portfolio strategy and advancement of development plans toward regulatory approvals. He began his career in biopharmaceuticals as a medical scientist at GSK, and has served in leadership positions of science and medicine at companies such as Sanofi/Genzyme, and LabCorp/Covance. Dr. Dagher earned his medical degree at Bordeaux University and St. Joseph University School of Medicine, serving residencies in psychiatry and internal medicine at Boston University Medical Center. A past Diplomat of the American Board of Neurology and Psychiatry, he is licensed to practice medicine in Massachusetts.

"I strongly believe in the company's mission and commitment to ALS and I have great faith in the potential of debamestrocel to make life better for those living with ALS and their families," said Stacy Lindborg, co-Chief Executive Officer. "I have great confidence in Bob as the leader of the Phase 3b program, and in the entire leadership teams' dedication to move this product forward. I'm pleased to continue working with all my Brainstorm colleagues in my new capacity on Brainstorm's Board of Directors."

Mr. Lebovits concluded, "I would like to thank Stacy for her outstanding commitment and achievements at BrainStorm She excelled as a leader and talented scientist dedicated to patients. We are very pleased that she will continue to be involved in Brainstorm as a member of our Board of Directors and look forward to her contributions and strategic insights in this new role."

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

BrainStorm Cell Therapeutics Regains Compliance with NASDAQ Minimum Market Value Rule

Thu, 11 Apr 2024 12:00:00 GMT

According to the Notification Letter on Compliance, Nasdaq's staff has determined that for the 11 consecutive business days, from March 22, 2024 through April 9, 2024, the Company's market value of listed securities has been $35,000,000 or greater, and the Company has regained compliance with the Rule.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association and I AM ALS. BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Contacts

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces Peer-reviewed Publication of Biomarker Data from NurOwn's® Phase 3 Clinical Trial in ALS

Wed, 10 Apr 2024 12:00:00 GMT

The study analyzed forty-five biomarkers and identified three that are predictive of clinical outcomes in debamestrocel-treated participants, including neurofilaments light (NfL), LAP/TGFb1 and Galcetin-1. Treatment with debamestrocel led to significant changes in 64% of the forty-five analyzed biomarkers, spanning various pathways involved in ALS pathology. These changes included increases in anti-inflammatory and neuroprotective markers suggesting a potential ability to reduce inflammation and protect neurons, and decreases in inflammatory and neurodegenerative markers indicating a possible reduction in disease activity and nerve cell damage.

"The publication of these findings is important, because it demonstrates a potential biologic mechanism by which modified mesenchymal stem cells (debamestrocel) may benefit patients with ALS," said Dr. Anthony J. Windebank, MD, Professor of Neurology and Judith and Jean Pape Adams Professor of Neuroscience, Mayo Clinic College of Medicine and Science. "There was a strong signal in the phase III trial suggesting a benefit of these cells in a sub-group of patients with less advanced disease. The fact that BrainStorm has reached agreement with FDA through a special protocol assessment (SPA) is also very encouraging that the agency is firmly committed to working with the company to rigorously evaluate the clinical benefit of debamestrocel."

Stacy Lindborg, PhD, Co-Chief Executive Officer of BrainStorm Cell Therapeutics, added: "Biomarkers are becoming an increasingly important part of drug development in ALS. Having these data peer reviewed and published in a prestigious journal is an important milestone in the NurOwn® development program. We look forward to confirming these findings in our upcoming Phase 3b trial, which is in planning for the most expeditious path forward to bring NurOwn to people living with ALS."

About the Biomarker Study

The study was conducted by researchers at Massachusetts General Hospital, University of Massachusetts, Mayo Clinic, University of California Irvine, California Pacific Medical Center, and Cedars-Sinai Medical Center, evaluating the effect of NurOwn on cerebrospinal fluid (CSF) biomarkers, offering valuable insights into the potential mechanisms of action and suggests a possible, related clinical impact. Merit Cudkowicz, MD, Chair of Neurology Massachusetts General Hospital, Julieanne Doran, Professor of Neurology Harvard Medical School and Robert Brown, MD, Donna and Robert J. Manning Chair in Neuroscience Director, Program in Neurotherapeutics UMass Chan Medical School, share the senior author position on the paper.

Data from the paper are from a randomized, double-blind, placebo-controlled Phase 3 trial, evaluating the safety and efficacy of repeat intrathecal doses of NurOwn® in study participants.

"These findings are encouraging and provide preliminary evidence that debamestrocel may be effective in treating ALS. The impact on biomarkers suggests debamestrocel targets inflammation and neurodegeneration," said Chaim Lebovits, President and CEO of BrainStorm Cell Therapeutics. "We are grateful to the trial participants, lead authors Dr. Merit Cudkowicz and Dr. Robert Brown, in addition to all of the Phase 3 Principal Investigators. This manuscript, nor the insights into known and emerging ALS biomarkers wouldn't exist without them."

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process, to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association and I AM ALS. BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS

IR:Michael WoodPhone: +1 646-597-6983mwood@lifesciadvisors.com

Manuscript Summary

Treatment with debamestrocel led to significant changes in 64% of the forty-five analyzed biomarkers, spanning various pathways involved in ALS pathology. These changes included increases in anti-inflammatory and neuroprotective markers suggesting a potential ability to reduce inflammation and protect neurons, and decreases in inflammatory and neurodegenerative markers indicating a possible reduction in disease activity and nerve cell damage. For example, a significant reduction from baseline of 11% in neurofilaments light (NfL), a marker of nerve cell damage, was observed with NurOwn compared to placebo (p<0.05).

Predictive Biomarkers: Certain biomarkers, such as baseline NfL, LAP/TGFb1 and Galectin- 1, were found to be predictive of clinical outcomes in debamestrocel-treated participants.

Contacts

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Manuscript Summary

Treatment with debamestrocel led to significant changes in 64% of the forty-five analyzed biomarkers, spanning various pathways involved in ALS pathology.

These changes included increases in anti-inflammatory and neuroprotective markers suggesting a potential ability to reduce inflammation and protect neurons, and decreases in inflammatory and neurodegenerative markers indicating a possible reduction in disease activity and nerve cell damage. For example, a significant reduction from baseline of 11% in neurofilaments light (NfL), a marker of nerve cell damage, was observed with NurOwn compared to placebo (p<0.05).

Predictive Biomarkers: Certain biomarkers, such as baseline NfL, LAP/TGFb1 and Galectin- 1, were found to be predictive of clinical outcomes in debamestrocel-treated participants.

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

Tue, 09 Apr 2024 12:00:00 GMT

The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS.

"We are pleased to have reached an agreement with the FDA on key elements of the Phase 3b trial design that provides a potential path forward towards obtaining regulatory approval," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We believe that having this SPA in place will help de-risk certain regulatory aspects of the NurOwn clinical program. BrainStorm's ultimate goal is to provide a new treatment option that can help patients afflicted with ALS, and we believe that the SPA potentially brings us one step closer to this goal. We appreciate the Agency's engagement and guidance during the SPA process and look forward to moving forward with the study."

BrainStorm anticipates commencement of the Phase 3b study in 2024, after reviewing the protocol with investigators, securing study site Institutional Review Board approvals, and engaging with appropriate members of the ALS community.

Stacy Lindborg, Co-CEO of BrainStorm, commented, "We have worked with leading neurologists, scientists, and members of the ALS community to create a robust study designed to evaluate the effectiveness and safety of NurOwn. This trial builds on valuable insights from our earlier studies and will enroll people living with ALS who are earlier in the course of their disease. Based on the evidence generated on NurOwn to date, we have a trial that we're optimistic will be positive. Over the past year, we've assembled an excellent team in clinical development that is highly qualified to execute this trial with excellence. We've been parallel processing to enable us to deliver the first dose in the trial in 2024, and we're anxious to get started."

The Phase 3b trial (Study BCT-006-US) will be a two-part, multicenter, study designed to assess the efficacy and safety of NurOwn in patients with ALS. The entry criteria will enroll participants earlier in the course of their disease, having the onset of ALS symptoms, including limb weakness, within the prior 24 months, all ALSFRS-R items 2 at Screening, and upright slow vital capacity >=65% of predicted for gender, height and age. Patients will also be allowed to receive concomitant treatment of an approved standard of care.

Part-A is a double blind, placebo-controlled period of 24 weeks duration. Up to approximately 200 patients are planned to be enrolled and randomized 1:1 to NurOwn or placebo treatment groups. There will be a screening period of six to nine weeks, during which eligible participants will undergo a single bone marrow aspiration procedure to procure the mesenchymal stem cells (MSCs) that will be used to manufacture each participant's NurOwn treatment for the duration of the trial. Patients will then be randomized 1:1 and treated with NurOwn or placebo via three repeated intrathecal injections, once every eight weeks. All eligible patients who complete Part-A will have the option of entering Part-B, open-label extension period of 24 weeks duration, where all participants will receive three repeated intrathecal injections of NurOwn, once every eight weeks.

The primary efficacy endpoint is the change in the Revised Amyotrophic Lateral Sclerosis Functional Rating (ALSFRS-R) total score from baseline to Week 24. Primary inference from the trial will be based on a p-value from the combined assessment of function and survival (CAFS) to account for mortality observed in the trial. Cerebrospinal Fluid (CSF) and blood samples will be collected for analysis of biomarkers of neuroinflammation, neurodegeneration, and neuroprotection. An independent Data Monitoring Committee (DMC) will monitor the safety of the trial participants.

Special Protocol Assessment A Special Protocol Assessment (SPA) is a process in which drug developers may ask to meet with the FDA to reach an agreement on the design and size of certain clinical trials to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. A SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future marketing application. These elements are critical to ensuring that the trial conducted under the protocol can be considered an adequate and well-controlled study that can support marketing approval. Feedback on these issues provides the greatest benefit to companies in planning late-phase development strategy. A SPA agreement does not indicate FDA concurrence on every protocol detail.

Conference Call and Webcast

BrainStorm management will host a conference call and webcast at 8:00 a.m. ET today to discuss the SPA and planned Phase 3 program, after which investment community questions will be answered. Investors may participate in the conference call by clicking the link below or dialing the following numbers:

Participant Numbers:

Toll-Free:

1-888-407-2553

International:

1-347-487-1157

(No entry code needed)

Webcast URL: https://veidan.activetrail.biz/NurOwnProgram-2024

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available until April 24, 2024.

Teleconference Replay Number:

International:

1-888-254-7270

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

IR:

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics to Provide Update on NurOwn Program

Mon, 08 Apr 2024 12:00:00 GMT

BrainStorm's President and Chief Executive Officer, Chaim Lebovits, Co-Chief Executive Officer, Stacy Lindborg, PhD and Chief Development Officer, Bob Dagher, MD, will present the update after which investment community questions will be answered.

The investment community may participate in the conference call by clicking the link below or dialing the following numbers:

Participant Numbers:

Toll-Free:

1-888-407-2553

International:

1-347-487-1157

(No entry code needed)

Webcast URL: https://veidan.activetrail.biz/NurOwnProgram-2024

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available until April 24, 2024.

Teleconference Replay Number:

International:

1-888-254-7270

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts:

Contacts

Contacts:

Investor Relations

Michael Wood

Phone: +1 646-597-6983

mwood@lifesciadvisors.com

BrainStorm Cell Therapeutics Announces Full Year 2023 Financial Results and Provides Corporate Update

Mon, 01 Apr 2024 12:00:00 GMT

Conference call planned for early April 2024 to provide update on NurOwn program

NEW YORK, April 1, 2024 / PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the full year ended December 31, 2023 and provided a corporate update.

“Brainstorm’s priority for 2024 is to move forward with a confirmatory Phase 3b trial for NurOwn that will potentially support a new Biologics License Application,” said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. “We have been working closely with the FDA with the goal of agreeing on a Special Protocol Assessment (SPA) so that we are aligned on the study design. We believe that an SPA will substantially de-risk the regulatory aspects of our program. Our team is committed to this rigorous planning process, recognizing its critical importance in the potential success and validity of the trial outcomes. We continue to believe that, if approved, NurOwn has the potential to be a valuable treatment option for ALS patients in need. We look forward to providing a further update in the near future.”

Stacy Lindborg, Ph.D., co-CEO BrainStorm commented, “We are acutely aware of the challenges faced by those afflicted with ALS. Our planned Phase 3b trial will be conducted with the highest standards of scientific excellence and integrity, driven by our commitment to the ALS community and our goal of expanding the treatment landscape."

Fourth Quarter 2023 and Recent Highlights

Clinical and regulatory

· In February 2024, Brainstorm submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn. An SPA agreement would indicate concurrence by FDA with the adequacy and acceptability of the overall protocol design for a planned Phase 3b study, intended to support a future marketing application. The request is currently under review, and the Company is expecting to have a response from the US FDA very soon as we approach the 45-day SPA review cycle.

· Brainstorm’s proposed design for the planned Phase 3b trial of NurOwn ALS was presented in a poster at the MDA Clinical and Scientific Conference in March, 2024 . The design is for a two-part, multicenter, Phase 3b study to assess the efficacy and safety of NurOwn in participants with ALS, earlier in the disease.

· In December 2023, company management attended an in-person meeting with the FDA to discuss the regulatory path forward for NurOwn in ALS, including plans for an SPA prior to commencing the planned Phase 3b confirmatory trial.

· In November 2023, Bob Dagher, MD, Executive Vice President and Chief Development Officer at BrainStorm, delivered a presentation titled, "NurOwn for ALS: Biomarker exploration of NurOwn multimodal mechanism of action on neuroinflammation, neuroprotection and neurodegeneration" at the 6th Annual ALS Research Symposium hosted by ALS ONE.

· In October 2023, Brainstorm withdrew its Biological License Application (BLA) for NurOwn in ALS. This action was coordinated with FDA and was viewed by the Agency as a withdrawal without prejudice. This decision was made following the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee meeting that took place in September 2023. The Committee voted that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS.

Corporate

· In October 2023, Brainstorm announced a strategic realignment to enable accelerated development of NurOwn for the treatment of ALS. The company reduced and refocusing resources by streamlining clean room operations and undertook a targeted reduction in headcount of approximately 30 percent.

Financial Results for the Year Ended December 31, 2023

· Cash, cash equivalents, and restricted cash amounted to $1.45 million, as of December 31, 2023, compared to cash, cash equivalents, and short-term deposits of $3 million as of December 31, 2022.

· Research and development expenses for the twelve months ended December 31, 2023, and 2022 were approximately $10.8 million and $14 million, respectively.

· General and administrative expenses for the twelve months ended December 31, 2023, and 2022 were approximately $10.7 million and $10.9 million, respectively.

· Net loss for the year ended December 31, 2023 was $17.2 million as compared to a net loss of $24.3 million for the year ended December 31, 2022.

· Net loss per share for the year ended December 31, 2023 and December 31, 2022 was $0.40 and $0.66, respectively.

Conference Call and Webcast

BrainStorm management will host a conference call for the investment community in early April 2024 to discuss plans for NurOwn including an update on the SPA. As described above, the Company is expecting to have a response from the US FDA very soon as we approach the 45-day SPA review cycle. Details on the conference call will be provided when available.

About BrainStorm Cell Therapeutics Inc .

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Media : Lisa Guiterman Phone: +1 202-330-3431 lisa.guiterman@gmail.com

IR: Michael Wood Phone: +1 646-597-6983 mwood@lifesciadvisors.com

BrainStorm Cell Therapeutics to Unveil Phase 3b NurOwn® Trial Design at MDA Clinical and Scientific Conference

Tue, 27 Feb 2024 12:00:00 GMT

BrainStorm recently submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for this Phase 3b study of NurOwn. A SPA agreement would indicate concurrence by FDA with the adequacy and acceptability of the overall protocol design for the planned Phase 3b study, intended to support a future marketing application. The details are currently under review by the FDA and the company plans to finalize the details following the receipt of input from the Agency.

"We are committed to doing everything we can to make NurOwn available to ALS patients in need and we are pleased to present an outline of our planned confirmatory Phase 3b trial," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "Together with our advisors, we have designed a trial that we believe will generate robust and conclusive data. Our goal is to develop an efficacious treatment option that, if approved, can help patients and generate value for our stakeholders."

Bob Dagher, MD, commented, "We have given careful consideration to a Phase 3b trial that will conclusively demonstrate the efficacy and safety of NurOwn and support a new NDA. Our previous studies have provided us with valuable insight into the NurOwn treatment effect. We believe that by incorporating these learnings into the design of a confirmatory study we can maximize the prospects of a successful outcome. The planned study will enroll mild-to-moderate ALS patients, as we believe that this is the appropriate patient population in which the course of the disease can be accurately measured using ALSFRS-R. We are grateful for the FDA's ongoing engagement and look forward to its feedback and to finalizing the SPA."

The abstract for this presentation can be viewed here. Brainstorm will post a copy of the poster to its corporate website at the conclusion of the presentation.

Special Protocol Assessment A Special Protocol Assessment (SPA) is a process in which drug developers may ask to meet with the FDA to reach agreement on the design and size of certain clinical trials to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. An SPA agreement indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future marketing application. These elements are critical to ensuring that the trial conducted under the protocol can be considered an adequate and well-controlled study that can support marketing approval. Feedback on these issues provides the greatest benefit to companies in planning late-phase development strategy. An SPA agreement does not indicate FDA concurrence on every protocol detail.

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACT:

Contacts

CONTACT:

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn® in ALS

Fri, 23 Feb 2024 12:00:00 GMT

The submission follows an in-person meeting that BrainStorm held with the FDA in December 2023. The interactions leading up to this submission have provided guidance on advancing the planned Phase 3b trial. Participating in an SPA program would allow BrainStorm to reach consensus with the FDA on its clinical trial design, including the proposed statistical analysis, before the study is initiated. This would help ensure that the study would be considered adequate to support a future marketing evaluation. The response is expected within 45 days of submission.

"Having an SPA in place is an important next step in advancing our development program for NurOwn," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We believe that the SPA will potentially de-risk certain regulatory aspects of the program. We look forward to working with the Agency to complete the SPA."

Stacy Lindborg, Ph.D., Co-CEO of BrainStorm added, "BrainStorm remains deeply committed to the ALS community. We continue to believe that NurOwn, if approved, has the potential to make a substantial difference in the lives of those affected by this devastating disease. We are grateful for the FDA's ongoing guidance and look forward to finalizing the SPA of this registration enabling trial."

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics to Present at European Life Sciences CEO Forum

Tue, 13 Feb 2024 12:00:00 GMT

Presentation DetailsPresentation Date: Wednesday, 28th FebruaryTime: 13:40h CETLocation: Panorama Room (Track C), Hilton Zurich Airport Hotel

Dr. Stacy Lindborg, Co-CEO of BrainStorm, will also participate in a panel discussion Neuro Advances Panel: Highlighting the Main Opportunities, at 17:20h on February 28.

Dr. Lindborg and Mr. Chaim Lebovits, President and CEO of Brainstorm, will be available for in-person meetings with conference attendees, February 28 – 29, and virtual meetings March 6 – 8.

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Granted Patents for Allogeneic Exosome Platform-Product in Neurological Disorder Treatments

Tue, 26 Dec 2023 12:00:00 GMT

The European Patent office granted patent No. 3105587 titled 'Method of Qualifying of Cells' for a method of qualifying whether a cell population is a suitable therapeutic for treating ALS. The patent also grants claims for an isolated population of mesenchymal stem cells for use in treating ALS.

The Australian patent Office granted patent No. 2019252987 titled 'Cell-Type Specific Exosomes and Use Thereof' for an isolated Exosomes population derived from MSC-NTF cells as well as a pharmaceutical composition for the treatment of neurodegenerative diseases.

The Israel Patent Office announced the allowance of the same claims for application No. 277447 with an Acceptance date on December 01, 2023.

"We are committed to fortifying our technological advancements with robust intellectual property strategies," stated BrainStorm's CEO, Chaim Lebovits. "The recent acquisition of the European patent for our unique MSC-NTF cell population marks an important step in safeguarding our proprietary NurOwn technology, particularly for ALS treatment. The Australian patent, which is our inaugural grant for the specialized MSC-NTF cell exosomes, represents a pivotal achievement in the evolution of our exosome technology, meticulously crafted by the Brainstorm research team. Securing this European patent, alongside our existing patents in the US, Canada, Israel, Brazil, and Japan, enhances our capability to forge new global commercial partnerships, further expanding the reach of NurOwn."

About NurOwn®The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals. The NurOwn clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted, but never before explored in depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic analysis of clinical outcome, offering great promise for the development of future treatments for ALS.

Notice Regarding Forward-Looking StatementsThis press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

CONTACTS:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

BrainStorm Issues 2023 Letter to Shareholders

Wed, 20 Dec 2023 12:00:00 GMT

Dear Shareholders,

We remain steadfast in our commitment to advancing NurOwn as a promising treatment for ALS patients. Recognizing the challenges faced in our recent BLA submission, we are ambitiously pursuing a Phase 3b trial, aligning with our dedication to the ALS community and our goal of making NurOwn commercially available. Despite the setbacks with the ADCOM's unfavorable vote, our focus remains to align with the FDA on a phase 3b trial design, as we acknowledge that this represents the most expedient pathway to approval.

We are exploring various strategies to secure the necessary funding. We intend to seek a Special Protocol Assessment (SPA), which, when agreed with the FDA, could significantly de-risk the regulatory aspects of the NurOwn program. We are very encouraged by the FDA's ongoing engagement, including the opportunity provided by the expedited in-person Type A meeting on December 6, a rare occurrence in today's regulatory environment. We appreciate the Agency's feedback, comments and other regulatory accommodations, signaling its recognition for the unmet need in ALS and its willingness to reach alignment with Brainstorm on our new clinical strategy.

Our team is diligently preparing to submit a clinical protocol, and Statistical Analysis Plan, for the FDA's review. Following alignment with the FDA's expectations, we will formally submit our SPA request. We anticipate making this submission in February 2024. The FDA's response is expected within 45 days of submission.

We believe that agreement on an SPA would open a broad spectrum of financing options for the trial. Concurrently, we are committed to maintaining our NASDAQ listing status. Our strategy focuses on enhancing the value of our assets, thereby garnering market support that is crucial for our stock price to reach its requisite level by April. We prefer this approach over a reverse stock split, as it aligns more closely with our long-term goals and shareholder interests.

We thank you for your continued support. Your faith in our mission fuels our determination to overcome the recent challenges and ultimately deliver groundbreaking treatments that will help patients in need and create value for our stakeholders.

Sincerely,

Chaim Lebovits President and CEO BrainStorm Cell Therapeutics Inc

Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

BrainStorm Cell Therapeutics Announces Outcome of FDA Meeting on NurOwn® in ALS

Thu, 07 Dec 2023 12:00:00 GMT

The primary objective of the meeting was to discuss key considerations for a Special Protocol Assessment (SPA) for a planned Phase 3b registrational trial for NurOwn. As an outcome of the meeting, BrainStorm will submit relevant documentation as outlined by the FDA to support the SPA. The ultimate goal is to secure the FDA's agreement that critical elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a study intended to support a future marketing application.

"Our meeting with the FDA provided us with valuable input on the Phase 3b trial design, outlining clear steps forward," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We believe that a SPA will serve to help de-risk certain regulatory aspects of the NurOwn clinical program. We recognize the urgency in providing ALS patients with safe and efficacious treatments and are committed to agreeing on a regulatory path forward for NurOwn. We are grateful for the FDA's continued support and guidance and look forward to providing further updates once we have more clarity on an SPA."

Notice Regarding Forward-Looking StatementsThis press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces In-Person Meeting with the FDA to Discuss Confirmatory Phase 3 Trial for NurOwn® in ALS

Mon, 20 Nov 2023 12:00:00 GMT

"We are pleased that the FDA has granted this expedited in-person meeting to discuss the best path forward for NurOwn for ALS," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "Our proposed plan is to conduct a confirmatory Phase 3b trial and it is important that we are aligned with the Agency on the expected requirements for re-submitting a Biologics License Application. We believe that reaching an agreement through a SPA on the overall protocol design and the adequacy to address the requirements for marketing approval will be a key step to position the company for success and to potentially de-risk the program. We are grateful for the FDA's support and quick response in granting this meeting as we remain committed to our goal of making NurOwn available to the ALS community."

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

BrainStorm Cell Therapeutics to Present at 6th Annual ALS Research Symposia

Fri, 17 Nov 2023 12:00:00 GMT

A copy of the presentation will be available on the Events & Presentation page of Brainstorm's corporate website following the presentation.

"Biomarkers of ALS progression and underlying disease mechanisms are starting to emerge and while the field is still early, there are a number of biomarkers associated with neurodegeneration, neuroinflammation, and neuroprotection that correlate with disease severity" stated Dr. Stacy Lindborg, co-Chief Executive Officer of BrainStorm. "In this analysis, NurOwn demonstrated evidence of a biological effect in data from all Phase 3 trial participants. These data reinforce the clinical outcomes from the trial and provide strong statistical evidence of a NurOwn effect across biomarkers over time."

Phase 3 NurOwn Study Design

The Phase 3 NurOwn trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of repeat doses of NurOwn in 189 ALS participants. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford, Dr. Robert Baloh); California Pacific Medical Center (Prof. Robert Miller, Dr. Jonathan Katz); Massachusetts General Hospital (Prof. Merit Cudkowicz, Dr. James Berry); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as participants with at least a 3-point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn or placebo. Participants were followed for 28 weeks after treatment. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where a response was defined as participants with a 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment. Secondary endpoints included the percentage of participants with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival, and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Announces Third quarter 2023 Financial Results and Provides Corporate Update

Tue, 14 Nov 2023 12:00:00 GMT

Conference call and webcast at 8:30 a.m. Eastern Time today

NEW YORK, November 14, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.

“We are committed to our goal of making NurOwn® available to the ALS community and intend to work with the FDA to agree on a path forward,” said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. “We acknowledge that approval will require a confirmatory Phase 3b trial and look forward to meeting with the FDA to align on the details. The recently announced strategic realignment is a necessary step to conserve and refocus resources, and we believe this will position us better to accelerate our ALS development program.”

Stacy Lindborg, Ph.D., co-CEO BrainStorm commented, “We believe we have generated a compelling body of clinical data that support the utility of NurOwn in ALS. We intend to harness the learnings from our prior studies to conduct a Phase 3b trial as efficiently as possible. We will also continue to engage with the academic community to share new data with our goal of leveraging the latest results to contribute to new insights into ALS and NurOwn.”

Third quarter 2023 and Recent Highlights

Clinical and regulatory

· In October 2023, Brainstorm withdraw its Biological License Application (BLA) for NurOwn in ALS. This action was coordinated with FDA and is viewed by the Agency as a withdrawal without prejudice. This decision was made following the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee meeting that took place on September 27. The Committee voted that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS.

· The FDA has invited Brainstorm to request an expedited face-to-face meeting to discuss the path forward for NurOwn® as a treatment for ALS.

· In July 2023, new biomarker data from the Phase 3 trial of NurOwn were presented at the 2023 ALS and Related Motor Neuron Diseases Gordon Research Conference. These data show that treatment with NurOwn significantly elevated markers of neuroprotection and lowered markers of neuroinflammation and neurodegeneration over time, including neurofilament light (NfL) compared to placebo in all trial participants. It is believed that reductions in plasma NfL are reasonably likely to predict clinical benefit in ALS.

Corporate

· In October 2023, Brainstorm announced a strategic realignment to enable accelerated development of NurOwn® for the treatment of ALS. The company is actively exploring various options to raise capital including non-dilutive grants and capitalizing on its exosome technology. At the same time, it is reducing and refocusing resources by streamlining clean room operations and undertaking a targeted reduction in headcount of approximately 30 percent. The strategic realignment is expected to cut total resource consumption by approximately half.

· In July 2023, Brainstorm closed a registered direct offering with a single institutional investor raising gross proceeds, before deducting the placement agent's fees and other offering expenses, of approximately $7.5 million.

· In July 2023, Brainstorm appointed Bob Dagher, MD, as Executive Vice President and Chief Development Officer.

Financial Results for the Quarter Ended September 30, 2023

Cash, cash equivalents, and short-term bank deposits were approximately $1.4 million as of September 30, 2023, compared to $3 million as of December 31, 2022.

Research and development expenses for the three months ended September 30, 2023 and 2022 were approximately $3.3 million and $3.8 million, respectively.

General and administrative expenses for the three months ended September 30, 2023 and 2022 were approximately $2.7 million and $3.1 million, respectively.

Net loss for the three months ended September 30, 2023 was approximately $1.2 million, as compared to a net loss of approximately $6.9 million for the three months ended September 30, 2022.

Net loss per share for the three months ended September 30, 2023 and 2022 was $0.03 and $0.19, respectively.

For more details on the financials, including results for the 9 month period ended September 30, 2023, refer to Form 10Q filed with the SEC.

Conference Call and Webcast, 8:30 a.m. Eastern Time Today

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:

Toll Free: 888-506-0062

International: 973-528-0011

Access Code: 944879

Webcast URL: https://rb.gy/875eq4

Those interested in listening to webcast may do so by using the link above or by visiting the "Investors & Media" page of BrainStorm's website at

https://brainstorm-cell.com/investors/ and clicking on the webcast link.

The replay of the conference call can do so by dialing the numbers below and will be available until November 28, 2023.

Replay Numbers:

Toll Free: 877-481-4010

International: 919-882-2331

Replay Passcode: 49431

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations : John Mullaly LifeSci Advisors, LLC Phone: +1 617-429-3548 jmullaly@lifesciadvisors.com

Media : Lisa Guiterman

Phone: +1 202-330-3431 lisa.guiterman@gmail.com

BrainStorm to Announce Third Quarter 2023 Financial Results and Provide a Corporate Update

Tue, 07 Nov 2023 12:00:00 GMT

BrainStorm's President and Chief Executive Officer, Chaim Lebovits, and Co-Chief Executive Officer, Stacy Lindborg, PhD, will provide a corporate update and Alla Patlis, CPA, MBA, Interim Chief Financial Officer, will discuss the financials. Investment community questions will be answered after the prepared remarks.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:Toll Free: 888-506-0062International: 973-528-0011Participant Access Code: 944879Webcast URL: https://rb.gy/875eq4

Those interested in listening to webcast may do so by using the link above or by visiting the "Investors & Media" page of BrainStorm's website at

https://brainstorm-cell.com/investors/ and clicking on the webcast link.

The replay of the conference call can do so by dialing the numbers below and will be available until November 28, 2023.

Replay Numbers:Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 49431

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding BrainStorm's Type A meeting with the FDA and the clinical development of NurOwn® as a therapy for the treatment of ALS, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "intend," "should," "could," "will," "believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn®, whether BrainStorm's future interactions with the FDA will have productive outcomes, the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts:

Contacts

Contacts:

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Announces Strategic Realignment Prioritizing NurOwn® for the Treatment of ALS

Tue, 24 Oct 2023 12:00:00 GMT

"While the Phase 3 trial was confounded by the ALSFRS-R scale's inability to measure disease progression in participants with advanced ALS, the trial did demonstrate a clinically meaningful response in a pre-specified subgroup of patients with less advanced disease. This finding was further supported by biomarker data," said Stacy Lindborg PhD, co-Chief Executive Officer of BrainStorm. "Based on learnings from the Phase 3 trial, we believe in the utility of NurOwn in mild to moderate ALS and that the ALS community deserves every effort we can give to definitively demonstrate its clinical value."

To fund the Phase 3b study and ALS priorities, BrainStorm is actively exploring various options to raise capital including non-dilutive grants and capitalizing on its exosome technology. At the same time, the company will reduce and refocus resources by streamlining clean room operations and undertaking a targeted reduction in headcount of approximately 30 percent. Positions most critical to the implementation of the Phase 3b trial and regulatory submission and review will be retained. The strategic realignment will cut total resource consumption by approximately half.

As part of this strategic realignment, Dr. Kirk Taylor, EVP and Chief Medical Officer, will be stepping down from his post, which largely focused on leading global medical affairs and broader launch activities. Certain other positions that are outside the current prioritized scope will be eliminated.

"We are extremely grateful for the dedication and contributions of our impacted colleagues, particularly Dr. Taylor who added tremendous value during his time with BrainStorm," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We remain steadfast in our goal to make NurOwn available to the ALS community as quickly as possible, and we believe that this strategic realignment offers our best chance for success. While remaining open to partnership opportunities that could accelerate growth, the steps we are taking now reflect our unwavering commitment to those battling this horrific disease and our firm belief in the potential value of NurOwn."

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

CONTACTS:

Contacts

CONTACTS:

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics to Meet with US FDA to Discuss Development Plan for NurOwn as a Treatment of ALS

Wed, 18 Oct 2023 12:00:00 GMT

"We are confident in the data supporting the value of NurOwn as an addition to the options for treating ALS, and we have every desire to bring it to the ALS community," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We look forward to working with the FDA to define the path forward. We understand that an additional pivotal trial will be necessary, and we are doing everything in our power to execute on this as quickly as possible."

Brainstorm is withdrawing the Biologics License Application (BLA) for NurOwn. The decision to withdraw the BLA was coordinated with FDA and is viewed by FDA as a withdrawal without prejudice.

Conference call and webcast

Toll Free: 888-506-0062International: 973-528-0011Participant Access Code: 610368

Webcast : https://www.webcaster4.com/Webcast/Page/2354/49296

Those interested in listening to the conference call live via the internet may do so by using the webcast link above or by visiting the "Investors & Media" page of BrainStorm's website here and clicking on the conference call link.

A replay will be available, those that wish to listen to the replay of the conference call can do so via the webcast link or by dialing the numbers below.

Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 49296

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

The NurOwn clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted but never before explored in depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic analysis of clinical outcome, offering great promise for the development of future treatments for ALS.

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

Contacts

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS

Wed, 27 Sep 2023 12:00:00 GMT

Today the Committee voted that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS.

"The Committee's vote was a sad outcome for the ALS community, who have too few options to help manage this merciless and deadly disease," said Stacy Lindborg, PhD, co-CEO of BrainStorm. "We firmly believe that the totality of data presented for NurOwn today provide a compelling case for approval, with clinical evidence in those with less advanced disease supported by strong and consistent biomarker data that are predictive of clinical response. We truly did our best to make the NurOwn data clear to the FDA Advisory Committee. Unfortunately, had more time and opportunity been allowed, many remaining questions posed by Advisory Committee members could have been sufficiently addressed."

Chaim Lebovits, President and Chief Executive Officer of BrainStorm, added: "The discussion in today's Advisory Committee meeting, and the heartrending testimony of those living with ALS and their loved ones, underscores not only the need for regulatory flexibility but also for continuing research in the field. The people of BrainStorm will do everything in our power to fulfill the obligation we deeply feel we owe to the ALS community, and in the coming weeks we will explore all options available to us."

The Phase 3 pivotal trial of NurOwn did not reach statistical significance on the primary or secondary endpoints, likely due to a "floor effect," which confounds measurement of disease progression in patients with more advanced disease. A thorough analysis of NurOwn Phase 3 data shows evidence of clinically meaningful effectiveness in ALS participants who have not progressed to advanced levels of disease progression. In a pre-specified group of participants with an ALSFRS-R score ³35, there was a larger treatment effect across all endpoints with NurOwn compared to placebo, which aligned with historical trials and the study power assumptions and resulted in a statistically significant difference on a key endpoint (change from baseline in ALSFRS-R). Additionally, a post-hoc sensitivity analysis of patients across threshold of >26 through ≥35 on the ALSFRS-R highlighted that NurOwn-treated patients retain, on average, two points of function more compared to placebo–clinically meaningful preservation and important for quality of life for a person living with ALS and their loved ones.

NurOwn's clinical program also included most robust cerebrospinal fluid (CSF) biomarker study ever done in ALS, strong and consistent biomarker data, which are predictive of clinical response in the trial, span pathways that are important to ALS (neuroinflammation, neurodegeneration, neuroprotection), and align with NurOwn's mechanism of action. Biomarker data in all trial participants showed consistent biological patterns of NurOwn reducing markers of inflammation and neurodegeneration and increasing neuroprotective markers relative to placebo. Biomarker patterns were consistent across all NurOwn-participants, including in those with Advanced ALS disease where clinical scales, such as the ALS Functional Rating Scale, have demonstrated measurement challenges. Three CSF biomarkers were predictive of clinical outcomes in NurOwn-treated participants–NfL, galectin-1, latency associated peptide of TGF-beta1 (LAP or TGF-b).

The NurOwn clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted but never before explored in depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic analysis of clinical outcome, offering great promise for the development of future treatments for ALS.

BrainStorm previously announced the FDA's intention to hold an ADCOM meeting to review NurOwn for the treatment of ALS. BrainStorm filed a BLA for NurOwn on September 9, 2022, and received a Refusal to File (RTF) letter from FDA on November 8, 2022. Following a Type A meeting and subsequent discussions with the FDA BrainStorm requested that CBER utilize the FDA's "File Over Protest" procedure, which offers the shortest amount of time to complete the regulatory process. The BLA was filed over protest, allowing completion of the regulatory process in the shortest time possible, and active review resumed on February 7, 2023.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking StatementsThis press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the upcoming ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital,

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Stock Trading Halted Today

Wed, 27 Sep 2023 12:00:00 GMT

The U.S. Food and Drug Administration's (FDA) Cellular, Tissue and Gene Therapies Advisory Committee is meeting today to review BrainStorm's Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). The ADCOM meeting is scheduled to take place 10:00 am to 6:00 pm ET.

The FDA has posted briefing materials, agendas and webcast information for the meeting that can be accessed on the Agency's website here. The online web conference meeting can be viewed through this link.

BrainStorm's BLA for NurOwn® has a Prescription Drug User Fee Act (PDUFA) action date targeted to occur by December 8, 2023.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn® is for the treatment of ALS, which is under FDA review. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

The Phase 3 pivotal trial of NurOwn® did not reach statistical significance on the primary or secondary endpoints, likely due to a "floor effect," which confounds measurement of disease progression in patients with more advanced disease. A thorough analysis of NurOwn® Phase 3 data shows evidence of clinically meaningful effectiveness in ALS participants who have not progressed to advanced levels of disease progression. In a pre-specified group of participants with an ALSFRS-R score ³35, there was a larger treatment effect across all endpoints with NurOwn® compared to placebo, which aligned with historical trials and the study power assumptions and resulted in a statistically significant difference on a key endpoint (change from baseline in ALSFRS-R). Additionally, a post-hoc sensitivity analysis of patients across threshold of >26 through ≥35 on the ALSFRS-R highlighted that NurOwn®-treated patients retain, on average, two points of function more compared to placebo–clinically meaningful preservation and important for quality of life for a person living with ALS and their loved ones.

NurOwn®'s clinical program also included the most robust cerebrospinal fluid (CSF) biomarker study ever done in ALS, strong and consistent biomarker data, which are predictive of clinical response in the trial, span pathways that are important to ALS (neuroinflammation, neurodegeneration, neuroprotection), and align with NurOwn®'s mechanism of action. Biomarker data in all trial participants showed consistent biological patterns of NurOwn® reducing markers of inflammation and neurodegeneration and increasing neuroprotective markers relative to placebo. Biomarker patterns were consistent across all NurOwn® participants, including in those with Advanced ALS disease where clinical scales, such as the ALS Functional Rating Scale, have demonstrated measurement challenges. Three CSF biomarkers were predictive of clinical outcomes in NurOwn®-treated participants–NfL, galectin-1, latency associated peptide of TGF-beta1 (LAP or TGF-b).

The NurOwn® clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted but never before explored in depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic analysis of clinical outcome, offering great promise for the development of future treatments for ALS.

BrainStorm previously announced the FDA's intention to hold an ADCOM meeting to review NurOwn® for the treatment of ALS. BrainStorm filed a BLA for NurOwn® on September 9, 2022, and received a Refusal to File (RTF) letter from FDA on November 8, 2022. Following a Type A meeting and subsequent discussions with the FDA BrainStorm requested that CBER utilize the FDA's "File Over Protest" procedure, which offers the shortest amount of time to complete the regulatory process. The BLA was filed over protest, allowing completion of the regulatory process in the shortest time possible, and active review resumed on February 7, 2023.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the ADCOM meeting related to NurOwn®, the timing of a PDUFA action date for the BLA for NurOwn®, and the clinical development of NurOwn® as a therapy for the treatment of ALS. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn®, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Announces Second Quarter 2023 Financial Results and Provides Corporate Update

Mon, 14 Aug 2023 12:00:00 GMT

FDA advisory committee (ADCOM) meeting to discuss NurOwn® for Amyotrophic Lateral Sclerosis (ALS) scheduled for September 27, 2023

BrainStorm's Biologics License Application (BLA) for NurOwn has a Prescription Drug User Fee Act (PDUFA) action date targeted to occur by December 8, 2023

Company prepares for ADCOM date presentation and builds resources for FDA review and decision

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2023 and provided a corporate update.

BrainStorm's immediate priorities are to prepare for the upcoming ADCOM meeting to review the BLA for NurOwn®, scheduled for September 27, and complete preparations for commercial launch. The Company's senior team is working with expert consultants to ensure it will deliver a compelling presentation to the ADCOM and is prepared to address the questions that the FDA and members of the committee might raise.

"We appreciate the FDA's guidance and input throughout the review process, which will be instrumental in making a policy decision that meets the needs of those living with ALS," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "In parallel with the regulatory work, we are preparing the company for success, with the goal of making NurOwn available to patients, if approved in December. As part of this initiative, we have been making important additions to our talented team throughout the year and recently added Dr. Kirk Taylor as our EVP, Chief Medical Officer, Dr. Bob Dagher as EVP, Chief Development Officer, as well as Nir Naor as Board Member."

Dr. Stacy Lindborg, Co-Chief Executive Officer of BrainStorm commented, "We look forward to discussing NurOwn's full dataset at the forthcoming ADCOM meeting. Our clinical program has generated complex results, and the ADCOM meeting will provide us with the opportunity for a thoughtful discussion with scientists, ALS experts, FDA reviewers, advocates, and patients. We have full confidence in the data we have compiled, and believe that a comprehensive analysis of our results strongly supports NurOwn's clinically meaningful effectiveness. In addition, we continue to share our data with the ALS community at scientific meetings and recently delivered an important presentation at the 2023 ALS and Related Motor Neuron Diseases Gordon Research Conference . The data from this new analysis showed that treatment with NurOwn significantly elevated markers of neuroprotection and lowered markers of neuroinflammation and neurodegeneration, including neurofilament light (NfL). Reductions in plasma NfL are believed to be a predictor of clinical benefit in ALS."

Second Quarter 2023 and Recent Highlights

Clinical and regulatory

· The U.S. Food and Drug Administration (FDA) notified BrainStorm that a meeting of the Cellular, Tissue and Gene Therapies Advisory Committee to review the BLA for NurOwn® has been scheduled for September 27, 2023 . In addition, BrainStorm's BLA for NurOwn has been assigned a PDUFA action date targeted to occur by December 8, 2023.

· In July 2023, new biomarker data from the Phase 3 trial of NurOwn were presented at the 2023 ALS and Related Motor Neuron Diseases Gordon Research Conference . These data show that treatment with NurOwn significantly elevated markers of neuroprotection and lowered markers of neuroinflammation and neurodegeneration, including NfL over time compared to placebo in all trial participants. It is believed that reductions in plasma NfL are reasonably likely to predict clinical benefit in ALS.

Corporate

· In July 2023, BrainStorm closed a registered direct offering with a single institutional investor raising gross proceeds, before deducting the placement agent's fees and other offering expenses, of approximately $7.5 million.

· In July 2023, BrainStorm appointed Dr. Bob Dagher as Executive Vice President and Chief Development Officer . Dr. Dagher will be responsible for the portfolio strategy and advancement of clinical development plans towards regulatory approval, including the expansion of NurOwn into new diseases and the translation of pre-clinical research into first-in-human trials. He will serve on BrainStorm's executive leadership team reporting to Dr. Lindborg.

· In June 2023, BrainStorm appointed Nir Naor, CPA, CFA, MBA (IMD), LL.M, as Board Member , chairman of its Audit Committee and member of its Governance, Nomination and Compensation Committee. Mr. Naor replaced Mr. Malcolm Taub, who retired from the same roles after 14 years of service on BrainStorm's Board of Directors.

· In April 2023, BrainStorm appointed Dr. Kirk Taylor as Executive Vice President and Chief Medical Officer , continuing a targeted capability build that was launched with the promotion of Dr. Lindborg to Co-CEO in January 2023. The capability build is being implemented to hire and bring expertise inside BrainStorm in preparation for anticipated growth.

Financial Results for the Quarter Ended June 30, 2023

Cash, cash equivalents, and short-term bank deposits were approximately $.75 million as of June 30, 2023, compared to $3.0 million as of December 31, 2022. In July 2023, subsequent to the end of the quarter, BrainStorm raised gross proceeds of approximately $7.5 million in a registered direct offering.

Research and development expenses for the three months ended June 30, 2023 and 2022 were approximately $2.8 million and $5.1 million, respectively.

General and administrative expenses for the three months ended June 30, 2023 and 2022 were approximately $2.7 million and $2.5 million, respectively.

Net loss for the three months ended June 30, 2023 was approximately $5.3 million, as compared to a net loss of approximately $7.0 million for the three months ended June 30, 2022.

Net loss per share for the three months ended June 30, 2023 and 2022 was $0.13 and $0.19, respectively.

Conference Call and Webcast, 8:00 a.m. Eastern Time Today

Participant Numbers: Participant Numbers:

Toll Free: 888-506-0062

International: 973-528-0011

Participant Access Code: 569863

Webcast URL: https://rb.gy/hblmt

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available until August 28, 2023.

Replay Numbers: Replay Numbers:

Toll Free: 877-481-4010

International: 919-882-2331

Replay Passcode: 48916

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS, which is under FDA review. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

The NurOwn clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted but never before explored in depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic analysis of clinical outcome, offering great promise for the development of future treatments for ALS.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the upcoming ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations :

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media :

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm to Announce Second Quarter 2023 Financial Results and Provide a Corporate Update

Mon, 07 Aug 2023 12:00:00 GMT

BrainStorm's President and Chief Executive Officer, Chaim Lebovits, and Co-Chief Executive Officer, Stacy Lindborg, PhD, will provide a corporate update after which investment community questions will be answered. Joining Mr. Lebovits and Dr. Lindborg in the Q&A session will be Kirk Taylor, M.D., Executive Vice President and Chief Medical Officer, and Alla Patlis, CPA, MBA, Interim Chief Financial Officer.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:Toll Free: 888-506-0062International: 973-528-0011Participant Access Code: 569863

Webcast URL: https://rb.gy/hblmt

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available until August 28, 2023.

Replay Numbers:Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 48916

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts:

Contacts

Contacts:

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

Brainstorm Cell Therapeutics Announces Pricing of $7.5 Million Registered Direct Offering

Mon, 17 Jul 2023 12:00:00 GMT

The offering is expected to close on or about July 19, 2023, subject to satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses payable by the Company, are expected to be approximately $7.5 million.

The securities are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-258640) filed with the U.S. Securities and Exchange Commission (the "SEC") on August 9, 2021 and declared effective by the SEC on August 19, 2021. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at syndicate@maximgrp.com or telephone at (212) 895-3745.

About BrainStorm Cell Therapeutics Inc.

Notice Regarding Forward-Looking Statements

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

BrainStorm Cell Therapeutics Appoints Bob Dagher, M.D., as Executive Vice President and Chief Development Officer

Wed, 12 Jul 2023 12:00:00 GMT

"Bob is an important addition to our expanding leadership team to help guide BrainStorm through critical inflection points for NurOwn and our growing pipeline," said Chaim Lebovits, President and CEO of BrainStorm "His background, which includes experience in neurology, psychiatry and rare diseases, provides a high level of scientific credibility and expertise in clinical management and corporate leadership. His personal integrity makes him a perfect cultural fit for our already strong team."

Dr. Dagher joins BrainStorm from Enveric Biosciences where, as Chief Medical Officer, he was responsible for defining the portfolio strategy and advancement of development plans toward regulatory approvals. He began his career in biopharmaceuticals as a medical scientist at GSK, and has served in leadership positions of science and medicine at companies such as Sanofi/Genzyme, and LabCorp/Covance, for more than 20 years. Dr. Dagher earned his medical degree at Bordeaux University and St. Joseph University School of Medicine, serving residencies in psychiatry and internal medicine at Boston University Medical Center. A past Diplomat of the American Board of Neurology and Psychiatry, he is licensed to practice medicine in Massachusetts.

Dr. Dagher commented, "I am delighted to join Brainstorm at such an exciting and important juncture. I believe Brainstorm has an innovative and versatile, industry-leading stem cell technology platform, which can rapidly advance autologous targeted therapeutics from bench to clinical development and eventual commercialization. I feel very fortunate to be joining Brainstorm's world-class team of highly experienced and dedicated professionals and be able to contribute to the important work of bringing advanced treatments to improve the lives of those with serious neurodegenerative diseases."

Dr. Dagher joins BrainStorm at a pivotal time. NurOwn®, the company's lead investigational platform, is currently under review by the U.S. Food and Drug Administration for the treatment of for amyotrophic lateral sclerosis (ALS). NurOwn (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. The FDA will hold an Advisory Committee meeting for the ALS indication on September 27, 2023, with a PDUFA target action date of December 8, 2023.

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Data Show Treatment with NurOwn Significantly Reduces NfL, a Key Biomarker of Neurodegeneration

Fri, 07 Jul 2023 12:00:00 GMT

New data analysis presented this week was motivated by the regulatory precedent set by a recent FDA drug approval in ALS, and the knowledge gained through the regulatory process, suggesting that the blood-based biomarker neurofilament light (NfL) is associated with disease prognosis and progression in patients with ALS and potentially other neurodegenerative diseases. It is believed that reductions in plasma NfL are reasonably likely to predict clinical benefit in ALS.

"It's well known that in ALS, accounting for disease characteristics such as site of onset, time from first symptom to treatment and baseline physical function are important to understanding the treatment effect in clinical trials given the great heterogeneity in the disease, which can influence prognosis," said Stacy Lindborg, PhD, BrainStorm co-CEO and presenter of the poster. "The data we presented at the Gordon Research Conference show that it is equally important to examine biomarker data, particularly neurofilament light, which is a predictor of disease progression. Treatment-driven reductions in NfL are associated with better clinical outcomes in ALS."

About the data analysis

The presentation, titled "CSF biomarkers identified as predictive of clinical outcomes in ALS participants following NurOwn treatment in a phase 3 clinical trial: Reductions in NfL associated with less ALSFRS-R decline", examined biomarkers that were pre-specified in the NurOwn study: 16 pro-inflammatory/anti-inflammatory, eight neurodegeneration, and nine neuroprotection biomarkers. This analysis is the largest biomarker study conducted in people living with ALS. Cerebrospinal fluid was collected for all participants in the trial seven times, per the protocol. The data provide further evidence of the importance of NfL as a prognostic and predictive biomarker. The addition of baseline disease covariates and additional biomarkers to NfL encompassing inflammation and neuroprotection more fully explains the clinical response to NurOwn observed in the trial.

The poster presentation is available on the BrainStorm website, on the Events & Presentations section: https://brainstorm-cell.com/investors/events-and-presentations/

Highlights of the biomarker analysis:

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS, which is under FDA review. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

The Phase 3 pivotal trial NurOwn did not reach statistical significance on the primary or secondary endpoints, likely due to a "floor effect," which confounds measurement of disease progression in patients with more advanced disease. A thorough analysis of NurOwn Phase 3 data shows evidence of clinically meaningful effectiveness in ALS participants who have not progressed to advanced levels of disease progression. In a pre-specified group of participants with an ALSFRS-R score ³35, there was a larger treatment effect across all endpoints with NurOwn compared to placebo, which aligned with historical trials and the study power assumptions. With a statistically significant difference on a key endpoint (change from baseline in ALSFRS-R). Additionally, a post-hoc sensitivity analysis of patients across threshold of >26 through ≥35 on the ALSFRS-R highlighted that NurOwn-treated patients retain, on average, two points of function more compared to placebo -- clinically meaningful preservation and important for quality of life for a person living with ALS and their loved ones.

NurOwn's clinical program also included the largest cerebrospinal fluid (CSF) biomarker study ever done in ALS, strong and consistent biomarker data, which are predictive of clinical response in the trial, span pathways that are important to ALS (neuroinflammation, neurodegeneration, neuroprotection), and align with NurOwn's mechanism of action. Biomarker data in all trial participants showed consistent biological patterns of NurOwn reducing markers of inflammation and neurodegeneration and increasing neuroprotective markers relative to placebo. Biomarker patterns were consistent across all NurOwn-participants, including in those with Advanced ALS disease where clinical scales, such as the ALS Functional Rating Scale, have demonstrated measurement challenges. Three CSF biomarkers were predictive of clinical outcomes in NurOwn-treated participants– neurofilament light (NfL), galectin-1, latency associated peptide of TGF-beta1 (LAP or TGF-b).

The NurOwn clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted but never before explored in depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic analysis of clinical outcome, offering great promise for the development of future treatments for ALS.

BrainStorm previously announced the FDA intension to hold an ADCOM meeting to review NurOwn for the treatment of ALS. The company filed a BLA for NurOwn on September 9, 2022, and received a Refusal to File (RTF) letter from FDA on November 8, 2022. Following a Type A meeting and subsequent discussions with the FDA BrainStorm requested that CBER utilize the FDA's "File Over Protest" procedure, which offers the shortest amount of time to complete the regulatory process. The BLA was filed over protest, allowing completion of the regulatory process in the shortest time possible, and active review resumed on February 7, 2023.

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

BrainStorm Cell Therapeutics Appoints Nir Naor as Board Member and Audit Committee Chair

Tue, 20 Jun 2023 12:00:00 GMT

"We welcome the addition of Nir as a new independent board member, and we are confident that his impressive corporate experience in both the U.S. and Europe will add further breadth to the Company's finance and compliance capabilities," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "I believe BrainStorm has much to gain from Nir's expertise as we prepare for success and position the company for our first potential commercial launch".

Mr. Naor remarked, "I am delighted to join BrainStorm at this exciting point in the company's evolution. I am impressed by the vision of the management team and in their commitment to serving ALS patients, who are in dire need of new treatments."

Mr. Lebovits concluded, "I would like to thank our colleague and dear friend Malcolm Taub for his long-standing contributions to Brainstorm. Malcolm has been a vital part of the company throughout our formative years - from being a small pre-clinical company, to an advanced-stage stem cell treatments' manufacturer."

Nir Naor has over 20 years of global work experience as CFO and senior finance leader, with the majority of his career spent at U.S. and European corporations. He has a broad background that includes large pharma and biotech, and has overseen organizations with up to $2.5B in sales and $1B in annual spend. His experience includes serving as CFO of Arbor Pharmaceuticals, a PE-backed (KKR) company, and was instrumental in its sale to Azurity Pharma / NovaQuest Capital. He also founded the Portfolio Management function in UCB, and later on became UCB's US CFO. Mr. Naor's CFO experience includes IPO Preparedness projects, as well as leading turnarounds, and finance transformations, while overseeing Finance, IT, Investor Relations, Contracting & Pricing and Commercial Ops functions at AstraZeneca, UCB and Mölnlycke Healthcare. Prior to joining the industry, Nir worked as an Investment Banker, specializing in IPOs and M&A, and prior to that was a commercial Lawyer. In addition, Mr. Naor currently serves as an advisor and advisory-board member to several biotech and tech startups.

Mr. Naor is a Certified Public Accountant (CPA), Chartered Financial Analyst (CFA) and Advocate. He holds a Master of Business Administration from IMD Business School in Switzerland, and a master degree in Law from Hamburg University in Germany. He also received a bachelor degree in Law (LL.B) and BA (Accounting) from Tel Aviv University In Israel.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding BrainStorm's Type A meeting with the FDA and the clinical development of NurOwn® as a therapy for the treatment of ALS, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "intend," "should," "could," "will," "believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn®, whether BrainStorm's future interactions with the FDA will have productive outcomes, the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics to Participate in the Maxim Group Healthcare Virtual Conference

Fri, 16 Jun 2023 12:00:00 GMT

The conference will be hosted by M-Vest, and a live streaming can be viewed by clicking the link here (registration is required).

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review NurOwn® Biologics License Application Scheduled for September 27, 2023

Tue, 06 Jun 2023 12:00:00 GMT

"We are encouraged by the regulatory flexibility that the FDA has shown over the last year in ALS broadly, and with respect to NurOwn in particular, and believe an Advisory Committee meeting is good for patients," said Chaim Lebovits, BrainStorm President & CEO. "We are of course deeply committed to the scientific and regulatory process, which includes continuing research to confirm the results of the NurOwn clinical program and are working with ALS experts in designing a rigorous clinical study to answer important questions about this therapy and inform further research on ALS."

Stacy Lindborg, Ph.D., BrainStorm co-CEO, commented: "We welcome the opportunity to present our data at the forthcoming ADCOM. We remain confident in NurOwn and believe our data support regulatory approval. As is the case with most ALS research, our clinical program generated complex results, which deserve a thoughtful and holistic review by scientists, ALS experts, FDA reviewers, advocates, and patients. We believe this approach honors the needs of those living with ALS and offers the greatest promise for BrainStorm to fulfill our commitment to the ALS community."

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS, which is under FDA review. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

The Phase 3 pivotal trial NurOwn did not reach statistical significance on the primary or secondary endpoints, likely due to a "floor effect," which confounds measurement of disease progression in patients with more advanced disease. A thorough analysis of NurOwn Phase 3 data shows evidence of clinically meaningful effectiveness in ALS participants who have not progressed to advanced levels of disease progression. In a pre-specified group of participants with an ALSFRS-R score ³35, there was larger treatment effect across all endpoints with NurOwn compared to placebo, which aligned with historical trials and the study power assumptions. With a statistically significant difference on a key endpoint (change from baseline in ALSFRS-R). Additionally, a post-hoc sensitivity analysis of patients across threshold of >26 through ≥35 on the ALSFRS-R highlighted that NurOwn-treated patients retain, on average, two points of function more compared to placebo - clinically meaningful preservation and important for quality of life for a person living with ALS and their loved ones.

NurOwn's clinical program also included the largest cerebrospinal fluid (CSF) biomarker study ever done in ALS, strong and consistent biomarker data, which are predictive of clinical response in the trial, span pathways that are important to ALS (neuroinflammation, neurodegeneration, neuroprotection), and align with NurOwn's mechanism of action. Biomarker data in all trial participants showed consistent biological patterns of NurOwn reducing markers of inflammation and neurodegeneration, and increasing neuroprotective markers relative to placebo. Biomarker patterns were consistent across all NurOwn-participants, including in those with Advanced ALS disease where clinical scales, such as the ALS Functional Rating Scale, have demonstrated measurement challenges. Three CSF biomarkers were predictive of clinical outcomes in NurOwn-treated participants– neurofilament light (NfL), galectin-1, latency associated peptide of TGF-beta1 (LAP or TGF-b).

The NurOwn clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted but never before explored in depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic analysis of clinical outcome, offering great promise for the development of future treatments for ALS.

BrainStorm previously announced the FDA intention to hold an ADCOM meeting to review NurOwn for the treatment of ALS. The company filed a BLA for NurOwn on September 9, 2022, and received a Refusal to File (RTF) letter from FDA on November 8, 2022. Following a Type A meeting and subsequent discussions with the FDA, BrainStorm requested that CBER utilize the FDA's "File Over Protest" procedure, which offers the shortest amount of time to complete the regulatory process. The BLA active review was resumed on February 7, 2023.

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Summarizes Key Messages from Its Participation as Expert Speakers in an Invited Presentation and Panel Discussion at The 2023 ALS Drug Development Summit

Fri, 19 May 2023 12:00:00 GMT

Stacy Lindborg, Ph.D., Co-Chief Executive Officer BrainStorm and Antonio Trejo Diaz, Vice President, Regulatory Affairs, both participated as invited expert speakers at the summit which was focused on transforming translational tools to accelerate future ALS approvals.

Dr. Lindborg presented an invited talk entitled "Reviewing ALSFRS-R as the Established Endpoint for ALS Clinical trials".

Highlights from the presentation included:

Mr. Trejo Diez participated in a panel entitled "A Year in Review: Showcasing the Breakthrough Developments in ALS Drug Development". The panel reviewed the important progress made during the past year with two new therapies approved by the U.S. Food and Drug Administration (FDA) for ALS and recognized the efforts of the agency to show regulatory flexibility for the benefit of the ALS community. The panel agreed that there is an opportunity to leverage the experience in the US and start a discussion with other Health Authorities around the world.

The regulatory flexibility shown by the US FDA is a positive sign to address the unmet need for ALS therapies. BrainStorm communicated to the conference that it has been granted an FDA Advisory Committee Meeting to discuss its Biologics License Application for NurOwn, which it expects will enable the transparent sharing of information with the medical, scientific and advocacy communities dedicated to improving the lives of people living with ALS.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Announces First Quarter 2023 Financial Results and Provides Corporate Update

Mon, 15 May 2023 12:00:00 GMT

Biologics License Application for NurOwn® for the treatment of ALS to be subject of an upcoming FDA Advisory Committee Meeting

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, May 15, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the quarter ended March 31, 2023 and provided a corporate update.

“We continue to diligently prepare for NurOwn’s upcoming ADCOM supported by a robust dataset providing compelling evidence of its efficacy in ALS, as well as a talented team that was recently bolstered by the addition of Dr. Kirk Taylor as our EVP, Chief Medical Officer,” said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. “Kirk’s appointment is part of a strategic initiative to build our medical, regulatory, advocacy, and commercial teams as we prepare for anticipated growth and a potential transition to a commercial organization. On the strength of the data we have generated, and the feedback received from leading ALS experts, we believe we are well positioned to achieve a successful outcome at the upcoming ADCOM. We recognize that time is of the essence for patients with ALS and remain fully committed to working expeditiously towards our goal of making NurOwn widely available to those in need.”

“We are equally excited by the addition of Antonio Trejo, VP of Regulatory Affairs, and Robin Wallace, VP of Clinical Operations to our leadership team”, said Stacy Lindborg, Ph.D., co-CEO BrainStorm. “As we add to the depth of expertise and capacity of our entire team we will prioritize activities for the upcoming ADCOM and additional tasks that will aide FDA approval, while keeping the horizon of opportunities that lay ahead for Brainstorm. Opportunities such as expanding geographies where NurOwn is approved to treat ALS, expanding the scope of diseases we target as part of our clinical portfolio for NurOwn, in addition to allowing for the development of our next technology platform based on exosomes. We are excited about the multitude of upcoming challenges and opportunities that lay ahead.”

First Quarter 2023 and Recent Highlights

· The U.S. Food and Drug Administration (FDA) notified BrainStorm in a written communication that the Agency will hold an Advisory Committee Meeting to review the Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). The FDA noted that it will provide a date for the ADCOM and a Prescription Drug User Fee Act (PDUFA) target action date for the BLA in due course.

· In April 2023, BrainStorm announced the appointment of Dr. Kirk Taylor as Executive Vice President and Chief Medical Officer , continuing a targeted capability build that was launched with the promotion of Dr. Stacy Lindborg to Co-CEO in January 2023. The capability build is being implemented to hire and bring expertise inside BrainStorm in preparation for anticipated growth.

· A presentation at the 2023 MDA Clinical and Scientific Conference featured post hoc sensitivity analyses that suggest a floor effect of the ALSFRS-R resulted in measurement challenges in participants with advanced ALS enrolled in NurOwn’s Phase 3 trial and in historical studies included in the PRO-ACT database. Analyses of data from participants from NurOwn’s Phase 3 trial who were not impacted by the floor effect at baseline revealed statistically significant, clinically meaningful effects with NurOwn on the primary and key secondary endpoints. The presentation was delivered by Dr. Lindborg.

· A presentation delivered by Dr. Lindborg at the 13 th Annual California ALS Research Summit included Phase 3 results showing that, in analyses controlling for the ALSFRS-R floor effect, participants treated with NurOwn had significantly better outcomes compared to participants treated with placebo. These findings aligned with historical data and power calculations of the Phase 3 trial.

· In January 2023, BrainStorm announced a partnership with the Northeast Amyotrophic Lateral Sclerosis (NEALS) Consortium, The ALS Association and I AM ALS to make biospecimens from NurOwn's placebo-controlled Phase 3 ALS trial available for use by the research community. This partnership is in connection to a $500,000 grant previously awarded to BrainStorm by The ALS Association and I AM ALS to support biomarker research. The specimens have been received by the biorepository and access to them will be governed by NEALS.

Financial Results for the Quarter Ended March 31, 2023

Cash, cash equivalents, and short-term bank deposits were approximately $2.2 million as of March 31, 2023, compared to $3 million as of December 31, 2022.

Research and development expenses for the three months ended March 31, 2023 and 2022 were approximately $2.9 million and $2.6 million, respectively.

General and administrative expenses for the three months ended March 31, 2023 and 2022 were approximately $2.2 million and $2.9 million, respectively.

Net loss for the three months ended March 31, 2023 was approximately $5.1 million, as compared to a net loss of approximately $5.4 million for the three months ended March 31, 2022.

Net loss per share for the three months ended March 31, 2023 and 2022 was $0.14 and $0.15, respectively.

Conference Call and Webcast

May 15, 2023, at 8:00 a.m. Eastern Time

Participant Numbers: Toll Free: 877 545 0523 International: 973 528 0016 Entry Code: 771387

Webcast URL: https://shorturl.at/knox2

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Numbers:

Toll Free: 877 481 4010

International: 919 882 2331

Replay Passcode: 48424

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding BrainStorm's Type A meeting with the FDA and the clinical development of NurOwn® as a therapy for the treatment of ALS, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "intend," "should," "could," "will," "believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn®, whether BrainStorm's future interactions with the FDA will have productive outcomes, the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations : John Mullaly LifeSci Advisors, LLC Phone: +1 617-429-3548 jmullaly@lifesciadvisors.com

Media : Lisa Guiterman

Phone: +1 202-330-3431 lisa.guiterman@gmail.com

BrainStorm to Announce First Quarter 2023 Financial Results and Provide a Corporate Update

Tue, 09 May 2023 12:00:00 GMT

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:Toll Free: 877 545 0523 International: 973 528 0016 Entry Code: 771387

Webcast URL: https://shorturl.at/knox2

Those interested in listening to the conference call live via the internet may do so by using the webcast link above or by visiting the "Investors & Media" page of BrainStorm's website at

https://shorturl.at/eko26 and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available until May 29th, 2023.

Replay Numbers:Toll Free: 877 481 4010 International: 919 882 2331 Replay Passcode: 48424

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Contacts:

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Strengthens Leadership Team with Appointment of Kirk Taylor, M.D., as Executive Vice President and Chief Medical Officer

Mon, 24 Apr 2023 12:00:00 GMT

Dr. Taylor will lead the global medical affairs function and launch activities, including product launches, post-approval commercialization efforts and deepening relationships with the medical community. He will also support clinical development and overall corporate strategy, including advancement of the Company's long-term business model.

"Kirk's appointment is the first important step in strengthening a targeted, capability build to expand our medical, regulatory and advocacy teams in preparation for anticipated growth," said Chaim Lebovits, President and CEO of BrainStorm. "His experience as a practicing neurologist and building and leading global medical teams will be an invaluable asset as we work to advance NurOwn to regulatory review with the goal of making it widely available to individuals with ALS. We are thrilled to welcome Kirk to BrainStorm and look forward to the contributions he will make."

BrainStorm Cell Therapeutics is entering a pivotal time, as the company prepares for regulatory review of the company's Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). On March 27, 2023, BrainStorm announced that the U.S. Food and Drug Administration intends to hold an Advisory Committee meeting to prepares for FDA review of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).

Dr. Taylor remarked, "It is an honor to join BrainStorm. This is an exciting time for the company and the ALS community. I am encouraged by the regulatory flexibility that the FDA has shown these rapidly progressing neurological illnesses, such as ALS, where patients are in dire need of new treatments now. I am confident in the effectiveness of NurOwn and grateful for the opportunity to review the full body of clinical evidence with the entire stakeholder community. Time is of the essence for people with ALS and I am ready to hit the ground running."

Dr. Taylor has more than 26 years of experience in global drug development programs, from Phase 1 through post-approval studies, across multiple therapeutic areas including neurology and rare diseases. He is joining BrainStorm from EMD Serono (a Merck KGaA, Darmstadt, Germany company), where, as Senior Vice President, North American Medical Affairs, he led the medical team's efforts across four therapeutic areas and the launch of three new treatments. Prior to EMD Serono, Dr. Taylor served as Senior Vice President, Medical Affairs Strategy and Operations at Verastem Oncology and CMO and Chief of Strategy and Late Phase Development at Finch Therapeutics Group, where he created a plan for filing and commercializing the company's internal assets. Earlier in his career, Dr. Taylor held high-prominent medical roles at companies such as Biogen, Pfizer and Sanofi-Genzyme.

Dr. Taylor holds a B.A. from Harvard University and a M.D. from University of New York Downstate Health Sciences University. He completed a neurology residency at the Albert Einstein College of Medicine and a postdoctoral fellowship in pain management at the University of California, San Francisco. He taught pain management to neurology residents while on faculty at Yale VA Hospital for two years. He also completed executive leadership training at Harvard, Stanford and INSEAD business schools.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding BrainStorm's Type A meeting with the FDA and the clinical development of NurOwn®as a therapy for the treatment of ALS, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "intend," "should," "could," "will," "believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn®, whether BrainStorm's future interactions with the FDA will have productive outcomes, the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces Full Year 2022 Financial Results and Provides a Corporate Update

Thu, 30 Mar 2023 12:00:00 GMT

Biologics License Application for NurOwn ® for the treatment of ALS to be discussed in an upcoming FDA Advisory Committee Meeting

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, March 30, 2023 - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the fiscal year ended December 31, 2022 and provided a corporate update.

“Our priority in 2023 is to advance NurOwn ® through the regulatory process as expeditiously as possible, including making preparations for our upcoming Advisory Committee Meeting,” said BrainStorm’s President and Chief Executive Officer (CEO) Chaim Lebovits and Co-CEO Dr. Stacy Lindborg in a joint statement. “The ADCOM will provide an invaluable opportunity for an open and thoughtful discussion among BrainStorm, regulators, ALS experts, and other key stakeholders on both the urgent need for new ALS therapies and the robust and intricate dataset that we believe supports NurOwn’s approval. As we move towards this important event, our clinical trial results and experienced team give us confidence in our ability to secure a successful outcome and execute on our mission of improving the lives of individuals with ALS.”

Fourth Quarter 2022 and Recent Highlights

U.S. Food and Drug Administration (FDA) notified BrainStorm in a written communication that the Agency will hold an Advisory Committee Meeting (ADCOM) to review the company’s Biologics License Application (BLA) for NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).

· To meet its goal of proceeding to an ADCOM as expeditiously as possible, BrainStorm utilized the FDA’s File Over protest procedure to return the BLA to active review and filed an amendment which responds to most of the outstanding questions previously posed by the FDA. The Agency notified Brainstorm that it will set a date for the ADCOM as well as a Prescription Drug User Fee Act (PDUFA) target action date in due course.

· In January 2023, Dr. Stacy Lindborg was promoted to Co-CEO, launching a targeted capability build designed to position BrainStorm for sustained success.

· A presentation at the 2023 MDA Clinical and Scientific Conference delivered by Dr. Lindborg featured post hoc sensitivity analyses from NurOwn’s Phase 3 ALS trial. The presentation showed that a floor effect was observed in the PRO-ACT database, and a pattern of a plateau in ALSFRS-R total score was accompanied by scale items of 0 suggesting measurement challenges in those with advanced ALS due to the floor effect of the ALSFRS-R in the NurOwn phase 3 trial and historical studies which are included in the PRO-ACT database. Analyses conducted in participants not impacted by the floor effect at baseline of the NurOwn phase 3 trial revealed statistically significant, clinically meaningful effects with NurOwn on the primary and key secondary endpoints.

· Announced a partnership with the Northeast Amyotrophic Lateral Sclerosis (NEALS) Consortium, The ALS Association and I AM ALS to provide biospecimens from NurOwn's placebo-controlled Phase 3 ALS trial to for use by the research community. The specimens are being submitted to the NEALS biorepository in connection with a $500,000 grant previously awarded to BrainStorm by The ALS Association and I AM ALS, to support biomarker research.

· Additional analyses from the Phase 3 trial of NurOwn in ALS were featured in a presentation at the 21 st Annual NEALS Meeting . These analyses further strengthened the body of evidence supporting a clinically meaningful treatment effect with NurOwn in ALS. Two complementary post-hoc sensitivity analysis methods showed that, after controlling for the impact of the ALSFRS-R floor effect, participants treated with NurOwn had a higher rate of clinical response and less function lost across 28 weeks compared to placebo. The presentation was co-delivered by Dr. Lindborg and Merit Cudkowicz, MD, MSC, Chief of Neurology at Massachusetts General Hospital, Julieanne Dorn Professor of Neurology at Harvard Medical School, and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.

· Biomarker data from the Phase 3 trial of NurOwn in ALS were featured in a presentation delivered by Dr. Lindborg at the 5 th Annual ALS ONE Research Symposium . The data showed NurOwn modulated pathways related to neurodegeneration, neuroinflammation, and neuroprotection, with changes that were consistent regardless of a participant’s level of disease progression at baseline. These data provide further evidence of NurOwn’s multifaceted mechanism of action and of the importance of accounting for ALSFRS-R floor effects when evaluating clinical endpoints.

· Findings from the Phase 3 trial of NurOwn in ALS, including biomarker data and analyses accounting for the ALSFRS-R floor effect, were presented at the 13 th Annual California ALS Research Summit by Dr. Lindborg. The presentation demonstrated that NurOwn had significantly better outcomes in analyses controlling for the floor effect. Outcomes that aligned with historical data and power calculations of the trial.

· Biomarker data from the Phase 2 trial of NurOwn in progressive multiple sclerosis were presented at the 38 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The data showed robust increases in levels of neuroprotective biomarkers in cerebrospinal fluid with NurOwn treatment, thereby providing important biological context for clinical outcome data showing large, clinically meaningful improvements in some trial participants, as defined by response criteria, across all endpoints measured. These observed improvements diverged from what was seen in matched patients with progressive MS from the Comprehensive Longitudinal Investigation of Multiple Sclerosis (CLIMB) registry. The presentation was delivered by Jeffrey Cohen, MD, Hazel Prior Hostetler Endowed Chair and Professor of Neurology, Cleveland Clinic Lerner College of Medicine, Director, Experimental Therapeutics, Mellen Center for MS Treatment and Research.

Financial Results for the Year Ended December 31, 2022

Cash, cash equivalents, and short-term bank deposits were approximately $3 million as of December 31, 2022, compared to $22 million as of December 31, 2021.

Research and development expenses for the twelve months ended December 31, 2022, and 2021 were approximately $14 million and $15.2 million, respectively.

General and administrative expenses for the twelve months ended December 31, 2022, and 2021 were approximately $10.9 million and $9.3 million, respectively.

Net loss for the twelve months ended December 31, 2022, was approximately $24.3 million, as compared to a net loss of approximately $24.5 million for the twelve months ended December 31, 2021.

Net loss per share for the twelve months ended December 31, 2022, and 2021 was $0.66 and $0.68, respectively.

Conference Call and Webcast

March 30, 2023, at 8:00 a.m. Eastern Time

Participant Numbers:

Toll Free: 877-545-0523

International: 973-528-0016

Entry Code: 943129

Webcast URL: https://bit.ly/40EuACf

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Numbers:

Toll Free: 877-481-4010

International: 919-882-2331

Replay Passcode: 47908

About NurOwn ®

The NurOwn ® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

BrainStorm filed the BLA for ALS on September 9, 2022. BrainStorm received a Refusal to File letter from FDA on November 8, 2022, and requested a Type A meeting on December 9, 2022, which was held on January 11, 2023. The perspective shared by the FDA review team reflected what was in the previously issued RTF letter. Conversations with the FDA continued, following the Type A meeting, on the best pathway to resolve the outstanding questions that remained. During these discussions, BrainStorm was presented with multiple options to return the BLA to regulatory review, which included the regulatory procedure to File over Protest. With the commitment by FDA to accept amendments that were filed to address items raised in the FTF letter, BrainStorm notified the FDA on February 6, 2023 of our decision to request the FDA to file the NurOwn BLA for ALS over Protest.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn ® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding BrainStorm's Type A meeting with the FDA and the clinical development of NurOwn ® as a therapy for the treatment of ALS, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "intend," "should," "could," "will," "believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn ® , whether BrainStorm's future interactions with the FDA will have productive outcomes, the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations: John Mullaly LifeSci Advisors, LLC Phone: +1 617-429-3548 jmullaly@lifesciadvisors.com

Media: Lisa Guiterman

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn® for the Treatment of ALS

Mon, 27 Mar 2023 12:00:00 GMT

"The FDA provided us with more than one path to an ADCOM for NurOwn. Our goal has always been to make NurOwn available to people living with ALS as quickly as possible, therefore we chose the File Over Protest pathway since this offered the fastest path to an ADCOM and regulatory decision relative to other pathways provided by the FDA," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "The ALS community needs additional treatment options now, and we firmly believe our data support regulatory approval of NurOwn. We are grateful to the FDA for the opportunity to have the clinical evidence supporting NurOwn reviewed."

Stacy Lindborg, Ph.D., BrainStorm's Co-Chief Executive Officer commented, "ALS is a horrific, neurodegenerative disease that moves at a terrifying speed, robbing people of their ability to move, speak, eat, and breathe. Securing an ADCOM represents an important step towards our goal of making NurOwn broadly available to individuals living with ALS who are in urgent need of new, effective therapies. The meeting will provide an open forum for BrainStorm and the FDA, together with medical experts, statisticians, and the ALS community, to thoughtfully review all available evidence supporting NurOwn. We remain confident in NurOwn and we are committed to doing everything in our power to make the product available quickly to people living with ALS. We look forward to a robust scientific discussion."

Brian Wallach, patient advocate and founder of the non-profit organization I AM ALS, added, "I want to thank the FDA and BrainStorm for having this important ADCOM. As was said in the petition submitted to the FDA and signed by over 30,000 people living with ALS, caregivers, and advocates, 'an Advisory Committee Meeting will allow for an independent review of NurOwn as well as the data on efficacy and safety. It is critical for all ALS treatments that they be given the chance to proceed to an ADCOM.' The ALS community has waited years for this ADCOM. It is time to let the science have a full, fair, and transparent hearing so that we can get this treatment to people who are living with and dying from ALS as soon as possible."

Conference Call and webcast:

Brainstorm management will host a conference call and webcast, including a Q&A session, today, March 27, 2023, at 8:00 a.m. ET. The investment community may participate in the conference call by dialing the following numbers:

Toll Free: 888-506-0062 International: 973-528-0011 Entry Code: 102674

Webcast URL: https://bit.ly/3lAfCOv

Those interested in listening to the conference call live via the internet may do so by using the webcast link above or by visiting the 'Investors & Media' page of BrainStorm's website at

https://brainstorm-cell.com/investors/events-and-presentations/ and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Numbers: Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 47939

Teleconference Replay Expiration: Monday, April 10, 2023.

Webcast link: https://bit.ly/3lAfCOv (Webcast Replay Expiration: Wednesday, March 27, 2024)

About NurOwn®

BrainStorm filed the BLA for ALS on September 9, 2022. BrainStorm received a Refusal to File letter from FDA on November 8, 2022, and requested a Type A meeting on December 9, 2022, which was held on January 11, 2023. On January 25, 2023, Brainstorm held a meeting with the Center for Biologics Evaluation and Research (CBER) as part of dispute resolution, during which FDA provided multiple options to return the BLA to active review and an FDA Advisory Committee Meeting.

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm to Announce Fourth Quarter and Fiscal Year 2022 Financial Results and Provide a Corporate Update

Tue, 21 Mar 2023 12:00:00 GMT

BrainStorm's President and Chief Executive Officer, Chaim Lebovits, and Co-Chief Executive Officer, Stacy Lindborg, PhD will present a corporate update after which investment community questions will be answered. Joining Mr. Lebovits and Dr. Lindborg in the Q&A session will be David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Alla Patlis, CPA, MBA, Interim Chief Financial Officer.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:Toll Free: 877 545 0523 International: 973 528 0016 Entry Code: 943129

Webcast URL: https://bit.ly/40EuACf

Participants will be greeted by an operator and asked for the access code. If a caller does not have the code, they can reference the company name. We have found that using access codes expedites entry into the call and suggest the code be distributed with the dial in numbers.

Those interested in listening to the conference call live via the internet may do so by using the webcast link above or by visiting the "Investors & Media" page of BrainStorm's website at

https://brainstorm-cell.com/investors/events-and-presentations/ and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Teleconference Replay Number:

Toll Free: 877 481 4010International: 919 882 2331Replay Passcode: 47908

Teleconference Replay Expiration: Thursday, April 13, 2023

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts:

Contacts

Contacts:

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

Phone: +1 202-330-3431

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Partners with NEALS, The ALS Association, and I AM ALS to Provide Public Access to Biospecimens from NurOwn's Phase 3 ALS Study

Tue, 10 Jan 2023 12:00:00 GMT

The specimens submitted to the NEALS biorepository include serum and cerebrospinal fluid (CSF) samples collected from trial participants treated with placebo. Samples of both biofluids were collected in a matched fashion and longitudinally at multiple (up to seven) time points over a 20-week period, allowing for the evaluation of intra-patient biomarker changes over time as well as comparisons of biomarker levels between serum and CSF.

"Our Phase 3 trial included one of the largest longitudinal specimen collection protocols in trial participants with ALS, which has allowed us to perform extensive and unique biomarker analyses," said Stacy Lindborg PhD, Co-Chief Executive Officer of BrainStorm. "These analyses have greatly increased our understanding of both the mechanisms driving ALS progression, as well as the biological changes in participants treated with NurOwn. We are pleased to be providing the research community with access to our clinical samples, which will drive new research and can facilitate the discovery of new breakthroughs for patients with ALS."

Chaim Lebovits, Chief Executive Officer of BrainStorm, commented, "We would like to thank The ALS Association and I AM ALS for providing important funding for our biomarker analyses, as well as NEALS for housing our clinical samples for future use by the research community. The opportunity to collaborate with these three premier ALS organizations has been invaluable as BrainStorm works to advance NurOwn through the regulatory process and towards a potential approval."

"As a clinical research organization, NEALS is committed to using the NEALS Biorepository to help ALS researchers around the globe identify biomarkers and novel therapies as rapidly as possible. We are deeply appreciative of this contribution of samples, which adds to the biorepository and helps facilitate that goal," said James Berry, MD, MPH

"We are so proud to support BrainStorm's biomarker program which will help change ALS drug development. Biomarkers are critical to understanding the biology of ALS and enabling targeted new treatments. This program gives people living with ALS hope that we will see more and more approved treatments, making ALS the next cancer," said Brian Wallach, co-Founder I AM ALS.

"We are pleased to have supported the NurOwn biomarkers study with I AM ALS, and are encouraged the scientific community will now have access to these biospecimens. This will allow for independent replication and validation of the critical biomarkers data," said Kuldip Dave, Ph.D., Senior Vice President of Research for The ALS Association

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

About the Northeast ALS Consortium

The Northeast ALS Consortium (NEALS) is an international, independent, non-profit group of 147 research sites around the world who collaboratively conduct clinical research in Amyotrophic Lateral Sclerosis (ALS) and other motor neuron diseases. The mission of NEALS is to translate scientific advances into clinical research and new treatments for people with ALS and motor neuron disease.

The NEALS Biorepository contains serum, plasma, cerebrospinal fluid (CSF), whole blood, extracted DNA, and urine samples from research studies of ALS and motor neuron disease. Samples from this repository are available to researchers for the purpose of furthering the understanding of ALS or motor neuron disease and developing disease biomarkers.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics to Present at Biotech Showcase™ 2023

Thu, 05 Jan 2023 12:00:00 GMT

Registered attendees may attend the presentation in-person or view it via webcast through the Biotech Showcase platform.

Those interested in registering for Biotech Showcase may do so using the link, here.

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces Promotion of Dr. Stacy Lindborg to Co-Chief Executive Officer

Wed, 04 Jan 2023 12:00:00 GMT

Dr. Lindborg, who joined BrainStorm in 2020 and is based in the U.S., brings to her expanded role more than 25 years of pharmaceutical industry experience in R&D, strategy development, regulatory, and analytics. She will work alongside Mr. Chaim Lebovits, who is retaining his position as President and CEO. In addition, Dr. Ralph Kern will retire from his current role as President and Chief Medical Officer in January 2023 and will continue to support BrainStorm as part of the company's Scientific Advisory Board.

"I am pleased to announce Stacy's promotion to Co-CEO which is part of a broader strategic initiative to build out our leadership team and position BrainStorm for success," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "Stacy is a strong, collaborative leader who is passionate about transforming the lives of patients through innovation. Her track record in late-stage clinical development and commercial strategy means that she is exceptionally well qualified to guide BrainStorm as we prepare to enter our next phase as a company. I look forward to working with Stacy as we execute on our ultimate goals -- to make NurOwn available to patients and to create value as a commercial organization."

"It has been the focus of my career to drive innovation at the heart of drug development and to bring forward life-altering medicines for patients in need. BrainStorm has produced and developed NurOwn, a novel cell treatment, generating compelling data that I am more convinced than ever holds the promise to be a valuable treatment for patients who are suffering. Having worked closely with Chaim over the past two years, I am incredibly impressed by his dedication to patients, the breadth of experience and business insights he brings to his job on a daily basis, and his unique ability to invest and build for the long term," Dr. Lindborg commented. "I couldn't be more thrilled to transition into this expanded role at BrainStorm. Together with Chaim and our talented team at BrainStorm, I will relentlessly focus on the regulatory process to secure a path with FDA with the goal to make NurOwn available for ALS patients."

Mr. Lebovits added, "I would like to thank Ralph for his important contributions and dedicated service over the past six years as Chief Medical Officer. I am pleased that he will remain actively involved with BrainStorm as a member of our Scientific Advisory Board and I look forward to his continued contributions."

Stacy Lindborg, Ph.D. joined BrainStorm in 2020 serving most recently as Executive Vice President and Chief Development Officer. Her experience includes senior roles at Eli Lilly & Company and Biogen. At Biogen she was Vice President, Analytics and Data Science, and managed a team that contributed in material ways towards the regulatory approval of products such as Spinraza®. At Eli Lilly & Company, she held positions of increasing responsibility including Head of R&D Strategy, where she was responsible for characterizing the productivity of the portfolio and driving key R&D strategy projects including the annual R&D Long-Range Plan. She was also Leader of Zyprexa Product Management in which she was responsible for R&D, Commercial and Manufacturing plans. She was accountable for driving market share through product differentiation, global registration and launching of an injectable form of Zyprexa, working through regulatory manufacturing inspections and 483 citations. Zyprexa had peak sales of $4.7 billion. Dr. Lindborg holds a Ph.D. in statistics from Baylor University. She serves on the Scientific Advisory Board of biotechnology and technology companies and on the board of directors of Imunon, Inc. and the Massachusetts Down Syndrome Congress.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and a grant from IAMALS and the ALS Association. BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding BrainStorm's interactions with the FDA and the clinical development of NurOwn® as a therapy for the treatment of ALS, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "intend," "should," "could," "will," "believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn®, whether BrainStorm's interactions with the FDA, including the upcoming Type A meeting, will have productive outcomes, the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Announces Type A Meeting with FDA Granted for NurOwn®

Tue, 27 Dec 2022 12:00:00 GMT

"We look forward to the Type A meeting which will provide an opportunity to discuss the path forward for NurOwn in ALS, including a possible Advisory Committee Meeting," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We believe that an Advisory Committee Meeting would serve as an important part of the review process and would provide an open forum for BrainStorm, together with medical experts, statisticians, patients and other members of the ALS community to discuss the body of clinical evidence supporting NurOwn. We intend to provide a further update once we have received the minutes from the meeting, or when we have more clarity on the next steps in the approval process."

About the Phase 3 Trial of NurOwn in ALS

BrainStorm previously completed a Phase 3 trial in approximately 200 participants with ALS (Cudkowicz et al., 2022 Muscle and Nerve). In an attempt to examine a real-world population, the study enrolled people with more advanced disease than other late-stage ALS trials. In fact, more than a third of these participants with advanced disease entered the trial with one or more dimensions of physical function (e.g., dressing/hygiene, cutting food, walking) starting at the lowest possible score of 0 on the ALSFRS-R; thereby preventing the measurement of further deterioration. A pre-specified subgroup of participants, with baseline ALSFRS-R ≥35, which controls for this 'scale effect' showed a trend to a meaningful increase in the clinical response with NurOwn compared to placebo. The secondary endpoint, average ALSFRS-R change from baseline to 28 weeks in this subgroup, was statistically significant (p=0.050, Muscle and Nerve Supplemental File and Muscle and Nerve Erratum). In addition, post-hoc sensitivity analyses were presented in November 2022 (21st Annual NEALS Meeting 2022) which also showed a statistical trend towards a clinically meaningful treatment effect with NurOwn across subgroups, and one that is consistent with the pre-specified subgroup of participants with less advanced ALS at baseline. Finally, biomarker data in all trial participants also showed consistent patterns of NurOwn reducing markers of inflammation and neurodegeneration, and increasing neuroprotective and anti-inflammatory markers relative to placebo, further supporting the notion that trial participants taking NurOwn are indeed experiencing a positive biological effect (ALS ONE Research Symposia 2022).

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Submits Type A Meeting Request to U.S. Food and Drug Administration

Mon, 12 Dec 2022 12:00:00 GMT

As previously reported, the contents of the refusal to file letter focus on topics related to chemistry, manufacturing, and controls (CMC), as well as clinical data and statistics. As part of the Type A Meeting, BrainStorm intends to discuss a path to an FDA Advisory Committee Meeting.

"Participating in a Type A meeting will be an important next step towards enabling NurOwn's advancement through the regulatory process," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "The extensive briefing package submitted with our request contains a comprehensive strategy to fully address the CMC matters raised in the refusal to file letter. We anticipate achieving quick alignment with the FDA on the CMC strategy and expect that its execution will be straightforward. We therefore anticipate a Type A meeting focused primarily on discussing how we can secure an Advisory Committee Meeting, which we believe will be a critical step on NurOwn's path towards approval as an ALS therapy."

About the Phase 3 Trial of NurOwn in ALS

BrainStorm previously completed a Phase 3 trial in approximately 200 participants with ALS (Cudkowicz et al., 2022 Muscle and Nerve). In an attempt to examine a real-world population, the study enrolled people with more advanced disease than other late-stage ALS trials. In fact, more than a third of these participants with advanced disease entered the trial with one or more dimensions of physical function (e.g., dressing/hygiene, cutting food, walking) starting at the lowest possible score of 0 on the ALSFRS-R; thereby preventing the measurement of further deterioration. A pre-specified subgroup of participants, with baseline ALSFRS-R ≥35, which controls for this "scale effect" showed a trend to a meaningful increase in the clinical response with NurOwn compared to placebo. The secondary endpoint, average ALSFRS-R change from baseline to 28 weeks in this subgroup, was statistically significant (p=0.050, Muscle and Nerve Supplemental File and Muscle and Nerve Erratum). In addition, post-hoc sensitivity analyses were presented in November 2022 (21st Annual NEALS Meeting 2022) which also showed a statistical trend towards a clinically meaningful treatment effect with NurOwn across subgroups, and one that is consistent with the pre-specified subgroup of participants with less advanced ALS at baseline. Finally, biomarker data in all trial participants also showed consistent patterns of NurOwn reducing markers of inflammation and neurodegeneration, and increasing neuroprotective and anti-inflammatory markers relative to placebo, further supporting the notion that trial participants taking NurOwn are indeed experiencing a positive biological effect (ALS ONE Research Symposia 2022).

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding BrainStorm's request for a Type A meeting with the FDA and the clinical development of NurOwn® as a therapy for the treatment of ALS, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "intend," "should," "could," "will," "believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn®, whether the FDA will grant BrainStorm's request for a Type A meeting and whether BrainStorm's future interactions with the FDA will have productive outcomes, the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces Third Quarter 2022 Financial Results and Provides a Corporate Update

Mon, 14 Nov 2022 12:00:00 GMT

BrainStorm to request Type A meeting with FDA to facilitate NurOwn’s advancement following receipt of a refusal to file letter regarding the company’s new Biologics License Application

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, November 14, 2022 - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2022, and provided a corporate update.

“Our commitment to ALS patients and our belief in NurOwn’s potential to address their unmet medical needs remains unchanged, despite our receipt of a refusal to file letter regarding our new Biologics License Application,” said Chaim Lebovits, Chief Executive Officer of Brainstorm. “Our next step is to request a Type A meeting with the FDA, which will help us explore the best path forward to accomplish our goal of providing ALS patients with broad access to NurOwn. We believe that an important part of the regulatory process will be an FDA Advisory Committee meeting to discuss NurOwn, as this will allow a fair hearing in an open and transparent setting. We are grateful for the support we are receiving and look forward to providing more information on our Earnings Call around the FDA feedback we have received, and our next steps.”

Third Quarter 2022 and Recent Highlights

· BrainStorm intends to request a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the contents of a refusal to file letter issued by the FDA regarding the company’s New Biologics License Application (BLA) for NurOwn for the treatment of ALS. As part of the Type A meeting, the company plans to discuss with the FDA a path to an FDA Advisory Committee meeting.

· Additional analyses from NurOwn’s Phase 3 ALS trial that account for measurement limitations in the lower part of the Revised ALS Functional Rating Scale (ALSFRS-R) were presented at the 21 st Annual NEALS Meeting . These analyses add to the robust body of evidence supporting a clinically meaningful treatment effect with NurOwn in ALS, as two complementary post-hoc sensitivity analysis methods showed that, after controlling for the impact of the ALSFRS-R floor effect, participants treated with NurOwn had a higher rate of clinical response and less function lost across 28 weeks compared to placebo. The presentation was jointly delivered by Stacy Lindborg, PhD, Executive Vice President and Chief Development Officer at BrainStorm and Merit Cudkowicz, MD, MSC, Chief of Neurology at Massachusetts General Hospital, Julieanne Dorn Professor of Neurology at Harvard Medical School, and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.

· Biomarker analyses from NurOwn’s Phase 3 ALS trial presented at the 5th Annual ALS ONE Research Symposium confirmed the importance of accounting for ALSFRS-R floor effects when evaluating clinical endpoints. The new biomarker data presented indicate that NurOwn had similar biological effects on Phase 3 trial participants regardless of the level of disease progression at baseline, providing further evidence confirming NurOwn’s multifaceted mechanism of action. Furthermore, biomarkers spanning the 3 key pathways of neurodegeneration, neuroinflammation and neuroprotection were identified by a pre-specified model linking the changes in biomarkers in participants treated with NurOwn to the clinical outcomes observed in the trial. The presentation was delivered by Dr. Stacy Lindborg, Executive Vice President and Chief Development Officer at Brainstorm.

· Full results from a single-arm, Phase 2 trial of NurOwn were published in the peer-reviewed Multiple Sclerosis Journal. The results demonstrate NurOwn’s safety and provide preliminary evidence of efficacy in patients with progressive multiple sclerosis (MS). Treatment with NurOwn resulted in large, clinically meaningful improvements in some progressive MS patients, as defined by response criteria, across all endpoints measured. These observed improvements diverged from what was seen in matched patients with progressive MS from the Comprehensive Longitudinal Investigation of Multiple Sclerosis (CLIMB) registry. In addition, biomarker analyses confirmed NurOwn’s proposed mechanism of action in progressive MS by showing consistent treatment effects in neuroinflammation and neuroprotection pathways.

· Biomarker data from the Phase 2 trial of NurOwn in progressive MS was presented at the 38 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) by Jeffrey Cohen, MD, Hazel Prior Hostetler Endowed Chair and Professor of Neurology, Cleveland Clinic Lerner College of Medicine, Director, Experimental Therapeutics, Mellen Center for MS Treatment and Research. The presented data provide important biological context for the trial’s observed clinical outcomes, as they showed NurOwn treatment resulting in robust increases in neuroprotective biomarkers in cerebrospinal fluid.

Financial Results for the Third Quarter Ended September 30, 2022

Cash, cash equivalents, and short-term bank deposits were approximately $7.4 million as of September 30, 2022, compared to $12.2 million as of June 30, 2022.

Research and development expenses for the three months ended September 30, 2022, and 2021 were approximately $3.8 million and $3.6 million, respectively.

General and administrative expenses for the three months ended September 30, 2022, and 2021 were approximately $3.1 million and $1.7 million, respectively.

Net loss for the three months ended September 30, 2022, was approximately $6.9 million, as compared to a net loss of approximately $5.3 million for the three months ended September 30, 2021.

Net loss per share for the three months ended September 30, 2022, and 2021 was $0.19 and $0.15, respectively.

Conference Call and Webcast

November 14, 2022, at 8:00 a.m. Eastern Time

Participant Numbers:

Toll Free: 877-545-0523

International: 973-528-0016

Entry Code: 710870

Webcast URL: https://bit.ly/3AeRBkr

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Numbers:

Toll Free: 877-481-4010

International: 919-882-2331

Replay Passcode: 47063

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding BrainStorm’s intent to request a Type A meeting with the FDA and the clinical development of NurOwn® as a therapy for the treatment of ALS, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "intend," "should," "could," "will," "believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, management’s ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn®, whether the FDA will grant BrainStorm’s request for a Type A meeting and whether BrainStorm’s future interactions with the FDA will have productive outcomes, , the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations: John Mullaly LifeSci Advisors, LLC Phone: +1 617-429-3548 jmullaly@lifesciadvisors.com

Media: Lisa Guiterman

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Receives Refusal to File Letter from FDA for its New Biologics License Application for NurOwn for the treatment of ALS

Thu, 10 Nov 2022 12:00:00 GMT

"While we are disappointed that the FDA has not accepted our BLA for NurOwn in ALS, we remain committed to NurOwn's advancement as a treatment for this devastating disease. The company intends to request a Type A meeting and looks forward to continued discussions with the FDA," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We continue to believe that NurOwn's Phase 3 trial represents a significant contribution to ALS therapy and will continue to work tirelessly to address the needs of people living with ALS by advancing science and partnering with researchers around the world."

The three, co-principal investigators of the NurOwn Phase 3 study were Dr. Robert Brown, Director of the Program in Neurotherapeutics at the University of Massachusetts Medical School, Dr. Merit Cudkowicz, Chief of Neurology at Massachusetts General Hospital, Julieanne Dorn Professor of Neurology at Harvard Medical School, Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and Dr. Tony Windebank, Professor of Neurology and Judith and James Pape Adams Foundation Professor of Neuroscience at Mayo Clinic.

Drs. Brown, Cudkowicz and Windebank jointly stated, "While the pre-specified primary outcome measure was not met, there were participants with beneficial clinical effects and overall changes in relevant biomarkers of drug effect. Understanding whether there are people with ALS who might respond better to NurOwn is important given the unmet therapeutic need. As the three co-PIs of the Phase 3 study of NurOwn, we support continued discussions with the FDA on the best path forward."

BrainStorm completed a Phase 3 trial in 200 participants with ALS (Cudkowicz et al., 2022 Muscle and Nerve). In the attempt to examine a real-world population, the study enrolled people with more advanced disease than other late-stage ALS trials. In fact, more than a third of these participants with advanced disease entered the trial with the one or more dimensions of physical function (e.g., dressing/hygiene, cutting food, walking) starting at the lowest possible score of 0 on the ALSFRS-R; thereby preventing the measurement of further deterioration. A pre-specified subgroup of participants, with baseline ALSFRS-R³35, which controls for this "scale effect" showed a trend to a meaningful increase in the clinical response with NurOwn compared to placebo. The secondary endpoint, average ALSFRS-R change from baseline to 28 weeks in this subgroup, was statistically significant (p=0.050, Muscle and Nerve Supplemental File and Muscle and Nerve Erratum). In addition, post-hoc sensitivity analyses were presented last week (21st Annual NEALS Meeting 2022) which also showed a statistical trend towards a clinically meaningful treatment effect with NurOwn across subgroups, and one that is consistent with the pre-specified subgroup of participants with less advanced ALS at baseline. Finally, biomarker data in all trial participants also showed consistent patterns of NurOwn reducing markers of inflammation and neurodegeneration, and increasing neuroprotective and anti-inflammatory markers relative to placebo, further supporting the notion that trial participants taking NurOwn are indeed experiencing a positive biological effect (ALS ONE Research Symposia 2022).

BrainStorm will discuss its corporate strategy and plans to advance NurOwn's development on its third quarter 2022 earnings call, to take place at 8:00 a.m. Eastern Time on Monday, November 14, 2022. Those interested in joining the call can find additional information here.

Phase 3 NurOwn Study Design

The Phase 3 NurOwn trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of repeat doses of NurOwn in 189 ALS participants. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford, Dr. Robert Baloh); California Pacific Medical Center (Prof. Robert Miller, Dr. Jonathan Katz); Massachusetts General Hospital (Prof. Merit Cudkowicz, Dr. James Berry); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as participants with at least a 3-point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn or placebo. Participants were followed for 28 weeks after treatment. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment. Secondary endpoints included the percentage of participants with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our products and services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics to Announce Third Quarter Results and Provide a Corporate Update

Mon, 07 Nov 2022 12:00:00 GMT

BrainStorm's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Chief Development Officer, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Alla Patlis, CPA, MBA, Interim Chief Financial Officer.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:Toll Free: 877-545-0523International: 973-528-0016Entry Code: 710870

Webcast URL: https://bit.ly/3AeRBkr

The replay of the conference call can be accessed by dialing the numbers below, and will be available for 14 days.

Replay Numbers:Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 47063

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Presents New Analyses from NurOwn's Phase 3 ALS Trial at the 21st Annual NEALS Meeting

Mon, 07 Nov 2022 12:00:00 GMT

A copy of the poster is available on the Events & Presentation page of Brainstorm's corporate website.

"We are pleased to be sharing this confirmatory evidence of NurOwn's clinically-meaningful effects with the ALS community at this year's NEALS meeting," stated Dr. Stacy Lindborg. "Our confidence in NurOwn continues to grow as we conduct further analysis of the Phase 3 data. Two orthogonal approaches designed to account for ALSFRS-R's inability to accurately assess disease progression in patients with advanced ALS demonstrate a statistical trend towards a clinically meaningful treatment effect with NurOwn, and one that is consistent with the pre-specified subgroup of participants with less advanced ALS at baseline (ALSFRS-R ≥ 35). We believe this consistency, together with the biomarker data we reported last month at the ALS ONE Symposium, adds weight to the important conclusions we can draw from our new analyses."

Dr. Cudkowicz commented, "We have learned a lot about both the clinical and biological (biomarker) effects of NurOwn in people with ALS. This presentation provides new insights into the NurOwn phase 3 trial demonstrating the consistency of treatment effect with NurOwn. We were honored to present these results at the NEALS annual conference."

Poster Highlights

NurOwn Phase 3 Trial Patient Population and ALSFRS-R Floor Effect

Pre-specified Subgroup Analyses

Post-hoc Analyses to Account for ALSFRS-R Floor Effects

Biomarker Data

Phase 3 NurOwn Study Design

The Phase 3 NurOwn trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of repeat doses of NurOwn in 189 ALS participants. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford, Dr. Robert Baloh); California Pacific Medical Center (Prof. Robert Miller, Dr. Jonathan Katz); Massachusetts General Hospital (Prof. Merit Cudkowicz, Dr. James Berry); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as participants with at least a 3-point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn or placebo. Participants were followed for 28 weeks after treatment. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment. Secondary endpoints included the percentage of participants with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Presents NurOwn® Phase 2 Progressive MS Biomarker Data at the 38th ECTRIMS Congress

Thu, 20 Oct 2022 12:00:00 GMT

Cerebrospinal fluid (CSF) biomarker analyses from the phase 2 progressive MS clinical trial demonstrate that intrathecal NurOwn treatment resulted in robust increases in CSF neuroprotective biomarkers, consistent with the proposed mechanism of action, and provide important biological context for the observed clinical trial outcomes.

The poster will be presented by Jeffrey Cohen, MD, Hazel Prior Hostetler Endowed Chair and Professor of Neurology, Cleveland Clinic Lerner College of Medicine, Director, Experimental Therapeutics, Mellen Center for MS Treatment and Research.

Presentation Details:

NurOwn (MSC-NTF) Phase 2 Clinical Trial in Progressive MS: Effects on CSF Neuroprotective Biomarkers Presenter: Jeffrey Cohen, MD Session Title: Poster Session 2 Session Date: 27.10.2022 Presenting Time: 17:00 h. Central European Time Poster Number: P721 (link to published abstracts)

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

+1 (617) 429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

BrainStorm Presents New Biomarker Analyses from NurOwn's Phase 3 ALS Trial at the ALS ONE Research Symposium

Fri, 07 Oct 2022 12:00:00 GMT

"The new biomarker analyses presented today provide further evidence of NurOwn's multifaceted mechanism of action and show consistent patterns in study participants regardless of the level of disease progression at baseline," said Dr. Stacy Lindborg, Chief Development Officer at Brainstorm. "This compelling finding confirms the importance of accounting for ALSFRS-R floor effects when evaluating clinical endpoints in our phase 3 trial and may further validate the results of subgroup analyses on clinical endpoints in our Phase 3 study which minimize the ALSFRS-R floor. When the subgroup of participants above 26 are analyzed, 2 points of function are preserved on average across 28 weeks in participants treated with NurOwn compared to placebo (p<.05). Moreover, statistical modeling identified biomarkers that have the potential to predict clinical response to NurOwn observed in the trial, with markers of neuroinflammation, neurodegeneration, and neuroprotection selected in the final model. Novel therapies that simultaneously target multiple pathways may offer great potential in the treatment of ALS and highlights the advantages that may come with NurOwn's ability to simultaneously modulate multiple biological pathways."

Presentation Highlights

NurOwn Phase 3 Trial Patient Population and Clinical Outcomes

Biomarker Data

Chaim Lebovits, Chief Executive Officer of Brainstorm commented, "We are grateful to ALS ONE for the opportunity to present these important new data on NurOwn. The biomarker data and statistical analyses further our understanding of NurOwn's mechanism of action and therapeutic potential."

A copy of the of Dr. Lindborg's presentation is available here and on the Events & Presentation page of Brainstorm's corporate website. A replay of Dr. Lindborg's recorded presentation will be available on the Events & Presentation page as of 12pm U.S. EST on Wednesday, October 12, 2022.

Phase 3 NurOwn Study Design The Phase 3 NurOwn trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of repeat doses of NurOwn in 189 ALS participants. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford, Dr. Robert Baloh); California Pacific Medical Center (Prof. Robert Miller, Dr. Jonathan Katz); Massachusetts General Hospital (Prof. Merit Cudkowicz, Dr. James Berry); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as participants with at least a 3-point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn or placebo. Participants were followed for 28 weeks after treatment. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment. Secondary endpoints included the percentage of participants with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

About NurOwn® The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future BLA submission, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, BrainStorm's plan to submit a BLA for NurOwn® to the FDA, prospects that the FDA will accept BrainStorm's BLA for NurOwn® for filing and review, prospects that the FDA does not view BrainStorm's NurOwn® product candidate to have demonstrated adequate safety or effectiveness, prospects for future regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for BrainStorm's products, if approved, and services, the ability to secure and maintain research institutions to conduct BrainStorm's clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, health reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; the impacts of the COVID-19 pandemic and additional strains of COVID-19 or any other health epidemic on our clinical trials, supply chain, and operations; potential delays in any planned or anticipated review or interactions with the FDA due to disruptions at, or inadequate funding of, the FDA; the impact of global economic and political developments on our business, including rising inflation and capital market disruptions; the current conflict in Ukraine, economic sanctions and economic slowdowns or recessions that may result from such development; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Announces Peer Reviewed Publication of Results from the NurOwn® Phase 2 Progressive MS Trial in Multiple Sclerosis Journal

Thu, 15 Sep 2022 12:00:00 GMT

Results from the Phase 2, single-arm, open-label study demonstrated NurOwn's safety and provided preliminary evidence of its efficacy in people with progressive MS. Additionally, biomarker analyses confirmed NurOwn's proposed mechanism of action by showing consistent treatment effects in neuroinflammation and neuroprotection pathways.

Twenty participants were enrolled into the Phase 2 trial, with seventeen receiving all three scheduled NurOwn treatments. The mean age of study participants was 47 years with a mean expanded disability status scale (EDSS) score of 5.4 at screening. Results from the trial were compared to 48 matched control patients who were selected from the from the Comprehensive Longitudinal Investigation of Multiple Sclerosis (CLIMB) registry (Brigham and Women's Hospital and the Ann Romney Center for Neurologic Diseases) at the beginning of the trial.

Treatment with NurOwn resulted in large, clinically meaningful improvements in some patients, as defined by response criteria, across all endpoints measured. These endpoints included timed 25-foot walk speed (T25FW), 9-hole peg test (9HPT), multiple sclerosis walking scale (MSWS), symbol digit modality test (SDMT), and low contrast letter acuity (LCLA). These observed improvements diverged from what was seen in matched patients with progressive MS from the CLIMB registry. Key data from the trial, as well as relevant comparisons to the matched CLIMB registry patients, are shown below.

Across all participants, improvements in function as measured by LCLA, SDMT and MS Functional Composite (MSFC) were observed. Mean improvements from baseline of 3.3 points in the LCLA binocular (2.5% contrast), 3.8 points on the SDMT, and 0.18 points in MSFC were observed in treated trial participants. The corresponding changes in matched CLIMB registry patients estimated at 28 weeks showed declines in function on the LCLA and MSFC. The average change in function decline as measured by T25FW, 9HPT, and EDSS across all treated trial participants demonstrated stabilization of functional decline, with similar or slightly worse findings observed in the matched CLIMB registry patients for the same endpoints.

There were no adverse events related to worsening of MS disease and no clinically significant changes in safety lab results/vital signs, confirming NurOwn's favorable safety profile. Two patients developed symptoms of low back and leg pain, consistent with arachnoiditis, occurring in one of three treatments in both participants.

Treatment also consistently resulted in increases in cerebrospinal fluid neuroprotective factors (VEGF–A, HGF, NCAM-1, Follistatin, LIF and Fetuin–A) and reductions in inflammatory biomarkers (MCP-1, sCD27, SDF-1, and Osteopontin), confirming NurOwn's proposed mechanism of action in progressive MS.

"We were pleased that the study's initial results showed efficacy in patients with progressive MS," said Jeffrey Cohen, M.D., Hazel Prior Hostetler Endowed Chair Professor, Cleveland Clinic Lerner College of Medicine, Director, Experimental Therapeutics, Mellen Center for MS Treatment and Research, and the paper's lead author. "There are both promising biological and preliminary clinical signals of a treatment effect that will require confirmation in a randomized trial."

"There is a high unmet need for better treatments for progressive forms of MS and we congratulate the Brainstorm Cell Therapeutics team for the successful completion and publication of this important study. We look forward to future studies that will help to fully understand the potential of NurOwn and other cell-based therapies for this hard-to-treat form of disease" said Bruce Bebo, EVP Research National MS Society.

Chaim Lebovits, Chief Executive Officer, BrainStorm Cell Therapeutics stated, "Having these data peer reviewed and published in the prestigious Multiple Sclerosis Journal is an important step in the evaluation of NurOwn in progressive MS. We appreciate the expertise and commitment of the study investigators and contributions of study participants to advance our understanding of NurOwn's cellular technology platform. Thanks to their efforts and those of the BrainStorm team, we believe we are closer to providing a meaningful treatment option for those with progressive MS".

Ralph Kern, M.D., MHSc, President and Chief Medical Officer of BrainStorm Cell Therapeutics and co-author of the paper commented, "This publication provides preliminary evidence of NurOwn's potential to modify functional outcomes in progressive MS, which we believe warrants further study. In addition, consistent changes in cerebrospinal fluid neuroinflammation and neuroprotection biomarkers reveal how NurOwn may impact disease mechanisms in progressive MS and are complementary to biomarker results observed in our Phase 3 ALS trial. These observations provide further support for NurOwn as a platform technology with potential broad applications and will bolster BrainStorm's efforts to bring much needed solutions to patients with progressive MS, ALS, and other neurodegenerative diseases."

Study Design The Phase 2 study (BCT-101) was designed to evaluate the safety, efficacy, and biomarker effects of three intrathecal administrations of NurOwn (MSC-NTF cells), given at two-month intervals, to adults with progressive MS. The trial was conducted at four MS centers of excellence: Cleveland Clinic Mellen Center for MS, Icahn School of Medicine at Mount Sinai, Keck School of Medicine of the University of Southern California, and Stanford University School of Medicine. Twenty participants ages 18-65 with progressive MS were enrolled and 17 received all three treatments and were followed for up to 28 weeks. Participants had baseline EDSS scores of between 3.0 and 6.5, were able to walk 25 feet in 60 seconds or less and had not experienced an MS relapse in the 6 months prior to study enrollment.

The primary efficacy outcome was pre-specified improvement (≥25%) in T25FW or 9-HPT. Additional efficacy endpoints included pre-specified improvements in EDSS, SDMT, LCLA, and MSWS-12. The efficacy outcomes were compared to a pre-specified matched group of progressive MS patients from CLIMB registry (n=48) (Tanuja Chitnis, M.D. Brigham and Women's Hospital and the Ann Romney Center for Neurologic Diseases). The study was sponsored by Brainstorm Cell Therapeutics with additional financial support for biomarker analyses received from the National Multiple Sclerosis Society, Fast-Forward Commercial Research Funding Program. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03799718.

About NurOwn® The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our products and services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS Investor Relations: John Mullaly LifeSci Advisors, LLC Phone: +1 617-429-3548 jmullaly@lifesciadvisors.com Media: Lisa Guiterman lisa.guiterman@gmail.com

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Lisa Guiterman

lisa.guiterman@gmail.com

BrainStorm Cell Therapeutics Announces Second Quarter 2022 Financial Results and Provides a Corporate Update

Mon, 15 Aug 2022 12:00:00 GMT

BrainStorm to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for NurOwn® for the treatment of ALS

New clinical analyses reinforce the conclusions from NurOwn’s® Phase 3 clinical trial

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, August 15, 2022 - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2022, and provided a corporate update. The company also announced its decision to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration for NurOwn ® for the treatment of amyotrophic lateral sclerosis (ALS).

BrainStorm announces decision to submit a BLA to the FDA for NurOwn® for the treatment of ALS

“Brainstorm Cell Therapeutics is at a pivotal moment as a company as we finalize the regulatory filing for NurOwn ® in the treatment of ALS. The continued analysis and the feedback received from the many scientific presentations of NurOwn’s ® Phase 3 data have uncovered key insights that furthered our understanding of the product mechanism of action and therapeutic potential and strengthened the conclusions of NurOwn’s ® efficacy,” said Chaim Lebovits, Chief Executive Officer. “After carefully considering these learnings, the totality of the evidence from NurOwn’s ® clinical studies, and the feedback received from key opinion leaders and the broader ALS community, we will submit a Biologics License Application to the FDA. We are deeply grateful to the ALS clinical experts, members of the ALS community and faithful investors for their contribution to the development of NurOwn ® and what it may mean to those living with ALS. Their contributions and commitment made our current progress possible and continue to inspire us as we prepare for the considerable work ahead. We intend to provide additional updates upon learning whether the FDA files our BLA submission.”

New clinical analyses strengthen the conclusions from NurOwn’s® Phase 3 clinical trial

A correction was made to the Muscle and Nerve publication from December 2021 describing the results of NurOwn’s® Phase 3 clinical trial in ALS following new clinical analyses which strengthen the Company’s original conclusions from the trial. The correction results in a statistically significant treatment difference (p=0.050) of more than 2 points for an important secondary endpoint, average change from baseline in ALSFRS-R, in the pre-specified efficacy subgroup of participants with a baseline score of at least 35. Analyses reported in the original publication utilized an efficacy model that unintentionally deviated from the trial’s pre-specified statistical analysis plan by erroneously incorporating interaction terms between the subgroup and treatment. The newly published results, which includes supporting information to the publication, employ the efficacy model as pre-specified in the trial’s statistical analysis plan, correcting the analyses. The correction also relates to the other subgroup analyses published for this endpoint, demonstrating that all subgroups with ALSFRS-R baseline scores of at least 26 to 35 showed a statistically significant benefit following treatment with NurOwn® (p≤0.050) on this secondary endpoint.

Other Second Quarter 2022 and Recent Highlights

· Presented new analyses from NurOwn's® Phase 3 ALS trial that showed a treatment effect in participants predicted by the ENCALS model to have intermediate to very long survival. These analyses confirmed the importance of avoiding potentially misclassifying treatment responses due to the ALSFRS-R floor effect and were presented in a poster presentation at the 2022 European Network for the Cure of ALS (ENCALS) Meeting. The presentation was delivered by Dr. Jonathan Katz, principal investigator on the trial and Chair of the Neurology Department and Director of the Forbes Norris ALS Clinic at the California Pacific Medical Center.

· Biomarker analyses from NurOwn’s® Phase 3 ALS trial were the subject of an abstract presented at the 2022 American Academy of Neurology Congress by Dr. James Berry, MD, MPH, principal investigator on the trial and Director of the Massachusetts General Hospital Multidisciplinary ALS Clinic and Chief of the Division of ALS and Motor Neuron Diseases. Results of the analyses showed significant changes across multiple cerebrospinal fluid (CSF) biomarkers following NurOwn® treatment, with the strongest effects observed on biomarkers related to neuroprotection and neuroinflammation.

· Presented a summary of analyses from the Phase 3 trial of NurOwn® in ALS that highlighted the ability of biomarkers to predict clinical treatment response and provide a window into the complex biological pathways underlying disease progression. The presentation was delivered at the ALS Drug Development Summit by BrainStorm’s President and Chief Medical Officer, Dr. Ralph Kern, MD, MHSc.

· Reported new results from the open-label Phase 2 study of NurOwn® in progressive multiple sclerosis (MS) that highlighted post-treatment improvements in monocular and binocular low contrast letter acuity (LCLA) outcomes (1.25% and 2.5% thresholds). In contrast, matched patients from the long-term Comprehensive Longitudinal Investigation of Multiple Sclerosis (CLIMB) study and participants from the placebo arm of the SPRINT study showed worsening in LCLA outcomes over a similar time period. The results were presented in a poster presentation delivered by Dr. Kern at the 2022 Consortium of Multiple Sclerosis Centers (CMSC) Meeting.

· Presented biomarker analyses from the open-label Phase 2 study of NurOwn® in progressive MS showing consistent post-treatment reductions in CSF inflammatory biomarkers that may be relevant to disease progression and treatment response. The presentation was delivered by Dr. Christopher Lock, PhD, Clinical Associate Professor, Neurology and Neurological Studies, at Stanford School of Medicine, at the CMSC 2022 Meeting.

· Preclinical in-vitro data that showed NurOwn® cells maintaining their neurotrophic and immunomodulatory effects in the presence of Siponimod, an S1P modulator recently approved for the treatment of secondary progressive MS, were presented in a poster presentation at the CMSC 2022 Meeting. The presentation was delivered by Dr. Sidney Spector, MD, PhD, Senior Vice President, Medical Affairs and Global Strategy at BrainStorm Cell Therapeutics.

Reported preclinical data from a murine lung injury model (the bleomycin model) that demonstrated intrathecal administration of NurOwn®-derived exosomes (Exo MSC-NTF) may have potential as a clinical therapy for inflammatory pulmonary pathologies and display superior macrophage immunomodulation compared to naïve mesenchymal stem cell-derived exosomes (Exo-MSC). The data were presented at the International Society for Extracellular Vesicles (ISEV) 2022 Annual Meeting by Haggai Kaspi, PhD, Preclinical Research Manager at BrainStorm Cell Therapeutics.

Preclinical in vitro data demonstrating the superior anti-inflammatory effects of Exo MSC-NTF compared to Exo-MSC were featured in a poster at the International Society of Cell & Gene Therapy (ISCT) 2022 Meeting. The poster was presented by Dr. Kim Thacker, Senior Vice President, Medical Affairs and Clinical Innovation at BrainStorm Cell Therapeutics.

Strengthened executive team in preparation for anticipated growth and corporate development, with the appointment of Netta Blondheim-Shraga, PhD, as VP of Research & Development and Antal Pearl-Lendner, Adv., as Chief Legal Counsel

Financial Results for the Second Quarter Ended June 30, 2022

Cash, cash equivalents, and short-term bank deposits were approximately $12.2 million as of June 30, 2022, compared to $18.4 million as of March 31, 2022.

Research and development expenses for the three months ended June 30, 2022, and 2021 were approximately $5.1 million and $3.6 million, respectively.

General and administrative expenses for the three months ended June 30, 2022, and 2021 were approximately $2.5 million.

Net loss for the three months ended June 30, 2022, was approximately $7.0 million, as compared to a net loss of approximately $6.3 million for the three months ended June 30, 2021.

Net loss per share for the three months ended June 30, 2022, and 2021 was $0.19 and $0.17, respectively.

Conference Call and Webcast

August 15, 2022, at 8:00 a.m. Eastern Time

Participant Numbers: Toll Free: 888-506-0062

International: 973-528-0011 Participant Access Code: 955552

Webcast URL: https://bit.ly/3cXwQkt

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 46290

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future BLA submission, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, BrainStorm’s plan to submit a BLA for NurOwn® to the FDA, prospects that the FDA will accept BrainStorm’s BLA for NurOwn® for filing and review, prospects that the FDA does not view BrainStorm’s NurOwn® product candidate to have demonstrated adequate safety or effectiveness, prospects for future regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for BrainStorm’s products, if approved, and services, the ability to secure and maintain research institutions to conduct BrainStorm’s clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, health reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; the impacts of the COVID-19 pandemic and additional strains of COVID-19 or any other health epidemic on our clinical trials, supply chain, and operations; potential delays in any planned or anticipated review or interactions with the FDA due to disruptions at, or inadequate funding of, the FDA; the impact of global economic and political developments on our business, including rising inflation and capital market disruptions; the current conflict in Ukraine, economic sanctions and economic slowdowns or recessions that may result from such development; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations: John Mullaly LifeSci Advisors, LLC

Phone: +1 617-429-3548 jmullaly@lifesciadvisors.com

Media: Lisa Guiterman Phone: +1 202 330-3431 lisa.guiterman@gmail.com

BrainStorm to Announce Second Quarter Results and Provide a Corporate Update

Mon, 01 Aug 2022 12:00:00 GMT

BrainStorm's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Chief Development Officer, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Alla Patlis, CPA, MBA, Interim Chief Financial Officer.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers: Toll Free: 888-506-0062 International: 973-528-0011 Participant Access Code: 955552

Webcast URL: https://bit.ly/3cXwQkt

The replay of the conference call can be accessed by dialing the numbers below, and will be available for 14 days.

Replay Numbers: Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 46290

About Brainstorm Cell Therapeutics Inc.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, Brainstorm's need to raise additional capital, Brainstorm's ability to continue as a going concern, the prospects for regulatory approval of Brainstorm's NurOwn® treatment candidate, the initiation, completion, and success of Brainstorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of Brainstorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, Brainstorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, Brainstorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in Brainstorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on Brainstorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Contacts:

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media: Uri Yablonka

BrainStorm Cell Therapeutics

uri@brainstorm-cell.com

BrainStorm Announces Presentations at June 2022 Scientific Conferences

Tue, 31 May 2022 12:00:00 GMT

ENCALS Meeting, Edinburgh Scotland:

Presentation Details: ALS Phase 3 NurOwn Trial: Insight into the primary outcome through ENCALS modeled trajectories Presenter: Jonathan Katz MD, California Pacific Medical Center, San Francisco, CA USA Date/Time: Thurs June 2, 17.00-18.30 BST Conference Link: ENCALS

NurOwn's Phase 3 trial (BCT-002-US) included participants with advanced and rapidly declining ALS, making this trial subject to floor effects and reduced sensitivity of the clinical endpoint, the Revised ALS Functional Rating scale (ALSFRS-R). This presentation will summarize the clinical response on the primary endpoint this trial after applying two methods, ENCALS model and ALSFRS-R baseline value, to identify and minimize the impact of participant data most impacted by floor effects of the ALSFRS-R scale . Key findings:

In summary, the results confirm the importance of accounting for the floor effect in more advanced and rapidly declining ALS participants to potentially avoid misclassifying treatment responses.

CMSC 2022 Meeting, National Harbor MD, USA:

Presentation Details: NurOwn (MSC-NTF Cells) Phase 2 Clinical Trial in Progressive MS: Effects on Monocular and Binocular Low Contrast Letter Acuity (LCLA) Outcomes Presenter: Ralph Kern MD, MHSc, President and Chief Medical Officer, Brainstorm Cell Therapeutics. Date/Time: Thursday June 2, 2022, 17:00- 19:00 ET Conference Link: CMSC

This presentation evaluated the impact of NurOwn therapy on visual outcomes (monocular and binocular LCLA) in progressive MS study participants in an open-label Phase 2 clinical trial in progressive MS (NCT 03799718). The key findings were:

In summary, this Phase 2 study of NurOwn therapy in progressive MS demonstrated encouraging results in monocular and binocular LCLA that should be further evaluated in a placebo-controlled clinical trial. This poster was nominated for an award at the CMSC meeting.

Presentation Details: NurOwn (MSC-NTF) Phase 2 Clinical Trial in Progressive MS: Effects on CSF Inflammatory Biomarkers Presenter: Christopher Lock, MD PhD, Stanford School of Medicine. Date/Time: Thursday June 2, 2022, 17:00- 19:00 ET Conference Link: CMSC

In this scientific presentation, the effect of NurOwn treatment on CSF biomarkers in the Phase 2 clinical trial in progressive MS (NCT 03799718) is described. The key findings were:

In summary, these observations may guide future efforts to optimize this innovative autologous mesenchymal cellular therapy in progressive MS. This poster was nominated for an award at the CMSC meeting.

Presentation Details: NurOwn (MSC-NTF) Cells Maintain Neurotrophic and Immunomodulatory Effects with S1P Modulator Siponimod Presenter: Sidney Spector MD PhD, Senior Vice President, Medical Affairs and Global Strategy, Brainstorm cell Therapeutics Date/Time: Thursday June 2, 2022, 17:00- 19:00 ET Conference Link: CMSC

This presentation describes the results of an invitro preclinical experiment evaluating the interaction of the S1P modulator Siponimod with MSC-NTF cell-induced neurite outgrowth in a human neuroblastoma cell line, and on the immunomodulatory effect on human activated peripheral blood mononuclear cells (PBMC).

MSC-NTF cells were able to induce neurite extension and inhibit inflammatory cytokine secretion, a finding that was not modified by co-culture with Siponimod, an S1P modulator recently approved for the treatment of secondary progressive MS (SPMS).

In summary, this suggests that co-administration of Siponimod does not interfere with known measures of MSC-NTF cell neuroprotection and immunomodulation and may guide future efforts to optimize this innovative autologous mesenchymal cellular therapy in progressive MS.

CMSC abstracts are available on-line: abstracts

"We are very privileged to share scientific insights at these meetings with world experts in ALS and MS," said Ralph Kern MD MHSc, President and Chief Medical Officer at Brainstorm. "Importantly, these very insightful analyses help us identify where NurOwn may provide better benefits for ALS and MS patients. This work underscores our commitment to advancing our cellular therapy technology to address the unmet medical need in these two patient populations, while continuing to contribute to the scientific community."

Chaim Lebovits, CEO Brainstorm Cell Therapeutics commented, "Brainstorm is very proud of the continued efforts of our dedicated teams in advancing scientific understanding in ALS and progressive MS. We remain committed to addressing patient unmet needs and at the same time creating shareholder value".

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Uri Yablonka

uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Announces First Quarter 2022 Financial Results and Provides a Corporate Update

Mon, 16 May 2022 12:00:00 GMT

BrainStorm continues to gain insights and perspectives from leading ALS experts as it seeks the optimal path forward to provide broad patient access to NurOwn ®

Strengthened executive team in preparation for anticipated growth and corporate development, with the appointment of Netta Blundheim-Shraga, PhD, as VP of Research & Development and Antal Pearl-Lendener, LLB, as Chief Legal Counsel

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, May 16, 2022 - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the financial results for the first quarter ended March 31, 2022 and provided a corporate update.

“We remain firmly committed to addressing the urgent needs of ALS patients by working expeditiously towards our goal of enabling broad access to NurOwn ® ,” said Chaim Lebovits, Chief Executive Officer. “Our efforts here are bolstered by peer-reviewed Phase 3 data that provide evidence of NurOwn’s greater treatment effects for ALS patients with less advanced disease, and by our ongoing interactions with the broader physician and patient community. These have allowed us to gain valuable perspective from the world’s most prominent thought leaders as we seek NurOwn’s optimal path forward. Looking ahead, we will continue to leverage expert feedback as we work with the regulatory authorities to enable NurOwn’s advancement. We believe our strong clinical and biomarker data and highly talented leadership team has us poised for sustained success.”

First Quarter 2022 and Recent Highlights

Biomarker analyses from NurOwn’s Phase 3 trial in ALS were presented by James Berry, MD, MPH, Winthrop Family Scholar in ALS Sciences, Director of the Massachusetts General Hospital Multidisciplinary ALS Clinic and Chief of the Division of ALS and Motor Neuron Diseases, in an abstract at the American Academy of Neurology 2022 Virtual Congress. These results demonstrated significant changes across multiple cerebrospinal fluid biomarkers following NurOwn treatment, with the strongest effects observed in biomarkers related to neuroprotection and neuroinflammation.

Presented a prospective genetic analyses from NurOwn’s Phase 3 ALS trial suggesting that NurOwn treatment may influence disease progression in patients carrying the ALS UNC13A risk allele. The presentation was featured in a late-breaking oral session at the 2022 Muscular Dystrophy and Association (Clinical & Scientific Conference ) and delivered by Merit E. Cudkowicz, MD, MSc, Chief of Neurology at Massachusetts General Hospital, Julieanne Dorn Professor of Neurology at Harvard Medical School, and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.

Presented preclinical data demonstrating greater macrophage immunomodulation of NurOwn-derived exosomes (Exo MSC-NTF) compared to naïve mesenchymal stem cell-derived exosomes (Exo MSC) against acute lung injury at the International Society of Cell & Gene Therapy (ISCT) 2022 Meeting . The presentation was delivered by Dr. Kim Thacker, Senior Vice President, Medical Affairs and Clinical Innovation, BrainStorm Cell Therapeutics.

Announced upcoming presentations at the ALS Drug Development Summit (May 25, 2022) and the ISEV 2022 Annual Meeting (May 26, 2022). The ALS Drug Development Summit presentation by Ralph Kern MD MHSc, President and Chief Medical Officer Brainstorm Cell Therapeutics, will focus on the use of cerebrospinal fluid biomarkers to interrogate multiple neuroinflammatory, neurodegenerative and neuroprotection pathways in NurOwn’s Phase 3 ALS trial and how this information may be leveraged to confirm ALS target engagement and improve therapeutic outcomes. The ISEV presentation features the results of a preclinical study examining the advantages of Exo MSC-NTF over Exo MSC in models of acute lung injury and will be presented by Haggai Kaspi PhD, Brainstorm R&D.

Strengthened the Company’s executive team in preparation for anticipated growth and corporate development, with the appointments of Netta Blundheim-Shraga, PhD, as VP of Research & Development and Antal Pearl-Lendner, Adv, as Chief Legal Counsel.

Granted a new Brazilian patent covering methods of manufacturing NurOwn titled - A method of generating cells which secrete Brain Derived Neurotrophic Factor (BDNF), Glial Derived Neurotrophic Factor (GDNF), Hepatocyte Growth Factor (HGF) And Vascular Endothelial Growth Factor (VEGF), wherein said cells do not Secrete Nerve Growth Factor (NGF) .

Presented a corporate and Phase 3 ALS clinical overview at the 12 th Annual California ALS Research Summi t on January 27, 2022 by R alph Kern MD MHSc, President and Chief Medical Officer Brainstorm Cell Therapeutic s .

Financial Results for the First Quarter Ended March 31, 2022

Cash, cash equivalents, and short-term bank deposits were approximately $18.4 million as of March 31, 2022, compared to $22.1 million as of December 31, 2021.

Research and development expenses for the three months ended March 31, 2022, and 2021 were approximately $2.6 million and $4.3 million, respectively.

General and administrative expenses for the three months ended March 31, 2022, and 2021 were approximately $2.9 million and $2.6 million, respectively.

Net loss for the three months ended March 31, 2022, was approximately $5.4 million, as compared to a net loss of approximately $6.7 million for the three months ended March 31, 2021.

Net loss per share for the three months ended March 31, 2022, and 2021 was $0.15 and $0.19 respectively.

Conference Call and Webcast

May 16, 2022, at 8:00 a.m. Eastern Time

Participant Numbers:

Toll Free: 888-506-0062

International: 973-528-0011

Entry Code: 476792

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/45459

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Toll Free: 877-481-4010

International: 919-882-2331

Replay Passcode: 45459

About NurOwn ®

The NurOwn ® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn ® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of BrainStorm's NurOwn ® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our products and services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn ® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn ® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations: John Mullaly LifeSci Advisors, LLC Phone: +1 617-429-3548 jmullaly@lifesciadvisors.com

Media: Uri Yablonka uri@brainstorm-cell.com

BrainStorm Strengthens Executive Team with Key Appointments in R&D and Legal

Thu, 12 May 2022 12:00:00 GMT

"We are thrilled to welcome Netta and Antal, each of whom brings valuable experience in their respective areas of R&D and Legal Affairs," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "As we prepare the company for growth, it is important that we continue to build out our senior executive team and attract professionals with the appropriate skillsets. We look forward to leveraging their backgrounds as we execute on our mission to bring autologous cell therapies to patients with debilitating neurodegenerative diseases."

Dr. Blondheim-Shraga will be responsible for advancing the company's pipeline and steering the R&D team towards significant breakthroughs in the field of cell therapy and development of novel solutions to positively impact patients' health. Dr. Blondheim-Shraga joins BrainStorm with over 14 years of translational research experience in academic, biotech and pharma settings, having led teams in Israel, USA and China, combining scientific, entrepreneurial and management skills. Prior to joining BrainStorm, she was Project Leader on the Academic Affairs team at Teva Pharmaceuticals, Israel. In this role, she managed a portfolio of diverse and highly impactful strategic scientific collaborations with Teva's academic partners and managed Teva's involvement in several international consortia. Prior to Teva, she was Study Director and Senior Scientist at CrownBio, San Diego, CA. Earlier in her career, she was a Senior Scientist at Lifemap Sciences LTD in Tel-Aviv and served as Scientific Advisor to ImmunoHiTech LTD, Ramat Hasharon, Israel for several years. Dr. Blondheim-Shraga received a PhD from the Faculty of Medicine, Bar-Ilan University, Safed, Israel, an MSc Med from The Faculty of Medicine, Tel Aviv University, Israel and a BSc Med from The Faculty of Medicine, Hebrew University Jerusalem, Israel.

Antal Pearl-Lendner, Adv. is an experienced bilingual attorney with a proven track record in legal and business development capacities. Prior to joining Brainstorm, Ms. Pearl-Lendner spent 8 years at Mizrahi-Tefahot Bank in Israel where her responsibilities included spearheading bank-wide complex projects, negotiating large scale international contracts and providing ongoing advice regarding the international activities of the bank. Before her tenure at the bank, she worked at GE Capital in Chicago and Connecticut, USA, where she served in GE's premier commercial leadership program, working in business development, strategy & analytics. Earlier in her career, Ms. Pearl-Lendner was an Associate Attorney in the international department of Caspi & Co. Advocates & Notaries in Tel Aviv, Israel. In this role she represented clients in M&A transactions and led due diligence processes for investments ranging from $5M to $350M. Ms. Pearl-Lendner received an MBA from the MIT Sloan School of Management in Cambridge, Massachusetts and an LLB from Tel Aviv University.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Uri Yablonka

uri@brainstorm-cell.com

BrainStorm Announces Presentation of NurOwn® Exosome Preclinical Data at ISCT 2022 San Francisco Meeting

Wed, 04 May 2022 12:00:00 GMT

POSTER DETAILS:

Poster 313: MSC-NTF derived small extracellular vesicles display superior macrophage immunomodulation compared with vesicles derived from naïve MSCs. Exosome/EV session: Wednesday May 4, 6:30 p.m. - 8:00 p.m. (Pacific Time)

POSTER HIGHLIGHTS:

Background:

Study Rationale and Objective:

Results:

Conclusion:

"These compelling preclinical data provide important insights into Exo MSC-NTF's mechanism of action," said Ralph Kern, MD MHSc, President and Chief Medical Officer of BrainStorm. "They suggest that the preclinical efficacy previously observed in acute lung injury models is due to the anti-inflammatory effects of Exo MSC-NTF on macrophage populations. Our scientific team is privileged to share this important finding at the International Society for Cell and Gene Therapy (ISCT), a globally recognized organization focused on translational aspects of developing cell-based therapeutics. We look forward to productive scientific engagements with experts at the meeting."

Chaim Lebovits, Chief Executive Officer of BrainStorm, added, "At BrainStorm, we are committed to exploring the full potential of our proprietary cell technology platform and continue to make key scientific progress that will enable us to address serious unmet medical needs. At the same time, we remain fully committed to advancing our cellular therapeutic pipeline in ALS and progressive MS."

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Uri Yablonka

uri@brainstorm-cell.com

BrainStorm Announces Upcoming Scientific Conference Presentations

Tue, 03 May 2022 12:00:00 GMT

International Society of Cell & Gene Therapy Meeting

Presentation Details: MSC-NTF derived small extracellular vesicles display superior macrophage immunomodulation compared with vesicles derived from naïve MSCs

Presenter: Dr. Kim Thacker, Senior Vice President, Medical Affairs and Clinical Innovation, Brainstorm Cell Therapeutics Date/Time Wednesday May 4, 18:30-20:00 (Pacific Time), Exosome/EV session Conference Link: ISCT 2022

The presentation will highlight results of a preclinical study undertaken to understand the mechanisms underlying the superior preclinical efficacy of Exo MSC-NTF versus Exo-MSC against acute lung injury. The effects of each on macrophage secretion of inflammatory factors were assessed.

ISEV 2022 Annual Meeting, Lyon France

Presentation Details: Therapeutic effect of MSC-NTF exosomes in experimental bleomycin-induced lung injury

Presenter: Haggai Kaspi PhD, Brainstorm Cell Therapeutics. Date/Time: Thursday May 26, 2022, 16:00- 17:00 (Central European Time) Conference Link: https://www.isev.org/

Results will be presented from a preclinical study examining the advantage of Exo MSC-NTF over Exo MSC, focusing on different lung injury

ALS Drug Development Summit, Boston MA

Presentation Details: Advancing novel CSF biomarkers to evaluate ALS target engagement & improve therapeutic outcomes

Presenter: Ralph Kern MD MHSc, Brainstorm Cell Therapeutics Date/Time: May 25, 2022, 0930- 1000 (Eastern Time) Conference Link: https://www.als-drug-development.com/

The presentation will focus on the use of CSF biomarkers to interrogate multiple neuroinflammatory, neurodegenerative and neuroprotection pathways and confirm the mechanism of action and target engagement of NurOwn (MSC-NTF) cell therapy in Brainstorm's Phase 3 ALS randomized trial.

Dr. Kern will be acting as Conference Chair on Day One of the ALS Drug Development Summit

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Uri Yablonka

uri@brainstorm-cell.com

BrainStorm to Announce First Quarter 2022 Financial Results and Provide a Corporate Update

Mon, 02 May 2022 12:00:00 GMT

BrainStorm's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Chief Development Officer, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Alla Patlis, CPA, MBA, Interim Chief Financial Officer.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers: Toll Free: 888-506-0062 International: 973-528-0011 Entry Code: 476792

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/45459

Those interested in listening to the conference call live via the internet may do so by using the webcast link above or by visiting the "Investors & Media" page of BrainStorm's website at

https://brainstorm-cell.com/investors/events-and-presentations/ and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Numbers: Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 45459

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Uri Yablonka

uri@brainstorm-cell.com

Brainstorm Cell Therapeutics to Participate in the 2022 Virtual Growth Conference Presented by Maxim Group LLC and hosted by M-Vest on March 28th - 30th from 9:00 a.m. - 5:00 p.m. EDT

Mon, 28 Mar 2022 12:00:00 GMT

During this virtual conference, investors will hear from executives from a wide range of sectors including Biotech, Clean Energy, Electric Vehicles, Financial Services, Fintech & REITS, Gaming & Entertainment, Healthcare, Healthcare IT, Infrastructure, Shipping and Technology/ Media/Telecom. The conference will feature company presentations, fireside chats, roundtable discussions, and live Q&A with CEOs moderated by Maxim Research Analysts.

This conference will be live on M-Vest. To attend, just sign up to become an M-Vest member.

Click Here to Reserve your seat

About NurOwn®

About Brainstorm Cell Therapeutics Inc.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Uri Yablonka

uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Announces Full Year 2021 Financial Results and Provides a Corporate Update

Mon, 28 Mar 2022 12:00:00 GMT

Results and Provides a Corporate Update

BrainStorm continues to collect and leverage expert feedback as it pursues the optimal path

forward to provide broad access to NurOwn® for patients with ALS

Announced the peer reviewed publication of the full analysis of the NurOwn Phase 3 trial in ALS

showing greater treatment effects in participants with less advanced disease

Extended treatment period for NurOwn’s Expanded Access Protocol authorized by the United States Food and Drug Administration

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, March 28, 2022 - Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the financial results for the fiscal year ended December 31, 2021 and provided a corporate update.

“We began 2022 with strong momentum and Phase 3 data showing that NurOwn® appears to deliver meaningful clinical benefits to ALS patients with less advanced disease,” said Chaim Lebovits, Chief Executive Officer. “These data have been validated through a manuscript reviewed and accepted by a prestigious peer-reviewed journal and feedback from key opinion leaders at numerous medical conferences. The insights gained from these interactions are invaluable as we pursue the optimal path forward to provide broad access to NurOwn for patients with ALS. We also took important steps to increase our manufacturing capacity and made key additions to our leadership team in preparation for anticipated growth and success. Looking ahead, we believe we are well positioned to execute on our clinical, regulatory, and corporate goals as we pursue NurOwn’s continued advancement in ALS and progressive multiple sclerosis (PMS).”

Fourth Quarter 2021 and Recent Highlights

· Full results from NurOwn’s Phase 3 trial in ALS published in Muscle and Nerve . Although previously announced results showed the trial did not reach statistical significance on the primary or secondary endpoints, pre-specified and post hoc analyses featured in the publication show a treatment effect with NurOwn across both primary and secondary efficacy outcomes in patients with less advanced disease. Additionally, the publication links these clinical results to biomarker changes and confirmed treatment safety.

· Analyses leveraging the validated ENCALS prediction model and the primary endpoint from NurOwn’s Phase 3 trial in ALS presented at the 4 th Annual ALS ONE Research Symposium . We showed that in participants with less advanced disease (i.e., those predicted to have long to very long survival) there were more responders with NurOwn compared to placebo (33% vs. 14%). The presentation was delivered by Jonathan S. Katz, MD, a co-principal investigator on the trial and Chair of the Neurology Department and Director of the Forbes Norris ALS Clinic at the California Pacific Medical Center.

· In Q1 2022, presented genetic analyses from the NurOwn Phase 3 trial in ALS suggesting that NurOwn treatment may influence disease progression in patients who possess the UNC13A risk allele. The presentation was delivered in a late-breaking oral session at the 2022 MDA Clinical & Scientific Conference by Merit E. Cudkowicz, MD, MSc, Chief of Neurology at Massachusetts General Hospital, Julieanne Dorn Professor of Neurology at Harvard Medical School, Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.

· Presented biomarker data from NurOwn’s Phase 3 trial in ALS at the 32 nd International Symposium on ALS/MND and at the 2021 Northeast Amyotrophic Lateral Sclerosis Consortium ® . Collectively, these data show significant NurOwn-driven changes across a range of neural biomarkers and suggest the NurOwn's biological activity of NurOwn observed across multiple disease pathways could prove important to impacting the progression of ALS. They also provide an increased understanding of NurOwn's mechanism of action in ALS and additional evidence linking this mechanism of action to NurOwn’s potential impact on ALS disease progression. The presentations were delivered by two principal investigators from the NurOwn Phase 3 trial: Robert H. Brown Jr., MD, Director of the Program in Neurotherapeutics at the University of Massachusetts Medical School, and James D. Berry, MD, MPH, Winthrop Family Scholar in ALS Sciences, Director of the Massachusetts General Hospital multidisciplinary ALS clinic and Chief of the Division of ALS and Motor Neuron Diseases.

· Received authorization from the United States Food and Drug Administration (FDA) for an extension of the dosing period in NurOwn’s Expanded Access Protocol (EAP). The Agency recommended that BrainStorm submit the protocol amendment that led to this authorization, which provides patients who completed the EAP with the opportunity to receive up to three additional doses of NurOwn.

· Presented Phase 2 clinical trial data of NurOwn in progressive multiple sclerosis (MS) showing general tolerability, preliminary evidence of efficacy, a reduction in neuroinflammatory biomarkers in the cerebrospinal fluid (CSF), and an increase in neuroprotective biomarkers in the CSF at the 37 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The presentation was delivered by Jeffrey Cohen, MD, Director of Experimental Therapeutics at the Cleveland Clinic Mellen Center for MS and Principal Investigator in the NurOwn MS Phase 2 trial.

· Finalized the technology transfer for NurOwn manufacturing at Catalent’s world-class, 32,000 square-foot, cell-therapy facility in Houston, Texas.

· Granted a new patent in Brazil covering methods of manufacturing NurOwn.

· Delivered a presentation at the 2021 Cell & Gene Meeting on the Mesa highlighting the expansion of BrainStorm's technology portfolio to include autologous and allogeneic product candidates covering multiple neurological diseases.

· Presented positive preclinical results at the NYSCF 2021 VIRTUAL Meeting. These results suggest that intrathecal administration of small extracellular vesicles (sEVs) isolated from mesenchymal stem cells that were induced to secrete increased levels of regenerative and immunoregulatory factors based on the NurOwn technology platform may have therapeutic potential in acute lung-related pathologies (e.g., acute respiratory distress syndrome).

· Appointed Kim Thacker, MD, as Senior VP, Medical Affairs and Clinical Innovation and Sidney A. Spector, MD, PhD, as Senior VP, Global Strategy and Medical Affairs. Drs. Thacker and Spector are working together to create a formal global medical affairs function as the Company prepares for anticipated growth.

· Expanded the responsibilities of Stacy Lindborg, PhD, with a promotion to the new position of Chief Development Officer.

· Appointed Menghis Bairu, MD, to the Company's Board of Directors.

· Presented a corporate and clinical overview at the 12 th Annual California ALS Research Summit .

Financial Results for the Year Ended December 31, 2021

Cash, cash equivalents, and short-term bank deposits were approximately $22.1 million as of December 31, 2021, compared to $41.9 million as of December 31, 2020.

Research and development expenses for the twelve months ended December 31, 2021, and 2020 were approximately $15.2 million and $22.3 million, respectively.

General and administrative expenses for the twelve months ended December 31, 2021, and 2020 were approximately $9.3 million and $9.4 million, respectively.

Net loss for the twelve months ended December 31, 2021, was approximately $24.5 million, as compared to a net loss of approximately $31.8 million for the twelve months ended December 31, 2020.

Net loss per share for the twelve months ended December 31, 2021, and 2020 was $0.68 and $1.07, respectively.

Conference Call and Webcast

Monday March 28, 2022, at 8:00 a.m. Eastern Time

Toll Free: 888-506-0062

International: 973-528-0011

Entry Code: 108732

Webcast URL: https://bit.ly/3vITeFB

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Toll Free: 877-481-4010

International: 919-882-2331

Replay Passcode: 44771

About NurOwn ®

The NurOwn ® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About Brainstorm Cell Therapeutics Inc.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of BrainStorm's NurOwn ® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our products and services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn ® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn ® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Uri Yablonka

uri@brainstorm-cell.com

BrainStorm to Announce Fourth Quarter and Fiscal Year 2021 Financial Results and Provide a Corporate Update

Mon, 14 Mar 2022 12:00:00 GMT

BrainStorm's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Global Head of Clinical Research, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Alla Patlis, CPA, MBA, Interim Chief Financial Officer.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers: Toll Free: 888-506-0062 International: 973-528-0011 Entry Code: 108732

Webcast URL: https://bit.ly/3vITeFB

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Numbers: Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 44771

About Brainstorm Cell Therapeutics Inc.

Safe-Harbor Statement

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Contacts:

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Uri Yablonka

BrainStorm Cell Therapeutics

uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Abstract Selected as Late-Breaking Presentation at the 2022 MDA Clinical & Scientific Conference

Mon, 28 Feb 2022 12:00:00 GMT

Details on the upcoming oral presentation are provided below. A copy of the corresponding abstract is available on the 2022 MDA Clinical & Scientific Conference website.

Title: Relationship of ALS genes and Single-Nucleotide Polymorphisms with Clinical Outcomes in NurOwn Phase 3 ALS Clinical Trial

Date: March 16, 2022

Time: 1:00 p.m. CT / 2:00 p.m. ET

Presenter: Merit Cudkowicz, MD, MSc, Chief of Neurology Massachusetts General Hospital, Julieanne Dorn Professor of Neurology Harvard Medical School, Director Sean M. Healey & AMG Center for ALS at Mass General Hospital

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Uri Yablonka

BrainStorm Cell Therapeutics

uri@brainstorm-cell.com

Brainstorm Cell Therapeutics Announces Grant of a New Brazilian Patent Covering Methods of Manufacturing NurOwn®

Tue, 15 Feb 2022 12:00:00 GMT

"We are committed to the development of NurOwn as a potential treatment for ALS and other neurodegenerative diseases. This patent, which covers the industrial manufacturing process for NurOwn® developed by Brainstorm's scientists, enhances our ability to do so worldwide," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "A strong IP portfolio is important in establishing commercial preparedness as we work urgently toward a regulatory pathway. Adding a Brazilian patent to our existing portfolio of US, Canadian, EU, Israel and Japanese patents should position us well to enter into new commercial partnerships for NurOwn® in South America and worldwide."

About NurOwn®

About Brainstorm Cell Therapeutics Inc.

Safe-Harbor Statement

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Uri Yablonka

uri@brainstorm-cell.com

BrainStorm Cell Therapeutics to Present at the 12th Annual California ALS Research Summit

Thu, 27 Jan 2022 12:00:00 GMT

Dr. Kern's presentation will take place on January 27, 2022, at 4:45 p.m. ET. Those interested in registering for the summit can do so here.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions. NurOwn (autologous MSC-NTF cells) is designed to effectively deliver high levels of multiple neurotrophic factors (NTFs) and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989) and a grant from I AM ALS and the ALS Association. BrainStorm completed a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Contacts

Contacts:

Brainstorm Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Mariesa Kemble

kemblem@mac.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics to Present at Biotech Showcase™ 2022

Tue, 04 Jan 2022 12:00:00 GMT

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions. NurOwn (autologous MSC-NTF cells) is designed to effectively deliver high levels of multiple neurotrophic factors (NTFs) and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989) and a grant from I AM ALS and the ALS Association. BrainStorm completed a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Contacts

Contacts:

Brainstorm Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Mariesa Kemble

kemblem@mac.com

FDA Authorizes Further NurOwn® Dosing Under Expanded Access Program

Mon, 27 Dec 2021 12:00:00 GMT

"This dosing extension for the expanded access protocol is an appropriate next step following the new analysis and biomarkers results of the Phase 3 study. It is deeply appreciated by our ALS patients. Eligible patients now have the opportunity to receive as many as 9 doses of NurOwn in total, allowing additional data collection to better understand the potential benefits of longer-term treatment," said Robert Brown, MD DPhil, Leo P. and Theresa M. LaChance Chair in Medical Research, and Chair, Department of Neurology, University of Massachusetts Medical School and UMass Memorial Medical Center, and one of the Principal Investigators in the NurOwn® Phase 3 study.

"I applaud BrainStorm for having the conviction to continue their EAP which has brought true hope to those in it. I am also grateful that they recognize the value and importance of EAPs and are willing to invest in doing them right despite being a small company. I look forward to the day, hopefully very soon, when every person living with ALS has access to NurOwn," stated Brian Wallach, person living with ALS, and Co-Founder of I AM ALS.

Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics, commented, "We are pleased to be able to provide additional treatments to these patients. This program is an outcome of a fruitful collaboration between the FDA, Patient Advocacy groups and Brainstorm. We look forward to continuing this dialogue with the FDA for the best path forward."

The NurOwn EAP was established in 2020, following conclusion of the Phase 3 trial, and the protocol was developed in partnership with the FDA. Patients were treated at one of six clinical centers of excellence that participated in the Phase 3 trial. These six centers are: University of California, Irvine; Cedars-Sinai Medical Center; California Pacific Medical Center; Massachusetts General Hospital; University of Massachusetts Medical School; and Mayo Clinic. The FDA approved BrainStorm to manufacture NurOwn for the EAP Program at the Catalent facility in Houston, Texas.

According to the FDA, EAPs, alternatively known as "compassionate use" programs, provide a pathway for appropriate patients to receive an investigational medicine for treatment of a serious disease or condition outside of a clinical trial when no comparable or satisfactory alternative therapy options are available.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056) which was published in Muscle and Nerve; this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), in addition to a grant from I AM ALS and the ALS Association. BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trials, the continued development of NurOwn® and the potential therapeutic effects and expected patient population of NurOwn®, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Contacts

Contacts:

Brainstorm Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Mary Kay Turner

mkt@brainstorm-cell.com

BrainStorm Cell Therapeutics Announces peer reviewed publication of NurOwn's® Phase 3 Study for ALS in Muscle and Nerve

Mon, 13 Dec 2021 12:00:00 GMT

Data from the paper are from a randomized, double-blind, placebo-controlled, Phase 3 trial evaluating the safety and efficacy of repeat doses of NurOwn® in study participants. Although previously announced results showed the trial did not reach statistical significance on the primary or secondary endpoints, pre-specified and post hoc analyses show a NurOwn-induced treatment effect across both primary and secondary efficacy outcomes in those with less advanced disease.

"I am thankful for all the participants, faculty and staff at the six trial sites who all worked together to ensure the quality and rigor of this study," said Merit Cudkowicz, MD, MSc, Chief of Neurology Massachusetts General Hospital, Julieanne Dorn Professor of Neurology Harvard Medical School, Director Sean M. Healey & AMG Center for ALS at Mass General Hospital, and the study's lead author. "There are both biological and clinical signals of a treatment effect - as a community, we must review these carefully. Understanding how to use biomarkers to tailor treatments, like NurOwn, is an essential new direction in ALS therapy development."

"Having these data peer reviewed and published in such a prestigious journal is an important milestone in the NurOwn development program, providing us with the ability to allow full transparency into the trial results and gain external validation from a journal devoted to publishing the most important findings on neuromuscular disorders and treatment options," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "When viewed in totality, we believe the trial's data provide evidence of NurOwn's effectiveness in driving meaningful clinical benefit for ALS patients with less advanced disease. We look forward to discussing these findings with regulators and remain fully committed to pursuing the best and most expeditious path forward to bring NurOwn to patients."

Key data and conclusions from the paper include:

Demographics:

Efficacy:

Biomarkers:

Safety:

NurOwn was well tolerated in the trial with no clinically significant differences in safety assessments observed between treatment groups.

Stacy R. Lindborg, PhD, Executive Vice President and Chief Development Officer, Brainstorm Cell Therapeutics, and co-author of the paper commented, "The publication provides a transparent view into this important NurOwn Phase 3 trial suggesting a meaningful clinical impact with NurOwn. The magnitude of the treatment effect in patients with less severe disease show that NurOwn is providing a robust and clinically meaningful benefit in this population. These benefits may also extend to additional patients, as pre-specified and post hoc analyses indicate that limitations in ALSFRS-R may have led to a floor effect that masked NurOwn-induced changes in patients with severe disease. This belief is further supported by biomarker data showing that NurOwn treatment led to significant, robust, and sustained changes across multiple pathways linked to ALS progression. We believe that collectively, these results demonstrate the potential of NurOwn to address the unmet needs of ALS patients and show that the future is bright for this differentiated cellular therapy."

Study Design

The Phase 3 NurOwn trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of repeat doses of NurOwn in 189 ALS patients. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford, Dr. Robert Baloh); California Pacific Medical Center (Prof. Robert Miller, Dr. Jonathan Katz); Massachusetts General Hospital (Prof. Merit Cudkowicz, Dr. James Berry); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as patients with at least a 3-point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn or placebo. Participants were followed for 28 weeks after treatment. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment. Secondary endpoints included the percentage of patients with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Contacts

Contacts:

Brainstorm Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Mariesa Kemble

kemblem@mac.com

BrainStorm Cell Therapeutics and Catalent Announce Completion of Technology Transfer for NurOwn® Manufacturing

Tue, 07 Dec 2021 12:00:00 GMT

Catalent entered into a partnership with Brainstorm in 2020 to provide CGMP clinical supply of NurOwn, in anticipation of the product candidate's potential regulatory approval. NurOwn will be manufactured at Catalent's world-class 32,000 square-foot cell therapy manufacturing facility in Houston, Texas.

"The successful completion of this technology transfer with Catalent is an important step in establishing manufacturing preparedness for NurOwn," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "The manufacturing of cellular therapies such as NurOwn is complex, and requires careful planning and very specific expertise. We are very pleased with the progress we have made with our partner Catalent, which has industry-leading capabilities in this area."

Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy, said, "Our extensive experience in cell therapy development and scale-up was key to the completion of this technology transfer to our state-of-the-art cell therapy facility in Houston, Texas. We look forward to continuing our partnership with BrainStorm and are committed to enabling the advancement of their autologous stem cell therapy product candidate toward a potential future commercial launch."

About NurOwn®

About Catalent

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world.

With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually.

Catalent's expert workforce exceeds 17,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Contacts

Contacts:

Brainstorm Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Mariesa Kemble

kemblem@mac.com

Catalent Media Contact:

Chris Halling

Phone : +44 (0)7580 041073

chris.halling@catalent.com

BrainStorm Cell Therapeutics to Present New Biomarker Data on NurOwn® at the International Symposium on ALS/MND

Thu, 02 Dec 2021 12:00:00 GMT

Brainstorm previously announced clinical results from the Phase 3 randomized, placebo control trial which evaluated the safety and efficacy of repeat administrations of NurOwn in ALS. This new analysis evaluated the treatment effects of NurOwn on cerebrospinal fluid (CSF) biomarkers and the relationship between these biomarkers and clinical outcomes. In the Phase 3 trial, CSF samples were obtained prior to the first treatment and at 6 additional time points.

Key findings

"This analysis showed how significant changes in CSF biomarkers in patients treated withNurOwn were associated with clinical response, suggesting that NurOwn has important effectson multiple important ALS disease pathways," said Robert Brown, MD, NurOwn Phase 3 StudyPrincipal Investigator and Director of the Program in Neurotherapeutics at the University ofMassachusetts Medical School. "Simultaneously targeting these multiple ALS disease pathwaysmay be an important factor in achieving meaningful clinical outcomes."

"This is an important step in understanding the promise of NurOwn as a novel stem cell therapy for neurodegenerative diseases with tremendous unmet need, including ALS. We are keen to understand the effects that longer term treatment with NurOwn could drive in biomarkers of neuroinflammation, neurodegeneration and neuroprotection and ultimately the effect on clinical outcomes. We are poised to gain preliminary insights into longer term treatment with NurOwn through our Expanded Access Program", said Stacy R. Lindborg, EVP and Chief Development Officer. "We believe the future is bright for novel treatments like NurOwn".

A copy of the abstract can been viewed on the MND Association website here (SESSION 2 CLINICAL TRIALS, abstract C5).

The slides from the presentation will be available on the Publications page of Brainstorm's corporate website following the conclusion of the International Symposium on ALS/MND.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Contacts

Contacts:

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Mariesa Kemble

kemblem@mac.com

Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

BrainStorm Cell Therapeutics Announces the Presentation of New Analyses from the Phase 3 Trial of NurOwn® in ALS at the 4th Annual ALS ONE Research Symposium

Mon, 29 Nov 2021 12:00:00 GMT

Additional key findings from the presentation included:

"These compelling analyses add to the positive momentum behind our ALS program, and we were pleased to have the opportunity to share them with the clinical community at this year's ALS ONE Research Symposium," said Stacy Lindborg, PhD, Executive Vice President and Chief Development Officer, Brainstorm Cell Therapeutics. "We are very encouraged by the observation that there appears to be a meaningful treatment effect in patients with less severe disease at baseline that is consistent when using baseline ALSFRS-R scores and the ENCALS model which incorporates additional important disease characteristics that have been shown to be predictive of survival time. We believe this is an important finding, especially since this effect was protected by randomization. Looking ahead, we are eager to share additional analyses from our Phase 3 trial with the clinical community through a peer reviewed publication and remain committed to pursuing the best and most expeditious path forward to bring NurOwn to patients with ALS."

The slides from the presentation will be available on the Publications page of Brainstorm's corporate website following the conclusion of the ALS ONE Research Symposium.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Contacts

Contacts:

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Mariesa Kemble

kemblem@mac.com

BrainStorm Cell Therapeutics Announces Third Quarter 2021 Financial Results and Provides a Corporate Update

Mon, 15 Nov 2021 12:00:00 GMT

BrainStorm remains committed to pursuing the best and most expeditious path forward to facilitate access to NurOwn® for people living with ALS

Presented important new ALS biomarker data at NEALS meeting showing significant NurOwn-driven changes across neural biomarkers and that treatment response to NurOwn can be predicted in the trial using biomarker data and innovative statistical models

Expanded leadership by naming Stacy R. Lindborg, PhD, EVP and Chief Development Officer and appointment of Sidney A. Spector, MD, PhD, as SVP, Global Strategy and Medical Affairs and Kim Thacker, MD, as SVP, Medical Affairs and Clinical Innovation

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, Nov. 15, 2021 -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced financial results for the quarter ended September 30, 2021, and provided a corporate update.

"We made strong progress towards our goal of advancing NurOwn in ALS and MS over the past months," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "Our productive discussions with leading clinical experts continue, and we continue to bring forward new evidence of NurOwn's effectiveness in the scientific domain, as highlighted by our recent NEALS presentation of Phase 3 ALS data showing that NurOwn drove significant changes in important neural biomarkers that could be used to predict treatment outcomes within the trial. The insights we have gained from these discussions have generated strong momentum in our pursuit of the best and most expeditious path forward to bring NurOwn to patients. We also strengthened our leadership team and increased our manufacturing capacity, supporting our readiness to provide broad patient access as we seek paths for potential regulatory approval. The devastating and progressive nature of ALS creates an urgent unmet need for patients, and one that we are fully committed to addressing through NurOwn's continued advancement."

Third Quarter 2021 and Subsequent Corporate Highlights

· Presented important new Phase 3 ALS Biomarker data showing significant NurOwn-driven changes across a range of neural biomarkers, and that treatment response in the trial can be predicted using biomarker data and an innovative statistical model at the 2021 Northeast Amyotrophic Lateral Sclerosis Consortium® (NEALS) conference. This data furthers our understanding of NurOwn's mechanism of action in ALS and provides additional evidence linking the mechanism of action to NurOwn's impact on ALS disease progression. Data were presented by Dr. James Berry, MD, Director of the Mass General Hospital (MGH) multidisciplinary ALS clinic and Principal Investigator in the NurOwn ALS Phase 3 trial.

· Presented Phase 2 clinical trial data of NurOwn in progressive multiple sclerosis (MS) showing safety, preliminary evidence of efficacy, a reduction in neuroinflammatory biomarkers in the cerebrospinal fluid (CSF), and an increase in neuroprotective biomarkers in the CSF in an oral presentation at the 37 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Data were presented by Dr. Jeffrey Cohen, MD, Director of Experimental Therapeutics at the Cleveland Clinic Mellen Center for MS and Principal Investigator in the NurOwn MS phase 2 trial.

· Highlighted the expansion of BrainStorm's technology portfolio to include autologous and allogeneic product candidates covering multiple neurological diseases at the 2021 Cell & Gene Meeting on the Mesa.

· Presented positive preclinical results suggesting that intrathecal administration of small extracellular vesicles (sEVs) isolated from MSCs which were induced to secrete increased levels of regenerative and immunoregulatory factors based on the NurOwn technology platform may have clinical potential as a therapy for acute lung related pathologies (ARDS) at the NYSCF 2021 VIRTUAL Meeting.

· Appointed Sidney A. Spector, MD, PhD, as Senior VP, Global Strategy and Medical Affairs and Kim Thacker, MD, as Senior VP, Medical Affairs and Clinical Innovation.

o Drs. Spector and Thacker will work together to create a formal global Medical Affairs function as the Company prepares for anticipated growth.

· Expanded the responsibilities of Stacy Lindborg, PhD, Executive Vice President, named to the new position of Chief Development Officer.

· Appointed Menghis Bairu, MD, to the Company's Board of Directors.

· Increased commercial manufacturing capacity with the receipt of Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health for three state-of-the-art cleanrooms leased by the Company at the Tel Aviv Sourasky Medical Center ("Sourasky Hospital") in Tel Aviv, Israel.

Financial Results for the Three Months Ended September 30, 2021

Cash, cash equivalents, and short-term bank deposits were approximately $28 million as of September 30, 2021, compared to approximately $35 million on June 30, 2021.

Research and development expenses, for the three months ended September 30, 2021 and 2020 were approximately $3.6 million and $4.1 million, respectively.

General and administrative expenses for the three months ended September 30, 2021 and 2020 were approximately $1.7 million and $2.6 million, respectively.

Net loss for the three months ended September 30, 2021 was approximately $5.3 million, as compared to a net loss of approximately $4.5 million for the three months ended September 30, 2020.

Net loss per share for the three months ended September 30, 2021 and 2020 was $0.15 and $0.14, respectively.

Conference Call and Webcast

Monday, November 15, 2021, at 8:00 a.m. Eastern Time Monday, November 15, 2021, at 8:00 a.m. Eastern Time

From the U.S.: 888-506-0062

International: 973-528-0011

Entry Code: 837509

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/43351

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

From the U.S.: 877-481-4010

International: 919-882-2331

Replay Passcode: 43351

About NurOwn®

The NurOwn ® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn ® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn ® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn ® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn ® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn ® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Contacts Investor Relations: John Mullaly LifeSci Advisors, LLC Phone: +1 617-429-3548 jmullaly@lifesciadvisors.com

Media: Mariesa Kemble kemblem@mac.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands

(Except share data)

BrainStorm Cell Therapeutics Expands Leadership Team to Support Clinical Development and Medical Affairs

Mon, 08 Nov 2021 12:00:00 GMT

These appointments mark an investment in accelerating BrainStorm's progress. Reporting to Ralph Kern, MD, MHSc, President and Chief Medical Officer, Dr. Spector and Dr. Thacker will work together to create a formal global Medical Affairs function as the company prepares for anticipated growth. As Chief Development Officer, Dr. Lindborg will build a leadership team required for development and regulatory affairs to support clinical development in multiple disease areas and technologies. She continues to report to Chaim Lebovits, Chief Executive Officer of BrainStorm.

"We are at a pivotal juncture in the history of BrainStorm Cell Therapeutics," said Mr. Lebovits. "Sid and Kim bring a rich combination of scientific expertise and experience that will be invaluable as we seek potential paths for regulatory approval of NurOwn® and advance our development portfolio of innovative treatments, as we continue to add new leaders with capabilities to complement our already strong team."

Dr. Spector, a physician and scientist with extensive experience in the development of innovative medicines, is Clinical Associate Professor of Neurology at the University of Arizona College of Medicine. Prior to BrainStorm, he was Vice President of U.S. Medical Affairs at AveXis prior to the company's acquisition by Novartis, and remained at Novartis as medical director of clinical development, regulatory submission and launch of Zolgenzma, a gene replacement therapy for spinal muscular atrophy. Dr. Spector was also clinical lead responsible for management of Asia/Pacific clinical development and regulatory submissions in Japan.. Earlier in his career, he held senior roles in CNS drug development at Elan Pharmaceuticals and Pfizer Inc. Dr. Spector earned his medical degree at the University of Tel Aviv Sackler School of Medicine, and his PhD in Kinesiological Sciences at the University of California, Los Angeles. He completed post-doctoral fellowships at the National Institutes of Health, NINCDS in Neuromuscular Diseases and Neurokinesiology.

Dr. Spector stated: "I've committed my career to developing medicines that have a meaningful impact on patients' lives. I am impressed by BrainStorm's development of such important, potentially best-in-class autologous cellular therapeutics for the treatment of highly debilitating neurodegenerative diseases."

Dr. Thacker is a neurologist, executive and patient advocate with more than twenty years of experience in pharma and biotech. Prior to joining BrainStorm, she was Vice President, Medical Affairs at Urogen Pharma. She also held senior roles at Mesoblast, Forest Research Institute, Sanofi Aventis, Pfizer and Roche Laboratories. She has a successful track record in innovation to support the advancement of human health, particularly related to eldercare and neuroscience and making a meaningful difference in healthcare. She has expertise in clinical development and launches, health economics and outcomes research, neuroethics and neurotechnology and compliance, including multiple publications and 12 product launches. Dr. Thacker earned her medical degree at the State University of New York Health Science Center at Brooklyn. She served an internship in Internal Medicine at Danbury Hospital and residency in Adult Neurology at Long Island Jewish Medical Center, becoming Chief Resident. She also has received training in Bioethics at Columbia University. Dr. Thacker is a Fellow of the New York Academy of Medicine.

Dr. Thacker commented: "I am excited to join BrainStorm's leadership team during such a transformational period for the Company. BrainStorm's unique approaches to the treatment of ALS, MS and other highly debilitating neurodegenerative diseases is grounded in breakthrough scientific innovation."

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Mariesa Kemble

kemblem@mac.com

Brainstorm Cell Therapeutics Announces Appointment of Menghis Bairu, MD, to Board of Directors

Thu, 28 Oct 2021 12:00:00 GMT

"I am pleased to welcome Menghis to our Board of Directors," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "Brainstorm will benefit greatly from his expertise and world view, and we look forward to his guidance as we approach a new phase of our mission."

Menghis Bairu, MD, commented, "I have spent my entire professional life working with organizations and treatments that offer the promise of transformational change for people everywhere, so joining the Brainstorm team is especially appealing to me. I am looking forward to being a part of Brainstorm's science-based and thoughtful approach to developing therapies for neurodegenerative diseases that the world desperately needs."

Dr. Bairu, a physician, entrepreneur, business executive, editor, author, and philanthropist, is founder, chairman, and CEO of Proxenia Venture Partners, which provides capital, talent management and access to a global network of experts to companies in late preclinical and early-stage clinical development in biotechnology. He is also Chairman and CEO of Bairex, an international medical education and market research organization focused on Africa and the Middle East.

Sankesh Abbhi, who has served on the board since March 30, 2020 will not be standing for re-election at the Company's annual shareholder meeting.

Mr. Abbhi commented, "It has been a real privilege to serve on Brainstorm's board and participate in the company's mission and strategy. As a backer of transformative life-sciences, healthcare and technology companies, I continue to support Brainstorm and remain enthusiastic about the potential of its technology to improve the treatment of neurodegenerative diseases for which there are serious unmet needs."

Mr. Lebovits concluded, "I also want to thank Sankesh, whose counsel and friendship have been invaluable in bringing strength and depth to Brainstorm, helping us reach a pivotal point in a history that we continue to write."

About Dr. Bairu

Menghis Bairu, MD, is a physician, entrepreneur, business executive, editor, author, and philanthropist with more than 30 years of international experience in the biotechnology, pharmaceutical, drug delivery and device, global health, and non-profit arenas. He is founder, chairman, and CEO of Proxenia Venture Partners, which provides capital, talent management l, and access to a global networks of experts to companies in late preclinical and early-stage clinical development in biotechnology that address global challenges and improve patient lives. Dr. Bairu also is Chairman and CEO of Bairex, an international medical education and market research organization focused on Africa and the Middle East. Bairex specializes in hands-on educational activities for physicians, clinical trialists, nurses, regulators, pharmacovigilance officers, CROs, and other life science professionals.

Prior to founding Proxenia, Dr. Bairu served as Executive Chairman of Treos Bio, a start-up company that uses computational biology to develop precision cancer immunotherapies tailored to patients' genetics. In addition, he is Founder and Chairman Emeritus of Serenus Biotherapeutics, an emerging market focused specialty biopharmaceutical company.

Dr. Bairu concurrently served as Executive Vice President, Chief Medical Officer, Head of Global Development for Elan and President/CEO of Speranza Therapeutics. As EVP and CMO, Dr. Bairu was member of the Elan's Operating Committee. He successfully led corporate R&D due diligence processes that resulted in a transaction with J&J at a value of approximately $1.5 billion. In 2013, he also led corporate R&D due diligence resulting in the sale of Elan to Perrigo for $8.6 billion. Dr. Bairu worked at Genentech for more than six years in several managed care, medical, and commercial roles for rituximab, Herceptin, TNK, tPA and growth hormone.

Dr. Bairu currently serves as Adjunct Professor at the University of California, San Francisco School of Medicine, where he lectures on global clinical trials' design, development, and conduct.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Eric Goldstein

LifeSci Advisors, LLC

Phone: +1 646.791.9729

egoldstein@lifesciadvisors.com

Media:

Mariesa Kemble

kemblem@mac.com

BrainStorm to Announce Third Quarter Financial Results and Provide a Corporate Update

Mon, 25 Oct 2021 12:00:00 GMT

BrainStorm's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Global Head of Clinical Research, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Alla Patlis, CPA, MBA, Interim Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. Eastern Time on Sunday, November 14, 2021.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:

Toll Free:

888-506-0062

International:

973-528-0011

Entry Code:

837509

Webcast URL:

https://www.webcaster4.com/Webcast/Page/2354/43351

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Numbers:

Toll Free:

877-481-4010

International:

919-882-2331

Replay Passcode:

43351

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts:

Contacts

Contacts:

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-429-3548

jmullaly@lifesciadvisors.com

Media:

Daniel J. McIntyre

100 High Street

Boston, MA 0212

+1 914-297-8781

dan@publickhousegroup.com

BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Data at NYSCF 2021 VIRTUAL Meeting

Mon, 18 Oct 2021 12:00:00 GMT

POSTER HIGHLIGHTS:

The observed positive preclinical results suggest that intratracheal administration of Exo MSC-NTF may have clinical potential as a therapy for acute lung related pathologies and may be more effective at modifying physiological, pathological, and biochemical outcomes than sEVs isolated from naïve MSCs.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Contacts

Contacts:

Investor Relations:

Eric Goldstein

LifeSci Advisors, LLC

1 (646) 791-9729

egoldstein@lifesciadvisors.com

Daniel J. McIntyre:

100 High Street

Boston, MA 0212

1 914-297-8781

dan@publickhousegroup.com

Phase 2 Clinical Trial Data of NurOwn® in Progressive MS Will Be Presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

Thu, 14 Oct 2021 12:00:00 GMT

The Phase 2 clinical trial was designed to evaluate intrathecal administration of NurOwn (autologous MSC-NTF cells) in participants with progressive MS. The study achieved the primary endpoint of safety and tolerability. It demonstrated a reduction of neuroinflammatory biomarkers and an increase in neuroprotective biomarkers in the cerebrospinal fluid (CSF) and consistent improvement across MS functional outcome measures, including measures of walking, upper extremity function, vision and cognition.

"We were pleased that this study demonstrated safety, preliminary evidence of efficacy and relevant biomarker outcomes in patients with progressive multiple sclerosis, in an area of high unmet need," said Jeffrey Cohen, M.D., Director of Experimental Therapeutics at the Cleveland Clinic Mellen Center for MS and principal investigator for the trial. "These results should be confirmed in a randomized placebo-controlled trial."

The study was sponsored by Brainstorm Cell Therapeutics with additional financial support for biomarker analyses from the National Multiple Sclerosis Society Fast-Forward Program. It was conducted at four U.S. MS centers of excellence:

"We very much appreciate the tremendous collaboration among many premier organizations, for their generous sharing of expertise, support and data, which enabled the important balance between scientific rigor and ethical treatment of progressive MS participants in the trial," said Ralph Kern, M.D., MHSc., President and Chief Medical Officer, Brainstorm Cell Therapeutics. "We are holding discussions with key MS experts, and seeking guidance from the FDA to determine next steps for the development of NurOwn in progressive MS."

"The National MS Society is pleased to support the biomarker portion of this study through our commercial funding program Fast Forward," said Mark Allegretta, Ph.D., Vice President, Research. "We're encouraged to see evidence that the biomarker analysis showed proof of concept for detecting neuroprotection and reduced inflammation."

About the trial

The Phase 2 open-label study evaluated the safety and efficacy of intrathecal administration of autologous MSC-NTF cells in patients with primary or secondary progressive MS. The primary study endpoint was safety and tolerability. Secondary efficacy endpoints included: timed 25-foot walk (T25FW); 9-Hole Peg Test (9-HPT); Low Contrast Letter Acuity (LCLA); Symbol Digit Modalities Test (SDMT); 12 item MS Walking Scale (MSWS-12); as well as cerebrospinal fluid (CSF) and blood biomarkers. Clinical efficacy outcomes were compared with matched (n=48) participants in the Comprehensive Longitudinal Investigation of Multiple Sclerosis (CLIMB) registry, Tanuja Chitnis, MD Brigham and Women's Hospital and the Ann Romney Center for Neurologic Diseases, and 255 patient randomized double blind placebo controlled NN-102 SPRINT-MS Study, courtesy NIH/NINDS, PI: Robert J. Fox, MD, MS, FAAN, Cleveland Clinic, CTR: NCT01982942. Baseline characteristics from these two cohorts were similar allowing for comparison of efficacy results, comparisons with SPRINT-MS were with the placebo arm of this study.

Mean age of participants was 47 years, 56% were female, and mean baseline EDSS score was 5.4. 18 participants were treated, 16 (80%) received all 3 treatments and completed the entire study; 2 study discontinuations were due to procedure-related adverse events. No deaths or treatment-related adverse events due to worsening of MS were observed.

In responder analyses, 14% and 13% of MSC-NTF treated participants showed at least a 25% improvement in T25FW and 9-HPT (combined hands) respectively, compared to 5% and 0% in matched CLIMB patients and 9% and 3% in SPRINT. Twenty-seven percent (27%) showed at least an 8-letter improvement in LCLA (binocular, 2.5% threshold) and 67% showed at least a 3-point improvement in SDMT, compared to 6% and 18% in CLIMB and 13% and 35% in SPRINT, respectively.

Mean improvements of +0.10 ft/sec in T25FW and -0.23 sec in 9-HPT (combined hands), were observed in MSC-NTF treated participants, compared to a mean worsening of -0.07 ft/sec and +0.49 sec in CLIMB and -0.06 ft/sec and +0.28 sec in SPRINT, respectively. MSC-NTF treated participants showed a mean improvement of +3.3 letters in LCLA (binocular, 2.5% threshold) and 3.8 points in SDMT, compared to a mean worsening of -1.07 letters in LCLA (binocular, 2.5% threshold) and mean improvement of +0.10 in SDMT, in CLIMB and -0.6 and -0.1 in SPRINT. In addition the MSFC-4 Composite Z-score of T25W, 9-HPT, SDMT and LCLA showed a 0.18 point improvement in MSC-NTF treated participants, while CLIMB and SPRINT showed decreases of -0.02 and -0.05.

Furthermore, 38% of treated patients showed at least a 10-point improvement in the MSWS-12 a patient reported outcome that evaluates the impact of MS on walking function, whereas this outcome was not evaluated in CLIMB or SPRINT.

CSF biomarkers obtained at 3 consecutive time points, showed increases in neuroprotective molecules (VEGF, HGF, NCAM-1, Follistatin, Fetuin-A) and decreases in neuroinflammatory biomarkers (MCP-1, SDF-1, sCD27 and Osteopontin).

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts:

Contacts

Contacts:

Investor Relations:

Eric Goldstein

LifeSci Advisors, LLC

Phone: +1 (646) 791-9729

egoldstein@lifesciadvisors.com

Media:

Mariesa Kemble

kemblem@mac.com

BrainStorm to Present ALS Phase 3 Biomarker Analyses at Annual NEALS Meeting October 6th, 2021

Wed, 06 Oct 2021 12:00:00 GMT

Presentation details:Session Date: October 6th 2021Presenting Time: 4:00pm – 5:00pm ET

"We are fully committed to advance our proprietary cell therapy NurOwn® in ALS" said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We believe that making tangible progress in ALS science and clarifying the molecular signature of NurOwn's mechanism of action in ALS will be an important next step in bringing a much needed therapy to patients with ALS who have a terminal disease and have limited treatment options."

Stacy Lindborg, EVP and Head of Global Clinical Research at Brainstorm commented, "We are excited to show the significant changes of NurOwn across a range of biomarkers spanning important domains such as neurodegeneration, neuroinflammation and neuroprotection. Furthermore, by using biomarker response and an innovative statistical model, we can predict treatment outcomes in the study with great accuracy. These objective biomarker endpoints provide more confidence as we continue researching and developing NurOwn."

The poster will be available on the Publications page of Brainstorm's corporate website, following the presentation at the NEALS conference.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Eric Goldstein

LifeSci Advisors, LLC

Phone: +1 646.791.9729

egoldstein@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm to Present at the 2021 Cell & Gene Meeting on the Mesa

Mon, 04 Oct 2021 12:00:00 GMT

Dr. Lindborg's presentation highlights the expansion of Brainstorm's technology portfolio to include autologous and allogeneic product candidates, covering multiple neurological diseases. The most progressed clinical development program, which includes a completed phase 3 trial of NurOwn® in ALS patients, remains the highest priority for Brainstorm. Brainstorm is committed to pursuing the best and most expeditious path forward to enable patients to access NurOwn.

Dr. Lindborg's presentation will be in the form of an on-demand webinar that will be available beginning October 12. Those who wish to listen to the presentation are required to register here. At the conclusion of the 2021 Cell & Gene Meeting on the Mesa, a copy of the presentation will also be available in the "Investors and Media" section of the BrainStorm website under Events and Presentations.

About the 2021 Cell & Gene Meeting on the Mesa

The meeting will feature sessions and workshops covering a mix of commercialization topics related to the cell and gene therapy sector including the latest updates on market access and reimbursement schemes, international regulation harmonization, manufacturing and CMC challenges, investment opportunities for the sector, among others. There will be over 135 presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies.

The conference will be delivered in a hybrid format to allow for an in-person experience as well as a virtual participation option. The in-person conference will take place October 12-14 in Carlsbad, CA. Virtual registrants will have access to all content via livestream during program dates. Additionally, all content will be available on-demand within 24 hours of the live program time. Virtual partnering meetings will take place October 19-20 via Zoom.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Eric Goldstein

LifeSci Advisors, LLC

Phone: +1 646.791.9729

egoldstein@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm to Present Phase 2 Progressive MS Study Results in Oral Presentation at 37th Congress of ECTRIMS

Fri, 01 Oct 2021 12:00:00 GMT

The presentation will feature results from a Phase 2 trial that evaluated three repeated intrathecal administrations of NurOwn® (MSC-NTF cells), each given 2 months apart, as a treatment for progressive multiple sclerosis (MS). The trial achieved the primary endpoint of safety and tolerability, and improvements were observed in secondary endpoints spanning neurologic function, cognition, and biomarkers. Abstracts are now available online: https://ectrims2021.abstractserver.com/program/#/results.

Presentation details:

Session Title: Free Communications 2 - Treatment trials - ImmunomodulationSession Date: October 14th 2021Presenting Time: 4:45 p.m. - 5:45 p.m. CEST

"We are excited to communicate the potential of our proprietary cell therapy NurOwn® in progressive MS at the 37th Congress of ECTRIMS," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We appreciate the contributions of the study participants and investigators who have advanced our understanding of NurOwn as an important therapeutic option for patients with progressive MS and are grateful that Dr Jeffrey Cohen will be giving this important oral presentation on behalf of the study investigators and BrainStorm."

Ralph Kern, MD MHSc, President and Chief Medical Officer of BrainStorm added, "It is a great privilege to share our Phase 2 progressive MS clinical trial results with leading MS experts from around the globe at the 37th Congress of ECTRIMS. The scientific exchange at ECTRIMS will be critical to inform our ongoing efforts to advance our proprietary cell therapy in progressive MS."

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Eric Goldstein

LifeSci Advisors, LLC

Phone: +1 646.791.9729

egoldstein@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Second Quarter 2021 Financial Results and Provides a Corporate Update

Thu, 05 Aug 2021 12:00:00 GMT

Continuing to assess regulatory strategy for advancing NurOwn® towards potential approval in ALS

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, August 5, 2021 -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the first quarter ended June 30, 2021 and provided a corporate update.

“We continue to take important steps to advance NurOwn in ALS and progressive MS and position ourselves for sustained success,” said Chaim Lebovits, Chief Executive Officer of BrainStorm. “Our discussions with leading ALS experts have provided invaluable insights that we will leverage as we assess NurOwn’s potential regulatory pathways in major markets. We also doubled our capacity to supply NurOwn® across Israel and Europe, supporting our readiness to provide broad patient access following any potential approval. Looking ahead, we will continue to work expeditiously with key opinion leaders and the broader ALS community to address the urgent unmet needs of ALS patients, who remain our greatest inspiration.”

Second Quarter 2021 and Subsequent Corporate Highlights

· Announced the expansion of the NurOwn® intellectual property portfolio with the grant and allowance of multiple patents and applications in key territories including the U.S., European Union, Canada, Israel, and Hong Kong.

· Presented preclinical data showing that intrathecal administration of NurOwn-derived exosomes resulted in statistically significant improvements in multiple lung parameters in a mouse model of acute respiratory distress syndrome (ARDS) at the ISCT 2021 New Orleans VIRTUAL Meeting .

Cash and Liquidity as of June 30, 2021

The Company’s cash, cash equivalents and short-term bank deposits as of June 30, 2021, totaled approximately $35.0 million.

During the quarter ended June 30, 2021, the Company did not sell any ordinary shares pursuant to its ATM offering established in September 2020. Since commencement of the ATM offering in September 2020, the Company has raised gross proceeds, before payment of commissions and offering expenses, of approximately $29.1 million under this facility.

Financial Results for the Three Months Ended June 30, 2021

Cash, cash equivalents, and short-term bank deposits were approximately $35.0 million as of June 30, 2021, compared to approximately $40.0 million on March 31, 2021.

Research and development expenses, net for the three months ended June 30, 2021 and 2020 were approximately $3.6 million and $5.7 million, respectively.

Excluding participation from IIA and other grants, research and development expenses decreased by approximately $2.2 million from $6.0 million in the second quarter of 2020 to $3.8 million in the second quarter of 2021.

General and administrative expenses for the three months ended June 30, 2021 and 2020 were approximately $2.5 million and $1.7 million, respectively.

Net loss for the three months ended June 30, 2021 was approximately $6.3 million, as compared to a net loss of approximately $7.4 million for the three months ended June 30, 2020.

Net loss per share for the three months ended June 30, 2021 and 2020 was $0.17 and $0.25, respectively.

Conference Call & Webcast

Thursday, August 5, 2021 at 8:00 a.m. Eastern Time From the U.S.: 888-506-0062 International: 973-528-0011

Entry Code: 298566 Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/41929

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days. From the U.S.: 877-481-4010 International: 919-882-2331 Replay Passcode: 41929

About NurOwn®

The NurOwn ® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn ® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS).

For more information, visit the company's website at www.brainstorm-cell.com .

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn ® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital; the prospects for regulatory approval of BrainStorm's NurOwn ® treatment candidates for the treatment of ALS and MS; the initiation, completion, and results of BrainStorm's preclinical and clinical development programs; research, regulatory and personnel issues; if approved, development of a global market for our treatment candidates; the ability to secure and maintain research institutions to conduct our clinical trials; if approved and commercialized, the ability to generate any significant revenue; the ability of BrainStorm's NurOwn ® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases; BrainStorm's ability to manufacture, or to use third parties to manufacture, and, if approved, commercialize the NurOwn ® treatment candidates; obtaining patents that provide meaningful protection, competition and market developments; BrainStorm's ability to protect our intellectual property from infringement by third parties; heath reform legislation; currency exchange rates; and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts Investor Relations: Eric Goldstein LifeSci Advisors, LLC Phone: +1 646.791.9729 egoldstein@lifesciadvisors.com

Media: Paul Tyahla SmithSolve Phone: + 1.973.713.3768 Paul.tyahla@smithsolve.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands

(Except share data)

BrainStorm Increases Commercial Manufacturing Capacity; Granted GMP Certification for a Second Production Site in Israel

Tue, 27 Jul 2021 12:00:00 GMT

"We are proud to be the first company to have been granted GMP certificate at the Sourasky Hospital's Institute for Advanced Cellular Therapies, that hosts a newly built state-of-the-art cleanroom suites to advance our proprietary cellular technology platform in ALS and other neurodegenerative diseases," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "The GMP certification of these additional cleanrooms means that we now have more than doubled the capacity to supply NurOwn to ALS patients across Israel and Europe. This is critical, as ALS is a truly debilitating disease and patients are in urgent need of new therapies. We remain committed to addressing this unmet need and continue to discuss our clinical data with leading experts as we assess potentially regulatory pathways for NurOwn in various jurisdictions."

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Eric Goldstein

LifeSci Advisors, LLC

Phone: +1.516.521.2470

egoldstein@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm to Announce Second Quarter Financial Results and Provide a Corporate Update

Mon, 26 Jul 2021 12:00:00 GMT

BrainStorm's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Global Head of Clinical Research, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. Eastern Time on Wednesday, August 4, 2021.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:Toll Free: 888-506-0062 International: 973-528-0011 Entry Code: 298566

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/41929

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Numbers:Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 41929

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Investor Relations:

John Mullaly

LifeSci Advisors, LLC

Phone: +1 617-430-7485

jmullaly@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

Brainstorm Announces Expansion of NurOwn® IP Portfolio with Grant and Allowance of Multiple Patents and Applications in Major Markets

Tue, 15 Jun 2021 12:00:00 GMT

"We continue to see success developing a comprehensive global patent portfolio for NurOwn and these latest patents further strengthen our overall IP position in major markets," said Chaim Lebovits, Chief Executive Officer of Brainstorm Cell Therapeutics. "The claims of these patents are the result of Brainstorm's world class expertise in applying cell therapy to treat neurodegenerative disorders. They underscore the potential value of NurOwn as a novel treatment for diseases such as ALS and MS, which represent major unmet needs."

Title: Methods of generating mesenchymal stem cells which secrete neurotrophic factorsPatent #: EU Patent No. 2880151Grant Date: 3 June 2020Patent #: Hong-Kong patent No. HK1209453Grant date: 19 February 2021Details: Claims cover a method of manufacturing MSC-NTF cells (NurOwn®)

Title: Methods of qualifying cellsPatent #: Israel Patent Application No 246943Issue date: 1 September 2020Details: Allowed claims include a cell population that secretes neurotrophic factors which is qualified as useful as a therapeutic for treating ALS and a method for qualifying said population

Title: Pharmaceutical composition comprising bone-marrow derived mesenchymal stem cells Patent #: Canadian patent application No. 2,937,305Grant date: 15 December 2020Details: Allowed claims cover a pharmaceutical composition comprising NurOwn® (MSC-NTF cells, mesenchymal stem cells secreting neurotrophic factors)

Title: Isolated cells and populations comprising same for the treatment of CNS diseases Patent #: US patent No. 10,869,899 Grant date: 22 December 2020Details: Allowed claims cover a cell population secreting GDNF, a pharmaceutical composition comprising the isolated cells, and a device comprising the pharmaceutical composition, including a device that is adapted for administration of the isolated cell population into the spinal cord

Title: Mesenchymal stem cells for the treatment of CNS diseasesAllowance date: 1 June 2021 US Patent Application No.: 16/047,129 Details: Allowed claims cover a method of treating a disease selected from the group consisting of Parkinson's, amyotrophic lateral sclerosis (ALS), Alzheimer's disease, stroke and Huntington's disease using MSC-NTF cells (NurOwn)

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Data at ISCT 2021 New Orleans VIRTUAL Meeting

Tue, 25 May 2021 12:00:00 GMT

POSTER HIGHLIGHTS:

"Our strategy at Brainstorm is to explore the full potential of our proprietary platform cell technology and we have identifying ARDS as a serious unmet medical need where our exosome technology can potentially benefit patients," said Chaim Lebovits, CEO of Brainstorm. "At the same time we remain fully committed to advancing our cellular therapeutic pipeline in ALS and progressive MS."

Revital Aricha, Ph.D., VP, Research & Development of BrainStorm added, "The International Society for Cell and Gene Therapy (ISCT) is a globally recognized organization focused on translational aspects of developing cell-based therapeutics. We are pleased to present our exciting preclinical data at this conference."

About NurOwn® The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Announces First Quarter 2021 Financial Results and Provides a Corporate Update

Mon, 26 Apr 2021 12:00:00 GMT

Positive Phase 2 data demonstrate the potential of NurOwn® as a treatment for progressive MS

Regulatory strategy progressing to advance NurOwn’s approval in ALS

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, April 26, 2021 -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the first quarter ended March 31, 2021 and provided a corporate update.

“In the first quarter we were excited to announce positive top line data from our Phase 2 trial evaluating NurOwn® as a treatment for progressive multiple sclerosis (MS). These data expand the body of evidence supporting the NurOwn® technology platform across neurodegenerative diseases,” said Chaim Lebovits, Chief Executive Officer of BrainStorm. “In our ALS program, we intend to submit a manuscript for peer review shortly and are delivering scientific presentations. We are currently in active discussions with various experts including principal investigators, ALS physicians, statisticians, regulatory advisors as well as patient advocacy groups, in addition to potential strategic partners. Based on all feedback received, we will assess the best path forward to enable patients access to NurOwn including FDA BLA submission and/or other regulatory and business options.”

First Quarter 2021 Corporate Highlights

· Announced positive top-line data from the open label Phase 2 trial evaluating NurOwn® as a treatment for progressive multiple sclerosis (MS). The trial achieved the primary endpoint of safety and demonstrated clinically meaningful improvements in multiple endpoints.

o Consistent improvement across all functional measures were observed, in comparison to the matched clinical cohort from the Comprehensive Longitudinal Investigations in MS at the Brigham & Woman's Hospital (CLIMB Study).

o Pre-specified responder analysis demonstrated consistent improvements in functional measures including walking, vision and cognition. These improvements were not seen in any of the matched CLIMB patients.

o Consistent increases in delivered neurotrophic factors and a reduction across key inflammatory biomarkers were observed.

· Following FDA feedback on the Phase 3 NurOwn ALS clinical data, and enacting FDA advice, we have made great progress in the important steps needed to develop and then act on our regulatory strategy. These include submission of a manuscript for a peer-reviewed publication of NurOwn’s Phase 3 clinical trial results and conducting ongoing consultations with key ALS stakeholders in the U.S. and other jurisdictions confirming the strength of the data and providing feedback and valuable guidance on next steps.

· Published data from a preclinical study showing that intrathecal administration of NurOwn derived exosomes significantly improved lung function and histology in a mouse model of acute respiratory distress syndrome (ARDS), a type of respiratory failure frequently associated with COVID-19. The study, entitled, "MSC-NTF (NurOwn) exosomes: a novel therapeutic modality in the mouse LPS-induced ARDS model," was published in the peer-reviewed journal Stem Cell and Research Therapy .

Presented at the following investor conferences:

· 10 th Annual SVB Leerink Global Healthcare Conference

Cash and Liquidity as of March 31, 2021

Total available funding as of March 31, 2021, which includes cash, cash equivalents and short-term bank deposits of approximately $40.0 million, an untapped ATM capacity of approximately $16.0 million, as well as remaining non-dilutive funding from grants, amounts to approximately $57.0 million.

Financial Results for the Three Months Ended March 31, 2021

Cash, cash equivalents, and short-term bank deposits were approximately $40.0 million as of March 31, 2021, compared to approximately $42.0 million on December 31, 2020.

Research and development expenses, net for the three months ended March 31, 2021 and 2020 were approximately $4.3 million and $5.9 million, respectively.

Excluding participation from IIA and CIRM under the grants and proceeds received under the hospital exemption regulatory pathway, research and development expenses decreased by approximately $2.3 million from $7.1 million in the first quarter of 2020 to $4.8 million in the first quarter of 2021.

General and administrative expenses for the three months ended March 31, 2021 and 2020 were approximately $2.6 million and $2.4 million, respectively.

Net loss for the three months ended March 31, 2021 was approximately $6.6 million, as compared to a net loss of approximately $8.1 million for the three months ended March 31, 2020.

Net loss per share for the three months ended March 31, 2021 and 2020 was $0.19 and $0.32, respectively.

Conference Call & Webcast

Monday, April 26, 2021 at 8:00 a.m. Eastern Time

From the U.S.: 877-407-9205

International: 201-689-8054

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/40513

Replays, available through May 10, 2021

From the U.S.: 877-481-4010

International: 919-882-2331

Replay Passcode: 40513

About NurOwn®

The NurOwn ® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn ® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn ® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn ® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn ® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn ® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts Investor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138 cdavis@lifesciadvisors.com

Media: Paul Tyahla SmithSolve Phone: + 1.973.713.3768 Paul.tyahla@smithsolve.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands

(Except share data)

BrainStorm to Announce First Quarter Financial Results and Provide a Corporate Update

Mon, 19 Apr 2021 12:00:00 GMT

BrainStorm's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Global Head of Clinical Research, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. Eastern Time, Sunday, April 25, 2021.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:Toll Free: 877-407-9205International: 201-689-8054 Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/40513

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at https://brainstorm-cell.com/investors/ and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Numbers:Toll Free: 877-481-4010International: 919-882-2331 Replay Passcode: 40513

About NurOwn® The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive multiple sclerosis (MS).

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1 973-713-3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Positive Topline Data in Phase 2 Study Evaluating NurOwn® as a Treatment for Progressive MS

Wed, 24 Mar 2021 12:00:00 GMT

"This is an extremely exciting outcome, as it demonstrates the potential of our proprietary cell therapy NurOwn in progressive MS and expands the body of evidence supporting the NurOwn® technology platform in neurodegenerative disease," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We appreciate the efforts of the Brainstorm team and the commitment and expertise of the clinical trial sites and patients who participated in this important trial despite the challenges imposed by the COVID-19 pandemic. We plan to fully evaluate the results of this study, review the data with the MS scientific community and hopefully continue to advance NurOwn as an important therapeutic option for patients with progressive MS."

The 28-week open-label Phase 2 clinical trial enrolled 20 primary and secondary progressive MS patients based on the 2017 revised McDonald Criteria, ages 18-65, with baseline Expanded Disability Status Scale (EDSS) scores between 3-6.5, without evidence of relapse within 6 months of enrollment, able to walk 25 feet in 60 seconds or less and were permitted to be on a stable dose of disease modifying therapy.

Of the 20 patients enrolled, 18 were treated and 16 (80%) completed the study. Two patients discontinued related to procedure-related AEs. There were no study deaths or AEs related to multiple sclerosis worsening. The mean age of study patients was 47, 56% were female, and mean baseline EDSS score was 5.4. The clinical trial compared clinical efficacy outcomes with a 48 patient matched clinical cohort from the Comprehensive Longitudinal Investigations in MS at the Brigham & Woman's Hospital (CLIMB Study).

MS Function and Cognition measures in the top-line results included the timed 25-foot walk (T25FW); 9 hole peg test (9-HPT); Low Contrast Letter Acuity (LCLA); Symbol Digit Modality Test (SDMT); and the 12 item MS Walking Scale (MSWS-12). Prespecified 25% improvements in the timed 25-foot walk (T25FW) and 9-hole peg test (9-HPT) from baseline to 28 weeks were observed in 14% and 13% of NurOwn treated patients, respectively, and was observed in 0% of the pre-specified matched historical controls in the CLIMB registry. Thirty eight percent of NurOwn treated patients showed at least a 10-point improvement in the MSWS-12 from baseline to week 28, a patient reported outcome that evaluates walking function. In addition, 47% of treated patients showed at least an 8-letter improvement across 28 weeks in the low contrast letter acuity test (LCLA), a visual function test, and 67% showed at least a 3-point improvement in the symbol digit modality test (SDMT), a measure of cognitive processing.

In addition, NurOwn treated patients showed a mean improvement from baseline of 10% in T25FW and a 4.8% improvement from baseline on the 9-HPT dominant hand, compared to 1.8% and 1.4% worsening respectively in matched historical controls from the CLIMB registry. Also, NurOwn treated patients showed a 6% improvement from baseline in MSWS-12. All results reported are based on observed data.

Cerebrospinal fluid (CSF) biomarkers were obtained at 3 consecutive time points, just prior to each intrathecal administration of NurOwn. We observed increases in neuroprotective molecules (VEGF, HGF) and decreases in neuroinflammatory biomarkers (MCP-1, SDF-1 and osteopontin). Additional secondary efficacy data, and detailed CSF and blood biomarker analyses are currently underway and will be reported at upcoming scientific meetings.

"These positive results indicate the potential of MSC-NTF cells to lessen inflammatory mechanisms, promote repair, and restore function in progressive MS, a condition for which there is great need for effective therapy," said Jeffrey Cohen, M.D, Director of Experimental Therapeutics, Cleveland Clinic Mellen Center for MS. Dr. Cohen reports no disclosures related to this study.

"We applaud Brainstorm for completion of this first in human trial of NurOwn in progressive MS, and are encouraged by the early indication of safety and effectiveness," said Mark Allegretta, PhD, Vice President of Research at the National MS Society. "We're hopeful that our collaboration will uncover insights into clinically relevant biomarkers that may predict a treatment effect in progressive MS."

Ralph Kern MD MHSc, President and Chief Medical Officer of Brainstorm stated, "The unprecedented results of this phase 2 clinical trial provide strong support for the potential of NurOwn to address the unmet clinical and biological need in progressive MS. Currently, few therapeutic options exist to address the relentless clinical progression and disability accumulation, ongoing compartmentalized and intrathecal CNS inflammation, and progressive loss of neural function in progressive MS. We plan to present a detailed summary of the study outcomes at an upcoming scientific meeting, publish our findings in a peer-reviewed journal and consider how best to advance NurOwn in progressive MS."

Stacy Lindborg Ph.D., EVP and Head of Global Clinical Research added, "We are pleased by the consistency of treatment effect observed across these functional and cognitive measures in patients who were either on standard of care or had prior treatment with existing disease modifying treatments. Our goal was to achieve proof of concept in progressive MS through an efficient design, which we have successfully delivered. We are also pleased to see accumulating evidence and confirmation of NurOwn's mechanism of action through CSF biomarker data in patients with multiple neurodegenerative diseases."

Study Design

The Phase 2 NurOwn® trial was a multi-center, open-label trial designed to evaluate the safety and efficacy of NurOwn® in 20 progressive MS patients at four MS centers of excellence: Cleveland Clinic, Mount Sinai School of Medicine,Stanford, and USC. Progressive MS patients were screened, provided informed consent and following a 10-week run-in period received three intrathecal administrations of 100-125 million autologous MSC-NTF cells at 2-month intervals. Patients were followed for 28 weeks after the first treatment. The primary endpoint of the trial was safety. Secondary endpoints included functional and cognitive measures and modulation of CSF and blood biomarkers (neurotrophic factors, neurodegenerative, and inflammatory biomarkers). Outcomes assessed included: Timed 25-Foot Walking Speed (T25FW); Expanded Disability Status Scale (EDSS); 9-Hole Peg Test (9HPT); Low Contrast Letter Acuity (LCLA); Symbol Digit Modality Test (SDMT); the 12 item MS Walking Scale (MSWS-12); average daily step count (using a wearable sensor); and quantitative MRI measures. For more information, refer to ClinicalTrials.gov Identifier: NCT03799718. A grant for $495k was received from the National Multiple Sclerosis Society, through its Fast Forward program, to support the Phase 2 open-label, multicenter clinical trial of repeated intrathecal administration of NurOwn® (autologous MSC-NTF cells) in participants with progressive Multiple Sclerosis.

About progressive MS

Progressive MS is a chronic neuroinflammatory and neurodegenerative disorder that affects the brain and spinal cord. MS affects approximately 1 million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of individuals affected by MS will eventually develop a progressive form of the disease, which may lead to increasing levels of motor, visual, and cognitive functional impairment, and relentless accumulation of disability.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1-646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: +1-973-713-3768

paul.tyahla@smithsolve.com

BrainStorm to Present at SVB Leerink 10th Global Healthcare Conference

Tue, 23 Feb 2021 12:00:00 GMT

Dr. Stacy Lindborg, the Company's EVP, head of Global Clinical Research will deliver a corporate update on February 26th at 8.40 AM Eastern Time. The live webcast of Dr. Lindborg's presentation can be accessed at: https://bit.ly/3qMP3mJ

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1-973-713-3768

Paul.tyahla@smithsolve.com

BrainStorm Announces High-Level FDA Feedback on NurOwn® ALS Clinical Development Program

Mon, 22 Feb 2021 12:00:00 GMT

"Brainstorm will first consult with principal investigators, ALS experts, expert statisticians, regulatory advisors, and ALS advocacy groups to assess the benefit/risk of a BLA submission before making a final decision," said Chaim Lebovits, CEO Brainstorm Cell Therapeutics. "We want to thank our independent advisors for their candor and unwavering commitment to our ALS program. We also would like to give a heartfelt thank you to all ALS patients and their families that were involved in this clinical research program. The company will continue to build on the strength of its wonderful, professional and dedicated team while being well funded at a current position of over $40M in cash. We will soon announce our next flagship product and program for other diseases with unmet needs."

"Many of us with longstanding experience in ALS therapy development agree that there was evidence of benefit from NurOwn cell therapy and hope that there will be an opportunity for further assessment of this modality in ALS," said Robert Brown, DPhil, MD, Director of the Program in Neurotherapeutics at the University of Massachusetts Medical School.

"ALS is a devastating disease with worse outcomes than most forms of cancer," said Anthony Windebank MD, Jean and Judith Pape Adams Professor of Neuroscience, Mayo Clinic College of Medicine and Science. "The clear signal in this trial that some patients with ALS respond to treatment with NurOwn is a light at the end of the tunnel. The careful study of biomarkers associated with response will help lead us forward towards a broadly effective therapy. The patients and their families who have brought us to this point are true heroes."

"I share my profound gratitude and thanks to the patients and families that participated in this phase 3 trial and all the teams at the six sites," said Merit Cudkowicz MD, Chief of Neurology and Director of the Healey & AMG Center for ALS at Mass General Hospital, and the Julieanne Dorn Professor of Neurology, Harvard Medical School. "We learned a lot about the efficacy and safety of NurOwn in people with ALS in this well conducted trial. We also learned some of the challenges with the use of ALSFRS-R at the lower end of the scale. Additional discussions with the community and sharing all the data in a peer reviewed publication are critical next steps."

"We will complete all ALS phase 3 study analyses to support scientific communication of the phase 3 data, including a peer-reviewed manuscript," said Ralph Kern MD MHSc, President and Chief Medical Officer Brainstorm Cell Therapeutics. "The results of the phase 3 clinical trial are very important, and we are confident that the analysis of key ALS disease biomarkers will contribute to our understanding of ALS. Our focus is to advance our proprietary cellular technology platform and to prioritize product development efforts based on data and business priorities."

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm is also conducting an FDA-approved Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter 2021.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1-646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: +1-973-713-3768

paul.tyahla@smithsolve.com

BrainStorm Announces Feedback from FDA Type-C Meeting on Future NurOwn® Manufacturing Plan

Tue, 09 Feb 2021 12:00:00 GMT

"We are pleased with the outcome of the type C meeting and the actionable guidance on FDA's expected requirements for a future semi-automated process," said Chaim Lebovits. "As we consider potential paths toward a regulatory submission for NurOwn, we believe it is prudent to validate and seek guidance from the FDA on our manufacturing plan. The transition from a manual manufacturing process to semi-automated manufacturing is a very important opportunity to increase capacity. It also incorporates measures that are designed to mitigate risk in the manufacturing process. This meeting was a positive milestone toward implementing a new process."

Brainstorm has generated extensive feasibility data on the semi-automated process, the design of which is now at an advanced stage. The company will incorporate feedback from the FDA meeting and its experience from Phase 3 manufacturing to finalize a robust comparability plan that enables semiautomatic manufacturing to be introduced at the appropriate time in the future. It will also finalize the remaining steps necessary to proceed with running NurOwn® conformance batches.

The FDA also provided comments on several key aspects of the current manufacturing process, which BrainStorm will use as the company continues its work to enable operations at its commercial manufacturing partner, Catalent.

"As we review our clinical data with the FDA, we will also continue communications on manufacturing to ensure our plans remain aligned with the Agency's expectations as we advance the development of NurOwn," Lebovits concluded.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm is in active discussions with the FDA to identify regulatory pathways that may support NurOwn's approval in ALS. BrainStorm is also conducting an FDA-approved Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter 2021.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1-646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: +1-973-713-3768

paul.tyahla@smithsolve.com

BrainStorm Announces Full Year 2020 Financial Results and Provides a Corporate Update

Thu, 04 Feb 2021 12:00:00 GMT

Company met with the FDA to present phase 3 data and is in ongoing discussions with the FDA to identify agreed upon regulatory pathways that may support NurOwn’s future approval in ALS

Progressive MS Phase 2 trial remains on track for top-line data readout in Q1 2021

Conference call and webcast at 8 a.m. ET today

NEW YORK, February 4, 2021 -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the fiscal year ended December 31, 2020, and provided a corporate update.

“In 2020 we achieved several important company milestones, the most significant of which was the timely completion of our pivotal Phase 3 ALS trial,” said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. “The trial generated robust data suggesting that NurOwn ® has a clinically meaningful treatment effect and the FDA is actively reviewing these data following a recent meeting with our clinical team. The unmet needs of ALS patients continue to be our greatest inspiration and foremost priority, and we will keep the market updated as we receive formal feedback from the FDA and diligently pursue next steps to advance NurOwn’s development in this devastating disease.”

Mr. Lebovits continued, “Beyond our lead ALS program, we continue to make progress and are poised for a catalyst rich 2021 for our NurOwn technology platform. In progressive MS, our Phase 2 top-line data are expected by the end of the first quarter, which we believe will highlight the broad applicability of NurOwn’s mechanism of action (MOA). We plan to further advance our pipeline through our clinical development program in Alzheimer’s disease, a highly prevalent disease with enormous societal impact and limited treatment options. These clinical programs will be complemented by the expansion of our manufacturing capabilities and advancement of our exosome-based platform technology, which has demonstrated the potential to treat COVID-19 acute respiratory distress syndrome in a recently published preclinical study. We believe that execution of these milestones will help move us toward our ultimate goal of addressing the critical unmet needs of patients with neurodegenerative diseases while simultaneously positioning the company to generate shareholder value.”

Fourth Quarter 2020 and Recent Corporate Highlights:

· Announced top-line results from the NurOwn ® Phase 3 amyotrophic lateral sclerosis (ALS) trial. Though the trial did not meet statistical significance in the primary efficacy endpoint, pre-specified analyses suggest that NurOwn ® has a clinically meaningful treatment effect, which we seek to further explore in ongoing discussions with the FDA.

· Presented the NurOwn ® Phase 3 results in a platform session at the 31 st International Symposium on ALS/MND.

· Initiated a NurOwn ® Expanded Access Program for patients who completed the Phase 3 ALS trial and meet specific eligibility requirements.

· Completed dosing of all patients in the ongoing Phase 2 clinical trial evaluating NurOwn ® as a treatment for adults with progressive multiple sclerosis (MS). Top-line data from the trial are expected by the end of the first quarter 2021.

· Announced a partnership with Catalent for NurOwn ® manufacturing. The partnership is designed to support a continuous supply of NurOwn ® for future clinical trials and initial commercialization.

· Selected Rapid Reshore & Development (RR&D) as our partner to expedite site selection and design services for a state-of-the-art manufacturing facility for NurOwn ® in the U.S.

· Announced the publication of a preclinical study entitled “MSC-NTF (NurOwn ® ) exosomes: a novel therapeutic modality in the mouse LPS-induced ARDS model,” in the peer-reviewed journal Stem Cell and Research Therapy . Data from the study showed that intrathecal administration of NurOwn ® derived exosomes significantly improved lung function and histology in a mouse model of acute respiratory distress syndrome (ARDS), a type of respiratory failure frequently associated with COVID-19.

· Presented preclinical NurOwn ® derived exosome ARDS data at the Virtual New York Stem Cell Foundation Conference.

· Presented an on-demand webinar at the 2020 Cell & Gene Meeting on the Mesa.

Cash and Liquidity as of January 31, 2021

Total cash and liquidity as of January 31, 2021 was approximately $45.0 million.

Financial Results for the Year Ended December 31, 2020

· Cash, cash equivalents, and short-term bank deposits were approximately $41.9 million as of December 31, 2020, compared to approximately $0.6 million on December 31, 2019.

· Research and development expenses, net for year ended December 31, 2020 and 2019 were approximately $22.3 million and $17.2 million, respectively.

o Excluding participation from IIA and CIRM under the grants and proceeds received under the hospital exemption regulatory pathway, research and development expenses decreased by $133,000 from approximately $24.7 million in the year ended December 31, 2019 to approximately $24.6 million in the year ended December 31, 2020.

· General and administrative expenses for the year ended December 31, 2020 and 2019 were approximately $9.4 million and $5.8 million, respectively.

· Net loss for the year ended on December 31, 2020 was $31.8 million, as compared to a net loss of $23.3 million for the year ended December 31, 2019.

o Net loss per share for the year ended December 31, 2020 and 2019 was $1.07 and $1.06, respectively.

For further details on BrainStorm’s financials, including financial results for the year ended December 31, 2020, refer to the Form 10-K filed with the SEC today.

Conference Call & Webcast

Thursday, February 4, 2021 at 8 a.m. Eastern Time

From the US: 877-407-9205

International: 201-689-8054

Webcast: https://cutt.ly/vjBvkTp

Replays, available through February 18, 2021 Replays, available through February 18, 2021

From the US: 877-481-4010

International: 919-882-2331

Replay Passcode: 39495

About NurOwn ®

The NurOwn ® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn ® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm is in active discussions with the FDA to identify regulatory pathways that may support NurOwn's future approval in ALS. BrainStorm is also conducting an FDA-approved Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter 2021.

For more information, visit the company's website at www.brainstorm-cell.com .

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of BrainStorm's NurOwn ® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our products and services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn ® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn ® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov . These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts Investor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138 cdavis@lifesciadvisors.com

Media: Paul Tyahla SmithSolve Phone: + 1.973.713.3768 Paul.tyahla@smithsolve.com

BRAINSTORM CELL THERAPEUTICS INC.

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

The accompanying notes are an integral part of the consolidated financial statements.

BRAINSTORM CELL THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S. dollars in thousands

(Except share data)

The accompanying notes are an integral part of the consolidated financial statements.

BrainStorm-Cell Therapeutics to Announce Fourth Quarter and Fiscal Year 2020 Financial Results and Provide a Corporate Update

Thu, 28 Jan 2021 12:00:00 GMT

BrainStorm’s CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Global Head of Clinical Research ,David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. EDT, Wednesday, February 3, 2021.

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers: Toll Free: 877-407-9205 International: 201-689-8054 Webcast URL: https://cutt.ly/vjBvkTp

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at brainstorm-cell.com/investors/ and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Number: Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 39495

About NurOwn® The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm is in active discussions with the FDA to identify regulatory pathways that may support NurOwn's approval in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter 2021.

For more information, visit the company's website at www.brainstorm-cell.com.

Contacts Investor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138 cdavis@lifesciadvisors.com

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Announces the Publication of Preclinical Data Highlighting the Potential of a NurOwn® Derived Exosome-Based Treatment for COVID-19 ARDS

Wed, 20 Jan 2021 12:00:00 GMT

ARDS is a type of respiratory failure that is frequently associated with COVID-19 and mediated by dysregulated cytokine production. While there are currently no effective therapies to prevent or reverse ARDS, mesenchymal stem cell (MSC)-derived exosomes have been suggested as a potential novel treatment option due to their ability to penetrate deep into tissues and efficiently deliver immunomodulatory molecules.

Results from the recently published study showed that intratracheal administration of NurOwn® derived exosomes led to a statistically significant reduction in lung disease severity score (p < 0.05; based on criteria set forth by the American Thoracic Society Documents: Matute-Bello et al., Am J Respir Cell Mol Biol 44;725-738, 2011) and improvements in several additional clinically relevant lipopolysaccharide (LPS)-induced ARDS markers such as lung function, fibrin presence, neutrophil accumulation, cytokine expression, and blood oxygenation levels. Notably, these improvements were significantly superior to those observed following administration of naïve MSC-derived exosomes.

"These exciting preclinical data suggest that NurOwn® derived exosomes have the potential to treat COVID-19-induced ARDS or other severe respiratory complications, and that they are more effective than exosomes isolated from naïve MSCs at combatting the various symptoms of the syndrome," said Dr. Revital Aricha, Vice President of Research & Development at BrainStorm. "This publication in a highly regarded journal provides important validation for the scientific advances and significance of BrainStorm's preclinical research programs, including on our exosome-based technology platform."

Chaim Lebovits, Brainstorm's Chief Executive Officer added, "While our primary focus is on advancing NurOwn® towards regulatory approval in ALS, we continue to evaluate the potential of our exosome-based platform to address unmet medical needs. The publication of these proof-of-concept data highlights this potential, and we are now actively assessing next steps to determine how to best generate value. We are also actively discussing with possible partners several development opportunities for the exosome technology."

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm is in active discussions with the FDA to identify regulatory pathways that may support NurOwn's approval in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter 2021.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1-646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: +1-973-713-3768

paul.tyahla@smithsolve.com

BrainStorm Issues 2020 Letter to Shareholders

Mon, 28 Dec 2020 12:00:00 GMT

Dear Valued Shareholders,

I am incredibly proud of the tremendous progress BrainStorm made as a company in 2020. The many scientific and corporate milestones we have achieved this year are a testament to the talent and unwavering commitment of our employees, partners and investigators. I deeply appreciate the work they've done, and their ability to execute in this challenging COVID environment. I want to thank especially the patients and caregivers, who showed a steadfast dedication to our clinical trials despite the pandemic. We remain committed to bringing NurOwn® to patients with neurodegenerative diseases as a much-needed treatment option. In addition, we are expanding our pipeline with the application of our exosome platform technology to include new indications that have significant unmet medical need.

BrainStorm's most significant clinical milestone of 2020 was the timely completion of the NurOwn® Phase 3 ALS clinical trial, despite the challenges of COVID-19. We believe the totality of evidence that we have generated are supportive of NurOwn's clinical benefit. We are diligently pursuing next steps, including active discussions with the United States Food and Drug Administration (FDA) to identify regulatory pathways that may support NurOwn's approval in ALS.

While we did not demonstrate statistical significance in the primary efficacy endpoint in the full study population, pre-specified analyses suggest that NurOwn® has a clinically meaningful treatment effect. For example, in a pre-specified participant subgroup with early disease and preserved function based on the ALSFRS-R baseline score, NurOwn® showed the expected numerically superior treatment response compared to placebo. Furthermore, phase 3 cerebrospinal fluid neurodegenerative and inflammatory biomarkers were consistently modified by NurOwn treatment, supporting NurOwn's proposed mechanism of action in ALS. We are thankful to the FDA for prioritizing our IND, as we and the Agency clearly understand the urgency needed for ALS patients.

Following the completion of our Phase 3 ALS clinical trial, we recently initiated an Expanded Access Program (EAP) to provide NurOwn® treatment for patients who completed the Phase 3 trial and meet specific eligibility requirements. This EAP was developed in partnership with the FDA and will take place at the six clinical centers of excellence that participated in the trial. Initiating the EAP immediately after the Phase 3 trial's completion speaks to the promise of NurOwn's phase 3 clinical data, the urgent unmet medical need for ALS patients and our commitment to patients. The ALS physician, advocacy and patient community feedback on the EAP has been extremely positive.

In parallel with the clinical programs to advance NurOwn, Brainstorm is also working to establish the manufacturing capability necessary for a commercial ramp up. To this effect, we engaged in strategic partnerships to expand our Current Good Manufacturing Practice (cGMP) capabilities. Our tech transfer to Catalent has already been initiated and will allow for continuous supply of NurOwn® for future clinical trials and initial commercialization. Our work with Rapid Reshore & Development, to help BrainStorm establish in-house manufacturing capabilities, will accelerate once a regulatory pathway is clear. These agreements will help to ensure an ongoing cGMP clinical supply of NurOwn® and will be integral to ensuring rapid access for patients following a potential regulatory approval. We also signed a lease agreement with the Tel Aviv Sourasky Medical Center (Ichilov Hospital) in Tel Aviv, Israel, to produce NurOwn® in three state-of-the-art cleanrooms. The new facility will significantly increase our manufacturing capacity, positioning us to strategically enter the European and Israeli markets. In addition to our clinical data review, we are also in active dialog with the FDA around this component of NurOwn's regulatory review. I am happy to share with you that we have recently had a successful meeting with the FDA regarding Chemistry, Manufacturing and Controls (CMC). We will provide an update when the minutes are finalized.

We have made excellent progress in our NurOwn clinical program in progressive MS, despite some delays in clinical trial enrollment due to COVID-19 healthcare restrictions. The next milestone will be the generation of top line results from our fully dosed Phase 2 trial which we expect by the end of first quarter 2021. Detailed analyses of the full study clinical and biomarker dataset can help demonstrate the potential of NurOwn technology in progressive MS. The broader objective for NurOwn is to continue to grow a strong body of evidence for NurOwn in ALS, MS in addition to other neurodegenerative diseases.

As part of our strategy to advance the NurOwn technology and expand our pipeline, we announced earlier this year a new clinical program in Alzheimer's disease. NurOwn has the capability to simultaneously target multiple relevant Alzheimer's disease pathways and bring a comprehensive approach that addresses both neurodegeneration and neuroinflammation. This is a fundamentally different approach to many previous Alzheimer's therapies which have focused on a single target such as tau or beta-amyloid. We intend to conduct a 52-week, Phase 2 open-label, proof-of-concept clinical trial to evaluate NurOwn in 40 participants with prodromal to mild Alzheimer's disease. The trial will be conducted at the Brain Research Centers affiliated with the Alzheimer Center Amsterdam, Pitié-Salpêtrière Hospital (Paris), and several other clinical trial sites in the Netherlands and France.

We were also pleased to announce a new program utilizing our exosome-based platform-technology for the treatment of severe COVID-19 infection and released proof-of-concept results from a pre-clinical study. In the pre-clinical study in mice, we demonstrated that intratracheal administration of exosomes extracted from Mesenchymal stem cells resulted in a statistically significant improvement in multiple lung parameters. The results from this study have been accepted and will be published in a peer-reviewed medical journal in 2021. We are actively evaluating next steps to determine the best path forward with our exosome platform.

We made important additions to the senior management team during 2020 including Dr. David Setboun as Chief Operating Officer and Dr. Stacy Lindborg as Head of Global Clinical Research. Dr. Setboun has extensive experience in the biopharmaceutical industry having held key leadership roles in commercial development and product launches at Biogen. Dr. Lindborg is an experienced healthcare executive and globally recognized medical statistician with over two decades of multinational experience in R&D, regulatory drug approvals, strategy development, analytics and big data at Lilly and Biogen. Prof. Jacob Frenkel joined us as Chairman of our Board earlier in the year. These appointments, as well as the other recent hires, are part of a strategic initiative to build a senior team with proven commercial capabilities, as we transition to potentially becoming a commercial organization.

Looking ahead to 2021, our main focus areas are to reach agreement with FDA on a path for regulatory approval NurOwn® in ALS, to generate top-line results for our Phase 2 MS study in the first quarter, to advance our Phase 2 Alzheimer's disease trial, to expand our exosome-based technology, and to further develop our cellular technology and manufacturing capabilities and infrastructure.

In 2021, we will leverage our strong financial position with over $40 million in cash and our experienced team will continue to be inspired by the ALS patients to bring our innovative treatment option forward while delivering value to our shareholders.

I would like to thank you for your continued support.

Sincerely,

Chaim LebovitsChief Executive OfficerBrainStorm Cell Therapeutics Inc.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Completion of All Dosing in NurOwn® Phase 2 MS Study

Fri, 18 Dec 2020 12:00:00 GMT

"Completed dosing of the Phase 2 progressive MS clinical trial is a major milestone for BrainStorm as we advance our goal to develop the NurOwn platform technology in neurodegenerative diseases," said Chaim Lebovits BrainStorm CEO. "We are very thankful for the dedicated efforts of the investigators and their teams and to the patients who participated in this important clinical trial. Through their combined efforts, we hope to bring a promising therapeutic option to those affected by progressive MS."

Ralph Kern MD, MHSc BrainStorm President and Chief Medical Officer commented, "Now that all dosing of the NurOwn Phase 2 progressive MS clinical trial is complete, we will shift our focus to completing all remaining patient clinical trial assessments and biomarker analyses. We look forward to generating clinical trial top line results by the end of the first quarter 2021 and to advancing this promising treatment option based on a thorough analysis of the clinical trial outcomes."

Stacy Lindborg PhD, EVP and Head of Global Clinical Research at BrainStorm added, "Detailed analyses of the full study data set at the conclusion of the trial will add to our understanding of the potential of NurOwn technology in progressive MS and to the growing body of evidence for NurOwn in neurodegenerative disease. The data and scientific insights we will share with the MS scientific community at upcoming conferences and in subsequent publications will help advance understanding of progressive MS and the potential benefits of NurOwn as a treatment."

MS is a chronic neuroinflammatory and neurodegenerative disorder that affects the brain and spinal cord. MS affects approximately 1 million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of affected individuals will eventually develop a progressive form of the disease, which may lead to increasing levels of motor, visual, and cognitive functional impairment, and disability.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a phase 3 pivotal trial in ALS (NCT03280056); this trial is investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1-646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: +1-973-713-3768

paul.tyahla@smithsolve.com

BrainStorm Announces NurOwn® Expanded Access Program

Mon, 14 Dec 2020 12:00:00 GMT

The protocol for the EAP was developed in partnership with the United States Food and Drug Administration (FDA) to provide access to NurOwn for Phase 3 clinical trial participants who meet specific eligibility criteria. Initially, patients less severely affected by ALS, as measured by the Revised ALS Functional Rating Scale (ALSFRS-R), will be the first to receive treatment. This approach is informed by recently announced topline data from the Company's Phase 3 clinical trial. According to the FDA, EAPs, alternatively known as "compassionate use" programs, provide a pathway for patients to receive an investigational medicine for a serious disease or condition outside of a clinical trial.

"This expanded access program is an appropriate and welcome next step in following up the exciting results of the Phase 3 study; it is widely anticipated and deeply appreciated by our ALS patients," said Robert Brown, MD DPhil, Leo P. and Theresa M. LaChance Chair in Medical Research, and chair, department of neurology, University of Massachusetts Medical School and UMass Memorial Medical Center, and one of the Principal Investigators in the NurOwn® Phase 3 study.

Through the newly announced EAP, the six clinical centers of excellence participating in the Phase 3 NurOwn® trial will each have the opportunity to treat ALS patients who completed the trial. These six centers are: University of California, Irvine; Cedars-Sinai Medical Center; California Pacific Medical Center; Massachusetts General Hospital; University of Massachusetts Medical School; and Mayo Clinic. EAP treatment of ALS patients who have completed the Phase 3 clinical trial will not interfere with data or regulatory timelines. The Dana Farber Cancer Institute will initially manufacture the investigational therapy, assisted by BrainStorm personnel who will be on-site.

Chaim Lebovits, CEO of BrainStorm, commented, "We are pleased to have the opportunity to treat additional patients with NurOwn through this Expanded Access Program, which was strongly advocated for by members of the ALS advocacy community. We recognize the urgency with which people with ALS want and need access to new potential treatments. This EAP is an important next step to providing an immediate option for some patients. We remain committed to rapidly advancing NurOwn through clinical development and regulatory review in the hope that the greatest number of people living with ALS may benefit."

Brian Wallach, person living with ALS and Co-Founder of I AM ALS, added, "The entire ALS community has worked tirelessly to find pathways to access promising investigational therapies because ALS waits for no one. The launch of this EAP represents an important step forward and precedent for realizing the vision of access to promising investigational therapies for all, and I am thankful to see it come to fruition."

Nancy Frates, ALS Advocate and TED Speaker remarked, "Recently our family took pause as we reflected on 1 year of living without our Peter. Continuing my promise to my son, I remain committed to his mission to #StrikeOutALS for the ALS patients of today and tomorrow. What has always been clear, is the importance of the community to work together to advance all legitimate potential treatments. I support the efforts of Brainstorm, as they take this important step toward realizing the potential promise of NurOwn in ALS. This Expanded Access Program provides real hope."

"On behalf of the largest ALS community in the United States, which includes three of the NurOwn clinical trial sites, the Golden West Chapter is extremely grateful to Brainstorm and our clinic partners for establishing and executing an Early Access Program for those who participated in the Phase 3 trial of NurOwn. Enabling early access, while the data review continues, is an extraordinary gesture of support and compassion for those living with ALS, and reflects an understanding of the ALS community's urgent need for an effective therapy. I applaud Brainstorm for taking this important step, and I look forward to learning the results of their full data analysis," said Fred Fisher, President & CEO of Golden West Chapter of The ALS Association.

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Investor Relations:

Corey Davis Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm to present NurOwn® Phase 3 Clinical Trial Results at 31st International Symposium on ALS/MND

Mon, 23 Nov 2020 12:00:00 GMT

Each year, the Symposium attracts over 1,000 delegates. It is the largest medical and scientific conference specific to MND/ALS and is a premier event in the MND research calendar for discussion on the latest advances in research and clinical management.

The platform presentation will be jointly made by Ralph Kern, MD MHSc, President and Chief Medical Officer of Brainstorm Cell Therapeutics and Merit Cudkowicz MD, one of the Principal Investigators of this trial and the Julieanne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital on December 9th in Session 3: Clinical Trials from 1110-1130 ET.

The poster presentation describing the clinical experience with NurOwn outpatient administration during the phase 3 clinical trial will be made by Dr. James Berry, Associate Professor of Neurology, Massachusetts General Hospital, Chief, Division of Motor Neuron Disorders, Massachusetts General Hospital at the virtual poster presentation.

"We are encouraged by the results of the phase 3 pivotal trial of NurOwn in ALS and are privileged to make these important scientific presentations to the 31st International Symposium on ALS/MND." said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We believe that presentation of these important phase 3 clinical and biomarker outcomes will increase awareness of the potential of NurOwn therapy in ALS and will enable us to listen to the ALS scientific and patient advocacy community as we seek a regulatory pathway forward with our innovative ALS cellular therapy, and hopefully provide a much-needed solution to ALS patients".

"It is an honor to jointly present our clinical trial results with Dr Cudkowicz on behalf of the study's principal investigators", said Ralph Kern, President and CMO of Brainstorm. "The trial has generated an important set of biomarkers that clearly demonstrates NurOwn's mechanism of action and may help predict ALS treatment response. We believe that there are important insights from our clinical trial and that NurOwn could potentially benefit ALS patients."

"The carefully outlined & detailed analysis plan of clinical trial and biomarker data, both finalized prior to viewing the data, provides the framework for generating evidence from this trial. The Placebo response observed in the NurOwn Phase 3 clinical trial combined with the natural heterogeneity in ALS confounds analysis of clinical trials data", said Stacy Lindborg, EVP and Head of Global Clinical Research. "The process of sharing data with ALS experts, such as a meeting like MND which draws world-renowned ALS physicians and researchers, is critical to producing evidence of NurOwn's treatment effect for patients that will stand over time. We are progressing our knowledge of the Phase 3 data and look forward to the sharing our latest insights into the Phase 3 trial data with the ALS research community."

Study Design

The Phase 3 NurOwn® trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of NurOwn® in 189 ALS patients. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford); California Pacific Medical Center (Prof. Robert Miller); Massachusetts General Hospital (DrsMerit Cudkowicz, James Berry and Katie Nicholson); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as patients with at least a 3 point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn® or placebo. Participants were followed for 28 weeks after treatment. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a ³ 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment. Secondary endpoints included the percentage of patients with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

(NCT03280056); this trial investigated repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study was intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS and discussion of potential regulatory pathways for approval are planned with the U.S. FDA. BrainStorm is also conducting an FDA-cleared Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Topline Results from NurOwn® Phase 3 ALS Study

Tue, 17 Nov 2020 12:00:00 GMT

The Phase 3 clinical trial's primary efficacy endpoint, a responder analysis evaluating the proportion of participants who experienced a 1.25 points per month improvement in the post-treatment Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope, was powered on assumed treatment response rates of 35% on NurOwn versus 15% on Placebo. These estimates were based on available historical clinical trial data and the NurOwn Phase 2 data. The primary endpoint was achieved in 34.7% of NurOwn participants versus 27.7% for Placebo (p=0.453). Therefore, the trial met the expected 35% NurOwn treatment group efficacy response assumption, however the high placebo response exceeded placebo responses observed in contemporary ALS trials. The secondary efficacy endpoint measuring average change in ALSFRS-R total score from baseline to Week 28, was -5.52 with NurOwn versus -5.88 on Placebo, a difference of 0.36 (p= 0.693).

In an important, pre-specified subgroup with early disease based on ALSFRS-R baseline score ³ 35, NurOwn demonstrated a clinically meaningful treatment response across the primary and key secondary endpoints and remained consistent with our pre-trial, data-derived assumptions. In this subgroup, there were 34.6% responders who met the primary endpoint definition on NurOwn and 15.6% on Placebo (p=0.288), and the average change from baseline to week 28 in ALSFRS-R total score was -1.77 on NurOwn and -3.78 on Placebo (p=0.198), an improvement of 2.01 ALSFRS-R points favoring NurOwn.

Cerebrospinal fluid (CSF) biomarker analyses confirmed that treatment with NurOwn resulted in a statistically significant increase of neurotrophic factors and reduction in neurodegenerative and neuroinflammatory biomarkers that was not observed in the placebo treatment group. We also carried out pre-specified statistical modeling designed to predict clinical response with high sensitivity and specificity based on ALS biomarkers and ALS Function and confirmed that NurOwn treatment outcomes could be predicted by baseline ALS function as well as key CSF neurodegenerative and neuroinflammatory biomarkers.

Dr. Merit Cudkowicz, one of the Principal Investigators of this trial and the Julianne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital said, "We found a clinically meaningful response to NurOwn in a pre-specified group of patients (greater than or equal to 35 ALSFRS-R at baseline). A change in pre- to post- treatment slope of 1.25 or more is substantial and clinically important. Given the heterogeneity of ALS, it is not surprising that measurement of treatment effect may be influenced by disease severity including the behavior of disease progression rates at the lower end of the scale. It is important to fully explore this finding. In addition, NurOwn was observed to have its clear intended biological effects with important changes in the pre-specified disease and drug related biomarkers."

"This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials. We identified a superior treatment response in a pre-specified subgroup of patients with less advanced disease. We are in active discussions with the FDA who have expressed their eagerness to review the data and have committed to prioritize review of this data. The FDA will review the data to see if there is a path forward to support approval" said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We would like to sincerely thank the patients, their families and caregivers, investigators and staff who participated in this study, as their dedication and hard work allowed for the study's on-time completion despite the ongoing COVID-19 pandemic. I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial."

"The findings from this clinical trial demonstrated that NurOwn treatment was associated with a clinically meaningful treatment response and consistent biomarker effects in known ALS disease pathways and that the ability of the clinical trial to demonstrate treatment effects compared to placebo are influenced by baseline disease status, as revealed through ALS function and key biomarkers. We are committed to advancing discussions with the FDA to identify regulatory pathways that may support NurOwn in ALS," commented Ralph Kern MD MHSc, President and CMO of Brainstorm. "In addition to planned scientific engagements, biosamples from this study will be shared through the NEALS biorepository to enable additional scientific discovery efforts. We want to thank our partners, I AM ALS, and ALSA, who kindly supported the biomarker study".

"The consistency of effect observed across NurOwn treated patients, including within pre-specified subgroups, highlights an important treatment effect in a fatal disease with very limited treatment options. The placebo response observed in this trial is unprecedented and the ability to show treatment benefit in this context provides evidence of the clinical value of NurOwn. The robust changes in biomarkers of Neurodegeneration, including NfL and MCP-1, which allows identification of likely responders prior to treatment is encouraging", said Stacy Lindborg PhD, EVP and Head of Global Clinical Research. "More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications. We are committed to learning as much as we can from this trial and to partner with the ALS community to progress our collective understanding of ALS, which in turn will help us to continue to bring forward new treatments for this unrelenting disease."

Study Design

The Phase 3 NurOwn® trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of NurOwn® in 189 ALS patients. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford); California Pacific Medical Center (Prof. Robert Miller); Massachusetts General Hospital (Prof. Merit Cudkowicz, Dr. James Berry); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as patients with at least a 3 point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn® or placebo. Participants were followed for 28 weeks after treatment. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a ³ 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment. Secondary endpoints included the percentage of patients with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

Conference Call and Webcast Details

BrainStorm's management team will host a call and webinar to discuss the Phase 3 data today at 8.30 AM EST. The call can be accessed by dialing the numbers below:

Participant Numbers:

Toll Free: 877-407-9205International: 201-689-8054

Event Link:

Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/38723

Webcast Replay Expiration:

Wednesday, November 17, 2021

There will also be a replay of the call which can be accessed by using the webcast link above or by dialing the numbers below. The replay will be available for 14 days.

Replay Number:

Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 38723

Teleconference Replay Expiration:

Tuesday, December 01, 2020

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding the topline results from the NurOwn® Phase 3 ALS study and future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, the regulatory approval potential of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate, if approved, to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1-646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

Rapid Reshore & Development and BrainStorm Cell Therapeutics Announce Agreement to Advance Construction of BrainStorm's U.S. Manufacturing Facility

Mon, 26 Oct 2020 12:00:00 GMT

BrainStorm is investigating NurOwn as a potential treatment for neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). BrainStorm's most advanced clinical program for NurOwn is in ALS, which is currently being evaluated in a pivotal Phase 3 clinical trial.

BrainStorm seeks to locate, design and construct a new commercial manufacturing facility in the U.S. to prepare for potential commercialization. RR&D, a three-firm services alliance consisting of EwingCole, Facility Logix and Biggins, Lacy, Shapiro & Company, will identify the location and develop the design of BrainStorm's new commercial manufacturing facility.

"We're thrilled to be working with BrainStorm on this project and to have the opportunity to deliver this critical work to our region," said EwingCole CEO, Jared Loos, PE, AIA. "We embrace the spirit of creating potentially life-changing technology and we will do everything we can to move the project forward in an efficient and yet responsible manner."

BrainStorm intends to use the facility primarily for cell therapy production. RR&D will provide custom, streamlined project management, site selection analysis and design/construction management services throughout the project's lifecycle.

Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics commented, "Our decision to partner with RR&D was driven by the strong capabilities of the individual partners and their holistic approach to planning, site selection and design services. The expansion of BrainStorm's manufacturing capabilities is a key part of our broader corporate strategy to prepare for potential regulatory approvals of NurOwn and becoming a commercial organization. This new partnership follows our recently announced agreement with Catalent Pharma Solutions to manufacture NurOwn at a scale large enough to meet potential commercial needs at the time of launch. The dedicated, state-of-the-art manufacturing facility developed by RR&D will provide us with important long-term autonomy and strategic flexibility, including the capacity to supply NurOwn for additional disease indications beyond ALS. Together these two partnerships will help ensure that BrainStorm has the manufacturing capacity to meet the needs of patients today and well into the future."

Site selection analyses will begin immediately with the goal of identifying locations that offer a cost-effective solution for BrainStorm's new manufacturing facility. At the same time, the design team will begin developing a conceptual design of the manufacturing facility, based upon input from BrainStorm's process, engineering, and scientific staff, by defining the main steps of the production process and Current Good Manufacturing Practices (cGMP) requirements. The approximately 50,000 square-foot building will contain manufacturing suites, complementary support and infrastructure, and the ability to expand the facility to 100,000 square feet to anticipate future programmatic needs.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed enrollment in August 2020. For more information, visit the company's website at www.brainstorm-cell.com.

About Rapid Reshore & Development:

Rapid Reshore & Development is an alliance of expert firms providing confidence and support throughout the life sciences industry, representing an evolution from transaction-driven service models to a holistic focus on client needs, integrating an interdisciplinary team customized for a variety of individual projects. To optimize and strengthen confidence in decision-making and speed-to-market, Rapid Reshore & Development alliance was formed to deliver best-in-class professionals with deep experience in all aspects of life sciences' project planning, site selection, design and execution including financial, labor market, development incentives, real estate, design and engineering, and construction management. For additional information, visit: www.rapidreshore.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Brainstorm:Investor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138cdavis@lifesciadvisors.com

Rapid Reshore & Development (RR&D):Media Contact:Zachary DeRitisCommunications Specialist 215-409-4249zdertis@rapidreshore.com

Contacts

Brainstorm:

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

Rapid Reshore & Development (RR&D):

Media Contact:

Zachary DeRitis

Communications Specialist

215-409-4249

zdertis@rapidreshore.com

Catalent and BrainStorm Cell Therapeutics Announce Partnership for the Manufacture of Mesenchymal Stem Cell Platform Therapy NurOwn®

Thu, 22 Oct 2020 12:00:00 GMT

NurOwn induces mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs) known to promote the survival of neurons and neuroprotection. The therapy has received Fast Track status from the U.S. FDA for ALS and has also been granted Orphan Drug Status for ALS by both the FDA and the European Medicines Agency. BrainStorm is currently completing a 200-patient, double-blind, placebo-controlled, repeat-dosing NurOwn Phase 3 study in the U.S.

As part of its commitment, Catalent will undertake the transfer of the manufacturing process to, and provide future CGMP clinical supply of NurOwn from, its new, 32,000 square-foot cell therapy manufacturing facility in Houston, Texas. On completion of the clinical trials and in anticipation of potential approval of NurOwn, the companies will look to extend the partnership to include commercial supply from the Houston facility.

“We are proud to have a partner in Catalent whose excellence in manufacturing quality therapies will support commercial supply of NurOwn,” said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. “We know that ALS patients are in urgent need of a new treatment option. If NurOwn is successful in the current clinical trials, this agreement will be integral to ensuring rapid access for patients.”

Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy, said, “Our experience in cell therapy development, and the manufacturing capabilities that our newly constructed, state-of-the-art facility in Houston offers, position us to best support BrainStorm, with its leading therapeutic candidate for ALS treatment. We look forward to partnering with BrainStorm and providing our stem cell manufacturing expertise as we work to optimize production and streamline the product’s path towards commercial launch.”

About Catalent Cell & Gene Therapy

With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.

About Catalent

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 14,000 people, including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com

More products. Better treatments. Reliably supplied.™

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed enrollment in August 2020. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Catalent

BrainStorm Cell Therapeutics

Chris Halling +44 (0)7580 041073 chris.halling@catalent.com

Richard Kerns +44 (0) 161 728 5880 richard@nepr.agency

Investor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138 cdavis@lifesciadvisors.com

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media Contacts:

Catalent

BrainStorm Cell Therapeutics

Chris Halling

+44 (0)7580 041073

chris.halling@catalent.com

Richard Kerns

+44 (0) 161 728 5880

richard@nepr.agency

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Outcomes at the Virtual New York Stem Cell Foundation Conference

Mon, 19 Oct 2020 12:00:00 GMT

POSTER HIGHLIGHTS:

"Brainstorm continues to explore the full potential of our proprietary platform cell technology and we are very proud of the therapeutic pipeline advances made by our scientific teams," said Chaim Lebovits, CEO of Brainstorm, "At the same time we remain fully focused on delivering top-line data for our pivotal phase 3 ALS clinical trial as planned and completing the necessary activities to submit a BLA following data review."

About NYSCF

The NYSCF Conference is the leading scientific meeting on translational stem cell research. It annually convenes over 500 participants from academia, industry government, non-profits, and patient groups.

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed enrollment in August 2020. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1-646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: +1-973-713-3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Financial Results for the Third Quarter of 2020 and Provides a Corporate Update

Thu, 15 Oct 2020 12:00:00 GMT

Pivotal Phase 3 ALS trial remains on track for top-line data readout by the end of November 2020

New senior executives strengthen regulatory and market access capabilities as the Company prepares to transition to a commercial organization

Conference Call and Webcast at 8 a.m. ET Today

NEW YORK, October 15, 2020 -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the third quarter ended September 30, 2020, and provided a corporate update.

“The most important near-term event for BrainStorm will be the upcoming top-line data readout for the NurOwn® Phase 3 trial in ALS, expected by the end of November. A successful outcome will set us on the path to filing a Biologic License Application (BLA) for what we believe will be a valuable new treatment for ALS,” said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. “In parallel to our preparations for upcoming data read out, we are very busy planning and executing on other pre-BLA activities. On the management front, we appointed William K. White and Dr. Anthony Waclawski, adding valuable commercial and regulatory expertise to our leadership team. This expertise will be crucial as we work towards obtaining regulatory approval for NurOwn and ensuring that, if approved, it will be readily accessible to ALS patients in need of new treatment options for this devastating disease.”

NurOwn has an innovative mechanism of action that is broadly applicable across neurodegenerative diseases and BrainStorm continues to invest in clinical trials evaluating the product in conditions beyond ALS to maximize value creation for its various stakeholders. The company remains on track to complete dosing in its Phase 2 clinical trial in progressive multiple sclerosis (PMS) by the end of 2020. In addition, the Company recently unveiled a clinical development program in Alzheimer’s’ disease (AD) and is planning a Phase 2 proof-of-concept clinical trial at several leading AD centers in the Netherlands and France.

Third Quarter 2020 and Recent Corporate Highlights:

· Completed dosing of all patients in the ongoing NurOwn Phase 3 clinical trial in ALS and plans remains on track to report top-line data by the end of November 2020.

· Announced the publication of a manuscript titled “ Effects of MSC-NTF cells on T and B regulatory cell function in ALS " in the journal Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. The manuscript describes NurOwn’s immunomodulatory effects on T and B regulatory cell function, suggesting that its mechanism of action is broadly applicable in ALS, PMS and Alzheimer’s disease.

· Presented a scientific poster titled “ Advancing NurOwn® for ALS: Phase 3 Clinical Trial Design " at the Annual Northeast ALS (NEALS) Meeting.

· A Phase 2 trial evaluating NurOwn® as a treatment for progressive multiple sclerosis (PMS) is ongoing at 5 leading U.S. multiple sclerosis centers. The Company remains on track to complete dosing by year end 2020.

· Presented progressive MS natural history data at the MSVirtual2020 meeting documenting an association between magnetic resonance imaging (MRI) measures and functional improvement in patients matched to the phase 2 NurOwn clinical trial.

· Hosted a Key Opinion Leader (KOL) webinar on the Alzheimer’s disease program and the planned European Phase 2 trial. The webinar featured presentations by two lead investigators in the trial: Philip Scheltens, M.D., Ph.D., Professor of Cognitive Neurology and Director of the Alzheimer Centre at the VU University Medical Center in Amsterdam, Netherlands; and Bruno Dubois, M.D., Ph.D., Professor of Neurology at the Neurological Institute of the Salpétrière University Hospital in Paris, France.

· Announced a groundbreaking pre-clinical study of a NurOwn® derived exosome-based treatment for COVID-19 acute respiratory distress syndrome (ARDS).

· Appointed Anthony Waclawski Ph.D. as Executive Vice President, Global Head of Regulatory Affairs.

· Appointed William K. White as Senior Vice President, Head of Market Access and Pricing.

· Received a non-dilutive bonus payment of $700,000 from California Institute for Regenerative Medicine (CIRM) for treating more California participants than originally proposed in the Phase 3 ALS trial.

· Announced the grant of Japanese Patent No. 6,753,887, titled: “ Methods of Generating Mesenchymal Stem Cells which Secrete Neurotrophic Factors” .

Presented at the following Investor Conferences:

· 40 th Annual Canaccord Genuity Growth Conference

Cash and Liquidity as of October 14, 2020

Total available funding as of October 14, 2020, which includes cash, cash equivalents and short-term bank deposits of approximately $33.1 million as well as remaining non-dilutive funding from CIRM, IIA and other grants, amounts to approximately $36 million.

Financial Results for the Three Months Ended September 30, 2020

· Cash and cash equivalents, and short-term bank deposits amounted to approximately $28.8 million at September 30, 2020 compared to $16.2 million at June 30, 2020.

· Research and development expenses, net for the three months ended September 30, 2020 and 2019 were $1.87 million and $4.01 million, respectively.

o Excluding participation from IIA and CIRM under the grants and proceeds received under the hospital exemption regulatory pathway, research and development expenses decreased by $1.68 million from $5.66 million in the third quarter of 2019 to $3.98 million in the third quarter of 2020.

· General and administrative expenses for the three months ended September 30, 2020 and 2019 were $2.62 million and $1.54 million, respectively.

· Net loss for the three months ended on September 30, 2020 was $4.49 million, as compared to a net loss of $5.63 million for the three months ended September 30, 2019.

o Net loss per share for the three months ended September 30, 2020 and 2019 was $0.14 and $0.25, respectively.

Conference Call & Webcast

Thursday, October 15, 2020 at 8 a.m. Eastern Time

From the US: 877-407-9205

International: 201-689-8054

Webcast: https://www.webcaster4.com/Webcast/Page/2354/37811

Replays, available through October 29, 2020

From the US: 877-481-4010

International: 919-882-2331

Replay Passcode: 37811

About NurOwn®

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and completed enrollment in August 2020.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed enrollment in August 2020. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts Investor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138 cdavis@lifesciadvisors.com

Media: Paul Tyahla SmithSolve Phone: + 1.973.713.3768 Paul.tyahla@smithsolve.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(UNAUDITED)

U.S. dollars in thousands

(Except share data)

BrainStorm to Present at the 2020 Cell & Gene Meeting on the Mesa

Mon, 12 Oct 2020 12:00:00 GMT

Dr. Lindborg's presentation will be in the form of an on-demand webinar that will be available beginning today. Those who wish to listen to the presentation are required to register here. At the conclusion of the 2020 Cell & Gene Meeting on the Mesa, a copy of the presentation will also be available in the "Investors and Media" section of the BrainStorm website under Events and Presentations.

About the 2020 Cell & Gene Meeting on the Mesa

The conference will feature 80+ on-demand company presentations by leading public and private companies, highlighting their technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, and tissue engineering. Registrants will have access to 15+ expert-led panels and workshops including a mix of both live and on-demand sessions. The conference will be delivered in a virtual format over the course of five days – October 12-16. There is also a premier partnering system, partneringONE, allowing registrants to plan 1×1 meetings with other attendees. For a list of presenting companies, refer to https://www.meetingonthemesa.com/company-presentations/.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Cell Therapeutics to Announce Third Quarter Financial Results and Provide a Corporate Update

Fri, 02 Oct 2020 12:00:00 GMT

BrainStorm's CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. EDT, Tuesday, October 13, 2020.

Teleconference Details – BRAINSTORM CELL THERAPEUTICS 3Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:

Toll Free: 877-407-9205International: 201-689-8054

Event Link: Webcast URL: https://bit.ly/30pVpNG Webcast Replay Expiration: Friday, October 15, 2021

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Number:

Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 37811

Teleconference Replay Expiration:

Thursday, October 29, 2020

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Scientific Presentation at the Annual NEALS Meeting

Wed, 30 Sep 2020 12:00:00 GMT

"This pivotal study has been rigorously designed and powered to detect clinically meaningful effects of NurOwn® in rapidly progressing ALS patients," said Dr. Lindborg. "Compelling Phase 2 data showed that a single NurOwn® administration slowed disease progression in this patient population, and the current Phase 3 trial aims to confirm this effect in a larger study cohort and show that its duration can be extended through repeated administrations. To test this hypothesis, we are comparing the rate of patient level decline in ALS disease as measured by the ALS Functional Rating Scale between the pre-treatment period to the rate of decline observed after the initiation of treatment. Such an analysis allows us to compare the magnitude of change in disease progression resulting from NurOwn® and placebo treatments while accounting for important variable factors known to influence disease progression. We look forward to sharing the results of this analysis later this year."

The poster will be discussed by Dr. Lindborg during a live session at NEALS. A copy of the poster will be also be available in the "Investors and Media" section of the BrainStorm website under Events and Presentations.

About the Phase 3 NurOwn® Trial

The Phase 3 NurOwn® trial is a placebo-controlled, randomized, double-blind trial being conducted at six centers of excellence: University of California, Irvine; Cedars-Sinai Medical Center; California Pacific Medical Center; Massachusetts General Hospital; University of Massachusetts Medical School and Mayo Clinic. Patient dosing in the trial is complete and topline data is expected in 4Q-2020. The primary endpoint of the trial is a responder analysis of the rate of decline in ALS Functional Rating Scale (ALSFRS-R) score over 28 weeks. Secondary endpoints include safety, the percentage of patients with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

About NEALS

The Northeast Amyotrophic Lateral Sclerosis (NEALS) Consortium is a multi-function organization that aims to translate scientific advances into new treatments for people with ALS and motor neuron disease (MND) as rapidly as possible. To achieve its goal, NEALS functions as an academic research consortium, a contracted research organization, and a resource tool for the ALS community. NEALS is committed to the principles of open scientific communication, peer review, full and open disclosure of potential conflicts of interest, and democratic governance of its organization and activities. For more information on NEALS, visit https://www.neals.org/.

About NurOwn®

The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a phase 3 pivotal trial in ALS (NCT03280056); this trial is investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) is fully enrolled.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Appoints William K. White as Senior Vice President, Head of Market Access & Pricing

Tue, 29 Sep 2020 12:00:00 GMT

"Bill has an extensive track record working with public and private payers to help secure patient access to innovative therapies, and brings an important skill set to BrainStorm. His appointment is part of a strategic initiative to build a senior team with proven commercial capabilities," commented Chaim Lebovits, BrainStorm's Chief Executive Officer. "Bill's experience will help us develop market access, patient services and distribution strategies that will be vital to the timely and efficient market entry of NurOwn® for ALS, assuming its approval by the FDA."

William White commented, "The life-changing potential of the investigational NurOwn technology platform, which is nearing completion of its Phase 3 pivotal trial in amyotrophic lateral sclerosis, makes this an opportune time to join BrainStorm. I look forward to leading a team that will help ensure, if approved by the FDA, that NurOwn is covered by insurers and is readily accessible to patients in need. I am proud to join a company with such visionary leadership and enormous growth potential, and I am excited about helping BrainStorm to deliver on its promise of bringing autologous cellular therapies to patients with debilitating neurodegenerative diseases."

Mr. White was most recently Vice President of Patient and Market Access at Avexis, now Novartis Gene Therapies. While at Avexis, he led a large team responsible for securing reimbursement and developing patient support services with national and regional insurers and state Medicaid payers. His work in developing and implementing the market access strategy for AVXS-101/Zolgensma® helped to expedite delivery of a novel new treatment to an underserved patient population and helped the company transition to the commercial stage. Mr. White has also held leadership positions in managed care and patient access at Insys Therapeutics and Lundbeck (formerly Ovation Pharmaceuticals).

In addition to his specialization in market access, reimbursement and distribution design and implementation, Mr. White has expertise in rare/orphan diseases, gene therapy, neuromuscular disease, managed care, and leadership development. He holds a B.S. in Business Administration from Rider University.

About NurOwn® The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational cellular therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented culture conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled and dosed a phase 3 pivotal trial in ALS (NCT03280056); this trial is investigating repeat-intrathecal administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) that is now fully enrolled (NCT03799718).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

Brainstorm Announces Grant of a New Japanese Patent for NurOwn®

Wed, 16 Sep 2020 12:00:00 GMT

The allowed claims cover a method of generating cells which secrete neurotrophic factors from human undifferentiated mesenchymal stem cells (MSCs) derived from the bone marrow of a single donor. The said neurotrophic factors includes: brain derived neurotrophic factor (BDNF); glial derived neurotrophic factor (GDNF); hepatocyte growth factor (HGF); and vascular endothelial growth factor (VEGF).

Patent families protecting NurOwn® manufacturing have been issued in the United States, Japan, Europe, Hong-Kong and Israel.

"We are extremely pleased with the continued development of our patent portfolio protecting our technology through strategic intellectual property achievements. This new patent grant from the Japanese Patent Office is an important addition to our IP portfolio for the NurOwn® technology and is an important element of our business strategy" commented Brainstorm's CEO Chaim Lebovits.

David Setboun, PharmD MBA, EVP and Chief Operating Officer, added: "Having our cell therapy product patented in Japan will increase our ability to enter into new commercial partnerships for NurOwn® in Japan."

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About Brainstorm Cell Therapeutics Inc.

Brainstorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. Brainstorm has fully enrolled its Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm also received U.S. FDA clearance to run a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statements

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause Brainstorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, Brainstorm's need to raise additional capital, Brainstorm's ability to continue as a going concern, regulatory approval of Brainstorm's NurOwn treatment candidate, the success of Brainstorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of Brainstorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, Brainstorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, Brainstorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in Brainstorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on Brainstorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: + 1.862.397.1860pshah@brainstorm-cell.com

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm to Present at Scientific Conferences in September

Thu, 03 Sep 2020 12:00:00 GMT

Participants can view the presentations via the event links and those unable to join will have access to an archived link on the Company's Events and Presentation webpage after the conclusion of the conferences.

BrainStorm is the recipient a non-dilutive grant of $16 million by California Institute for Regenerative Medicine (CIRM) to support the ongoing Phase 3 study of NurOwn®, for the treatment of amyotrophic lateral sclerosis (ALS).

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

CONTACTS

Investor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138 cdavis@lifesciadvisors.com

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1-973-713-3768

Paul.tyahla@smithsolve.com

BrainStorm Appoints Pharmaceutical Veteran Anthony Waclawski as Executive Vice President, Global Head of Regulatory Affairs

Wed, 02 Sep 2020 12:00:00 GMT

"Tony’s unique regulatory experience within one of the largest global pharmaceuticals, makes him exceptionally well qualified to join the BrainStorm leadership team,” commented Chaim Lebovits, BrainStorm’s Chief Executive Officer. “He has held leadership roles in many of the key functions of regulatory, including regulatory strategy and operations, establishing a track record of success for many development stage and marketed products. Dr. Waclawski will enhance our global regulatory strategy, as we work to bring better treatment options to patients afflicted with ALS and other neurodegenerative diseases. We look forward to the strategic contributions and key insights he will bring to BrainStorm.”

Anthony Waclawski commented, “I’m very excited to join the team at Brainstorm and do all I can to help bring new therapies to patients with ALS and other neurodegenerative diseases. This is a challenging area for drug development and there is a critical need for effective and safe therapies “.

Prior to his appointment at BrainStorm, Dr. Waclawski spent 35 years of increasing responsibility at Bristol-Myers Squibb, most recently as Vice President and Head, Regulatory and Pharmaceutical Sciences, Cardiovascular, Immunosciences, Fibrosis, and Genetically-defined diseases. In this role, he was responsible for the strategic and operational deliverables of regulatory, biostatistics, clinical pharmacology, and pharmacometrics for the development assets in these areas. Dr. Waclawski’s experience spans a broad range of regulatory capabilities across multiple therapeutic areas and geographies, guiding successful FDA interactions and establishing and executing successful global regulatory strategies.

Dr. Waclawski holds a Ph.D. in Pharmaceutical Sciences, a Master of Pharmaceutical Science, and a Bachelor of Science in Pharmacy from Rutgers University.

About NurOwn® The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a phase 3 pivotal trial in ALS (NCT03280056); this trial is investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Corey Davis, Ph.D. LifeSci Advisors, LLC Phone: +1 646-465-1138 cdavis@lifesciadvisors.com

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm to Present Data Linking MRI Measures to Functional Improvement in Progressive Multiple Sclerosis (MS)

Tue, 25 Aug 2020 12:00:00 GMT

"Although disability improvement is an important measure of function in individuals with progressive MS, the MRI features that correlate with disability improvement had not previously been explored," noted Tanuja Chitnis, M.D., FAAN, Professor of Neurology at Harvard Medical School, Senior Neurologist at Brigham and Women's Hospital, and Director of the Comprehensive Longitudinal Investigations in MS at the Brigham (CLIMB Study). "In this analysis, we have demonstrated a correlation between specific brain and spinal cord MRI measures and observed functional improvements in progressive MS patients. We are grateful to the joint ACTRIMS/ECTRIMS abstract committee for allowing us to present these data, which we hope will facilitate analysis of clinical trial outcomes that specifically evaluate functional improvements in progressive MS."

Dr. Chitnis and colleagues evaluated MRI features of 48 participants in the SysteMS substudy of the CLIMB study, a nested cohort selected to match the inclusion criteria of the Phase 2 NurOwn trial in progressive MS (NCT03799718). The participants underwent brain and lesion volumetric analysis, as well as mean upper cervical cord (MUCCA) analysis, 12-24 months following baseline 3 Tesla MRI. These analyses generated 34 MRI data measures performed by ICOMETRIX, which the investigators compared in patients with improved function versus those with worsening or stable function, as measured by 9-hole peg test (9HPT) or timed-25-foot-walk (T25FW) scores, two well-established measures of function in progressive MS.

Seventeen patients had improved 9HPT scores from baseline to 12-24 months later, compared to 29 with worsened or stable 9HPT scores over that same period. Whole brain volume at baseline (improved 9HPT: 1505±51 vs. stable-worse 9HPT: 1471±62; p=0.069; t-test) and follow-up (improved: 1501.555±52.039 vs. stable-worse: 1461.304±63.562; p=0.03; t-test) differed between the two 9HPT groups, as did gray matter volume at follow-up (improved 1505.059 ±50.961 vs. stable-worse 865.57±41.352; p=0.063: t-test). Eighteen patients had an improved T25FW score, compared to 27 whose score worsened or remained stable over the 12-month period. Deep white matter FLAIR/T2 lesion volume at baseline (improved: 0.43±0.507 vs. stable-worse: 0.827±0.561; p=0.03; t-test) and follow-up (improved: 0.429±0.503 vs. stable-worse: 0.864±0.603; p=0.02) differed between the two T25FW groups. The investigators did not observe any association between MUCCA and functional improvement measures.

Chaim Lebovits, Chief Executive Officer of BrainStorm stated "The important MRI correlations with measures of functional improvement in this matched natural history cohort will provide helpful context as we evaluate the clinical outcomes from our ongoing Phase 2 trial of NurOwn in patients with progressive MS and hopefully bring us a step closer to offering a new treatment option to individuals living with this devastating disease."

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

(NCT03280056); this trial is investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's fo/rward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1-973-713-3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Publication of New Preclinical Data Supporting Proposed NurOwn® Mechanism in ALS, Progressive MS and Alzheimer's Disease

Wed, 19 Aug 2020 12:00:00 GMT

NurOwn® (MSC-NTF cells) are autologous, mesenchymal stem cells induced by a culture-based approach to secrete significant higher levels of neurotrophic factors while retaining their intrinsic immunomodulatory activity. Brainstorm has demonstrated that a single administration of NurOwn increased circulating T regulatory cells in a phase 2a open label study and reduced cerebrospinal fluid (CSF) inflammatory biomarkers in a phase 2 randomized clinical study. To explore the link between these important biomarker observations, Brainstorm conducted a series of preclinical experiments in order to evaluate the potential of NurOwn to induce T and B regulatory cells and IL-10 secretion and confirm their immunomodulatory effects. Decreased T and B regulatory function appears to impact disease progression in ALS and other neuroinflammatory diseases. T and B cell secreted IL-10 may enhance microglia and cytokine networks and have shown therapeutic potential in ALS and neuroinflammatory preclinical models.

In the preclinical experiments, a significant (p<0.0001) decrease of interferon-g secretion by peripheral blood mononuclear cells (PBMC) in the presence of NurOwn® was demonstrated. When co-cultured with PBMC, NurOwn® induced CD4+CD25+FoxP3+ T regulatory cells (p < 0.001). When cocultured with B cells, NurOwn induced CD24hiCD38hi B regulatory cells, and increased IL-10 secretion (p < 0.001).

"These preclinical observations extend the understanding of immunomodulatory effects of NurOwn on CSF inflammatory biomarkers demonstrated in the US phase 2 randomized clinical trial by providing specific mechanisms by which NurOwn may exert its beneficial effects on these important cytokine pathways," said Ralph Kern MD MHSc, President and Chief Medical Officer of Brainstorm.

Chaim Lebovits, Brainstorm Chief Executive Officer added, "We continue to expand our scientific knowledge of NurOwn's mechanism of action through preclinical and clinical research. Our goal is to efficiently bring practical solutions to patients in need, through innovative science, completion of the phase 3 ALS clinical trial and advancement of clinical programs in progressive MS and Alzheimer's disease."

About NurOwn®The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's fo/rward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Corey Davis, Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm to Present at the 40th Annual Canaccord Genuity Growth Conference

Mon, 10 Aug 2020 12:00:00 GMT

Participants can view the presentation via the event link and those unable to join will have access to an archived link on the Company's Events and Presentation webpage after the conclusion of the conference.

Event: 40th Annual Canaccord Genuity Growth ConferenceTime: August 13, 2020 @ 3:30pm ETWebcast: https://bit.ly/3fFxqPr

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

CONTACTS Investor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: + 1.862.397.1860pshah@brainstorm-cell.com

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Corey Davis Ph.D.

LifeSci Advisors, LLC

Phone: +1 646-465-1138

cdavis@lifesciadvisors.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Financial Results for the Second Quarter of 2020 and Provides a Corporate Update

Wed, 05 Aug 2020 12:00:00 GMT

"Despite the impact of COVID-19 on healthcare access, we completed enrollment and dosing of our Phase 3 ALS clinical trial and expanded our pipeline across new indications," stated Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "We want to recognize and thank the relentless dedication of the trial participants, their loved ones, our investigators and the team here at BrainStorm for this outstanding achievement. We expect a topline data readout by the end of November this year."

The application of NurOwn® as a platform technology in neurodegenerative disease has great potential and we are actively investing in clinical trials to evaluate the product in other conditions beyond ALS. The Phase 2 clinical trial ongoing in progressive multiple sclerosis (PMS) is expected to complete dosing by the end of 2020. In addition, we recently unveiled a clinical development program in Alzheimer's disease and are planning a Phase 2 proof-of-concept clinical trial at several leading AD centers in the Netherlands and France. We believe that leveraging the NurOwn platform and potentially bringing much needed innovative treatment options to patients across multiple diseases will result in value creation for our various stakeholders.

Second Quarter 2020 and Recent Corporate Highlights:

Presented at the following Investor Conferences:

Cash and Liquidity as of July 31, 2020

Total available funding as of July 31, 2020, which includes cash on hand of approximately $34.7 million as well as remaining non-dilutive funding from CIRM, IIA and other grants, amounts to approximately $37.5 million.

Financial Results for the Three Months Ended June 30, 2020

Conference Call & Webcast

Wednesday, August 5, 2020 at 8am Eastern Time

From the US: 877-407-9205International: 201-689-8054 Webcast: https://bit.ly/2DciAC9

Replays, available through August 19

From the US: 877-481-4010 International: 919-882-2331 Replay Passcode: 36017

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Investor Relations:

Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: +1-862-397-1860 pshah@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands (Except share data)

June 30,

December 31,

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

Cash and cash equivalents

$ 12,153

$ 536

Short-term deposit (Note 4)

4,040

Other accounts receivable

259

2,359

Prepaid expenses and other current assets (Note 5)

176

432

Total current assets

16,628

3,360

Long-Term Assets:

Prepaid expenses and other long-term assets

Operating lease right of use asset (Note 6)

1,649

2,182

Property and Equipment, Net

918

960

Total Long-Term Assets

2,593

3,174

Total assets

$ 19,221

$ 6,534

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

Current Liabilities:

Accounts payable

$ 4,604

$ 14,677

Accrued expenses

2,022

1,000

Operating lease liability (Note 6)

1,224

1,263

Other accounts payable

990

714

Total current liabilities

8,840

17,654

Long-Term Liabilities:

Operating lease liability (Note 6)

559

1,103

Total long-term liabilities

559

1,103

Total liabilities

$ 9,399

$ 18,757

Stockholders' Equity (deficit):

Stock capital: (Note 7)

Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at June 30, 2020 and December 31, 2019 respectively; Issued and outstanding: 29,669,855 and 23,174,228 shares at June 30, 2020 and December 31, 2019 respectively.

Additional paid-in-capital

142,594

105,042

Receipts on account of shares

Accumulated deficit

(132,784)

(117,276)

Total stockholders' equity (deficit)

9,822

(12,223)

Total liabilities and stockholders' equity

$ 19,221

$ 6,534

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS(UNAUDITED)

U.S. dollars in thousands

(Except share data)

Six months ended

Three months ended

June 30,

Unaudited

Operating expenses:

Research and development, net

$ 11,642

$ 7,010

$ 5,694

$ 3,554

General and administrative

4,066

2,775

1,706

1,303

Operating loss

(15,708)

(9,785)

(7,400)

(4,857)

Financial expenses (income), net

(200)

142

(6)

Net loss

$ (15,508)

$ (9,927)

$ (7,394)

$ (4,900)

Basic and diluted net loss per share from continuing operations

$ (0.56)

$ (0.47)

$ (0.25)

$ (0.23)

Weighted average number of shares outstanding used in computing basic and diluted net loss per share

27,452,750

21,312,335

29,274,130

21,703,001

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1-862-397-1860

pshah@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

June 30,

December 31,

2020

2019

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

BrainStorm Cell Therapeutics to Announce Second Quarter Financial Results and Provide a Corporate and R&D Update

Mon, 27 Jul 2020 12:00:00 GMT

On the call, BrainStorm CEO Chaim Lebovits will present a corporate update, including details on the timeline for the data readout of the Company's Phase 3 pivotal trial studying the safety and efficacy of NurOwn® (MSC-NTF cell) in people with ALS. In addition, Dr. Revital Aricha. Brainstorm's Vice President of Research and Development, will provide an R&D update including recently announced data from the Company's groundbreaking preclinical study evaluating NurOwn-derived exosomes for the treatment of COVID-19 ARDS.

Thereafter, senior management officers will join the call for a Q&A session. Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. EDT, Monday, August 3, 2020.

Teleconference Details – BRAINSTORM CELL THERAPEUTICS 2Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:

Toll Free: 877-407-9205International: 201-689-8054

Event Link:

Webcast URL:https://bit.ly/2DciAC9

Webcast Replay Expiration:

Thursday, August 05, 2021

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Number:

Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 36017

Teleconference Replay Expiration:

Wednesday, August 19, 2020

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations:Preetam Shah, MBA, PhDChief Financial OfficerBrainStorm Cell Therapeutics Inc.Phone: +1-862-397-1860pshah@brainstorm-cell.com

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1-862-397-1860

pshah@brainstorm-cell.com

Media:

Paul Tyahla

SmithSolve

Phone: +1-973-713-3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Groundbreaking Pre-Clinical Study of NurOwn® derived Exosome-Based Treatment for COVID-19 ARDS

Thu, 23 Jul 2020 12:00:00 GMT

COVID-19 induced pneumonia carries a high fatality rate and has been associated with acute respiratory distress syndrome (ARDS). Currently, there is no effective treatment strategy to prevent or reverse ARDS, a type of respiratory failure associated with widespread inflammation and lung damage mediated by dysregulated cytokine production.

Exosomes are nano-sized (30–150 nm) vesicles secreted by all cell types. Mesenchymal stem cells (MSC) derived exosomes have been suggested as a potential treatment for ARDS due to their ability to penetrate into deep tissues, effectively deliver bioactive molecules to target cells and mitigate the inflammatory response. MSC exosomes may be delivered intravenously or directly into the lung via intratracheal administration.

Results from a study in a mouse model of lipopolysaccharide (LPS)-induced ARDS showed that intratracheal administration of NurOwn® (MSC-NTF cells) derived exosomes resulted in a statistically significant improvement in multiple lung parameters. These included the clinically relevant factors: functional lung recovery, reduction in pro-inflammatory cytokines and most importantly, attenuation of lung damage. Moreover, MSC-NTF cell derived exosomes exhibited a superior effect when compared to treatment with exosomes derived from naïve mesenchymal stem cells (MSC) from the same donor. BrainStorm intends to accelerate submission of these important results to peer-reviewed medical journals.

The preclinical experiment demonstrated a statistically significant reduction in lung disease severity score (p=0.03) (based on the American Thoracic Society Documents, 2011 ; Matute-Bello et al., Am J Respir Cell Mol Biol 44;725-738, 2011). and vastly improved lung histology following intratracheal administration of NurOwn (MSC-NTF) exosomes compared to MSC exosomes.

To-date, BrainStorm Cell Therapeutics has focused its clinical development on the application of the NurOwn technology platform to neurodegenerative disorders. Given these important pre-clinical results, the Company will revisit its strategy to determine if and when to proceed with a clinical trial in ARDS.

Dr. Revital Aricha, VP of Research & Development at BrainStorm, will discuss the results on the company’s second quarter 2020 earnings call and corporate update, scheduled for Wednesday August 5th, at 8.00am ET.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting a U.S. FDA approved Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: + 1.862.397.1860 pshah@brainstorm-cell.com

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Hosting KOL Webinar to Discuss NurOwn® Phase 2 Alzheimer's Disease Program

Wed, 08 Jul 2020 12:00:00 GMT

The webinar features presentations by two lead investigators in the Company's planned international Phase 2 trial: Philip Scheltens, M.D., Ph.D., Professor of Cognitive Neurology and Director of the Alzheimer Centre at VU University Medical Center in Amsterdam, Netherlands; and Bruno Dubois, M.D., Ph.D., Professor of Neurology at the Neurological Institute of the Salpétrière University Hospital in Paris, France. The 52-week, open-label, proof-of-concept clinical trial is designed to evaluate NurOwn in 40 participants with prodromal to mild AD. It will be conducted at VU University Medical Center (Amsterdam), Pitié-Salpêtrière Hospital (Paris), and other clinical trial sites in the Netherlands and France.

To participate in the webcast, please use the link below and to view a copy of the accompanying slide presentation, please refer to the Events & Presentations section of the Company's website. The presentation will be followed by a question-and-answer session with Professors Scheltens and Dubois and with BrainStorm management.

Philip Scheltens, M.D., Ph.D. received both his M.D. degree (1984) and his Ph.D. in Magnetic Resonance Imaging in Alzheimer's Disease (1993) from VU University in Amsterdam. His main clinical and research interests are Alzheimer's disease, vascular dementia, frontotemporal dementia, magnetic resonance imaging, PET imaging and fluid biomarkers. He has been the national principal investigator (PI) for over 35 studies, including several Phase 1-3 multicenter clinical trials. Dr. Scheltens founded the Alzheimer Centere at VU University in 2000, and co-founded and assumed the chairmanship of the board of Deltaplan Dementie, the Dutch national plan against dementia, in 2013. He is also the co-editor-in-chief of Alzheimer's Research & Therapy, one of the leading journals in this field.

Bruno Dubois, M.D., Ph.D., is Professor of Neurology at the University Salpêtrière Hospital in Paris, Sorbonne-University and Director of the Institute for Memory and Alzheimer Disease (IM2A). He also directs the Expert Memory Center Paris-Sud and the Research INSERM Unit on Cognition and Neuroimaging in Brain Diseases at the Institut du Cerveau et de la Moelle épinière (ICM, Brain and Spine Institute) in Paris. He is Coordinator of the National Reference Centers for Rare Dementias and Young-Onset Alzheimer Disease and of the Paris Center of Excellence in Neurodegeneration (CoEN). Dr. Dubois has published more than 600 peer-reviewed articles on anatomical and biochemical studies of the central cholinergic systems in rodents and humans, as well as on cognition in patients with dementia, with special focus on memory, executive functions and frontal lobe behaviors, and biomarkers in neurodegenerative disorders. He leads an international working group of experts (IWG) on the new criteria for Alzheimer disease. He is principal or co-investigator of several research programs focusing on AD, prodromal AD, and dementia in Parkinson's disease as well as the EU Joint Programme on Neurodegenerative Disease (JPND), IMI-EPAD and IMI- AMYPAD. Dr. Dubois is President of the French Society of Neurology and a member of the National Academy of Medicine.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1-862-397-1860

pshah@brainstorm-cell.com

Media:

Paul Tyahla

SmithSolve

Phone: +1-973-713-3768

Paul.tyahla@smithsolve.com

BrainStorm Announces Completion of All Dosing in NurOwn® Phase 3 Clinical Trial in ALS

Thu, 02 Jul 2020 12:00:00 GMT

"Completion of participant dosing in this clinical trial is an important milestone and brings us a step closer to potentially filing a Biologics License Application to make MSC-NTF cells available to people with ALS," Chaim Lebovits, CEO of BrainStorm stated. "I would like to thank the investigators and their staff at the participating sites for their clinical excellence, especially for enabling this trial to complete on time in the middle of the ongoing COVID-19 pandemic. I must also express my complete gratitude to the trial participants and their loved ones who fully devoted themselves to the challenges of bringing an investigational therapeutic forward. We look forward to the data readout later in 2020."

The Phase 3 NurOwn trial is being conducted at six centers of excellence: University of California, Irvine; Cedars-Sinai Medical Center; California Pacific Medical Center; Massachusetts General Hospital; University of Massachusetts Medical School and Mayo Clinic.

About NurOwn®

The NurOwn technology platform (autologous Mesenchymal stem cells, MSC-NTF cells) represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. With this press release, BrainStorm has now fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm to Showcase Alzheimer's Disease Clinical Program in KOL Webinar

Wed, 01 Jul 2020 12:00:00 GMT

The webinar will feature presentations by the two lead investigators in BrainStorm's planned international Phase 2 trial in AD: Philip Scheltens, M.D., Ph.D., Professor of Cognitive Neurology and Director of the Alzheimer Centre at VU University Medical Center in Amsterdam, Netherlands; and Bruno Dubois, M.D., Ph.D., Professor of Neurology at the Neurological Institute of the Salpétrière University Hospital in Paris, France. The 52-week, open-label, proof-of-concept clinical trial is designed to evaluate NurOwn® in 40 participants with prodromal to mild AD. It will be conducted at VU University Medical Center (Amsterdam), Pitié-Salpêtrière Hospital (Paris), and several other clinical trial sites in the Netherlands and France.

Dr. Scheltens has authored more than 1,000 peer-reviewed papers and more than 75 book chapters. He co-edited books on Magnetic Resonance in Dementia and Neuroimaging in Dementia (Springer) as well as Functional Magnetic Resonance Imaging: Clinical Applications (Oxford University Press). In 2011, he was elected to the Royal Dutch Academy of Arts and Sciences (KNAW) and served as Secretary General until 2020. In 2016 he was awarded the European Grand Prix for Alzheimer's Research. He is co-leading and participating in various European Union (EU) projects, including the Innovative Medicines Initiative projects on European Prevention of Alzheimer's Dementia (IMI-EPAD), the Amyloid Imaging to Prevent Alzheimer's Disease (IMI-AMYPAD), the European Medical Information Framework for Alzheimer's Disease (EMIF-AD) and Remote Assessment of Disease and Relapse in Alzheimer's Disease (RADAR-AD).

Webcast Information

The webinar will take place on July 8, 2020 at 8:15 AM ET. The presentation will be followed by a question-and-answer session with Professors Scheltens and Dubois and with BrainStorm management.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: + 1.862.397.1860 pshah@brainstorm-cell.com

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Expands Clinical Pipeline to Evaluate NurOwn® for the Treatment of Alzheimer's Disease

Wed, 24 Jun 2020 12:00:00 GMT

"Our newly announced Alzheimer's program is an important strategic expansion of BrainStorm's clinical pipeline," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We see this as an ideal complement to our lead amyotrophic lateral sclerosis (ALS) program, as there are compelling data suggesting that the benefits observed with NurOwn in ALS patients may extend to other neurological conditions, including Alzheimer's disease. As we move towards completion of our pivotal Phase 3 ALS study, the newly announced Alzheimer's program, combined with our ongoing progressive multiple sclerosis (MS) program, will continue to drive the advancement of the NurOwn platform. Through the completion of our clinical trial programs, BrainStorm hopes to advance NurOwn to address unmet needs across a broad population of patients with neurodegenerative disease."

The lead investigators of the trial are two world renowned clinical experts in Alzheimer's disease, Philip Scheltens, M.D., Ph.D., and Bruno Dubois, M.D., Ph.D. Prof. Scheltens, the principal investigator (PI) of the study, is Professor of Cognitive Neurology and Director of the Alzheimer Centre at Amsterdam University Medical Centers. He has extensive experience as PI of many international clinical trials in this field. Prof. Dubois, the French national coordinator of the study, is Professor of Neurology at the Neurological Institute of the Salpétrière University Hospital. He is President of the Scientific Committee of France-Alzheimer and of IFRAD (International Fund Raising for Alzheimer's Disease) as well as a member of the European Alzheimer Disease Consortium (EADC). Profs. Scheltens and Dubois will discuss the proposed clinical trial during an upcoming Key Opinion Leader (KOL) webinar and call hosted by BrainStorm on July 8, 2020 at 8:15 AM ET.

Speaking on the trial Prof. Scheltens stated, "We are very eager to evaluate the efficacy of NurOwn in the treatment of Alzheimer's disease, because of its unique mechanism of action. While many previous Alzheimer's therapies have focused on a single target such as tau or beta-amyloid, NurOwn has the capability to simultaneously target multiple relevant biological pathways and bring a comprehensive approach to this multifactorial disease. Importantly, NurOwn's mechanism of action may also allow the therapy to enable synergistic combinations with anti-tau or anti-beta-amyloid treatments, further underscoring its potential to address critical unmet needs in Alzheimer's disease."

Prof. Dubois added, "In such a complex disease, addressing inflammation and neuro-protection is an innovative and very interesting approach. It is a first in the world for this technology and Brainstorm is leveraging encouraging results from the Phase 2 study in ALS."

Ralph Kern, M.D., MHSc., President and Chief Medical Officer of BrainStorm, noted, "In the proposed Phase 2 clinical trial, our goal is to confirm that the potential shown by NurOwn in our lead ALS program may be extended to patients with Alzheimer's disease. We now have a compelling set of biomarker data supporting NurOwn's mechanism of action, including important pharmacodynamic changes in cerebrospinal fluid (CSF) inflammatory mediators. Additionally, our innovative biomarker-driven precision medicine approach, which will focus on patients with early-stage disease and pre-defined levels of CSF tau and beta-amyloid proteins, may greatly facilitate Phase 2 clinical trial success."

Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research at BrainStorm, said, "We are excited to introduce a novel approach to Alzheimer's disease that targets both inflammation as well as neurotrophic factors. Given the acute need for vastly different treatment methodologies, we believe our broad targeting approach, combined with robust effects on CSF measures and a favorable safety profile, allows us to go forward with confidence. Additionally, compiling NurOwn safety data across diseases will allow us to enhance patient safety for each trial."

Phase 2 Trial to be Conducted at Leading Alzheimer's disease Centers in Europe

BrainStorm plans to conduct a 52-week, Phase 2 open-label, proof-of-concept clinical trial to evaluate NurOwn in 40 participants with prodromal to mild Alzheimer's disease. Study participants will receive three intrathecal NurOwn doses 8 weeks apart. In addition to meeting well-defined clinical criteria for prodromal to mild Alzheimer's disease, participants must also meet biomarker defined criteria for Alzheimer's disease. The clinical trial will evaluate safety and pharmacodynamics of NurOwn, including effects on inflammatory, Alzheimer's-specific, neurodegenerative, and synaptic biomarkers, as well as a range of key clinical measures of cognition and function. The clinical trial will be conducted at the Brain research Center affiliated with the Alzheimer Center Amsterdam, Pitié-Salpêtrière Hospital (Paris), and several other clinical trial sites in the Netherlands and France.

NurOwn is protected by patents granted in the United States, Europe, Israel, and elsewhere covering treatments of neurodegenerative diseases, including Alzheimer's disease. These include European patent no. EP2620493B1 (Mesenchymal stem cells for the treatment of CNS diseases).

Key Opinion Leader Call and Webcast

BrainStorm will host a call and webinar featuring Philip Scheltens, M.D., Ph.D., and Bruno Dubois, M.D., Ph.D., on July 8, 2020 at 8:15 AM ET. The webinar will be followed by a question-and-answer session with Professors Scheltens and Dubois.

Dial-in and Webcast Information

About NurOwn®

NurOwn (autologous MSC-NTF cells) represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Paul Tyahla

SmithSolve

Phone: + 1.973.713.3768

Paul.tyahla@smithsolve.com

BrainStorm Cell Therapeutics to Join the Russell 2000® Index and Russell 3000® Index

Tue, 23 Jun 2020 12:00:00 GMT

Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of May 8, ranking them by total market capitalization. Membership in the US all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

About FTSE Russell

FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies. Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $16 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives. FTSE Russell indexes also provide clients with tools for asset allocation, investment strategy analysis and risk management.

A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on index innovation and customer partnership applying the highest industry standards and embracing the IOSCO Principles. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit http://www.ftserussell.com/.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Contacts

Investor Relations:

Michael Rice

LifeSci Advisors, LLC

Phone: +1 646 889 1200

mrice@lifesciadvisors.com

Public Relations:

Paul Tyhala

SmithSolve

973.442.1555

paul.tyahla@smithsolve.com

BrainStorm Granted SME Status by the European Medicines Agency

Mon, 15 Jun 2020 12:00:00 GMT

The newly granted SME status allows BrainStorm to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities as well as fee waivers for selective EMA pre and post-authorization regulatory filings, including Orphan Drug and PRIME designations.

Brainstorm is also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process.

“This is an additional and timely step in our global strategy as we continue to engage with the EMEA,” said David Setboun, Pharm.D, MBA, Chief Operating Officer of BrainStorm. “Our ALS investigational product received orphan drug status in Europe in July 2013 and we will benefit from the enhanced interaction and early dialogue allowing us to optimize development plans and speed up evaluation in Europe. EMA is facilitating pathways such as PRIME designation that enables critical medicines for major unmet medical need like NurOwn® to reach patients earlier.”

The EMA plays a central role in facilitating the development and authorization of medicines across Europe. The SME initiative promotes innovation from smaller companies such as BrainStorm to ensure Europe continues to be a favorable environment for preclinical and clinical development of promising new therapeutic options like NurOwn.

About NurOwn® NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: +1-862-397-1860 pshah@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1-862-397-1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1-646-677-1839

sean.leous@icrinc.com

BrainStorm to Present at the Raymond James Human Health Innovations Conference

Thu, 11 Jun 2020 12:00:00 GMT

Mr. Lebovits and Dr. Kern will update conference participants on the Company's investigational therapeutic, NurOwn®, that is currently in a fully enrolled phase 3 study for the treatment of ALS and a phase 2 study for the treatment of progressive multiple sclerosis. Additionally, they will present an overview of the Company's financial position and pipeline. After the presentation, the management team will participate in a question and answer session with institutional investors.

Mr. Lebovits and Dr. Kern will be joined by David Setboun, PhD, MBA, Chief Operating Officer, Stacy Lindborg, PhD, Head of Global Clinical Research, and Preetam Shah, PhD, MBA, Chief Financial Officer, for a series of one-on-one meetings, with select institutional investors arranged by Raymond James.

EVENT: Raymond James Human Health Innovations Conference

PRESENTATION: Thursday, June 18th at 9:00 am EST

LINK: https://bit.ly/2YmZf8u

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: +1-862-397-1860 pshah@brainstorm-cell.com

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1-862-397-1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1-646-677-1839

sean.leous@icrinc.com

The ALS Association, I AM ALS Award BrainStorm Cell Therapeutics $500,000 for ALS Biomarker Study

Tue, 09 Jun 2020 12:00:00 GMT

The study is designed to evaluate how NurOwn interacts with its targets in the brain and spinal cord and to explore the changes in the biomarkers that may correlate with response to the drug treatment. Biomarkers are any measurable substance in the body that change over time (such as cholesterol or blood pressure) and that correlate with disease processes or treatment response. If successful, this study will help confirm that the ALS treatment NurOwn works in the way it is intended and will help inform our larger understanding of ALS biomarkers.

"This grant to BrainStorm marks an important step forward in establishing how exactly NurOwn works in the body," said Calaneet Balas, President and CEO of The ALS Association. "This research is also important to our overall pursuit of identification and validation of ALS biomarkers. We hope NurOwn is ultimately proven effective in treating ALS and we stand ready to support BrainStorm in its plan to apply for a biologics license for NurOwn."

Danielle Carnival, CEO of I AM ALS commented, "We need to move with urgency in all of our efforts to deliver treatments and cures for ALS. This biomarker research will help us more expeditiously understand the effectiveness of NurOwn, while possibly unlocking discoveries that provide clues for other promising treatments. We are at a pivotal time for ALS research in pursuit of treatment solutions and will do whatever we can, together, to drive new answers and new hope for patients."

The joint award to BrainStorm consists of a $400,000 grant from The ALS Association and a $100,000 grant from I AM ALS. As part of this agreement, BrainStorm has agreed to share data and samples with the ALS community so that the results can be independently validated and to advance other ALS research.

Chaim Lebovits, CEO of BrainStorm stated, "We sincerely appreciate the scientific recognition and generous support from The ALS Association and I AM ALS and we are excited through this study to further an already strong partnership between The ALS Association, I AM ALS and Brainstorm. This critical research study involves one of the largest and most robust clinical trial collections of CSF biomarkers. Data generated from this study will increase our understanding of how NurOwn® therapy impacts ALS disease progression and may identify patients who benefit the most from this form of therapy. We also hope that this research study will benefit the broader ALS scientific community as we collectively advance towards our shared goal of delivering much needed treatments."

About NurOwn®

About The ALS Association

The ALS Association is the largest private funder of ALS research in the world. The Association funds global research collaborations, provides assistance for people with ALS and their families through our nationwide network of chapters and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association builds hope and enhances quality of life while urgently searching for new treatments and a cure. For more information about The ALS Association, visit our website at www.als.org.

About I AM ALS

Founded in 2019 by husband-wife team Brian Wallach and Sandra Abrevaya, I AM ALS was born out of their desire to change the future for Brian and the thousands of other ALS patients in the world. I AM ALS brings together patients, advocates, organizations and scientists to deliver critical and innovative resources for patients, empower and mobilize patients and their networks to lead the fight for cures, and transform the public understanding of ALS with a goal of flooding the research pipeline with new, lifesaving drugs. A cure is possible ... if we work together to re-imagine the fight against ALS. Learn more here: www.iamals.org.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

About ALS

ALS is a disease that attacks cells in the body that control movement. It makes the brain stop talking to the muscles, causing increased paralysis over time. Ultimately, ALS patients become prisoners within their own bodies, unable to eat, breathe, or move on their own. Their mind, however, often remains sharp so they are aware of what's happening to them.

Contacts

Contact: Brian Frederick

The ALS Association

(202) 464-8612

bfrederick@alsa-national.org

Contact: Kathleen Rooney

I AM ALS

(312) 529-0391

Kathleen@iamals.org

BrainStorm to Participate in BIO Digital 2020

Wed, 03 Jun 2020 12:00:00 GMT

Event:

BIO Digital 2020

Place:

https://www.bio.org/events/bio-digital/registration

Presentation Date:

June 8-12, 2020

Link to BrainStorm's Presentation:

https://www.bio.org/events/bio-digital/sessions/680253

Link to BIO Partnering:

https://www.bio.org/events/bio-digital/partnering

About BIO

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: +1-862-397-1860 pshah@brainstorm-cell.com

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1-862-397-1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1-646-677-1839

sean.leous@icrinc.com

BrainStorm Announces that Pivotal Phase 3 Trial Remains on Track for Topline Data in Q4-2020

Tue, 02 Jun 2020 12:00:00 GMT

Due to the importance of the clinical trial and the recognized high unmet need in ALS, Brainstorm and the 6 prestigious U.S. clinical sites have been able to continue treatment visits throughout the COVID-19 pandemic with only occasional scheduling changes to treatments. The decision to continue the trial is also shared by the ALS community and the FDA. The clinical trial sites are at University of California, Irvine; Cedars-Sinai Medical Center; California Pacific Medical Center; Massachusetts General Hospital; University of Massachusetts Medical School and Mayo Clinic. Importantly, the trial's primary outcome measurement (the ALSFRS-R rating scale) is fully validated for telephonic administration, which allowed non-treatment visits to be conducted remotely and to be aligned with protocol assessment timelines. This allows for ongoing high-quality data collection while prioritizing safety of patients and clinical trial site staff.

"Despite the challenges presented by COVID-19, patient dosing remains on track with all participants having received at least 2 treatments of NurOwn®," said Dr. Merit Cudkowicz, the Julieanne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital. "Moving forward, only 20 patients are still to be dosed for the third and final time, and these final treatments remain on schedule."

Chaim Lebovits, CEO of BrainStorm stated, "BrainStorm made the decision to continue our Phase 3 trial and we have been strongly supported by our partners in the clinical community. Quick planning and coordination across our clinical sites and the support and direction of the U.S. FDA enabled our Phase 3 investigational trial for NurOwn to advance, with final dosing by July 2020. While numerous clinical trials in the U.S. have been interrupted or completely shut down by the COVID-19 pandemic, trial participants, their families, and the investigational teams remain committed to the trial's advancement. I am extremely proud and grateful for the outstanding work and commitment of so many, and particularly by these trial participants and their caregivers. We hope to soon reward their commitment by bringing forward a much-needed treatment for ALS."

Ralph Kern, MD, MHSc, BrainStorm's President and Chief Medical Officer said, "We are very fortunate to have developed an outstanding team of partners who are committed to BrainStorm's investigational therapy NurOwn and share its promise in ALS research. Our primary concerns will always be the overall health and safety of trial participants and the scientific integrity of the trial. Fortunately, ALSFRS-R, the primary outcome measurement of the Phase 3 trial, is validated by phone and allows for the collection of quality data with minimal risk of COVID-19 exposure. This, along with the collective efforts of so many of our employees, partners, and patients, has enabled us to remain on track for study completion as planned in the fourth quarter of this year."

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: + 1.862.397.1860 pshah@brainstorm-cell.com

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Appoints Pharmaceutical Veteran Stacy R. Lindborg, Ph.D. as Executive Vice President, Head of Global Clinical Research

Wed, 27 May 2020 12:00:00 GMT

Prior to her appointment at BrainStorm, Dr. Lindborg spent 8 years at Biogen Inc. the global biotech that discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. She held several senior leadership positions, most recently Vice President, Analytics and Data Science, where she built a world class Analytics and Data Sciences team, responsible for global data as well as statistical and epidemiological support for R&D and marketed products. She served on R&D governance during a time of significant growth for Biogen, and was active in guiding the firm's long-term vision for growth through analytics and by stimulating innovative development platforms to increase productivity. As the portfolio grew to tackle a diverse set of neurological diseases, Dr. Lindborg motivated novel analytic and development approaches, shaving time off novel drug approvals to globally address chronic diseases. Her accomplishments at Biogen included a leadership role in seeking, receiving and maintaining global marketing approvals for Zinbryta®, Plegridy® and Spinraza®, all of which included novel data analytical elements. The Phase 3 Spinraza program was recognized with the prestigious 2017 Prix Galien Award Winner for Best Biotechnology Product (the biomedical industry's highest accolade). She also played a key role in the Phase 3 development program for Aducanumab in Alzheimer's Disease.

"The investigational NurOwn® technology platform currently in Phase 3 and Phase 2 for ALS and progressive MS, respectively, have life changing potential. This has been the most significant factor in my decision to join Brainstorm," said Dr. Stacy R Lindborg. "I have been impressed by the leadership, depth of talent and aspiration of goals at BrainStorm. I look forward to seeing NurOwn and the Company's pipeline advance across all stages of clinical development."

Chaim Lebovits, Chief Executive Officer of BrainStorm, commented, "Stacy's experience in launching and commercializing highly visible top selling neuroscience- based pharmaceutical products and her expertise in product launches from NDA to post-approval marketing studies make her exceptionally well qualified to join the BrainStorm leadership team at this pivotal time in the Company's history. She has played leadership roles in clinical trial design and regulatory interactions for development stage and marketed products in neuroscience, immunology and orphan diseases. Her experience includes global organization design and development at two of the world's leading neurology companies, including substantial corporate builds. Without question Dr. Lindborg, will significantly enhance our global commercialization and regulatory strategy, as we work to bring better treatment options to patients afflicted with neurodegenerative diseases. We look forward to the strategic contributions and insights she will being to BrainStorm."

Prior to her roles in Biogen, from 1996 to 2012, Dr. Lindborg held positions of increasing responsibility at Eli Lilly and Company. As Head of R&D strategy, she was responsible for characterizing the productivity of the portfolio and driving key R&D strategy projects including the annual R&D Long-Range Plan. In this role, she created seminal insights into R&D productivity by connecting individual drug program-based development decisions to portfolio risk practices, driving fundamental R&D decisions to increase number of drug launches. Additionally, she was Leader of Zyprexa Product Management in which she was responsible for R&D, Commercial and Manufacturing plans. She was accountable for driving market share through product differentiation, global registration and launching of an injectable form of Zyprexa, working through regulatory manufacturing inspections and 483 citations. Zyprexa had peak sales of $4.7 billion.

Dr. Lindborg holds a Ph.D. in statistics from Baylor University. She has been active in professional organizations across her career, holding numerous positions within the American Statistical Association and International Biometric Society, having been elected Fellow of the association in 2008. She serves on the Scientific Advisory Board of biotechnology and technology companies and on the board of directors of the Massachusetts Down Syndrome Congress. She was a Board Member to the Strategic Initiative: Women in Statistics. Dr. Lindborg was also profiled in the book "STEM Gems" (2017) as the only women from the pharmaceutical industry highlighted as a leader in science, technology, engineering and mathematics.

About NurOwn

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: +1-862-397-1860 pshah@brainstorm-cell.com

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1-862-397-1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1-646-677-1839

sean.leous@icrinc.com

BrainStorm Announces Financial Results for the First Quarter of 2020 and Provides a Corporate Update

Thu, 07 May 2020 12:00:00 GMT

“While many companies have been greatly hindered by the COVID-19 pandemic, Brainstorm, due to the incredible strength of our clinical trial participants, the amazing teams at our U.S. investigational sites and the talent and commitment of each and every team member at BrainStorm, the Phase 3 ALS trial remains on track for a Q4’20 topline data readout. Participants in the fully enrolled clinical trial in our 6 United States medical centers of excellence continue to receive their scheduled treatments with the necessary safety protocols in place,” stated Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. He added, “We were able to advance our global footprint by signing an agreement with a senior, leading EMEA (European Medicines Agency) regulatory consultant who will advise us as we approach EMEA Regulatory Institutions to present data for NurOwn in ALS, and the advancement of NurOwn in other disease indications. Additionally, we entered into a lease agreement with the Tel Aviv Sourasky Medical Center (Ichilov Hospital) in Tel Aviv, Israel, to produce NurOwn in three state-of-the-art cleanrooms. The new facility will significantly increase the Company’s manufacturing capacity, allowing us to strategically enter the European and Israeli markets.”

Dr. Ralph Kern, President and Chief Medical Officer of Brainstorm Cell Therapeutics said, “The COVID-19 pandemic has resulted in delays in the pace of enrollment for our Phase 2 Progressive MS clinical trial. Scheduled March and April 2020 new participant enrollments were deferred to May 2020 when the affected healthcare sites anticipate their access restrictions may be mitigated. We anticipate that enrollment will continue in 2020 subject to any site access restrictions related to COVID-19. Additionally, we are collecting clinical and biomarker data from the treated progressive MS participants and plan to perform an interim analysis after 50% of participants in the trial have been treated. Our clinical team has maximized this disruptive time to re-examine our data and make sure our data is pristine for future regulatory submissions.” Dr. Kern concluded, “In terms of the Hospital Exemption Program, the Company has not completed treatment of all the first 13 patients as non-Israeli patients are unable to travel to Israel at the present time due to COVID-19 travel restrictions. The Company is currently collecting HE clinical data for the patients who already received treatment at the Tel Aviv Sourasky Medical Center. Once the complete data set for the first 13 treated patients is available, we will perform a detailed analysis.”

First Quarter 2020 and Recent Corporate Highlights:

Scientific and Company Presentations:

Financial Results for the Three Months Ended March 31, 2020

For further details on BrainStorm’s financials, including financial results for the three months ended March 31, 2020, refer to Form 10-Q filed with the SEC on May 7th, 2020

Conference Call and Webcast: Thursday, May 7, 2020 @ 8:30 a.m. Eastern Time

A teleconference replay of the conference call will be available for 14 days on the “Investors & Media” page of BrainStorm’s website:

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: + 1.862.397.1860 pshah@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) U.S. dollars in thousands (Except share data)

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands

(Except share data)

BrainStorm Presents New Data Highlighting NurOwn® Immunomodulation in Neurology

Mon, 04 May 2020 12:00:00 GMT

The abstract was originally planned for presentation at the recently cancelled 2020 American Academy of Neurology (AAN) annual meeting. In addition to the online supplement, the abstract is also available through the AAN online abstracts website.

“Neuroinflammation is a prominent pathological feature of ALS and progressive MS. Reduced T and B regulatory function may contribute to disease progression, and lower IL-10 levels may be associated with reduced ALS function and with higher disability and MRI lesion load in secondary progressive MS,” said Ralph Kern MD, MHSc, President and Chief Medical Officer of Brainstorm, “The immunomodulatory properties of MSC-NTF cells, including their effects on T and B regulatory cells, and the observed increase in IL-10 secretion, may be an important contributor to the potential therapeutic benefits of NurOwn in ALS and progressive MS.”

“Brainstorm is committed to fully developing NurOwn technology while continuing to expand our understanding of potential biological mechanisms of action that may contribute to its therapeutic effects in neurodegenerative diseases,” said Chaim Lebovits, Brainstorm CEO, “We look forward to advance our technology platform across several neurodegenerative disease indications and bring much-needed solutions to patients.”

Brainstorm AAN 2020 abstract: MSC-NTF Cell Immunomodulation: Effects on T and B Regulatory Cells Revital Aricha, Natalie Abramov, Jonathan Semo, Haggai Kaspi, Chaim Lebovits, Ralph Kern.

About NurOwn® NurOwn® (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: + 1.862.397.1860 pshah@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm-Cell Therapeutics to Announce First Quarter Financial Results and Provide a Corporate Update

Wed, 29 Apr 2020 12:00:00 GMT

BrainStorm’s CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PhD, MBA, Executive Vice President and Chief Operating Officer and Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. EDT, Tuesday, May 5, 2020.

Teleconference Details – BRAINSTORM CELL THERAPEUTICS 1Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

ABOUT NUROWN® NurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

ABOUT BRAINSTORM CELL THERAPEUTICS INC.: BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Awarded $1.5 Million Non-Dilutive Grant for 2020 by the Israel Innovation Authority

Fri, 03 Apr 2020 12:00:00 GMT

BrainStorm's CEO Chaim Lebovits, commented, "The Israel Innovation Authority's support of our programs provides further validation for the potential of our treatments to help patients suffering from neurodegenerative disorders. The continued financial support for our research and development will further our ability to execute our strategic objectives, as we finalize our Phase 3 pivotal trial with NurOwn in ALS patients and advance our cellular technology pipeline."

The IIA has supported BrainStorm Cell Therapeutics Ltd. since 2007, providing grants totaling approximately 11.4 million USD in support of the development of NurOwn and other projects. BrainStorm will be required to pay mid-single digit royalties to the IIA based on sales of the products, up to a total of the cumulative amount of IIA grants received plus accumulated interest.

About NurOwn® NurOwn (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: + 1.862.397.1860 pshah@brainstorm-cell.com Media: Sean Leous Westwicke/ICR PR Phone: +1.646.677.1839 sean.leous@icrinc.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

David Setboun Joins BrainStorm as Executive Vice President and Chief Operating Officer

Wed, 01 Apr 2020 12:00:00 GMT

International pharmaceutical executive Dr. Setboun, has directed commercial development, business strategy, and product launches for 2 decades at 3 major biopharmaceutical companies. Most recently, Dr. Setboun served as VP Corporate Development, Strategy & Business at Life Biosciences. In this role, David was instrumental in the development of various critical commercial, operating and funding milestones. From June 2015 to June 2018, he served as President, Biogen, France where he launched Biogen’s rare disease franchise. In addition, he supervised the launch of key neurology products and oversaw the Biosimilar business unit. Prior to his tenure at Biogen, Dr. Setboun, served as President, AstraZeneca, Portugal from 2012 to 2015, where he managed a product portfolio that grossed over $200 million annually. Prior to this role, David led the European Sales & Marketing function as AstraZeneca’s VP Europe where he directed a team of executives in marketing, commercial excellence, pricing and market access. During his tenure, he expanded AstraZeneca’s Oncology, Diabetes and Cardiovascular franchises. From 2002 to 2009, Dr. Setboun directed national and international teams and projects for Eli Lilly and Company in France and the USA. Fluent in French, English, Spanish and Portuguese, Dr. Setboun received his Pharmaceutical Doctorate (Pharm.D.) from University Paris XI in 1997 and his MBA from H.E.C Paris in 2001. More recently, David graduated from Harvard Business School (AMP 194).

“BrainStorm’s investigational therapy, NurOwn® is an amazing technology platform that has the potential to bring treatment to those with ALS and progressive MS and other neurodegenerative indications. With a fully enrolled Phase 3 Pivotal Trial for ALS in place, a Phase 2 Trial for progressive MS, an investigational platform in exosomes and the most ambitious biomarker program in ALS, I know I am joining a company with outstanding potential,” said Dr. Setboun.

"David’s experience launching products for international biopharmaceutical companies and his expertise in commercial, business development and investments, make him an outstanding new member of the BrainStorm leadership team. His extensive experience at all levels of sales and marketing, coupled with his business strategy experience comes to us at a critical time in the evolution of NurOwn® and helps us achieve our goal of bringing new treatment options to patients afflicted with neurodegenerative diseases, including ALS and progressive MS," said Chaim Lebovits, Chief Executive Officer of BrainStorm.

“Additionally, I am very pleased to announce Ralph Kern MD, MHSc, has been promoted to President of BrainStorm. Ralph joined BrainStorm in March 2017 as Chief Operating Officer and Chief Medical Officer. Directing our clinical development, Ralph has helped the Company rapidly achieve clinical milestone, after clinical milestone, while guiding the Company to expand its product pipeline to investigate additional applications and disease indications. In recognition of his ongoing, outstanding service, Ralph has been elevated to the position of President and Chief Medical Officer of BrainStorm.”

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: + 1.862.397.1860 pshah@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: + 1.862.397.1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Appoints Renowned Distinguished Economist, Prof. Jacob Frenkel, Chairman of the Board of Directors

Tue, 31 Mar 2020 12:00:00 GMT

“Prof. Frenkel is joining our Board as Chairman at a crucial time where his leadership will add tremendous value,” stated Chaim Lebovits, President and CEO of BrainStorm. “Prof. Frenkel served on BrainStorm’s advisory board about a decade ago. Since that time, BrainStorm has demonstrated its ability to develop and deliver innovative stem cell treatments through the highly challenging path from the pre-clinical laboratory to phase 3 trials. Mr. Abbhi feels passionately about improving the lives of patients and families affected by neurodegenerative disease. His previously announced strategic financial support combined with his leadership as Director will help BrainStorm pursuing its mission to bring life-changing treatments to those impacted by ALS and MS. We are grateful to Dr. Arbel who will continue to serve as Vice Chair of the Board. We also thank Mr. Chen Schor for his decade long service and significant contribution to BrainStorm.”

Prof. Frenkel said, “I am honored to join BrainStorm as Chairman of the Board of Directors. The Company has advanced the investigational therapy NurOwn® into a fully enrolled phase 3 clinical trial for ALS - a critical juncture in its history.” He added, “Chaim Lebovits has built an impressive team and has led the Company with great commitment and inspiration. I look forward to joining by leading the Board and supporting BrainStorm’s global expansion and partnership strategy.”

Jacob Frenkel, Ph.D., currently serves as Chairman of the Board of Trustees of the Group of Thirty (G-30), a private, nonprofit, consultative group on international economic and monetary affairs. During 2001-11 he served as Chairman and chief executive officer of the G-30. Previously, Prof. Frenkel served as Chairman of JPMorgan Chase International (2009-2020), from 2009 to 2020, as Vice Chairman of American International Group, Inc. (AIG) (2004-9), and as Chairman of Merrill Lynch International (2000-2004).

Between 1991 and 2000 he served two terms as the Governor of the Bank of Israel, Previously he was the Economic Counselor and Director of Research at the International Monetary Fund (1987-91), and also served on the faculty of the University of Chicago, where he held the position of the David Rockefeller Professor of International Economics as well as serving as Editor of the Journal of Political Economy (1973-87).

Prof. Frenkel is a Fellow of the Econometric Society, a lifetime Fellow of the International Economic Association, a Foreign Honorary Member of the American Academy of Arts and Sciences, a member of the Boards of Directors of the National Bureau of Economic Research, the Institute for National Security Studies (INSS), the Japan Society, and the Peterson Institute for International Economics. He is a member of the Competitive Markets Advisory Council (CMAC) of the CME Group, the Boards of the Aspen Institute Italia and The Council for the US and Italy, a member emeritus of Temasek International Panel (TIP), a Senior Advisor of Temasek International Advisors, a member of the G20 Eminent Persons Group (EPG) on Global Financial Governance, a member of the International Advisory Council of China Development Bank, and a Global Member of the Trilateral Commission.

Prof. Frenkel is a Laureate of the 2002 Israel Prize in Economics, a recipient of the Scopus Award from the Hebrew University, the Hugo Ramniceanu Prize for Economics from the Tel-Aviv University, the Czech Republic’s Karel English Prize in Economics, the “Order de Mayo al Merito” (in the rank of Gran Cruz) decoration from the Government of Argentina, the “Order of Merit” (in the rank of Cavaliere di Gran Croce) decoration from the Republic of Italy, and the YIVO Lifetime Achievement Award.

He serves as Chairman of the Board of Governors of Tel Aviv University, where he is also Chairman of the Frenkel-Zuckerman Institute for Global Economics. He previously served as Chairman of the Board of Governors of the Inter-American Development Bank (1995-1996), as Vice Chairman of the Board of Governors of the European Bank for Reconstruction and Development (1999-2000), as Governor of the IMF and Alternate Governor of the World Bank for Israel (1991-2000), a member of the Economic Advisory Panel of the Federal Reserve Bank of New York (1986-2014), and a member of the Board of Trustees of the New York Economic Club (2013-2019).

Prof. Frenkel is the author of numerous books and articles in the fields of International Economics and Macroeconomics and is a recipient of several Honorary Doctoral degrees and other decorations and awards. He earned a B.A. in economics and political science at the Hebrew University of Jerusalem and an M.A. and Ph.D. in economics at the University of Chicago.

Sankesh Abbhi is the President and CEO of ArisGlobal, a leading provider of cloud-based, end-to-end, drug development technology solutions for over 250 of the world’s leading Life Science’s companies, CROs and government health authorities. Mr. Abbhi, also advises Abbhi Capital, his wholly owned family office, in its corporate investments in transformative life sciences, healthcare and technology companies. Prior to leading ArisGlobal and Abbhi Capital, Mr. Abbhi founded Synowledge, a knowledge process outsourcing company which he grew to over 1000 global employees and eventually sold to BioClinica. Mr. Abbhi graduated with a BA in Economics from Columbia University.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018, and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: +1.862.397.1860 pshah@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1.862.397.1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm to Hold a Conference Call to Update Investors on Corporate Steps Taken to Address COVID-19

Mon, 16 Mar 2020 12:00:00 GMT

The call will be hosted by CEO, Chaim Lebovits and key members of the senior leadership team.

Wednesday, March 18, 2020 @ 8:30am U.S. Eastern Time

Toll Free: 1-877-423-9813

Toll/International: 1-201-689-8573

Webcast Audio Link: https://bit.ly/2TPIfXe

Reply:

Toll Free: 1-844-512-2921 Toll/International: 1-412-317-6671 Replay Pin Number: 13700404 Replay Start: Wednesday, March 18, 2020, 11:30 AM ET Replay Expiry: Wednesday, April 1, 2020, 11:59 PM ET

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: 862-397-1860 pshah@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: 862-397-1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Cell Therapeutics Raises $10.0 Million in Common Stock Sale at $8.00 Per Share

Fri, 06 Mar 2020 12:00:00 GMT

The securities will be issued pursuant to the Company’s existing shelf registration statement on Form S-3 (File No. 333225517) (the “Registration Statement”), which was filed with the SEC and declared effective by the SEC on June 29, 2018.

BrainStorm intends to use the proceeds from this transaction to fund its operations, which includes, but is not limited to advancing the Company’s clinical programs, commercial production of the investigational therapeutic NurOwn® (whether for ALS or other indications), regulatory, pre-marketing and commercialization preparation activities of NurOwn® for ALS, working capital and general corporate purposes.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities. The securities offered and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws, and may not be offered or sold in the United States absent registration, or an applicable exemption from registration under the Securities Act and applicable state securities laws.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: 862-397-1860 pshah@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: 862-397-1860

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

Fifth and Final Site Announced for BrainStorm’s Progressive Multiple Sclerosis Phase 2 Clinical Trial

Thu, 27 Feb 2020 12:00:00 GMT

“Tanuja Chitnis, MD, Director of the CLIMB Natural History Study, which is assessing the disease course and prognosis of approximately 2000 MS patients, will serve as the Principal Investigator at Brigham and Women’s Hospital,” said Chaim Lebovits, President and CEO of BrainStorm. He added, “The Partners MS Center at Brigham and Women’s Hospital provides comprehensive patient care, innovative technology and ongoing clinical research trials. We’re excited to have them join the trial, and we expect that they will soon enroll participants under the supervision of Dr. Chitnis and her highly experienced clinical team.”

Ralph Kern, MD, MHSc, Chief Operating and Chief Medical Officer of BrainStorm added, “It has been less than a year since we contracted with our first progressive MS clinical site, half of the study participants have already been screened and 2 study participants have completed all study visits. We are very privileged to have Dr. Chitnis and her team advance our clinical study of NurOwn in progressive MS.”

“We are excited to participate in this research study, which will allow us the opportunity to investigate potential new therapies for our patients with progressive MS,” said Chitnis, who is also a professor of Neurology at Harvard Medical School and a senior neurologist at Brigham and Women's Hospital.

Tanuja Chitnis, MD, and the Partners MS Center at The Brigham and Women’s Hospital team join the other top US MS centers: Cleveland Clinic, Stanford University, School of Medicine, Mount Sinai Medical Center and University of Southern California for the Company’s Phase 2 open-label, multicenter study of repeated intrathecal administration of autologous MSC-NTF cells in participants with progressive Multiple Sclerosis (MS) (NCT03799718).

About NurOwn®

BrainStorm has fully enrolled a Phase 3 pivotal trial of repeat-dosing autologous MSC-NTF cells (NurOwn) for the treatment of amyotrophic lateral sclerosis (ALS).

BrainStorm received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter repeat-dosing trial of autologous MSC-NTF cells (NurOwn) in progressive MS and enrollment began in March 2019. Currently half of the expected trial participants are enrolled.

Top line results for both clinical trials are expected in the fourth quarter of 2020.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statements

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Announces Operational Highlights and Financial Results for the Year Ended December 31, 2019

Tue, 18 Feb 2020 12:00:00 GMT

“2019 was a tremendous year for BrainStorm, with significant progress and achievements across all clinical and operational fronts,” stated Chaim Lebovits, President and Chief Executive Officer of BrainStorm. “Most importantly, we fully enrolled our pivotal, double blind, placebo-controlled Phase 3 trial of NurOwn® for the treatment of ALS. We announced the trial conducted at six major U.S. medical centers of excellence for ALS, was fully enrolled on October 11, 2019, and on October 28, 2019 the Data and Safety Monitoring Board (DSMB), completed the second planned interim safety analysis for the first 106 patients who received repeat dosing of NurOwn in the Phase 3 trial. The DSMB concluded the trial should continue as planned without any clinical protocol changes.” He added, “In addition, one of the most prestigious peer-reviewed journals, Neurology, published ‘NurOwn Phase 2 Randomized Clinical Trial in ALS: Safety, Clinical and BioMarker Results,’ bringing news of our investigational therapy to the global scientific community. And, just last week, we were happy to announce that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn regulatory pathways for approval in ALS.”

Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm added, “2019 was also a very significant year for those who suffer from progressive Multiple Sclerosis (MS). In February 2019, we announced Cleveland Clinic would serve as our first contracted site for a Phase 2 open-label, multicenter study of repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) in participants with progressive MS (NCT03799718). We enrolled our first patient in March. We contracted with The Stanford University School of Medicine, The Keck School of Medicine of the University of Southern California, and the Mount Sinai Medical Center to further enroll patients.” Dr. Kern added, “The importance of our research in progressive MS was acknowledged by a $495,000 grant award from the National Multiple Sclerosis Society through it’s Fast Forward Program, and mid-December, the Data Safety Monitoring Board completed the first, pre-specified interim analysis, of safety outcomes for 9 participants and after careful review of all available clinical trial data, the DSMB unanimously concluded that the study should continue as planned without any protocol modification. As of December 31, 2019 we have enrolled 10 patients in the study (50% enrollment completed).”

Fourth Quarter Corporate Highlights:

Financial Results for the Year Ended December 31, 2019 and Recent Updates

For further details on BrainStorm’s financials, including financial results for the year ended December 31, 2019, refer to the Form 10-K filed with the SEC today.

Conference Call on Tuesday, February 18th @ 8:00 am Eastern Time

The investment community may participate in the conference call by dialing the following numbers:

Those interested in listening to the conference call live via the internet may do so by visiting the “Investors & Media” page of BrainStorm’s website at brainstorm-cell.com/investors/ and clicking on the conference call link.

A webcast replay of the conference call will be available for 30 days on the “Investors & Media” page of BrainStorm’s website:

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. Brainstorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: 862-397-8160 pshah@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC.

CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (Except share data)

BRAINSTORM CELL THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS U.S. dollars in thousands (Except share data)

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: 862-397-8160

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BRAINSTORM CELL THERAPEUTICS INC.

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

BRAINSTORM CELL THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S. dollars in thousands

(Except share data)

BrainStorm’s Chief Operating Officer to Present at Noble Capital Markets’ Sixteenth Annual Investor Conference

Mon, 17 Feb 2020 12:00:00 GMT

BrainStorm has a fully enrolled 200-patient Phase 3 clinical trial evaluating repeat intrathecal administration of NurOwn® cellular therapeutic (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). In late October 2019, the Data and Safety Monitoring Board (DSMB) completed the second planned interim safety analysis for the first 106 patients who received repeat dosing of NurOwn in the Phase 3 ALS trial.

Additionally, BrainStorm is enrolling patients in an investigational Phase 2 clinical trial of NurOwn for progressive MS, a disease with enormous unmet medical need.

Presentation Details:

Click Here For the Webcast of Brainstorm’s Presentation

** The video webcast will be available starting February 18, 2020 for 90 days **

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. Brainstorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

About Noble Capital Markets, Inc. Noble Capital Markets (“Noble”) is a research driven boutique investment bank that has supported small & microcap companies since 1984. As a FINRA and SEC licensed broker dealer Noble provides institutional-quality equity research, merchant and investment banking, wealth management and order execution services. In 2005, Noble established NobleCon, an investor conference that has grown substantially over the last decade. In 2018 Noble launched www.channelchek.com - a new investment community dedicated exclusively to small and micro-cap companies and their industries. Channelchek is tailored to meet the needs of self-directed investors and financial professionals. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 6,000 emerging growth companies are listed on the site, with growing content including webcasts, podcasts, and balanced news.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Katie Gallagher | Account Director, PR and Marketing LaVoieHealthScience Strategic Communications O: 617-374-8800 x109 M: 617-792-3937 kgallagher@lavoiehealthscience.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

Katie Gallagher | Account Director, PR and Marketing

LaVoieHealthScience Strategic Communications

O: 617-374-8800 x109

M: 617-792-3937

kgallagher@lavoiehealthscience.com

BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn® Regulatory Pathway for Approval in ALS

Tue, 11 Feb 2020 12:00:00 GMT

In the planned meeting with senior Center for Biologics Evaluation and Research (CBER) leadership and several leading U.S. ALS experts, the FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The FDA indicated that they will look at the "totality of the evidence" in the expected Phase 3 clinical trial data. Furthermore, based on their detailed data assessment, they are committed to work collaboratively with BrainStorm to identify a regulatory pathway forward, including opportunities to expedite statistical review of data from the Phase 3 trial.

Both the FDA and BrainStorm acknowledged the urgent unmet need and the shared goal of moving much needed therapies for ALS forward as quickly as possible. “This is a key turning point in our work toward providing ALS patients with a potential new therapy,” said Chaim Lebovits, President and CEO of BrainStorm. “We commend the FDA for its commitment to the ALS community and to facilitating the development, and we ultimately hope, the approval of NurOwn. The entire BrainStorm team is grateful for the ongoing and conscientious collaboration in the quest to beat ALS.”

Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, stated, “The entire team at BrainStorm has collectively worked to ensure that we conduct the finest, science-based clinical trials. We had the opportunity to communicate with Senior Leadership at the FDA and discuss how we can work together to navigate the approval process forward along a novel pathway. We appreciate their willingness and receptiveness to consider innovative approaches as we all seek to better serve the urgent unmet medical needs of the ALS community.”

Brian Wallach, Co-Founder of I AM ALS stated: “There is nothing more important to those living with ALS than having access to therapies that effectively combat this fatal disease. We have been working with BrainStorm for months now because we believe that NurOwn is a potentially transformative therapy in this fight. We were privileged to represent the patient voice at this meeting and are truly grateful to the company and the FDA for this critical agreement. This is a truly important moment of hope and we look forward to seeing both the Phase III data and the hopeful approval of NurOwn as soon as is possible.”

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Katie Gallagher | Account Director, PR and Marketing LaVoieHealthScience Strategic Communications O: 617-374-8800 x109 M: 617-792-3937 kgallagher@lavoiehealthscience.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

Katie Gallagher | Account Director, PR and Marketing

LaVoieHealthScience Strategic Communications

O: 617-374-8800 x109

M: 617-792-3937

kgallagher@lavoiehealthscience.com

BrainStorm Cell Therapeutics to Announce Fourth Quarter and Full Year 2019 Financial Results and Provide a Corporate Update

Mon, 10 Feb 2020 12:00:00 GMT

BrainStorm’s President & CEO, Chaim Lebovits, will present the full year 2019 corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, and Preetam Shah, PhD, Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com and questions should be submitted by 5:00 p.m., Eastern Time, Monday, February 17 2020.

The investment community may participate in the conference call by dialing the following numbers:

A webcast replay of the conference call will be available for 30 days on the “Investors & Media” page of BrainStorm’s website:

About NurOwn®

NurOwn® (autologous MSC-NTF cells) represent a promising investigational approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. Brainstorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: 862-397-8160 pshah@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investor Relations:

Preetam Shah, MBA, PhD

Chief Financial Officer

BrainStorm Cell Therapeutics Inc.

Phone: 862-397-8160

pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm CEO to Provide Company Update at the BIO CEO & Investor Conference

Tue, 04 Feb 2020 12:00:00 GMT

Brainstorm has a fully enrolled 200-patient Phase 3 clinical trial (NCT03280056) evaluating repeat intrathecal administration of NurOwn® cellular therapeutic (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). In late October 2019, the Data and Safety Monitoring Board (DSMB) completed the second planned interim safety analysis for the first 106 patients who received repeat dosing of NurOwn in the Phase 3 ALS trial.

Additionally, Brainstorm is enrolling participants in the Phase 2 study of repeat intrathecal administration of NurOwn for progressive MS, a disease with significant unmet medical need.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) for ALS. Brainstorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Receives Notice of Intention to Grant Additional EU patent for NurOwn®

Wed, 29 Jan 2020 12:00:00 GMT

“We continue to protect our technology through strategic intellectual property achievements and the intention to grant this patent by the European Patent Office is a welcome addition to our IP portfolio. This patent covers the industrial manufacturing process for NurOwn® developed by Brainstorm's scientists,” commented Brainstorm's CEO Chaim Lebovits. “Adding this EU patent to our patents granted in the United States, Canada, Israel and Japan, should increase our ability to enter into new commercial partnerships for NurOwn in the EU and worldwide.”

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. Brainstorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Cell Therapeutic’s COO and CMO, Dr. Ralph Kern, to Present at the 10th Annual California ALS Research Summit

Tue, 21 Jan 2020 12:00:00 GMT

Dr. Kern will provide an update on BrainStorm’s Phase 3 ALS Clinical Trial on Friday, January 24, 10:30 -11:10 AM PT, during the session: “CIRM funded Stem Cell Clinical Trials in California – Updates.”

Dr. Kern stated, “This prestigious Summit works to increase, expedite and promote the amount and level of amyotrophic lateral sclerosis (ALS) research done in California that has been reinforced and amplified by the international ALS scientific and medical community. I am pleased to have the opportunity to share all that BrainStorm has accomplished in our fully enrolled Phase 3 clinical trial of NurOwn® (NCT03280056).”

Chaim Lebovits, President and CEO of BrainStorm, stated, “California continues to be a global leader in stem cell research and scientific funding. Due to California’s commitment to stem cell scientific investigation, BrainStorm is at an inflection point as we bring our investigational therapy, NurOwn, toward the submission of a biological license application. In July 2017, BrainStorm was awarded a grant of $15.9 million from the California Institute for Regenerative Medicine (CIRM) and three of California’s most prestigious medical centers: University of California, Irvine, Cedars-Sinai Medical Center, and California Pacific Medical Center have contributed immensely to advancement of NurOwn. Everyone at BrainStorm is proud Dr. Kern will have the opportunity to present to the ALS community of California all that has been accomplished due to their ongoing support and encouragement.”

About The California ALS Research Summit:

The California ALS Research Summit is the tenth annual gathering of researchers, investigators, clinicians, biotech companies, government representatives, partner organizations, and advocates in ALS and related fields in the State of California.

The purpose of the Summit is to help increase, expedite and promote the amount and level of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's Disease) and related research done in California; and to foster networking, collaboration and cooperation among investigators, their peers and their colleagues to identify, develop and deliver new and effective treatments, ideas and, ultimately, cures for ALS.

The result of our efforts is an ongoing roadmap for ALS research in California, which will provide the basis for partnering within the state and other supporters to further studies to find new treatments and ultimately a cure for the disease.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Or: Katie Gallagher LaVoieHealthSciences Phone: + 1 617-374-8800 x109 kgallagher@lavoiehealthscience.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

Or:

Katie Gallagher

LaVoieHealthSciences

Phone: + 1 617-374-8800 x109

kgallagher@lavoiehealthscience.com

BrainStorm Cell Therapeutics to Present at the 2020 Biotech Showcase and 3rd Annual Neuroscience Innovation Forum at JPM Week

Tue, 07 Jan 2020 12:00:00 GMT

Mr. Lebovits will also present at the 3rd Annual Neuroscience Innovation Forum, taking place on January 12, 2020, at the Marines’ Memorial Club in San Francisco. Additionally, Ralph Kern M.D., MHSc, BrainStorm’s Chief Operating Officer and Chief Medical Officer, will participate on a Rare & Orphan Diseases Panel.

Meetings

BrainStorm’s senior management will also be hosting institutional investor and partnering meetings at the 2020 Biotech Showcase conference (https://goo.gl/SGFm62). Please use the Investor contact information provided below to schedule a meeting.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

NurOwn® Data Safety Monitoring Board Recommends MS Phase 2 Clinical Trial Continue

Thu, 19 Dec 2019 12:00:00 GMT

“BrainStorm is focused on completing the NurOwn progressive MS Phase 2 study and to bringing a much needed treatment option to MS patients,” said Chaim Lebovits, president and CEO of BrainStorm, “The DSMB review confirms the safety profile at this stage of the study of repeat dose intrathecal administration of NurOwn in this patient population.”

"We are very pleased with the DSMB recommendation that the Phase 2 progressive MS clinical trial continue without any protocol modification. This is an important next step towards completing this clinical trial and advancing the development of a much needed and innovative treatment option for patients with progressive MS,” said Ralph Kern MD, MHSc, BrainStorm Chief Operating Officer and Chief Medical Officer.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Issues 2019 Letter to Shareholders

Wed, 18 Dec 2019 12:00:00 GMT

Dear Valued Shareholders,

2019 was an extraordinary year for BrainStorm Cell Therapeutics! From a research and development, clinical, and corporate perspective, I appreciate the ongoing, dedicated support we have received from our patients and their families. I also want to acknowledge the many accomplishments of our employees, and the commitment we have received from our shareholders and our distinguished clinical partners, as we continue to execute on our goal of bringing much needed treatments to those suffering from neurodegenerative diseases.

In the second week of October, we announced full enrollment of the 200-patient Phase 3 clinical trial (NCT03280056) evaluating repeat intrathecal administration of NurOwn® cellular therapeutic (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). This clinical milestone is a key inflection point in the development of NurOwn as an investigational therapeutic and confirming BrainStorm as the leading biotechnology company developing autologous stem cell therapy treating neurogenerative disease.

In late October 2019, the Data and Safety Monitoring Board (DSMB) completed the second planned interim safety analysis for the first 106 patients who received repeat dosing of NurOwn in the Phase 3 ALS trial. The DSMB concluded the trial should continue as planned without any protocol changes. Dr. Carlayne Jackson, M.D., chair of the Phase 3 DSMB stated, “After reviewing all of the safety data as of September 30th, the DSMB has recommended the study continue without any changes in the protocol. We did not identify any significant safety concerns.”

At the end of 2018, we announced the expansion of our pipeline by introducing a new indication for NurOwn in progressive Multiple Sclerosis (MS). Progressive MS has deeply affected the lives of many and dramatically impacted family members, caregivers and others. Today, there is no U.S. FDA approved therapy addressing more than one progressive form of MS. In March 2019, we enrolled the first patient in our Phase 2 open-label, multicenter study of repeated intrathecal administration of autologous MSC-NTF cells in participants with progressive MS. Throughout the year, due to our dedicated efforts, we successfully contracted with leading US clinical sites for our Phase 2 open-label, multicenter clinical trial of repeated intrathecal administration of autologous MSC-NFT cells in progressive MS. These clinical sites, which include the Cleveland Clinic, Stanford University School of Medicine, the University of Southern California and Mount Sinai Medical Center, are Centers of Excellence for MS research and treatment and are led by prominent and well-respected clinical investigators and KOLs in the field of progressive MS. In November, Our Phase 2 ALS clinical data was published in “Neurology”, the highly respected peer-reviewed journal and the official journal of the American Academy of Neurology. Concurrently, Brainstorm was also selected to be featured in an editorial by independent reviewers titled “Stem Cells in Amyotrophic Lateral Sclerosis - Hype or Hope”, which commented on Brainstorm’s ALS clinical study design and stated: “Berry and associates are to be commended for presenting the framework of a well-planned and designed study that should serve as a framework for other investigators to emulate.”

BrainStorm was recently awarded a grant of $495K from The National MS Society (NMSS) to support our Phase 2 biomarker study of NurOwn in progressive MS. This funding from the National MS Society will help us explore key neuroinflammation and neural repair biomarkers in progressive MS to confirm NurOwn’s unique mechanism of action and will guide the design of future clinical trials to address this important unmet patient need.

We also expanded our intellectual patent portfolio by obtaining additional United States and Japanese patents for BrainStorm's NurOwn cellular technology for the treatment of various neurogenerative diseases. These patents add another layer of protection around our cellular technology and are the result of our ongoing technical development and clinical progress.

Lastly, we strengthened our executive team by bringing on board Dr. Preetam Shah as our Executive Vice President and Chief Financial Officer to expand our Investor Relations program and future business development and capital strategy initiatives.

Our ongoing Phase 3 and Phase 2 clinical programs investigating NurOwn in ALS and progressive MS have received extensive and positive news coverage in the mainstream US media over the last year. I want to make sure that all our investors have an opportunity to read these articles and view these news items. The list of selected articles is listed below. The ABC Nightline segment was broadcast to more than 3 million households across the US and continues to be a major part of a full form documentary that will be broadcast by ABC Nightline and partners in 2020.

What is clear from these news items is that ALS and progressive MS represent significant unmet medical needs and that, despite the limited options currently available, patients are highly motivated to seek out new treatments and physicians recognize the potential of our autologous cellular therapy technology platform.

Approximately 6,000 people in the U.S. are diagnosed with ALS each year and more than 30,000 Americans are currently living with the disease. Worldwide it is estimated that 450,000 patients are living with ALS. Since 1995, only two new pharmaceuticals have been approved, but the medical need remains. NurOwn is the first autologous cellular investigational therapy to have advanced as far in a Phase 3 clinical trial. Progressive MS represents a US and worldwide addressable market opportunity of 500,000 and 1,250,000, individuals, respectively.

Looking ahead to 2020, we are highly focused on generating top-line results for our ALS phase 3 and progressive MS phase 2 trials in the fourth quarter, to initiating the regulatory submission and eventual commercialization of NurOwn in ALS, to further advancing our cellular technology and manufacturing capabilities. We will actively seek additional opportunities to expand our pipeline to address unmet need and to grow as a biotechnology company.

I want to personally thank you for your continued support.

Sincerely,

Chaim

Chaim Lebovits President and CEO BrainStorm Cell Therapeutics Inc.

CONTACTS

Selected Video Clips:

ABC Nightline

ALS patients share about their life 5 years after 'Ice Bucket Challenge': Part 1 https://abcnews.go.com/Nightline/video/als-patients-share-life-years-ice-bucket-challenge-64874152

Part 2 https://abcnews.go.com/Nightline/video/als-patient-rides-motorcycle-unable-years-part-64874209

KTLA Southern California

https://ktla.com/2019/11/21/l-a-firefighter-among-patients-undergoing-promising-treatment-for-als/

CBS Philadelphia

https://philadelphia.cbslocal.com/2019/03/11/als-patients-fighting-fda-for-experimental-drug-nurown/

Selected News Articles:

Safe-Harbor Statements

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investors:

Preetam Shah, Chief Financial Officer

BrainStorm Cell Therapeutics Inc

Phone: +1-201-488-0460

Email: pshah@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

Email: sean.leous@icrinc.com

Selected Video Clips:

ABC Nightline

ALS patients share about their life 5 years after 'Ice Bucket Challenge': Part 1

https://abcnews.go.com/Nightline/video/als-patients-share-life-years-ice-bucket-challenge-64874152

Part 2

https://abcnews.go.com/Nightline/video/als-patient-rides-motorcycle-unable-years-part-64874209

KTLA Southern California

https://ktla.com/2019/11/21/l-a-firefighter-among-patients-undergoing-promising-treatment-for-als/

CBS Philadelphia

https://philadelphia.cbslocal.com/2019/03/11/als-patients-fighting-fda-for-experimental-drug-nurown/

Selected News Articles:

Safe-Harbor Statements

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

BrainStorm Selected as Buzz of BIO 2020 Winner

Wed, 11 Dec 2019 12:00:00 GMT

The Buzz of BIO contest provides an excellent opportunity for companies looking to make the connections needed to take their product to the next phase. The contest helps to identify U.S. based companies with groundbreaking, early stage technologies that have the overall potential to improve lives. Qualifying biotechs were nominated in each of the three categories: Public Therapeutic Biotech; Private Therapeutic Biotech; and Diagnostics and Beyond.

Chaim Lebovits, President and CEO of BrainStorm Cell Therapeutics said, “Thanks to everyone who voted for BrainStorm during the Buzz of BIO competition. This recognition, over all other nominated publicly traded companies, offers BrainStorm a complimentary presentation at the BIO CEO & Investor Conference in New York City, February 10-11, 2020. The entire management team at BrainStorm was very pleased with the results of this competition and we look forward to presenting to an audience of accredited investors who may benefit from the Company’s story. We thank the BIO team for singling out BrainStorm’s NurOwn® as a key technology with the potential to improve lives. 2019 was a banner year for BrainStorm and we will continue to share our story with the widest possible audience in 2020.”

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statements

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

BRAINSTORM CONTACTS: Investors: Uri Yablonka, Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: +1-201-488-0460 Email: uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

Email: sean.leous@icrinc.com

BrainStorm Cell Therapeutics to make scientific presentations at the 30th International Symposium on ALS/MND

Tue, 26 Nov 2019 12:00:00 GMT

The symposium will take place December 4 – 6, 2019, at the Perth Convention and Exhibition Centre in Perth, Australia. The International Symposium on ALS/MND is a unique annual event that brings together leading international researchers and health and social care professionals to present and debate key innovations in their respective fields.

Ralph Kern MD MHSc, BrainStorm’s Chief Operating and Chief Medical Officer, will deliver a podium presentation: “Modulation of innate immunity by MSC-NTF (NurOwn®) cells correlates with ALS clinical outcomes”, on December 4, from 11:50 – 12:10 pm AWST during the opening day Clinical Trials Session. In addition to the podium presentation, the Company will also present Poster 153: “MSC-NTF Differentiation Increases the Neurotrophic Effects of MSC Cells: Live Imaging Analysis”, that directly demonstrates the neuroprotective effects of NurOwn® in a neuronal cell culture model.

“Our fully-enrolled phase 3 clinical trial is one of the most advanced clinical programs in ALS,” stated Chaim Lebovits, President and CEO of BrainStorm. He added, “The International Symposium on ALS/MND is an important venue to update the community on our clinical and scientific efforts towards the advancement of therapies that may address the unmet needs of those living with ALS. BrainStorm Cell Therapeutics is proud to serve as a sponsor of this important annual symposium which underscores our commitment to the international community of ALS and MND patients, their families and their caregivers.”

Ralph Kern, MD, stated, “It is a privilege to present our innovative biomarker and preclinical research at the International Symposium on ALS/MND.” He added, “Every year, symposium participants gather together and discuss the opportunities and the challenges that we will face during the upcoming year. Research and medical breakthroughs for the ALS and MND community continue to make significant progress and we look forward to sharing our insights and engaging with colleagues from around the globe. The International Symposium on ALS/MND reminds us how far we have come in investigational therapies and how much more progress is still needed to bring patients a better and more promising future.”

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

The International Symposium on ALS/MND is a unique annual event that brings together leading international researchers and health and social care professionals to present and debate key innovations in their respective fields. The Symposium is planned as two parallel meetings, one on biomedical research and the other on advances in the care and management of people affected by ALS/MND. Joint sessions consider issues of mutual concern, challenging current views and practices.

Safe-Harbor Statements

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

BRAINSTORM CONTACTS: Investors: Uri Yablonka, Chief Business Officer BrainStorm Cell Therapeutics Inc Phone: : +1-201-488-0460 Email: uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

Email: sean.leous@icrinc.com

BrainStorm Announces the Mount Sinai Medical Center as a Progressive MS Phase 2 Clinical Trial Site

Mon, 25 Nov 2019 12:00:00 GMT

“Internationally recognized Multiple Sclerosis expert Fred Lublin, MD, will serve as the Principal Investigator at the Mount Sinai Medical Center,” said Chaim Lebovits, President and CEO of BrainStorm. He added, “The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai is a leading center in MS research and discovery and we are ready to enroll patients under the supervision of Dr. Lublin and his highly experienced clinical team.”

“BrainStorm looks forward to partnering with and supporting Dr. Lublin and the dedicated clinical trial team at the Mount Sinai Hospital to quickly advance the phase 2 progressive MS clinical trial,” said BrainStorm Chief Operating Officer and Chief Medical Officer, Ralph Kern MD MHSc.

“We are happy to be a part of this exciting study to determine if neurally-directed stem cells can be a therapeutic approach to treating MS,” said Dr. Lublin.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. Dr. Lublin and several leading MS experts previously served as consultants to Brainstorm in the initial study conception and design. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statements

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com Media: Sean Leous Westwicke/ICR PR Phone: +1.646.677.1839 sean.leous@icrinc.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Cell Therapeutics Announces Publication of NurOwn® ALS Phase 2 Randomized Clinical Trial Data in Neurology

Wed, 20 Nov 2019 12:00:00 GMT

The objective of the randomized placebo-controlled Phase 2 clinical trial was to determine the safety and efficacy of a single transplantation of autologous bone-marrow derived MSC-NTF cells (NurOwn) in participants with ALS. The clinical trial enrolled 48 participants randomized 3:1 (treatment: placebo) at three leading U.S. investigative sites: Massachusetts General Hospital, Mayo Clinic and University of Massachusetts Medical School. After a three-month pre-transplant run-in period, participants received one dose of MSC-NTF cells (n=36) or placebo (n=12) and were followed for six-months. CSF was collected prior to and two-weeks post-transplantation. The clinical trial confirmed that a single transplantation of MSC-NTF (NurOwn) cells was safe and well-tolerated. BrainStorm’s NurOwn cell therapy is the furthest advanced autologous stem cell treatment in development for ALS. On October 11, the Company announced that the NurOwn, Phase 3 clinical trial for ALS was fully enrolled.

Key efficacy findings:

“The entire investigative team working on the study are highly encouraged by the promising clinical results,” said Phase 2 trial manuscript lead author Robert Brown DPhil, Leo P. and Theresa M. LaChance Chair in Medical Research and Chair of the Department of Neurology at the University of Massachusetts Medical School (UMMS) and UMass Memorial Medical Center, “In addition, we observed a clear biological effect of the treatment on CSF biomarkers to support its proposed mechanism of action in ALS.”

“This was a high quality Phase 2 study that identified dosing, safety, and an important efficacy signal. These data are exactly what is needed to move forward with the current Phase 3 testing,” added Dr. Merit Cudkowicz the Julieanne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital. “These promising results encourage us to complete the pivotal Phase 3 trial as rapidly as possible,” said Dr. Anthony Windebank, Judith and Jean Pape Adams Foundation Professor of Neuroscience at the Mayo Clinic.

“The team at BrainStorm and the clinical investigators, led by Professors Brown, Cudkowicz and Windebank, have made a significant contribution to ALS research and to the peer reviewed-scientific literature with the publication of this study in Neurology,” said Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm. He added, “We met our primary endpoint and demonstrated that a single dose of NurOwn was safe and well-tolerated while supporting NurOwn’s mechanism of action on neuroprotection and neuroinflammation pathways in ALS. We look forward to completing the current Phase 3 study to confirm the promising Phase 2 findings and expand our understanding of the potential of MSC-NTF cell therapy in ALS.”

“Having a major study peer-reviewed, accepted and published by the highly respected journal Neurology is a significant milestone for BrainStorm, and I thank the entire team for the many hours they have contributed to the research and publication process,” said Chaim Lebovits, President and CEO of BrainStorm. “Results from the study underscore the importance of conducting a larger Phase 3 clinical trial that will build upon the data collected in our Phase 2 study. Our Phase 3 study has recently reached full recruitment. All 200 ALS patients have been enrolled. We look forward to reporting our clinical results in the scientific literature and through corporate announcements.”

“We are pleased that the U.S. Phase 2 results of NurOwn are published, and that the Phase 3 trial enrollment is now complete,” said Dr. Neil Thakur, PhD, Executive Vice President for Mission Strategy at the ALS Association. The initial testing of NurOwn in ALS is promising. We stand ready to support rapid review by the FDA of BrainStorm’s biologics license application of NurOwn.”

Brian Wallach, Co-Founder of I AM ALS, said, “The publication of this important Phase 2 data is a significant milestone in the clinical development program for BrainStorm’s NurOwn. I AM ALS supports the development of potentially transformative therapies like NurOwn and shares in the hope that when the Phase 3 is completed that it will be the first disease modifying therapy for ALS.”

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statements

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

BRAINSTORM CONTACTS: Investors: Uri Yablonka, Chief Business Officer BrainStorm Cell Therapeutics Inc Phone: : +1-201-488-0460 Email: uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

Email: sean.leous@icrinc.com

BrainStorm Announces Financial Results for the Third Quarter of 2019 and Provides a Corporate Update

Thu, 14 Nov 2019 12:00:00 GMT

A webcast replay of the conference call will be available for 30 days on the “Investors & Media” page of BrainStorm’s website:

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) U.S. dollars in thousands (Except share data)

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands

(Except share data)

BrainStorm Cell Therapeutics Announces Research Grant Award From the National Multiple Sclerosis Society

Thu, 14 Nov 2019 12:00:00 GMT

Chaim Lebovits, President and CEO of BrainStorm stated, “We are very pleased to receive this generous grant from the National MS Society. Currently, we are conducting our Phase 2 study in three leading US medical centers: The Keck School of Medicine of USC, The Stanford School of Medicine, and Cleveland Clinic. This research funding will help advance our investigational therapy NurOwn as a potential unmet need for patients with progressive MS. MS continues to devastate the lives of patients and their families and we thank the National MS Society for helping us advance our innovative research program.”

“Currently, progressive MS treatment options are limited and NurOwn is a promising new autologous cellular treatment modality that has the potential to directly address MS disease pathways,” said Ralph Kern MD MHSc, COO and CMO of BrainStorm. He added, “This funding from the National MS Society will help us explore key neuroinflammation and neural repair biomarkers in progressive MS to confirm NurOwn’s unique mechanism of action and guide the design of future clinical trials to address this important unmet patient need.”

”Leveraging resources in this Phase 2 clinical study of a cell-based therapy for progressive MS exemplifies our work to accelerate research to improve clinical care for people living with MS.” said Mark Allegretta, PhD, Vice President of Research at the National MS Society. “We’re pleased to work with BrainStorm to test a broad panel of biomarkers of neuroinflammation and repair as correlates of the effect of treatment with NurOwn®”. About Multiple Sclerosis Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. There is currently no cure for MS. Symptoms vary from person to person and range from numbness and tingling, to mobility challenges, blindness and paralysis. An estimated 1 million people live with MS in the United States. Most people are diagnosed between the ages of 20 and 50 and it affects women three times more than men.

About The National Multiple Sclerosis Society: The National MS Society, founded in 1946, funds cutting-edge research, drives change through advocacy, and provides programs and services to help people affected by MS live their best lives. Connect to learn more and get involved: nationalMSsociety.org, Facebook, Twitter, Instagram, YouTube or 1-800-344-4867.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Announces Grant of a New Japanese Patent for NurOwn®

Wed, 13 Nov 2019 12:00:00 GMT

The patent covers cell populations which are therapeutic for the treatment of ALS and the method of qualifying the cells for therapeutic use.

Patents protecting NurOwn® have previously been issued in the United States, Japan, Europe, Hong Kong and Israel.

“We continue to protect our NurOwn technology through strategic intellectual property achievements and this ‘Notice of Decision to Grant’ from the Japan Patent Office is an important addition to our IP portfolio,” commented BrainStorm's President & CEO, Chaim Lebovits. He added, “Having a stem-cell product patented in Japan increases our ability to enter into new commercial partnerships for NurOwn in Japan.”

About NurOwn®

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statements

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Cell Therapeutics Announces Ralph Kern MD MHSc to Present at the 7th International Stem Cell Meeting

Tue, 12 Nov 2019 12:00:00 GMT

Ralph Kern, MD, MHSc, said: “I welcome the opportunity to participate in the 7th International Stem Cell Meeting where I will share the advances BrainStorm has made with NurOwn. It is a privilege to participate and to exchange ideas with many of the international scientific leaders in stem cell research.”

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Cell Therapeutics to Announce Third Quarter Financial Results and Provide a Comprehensive Corporate Update

Tue, 05 Nov 2019 12:00:00 GMT

BrainStorm’s President & CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, and Preetam Shah, PhD, Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com; Questions should be submitted by 5:00 p.m., Eastern Standard Time, Tuesday, November 12.

The investment community may participate in the conference call by dialing the following numbers:

A webcast replay of the conference call will be available for 30 days on the “Investors & Media” page of BrainStorm’s website:

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

NurOwn® Data Safety Monitoring Board Recommends ALS Phase 3 Clinical Trial Continue

Mon, 28 Oct 2019 12:00:00 GMT

“After reviewing all of the safety data as of September 30th, the DSMB has recommended the study continue without any changes in the protocol. We did not identify any significant safety concerns,” said Carlayne Jackson, MD, FAAN Professor of Neurology and Otolaryngology UT Health San Antonio, and the DSMB Chairperson.

"We are very pleased with the DSMB recommendation that the Phase 3 clinical trial continue without any protocol modification. This represents an important clinical trial advancement for BrainStorm and for the development of NurOwn as an innovative cellular therapy approach for ALS patients. Enrollment is now completed and top line data is expected in Q4 2020, which will be used to support an FDA Biologics License Application," said Ralph Kern MD, MHSc, BrainStorm Chief Operating Officer and Chief Medical Officer.

BrainStorm is conducting a repeat dose, randomized, placebo-controlled Phase 3 trial of NurOwn (200 ALS participants randomized 1:1 to NurOwn or placebo) at 6 major US clinical sites, supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The study is now fully enrolled and will generate top line data in Q4 2020.

About NurOwn®

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Cell Therapeutics to Present at the Dawson James Securities 5th Annual Small Cap Growth Conference

Fri, 25 Oct 2019 12:00:00 GMT

Preetam Shah, PhD, MBA, Chief Financial Officer is scheduled to present on Tuesday, October 29th at 3:40 p.m. Eastern Time, in Track 2 - Preserve Ballroom B, with one-on-one meetings to be held throughout the conference.

Chaim Lebovits, President and CEO of BrainStorm said, “We are pleased to have the opportunity to have Dr. Shah present at the Dawson James Small Cap Growth Conference. Dr. Shah, joined BrainStorm in September 2019, and we look forward to having him present the Company’s growth strategy and future to a wide audience of accreditied investors.”

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

Safe-Harbor Statements Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Cell Therapeutics’ President and CEO to be Featured as Keynote Speaker at Cell Series UK 2019

Thu, 24 Oct 2019 12:00:00 GMT

Ralph Kern MD, MHSc, Chief Operating and Chief Medical Officer of Brainstorm, who will also participate at Cell Series UK stated, “We are very pleased to have Chaim Lebovits presenting at this prestigious conference where global leaders in stem cell and regenerative medicine will have the opportunity to learn more about NurOwn® and the critical research being conducted by the Company. Mr. Lebovits’ Keynote Address, ‘Stem Cell Therapeutic Approaches For ALS’, will be presented to leading members of the scientific and business community including potential partners and investors.”

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Cell Therapeutics Presentations at Neuromuscular Drug Development Summit

Wed, 23 Oct 2019 12:00:00 GMT

BrainStorm’s team will be leading the following sessions:

Neuromuscular Drug Development Summit: 1. Workshop A Title: Effectively Using Neuromuscular Biomarkers in Clinical Trials Speaker: Susan Ward PhD, Head of Clinical Operations, Brainstorm Cell Therapeutics Inc. Date: Wednesday, 23 October 2019 Time: 0900-1200 2. Navigating Clinical Trial Design Complications for Neuromuscular Disorders Title: How to Create Exclusion Criteria & Characterize Patient Populations Whilst Maintaining Patient Enrolment Quantity Through Phases Speaker: Ralph Kern MD, MHSc, Chief Operating and Chief Medical Officer, Brainstorm Cell Therapeutics. Date: Thursday, 24 October 2019 Time: 1500-1530 3. FDA Approval – Is This Therapeutic Success? Panel Discussion: Assessment of Approval Considerations Speaker: Ralph Kern MD, MHSc, Chief Operating and Chief Medical Officer, Brainstorm Cell Therapeutics. Date: Friday, 25 October 2019 Time: 1515-1545

“Our participation at this important scientific congress confirms our long-standing commitment to to advance clinical trial design and biomarker development in ALS and to develop practical drug approval strategies for patients affected by ALS and other neuromuscular disorders,” said Ralph Kern MD, MHSc, Chief Operating and Chief Medical Officer, Brainstorm.

“Brainstorm’s dedicated clinical and scientific teams are focused on advancing our understanding of neurodegenerative disease and how our innovative cell therapies may bring much needed solutions to patients suffering from these conditions,” said Chaim Lebovits, Brainstorm President and CEO, “We are very privileged to collaborate with leading medical researchers and scientists to advance our mission to quickly advance innovative treatment options.”

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm’s NurOwn® Phase 3 ALS Clinical Trial Now Fully Enrolled

Fri, 11 Oct 2019 12:00:00 GMT

“The BrainStorm team is very excited to reach this important milestone in the development and potential commercialization of NurOwn in ALS. We have been fully dedicated to this journey since we began clinical trial enrollment in October 2017. To date, a significant percentage of the 200 enrolled patients have received three treatments and we expect that all trial participants will complete planned study visits and assessments by October 2020.” commented Chaim Lebovits, President and CEO of BrainStorm.

“Having reached this turning point in our Company’s history, I would like to publicly acknowledge the professionalism and commitment of the clinical investigators, but, most of all, I want to express my sincere gratitude to the many patients and their families, who by participating in this trial have confirmed their belief in the potential of NurOwn. The entire BrainStorm team is grateful for your contribution in advancing the development of NurOwn and our understanding of ALS.”

Maria Millan, MD, President and CEO of the California Institute for Regenerative Medicine (CIRM) said, “CIRM’s mission is to accelerate stem cell treatments to patients with unmet medical needs. ALS is a debilitating and fatal neurodegenerative condition for which there is no effective treatment. Based on BrainStorm Cell Therapeutics’ scientific and early phase clinical trial data, CIRM awarded them $15.9 million to advance their investigational therapy NurOwn into a Phase 3 trial. Our support helped bring this program to three leading California medical centers. We congratulate Brainstorm Cell Therapeutics in completing enrollment, an important milestone toward developing a much-needed treatment for ALS.”

Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm stated, “We are very pleased to have fully enrolled our Phase 3 randomized placebo-controlled clinical trial in ALS and look forward to reporting top-line results before the end of next year. This clinical milestone is a key inflection point in the development of NurOwn. We are deeply thankful to many who have made an important contribution to this effort and look forward to quickly completing all clinical and biomarker analyses in support of the filing of a biological license application with the goal of bringing an innovative and much needed treatment option to ALS patients.”

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Announces Notice of US Patent Allowance for NurOwn® Cellular Therapeutic Technology Platform

Mon, 07 Oct 2019 12:00:00 GMT

The allowed claims cover a pharmaceutical composition for MSC-NTF cells secreting neurotrophic factors (NurOwn®) comprising a culture medium as a carrier and an isolated population of differentiated bone marrow-derived MSCs that secrete neurotrophic factors.

Patent families protecting NurOwn® have previously issued in the United States, Japan, Europe, Hong-Kong and Israel.

"This allowance further expands the patent protection of the NurOwn® Cellular Therapeutic Technology Platform and enables us to accelerate clinical development for new neurodegenerative indications,” commented BrainStorm President and CEO, Chaim Lebovits.

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statements

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Cell Therapeutics to Present NurOwn® Phase 2 Biomarker Data at North East Amyotrophic Lateral Sclerosis (NEALS) 18th Annual Meeting

Wed, 02 Oct 2019 12:00:00 GMT

Chaim Lebovits, President and CEO of BrainStorm, said, “BrainStorm is pleased that Dr. Kern will be presenting our innovative CSF surrogate biomarker data at NEALS. On September 23rd, the FDA issued a new ALS therapy development guidance document emphasizing the importance of biomarkers for the advancement of ALS investigational therapies. We are pleased to have the opportunity to present our ongoing research to clinical leaders who are at the forefront of ALS investigation and scientific discovery.”

Meeting and Presentation Details:

About NurOwn® NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statements Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm’s need to raise additional capital, BrainStorm’s ability to continue as a going concern, regulatory approval of BrainStorm’s NurOwn® treatment candidate, the success of BrainStorm’s product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm’s NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm’s ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm’s ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Cell Therapeutics Announces Support for FDA Guidelines on ALS Drug Development

Fri, 27 Sep 2019 12:00:00 GMT

In addition, Brainstorm’s President & CEO Chaim Lebovits, COO & CMO Ralph Kern MD MHSc, and Mary Kay Turner, VP Government Affairs and Patient Advocacy, convened a roundtable discussion with ALS advocacy group leaders in Washington, DC, on September 25, 2019. Members of The US Congress and their Staff, including the Staff of the Co-Chairs of the ALS Caucus, attended to listen to the voice of the ALS Community. Members of the ALS Community included: ALS Association, ALS One, Compassionate Care ALS, NoMoreExcuses, ALS Therapy Development Institute, Paralyzed Veterans of America, IamALS, and Project ALS. The Roundtable was convened for the ALS Community to learn more about Brainstorm’s NurOwn® phase 3 clinical development program in ALS and to ensure the patient voice was an ongoing, integral part of the discussion.

Chaim Lebovits, President and CEO of BrainStorm stated, “The updated guidelines recognize the serious and life-threatening nature of ALS and enormous unmet need. We are encouraged that the FDA has updated the ALS guidance document and we commend the advocacy community for keeping the patient voice at the center of this dialogue.” Mr. Lebovits added, “The guidance document proposes regulatory flexibility, the importance of establishing clinical benefit based on functional endpoints, and practicable study size and duration. We believe that these new guidelines are essential in order to develop critically needed drugs for those suffering from ALS.”

Mary Kay Turner, Vice President of Government Affairs and Patient Advocacy of BrainStorm stated, “Now is such a hopeful time for the ALS Community - the Community is active, informed and engaged in powerful ways. The roundtable discussion was organized as a forum where representatives of the ALS Advocacy Community, Members of the US Congress and their Staff, and the BrainStorm team exchanged many meaningful ideas. Over the course of several hours, challenges and hopes were expressed, and the incredible ALS community shared their visions for a future where ALS is no more. Having Members of Congress and their Staff join the meeting underscores the ALS patient voice is being heard in a powerful and very meaningful way.”

About NurOwn® NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

Safe-Harbor Statements Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Strengthens Senior Executive Management Team with the Appointment of Preetam Shah, Ph.D., M.B.A., as Chief Financial Officer

Mon, 09 Sep 2019 12:00:00 GMT

Dr. Shah is an experienced healthcare finance professional with over 18 years of diverse leadership experience in investment banking and venture capital, healthcare financial consulting, business development, sales and marketing, and scientific research.

Prior to his appointment as BrainStorm’s CFO, Dr. Shah served as Director of Healthcare Investment Banking at Barclays Capital Plc., where he focused on Life Sciences and Medical Device sectors, and was actively involved in closing more than $3.5 billion in M&A and equity transactions, and over $20bn in debt financings for publicly traded companies. Prior to his role at Barclays, Dr. Shah served as Vice President of Healthcare Investment Banking at Canaccord Genuity Inc., from July 2013 to May 2016, where he played an integral role in executing ~$1.5 billion in M&A transactions and equity financings for small and mid-cap publicly traded companies in the Medical Device and Diagnostics sectors.

Dr. Shah founded and served as Managing Director of Saisarva LLC., a healthcare financial consulting firm from January 2010 to June 2013 where he completed various engagements for healthcare-focused private equity firms, hedge funds, and global pharmaceutical companies. In this capacity, Dr. Shah has negotiated several licensing deals with pharmaceutical companies. From October 2006 to December 2009, Dr. Shah served as Vice President, U.S. Operations and Investments at Reliance Capital USA Ventures LLC., an affiliate of Reliance ADA Group Companies, to head up the Company’s investment operations, sales and business development activities across the U.S.

Dr. Shah completed his post-doctoral fellowship in Infectious Diseases from Stanford University School of Medicine. He holds a Ph.D. in Microbiology from the University of Mississippi Medical Center and a M.B.A. in Finance from the Wharton School, University of Pennsylvania.

“I am very pleased to announce that Preetam Shah, Ph.D., M.B.A. has joined the Senior Management Team of BrainStorm at this transformative time for the Company,” commented Chaim Lebovits, President and CEO of BrainStorm Cell Therapeutics. He added, “After meeting with a wide range of candidates, we were more than impressed with Preetam’s unique background across finance, investment banking, and deal-making, his superior academic credentials and knowledge of the Life Sciences sector, and his experience working in the critical healthcare investment markets of San Francisco, Boston, and New York City, which will well serve BrainStorm’s expanding Investor Relations program that will be rolled out over the next few months. As we advance key company milestones such as completing enrollment of our ALS Phase 3 clinical trial and advance our Phase 2 Progressive MS trial, Preetam will make an important contribution to advance BrainStorm’s corporate and business agenda. Speaking for everyone at BrainStorm, we are delighted Preetam has agreed to serve as our Chief Financial Officer. Additionally, Dr. Shah will be based in the Company’s New York City headquarters to optimize his interactions with the investment community. With Dr. Shah in place, the Company continues to expand US senior management, while preclinical R&D will remain in Israel.”

Dr. Shah stated, “Being appointed as the Chief Financial Officer at BrainStorm is an exciting, game-changing, milestone in my career. During the extensive interview process, I learned a great deal about BrainStorm’s superior science and the potential to be the first-in-class autologous stem cell therapy for various neurogenerative diseases, the passion of every employee, and most of all, I witnessed the commitment of a small but very dedicated team who are working around the clock to fulfill the unmet medical needs for patients with devastating and heart-breaking neurodegenerative diseases. I look forward to working with Chaim and Ralph and others to bring the BrainStorm story to Wall Street, Silicon Valley, Boston, and anywhere else the Company’s story needs to be told. The Company has an incredible future, and I look forward to being an integral part of the BrainStorm team and story.”

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

Investors:

Michael Levitan

Solebury Trout

Phone: +1.646.378.2920

mlevitan@soleburytrout.com

BrainStorm Cell Therapeutics to Present Late Breaking News ePoster at the 35th ECTRIMS Congress

Fri, 06 Sep 2019 12:00:00 GMT

BrainStorm is conducting a Phase 2 open-label, US-based, multicenter study of repeated intrathecal administration of NurOwn® in participants with Progressive Multiple Sclerosis. The Phase 2 study will evaluate validated MS efficacy outcome measures as well as innovative and validated CSF and serum biomarkers. The efficacy outcome data presented at this ECTRIMS meeting provides a natural history cohort matched to the phase 2 patient population. The phase 2 MS study is actively enrolling participants and should be fully enrolled by early 2020.

Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm said, “We are very pleased to have the opportunity to participate at ECTRIMS, the largest annual International Congress devoted to basic and clinical research in Multiple Sclerosis (MS). The BrainStorm team looks forward to meeting with many of the leading scientists in MS and sharing our ideas with the many researchers who are dedicated to changing the lives of those with MS.”

Meeting and Presentation Details:

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

BrainStorm Announces Financial Results for the Second Quarter of 2019 and Provides a Corporate Update

Tue, 13 Aug 2019 12:00:00 GMT

Toll/International: 1-412-317-6671

Replay Pin Number: 13693394

Replay Start: Tuesday August 13, 2019, 11:00 AM ET Replay Expiry: Tuesday August 27, 2019, 11:59 PM ET

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) U.S. dollars in thousands (Except share data)

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Levitan

Solebury Trout

Phone: 646-378-2920

mlevitan@soleburytrout.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands

(Except share data)

BrainStorm Cell Therapeutics to Announce Second Quarter Financial Results and Provide a Comprehensive Corporate Update

Mon, 05 Aug 2019 12:00:00 GMT

BrainStorm’s President & CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, Chief Medical Officer, and Eyal Rubin, Chief Financial Officer.

Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com

Questions should be submitted by 5:00 p.m. Eastern Daylight Time, Monday, August 12.

The investment community may participate in the conference call by utilizing the conference ID: 13693394 and dialing the following numbers:

Toll Free: 1-877-423-9813 Toll/International: 1-201-689-8573

Those interested in listening to the conference call live via the internet may do so by visiting the “Investors & Media” page of Brainstorm’s website at brainstorm-cell.com/investors/ and clicking on the conference call link.

A webcast replay of the conference call will be available for 30 days on the “Investors & Media” page of Brainstorm’s website.

Toll Free: 1-844-512-2921 Toll/International: 1-412-317-6671 Replay Pin Number: 13693394 Replay Start:Tuesday, August 13, 2019, 11:00 AM ET Replay Expiry:Tuesday, August 27, 2019, 11:59 PM ET

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statements

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

BRAINSTORM CONTACTS: Media: Sean Leous Westwicke/ICR PR Phone: +1.646.677.1839 Email: sean.leous@icrinc.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investors:

Michael Levitan

Solebury Trout

Phone: +1.646.378.2920

Email: mlevitan@soleburytrout.com

Third Clinical Site Initiated for BrainStorm Cell Therapeutic’s Phase 2 Progressive MS Study

Tue, 02 Jul 2019 12:00:00 GMT

“The BrainStorm team is pleased to have the opportunity to advance our Phase 2 clinical study for progressive MS at the USC Keck School of Medicine,” said Chaim Lebovits, President and CEO of BrainStorm. “We look forward to collaborating with Dr. Pelletier, an internationally renowned leader in the field of Multiple Sclerosis research and his team. Our NurOwn® technology is an innovative investigational therapy currently being studied in Phase 3 for ALS and in Phase 2 for progressive MS patients.”

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statements

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

BRAINSTORM CONTACTS: Media: Sean Leous Westwicke/ICR PR Phone: +1.646.677.1839 Email: sean.leous@icrinc.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Investors:

Michael Levitan

Solebury Trout

Phone: +1.646.378.2920

Email:mlevitan@soleburytrout.com

BrainStorm Presents Poster at Consortium of Multiple Sclerosis Centers (CMSC) 33rd Annual Meeting

Fri, 31 May 2019 12:00:00 GMT

POSTER HIGHLIGHTS:

“Remembering that World MS Day is a global event that raises awareness of the invisible symptoms of MS, we shared the design of our Phase 2 clinical study during the Annual Meeting of the Consortium of Multiple Sclerosis Centers," said Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm. He added, "CMSC is the largest North American gathering for healthcare professionals and researchers engaged in MS care and we were pleased to share our investigational study design with leading members of the MS medical community.”

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statements

CONTACTS Media: Sean Leous Westwicke/ICR PR Phone: +1.646.677.1839 Email: sean.leous@icrinc.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

Email: sean.leous@icrinc.com

Investors:

Michael Levitan

Solebury Trout

+1.646.378.2920

mlevitan@soleburytrout.com

BrainStorm Announces Second Clinical Site to Enroll Patients in Its Progressive MS Phase 2 Study

Thu, 30 May 2019 12:00:00 GMT

“I am especially pleased, we are able to announce the BrainStorm medical team continues to advance our Phase 2 clinical study in progressive MS on the World MS Day, a day set aside to raise awareness of the invisible symptoms of MS,” said Chaim Lebovits, president and CEO of BrainStorm. “Conducting clinical studies at top-tier US medical institutions will ensure that our FDA-approved clinical studies meet the highest scientific standards. The addition of study participants at the Stanford University School of Medicine with those who have received dosing at other clinical sites, brings us one step closer to our objective of advancing NurOwn® as an investigational therapy to address unmet need in progressive MS.”

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statements

CONTACTS

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

Email: sean.leous@icrinc.com

Investors:

Michael Levitan

Solebury Trout

+1.646.378.2920

mlevitan@soleburytrout.com

BrainStorm Senior Management to Present at BIO 2019

Tue, 28 May 2019 12:00:00 GMT

President & CEO, Chaim Lebovits, will present a corporate overview of BrainStorm’s business trajectory, an update on the Company’s clinical trials and outline the Company’s overall investment proposition on Tuesday, June 4, 2019 at 1:45 PM EDT, in Theater 2. CMO and COO, Ralph Kern, MD, MHSc, will serve as an expert panelist during a Round Table sponsored by industry leader Informa Pharma Intelligence. The Round Table discussion will feature scientific and medical specialists, who will discuss the many challenges and issues facing the unmet medical needs of Rare Diseases. The Round Table will be held on June 4th at the Windsor Suites Hotel.

“BrainStorm has made significant progress on all fronts since BIO 2018. Management looks forward to participating in BIO 2019 and we will provide a comprehensive company update. We also anticipate a full schedule of meetings with investors, potential business partners and members of the media. With over 16,000 industry leaders projected to attend BIO 2019, we are excited to share our progress with such an extensive audience of industry peers,” said Chaim Lebovits, President & CEO of BrainStorm.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: +1 646.666.3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1 646.666.3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

Investors:

Michael Levitan

Solebury Trout

Phone: +1.646.378.2920

mlevitan@soleburytrout.com

BrainStorm Issues Statement (Italian Translation Included)

Tue, 28 May 2019 12:00:00 GMT

, -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, issues today the following statement: Recently, numerous organizations approached BrainStorm Cell Therapeutics informing manageme

BrainStorm CEO to Present at the World Advanced Therapy and Regenerative Medicine Congress in London

Mon, 13 May 2019 12:00:00 GMT

About the World Advanced Therapies & Regenerative Medicine Congress The 14th annual World Advanced Therapies & Regenerative Medicine Congress will bring together 1000+ attendees and explores the rapidly developing world of next generation therapeutics and advanced therapy medical products (ATMPs). From clinical development to pricing, reimbursement and market access this congress will bring the most exciting case studies and new data for immunotherapy, cell therapy, gene therapy, CARs and bioprocessing. Experts in every area will help companies tackle the process and regulatory hurdles of developing all new therapeutic formats all the way through manufacture and into the clinic. This year’s conference will take place May 15 – 17 at the Business Design Center, London.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Levitan

Solebury Trout

Phone: 646-378-2920

mlevitan@soleburytrout.com

Media:

Sean Leous

Westwicke Public Relations

Phone: 646-677-1839

sean.leous@icrinc.com

BrainStorm Announces Financial Results for the First Quarter of 2019 and Provides a Corporate Update

Fri, 10 May 2019 12:00:00 GMT

“We are actively enrolling participants in our Phase 3 trial of NurOwn® in ALS (Amyotrophic lateral sclerosis) and in our Phase 2 trial of NurOwn® in Progressive MS (Multiple Sclerosis) in several of the preeminent U.S. medical institutions,” commented Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics. He added, “We anticipate approximately 150 patients will be enrolled in our investigational trials for the treatment of ALS by the end of this month and we are working diligently to finalize enrollment of all 200 patients during the Third Quarter of 2019. We are also moving forward with several clinical centers of excellence that will oversee our investigational studies for the treatment of Progressive MS and we will update the community as sites formally contract with BrainStorm and begin patient enrollment. Finally, I am pleased, not only with the success of patient enrollments, I am excited to announce that the team at BrainStorm expanded the Company’s proprietary cellular technology platform to include NurOwn®-derived exosomes for potential development across a broad range of Central Nervous System (CNS) disorders. We have a team of highly respected scientists advancing our understanding of stem cells and how they may one day offer breakthrough treatments for numerous unmet medical needs.”

First Quarter 2019 and Recent Corporate Highlights:

Financial Results for the Three Months Ended March 31, 2019

For further details on BrainStorm’s financials, including financial results for the three months ended March 31, 2019, refer to form 10Q filed with the SEC.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com Investors: Michael Levitan Solebury Trout Phone: 646-378-2920 mlevitan@soleburytrout.com

The accompanying notes are an integral part of the consolidated financial statements.

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Levitan

Solebury Trout

Phone: 646-378-2920

mlevitan@soleburytrout.com

The accompanying notes are an integral part of the consolidated financial statements.

BrainStorm’s Cellular Technology Platform Expanded to Include Exosomes for Neurodegenerative Diseases

Tue, 30 Apr 2019 12:00:00 GMT

Exosomes are nano-sized (30–120 nm), cell-derived vesicles that exhibit remarkable stability and may provide enhanced cell-to-cell delivery of bio-active molecules across the blood brain barrier into difficult to reach regions of the brain. Exosomal cargo provides important regulatory functions for many cell processes, including immunomodulation and neuroprotection.

“BrainStorm is leveraging cutting edge science and technology to continually explore and advance breakthrough scientific solutions,” said Revital Aricha PhD, BrainStorm’s VP R&D. She added, “We are actively developing our proprietary exosome technology as an ideal nano-carrier to effectively deliver bio-active molecules to the brain in a non-invasive manner, and leverage their exceptional biological properties, simplified long-term storage and transport which may facilitate repeat dosing as a potential allogeneic product in chronic neurodegenerative disease.”

“BrainStorm is committed to the development of highly innovative therapies for devastating neurodegenerative diseases,” said Chaim Lebovits, BrainStorm’s CEO. “We believe that exosomes have significant therapeutic potential in neurodegenerative disease through their unique biological characteristics, customizable cargo, and intrinsic ability to target specific CNS pathways. We plan to provide periodic business updates as we advance our R&D pipeline efforts and identify the lead indication for clinical evaluation.” About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstorm-cell.com. Safe-Harbor Statement

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: +1 646.666.3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1 646.666.3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

Investors:

Michael Levitan

Solebury Trout

Phone: +1.646.378.2920

mlevitan@soleburytrout.com

Two BrainStorm Scientific Abstracts Accepted for Presentation at the 71st American Academy of Neurology Annual Meeting

Thu, 28 Mar 2019 12:00:00 GMT

“We are thrilled that the AAN has selected two Brainstorm Scientific Abstracts for presentation at the 71st Annual meeting,” stated, Chaim Lebovits, CEO of Brainstorm Cell Therapeutics. He added, “We are honored to share our commitment to ALS translational science to many of the most distinguished international leaders in patient-centered neurologic care. Having one of our abstracts selected for oral presentation, during the “Emerging Science Session” underscores our commitment to impactful medical research and to advancing ground-breaking investigational treatments for unmet needs in life-altering and often fatal, neurological diseases.”

“The scientific abstracts selected by the AAN for presentation provide a detailed molecular genetics characterization of neurotrophic factor production by NurOwn® and further correlate cerebrospinal fluid biomarkers with clinical improvement in the completed Phase 2 ALS study,” said Ralph Kern MD MHSc, Brainstorm Chief Operating Officer and Chief Medical Officer. He concluded, “These findings contribute to our overall understanding of the mechanism of action of NurOwn® and provide further evidence linking ALS clinical outcomes to highly relevant disease biomarkers.”

Presentation details are as follows: Title: MODULATION OF CSF CASPASE-3 IN MSC-NTF CELLS (NUROWN®) IN A PHASE 2 ALS STUDY: CORRELATIONS WITH CSF BIOMARKERS AND CLINICAL RESPONSE

Date: Tuesday, May 7, 2019

Time: 12:15 p.m.: Oral data blitz – Emerging Science Session and 12:20 p.m. – 12:45 p.m.: Poster Presentation.

Title: MOLECULAR CHARACTERIZATION OF VEGF SECRETION BY MSC-NTF CELLS (NUROWN®): THERAPEUTIC IMPLICATIONS IN ALS

Date: Thursday, May 9, 2019

Time: 11:30 a.m. – 6:30 p.m.: Poster Session P5.

About NurOwn® NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and plans to start enrollment in early 2019.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstormcell.com.

About Progressive Multiple Sclerosis MS is an inflammatory disorder in which infection-fighting white blood cells enter the nervous system and cause injury. MS is a demyelinating disorder because the myelin sheath that protects nerves is stripped off during inflammation. Progressive MS is defined by the gradual accumulation of neurological disability independent of relapses, typically with lack of or incomplete recovery. Therapies utilizing regenerative medicine and repair approaches may offer an innovative treatment option. Autologous MSC-NTF cells are bone-marrow derived mesenchymal stem cells (MSCs) propagated and differentiated in culture to secrete high levels of neurotrophic factors (MSC-NTF). In preclinical models, there is increasing recognition that NTFs delivered by autologous MSCs have the potential for immunomodulation, remyelination, and neuroprotection in progressive MS. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: +1 646.666.3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: +1 646.666.3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

Investors:

Michael Levitan

Solebury Trout

Phone:+1.646.378.2920

mlevitan@soleburytrout.com

BrainStorm Announces Grant of an additional New European Patent for NurOwn®

Tue, 26 Mar 2019 12:00:00 GMT

The allowed claims cover the isolated cells as well as their use in the manufacture of a medicament for treating a CNS disease or disorder, selected from the group consisting of: Parkinson's, multiple sclerosis, epilepsy, amyotrophic lateral sclerosis, stroke, autoimmune encephalomyelitis, diabetic neuropathy, glaucomatous neuropathy, Alzheimer's disease and Huntingdon's disease.

“We continue to protect our technology through strategic intellectual property achievements and this Grant from the European Patent Office is another welcome addition to our IP portfolio,” commented BrainStorm's CEO, Chaim Lebovits. He added, “Having a EU patented product should increase our ability to enter into new commercial partnerships for NurOwn® in Europe”.

BrainStorm’s senior management team is currently in Europe attending the 13th Annual International Partnering Conference, BIO EUROPE SPRING® (#BIOEuropeSpring), Vienna, March 25-28, where we are also exploring potential partnering opportunities.”

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at www.brainstormcell.com.

Safe-Harbor Statement

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

sean.leous@icrinc.com

Investors:

Michael Levitan

Solebury Trout

Phone:+1.646.378.2920

mlevitan@soleburytrout.com

BrainStorm Announces First Patient Enrolled in Phase 2 Clinical Trial of Progressive MS

Thu, 14 Mar 2019 12:00:00 GMT

Chaim Lebovits, president and CEO of BrainStorm stated, “Midway through MS Awareness Week: March 10-16, we are pleased to announce the first participant with progressive MS has been enrolled in our Phase 2 clinical trial. Progressive MS has deeply affected the lives of many and dramatically impacted family members, caregivers and others. Today, there is no U.S. FDA approved therapy addressing more than one progressive form of MS and we are pleased to deploy our NurOwn® technology platform in this new indication. Soon, we will announce additional sites where the clinical trials will be conducted.”

“The first participant enrolled in our Phase 2 trial represents an important milestone in our commitment to address the unmet medical need in progressive MS,” said Ralph Kern, MD MHSc, Chief Operating and Chief Medical Officer of Brainstorm. “We plan to quickly initiate enrollment across all study sites and look toward top line data by the middle of 2020.”

MS is a chronic neuroinflammatory and neurodegenerative disorder that affects the brain and spinal cord. MS affects approximately 1 million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of affected individuals will eventually develop a progressive form of the disease, which may lead to increased levels of motor, visual, and cognitive functional impairment and disability.

For more information, refer to www.clinicaltrials.gov, using the NCT identifier (NCT03799718).

About NurOwn® Technology Platform

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

About Progressive Multiple Sclerosis

MS is an inflammatory disorder in which infection-fighting white blood cells enter the nervous system and cause injury. MS is a demyelinating disorder because the myelin sheath that protects nerves is stripped off during inflammation. Progressive MS is defined by the gradual accumulation of neurological disability independent of relapses, typically with lack of or incomplete recovery. Therapies utilizing regenerative medicine and repair approaches may offer an innovative treatment option. Autologous MSC-NTF cells are bone-marrow derived mesenchymal stem cells (MSCs) propagated and differentiated in culture to secrete high levels of neurotrophic factors (MSC-NTF). In preclinical models, there is increasing recognition that NTFs delivered by autologous MSCs have the potential for immunomodulation, remyelination, and neuroprotection in progressive MS. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

CONTACTS Media: Sean Leous Westwicke/ICR PR Phone: +1.646.677.1839 Email: sean.leous@icrinc.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

Email: sean.leous@icrinc.com

Investors:

Michael Levitan

Solebury Trout

+1.646.378.2920

mlevitan@soleburytrout.com

BrainStorm to Host Business Update Conference Call

Thu, 07 Mar 2019 12:00:00 GMT

Tuesday, March 12, 2018 @ 8:30am Eastern Daylight Time

US Toll Free: 1-877-423-9813

Toll/International: 1-201-689-8573

Israel Toll Free: 1-809-406-247

Webcast Audio Link: https://goo.gl/tG7DYn

Replay Dial-In Numbers US Toll Free: 1-844-512-2921 Toll/International: 1-412-317-6671 Replay Pin Number: 13688535 Replay Expiry: Tuesday, March 26, 2019, 11:59 PM

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

CONTACTS Media: Sean Leous Westwicke/ICR PR Phone: +1.646.677.1839 Email: sean.leous@icrinc.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

Email: sean.leous@icrinc.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Announces First Contracted U.S. Clinical Site for Phase 2 Progressive MS Study

Fri, 22 Feb 2019 12:00:00 GMT

MS is a chronic neuroinflammatory and neurodegenerative disorder that affects the brain and spinal cord. MS affects approximately 1 million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of affected individuals will eventually develop a progressive disease, which may lead to increasing levels of motor, visual, and cognitive functional impairment and disability.

“We are very excited to announce The Mellen Center for MS Treatment and Research at Cleveland Clinic as the first contracted U.S. clinical site for this very important Phase 2 progressive MS study that we plan to initiate in early 2019,” said Chaim Lebovits, president and CEO of BrainStorm. “This is a crucial step forward toward rapidly enrolling a Phase 2 study to evaluate this innovative autologous cell therapy approach using our NurOwn® technology platform in progressive MS patients.”

“Progressive MS treatment options are limited and do not directly address unmet need”, said Ralph Kern MD MHSc, COO and CMO of BrainStorm, “This phase 2 clinical trial is an important part of our commitment to bring a new treatment modality and hope to MS patients”.

Cleveland Clinic is currently ranked as the No. 2 hospital in the country, according to U.S. News & World Report (2017-2018). The Mellen Center for Multiple Sclerosis Treatment and Research at Cleveland Clinic is one of the largest and most comprehensive programs for MS care and clinical research worldwide, managing over 8,000 patients and over 21,000 total visits annually.

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and plans to start enrollment in early 2019.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

CONTACTS Media: Sean Leous Westwicke/ICR PR Phone: +1.646.677.1839 Email: sean.leous@icrinc.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Sean Leous

Westwicke/ICR PR

Phone: +1.646.677.1839

Email: sean.leous@icrinc.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm to Present at 2019 Sachs Associates European Life Sciences CEO Forum in Zurich, Switzerland

Thu, 21 Feb 2019 12:00:00 GMT

The 2019 Sachs Associates European Life Sciences CEO Forum features innovative bio-pharma companies in established and emerging global markets. The 12th annual CEO forum will address key challenges and bring together innovative companies developing transformative medicines uniquely positioned for growth in 2019 with a specialized emphasis on investments, partnering and alliance management.

Investor Meetings BrainStorm senior management will be hosting institutional investor meetings at the 2019 European Life Sciences CEO Forum. Please use the Investor contact information provided below to schedule a meeting.

About NurOwn® Technology Platform NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial (NCT03280056) of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial (NCT03799718) in progressive Multiple Sclerosis (MS) and plans to start enrollment in early 2019.

About BrainStorm Cell Therapeutics, Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Fast Track and Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

CONTACTS

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Michael Levitan

Solebury Trout

Phone: +1.917.626.8717

Email: MLevitan@troutgroup.com

BrainStorm Issues a Statement to Patients and Shareholders

Tue, 19 Feb 2019 12:00:00 GMT

We will begin by thanking the participants and their families for participating in BCT-002. BrainStorm wishes to express its sincere gratitude to all of you. Enrolling in the trial is a brave and selfless act. You're making a difference by offering a ray of hope for all people living with ALS. Without you, we could not advance the clinical development of the investigational therapy NurOwn®. You are all heroes.

The BCT-002 double-blind placebo-controlled phase 3 trial evaluating the efficacy and safety of repeated doses of the investigational therapy NurOwn® is actively recruiting eligible participants at all 6 U.S. sites. Since the trial is double-blinded, Brainstorm, the participants and the study researchers do not know who is receiving NurOwn treatment or placebo. Therefore, in order to protect the integrity of the trial and the clinical development program for the investigational therapy NurOwn®, we cannot comment on any of the social media postings by patients or the email requests we are receiving.

Please note that based on the broad experience in ALS clinical trials, one can expect that some study participants may not respond to therapy and at the same time transient improvements can be observed in some participants after receiving placebo. Therefore, individual reports of improvement or lack of improvement should be cautiously interpreted.

Brainstorm stays fully committed to advance our pivotal phase 3 ALS trial towards a BLA submission. We strongly believe that currently this is the best and most credible pathway to demonstrate that NurOwn® may be a safe and an effective treatment option for ALS patients. If the outcome of the trial is successful, we hope to be able to bring a much-needed solution to ALS patients as quickly as possible.

As stated publicly in June 2018, we have faithfully followed through on our commitment to Matt Bellina to provide treatment through the Right to Try pathway free of charge. We confirm that the treatment has been initiated, and since NurOwn® is still an “investigational therapy” we refrain from any further comment.

In conclusion, BrainStorm remains dedicated to rapidly advancing our pivotal phase 3 ALS trial and we appreciate the support and encouragement of the ALS community.

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statements

CONTACTS

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm to Present at 2019 BIO CEO & Investor Conference and Extracellular Vesicles in Diagnostics & Therapeutics Symposium

Mon, 04 Feb 2019 12:00:00 GMT

Ralph Kern MD, MHSc, Chief Operating Officer and Chief Medical Officer will present a poster at the Extracellular Vesicles in Diagnostics & Therapeutics Symposium on February 19, 2019 in New York City. Presented by The New York Academy of Sciences (NYAS), The Extracellular Vesicles in Diagnostics & Therapeutics Symposium will review the most recent advances in Research & Development and the increasing impact of EVs on Diagnostics and Drug Development for Cancer, Neurodegenerative Disease and Cardiovascular Disease.

Investor Meetings BrainStorm senior management will be hosting institutional investor meetings at the 2019 BIO CEO & Investor Conference. Please use the Investor contact information provided below to schedule a meeting.

About BrainStorm Cell Therapeutics, Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

CONTACTS

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Cell Therapeutics to Present at the 2019 NobleCon15 Annual Investor Conference in Fort Lauderdale, Florida

Fri, 25 Jan 2019 12:00:00 GMT

NobleCon15 is being held on Monday and Tuesday, January 28-29, 2019 at the W Hotel in Fort Lauderdale, Florida. Webcast will be available on Tuesday, January 29, 2019 on BrainStorm's website www.brainstorm-cell.com, NobleCon15 website www.nobleconference.com, and Channelchek portal www.channelchek.com. Webcast will be archived for 90 days.

Meetings

BrainStorm senior management will also be hosting institutional investor meetings at the 2019 NobleCon15 Conference. Please use the Investor contact information provided below to schedule a meeting.

About NurOwn® NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis (MS) and plans to start enrollment in early 2019.

About BrainStorm Cell Therapeutics, Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

About Noble Capital Markets, Inc. Noble Capital Markets is an equity-research driven, full-service, investment & merchant banking boutique focused on emerging growth companies. In addition to NobleCon, Noble hosts numerous “non-deal” corporate road shows across the United States and Canada. In late 2018, Noble launched Channelchek.com which features advanced market data, institutional-quality research, balanced news, videos and podcasts covering more than 6,000 emerging growth companies. Members: FINRA, SIPC, MSRB. www.noblecapitalmarkets.com.

CONTACTS

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Granted Additional Patent for NurOwn® in Israel

Tue, 22 Jan 2019 12:00:00 GMT

“Our intellectual property estate for NurOwn® technology platform continues to grow substantially as evidenced by this new patent granted by the Israel Patent Office which is a welcome addition to our IP portfolio. This patent covers NurOwn (MSC-NTF cells) and its manufacturing process developed by Brainstorm's scientists as well as the use of NurOwn for the treatment of neurodegenerative diseases, an acute unmet need” commented BrainStorm's CEO Chaim Lebovits. “Having an Israel patented product and manufacturing process will increase our ability to treat patients in desperate need of options for these debilitating diseases in Israel. We expect that additional patents owned or licensed exclusively by BrainStorm will be awarded this year and in future years, thereby broadening the utility of NurOwn in global markets across the world."

About NurOwn®

NurOwn® (autologous MSC-NTF) cells are an innovative cellular technology platform that targets disease pathways known to be important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated under patented and scalable manufacturing processes that induce the cells to secrete high levels of neurotrophic factors and immunomodulatory cytokines. Autologous MSC-NTF cells can effectively deliver these factors directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is actively enrolling a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS) (NCT03280056). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis (MS) and plans to start enrollment in early 2019 (NCT03799718).

About BrainStorm Cell Therapeutics, Inc.

Safe-Harbor Statements

CONTACTS

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm to Present NurOwn® Phase 3 Study Update at the 9th Annual California ALS Research Summit in Irvine, CA

Fri, 11 Jan 2019 12:00:00 GMT

The California ALS Research Summit is an annual meeting of researchers, investigators, clinicians, biotech companies, government representatives, partner organizations, and advocates in ALS and related fields in California.

9th Annual California ALS Research Summit Details:

Date: Friday, January 11, 2019

Time: 2:00-2:30pm Pacific Time

Location: Arnold and Mabel Beckman Center of the National Academy of Sciences

Agenda: https://sites.google.com/a/alsagoldenwest.org/california-als-research-summit/schedule

About NurOwn®

NurOwn® (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis (MS) and plans to start enrollment in early 2019.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

CONTACTS Media: Joseph Petroziello BrainStorm Cell Therapeutics Phone: +1.215.485.6797 Email: JP@brainstorm-cell.com

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Cell Therapeutics to Present at the 2019 Biotech Showcase and Sachs Associates Neuroscience Innovation Forum at JPM Week

Thu, 03 Jan 2019 12:00:00 GMT

Ralph Kern M.D., MHSc, Brainstorm Chief Operating Officer and Chief Medical Officer will also participate in a panel discussion at the Sachs Associates 2nd Annual Neuroscience Innovation Forum, taking place on Sunday, January 6, 2019, at the Marines’ Memorial Club in San Francisco.

Meetings

BrainStorm senior management will also be hosting institutional investor and partnering meetings at the 2019 Biotech Showcase conference (https://goo.gl/SGFm62). Please use the Investor contact information provided below to schedule a meeting.

About NurOwn®

NurOwn® (MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a pivotal Phase 3 clinical trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has also recently received U.S. FDA acceptance to initiate a Phase 2 trial in progressive Multiple Sclerosis (MS) and plans to start enrollment in early 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statements

CONTACTS

Source: BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Issues 2018 Letter to Shareholders

Thu, 27 Dec 2018 12:00:00 GMT

Dear Valued Shareholder,

This past year was an extraordinary success for BrainStorm Cell Therapeutics from a research and development, clinical, financial and corporate perspective. I appreciate the many accomplishments of our employees and the dedicated support we have received from investors, as we execute on our goal of bringing critical treatments to those suffering from neurodegenerative diseases.

I want to acknowledge the efforts of the six key centers enrolling patients in the Company’s NurOwn® Phase 3 clinical trial for the treatment of amyotrophic lateral sclerosis (ALS): Mass General Hospital, UMass, Mayo Clinic, CPMC, Cedars Sinai and UC Irvine, and to the ALS patients and their families for helping us advance the pivotal study. We are targeting to enroll 200 ALS patients in this trial, and we remain on track to achieve this key milestone by mid-2019.

In August 2018, the Data and Safety Monitoring Board (DSMB) completed the first planned interim safety analysis for the ALS Phase 3 study and concluded that there were no safety concerns and the study should continue as planned. Dr. Carlayne Jackson, M.D., who is the chair of the DSMB reviewing NurOwn commented, “We appreciate the continued commitment of BrainStorm Cell Therapeutics for conducting this trial in such an exemplary manner.” The DSMB will conduct an additional planned interim safety analysis by July 2019, for which we will report the outcome when it becomes available.

On the research and development front, the U.S. Food and Drug Administration recently approved the Company’s NurOwn investigational new drug application for a Phase 2 study in progressive Multiple Sclerosis (MS). We plan to initiate a study in this patient population in the first quarter of 2019 and will provide additional details regarding the trial design and participating centers. Expanding our clinical trial program into progressive MS is an important achievement in establishing NurOwn as a platform technology, and furthermore, we are conducting pre-clinical research in other neurodegenerative diseases, and plan to announce additional potential indications in 2019.

This year we also expanded our NurOwn manufacturing capabilities by transferring operations to the Dana Farber Cancer Institution, in addition to the on-going production at the City of Hope for Biomedicine and Genetics.

In 2018, we focused on strengthening our financial position; we received $12.3 million from warrant activation and additional milestone payments as part of the previously awarded $16 million non-dilutive grant from the California Institute for Regenerative Medicine. In addition, for the 11th consecutive year, we received non-dilutive grants from the Israel Innovation Authority to further support the development of NurOwn®, including a research and development grant of $1 million. BrainStorm is entering 2019 in a position of financial strength, which will enable us to remain laser focused on executing our clinical trials and operational initiatives.

We expanded our patent portfolio by obtaining additional United States, European and Japanese patents for BrainStorm's NurOwn® technology for the treatment of ALS and Parkinson's disease. These additional patents further protect our technology, and are the result of our ongoing technology development and clinical progress.

Lastly, we strengthened our executive team and board of directors. We added three senior members to our executive team: Arturo Araya as Chief Commercial Officer, Susan Ward as Head of Clinical Operations, and Joseph Petroziello as Vice President, Scientific & Corporate Communications. These individuals were sought after for their deep neuroscience experience, significant industry expertise and long track record of industry achievements. Our Board of Directors was strengthened with the appointment of Anthony Polverino, Ph.D., Executive Vice President of Early Development & Chief Scientific Officer at Zymeworks Inc. and formerly interim Chief Scientific Officer of Kite Pharma. Dr. Polverino is a highly accomplished senior biopharmaceutical executive with more than 25 years’ industry experience in drug research and development.

Looking ahead to 2019, we remain focused on completing enrolment in the ALS phase 3 study and initiating the progressive MS phase 2 studies are our highest priorities. We will continue to lead the development of cellular therapeutics in neurodegenerative disease, seek additional opportunities to expand our pipeline to address unmet need and continue to enhance our manufacturing capabilities and infrastructure.

I want to personally thank you for your continued support.

Sincerely, Chaim Lebovits, CEO

CONTACTS

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Expands Manufacturing of NurOwn® for Phase 2 Progressive MS Trial

Wed, 26 Dec 2018 12:00:00 GMT

MS affects approximately 1 million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of affected individuals will eventually develop a progressive disease, which may lead to increasing levels of motor, visual, and cognitive functional impairment and disability.

“We are excited to rapidly advance our investigational stem cell therapy for progressive MS patients and sincerely thank the Connell and O'Reilly Families Cell Manipulation Core Team for allocating resources and dedicated manufacturing space to allow us to initiate our Phase 2 progressive MS study in early 2019,” said Chaim Lebovits, president and CEO of BrainStorm.

BrainStorm expanded the existing manufacturing contract with the Connell and O'Reilly Families Cell Manipulation Core Facility (CMCF) at Dana-Farber Cancer Institute (Dana-Farber), to also produce NurOwn® for the new Phase 2 progressive MS trial in addition to supporting ongoing production for the Phase 3 pivotal ALS trial.

The CMCF Team at Dana-Farber is collaborating with clinical researchers in advancing novel cell-based therapies in trials for cancer and other diseases (like ALS and progressive MS) to evaluate the potential of adoptive cell therapy (for investigational cell product candidates like CAR-T cells and NurOwn®).

“Cellular therapies represent an exciting new therapeutic modality that can potentially benefit patients who do not have other effective treatment options. We are very glad to support BrainStorm’s plan to evaluate the potential role of NurOwn® in the treatment of other debilitating neurologic diseases such as progressive Multiple Sclerosis,” said Jerome Ritz, MD, Executive Director of the Connell and O’Reilly Families Cell Manipulation Core Facility at Dana-Farber.

About NurOwn®

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

CONTACTS

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Cell Therapeutics Inc.

FDA Accepts BrainStorm’s NurOwn® IND Application for Progressive Multiple Sclerosis

Mon, 17 Dec 2018 12:00:00 GMT

There are currently no FDA approved autologous cellular therapies addressing MS or other neurological diseases. While treatment options for patients with MS exist, there remains a significant unmet need in progressive MS. There is currently no FDA approved therapy that addresses more than one progressive form of MS.

“This is an extremely exciting moment as we expand BrainStorm’s pipeline by introducing a new indication for NurOwn® in neurodegenerative disease,” said Chaim Lebovits, president and CEO of BrainStorm. “Through this trial, we are advancing a novel treatment modality into clinical-stage testing for progressive MS in early 2019.”

MS affects approximately 1 million individuals in the U.S. and 2.5 million individuals worldwide. Approximately half of affected individuals will eventually develop progressive disease, which may lead to increasing levels of motor, visual, and cognitive functional impairment and disability.

“We are excited about the launch of early testing of this cell-based approach to treating progressive MS, for which there are few treatment options,” commented Bruce Bebo, Ph.D., Executive Vice President of Research at the National MS Society. “We look forward to better understanding the potential benefits and safety of this and other cell-based therapies for MS.”

“We are excited to participate in this Phase 2 clinical trial and hope that this innovative cell therapy approach leads to a new treatment option for patients with progressive MS,” said Dr. Fred Lublin, Director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center and Saunders Family Professor of Neurology at Mount Sinai School of Medicine in New York. “We are particularly pleased to see a scientifically rigorous approach to advance the science of stem cell therapeutics.”

About NurOwn® NurOwn® (MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm is currently conducting a pivotal Phase 3 clinical trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS).

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

CONTACTS

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics to Present at the 29th International Symposium on ALS/MND

Tue, 04 Dec 2018 12:00:00 GMT

Dr. Namita Goyal, Associate Clinical Professor and Director of the ALS Clinic for the Department of Neurology at UCI Health will present a poster titled, “A Systematic Review of Enrichment Strategies for Current Clinical Trials in ALS,” on December 7 from 6:00 – 7:00pm GMT during the Clinical Trials and Clinical Designs session. An abstract of the poster is available here.

“Regulatory guidance for interventional ALS trials encourages responder enrichment, however many current trials are designed with no or limited enrichment criteria,” commented Dr. Goyal. “The results of our comprehensive trial review suggest that additional efforts are needed to more fully integrate the concepts of disease heterogeneity and responder enrichment when designing interventional trials of ALS.”

“Brainstorm is committed to advancing the science of ALS clinical trial design and to ensure the highest quality data in the ongoing phase 3 ALS study,” said Ralph Kern M.D., MHSc, Brainstorm Chief Operating Officer and Chief Medical Officer. “We are proud to collaborate with Dr. Goyal and the study investigators in this important analysis of ALS clinical trial enrichment strategies.”

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm is currently enrolling a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at www.brainstorm-cell.com.

Safe-Harbor Statements

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Announces Submission of IND for NurOwn® in Progressive Multiple Sclerosis

Mon, 19 Nov 2018 12:00:00 GMT

"This important step toward the development of NurOwn® in progressive MS confirms our commitment to bring to the market innovative cellular therapies for neurodegenerative disease,” said Chaim Lebovits, president and CEO of BrainStorm. “This builds upon the important progress made in advancing NurOwn® in the ongoing pivotal study in ALS.”

“We plan to quickly initiate the Phase 2 clinical study of NurOwn® in progressive MS to address the significant unmet need for MS patients,” said Ralph Kern, M.D., MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm. “We believe the demonstrated safety and efficacy experience of NurOwn® in our ALS clinical program and the development of neurotrophic factors and other efficacy biomarkers will allow us to confidently expand our cellular therapy pipeline.”

MS affects approximately 1 million individuals in the U.S. and 2.3 million individuals worldwide. Approximately half of affected individuals will eventually develop progressive disease, which may lead to increasing levels of motor, visual, and cognitive functional impairment and disability.

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statements

CONTACTS

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics to Present at November Clinical and Investor Conferences

Wed, 07 Nov 2018 12:00:00 GMT

Clinical Conferences

Neuroscience 2018 Conference, San Diego, CA

More Information: Abstract of the poster is available here.

Investor Conferences

Inv€$tival Showcase, London, England- Chaim Lebovits, President & CEO will provide a corporate update presentation during the Jeffries-partnered Biotech & Money Inv€$tival Showcase.

About BrainStorm Cell Therapeutics Inc.

Safe-Harbor Statements

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Joseph Petroziello

BrainStorm Cell Therapeutics

Phone: +1.215.485.6797

Email: JP@brainstorm-cell.com

Investors:

Marcy Beth Nanus

Solebury Trout

Phone: +1.646.378.2927

Email: MNanus@troutgroup.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Announces Financial Results for the Third Quarter of 2018 and Provides a Corporate Update

Mon, 29 Oct 2018 12:00:00 GMT

“We continue to enroll participants in our Phase 3 trial of NurOwn® in ALS, and were delighted by the successful interim safety analysis conducted by the Data Safety Monitoring Board (DSMB),” commented Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics. “Moving forward, we are completely focused on taking the steps necessary to cross the finish line towards a potential U.S. FDA approval for NurOwn® in ALS, and we expect successful completion of enrollment in the ongoing pivotal trial in the first half of 2019. Our goal is to bring this potentially life-changing innovative cellular therapy to patients with ALS, who are in desperate need of new treatment options.”

“Our NurOwn® cellular technology platform has the potential to address the unmet need in other serious neurodegenerative diseases and we are excited to report that following a successful FDA Pre-IND Meeting we are now on track to file an IND in a second clinical indication,” added Mr. Lebovits.

Recent Corporate Highlights:

Financial Results for the Three Months Ended September 30, 2018

For further details on Brainstorm’s financials, including financial results for the nine months ended September 30, 2018, refer to form 10Q filed with the SEC.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading cellular therapy biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform through an exclusive, worldwide licensing agreement. NurOwn® has received Fast Track designation from the U.S. Food and Drug Administration (U.S. FDA) in ALS and has additionally been granted Orphan Status by the U.S. FDA and the European Medicines Agency (EMA). For more information, visit BrainStorm's website at www.brainstorm-cell.com.

About NurOwn® Phase 3 Clinical Program in ALS BrainStorm is currently enrolling a Phase 3 pivotal trial investigating repeat-administration of NurOwn® in ALS at six clinical sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The study will enroll 200 ALS patients, randomized 1:1 to receive NurOwn® or placebo, and will evaluate the ALS functional rating scale (ALSFRS-R) responder analysis as a primary efficacy outcome measure (NCT03280056). On August 23, 2018, BrainStorm announced a successful pre-specified interim safety analyses by an independent Data Safety Monitoring Board (DSMB). The completion of Phase 3 enrollment is anticipated in first half of 2019 and is expected to support a BLA filing for FDA approval of NurOwn® in ALS.

About U.S. Sites for NurOwn® Phase 3 Trial in ALS

Safe-Harbor Statement Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics Inc.

BrainStorm to Announce Third Quarter Financial Results and Provide Corporate Update on Monday, October 29

Wed, 17 Oct 2018 12:00:00 GMT

The Company has developed the NurOwn® technology into a commercially viable product. NurOwn® has been already administered to over 70 patients with ALS in clinical trials conducted in the United States and in Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U.S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. The Company is currently conducting a Phase 3 double blind, placebo-controlled clinical trial at multiple clinical sites throughout the US. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Media: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: (646) 666-3188 uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Poster Receives Clinical Abstract Award at NEALS Conference

Thu, 04 Oct 2018 12:00:00 GMT

The NEALS Consortium is an organization focused on translating scientific advances into novel treatment options for patients with high unmet need in ALS and Motor Neuron Disease (MND). Ralph Kern M.D., MHSc, COO & CMO, said “BrainStorm is honored to participate at this year’s NEALS conference and to have our ALS translation research recognized. Receiving this prestigious award acknowledges the potential significance of our early translational insights in support of NurOwn® as a best-in-class autologous cellular therapeutic approach to treat ALS.”

NEALS Clinical Poster #23, entitled “MicroRNA Changes in the NurOwn® Phase 2 ALS Randomized Clinical Trial: Relationship to Neuroprotection and Innate Immunity.”

About NurOwn® Phase 3 Clinical Program in ALS BrainStorm is currently enrolling a Phase 3 pivotal trial investigating repeat-administration of NurOwn® in ALS at six clinical sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The study will enroll 200 ALS patients, randomized 1:1 to receive NurOwn® or placebo, and will evaluate the ALS functional rating scale (ALSFRS-R) responder analysis as a primary efficacy outcome measure (NCT03280056). On August 23, 2018, BrainStorm announced a successful pre-specified interim safety analyses by an independent Data Safety Monitoring Board (DSMB). The completion of Phase 3 enrollment is anticipated in 1H2019 and is expected to support a BLA filing for FDA approval of NurOwn® in ALS.

About U.S. Sites for NurOwn® Phase 3 Trial in ALS

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Highlights Translational Data and Presentations Supporting NUROWN® Technology Platform as a Best-In-Class Strategy in ALS

Wed, 03 Oct 2018 12:00:00 GMT

Chaim Lebovits, President & Chief Executive Officer, will also be attending the MidCap Investor Event® sponsored by CF&B Communication in Europe on October 8-9, 2018 in Paris, France, and will be available for one-on-one meetings with potential institutional investors. To schedule a meeting, please use the Contact link on BrainStorm's website at www.brainstorm-cell.com.

NEALS Annual 2018 Conference Poster entitled, “MicroRNA Changes in the NurOwn® Phase 2 ALS Randomized Clinical Trial: Relationship to Neuroprotection and Innate Immunity.”

Cell & Gene Meeting on the Mesa 2018 Conference Scientific Workshop entitled, “Successful Strategies in the Design and Delivery of Cell & Gene Therapy Clinical Programs.”

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading cellular therapy biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform through an exclusive, worldwide licensing agreement. NurOwn® has received Fast Track designation from the U.S. Food and Drug Administration (U.S. FDA) in ALS and has additionally been granted Orphan Status by the U.S. FDA and the European Medicines Agency (EMA). For more information, visit BrainStorm's website at www.brainstorm-cell.com.

About NurOwn® Phase 3 Clinical Program in ALS BrainStorm is currently enrolling a Phase 3 pivotal trial investigating repeat-administration of NurOwn® in ALS at six clinical sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The study will enroll 200 ALS patients, randomized 1:1 to receive NurOwn® or placebo, and will evaluate the ALS functional rating scale (ALSFRS-R) responder analysis as a primary efficacy outcome measure (NCT03280056). On August 23, 2018, BrainStorm announced a successful pre-specified interim safety analyses by an independent Data Safety Monitoring Board (DSMB). The completion of Phase 3 enrollment is anticipated in 1H2019 and is expected to support a BLA filing for FDA approval of NurOwn® in ALS.

About U.S. Sites for NurOwn® Phase 3 Trial in ALS

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Granted New U.S. Patent for Industrial Scale Manufacturing of NurOwn®

Thu, 13 Sep 2018 12:00:00 GMT

“We continue to protect our technology through strategic intellectual property achievements and this patent Grant from the United States Patent Office is a welcome addition to our IP portfolio. This patent covers the industrial manufacturing process for NurOwn® developed by Brainstorm's scientists,” commented BrainStorm's CEO Chaim Lebovits. “Having a US patented product should increase our ability to enter into new commercial partnerships for NurOwn® in the US and worldwide.”

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to about 100 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U.S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics Inc.

BrainStorm to Present at FDA and Scientific Workshops Highlighting Innovation in ALS Trial Designs and Continued Progress with NurOwn® Cellular Therapy Platform

Wed, 12 Sep 2018 12:00:00 GMT

Chaim Lebovits, President and Chief Executive Officer, and Joe Petroziello, BSc, MSc, Vice President of Scientific and Corporate Communications, will be attending the Morgan Stanley 16th Annual Global Healthcare Conference on September 12-13 in New York City, and will be available for one-on-one meetings.

About NurOwn® Lead Clinical Program in ALS BrainStorm is currently enrolling a Phase 3 pivotal trial using repeat-administration of NurOwn® in ALS at leading clinical sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The study will enroll 200 ALS patients, randomized 1:1 to receive NurOwn® or placebo, and will evaluate the ALS functional rating scale (ALSFRS-R) responder analysis as a primary efficacy outcome measure (NCT03280056). On August 23, 2018, BrainStorm announced a successful pre-specified interim safety analyses by an independent Data Safety Monitoring Board (DSMB). The completion of Phase 3 enrollment is anticipated in 1H2019 and will enable a BLA filing in 2020 for FDA approval of NurOwn® in ALS.

About U.S. Sites for NurOwn® Phase 3 Trial in ALS

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Announces New Presentation Time at the H.C. Wainwright & Co. 20th Annual Investor Conference

Wed, 05 Sep 2018 12:00:00 GMT

Presentation Details: Date: Thursday, September 6 Time: 2:10pm Eastern Time (previously scheduled for 5:00pm Eastern Time) Location: Louis XVI B room, St. Regis Hotel, New York. Speaker: Ralph Kern, MD., MHSc., Chief Operating and Chief Medical Officer Webcast: http://wsw.com/webcast/rrshq28/bcli/index.aspx

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 100 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the US, a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the Company's website at www.brainstorm-cell.com.

CONTACTS Media: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Appoints Arturo Araya as Chief Commercial Officer

Tue, 04 Sep 2018 12:00:00 GMT

“Since joining our Board last year, Arturo’s guidance and insights have proven invaluable to the BrainStorm team as we continue to advance NurOwn® through late-stage clinical development as a potentially ground-breaking treatment for ALS,” said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. “With his vast experience and proven track record in global pharmaceutical commercialization, particularly in the area of complex cell and gene therapies, I am delighted that Arturo has joined our senior team.”

“I am honored to join the BrainStorm leadership team at this important time in the Company’s evolution,” said Mr. Araya. “There exists a significant need for innovative therapies to treat debilitating neurodegenerative diseases. I have been working closely with management and my fellow board members for the past 18 months, and I believe the Company’s NurOwn® technology, which has shown promising results in the clinic, has the potential to become an effective treatment for ALS where no effective therapies currently exist.”

Mr. Araya was employed at Novartis Pharmaceuticals from 2002 to 2016, where he served in various roles of increasing responsibility, ultimately as Global Head of Commercial of the company’s Cell and Gene Therapies Unit. Prior to joining Novartis, he served in general management, marketing and business development roles at Bristol-Myers Squibb. Mr. Araya earned an M.B.A. from the University of Michigan, an M.A. in Political Science and a B.S. in Civil Engineering, both from the University of Connecticut.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to over 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Drew Levinson

LifeSci Public Relations, LLC

Phone: 917-797-0388

drew@lifescipublicrelations.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics to Provide Corporate Update at the H.C. Wainwright & Co 20th Annual Investor Conference

Wed, 29 Aug 2018 12:00:00 GMT

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 100 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the US, a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the Company's website at www.brainstorm-cell.com.

CONTACTS Media: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Announces Successful Interim Safety Analysis in Phase 3 Trial of NurOwn® Therapy for ALS

Thu, 23 Aug 2018 12:00:00 GMT

“The DSMB appreciates the continued commitment of Brainstorm and the research teams to conducting this trial in such an exemplary manner”, said Carlayne Jackson MD, DSMB Chairperson, “We commend them on their outstanding enrollment and the quality of data collection.”

BrainStorm is conducting a repeat dose US Phase 3 trial of NurOwn® for ALS participants at 6 US sites, supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The study is expected to enroll 200 ALS participants, randomized 1:1 to NurOwn® or placebo, and is evaluating the ALS functional rating scale (ALSFRS-R) as the primary efficacy outcome measure, 28 weeks after the first of three NurOwn® intrathecal treatments.

To date, 82 participants have been enrolled in the trial, with 61 currently active. Many of the active participants have received two intrathecal treatments, with some completing all three. The Company anticipates that 110 participants in total will be enrolled in the trial by January 2019. Given the current pace of enrollment, we anticipate completing enrollment by mid 2019, which would then put us in a position to file a Biologics License Application for US FDA approval, once all clinical trial evaluations are completed.

“BrainStorm is focused on completing the NurOwn® ALS Phase 3 study and to bringing a much needed treatment option to ALS patients,” said Chaim Lebovits, president and CEO of BrainStorm, “We welcome the DSMB’s review which confirms the safety profile of NurOwn® following repeat dose intrathecal administration.”

Ralph Kern MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm said, "We are very pleased the DSMB has found no safety concerns that would require modification to the NurOwn® ALS Phase 3 protocol. This represents an important clinical advancement for BrainStorm and for NurOwn® as a viable cellular therapy approach for ALS patients”.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 100 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the US, a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the Company's website at www.brainstorm-cell.com.

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

BrainStorm Cell Therapeutics Inc.

Corporate Headquarters1325 Avenue of Americas, 28th FloorNew York City, NY 10019Phone: +1-201-488-0460

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Cell Therapeutics Inc.

BrainStorm Announces Grant of a New European Patent for NurOwn®

Wed, 25 Jul 2018 12:00:00 GMT

NEW YORK and PETACH TIKVAH, Israel, July 25, 2018 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the European Patent Office ("EPO") has granted an European-wide patent entitled 'Mesenchymal Stem Cells for the Treatment of CNS Diseases' for the treatment of Amyotrophic Lateral Sclerosis (ALS) with NurOwn®. This patent provides protection for NurOwn® in Europe until 2029.

The allowed claims cover methods of treating amyotrophic lateral sclerosis (ALS) using mesenchymal stem cells that secrete neurotrophic factors, including Brain derived neurotrophic factor (BDNF).

"We continue to protect our technology through strategic intellectual property achievements and this Grant from the European Patent Office is a welcome addition to our IP portfolio," commented BrainStorm's CEO Chaim Lebovits. "Having a EU patented product should increase our ability to enter into new commercial partnerships for NurOwn® in Europe."

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to over 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

BrainStorm to Announce Second Quarter Financial Results of 2018 and Provide a Corporate Update on Monday July 23

Tue, 17 Jul 2018 12:00:00 GMT

Conference Call – Monday, July 23rd @ 8:30am Eastern Time

USA Toll Free:

888-204-4368

International Investors:

323-994-2082

Israel Investors:

1809 212 883

Conference ID:

9977487

Webcast:

https://goo.gl/BV84Xi

Replays, Available through August 6th:

Domestic:

844-512-2921

International:

412-317-6671

Replay PIN:

9977487

CONTACTS Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Drew Levinson

LifeSci Public Relations

Phone: 917-797-0388

drew@lifescipublicrelations.com

BrainStorm Granted Japanese Patent for NurOwn®

Thu, 05 Jul 2018 12:00:00 GMT

This patent provides protection for MSC-NTF cells (NurOwn®) in Japan until 2033. The Decision to Grant notice is the final approval stage and precedes actual granting which is expected shortly. The identification number is Japanese Patent Application 2015-526006. The allowed claims cover a method of generating cells which secrete brain derived neurotrophic factor (BDNF), glial derived neurotrophic factor (GDNF), hepatocyte growth factor (HGF) and vascular endothelial growth factor (VEGF).

"We continue to protect our technology through strategic intellectual property achievements and this Notice of Decision to Grant from the Japanese Patent Office is an important addition to our IP portfolio. It is the first patent worldwide granted to BrainStorm for its development of the NurOwn® technology as a commercially viable product," commented BrainStorm's CEO Chaim Lebovits. "Having a stem-cell product patented in Japan will increase our ability to enter into new commercial partnerships for NurOwn® in Japan. We are expecting additional grants for this patent in other jurisdictions in the near future."

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Drew Levinson

LifeSci Public Relations

Phone: 917-797-0388

drew@lifescipublicrelations.com

BrainStorm Announces Second U.S. Manufacturing Site for NurOwn® Production

Mon, 02 Jul 2018 12:00:00 GMT

"We are pleased to announce a second partnership with Dana-Farber for the manufacturing of NurOwn," said Chaim Lebovits, president and CEO of BrainStorm. "Dana Farber is a world-renowned institution with decades of experience in stem cell transplantation. Its strong capabilities in this area and proven track record in the manufacture of NurOwn in the phase 2 trial, make it an ideal partner as we advance our Phase 3 trial to completion."

"We are pleased to support this important clinical trial. ALS is a devastating disease with no effective therapies. Our participation will allow more rapid patient accrual and will lead to earlier completion of the study," said Jerome Ritz, MD, Executive Director of the Connell and O'Reilly Families Cell Manipulation Core Facility.

In partnering with Dana-Farber for the manufacturing of NurOwn, BrainStorm has secured an additional facility to enhance production for the ongoing pivotal Phase 3 clinical trial, and to support manufacturing capacity for additional clinical indications.

BrainStorm is also pleased to update that CMC activities at City of Hope and enrollment in all six U.S. clinical sites are proceeding well. The first meeting of the Phase 3 Data and Safety Monitoring Board (DSMB) is expected by the end of August 2018 and Brainstorm will provide an update thereafter.

The Phase 3 trial is designed to enroll 200 patients with ALS, and is being conducted at six leading ALS clinical sites in the U.S. The primary outcome measure is the ALSFR-S score responder analysis. For more information, please refer to www.clinicaltrials.gov, using the NCT identifier NCT03280056.

About BrainStorm Cell Therapeutics Inc . BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the Company's website at www.brainstorm-cell.com.

CONTACTS

Corporate: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Drew Levinson

LifeSci Public Relations

Phone: 917-797-0388

drew@lifescipublicrelations.com

BrainStorm Strengthens Executive Management Team with the Appointment of Susan Ward, Ph.D. and Joseph Petroziello

Thu, 28 Jun 2018 12:00:00 GMT

Dr. Ward, who served as Director, Early Clinical Development at Pfizer, has more than 20 years of operational leadership experience in clinical trials, IND-enabling studies, protocol development and management of cross-functional teams. Joe Petroziello joins BrainStorm Cell Therapeutics from Juno Therapeutics (a Celgene company), where he served as Senior Director/Head of Scientific Communications & Publications, has over 20 years of experience in medical writing, scientific communication and drug research and development. Both will be based in the United States.

"We are delighted to have Joe and Susan join the BrainStorm team," said Chaim Lebovits, president and chief executive officer of BrainStorm Cell Therapeutics. "These are the latest in a series of key appointments to the executive management team and board, as we transform BrainStorm to a global biopharmaceutical stem cell therapeutic company and build our U.S. infrastructure. These additions build on our recent board appointments including Dr. Tony Polverino, currently the interim chief scientific officer at Kite Pharma, and Drs. June Almenof and Arturo Araya, both who have global pharmaceutical management experience. Also in 2017, were the appointments of Dr. Ralph Kern as chief operating officer and chief medical officer."

Joseph Petroziello, BrainStorm Cell Therapeutics' vice president of scientific and corporate communications added, "I look forward to joining the Executive Management team at BrainStorm, an emerging leader in the research and development of an innovative stem cell therapeutic approach being evaluated in global clinical trials for the treatment of debilitating neurodegenerative diseases of high unmet medical need, such as ALS."

Susan Ward, Ph.D., BrainStorm's director of clinical and research operations said, "I am thrilled to join the BrainStorm team at this important time in the company's development. NurOwn® has demonstrated promising efficacy in ALS and, if approved, has the potential to address the significant unmet need that exists with this disease. I see the ongoing Phase 3 trial as marking a pivotal moment in innovative therapies for patients with ALS."

Dr. Susan Ward has an established track record in leadership, design and execution of innovative, cross-disciplinary research and program management across all phases, including early phase clinical research and exploratory scientific collaboration. She joins BrainStorm from Pfizer, Inc., where she was the head of early development clinical trial operations, a group of clinical trial specialists supporting clinicians in operations and daily execution of clinical trials to advance the early clinical development portfolio. Prior to joining Pfizer, Dr. Ward was a clinical consultant in neuroscience clinical development at Roche and held positions of increasing responsibility at both biotechnology and pharmaceutical companies, including OvaScience, EnVivo Pharmaceuticals, Biogen Idec, and Sepracor. In addition, she started off her career at a niche CRO, Clinquest, working in various roles in clinical operations, strategic planning and execution, pharmacovigilance and data management. Later in her career, she rejoined Clinquest as vice president, global clinical affairs where she provided clinical, regulatory, and quality services to companies ranging from small, virtual start-ups early in development through mid-sized companies with late-stage programs. Dr. Ward worked in translational and experimental medicine at Biogen Idec developing exploratory studies to further research strategy across therapeutic indications and build clinical research collaborations. Her role at Pfizer capitalized on that experience as she continued to work in quantitative and human exploratory medicine. Dr. Ward earned a Doctorate in Behavioral Neuroscience from the Boston University School of Medicine in 2001, while working as a researcher and a Post-Doctoral Training Fellow at the Harold Goodglass Aphasia Research Center from 1993 to 2002. She received a Bachelor of Arts in Cognitive Science and Psychology from the University of Rochester.

Joe Petroziello joins BrainStorm from Juno Therapeutics, Inc. He received his Bachelor of Science in Biological Sciences and Master of Science in Medicinal Chemistry from the University of Scranton, Pennsylvania. He joined Genzyme in 1996 as senior scientist in Molecular Oncology. He then joined Seattle Genetics, Inc. in 2000, as head of antigen discovery, leading translational research efforts to identify and patent novel tumor-associated antigens for targeting as Antibody Drug Conjugates (ADCs) for Hematologic Malignancies. Over the next 8 years, Mr. Petroziello assumed roles as VP and medical director at consulting medical communications agencies in New York City with specialization in global scientific communication plans and regulatory technical writing for global publication plans, clinical advisory boards and clinical development plans for cancers and rare orphan diseases. Most recently, he was head of medical writing and scientific communications at Juno Therapeutics, Inc., from 2014-2018 with specialization in technical writing of clinical protocols, developing Key Opinion Leader (KOL) relationships at leading Chimeric Antigen Receptor (CAR)-T cell academic institutions and providing strategic direction for clinical advisory boards for drug development of novel cellular biologics, including Lisocabtagene Maraleucel (Liso-cel; JCAR017), an investigational CD19-Directed (CAR-T) cell therapy in pivotal-stage drug development for B-cell cancers.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Drew Levinson

LifeSci Public Relations

Phone: 917-797-0388

drew@lifescipublicrelations.com

BrainStorm Provides Update on "Right to Try" Policy

Tue, 26 Jun 2018 12:00:00 GMT

Brainstorm has carefully evaluated the ethical, legal and practical aspects of the newly enacted RTT legislation in detail, and has received detailed feedback from patients, clinicians, regulatory and legal experts. The company has established an ethical and practical framework with four key elements that must be satisfied in order to be able to provide NurOwn® to ALS patients under the RTT pathway. The four elements are: providing the treatment to a limited number of patients at clinical trial-experienced sites to ensure the necessary expertise and systems of care are in place to safely and effectively deliver the therapy; ensuring that patients are fully educated on the benefits and risks of the investigational therapy; limiting the inclusion to patients who do not meet the Phase 3 clinical trial inclusion criteria to ensure that the RTT pathway does not adversely impact the clinical trial; and lastly, finding alternative funding solutions for patients who are unable to afford the high cost of regenerative medicine cell therapies. The company has found practical solutions for all except the funding issue and, as a consequence, is unable to initiate the provision of NurOwn® under the RTT pathway until all elements are fully satisfied.

"We feel a tremendous sense of urgency and responsibility to provide an ethical, compassionate, and well-reasoned practical response to the demand for NurOwn® and have worked tirelessly with patients and other stakeholders to find a solution," said Chaim Lebovits, president and CEO of BrainStorm, "As we were unable to identify a practical funding solution, we unfortunately are not in a position to initiate access to NurOwn® under RTT at this time."

Webcast and Conference Call, Tuesday, June 26, 2018 @ 8:30am Eastern Time USA Toll Free: 888-668-9141Israel Investors: 03-9180609Webcast link: https://bit.ly/2ts9M3I

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the Company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

CONTACTS

Corporate: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.comn

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.comn

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Drew Levinson

LifeSci Public Relations

Phone: 917-797-0388

drew@lifescipublicrelations.com

BrainStorm to Host Tomorrow a Conference Call to Announce Its "Right To Try" Policy

Mon, 25 Jun 2018 12:00:00 GMT

Tuesday, June 26, 2018 @ 8:30am Eastern Time

USA Toll Free:

888-668-9141

Israel Investors:

03-9180609

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Media:

Drew Levinson

LifeSci Public Relations

Phone 917-797-0388

drew@lifescipublicrelations.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Announces Exercise of Warrants Resulting in Cash Proceeds of ~$12.3 Million at $5 Share

Thu, 07 Jun 2018 12:00:00 GMT

"Upon the closing of this warrant exercise, we have strengthened our balance sheet," stated Chaim Lebovits, BrainStorm's president and CEO. "We now have sufficient capital to not only complete our ongoing Phase 3 trial of NurOwn in ALS but also to advance the development of other promising R&D programs in our pipeline."

The shares of common stock and warrants issued in this transaction have not been registered under the Securities Act of 1933, as amended (the Securities Act), or state securities laws. These shares of common stock have been registered for resale on registration statement Form S-3 No. 333-201704. The issuance of the shares of common stock and warrants is exempt from the registration requirements of the Securities Act pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated under the Securities Act. The Company made this determination based on the representations that each party is an "accredited investor" within the meaning of Rule 501 of Regulation D. The Company made this determination based on the representations that each party is an "accredited investor" within the meaning of Rule 501 of Regulation D. This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act of 1933.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the Company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

CONTACTS

Corporate: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm to Host Call Following President Trump's Citing of Company's ALS Treatment During "Right-to-Try" Bill Signing

Fri, 01 Jun 2018 12:00:00 GMT

On May 30, 2018, President Trump signed "Right-to-Try" legislation, which will enable terminally ill patients expanded access to experimental therapies that do not yet have approval by the U.S. Food and Drug Administration (FDA). During the signing, President Trump highlighted the urgency and need for patients who don't meet inclusion criteria's to have access to investigational treatments when they have exhausted all treatment options. He cited the example of Matthew Bellina, an amyotrophic lateral sclerosis (ALS) patient who had been seeking access to BrainStorm's NurOwn® investigational therapy but did not qualify for clinical trials in the U.S. Mr. Bellina had plans to travel to Israel to pursue access to NurOwn® treatment. The President stated clearly that, with the passage of this bill, patients will be able to seek treatment in the U.S. without the burden of having to travel overseas. BrainStorm's president and CEO Chaim Lebovits was present during the bill signing at the White House to support and demonstrate commitment to the ALS community.

To view President Trump's speech on C-SPAN (referencing ALS treatment in Israel at timecode 19:35 through 20:35) refer to https://cs.pn/2skXaus.

"Since the signing of the 'Right-to-Try' bill, we have had numerous enquiries from patients, patient advocates and physicians who want to voice their opinions as we establish our RTT policy," stated Mr. Lebovits. "As part of our commitment to the community, we are happy to provide interested groups this opportunity to engage directly with us. We recognize the sense of urgency of ALS patients such as Matthew Bellina, and are evaluating ways to provide access to NurOwn® outside of our Phase 3 trial. At the same time, we remain fully focused on completing our Phase 3 trial of NurOwn® as rapidly as possible."

Members of BrainStorm's senior management team, including Chaim Lebovits, president and CEO and Ralph Kern, M.D., MHSc, CMO and COO, will host a conference call and webcast for the ALS community and interested participants on Thursday, June 7 at 8:15am Eastern Time.

Conference Call

Thursday, June 7th @ 8:15am Eastern Time

From the US:

800-263-0877

Outside the US:

646-828-8143

Israel:

1809 212 883

Conference ID:

9225858

Webcast:

https://goo.gl/h9pMGE

Replays, Available through June 21:

From the US:

844-512-2921

Outside the US:

412-317-6671

Replay PIN:

9225858

About NurOwn® NurOwn utilizes a patient's own cells which have been engineered outside the body, to produce and secrete factors known to promote neuronal survival. NurOwn has the potential to be the first ALS treatment to improve patient functioning as a regenerative medicine. Regenerative medicine solutions are desperately needed in the field of neurodegenerative diseases as current therapies have limited efficacy, only slow progression and do not maintain or restore function. NurOwn is currently being tested in a multi-site Phase 3 clinical trial in the U.S. and, if successful, the results from this trial will submitted to the FDA and other regulatory authorities around the world with the goal of obtaining marketing approval. BrainStorm has completed two single arm clinical trials which established the safety profile of NurOwn and provided indications of a treatment benefit. Additionally, the company has completed a double-blind, placebo-controlled Phase 2 study at three prestigious academic medical centers in the US. In this study, clinically meaningful changes in functioning were observed in patients receiving NurOwn.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Cell Therapeutics to Provide Corporate Update at the BIO International Convention

Wed, 30 May 2018 12:00:00 GMT

Presentation Details:

Date:

Monday, June 4th

Time:

5:15 PM

Speaker:

Chaim Lebovits, President & CEO

Location:

Boston Convention Center, Presentation Room, Theater 1

Webcast:

https://goo.gl/RcZsXS

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the Company's website at www.brainstorm-cell.com.

CONTACTS Media: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics Issues Statement on "Right to Try" Legislation

Fri, 25 May 2018 12:00:00 GMT

Chaim Lebovits, president and chief executive officer of BrainStorm Cell Therapeutics, stated, "BrainStorm understands the serious unmet medical need and urgency of people living with ALS. We have received countless inquiries after the passing of Federal 'Right-to-Try' legislation about patient access to NurOwn®. We have been, and will continue to, be engaged and collaborate with people with ALS, their families and caregivers, and legislators and government agencies to ensure that the voices of these groups are heard in this important discussion. Brainstorm is currently assessing the legislation and its potential implications, and when signed into law, will issue a formal policy on 'Right-to-Try' in early June."

"BrainStorm remains focused and fully committed to completing the Phase 3 clinical trial of NurOwn® as quickly as possible," added Lebovits. "While we continually evaluate ways to provide access to NurOwn® outside of the current Phase 3 trial to the many patients who can't wait, the most expedient way to make NurOwn® available to all is by completing the necessary clinical trial data collection and endpoint analyses, and submitting the required marketing applications without delay to regulatory agencies, including the FDA."

About NurOwn®

NurOwn utilizes a patient's own cells which have been engineered outside the body, to produce and secrete factors known to promote neuronal survival. NurOwn has the potential to be the first ALS treatment to improve patient functioning as a regenerative medicine. Regenerative medicine solutions are desperately needed in the field of neurodegenerative diseases as current therapies have limited efficacy, only slow progression and do not maintain or restore function. NurOwn is currently being tested in a multi-site Phase 3 clinical trial in the U.S. and, if successful, the results from this trial will submitted to the FDA and other regulatory authorities around the world with the goal of obtaining marketing approval. BrainStorm has completed two single arm clinical trials which established the safety profile of NurOwn and provided indications of a treatment benefit. Additionally, the company has completed a double-blind, placebo-controlled Phase 2 study at three prestigious academic medical centers in the US. In this study, clinically meaningful changes in functioning were observed in patients receiving NurOwn.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Announces First Quarter 2018 Financial Results and Provides Corporate and Clinical Highlights

Mon, 14 May 2018 12:00:00 GMT

"We are very pleased with the progress we are making with our ongoing Phase 3 trial in the U.S.," commented Chaim Lebovits, president and chief executive officer of BrainStorm. "we are also pleased with the regulatory progress via additional pathways that will allow access to NurOwn® for patients. In parallel we continue to heavily invest in HR and R&D so that we have the necessary expertise to develop NurOwn and advance our clinical pipeline."

First Quarter and Recent Corporate Highlights:

Financial Results for the First Quarter Ended March 31, 2017

Conference Call Today - Monday, May 14 th @ 8:30am Eastern Time

Members of BrainStorm's senior management team, including Chaim Lebovits, CEO, and Ralph Kern, M.D., MHSc, COO and CMO, and Eyal Rubin, CFO will host a conference call and live webcast for the investment community on Monday, May 14 th @ 8:30am Eastern Time. The details are as follows:

USA Toll Free: 800 239 9838 USA & International Investors: 323 794 2551Israel Investors: 1809 212 883 Conference ID: 6273879 Webcast: https://goo.gl/nNMzYw

Replay: Dial-In – available through May 28 :

Toll Free: 844-512-2921 International: 412-317-6671Conference ID: 6273879Webcast: https://goo.gl/nNMzYw

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the Company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

CONTACTS Media: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

March 31,

December 31,

2 0 1 8

2 0 1 7

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

Cash and cash equivalents

$ 3,246

$ 2,483

Short-term deposit (Note 4)

2,359

5,273

Account receivable

1,117

672

Prepaid expenses and other current assets

1,143

1,195

Total current assets

7,865

9,623

Long-Term Assets:

Prepaid expenses and other long-term assets (Note 5)

1,136

1,408

Property and Equipment, Net

412

392

Total long-term assets

1,548

1,800

Total assets

$ 9,413

$ 11,423

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities:

Accounts payable

$ 3,261

$ 1,424

Accrued expenses

442

817

Deferred grant income (Note 6)

1,202

2,625

Other accounts payable

674

677

Total current liabilities

5,579

5,543

Total liabilities

$ 5,579

$ 5,543

Stockholders' Equity:

Stock capital: (Note 7)

Common stock of $0.00005 par value - Authorized: 100,000,000 shares at each of March 31, 2018 and December 31, 2017; Issued and outstanding: 19,111,326 and 18,976,169 shares at March 31, 2018 and December 31, 2017, respectively.

Additional paid-in-capital

86,196

85,944

Accumulated deficit

(82,373)

(80,075)

Total stockholders' equity

3,834

5,880

Total liabilities and stockholders' equity

$ 9,413

$ 11,423

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

U.S. dollars in thousands

(Except share data)

Three months ended

March 31,

2 0 1 8

2 0 1 7

U.S. $ in thousands

Operating expenses:

Research and development, net

$ 977

$ 941

General and administrative

1,330

829

Operating loss

(2,307)

(1,770)

Financial expenses (income), net

(9)

Net loss

$ (2,298)

$ (1,785)

Basic and diluted net loss per share from continuing operations

$ (0.12)

$ (0.10)

Weighted average number of shares outstanding used in computing basic and diluted net loss per share

19,047,350

18,688,377

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

March 31,

December 31,

2 0 1 8

2 0 1 7

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

Cash and cash equivalents

BrainStorm CEO to Present at World Advanced Therapy and Regenerative Medicine Congress in London

Wed, 09 May 2018 12:00:00 GMT

World Advanced Therapies & Regenerative Medicine Congress 2018

Date:

Thursday, May 17

Time:

2:30pm BST

Location:

Business Design Centre, London

Title:

Brainstorm's NurOwn® Treatment for Neurodegenerative Diseases

Presenter:

Chaim Lebovits, Chief Executive Officer, BrainStorm Cell Therapeutics

About the World Advanced Therapies & Regenerative Medicine Congress The 13th annual World Advanced Therapies & Regenerative Medicine Congress will bring together 1000+ attendees and explores the rapidly developing world of next generation therapeutics and advanced therapy medical products (ATMPs). From clinical development to pricing, reimbursement and market access this congress will bring the most exciting case studies and new data for immunotherapy, cell therapy, gene therapy, CARs and bioprocessing. Experts in every area will help companies tackle the process and regulatory hurdles of developing all new therapeutic formats all the way through manufacture and into the clinic. This year's conference will take place May 16 – 18 at the Business Design Center, London.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Media:

Uri Yablonka

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Brainstorm to Announce First Quarter Financial Results and Provide Corporate Update on Monday, May 14

Tue, 08 May 2018 12:00:00 GMT

Monday, May 14, 2018 @ 8:30am Eastern Time

USA Toll Free:

800-239-9838

USA & International Investors:

323-794-2551

Israel Investors:

1809 212 883

Conference ID:

6273879

Webcast:

https://goo.gl/nNMzYw

Replays, available through May 28th, 2018

Toll Free:

844-512-2921

International:

412-317-6671

Conference ID:

6273879

Webcast:

https://goo.gl/nNMzYw

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Media:

Uri Yablonka

Chief Business Officer

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics to Participate in Movement Disorder Panel at the Neurotech Investing and Partnering Conference

Tue, 01 May 2018 12:00:00 GMT

Neurotech Panel Presentation Details:

Date:

Wednesday, May 2

Time:

10:40am Eastern Time

Panel Title:

Parkinson's and Other Movement Disorders

Location:

Renaissance Waterfront Hotel, Boston, MA

Panel Description:

Current treatments for movement disorders can improve functioning, but suffer from side effects and "off" period, especially as the disease progresses. A number of novel pipeline pharmaceuticals and devices seek to address these issues. This session will explore how disease modifying treatments alter the course of movement disorders, and how companion diagnostics can be leveraged to provide the most optimal outcomes for patients. The panel will be moderated by Julie G. Pilitsis, MD, Ph.D., Chair of Department of Neuroscience & Experimental Therapeutics, Professor of Neurosurgery, Albany Medical College.

About the Neurotech Investing & Partnering Conference

Now in its 13th year, the Neurotech Investing & Partnering Conference is the premier business and investment conference for commercial neuroscience including pharmaceuticals, medical devices, diagnostics and neurosoftware. The conference features keynotes, investor panels, cutting edge company presentations, and panel discussions on a comprehensive selection of neurotech topics. The goal is to provide a highly-interactive environment where cutting edge technologies, devices, drugs and therapies inspire new collaborations and secure financing to navigate the development path and ultimately reach patients.

Organized by the Neurotechnology Industry Organization and Cambridge Innovation Institute, the 13th annual conference will be held May 1-2, 2018 at the Renaissance Waterfront Hotel in Boston, MA.

The Neurotech Investing and Partnering Conference is a global forum where investors, executives, entrepreneurs, scientists and others involved in the development of new treatments and diagnostics for the brain and nervous system come together to shape the future of their organization and the industry.

This market-defining conference features keynotes on the state of the neurotech industry, cutting edge company presentations, leading translational research projects and panel discussions on a comprehensive selection of neurotech topics.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

CONTACTS

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Cell Therapeutics to Present at ARM's 6th Annual Cell & Gene Therapy Investor Day, April 17 in New York

Wed, 11 Apr 2018 12:00:00 GMT

In addition, two scientific posters describing ALSFRS-R subgroup analyses and innovative micro-RNA biomarker data from the NurOwn® Phase 2 randomized, double-blind, placebo-controlled study will be featured as podium presentations at the forthcoming American Academy of Neurology (AAN) Annual Meeting, to take place April 21-27 in Los Angeles, California.

ARM's 6th Annual Cell & Gene Therapy Investor Day Presentation :

Event:

Alliance for Regenerative Medicine's Cell & Gene Investor Day

Date:

April 17, 2018

Time:

2:30 PM EDT

Location:

Metropolitan Club, One East 60th Street, New York, NY

A live video webcast of the presentation will be available at: https://goo.gl/59HiF2 . The webcast will be posted for further viewing on the event website following the conference.

Attendance at this event is for credentialed investors and members of the media only. If you are interested in attending, please contact Laura Parsons at lparsons@alliancerm.org. Please visit http://www.arminvestorday.com for more information.

American Academy of Neurology (AAN) Annual Meeting

Title:

Modulation of CSF miRNAs in ALS Phase 2 study participants treated with MSC-NTF cells (NurOwn®)

Presenter:

Ralph Kern, MD, MHSc, Chief Operating Officer & Chief Medical Officer of BrainStorm Cell Therapeutics Inc.

Date:

April 24

Time:

4:18 PM (Pacific Time)

Title

NurOwn® Phase 2 ALS Trial: ALSFRS-R Improvement is Reflected in Subscale Domains

Presenter:

Merit Cudkowicz, MD, Chief Neurology Service; Director, Amyotrophic Lateral Sclerosis Clinic; Co-Director, Neuromuscular Division - Mass General Hospital in Boston, MA.

Date:

April 26

Time:

8:12 AM (Pacific Time)

About ARM's Cell & Gene Therapy Investor Day

This one-day program, organized by the Alliance for Regenerative Medicine (ARM) and co-hosted by Chardan, PNC Healthcare, Raymond James and Solebury Trout, will provide institutional, strategic and venture investors with unique insights into financing opportunities for cell and gene therapy-based treatment and tools. The event includes clinical and commercial experts on-hand to address specific questions regarding the outlook for these products, and how this sector is impacting key therapeutic areas including oncology, ophthalmology, rare disease, diabetes, cardiovascular disease, wound healing and tissue repair and neurodegenerative diseases. The program includes talks by key opinion leaders in the industry, analysts following the sector as well as presentations by more than 30 leading companies from across the globe. For more information, refer to http://arminvestorday.com/.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Media:

Uri Yablonka

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Cell Therapeutics' Phase 3 Trial of NurOwn® in ALS Now Open to Canadian Patients

Wed, 28 Mar 2018 12:00:00 GMT

"We are pleased to open enrollment to Canada-based ALS patients," said Chaim Lebovits, president and chief executive officer of BrainStorm Cell Therapeutics. "Although there are thousands of patients worldwide with ALS, we initially designed the Phase 3 trial to enroll U.S.-based patients only, primarily to make it easier for patient follow-up visits at the six U.S. clinical sites. However, due to an outpouring of inquiry and support from Canadian patients wanting to enroll in the trial, we filed an amendment with the FDA to allow Canada-based ALS patients to participate. The amendment was approved and we are pleased to announce today that Canada-based patients may now enroll in our study at the University of Massachusetts (UMass)."

The trial is designed to enroll 200 patients with ALS, and is being conducted at six leading ALS clinical sites in the U.S. The primary outcome measure is the ALSFR-S score responder analysis. The patient population is being optimized to include the pre-specified subgroups who demonstrated superior outcomes in the NurOwn Phase 2 ALS clinical trial. Top-line data are expected in 2019. For more information, refer to www.clinicaltrials.gov, using the NCT identifier NCT03280056.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Appoints Two Leading Thought Leaders in the Fields of Neuroscience and Regenerative Medicine to its Scientific Advisory Board

Wed, 21 Mar 2018 12:00:00 GMT

"We are extremely pleased and honored to have two of the leading thought leaders in the fields of neuroscience and regenerative medicine join our scientific advisory board," said Chaim Lebovits, president and chief executive officer of BrainStorm Cell Therapeutics. "Professors Appel and Bar-Or have decades of experience in the field of neurodegenerative diseases including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis (ALS) and neuromuscular disorders. Their guidance will be an asset as we execute on our Phase 3 program for NurOwn® in ALS and advance our pipeline programs with the goal of bringing new treatment options to patients afflicted with neurodegenerative diseases."

Stanley H. Appel, M.D., is the Peggy and Gary Edwards Distinguished Endowed Professor for the Treatment and Research of ALS, Department of Neurology, Neurological Institute, Houston Methodist Hospital and Professor of Neurology at Weill Medical College of Cornell University. He is director of the MDA/ALS Research and Clinical Center at the Methodist Neurological Institute, and a past director of a National Institute of Aging Alzheimer's Disease Research Center. He has received numerous awards for his accomplishments in neurology and biochemistry, including the Gold Medal Award in 1997 from Columbia College of Physicians and Surgeons for "Distinguished Achievements in Medicine" and the Sheila Essey Award in 2003 from the American Academy of Neurology for "outstanding research in Amyotrophic Lateral Sclerosis."

Amit Bar-Or, M.D., a neurologist and neuroimmunologist, is the Presidential Endowed Chair at the University of Pennsylvania (UPenn/CHOP) and the Melissa and Paul Anderson Professor of Neurology, founder and director of the Centre for Neuroinflammation and Experimental Neurotherapeutics and chief, Multiple Sclerosis Division. He leads a cellular and molecular neuroimmunology lab that studies basic principles of immune regulation and immuneneural interaction, in the context of inflammation, injury and repair of the human central nervous system (CNS). He is President-Elect of the International Society of Neuroimmunology (ISNI) and serves on the board of directors of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and on the steering committee of the Immune Tolerance Network (ITN).

"We are privileged that Professors Appel and Bar-Or have agreed to serve on the BrainStorm Scientific Advisory Board," said Ralph Kern, M.D., MHSc, chief operating officer and chief medical officer of BrainStorm. "Their contributions will be important as we continue to execute our pivotal phase 3 trial of NurOwn® in ALS and broaden our efforts to address unmet need in other neurodegenerative diseases."

Prof. Stanley Appel said, "BrainStorm's proprietary, stem cell-based technology has demonstrated promising results in the clinic. I look forward to working with the team at BrainStorm and am excited about this opportunity to contribute to the advancement of the company's therapeutic candidates."

Prof. Amit Bar-Or added, "BrainStorm is developing a promising pipeline of stem cell-based treatments to treat serious neurological conditions. With the lead candidate NurOwn in a Phase 3 study for ALS, I am pleased to be joining the scientific advisory board to help guide the company's efforts at this key stage."

About NurOwn ® NurOwn ® utilizes a patient's own cells which have been engineered outside the body, to produce and secrete factors known to promote neuronal survival. NurOwn ® has the potential to be the first ALS treatment to improve patient functioning as a regenerative medicine. Regenerative medicine solutions are desperately needed in the field of neurodegenerative diseases as current therapies have limited efficacy, only slow progression and do not maintain or restore function. NurOwn ® is currently being tested in a multi-site Phase 3 clinical trial in the U.S. and, if successful, the results from this trial will submitted to the FDA and other regulatory authorities around the world with the goal of obtaining marketing approval. BrainStorm has completed two single arm clinical trials which established the safety profile of NurOwn ® and provided indications of a treatment benefit. Additionally, the company has completed a double-blind, placebo-controlled Phase 2 study at three prestigious academic medical centers in the US. In this study, clinically meaningful changes in functioning were observed in patients receiving NurOwn ® .

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn ® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Cell Therapeutics to Present at the BIO Asia International Conference and the Wall Street Investor Forum

Thu, 15 Mar 2018 12:00:00 GMT

BIO Asia International Conference Company Presentation

Date:

Monday, March 19

Time:

11:45am (Tokyo Time – GMT+9)

Location:

Grand Hyatt Tokyo

Wall Street Investor Forum Company Presentation

Date:

Thursday, March 22

Time:

08.00am Eastern Time

Location:

University Club of NYC

Webcast:

https://goo.gl/7h3CCo

About BIO Asia International Conference The 15th Annual BIO Asia International Conference, co-hosted by the Biotechnology Innovation Organization (BIO), BioCentury and the Japan Bioindustry Association (JBA), brings together the global biotechnology and pharmaceutical industry to explore licensing and research collaborations in the current Asia-Pacific business and policy environments. Attendees can gain insights into the changes, challenges, and opportunities key opinion and policy leaders foresee for the Japanese biotech market. The conference will take place March 19-20, 2018 at the Grand Hyatt. Tokyo. For more information: https://goo.gl/ZPYT8k.

About Wall Street Investor Forum Wall Street Investor Forum has conducted 85 multitrack analyst conferences in which over 1800 different NYSE/NASDAQ/OTC companies have presented and over 3000 different institutions have attended in New York, Boston & London since 1990. Although the conferences is now focused on micro/small cap companies, public companies ranging from General Electric, Microsoft Corp, Mattel, Inc., Pfizer, Inc., Biogen, Unilever, EMC, and America Online have presented. Institutions ranging from Gabelli & Company, Neuberger Berman, Wellington Management, JP Morgan Asset Management, Dreyfus, Putnam Management have attended. For more information: https://goo.gl/JgE5u2.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U.S., a clinically meaningful benefit was demonstrated by a higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Announces Formation of Scientific Advisory Board and Appoints Neuroscientist Jerold Chun, M.D., Ph.D., to Chair

Mon, 12 Mar 2018 12:00:00 GMT

The SAB at BrainStorm will be composed of renowned scientists and clinical experts and will advise BrainStorm's management team on scientific matters such as research, clinical trials and drug development.

"We are establishing a Scientific Advisory Board to serve as a key strategic resource to BrainStorm that will provide scientific expertise and guidance as we execute on the ongoing Phase 3 trial of NurOwn® in ALS and continue to assess new product development opportunities from our technology," said Chaim Lebovits, president and chief executive officer of BrainStorm Cell Therapeutics. "We plan to build out the board with additional thought leaders in neuroscience and regenerative medicine in our mission to bring new treatments to patients afflicted with neurodegenerative diseases."

"To have Dr. Chun, a world-renowned neuroscientist, lead our scientific advisory board will enrich and focus our R&D efforts to bring solutions to neurology patients with high unmet need," said Ralph Kern, MD., MHSc, Chief Operating and Chief Medical Officer of BrainStorm. "With his extensive involvement in neuroscience research and drug discovery, he is exceptionally well qualified to provide scientific guidance and mentoring."

"I am honored to be appointed as chair of BrainStorm's SAB at this exciting time for the company and look forward to contributing to the ongoing development of novel and meaningful therapeutics through NurOwn and the company's pipeline in regenerative medicine," said Dr. Chun.

Dr. Chun is currently professor and the senior vice president of Neuroscience Drug Discovery at Sanford Burnham Prebys Medical Discovery Institute, with over 27 years of experience in academia and industry. He currently leads a team of 25 researchers in the study of genomic mosaicism (DNA sequence variation in brain cells) and lysophospholipid receptor signaling to understand and develop drug treatments for brain diseases such as Alzheimer's disease, multiple sclerosis, and hydrocephalus. Dr. Chun previously held professorships at The Scripps Research Institute, the University of California San Diego School of Medicine, and also headed the Department of Molecular Neuroscience at Merck Research Laboratories. Among his achievements, he identified the first lysophospholipid receptor (1996), was first to demonstrate genomic mosaicism in the brain (2001) and its alteration in Alzheimer's disease (2015). Dr. Chun is a recipient of over a dozen awards, has published ~300 scientific articles and three patents. He received M.D. and Ph.D. (Neuroscience) degrees through the Medical Scientist Training Program at Stanford University School of Medicine, and was a Helen Hay Whitney Fellow at the Whitehead Institute for Biomedical Research/MIT.

About NurOwn® NurOwn® utilizes a patient's own cells which have been engineered outside the body, to produce and secrete factors known to promote neuronal survival. NurOwn® has the potential to be the first ALS treatment to improve patient functioning as a regenerative medicine. Regenerative medicine solutions are desperately needed in the field of neurodegenerative diseases as current therapies have limited efficacy, only slow progression and do not maintain or restore function. NurOwn® is currently being tested in a multi-site Phase 3 clinical trial in the U.S. and, if successful, the results from this trial will submitted to the FDA and other regulatory authorities around the world with the goal of obtaining marketing approval. BrainStorm has completed two single arm clinical trials which established the safety profile of NurOwn® and provided indications of a treatment benefit. Additionally, the company has completed a double-blind, placebo-controlled Phase 2 study at three prestigious academic medical centers in the US. In this study, clinically meaningful changes in functioning were observed in patients receiving NurOwn®.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Announces Operational Highlights and Financial Results for the Year Ended December 31, 2017

Thu, 08 Mar 2018 12:00:00 GMT

"2017 was a very productive year for BrainStorm, with significant progress and achievements across clinical, operational and financial fronts," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "Most importantly, we began treating patients in our pivotal, double blind, placebo-controlled Phase 3 trial of NurOwn® for the treatment of ALS. The trial is being conducted at six leading ALS centers in the U.S., and is supported by a $16 million non-dilutive grant from the California Institute of Regenerative Medicine (CIRM)."

"We met and exceeded expectations in 2017 on the manufacturing and product development fronts," continued Mr. Lebovits. "We contracted with the City of Hope's Center for Biomedicine and Genetics in California, to produce clinical supplies of NurOwn® for our US Phase 3 trial. Furthermore we have recently been granted Good Manufacturing Practice (GMP) certification by the Israel Ministry of Health (MoH) for our Israeli contract manufacturing facility. "

"We are building a world class team at BrainStorm and made a number of senior management appointments throughout 2017 including Ralph Z. Kern, MD, MHSc (Chief Operating Officer and Chief Medical Officer), Mary Kay Turner (VP of Patient Advocacy and Government Affairs), and Eyal Rubin (CFO). BrainStorm has also recently elected Senior Kite Pharma executive Anthony Polverino, Ph.D., to its Board of Directors," concluded Mr. Lebovits.

Fourth Quarter and Recent Corporate Highlights:

Financial Results for the Year Ended December 31, 2017

Conference Call on Thursday, March 8 th @ 8:30am Eastern Time Members of BrainStorm's senior management team, including Chaim Lebovits, CEO, and Ralph Kern, M.D., MHSc, COO and CMO, and Eyal Rubin, CFO will host a conference call and live webcast for the investment community on Thursday, March 8 th @ 8:30am Eastern Time. The details are as follows:

Toll Free:

1-800-289-0438

International:

1-323-794-2423

Israel Toll Free:

1-809-212-883

Conference ID:

3071165

Webcast:

https://goo.gl/MnoNzL

Replay: Dial-In – available through March 22, 2018 / Webcast – available through March 7, 2019 :

Toll Free:

1-844-512-2921

Toll/international:

1-412-317-6671

Replay Pin Number:

3071165

Webcast:

https://goo.gl/MnoNzL

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Media: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

December 31,

2 0 1 7

2 0 1 6

U.S. $ in thousands

ASSETS

Current Assets:

Cash and cash equivalents

$ 2,483

$ 547

Short-term deposit (Note 8)

5,273

9,443

Account receivable (Note 4)

672

306

Prepaid expenses and other current assets

1,195

148

Total current assets

9,623

10,444

Long-Term Assets:

Prepaid expenses and other long-term assets (Note 5)

1,408

Property and Equipment, Net (Note 6)

392

297

Total Long-Term Assets

1,800

322

Total assets

$ 11,423

$ 10,766

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities:

Accounts payables

$ 1,424

$ 345

Accrued expenses

817

152

Deferred grant income (Note 9)

2,625

Other accounts payable

677

367

Total current liabilities

5,543

864

Total liabilities

$ 5,543

$ 864

Stockholders' Equity:

Stock capital: (Note 10)

Common Stock of $0.00005 par value - Authorized: 100,000,000

shares at December 31, 2017 and December 31, 2016

respectively; Issued and outstanding:

18,976,169 and 18,687,987 shares at December 31, 2017

and December 31, 2016 respectively.

Additional paid-in-capital

85,944

85,014

Accumulated deficit

(80,075)

(75,123)

Total stockholders' equity

5,880

9,902

Total liabilities and stockholders' equity

$ 11,423

$ 10,766

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

STATEMENTS OF COMPREHENSIVE LOSS

U.S. dollars in thousands

(Except share data)

Year ended

December 31,

2 0 1 7

2 0 1 6

U.S. $ in thousands

Operating expenses:

Research and development, net (Note 11)

$ 977

$ 2,250

General and administrative

4,022

2,833

Operating loss

(4,999)

(5,083)

Financial expenses (income), net

(47)

(101)

Taxes on income (Note 12)

Net loss

$ (4,952)

$ (4,982)

Basic and diluted net loss per share from

continuing operations

$ (0.26)

$ (0.27)

Weighted average number of shares

outstanding used in computing basic and

diluted net loss per share

18,777,348

18,663,162

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

December 31,

2 0 1 7

2 0 1 6

U.S. $ in thousands

ASSETS

Current Assets:

Cash and cash equivalents

$ 2,483

$ 547

Short-term deposit (Note 8)

BrainStorm to Host an Annual Financial Results Call and Provide a Corporate Update on Thursday, March 8

Mon, 05 Mar 2018 12:00:00 GMT

BrainStorm's senior management team, including Chaim Lebovits, CEO, Ralph Kern, M.D., MHSc, COO & CMO, and Eyal Rubin, CFO, will host a conference call and webcast for the investment community on Thursday, March 8 at 8:30am Eastern.

Thursday, March 8, 2017 @ 8:30am Eastern Time

TOLL-FREE: 1-800-289-0438

TOLL/INTERNATIONAL: 1-323-794-2423

ISRAEL TOLL-FREE: 1809 212 883 Webcast link: https://goo.gl/tMC3zV

Replays, available through March 22, 2018

Replay Dial-In Numbers:

TOLL-FREE: 1-844-512-2921

TOLL/INTERNATIONAL: 1-412-317-6671

Replay Pin Number: 3071165 About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm's NurOwn® Phase 2 ALS Clinical Trial and Biomarker Abstracts Accepted for Platform Presentations at the 70th Annual American Academy of Neurology Meeting in Los Angeles, California

Wed, 07 Feb 2018 12:00:00 GMT

Platform presentations:

"NurOwn® Phase 2 ALS Trial: ALSFRS-R Improvement is Reflected in Subscale Domains" Session S38: "Best of" Session: Clinical Trial Updates in Neuromuscular Disorders on April 26, 2018 Presenter: Merit E. Cudkowicz MD, Chief Neurology Service, Director Amyotrophic Lateral Sclerosis Clinic, Co-Director Neuromuscular Division, Massachusetts General Hospital.

"Modulation of CSF miRNAs in ALS phase 2 study participants treated with MSC-NTF cells (NurOwn®)" Session S25: Advances in Amyotrophic Lateral Sclerosis on April 24, 2018 Presenter: Ralph Z. Kern MD, MHSc, Chief Operating and Medical Officer, BrainStorm Cell Therapeutics.

"Our Phase 2 placebo-controlled trial demonstrated promising clinical activity for NurOwn ® in ALS, and the subgroup analyses confirm that ALSFRS-R subdomains contribute to this treatment effect. The CSF biomarker data confirms that micro-RNA released by NurOwn ® may contribute to its therapeutic effect in ALS", said Ralph Kern MD, BrainStorm's Chief Operating Officer and Chief Medical Officer.

"We are pleased to have these scientific abstracts accepted at the prestigious AAN Annual Meeting, which is the largest North American Neurology conference. We are committed to continuing to understand the value that NurOwn brings to ALS through innovative clinical and scientific evaluation, and to advance the phase 3 pivotal study to bring a meaningful solution to ALS patients," commented BrainStorm's CEO Chaim Lebovits.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com .

Contacts Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com Investors: Michael Rice LifeSci Advisors LLC Phone: 646-597-6979 mrice@lifesciadvisors.com Media: Matt Middleman, M.D.LifeSci Public Relations, LLC Phone: 646-627-8384 matt@lifescipublicrelations.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Cell Therapeutics to Present at the BIO CEO & Investor Conference

Tue, 06 Feb 2018 12:00:00 GMT

BIO CEO & Investor Conference Presentation Details

Date:

Monday, February 12

Time:

2:00pm Eastern Time

Location:

New York Marriott Marquis, Wilder Room

Webcast:

https://goo.gl/Dj4Dvc

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U.S., a clinically meaningful benefit was demonstrated by a higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Cell Therapeutics Appoints Senior Kite Executive, Anthony Polverino, Ph.D., to Board of Directors

Mon, 05 Feb 2018 12:00:00 GMT

"We are honored to have Dr. Polverino join our board of directors," said Chaim Lebovits, president and chief executive officer of BrainStorm Cell Therapeutics. "His extensive experience in the biotech industry and in academic research, which includes senior roles at Kite, a Gilead Company and Amgen, will be invaluable as we continue to develop NurOwn ® as a potential breakthrough treatment for amyotrophic lateral sclerosis (ALS) and pursue development of our pipeline candidates in other CNS diseases. We look forward to the strategic insights and contributions he will make."

Dr. Polverino is currently the interim chief scientific officer of Kite (now a wholly-owned subsidiary of Gilead Sciences), which he joined in 2015, and where he is currently responsible for establishing Kite's strategic non-clinical R&D roadmap to support its current and future portfolio. Prior to this, he was the vice president of research at Kite, where his responsibilities included corporate goal setting, budget allocation, scientific and investor interactions, business development in-licensing and partnership deals. Dr. Polverino spent 20 years in positions of increasing responsibilities at Amgen, Inc., most recently as executive director of its Therapeutic Innovation Unit, where he managed research programs in oncology, metabolic disease, inflammatory disease and schizophrenia. Prior to Amgen, he was a postdoctoral scientist at Cold Spring Harbor Laboratory, where he worked primarily on oncology research. Dr. Polverino is an author of several patents, and has been published in nearly 40 scientific and peer-reviewed journals. He earned a B.Sc. in Biochemistry/Physiology and a B.Sc. (Honors) in Pharmacology, both from Adelaide University in Adelaide, Australia and a Ph.D. in Biochemistry from Flinders University, also in Adelaide.

"I am excited to have the opportunity to join Brainstorm's board of directors," said Dr. Polverino. "Brainstorm is developing innovative treatments for patients with neurodegenerative diseases and I look forward to providing scientific and business guidance to the company."

About NurOwn® NurOwn® utilizes a patient's own cells which have been engineered outside the body, to produce and secrete factors known to promote neuronal survival. NurOwn® has the potential to be the first ALS treatment to improve patient functioning as a regenerative medicine. Regenerative medicine solutions are desperately needed in the field of neurodegenerative diseases as current therapies have limited efficacy, only slow progression and do not maintain or restore function. NurOwn® is currently being tested in a multi-site Phase 3 clinical trial in the U.S. and, if successful, the results from this trial will submitted to the FDA and other regulatory authorities around the world with the goal of obtaining marketing approval. BrainStorm has completed two single arm clinical trials which established the safety profile of NurOwn® and provided indications of a treatment benefit. Additionally, the company has completed a double-blind, placebo-controlled Phase 2 study at three prestigious academic medical centers in the US. In this study, clinically meaningful changes in functioning were observed in patients receiving NurOwn®.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm to Present at Precision Medicine World Conference 2018 Silicon Valley on January 22

Tue, 16 Jan 2018 12:00:00 GMT

Presentation Details:

Session: Emerging Therapeutics ShowcaseTime: 10:45 a.m. PT, January 22 Location: Computer History Museum, 1401 N Shoreline Blvd Mountain View, CA 94043

Brainstorm will participate in the Emerging Therapeutics Showcase session which will feature selected companies in the CRISPR, cell and gene therapy fields.

About Precision Medicine World Conference (PMWC) The Precision Medicine World Conference (PMWC), formerly known as the Personalized Medicine World Conference, is an independent and established conference series considered to be the preeminent precision medicine conference that attracts recognized leaders, top global researchers and medical professionals, and innovators across healthcare and biotechnology sectors to showcase practical content that helps close the knowledge gap between different sectors, thereby catalyzing cross-functional fertilization and collaboration. Since 2009, recognized as a vital cornerstone for all constituents of the health care and biotechnology community, PMWC provides an exceptional forum for the exchange of information about the latest advances in technology, in clinical implementation, research, and in all aspects related to the regulatory and reimbursement sectors.

About NurOwn ® NurOwn® utilizes a patient's own cells which have been engineered outside the body, to produce and secrete factors known to promote neuronal survival. NurOwn® has the potential to be the first ALS treatment to improve patient functioning as a regenerative medicine. Regenerative medicine solutions are desperately needed in the field of neurodegenerative diseases as current therapies have limited efficacy, only slow progression and do not maintain or restore function. NurOwn® is currently being tested in a multi-site Phase 3 clinical trial in the U.S. and, if successful, the results from this trial will submitted to the FDA and other regulatory authorities around the world with the goal of obtaining marketing approval. BrainStorm has completed two single arm clinical trials which established the safety profile of NurOwn® and provided indications of a treatment benefit. Additionally, the company has completed a double-blind, placebo-controlled Phase 2 study at three prestigious academic medical centers in the US. In this study, clinically meaningful changes in functioning were observed in patients receiving NurOwn®.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U.S., a clinically meaningful benefit was demonstrated by a higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstormcell.com.

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Granted GMP Certification for a Marketing-Level Manufacturing of NurOwn®

Wed, 03 Jan 2018 12:00:00 GMT

"BrainStorm received overwhelming demand from patients and physicians in many countries for access to NurOwn®. We are pleased to receive this important GMP approval, taking us one step closer to making our therapy available to patients who do not have the opportunity to participate in our U.S. trial," said Dr. Ralph Kern, M.D., Chief Operating Officer & Chief Medical Officer of BrainStorm.

"ALS is a debilitating neurodegenerative disease with few treatment options available," said Chaim Lebovits, President & CEO of BrainStorm. "NurOwn® is a novel advanced stem cell therapy now being studied in a multi-site Phase 3 pivotal trial at leading ALS centers, and we look forward to making it available to patients through innovative regulatory pathways."

About NurOwn ® NurOwn® utilizes a patient's own cells which have been engineered outside the body, to produce and secrete factors known to promote neuronal survival. NurOwn® has the potential to be the first ALS treatment to improve patient functioning as a regenerative medicine. Regenerative medicine solutions are desperately needed in the field of neurodegenerative diseases as current therapies have limited efficacy, only slow progression and do not maintain or restore function. NurOwn® is currently being tested in a multi-site Phase 3 clinical trial in the U.S. and, if successful, the results from this trial will submitted to the FDA and other regulatory authorities around the world with the goal of obtaining marketing approval. BrainStorm has completed two single arm clinical trials which established the safety profile of NurOwn® and provided indications of a treatment benefit. Additionally, the company has completed a double-blind, placebo-controlled Phase 2 study at three prestigious academic medical centers in the US. In this study, clinically meaningful changes in functioning were observed in patients receiving NurOwn®.

About BrainStorm Cell Therapeutics Inc.BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U.S., a clinically meaningful benefit was demonstrated by a higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

Brainstorm Issues 2017 Letter to Shareholders

Fri, 29 Dec 2017 12:00:00 GMT

Dear Valued Shareholders,

This past year was an extraordinary success for BrainStorm Cell Therapeutics. A key accomplishment was the enrollment of the first US patients in the Phase 3 clinical trial of NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). In addition to our clinical success, we have further developed our manufacturing capabilities in many ways, including validating the cryopreservation process. Financially, we received additional non-dilutive grants from the California Institute for Regenerative Medicine (CIRM) as well as the Israel Innovation Authority. In addition, we have further strengthened our executive team with new key appointments.

In October, we enrolled the first patients in the randomized, double-blind, placebo-controlled multi-dose Phase 3 clinical trial of NurOwn® for the treatment of ALS. Our Phase 3 trial builds upon the promising efficacy demonstrated in our Phase 2 randomized US trial, the first ALS study data to highlight the restoration of patient function.

As the most advanced stem cell therapy in development for the treatment of ALS, our Phase 3 trial will enroll approximately 200 patients at six leading clinical sites in the U.S. The NurOwn® phase 3 trial patient population will focus on the patient sub-groups which demonstrated superior outcomes in the Phase 2 ALS clinical trial. The primary outcome measure will be the ALSFR-S score responder analysis, a score that measures a patient's ability to perform tasks that are affected by ALS. We expect interim safety data in mid 2018 and top-line data in late 2019. The phase 3 trial will also expand upon phase 2 biomarkers to further evaluate their potential to predict ALS disease progression and NurOwn® treatment response.

The pivotal phase 3 NurOwn® trial is being supported by a $16 million non-dilutive grant from the California Institute for Regenerative Medicine (CIRM). In addition, for the tenth consecutive year, we have received non-dilutive grants from the Israel Innovation Authority to further support the development of NurOwn®, including a $2.1 million grant in 2017.

We met and exceeded expectations in 2017 on the manufacturing and product development front. As an important milestone for potential commercialization, in early 2017 our NurOwn® cryopreservation process was validated for the Phase 3 clinical study for treatment of ALS. Additionally, to further expand our manufacturing capabilities, we contracted the City of Hope's Center for Biomedicine and Genetics, California, to produce clinical supplies of NurOwn® for our Phase 3 trial.

We continue to explore strategic partnerships to advance NurOwn's clinical development and maximize its market potential. In 2017 we signed a Memorandum of Understanding (MOU) to explore the possibility of making NurOwn® available to ALS patients under provision of the MOH Hospital Exemption regulation with Tel Aviv Sourasky Medical Center.

In addition, this year we expanded our patent portfolio by obtaining an additional US patent for BrainStorm's NurOwn® technology for the treatment of ALS and Parkinson's disease. This move further protects our technology and is a result of BrainStorm's ongoing development and clinical successes.

In parallel to our NurOwn® successes, we strengthened our executive team and board of directors. We added three senior members to our executive team: Ralph Z. Kern, MD, MHSc joined Brainstorm in a dual role as Chief Operating Officer and Chief Medical Officer, starting in March. In August, Mary Kay Turner joined as Vice President of Patient Advocacy and Government Affairs. Eyal Rubin joined early November as Chief Financial Officer, responsible for corporate finance and accounting. These individuals were chosen for their deep neuroscience experience, significant industry expertise and long track record of industry achievements.

Our Board of Directors was strengthened in February with the addition of June S. Almenoff, M.D., Ph.D., FACP, and Arturo O. Araya, M.A., M.B.A. Their vast experience in drug development and commercialization, and cell and gene therapy are valuable assets to our company, particularly at this important time.

This year, in addition to support enrollment in the Phase 3 ALS clinical trial, we are also looking to advance BrainStorm's pipeline in other neurodegenerative diseases, based on strong preclinical data in Parkinson's disease and Multiple Sclerosis.

In closing, management is dedicated to achieving our primary goals to deliver value for our shareholders, to develop transformative cell therapies for ALS and other severe neurodegenerative diseases, and to be the leader in this field. We have accomplished much in the past year but there is no doubt in our mind that our best days are ahead of us. Thank you for your continued interest in and commitment to support Brainstorm.

Please do not hesitate to contact us directly with any additional questions; we can be reached at info@brainstorm-cell.com

Sincerely, Chaim Lebovits President and CEO BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics to Present at the 10th Annual Biotech Showcase

Wed, 20 Dec 2017 12:00:00 GMT

10th Annual Biotech Showcase Presentation Details

Date:

Monday, January 8, 2018

Time:

4:00pm Pacific Time

Location:

Hilton San Francisco Union Square, Yosemite B

Webcast:

https://goo.gl/pvpJbC

Meetings BrainStorm senior management will also be hosting institutional investor and partnering meetings at the Biotech Showcase conference or through the LifeSci Advisors Corporate Access Event taking place in San Francisco, January 8-10, 2018.

To schedule a meeting with BrainStorm Cell Therapeutics, investors can reach out through the Biotech Showcase one-on-one partnering system (https://goo.gl/a1XZB3) or register on the online system managed by the Company's US investor relations firm, LifeSci Advisors, LLC, or make a request via e-mail at Access@LifeSciAdvisors.com.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm's Abstracts on Phase 2 NurOwn® Biomarkers Accepted for Presentation at the International Symposium on ALS/MND in Boston

Wed, 29 Nov 2017 12:00:00 GMT

The posters will feature the analyses of chitotriosidase (CHIT-1) and microRNAs (miRNAs) in the cerebrospinal fluid (CSF) of ALS patients participating in the Phase 2 study, as biomarkers to evaluate ALS disease progression and NurOwn® treatment response.

"Our Phase 2 placebo-controlled trial demonstrated clinical activity for NurOwn® in ALS, including evidence of disease halting, and the data in these two abstracts support the mechanism of action of NurOwn®. We are pleased to have them accepted for poster presentation at the prestigious ALS/MND symposium, which is the largest medical and scientific conference specific to MND/ALS. We are committed to advancing ALS science and to the development of innovative and advanced cell therapies to meaningfully address neurological diseases," commented BrainStorm's CEO Chaim Lebovits.

Presentation details are as follows:

Title:

Chitotriosidase as a biomarker for ALS

Date:

Friday December 8, 2017

Time:

17.45 – 19.30, Eastern Time

Session:

Poster Session A

Title:

Modulation of miRNAs in the CSF of ALS patients treated with MSC-NTF cells

(NurOwn®)

Date:

Saturday December 9, 2017

Time:

17.45 – 19.30, Eastern Time

Session:

Poster Session B

The 28th International Symposium on ALS/MND will take place at the Westin Boston Waterfront, 425 Summer Street, Boston. For more information, refer to https://www.mndassociation.org/symposium/about-the-event/

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

New Peer Reviewed Publication Shows That BrainStorm's NurOwn® Has a Unique miRNA Signature

Thu, 09 Nov 2017 12:00:00 GMT

The publication shows that NurOwn® (MSC-NTF cells) - mesenchymal stem cells (MSC) induced to secrete neurotrophic factors (NTF) - have both an enhanced secretion of NTFs as well as a distinct miRNA expression profile that distinguishes them from their MSCs of origin. miRNAs are short, non-coding RNAs that regulate gene expression by post transcriptional silencing and have been shown to play critical roles in biological processes. The study shows that BrainStorm's proprietary differentiation process modulates miRNA expression, leading to a unique miRNA signature. These findings may form the basis for the development of sensitive identity release assays for clinical trials, for in vivo cell identification assays and to elucidate MSC-NTF cells' mechanism of action in ALS and other neurodegenerative diseases.

"This study further confirms NurOwn's unique characteristics and underscores our leadership and scientific capability to manufacture the most advanced cell therapies to address neurodegenerative diseases," commented BrainStorm's CEO Chaim Lebovits.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com .

Safe-Harbor Statement

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Strengthens Executive Team: Appoints Eyal Rubin as Chief Financial Officer

Thu, 02 Nov 2017 12:00:00 GMT

Eyal Rubin joins BrainStorm from Teva Pharmaceutical Industries, Ltd., where he served as Vice President and Head of Corporate Treasury since 2013. While at Teva, he was responsible for Teva's cash operations (over $35 billion in annual cash transactions), cash management (over $1 billion in cash) as well as Teva's equity and debt capital market transactions (over $35 billion of debentures and term loans). From 2010 through 2013, Mr. Rubin was the Finance & Banking Manager for Cellcom Israel, LTD., where he was responsible for cash management and the operational financial aspects, including payment and control, investments, and hedging. From 2006 to 2010, Mr. Rubin was Chief Financial Officer for IDT Carmel, Inc. a wholly owned subsidiary of IDT Corp., where he was responsible for all of the financial aspects of IDT Carmel, including budgeting, periodical reports to the parent corporation, costing, tax, and payroll. From 2003 to 2005, he was General Manager and Chief Financial Officer for V-Secure Technologies, where he managed the mergers and acquisition process from the early stage of negotiations, due diligence until successful completion of the acquisition by Radware in December 2005. From 1999-2003, he was the Chief Operating Officer and Vice President Finance for Sec2Wireless, where he managed the financial aspects of the reverse merger with TravelNG in 2003.

"We are pleased to have Eyal join the BrainStorm team," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics. "He is the third senior person to join our team in 2017, following the appointments of Dr. Ralph Kern as Chief Operating Officer and Chief Medical Officer, and Mary Kay Turner as Vice President of Patient Advocacy and Government Affairs. We recently initiated a Phase 3 clinical program investigating NurOwn® in amyotrophic lateral sclerosis (ALS), and we currently anticipate top-line data in 2019. Eyal's corporate finance experience with large commercial operations, including Teva Pharmaceuticals, will be invaluable to us."

Mr. Rubin earned his Masters of Business Administration from Bar Ilan University, where he graduated Summa Cum Laude with a specialization in Finance, and his Bachelor of Arts in Business Administration from the College of Management, where he graduated Summa Cum Laude with a specialization in Financing and IT Systems.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

CONTACTS Media: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Expands Its Patent Portfolio to Include a New US Patent For Its NurOwn® Technology for Parkinson's Disease And ALS

Mon, 23 Oct 2017 12:00:00 GMT

The allowed claims cover methods of treating amyotrophic lateral sclerosis (ALS) and Parkinson's disease using mesenchymal stem cells that secrete neurotrophic factors, including glial derived neurotrophic factor (GDNF).

"We continue to protect our technology through strategic intellectual property achievements and this Notice of Allowance from the USPTO is a welcome addition to our IP portfolio," commented BrainStorm's CEO Chaim Lebovits.

This patent is the result of Brainstorm's ongoing development of NurOwn® that initiated at the Tel Aviv University, neuroscience laboratory of Prof. Dani Offen, the company's chief scientific advisor.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 70 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstormcell.com.

Safe-Harbor Statement

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

BrainStorm Announces Third Quarter 2017 Financial Results

Tue, 17 Oct 2017 12:00:00 GMT

"We have had a very active third quarter culminating in the initiation of our Phase 3 trial investigating NurOwn® in amyotrophic lateral sclerosis(ALS), as announced yesterday. The first patients have enrolled into the trial, and we look forward to data in 2019," said Chaim Lebovits, president and chief executive officer of BrainStorm. "ALS is a devastating disease with very few treatment options for patients. In our placebo-controlled phase 2 trial NurOwn® demonstrated significant clinical benefit for ALS patients. We look forward to providing updates as the Phase 3 trial progresses."

Third Quarter Highlights:

Financial Results for the Third Quarter Ended September 30, 2017

Financial Results for the Nine Months Ended September 30, 2017

Conference Call on Tuesday, October 17, 2017 Members of BrainStorm's senior management team, including Chaim Lebovits, CEO, and Ralph Kern, M.D., MHSc, COO and CMO, will host a conference call and live webcast for the investment community on Tuesday, October 17, 2017 at 8:30am Eastern Time. The details are as follows:

Toll Free:

888-395-3237

Israel Investors:

1 80 924 5905

International:

719-325-2349

Conference ID:

4131959

Webcast:

http://public.viavid.com/index.php?id=126580

Replays, available through October 31, 2017

Toll Free:

844-512-2921

International:

412-317-6671

Conference ID:

4131959

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Media: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (Except share data)

September 30,

December 31,

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

Cash and cash equivalents

$ 2,464

$ 547

Short-term deposit (Note 4)

8,083

9,443

Account receivable

318

306

Prepaid expenses and other current assets

148

Total current assets

10,951

10,444

Long-Term Assets:

Prepaid expenses and other long-term assets

Property and Equipment, Net

358

297

Total Long-Term Assets

384

322

Total assets

$ 11,335

$ 10,766

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities:

Accounts payables

$ 275

$ 345

Accrued expenses

204

152

Deferred grant income (Note 5)

5,250

Other accounts payable

411

367

Total current liabilities

6,140

864

Stockholders' Equity:

Stock capital: (Note 6)

Common stock of $0.00005 par value - Authorized: 100,000,000 shares at September 30, 2017 and December 31, 2016 respectively; Issued and outstanding: 18,842,726 and 18,687,987 shares at September 30, 2017 and December 31, 2016 respectively.

Additional paid-in-capital

85,535

85,014

Accumulated deficit

(80,351)

(75,123)

Total stockholders' equity

5,195

9,902

Total liabilities and stockholders' equity

$ 11,335

$ 10,766

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) U.S. dollars in thousands (Except share data)

Nine months ended

Three months ended

September 30,

Unaudited

Operating expenses:

Research and development, net

$ 2,544

$ 1,927

$ 1,168

$ 790

General and administrative

2,693

2,506

1,224

848

Operating loss

(5,237)

(4,433)

(2,392)

(1,638)

Financial expense (income), net

(9)

(75)

(32)

Net loss

$ (5,228)

$ (4,358)

$ (2,403)

$ (1,606)

Basic and diluted net profit (loss) per share

$ (0.28)

$ (0.23)

$ (0.13)

$ (0.09)

Weighted average number of shares outstanding used in computing basic and diluted net loss per share

18,737,307

18,654,826

18,783,997

18,656,615

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

September 30,

December 31,

2017

2016

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

Cash and cash equivalents

BrainStorm Enrolls First Patients in Phase 3 Trial of NurOwn® in ALS

Mon, 16 Oct 2017 12:00:00 GMT

The trial is expected to enroll approximately 200 patients and will be conducted at six leading ALS clinical sites in the U.S. The primary outcome measure will be the ALSFR-S score responder analysis. The patient population will be optimized to include the pre-specified subgroups who demonstrated superior outcomes in the NurOwn® Phase 2 ALS clinical trial. Top-line data are expected in 2019. For more information, refer to www.clinicaltrials.gov , using the NCT identifier NCT03280056.

"NurOwn® is a highly innovative and advanced stem cell therapy now being studied in a phase 3 trial in ALS. The support of this trial by the California Institute of Regenerative Medicine (CIRM) highlights the importance of addressing ALS unmet need beyond currently available therapies, which slow disease progression but do not maintain or restore function," said Chaim Lebovits, president and CEO of Brainstorm. "BrainStorm plans to quickly advance the phase 3 trial to confirm promising phase 2 efficacy findings and bring much needed hope to ALS patients and their families."

Dr. Robert Miller, director of the Forbes Norris ALS Research Center at California Pacific Medical Center, added: "Stem cells are emerging as a potential viable candidate to treat ALS, and we are very excited to be participating in this important Phase 3 trial. The clinical data from NurOwn® have been encouraging, demonstrating clear evidence of clinical benefit and supported by analysis of inflammatory markers and neurotrophic factors in treated patients. NurOwn® cells have the important advantage of being autologous, so patients do not need to be immunosuppressed. In addition, the production process is relatively straightforward, and the harvesting and delivery of cells is much less invasive than other stem cell systems that have been tested in the clinic. We have been conducting ALS clinical trials for more than two decades at California Pacific Medical Center and this is, by far, the most exciting trial in which we have been involved to date."

Maria Millan, M.D., president and CEO of CIRM said: "CIRM's partnership with Brainstorm Therapeutics represents an international collaboration to find a treatment for ALS or 'Lou Gehrig's Disease,' a devastating neurologic and fatal condition for which there is currently no durable treatment or cure. CIRM is partnering with Brainstorm to follow up on the Company's promising phase 2 trial in patients with ALS." Abla Creasey, Ph.D. senior director of strategic Infrastructure at CIRM added: "Brainstorm will conduct this trial at multiple sites in California, including our Alpha Clinics Network and will also manufacture its product in California using CIRM-funded infrastructure."

This trial is supported by a $16 million non-dilutive grant from CIRM. A milestone payment of $5.5 million, representing approximately 30% of the grant, has been received.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U.S., a clinically meaningful benefit was demonstrated by a higher response to NurOwn® compared with placebo. For more information, visit the company's website at www.brainstormcell.com.

Safe-Harbor Statement

Contacts

Corporate: Uri Yablonka Chief Business Officer BrainStorm Cell Therapeutics Inc. Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Corporate:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Media:

Matt Middleman, M.D.

LifeSci Public Relations, LLC

Phone: 646-627-8384

matt@lifescipublicrelations.com

Brainstorm to Announce Third Quarter Financial Results And Provide Corporate Updates on Tuesday, October 17

Tue, 03 Oct 2017 12:00:00 GMT

Tuesday, October 17, 2017 @ 8:30am Eastern Time

Toll Free:

888-395-3237

Israel Investors:

1 80 924 5905

International:

719-325-2349

Conference ID:

4131959

Webcast:

http://public.viavid.com/index.php?id=126580

Replays, available through October 31, 2017

Toll Free:

844-512-2921

International:

412-317-6671

Conference ID:

4131959

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Media:

Uri Yablonka

Chief Business Officer

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Cell Therapeutics to Present at the 2017 Disruptive Growth Company Showcase NYC Presented by SeeThruEquity and RHK Capital

Wed, 27 Sep 2017 12:00:00 GMT

Each company will be provided with a 30-minute time slot to present to an audience of investors and industry professionals and company management will also be available for one-on-one meetings with institutional investors.

Conference registration: complimentary for qualified investors and equity research analysts. For more information on the conference please visit www.disruptnyc.com.

About SeeThruEquity

Since its founding in 2011, SeeThruEquity has been committed to its core mission: providing impactful, high quality research on underfollowed smallcap and microcap equities. SeeThruEquity has pioneered an innovative business model for equity research that is not paid for and is unbiased. SeeThruEquity is the host of acclaimed investor conferences that are the ultimate event for publicly traded companies with market capitalizations less than $1 billion.

SeeThruEquity is approved to contribute its research reports and estimates to Thomson One Analytics (First Call), the leading estimates platform on Wall Street, as well as Capital IQ and FactSet. SeeThruEquity maintains one of the industry's most extensive databases of opt-in institutional and high net worth investors. The firm is headquartered in Midtown Manhattan in New York City.

For more information please visit www.seethruequity.com.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS Media: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Announces Second Quarter 2017 Financial Results

Tue, 15 Aug 2017 12:00:00 GMT

"We are in the advanced stages of preparing for our pivotal Phase 3 trial to investigate NurOwn® in ALS," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We have agreements with Mass. General Hospital, California Pacific Medical Center and University of California-Irvine Medical Center to participate as centers in the trial, which will be funded in part by a non-dilutive grant of $16 million awarded by the California Institute for Regenerative Medicine (CIRM). Based on the body of preclinical and clinical data we have compiled on NurOwn®, including data from our placebo-controlled Phase 2 trial which showed evidence of halting in disease progression, we believe that NurOwn® has the potential to become a valuable treatment option for ALS patients."

Second Quarter and Recent Financial Highlights:

Financial Results for the Second Quarter Ended June 30, 2017

Financial Results for the Six Months Ended June 30, 2017

Conference Call on Wednesday, August 16 th

Members of BrainStorm's senior management team, including Chaim Lebovits, CEO, and Ralph Kern, M.D., MHSc, COO and CMO, will host a conference call and live webcast for the investment community on Wednesday, August 16, 2017 at 8:30am Eastern Time. The details are as follows:

Toll Free: 877-718-5095 Israel Investors: 1 80 924 6042 International: 913-312-0381 Conference ID: 1392963 Webcast: http://public.viavid.com/index.php?id=125868

Replays, available through August 30, 2017 Toll Free: 844-512-2921 International: 412-317-6671 Conference ID: 1392963

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

CONTACTS Media: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

June 30,

December 31,

2 0 1 7

2 0 1 6

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

Cash and cash equivalents

$ 5,784

$ 547

Short-term deposit (Note 4)

933

9,443

Account receivable

735

306

Prepaid expenses and other current assets

230

148

Total current assets

7,682

10,444

Long-Term Assets:

Prepaid expenses and other long-term assets

Property and Equipment, Net

295

297

Total Long-Term Assets

319

322

Total assets

$ 8,001

$ 10,766

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities:

Accounts payables

$ 227

$ 345

Accrued expenses

114

152

Other accounts payable

370

367

Total current liabilities

711

864

Stockholders' Equity:

Stock capital: (Note 5)

Common stock of $0.00005 par value - Authorized: 100,000,000 shares at June 30, 2017 and December 31, 2016 respectively; Issued and outstanding: 18,747,327 and 18,687,987 shares at June 30, 2017 and December 31, 2016 respectively.

Additional paid-in-capital

85,227

85,014

Accumulated deficit

(77,948)

(75,123)

Total stockholders' equity

7,290

9,902

Total liabilities and stockholders' equity

$ 8,001

$ 10,766

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

U.S. dollars in thousands

(Except share data)

Six months ended

Three months ended

June 30,

2 0 1 7

2 0 1 6

Unaudited

Operating expenses:

Research and development, net

$ 1,376

$ 1,137

$ 435

$ 151

General and administrative

1,469

1,658

640

832

Operating loss

(2,845)

(2,795)

(1,075)

(983)

Financial income, net

(20)

(43)

(35)

(21)

Net loss

$ (2,825)

$ (2,752)

$ (1,040)

$ (962)

Basic and diluted net profit (loss) per share

$ (0.15)

$ (0.06)

$ (0.05)

Weighted average number of shares outstanding used in computing basic and diluted net loss per share

18,713,575

18,653,922

18,738,496

18,654,040

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

June 30,

December 31,

2 0 1 7

2 0 1 6

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

Cash and cash equivalents

BrainStorm Announces Second Quarter 2017 Financial Results

Mon, 14 Aug 2017 12:00:00 GMT

Second Quarter and Recent Financial Highlights:

Financial Results for the Second Quarter Ended June 30, 2017

Financial Results for the Six Months Ended June 30, 2017

Conference Call on Wednesday, August 16 th

Toll Free: 877-718-5095 Israel Investors: 1 80 924 6042 International: 913-312-0381 Conference ID: 1392963 Webcast: http://public.viavid.com/index.php?id=125868

Replays, available through August 30, 2017 Toll Free: 844-512-2921 International: 412-317-6671 Conference ID: 1392963

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

CONTACTS Media: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

June 30,

December 31,

2 0 1 7

2 0 1 6

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

Cash and cash equivalents

$ 5,784

$ 547

Short-term deposit (Note 4)

933

9,443

Account receivable

735

306

Prepaid expenses and other current assets

230

148

Total current assets

7,682

10,444

Long-Term Assets:

Prepaid expenses and other long-term assets

Property and Equipment, Net

295

297

Total Long-Term Assets

319

322

Total assets

$ 8,001

$ 10,766

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities:

Accounts payables

$ 227

$ 345

Accrued expenses

114

152

Other accounts payable

370

367

Total current liabilities

711

864

Stockholders' Equity:

Stock capital: (Note 5)

Additional paid-in-capital

85,227

85,014

Accumulated deficit

(77,948)

(75,123)

Total stockholders' equity

7,290

9,902

Total liabilities and stockholders' equity

$ 8,001

$ 10,766

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

U.S. dollars in thousands

(Except share data)

Six months ended

Three months ended

June 30,

2 0 1 7

2 0 1 6

Unaudited

Operating expenses:

Research and development, net

$ 1,376

$ 1,137

$ 435

$ 151

General and administrative

1,469

1,658

640

832

Operating loss

(2,845)

(2,795)

(1,075)

(983)

Financial income, net

(20)

(43)

(35)

(21)

Net loss

$ (2,825)

$ (2,752)

$ (1,040)

$ (962)

Basic and diluted net profit (loss) per share

$ (0.15)

$ (0.06)

$ (0.05)

Weighted average number of shares outstanding used in computing basic and diluted net loss per share

18,713,575

18,653,922

18,738,496

18,654,040

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

June 30,

December 31,

2 0 1 7

2 0 1 6

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

Cash and cash equivalents

Brainstorm to Host Second-Quarter 2017 Earnings Teleconference and Provide Important Corporate Updates, on Wednesday, August 16

Thu, 10 Aug 2017 12:00:00 GMT

Wednesday, August 16, 2017 @ 8:30am Eastern Time Toll Free: 877-718-5095 Israel Investors: 1 80 924 6042 International: 913-312-0381 Conference ID: 1392963 Webcast: http://public.viavid.com/index.php?id=125868

Replays, available through August 30, 2017 Toll Free: 844-512-2921 International: 412-317-6671 Conference ID: 1392963

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Media:

Uri Yablonka

Chief Business Officer

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Supports Commitment to ALS Patient Community with Appointment of a Vice President of Patient Advocacy and Government Affairs

Mon, 07 Aug 2017 12:00:00 GMT

"We are pleased to have Mary Kay join our company as we advance our ALS clinical program and prepare to initiate Phase 3 testing of NurOwn®," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics. "Having a strong patient advocacy perspective and voice in the community is integral to our mission of advancing tomorrow's medicines. Mary Kay brings an extensive background in patient advocacy, government affairs and health policy. We are fortunate to have someone with her biopharma expertise and dedication to the patient community join our team."

"Mary Kay will lead the development and implementation of external collaborations that will address and support the needs of people living with ALS", said Dr. Ralph Z. Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm. "Working directly with patient advocacy groups deepens our understanding of patients' needs and aligns our efforts with the broader ALS community."

"I have been impressed by the progress BrainStorm has made with NurOwn, particularly the outstanding Phase 2 clinical data which showed meaningful improvements in disease symptoms," said Mary Kay Turner. "Joining the company at this exciting juncture provides a great opportunity to work with respected leaders in neurology and cell therapy and to contribute to the development of a new treatment that could potentially transform the ALS landscape."

Mary Kay is recognized as a leader within the biopharma industry for developing advocacy and government affairs strategies. Most recently she worked at Mitsubishi Tanabe Pharma America as Head of Patient Advocacy and Communications. Prior to this, Mary Kay spent 26 years at Bristol Myers Squibb Company where she played an essential role in establishing the company's advocacy function and held various positions of increasing responsibility in sales leadership, patient advocacy and government affairs. From 2010 to 2016, she was Head of State Government Affairs and Advocacy at Bristol-Myers. In this role she led a team of government affairs professionals that focused on significant legislative and regulatory issues that promoted and protected the discovery and development of innovative therapies. Mary Kay helped to define the company's advocacy strategy and engagement for each of its key therapeutic areas.

In 2016, Mary Kay was appointed to the Arizona Biomedical Research Commission by Arizona Governor Doug Ducey and served a one-year term. She was on the Board of Advisers for the International Cancer Advocacy Network (ICAN). Currently, Mary Kay is a member of the Board of Directors for the ALS Hope Foundation. She also served on the Board of Directors for Mental Health America for 3 years. Mary Kay has a Bachelor of Arts degree in Political Science and History from the University of Oregon.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Radicava™ is a registered trademark of Mitsubishi Tanabe Pharma America.

Contacts Media: Uri Yablonka Chief Business OfficerBrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Announces Agreement with University of California Irvine Medical Center to Participate in Phase 3 Trial of NurOwn® in ALS

Tue, 25 Jul 2017 12:00:00 GMT

UCI has become the third medical center to enter into a clinical trial agreement with BrainStorm to enroll patients in the planned Phase 3 study for NurOwn. Mass. General Hospital (MGH) and California Pacific Medical Center (CPMC) have both agreed to participate in the trial and will be enrolling patients, as announced last week.

"We are privileged to have UCI and Dr. Goyal join our pivotal Phase 3 study of NurOwn," said Chaim Lebovits, President and Chief Executive Officer. "Adding UCI as an enrolling center with Dr. Goyal as Principal Investigator will make the treatment more accessible to patients in California, and we welcome the opportunity to work with this prestigious institution."

"NurOwn is a very promising treatment with compelling Phase 2 data in patients with ALS; we look forward to further advancing it in clinical development and confirming the therapeutic benefit with Brainstorm," said Dr. Namita Goyal, Director, ALS Clinic, Neuromuscular Medicine Fellowship and Neuromuscular Diagnostic Laboratory, University of California, Irvine.

Namita Goyal, M.D. is an Associate Clinical Professor of Neurology in the Department of Neurology at the University of California, Irvine School of Medicine. She is a specialist in neuromuscular medicine, with board certifications in neurology, electrodiagnostic medicine and neuromuscular medicine. Dr. Goyal completed her residency in neurology at University of Chicago Medical Center, followed by a fellowship in clinical neurophysiology and neuromuscular disease at Harvard University's Massachusetts General Hospital, where she also served as a neuromuscular clinician for several years. Dr. Goyal is currently a treating physician at UC Irvine, with a special focus on ALS, and has been the lead site investigator in several ALS clinical trials.

UCI is also part of the Alpha Stem Cells Clinics Network, which is funded by the California Institute for Regenerative Medicine (CIRM). The Alpha Stem Cells Clinics Network is specializing in delivering stem cell clinical trials to patients.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Brainstorm Awarded $16 Million Non-Dilutive Grant from CIRM in Support of Phase 3 Clinical Trial of NurOwn® in ALS

Fri, 21 Jul 2017 12:00:00 GMT

The grant from CIRM is a significant endorsement of the potential for Brainstorm's novel approach to treat ALS using adult stem cells. CIRM is the World's Largest Institution Dedicated to Cell Therapies.

"We are honored to be awarded this CIRM grant, and appreciate the support of CIRM in the development of NurOwn," said Chaim Lebovits, President and CEO of Brainstorm. "This substantial award provides further support for our technology and clinical program, and recognizes the importance of developing effective treatments for patients afflicted with ALS."

Dr. Maria Millan, interim President and CEO of CIRM commented, "ALS is a devastating disease with an average life expectancy of less than five years and individuals afflicted with this condition suffer an extreme loss in quality of life. They lose the ability to walk, dress themselves, speak, swallow and breathe. CIRM is partnering with Brainstorm to follow up on the Company's promising phase 2 trial in patients with ALS. CIRM's mission is to accelerate stem cell treatments to patients with unmet medical needs and, in keeping with this mission, our objective is to find a treatment for patients ravaged by this neurologic condition for which there is currently no cure."

Brainstorm is in the advanced stages of planning a Phase 3 clinical trial investigating NurOwn in ALS. The trial is expected to enroll approximately 200 patients and will be conducted at 6 top ALS clinical sites in the U.S. The primary outcome measure will be the ALSFR-S score responder analysis. The patient population will be optimized to include faster-progressing patients who demonstrated superior outcomes in the NurOwn Phase 2 ALS trial.

About the California Institute for Regenerative Medicine (CIRM)

CIRM's mission is to accelerate stem cell treatments to patients with unmet needs. With $3 billion in funding and approximately 300 active stem cell programs in its portfolio, CIRM is the world's largest institution dedicated to helping people by bringing the future of cellular medicine closer to reality. To meet this challenge, CIRM has a team of highly trained and experienced professionals focused on actively partnering with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today's most promising stem cell technologies. For more information, go to www.cirm.ca.gov.

Safe-Harbor Statement

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause Brainstorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with Brainstorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in Brainstorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on Brainstorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

About Brainstorm Cell Therapeutics Inc.

Brainstorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U.S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Media:

Uri Yablonka

Chief Business Officer

Brainstorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Announces Agreements with Mass. General Hospital and California Pacific Medical Center to Participate in Phase 3 Trial of NurOwn® in ALS

Tue, 18 Jul 2017 12:00:00 GMT

"It is a privilege to be working with Mass. General once again and to welcome CPMC as a new clinical site in our Phase 3 trial," said Chaim Lebovits, President and CEO of BrainStorm. "We are excited to be taking the final steps towards U.S. launch of this trial and will be announcing the participation of other hospital sites in the near future."

"Prior studies of NurOwn showed promising biological and clinical effects," said Merit E. Cudkowicz, MD, MSc, Professor of Neurology at Harvard Medical School and Chief of Neurology at Massachusetts General Hospital. "Based on the results of the Phase 2 trial in which we participated, a larger confirmatory trial that incorporates repeat dosing is warranted. I look forward to working with Brainstorm on this pivotal study."

"We are all excited about the potential of stem cells for ALS, but the results to date with NurOwn are especially promising," said Dr. Robert Miller, Director of the Forbes Norris ALS Research Center at the California Pacific Medical Center in San Francisco. "The clinical impact observed to date, along with potential biomarker findings, make this upcoming Phase 3 trial one of the most exciting ALS clinical trials ever."

Dr. Merit Cudkowicz is the Julianne Dorn Professor of Neurology at Massachusetts General Hospital, at Harvard Medical School. She directs the Massachusetts General Hospital ALS Program and the Neurological Clinical Research Institute (NCRI; formerly the NCTU). She is one of the founders and previous co-director of the Northeast ALS Consortium (NEALS), a group of 109 clinical sites in the United States and Canada dedicated to performing collaborative academic led clinical trials in ALS. In conjunction with the NEALS consortium, she planned and completed many multi-center clinical trials in ALS.

Dr. Robert Miller is Director of the Forbes Norris ALS Research Center at the California Pacific Medical Center (CPMC) in San Francisco. He was the lead author of the AAN evidence-based practice parameters for managing the disease, published in 1999 and the updated in 2009. He has been active in ALS clinical trials and is the chair of the Western ALS Study Group, an organization that has carried out numerous clinical trials in ALS. He was the chair of the ALS Outcomes Research group, ALS CARE, and later ALS Connection, resulting in numerous publications about quality of care and outcomes in ALS. He has been involved with several collaborative efforts to find better markers for disease progression and better treatments for ALS.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Contacts

Media:

Uri Yablonka

Chief Business Officer

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Worldwide Clinical Trials Selected by BrainStorm as CRO for Phase 3 NurOwn Trial in ALS

Mon, 03 Jul 2017 12:00:00 GMT

"Selecting a CRO is a critical step before initiating patient enrollment into our Phase 3 study of NurOwn in the treatment of ALS," said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "We see Worldwide as the ideal partner for this important clinical trial - its deep expertise and capabilities in managing pivotal Phase 3 clinical trials in more than 60 countries, particularly in the fields of ALS and neurology, will be tremendous assets to us."

With support from Worldwide, BrainStorm will proceed with conducting a randomized, double-blind, placebo-controlled multi-dose Phase 3 trial that will be conducted at multiple sites.

About Worldwide Clinical Trials: Worldwide Clinical Trials employs more than 1,400 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world sees CROs – in the best possible way. From early phase and bioanalytical sciences through late phase and post-approval, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune-mediated inflammatory disorders (IMID) and rare diseases. We never compromise on science or safety. We're never satisfied with the status quo. We're the Cure for the Common CRO. For more information, visit Worldwide.com.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University . NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel . In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS

Worldwide Contacts Media: Sherri Stuart, Worldwide Clinical Trials, +1 610-563-8768, sherri.stuart@worldwide.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/worldwide-clinical-trials-selected-by-brainstorm-as-cro-for-phase-3-nurown-trial-in-als-300482969.html

Contacts

Media:

Uri Yablonka

Chief Business Officer

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

Worldwide Contacts

Media:

Sherri Stuart, Worldwide Clinical Trials, +1 610-563-8768,

sherri.stuart@worldwide.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/worldwide-clinical-trials-selected-by-brainstorm-as-cro-for-phase-3-nurown-trial-in-als-300482969.html

BrainStorm to Provide Corporate Update at the BIO International Convention

Wed, 14 Jun 2017 12:00:00 GMT

Presentation Details

Date: Wednesday, June 21Time: 2:00pm Pacific TimePresenter: Chaim Lebovits, Chief Executive Officer, BrainStorm Cell TherapeuticsLocation: San Diego Convention Center, Company Presentation Theater 3Webcast: http://www.veracast.com/webcasts/bio/internationalconvention2017/96236165162.cfm

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult mesenchymal stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-to-provide-corporate-update-at-the-bio-international-convention-300473770.html

Contacts

Media:

Uri Yablonka

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-to-provide-corporate-update-at-the-bio-international-convention-300473770.html

BrainStorm Awarded $2.1 Million Non-Dilutive Grant for 2017 by the Israel Innovation Authority

Tue, 13 Jun 2017 12:00:00 GMT

BrainStorm's CEO Chaim Lebovits, commented, "The Israel Innovation Authority's support of our NurOwn program provides further validation for the potential of this treatment to help patients suffering from amyotrophic lateral sclerosis (ALS). The continued financial support for our research and development is an important contribution to our ability to execute on our strategic plans, as we commence a Phase 3 pivotal trial with NurOwn."

This is the tenth year that BrainStorm has been in receipt of grant support from the Office of the Chief Scientist, which is part of the Ministry of Economy Program to support innovative technologies in Israel.

The IIA has supported BrainStorm Cell Therapeutics Ltd. since 2007, providing grants totaling approximately $7.5 million in support of the development of NurOwn. BrainStorm will be required to pay mid-single digit royalties to the IIA based on sales of the products, up to a total of the cumulative amount of IIA grants received plus accumulated interest.

About the Innovation Authority Israel Innovation Authority (IIA) in the Ministry of Economy is charged with execution of government policy for support of industrial R&D. The goal of the IIA is to assist in the development of technology in Israel as a means of fostering economic growth, encouraging technological innovation and entrepreneurship, leveraging Israel's scientific potential, enhancing the knowledge base of industry in Israel, stimulating high value-added R&D and encouraging R&D collaboration both nationally and internationally. A variety of ongoing support programs developed and offered by the IIA play a major role in enabling Israel to be a key center for high tech entrepreneurship. For more information, refer to http://www.matimop.org.il/about_authority.html.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-awarded-21-million-non-dilutive-grant-for-2017-by-the-israel-innovation-authority-300472865.html

Contacts

Media:

Uri Yablonka

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-awarded-21-million-non-dilutive-grant-for-2017-by-the-israel-innovation-authority-300472865.html

BrainStorm to Present at Cell & Gene Exchange Conference in Washington DC

Mon, 22 May 2017 12:00:00 GMT

Cell & Gene Exchange

Date:

Tuesday, May 23

Time:

9:00am EDT

Location:

Ronald Reagan Building, Washington DC

Title:

Clinical updates: Promising cell and gene therapy programs

Presenter:

Dr. Ralph Kern, MD, Chief Operating Officer & Chief Medical Officer

Date:

Tuesday, May 23

Time:

3:15pm EDT

Location:

Ronald Reagan Building, Washington DC

Title:

Industry Presentations

Presenter:

Chaim Lebovits, Chief Executive Officer

About the Cell & Gene Exchange

The Cell & Gene Exchange brings together leaders from patient advocacy groups, industry, academia and government to network, exchange ideas and explore partnership opportunities. The goal is facilitating conversations among patient groups and key stakeholders to advancing potentially curative therapies for life-threatening diseases. More information about the Cell & Gene Exchange can be found here: https://ebdgroup.knect365.com/cellgene-exchange/

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult mesenchymal stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U.S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

CONTACTS

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-to-present-at-cell--gene-exchange-conference-in-washington-dc-300461292.html

Contacts

Media:

Uri Yablonka

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-to-present-at-cell--gene-exchange-conference-in-washington-dc-300461292.html

BrainStorm Initiated Technology Transfer to City of Hope for U.S. Production of NurOwn® for Phase 3 ALS Study

Tue, 16 May 2017 12:00:00 GMT

"City of Hope is one of the world's pre-eminent cell product manufacturing centers," said Chaim Lebovits, President and CEO of BrainStorm. "The transfer of our proprietary autologous cell production technology to City of Hope's production team reflects the rapid progress we are making in preparing for our Phase 3 ALS clinical study and will ensure that we have adequate high-quality cell-production capacity in place when we begin the Phase 3 study. We welcome them as a clinical partner and appreciate their commitment to the success of this important clinical program."

"BrainStorm's NurOwn technology represents an innovative approach to treating ALS. City of Hope is excited to play a role in treating this devastating disease," said Joseph Gold, PhD, Director of manufacturing at the Center for Biomedicine and Genetics.

About City of Hope City of Hope is an independent research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as one of only 47 comprehensive cancer centers, the highest recognition bestowed by the National Cancer Institute, City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the world. City of Hope is located in Duarte, California, just northeast of Los Angeles, with community clinics throughout Southern California. It is ranked as one of "America's Best Hospitals" in cancer by U.S. News & World Report. Founded in 1913, City of Hope is a pioneer in the fields of bone marrow transplantation, diabetes and numerous breakthrough cancer drugs based on technology developed at the institution. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to over 30 patients with ALS in clinical trials conducted in Israel, and is currently being studied in a randomized, double-blind, placebo-controlled clinical trial in the United States. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Contacts

Brainstorm Cell Therapeutics

Uri Yablonka BrainStorm Cell Therapeutics Inc.Phone: 646-666-3188 uri@brainstorm-cell.com

City Of Hope:

Letisia Marquez Senior Media Relations SpecialistCity of Hope Phone: 626-218-3398 lemarquez@coh.org

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-initiated-technology-transfer-to-city-of-hope-for-us-production-of-nurown-for-phase-3-als-study-300458174.html

Contacts

Brainstorm Cell Therapeutics

Media:

Uri Yablonka

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

City Of Hope:

Letisia Marquez

Senior Media Relations Specialist

City of Hope

Phone: 626-218-3398

lemarquez@coh.org

BrainStorm Announces First Quarter 2017 Financial Results and Provides Corporate Update

Mon, 15 May 2017 12:00:00 GMT

"The NurOwn® Phase 3 amyotrophic lateral sclerosis (ALS) clinical program, designed to support a Biologics License Application (BLA), is in the final stages of preparation," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We are working closely with selected clinical trial sites in the U.S. and Israel and are coordinating the production of clinical trial supplies. We believe that NurOwn® has the potential to modify the course of ALS and to address a significant unmet medical need for ALS patients and their families."

First Quarter 2017 and Recent Corporate Highlights

First Quarter 2017 Financial Results

Research and development expenses, net for the three months ended March 31, 2017 and 2016 were $941,000 and $986,000, respectively, representing a decrease of $45,000. This decrease is due to a decrease of $222,000 for costs of activities related to the U.S. ALS Clinical Trial, offset by an increase of $177,000 for costs associated with the clinical trial, planned to be conducted in Israel, payroll and a net increase of other research and development expenses.

General and administrative expenses for the three months ended March 31, 2017 and 2016 were $829,000 and $826,000, respectively. The increase in general and administrative expenses of $3,000 is primarily due to: a decrease of $ 160,000 in stock-based compensation expenses offset by a net increase of $163,000 of other costs.

Net loss for the three months ended on March 31, 2017 was $1.8 million, or ($0.10) per share, as compared to a net loss of $1.8 million or ($0.10) per share for the three months ended March 31, 2016.

At March 31, 2017, Brainstorm had net working capital of $7.9 million including cash, cash equivalents and short-term bank deposits amounting to $8.3 million. This compares to cash, cash equivalents, and short-term deposits of approximately $10.0 million at December 31, 2016.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. Brainstorm holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U.S., a clinically meaningful benefit was demonstrated by higher response to NurOwn® compared with a placebo. For more information, visit Brainstorm's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", "goals", "targets", "hopes", "anticipates", "intends", "projects", "continues", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS Media: Uri Yablonka Brainstorm Cell Therapeutics Inc. Phone: (646) 666-3188 uri@brainstorm-cell.com

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

U.S. dollars in thousands

(Except share data)

Three months ended

March 31,

U.S. $ in thousands

Operating expenses:

Research and development, net

$ 941

$ 986

General and administrative

829

826

Operating loss

(1,770)

(1,812)

Financial expenses (income), net

(22)

Net loss

$ (1,785)

$ (1,790)

Basic and diluted net loss per share from continuing operations

$ (0.10)

Weighted average number of shares outstanding used in computing basic and diluted net loss per share

18,688,377

18,653,804

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

March 31,

December 31,

U.S. $ in thousands

ASSETS

Unaudited

Audited

Current Assets:

Cash and cash equivalents

$ 604

$ 547

Short-term deposit (Note 4)

7,743

9,443

Account receivable

202

306

Prepaid expenses and other current assets

176

148

Total current assets

8,725

10,444

Long-Term Assets:

Prepaid expenses and other long-term assets

Property and Equipment, Net

281

297

Total Long-Term Assets

307

322

Total assets

$ 9,032

$ 10,766

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities:

Accounts payables

$ 362

$ 345

Accrued expenses

152

Other accounts payable

337

367

Total current liabilities

789

864

Stockholders' Equity:

Stock capital: (Note 5)

Common stock of $0.00005 par value - Authorized: 100,000,000 shares at March 31, 2017 and December 31, 2016 respectively; Issued and outstanding: 18,699,665 and 18,687,987 shares at March 31, 2017 and December 31, 2016 respectively.

Additional paid-in-capital

85,140

85,014

Accumulated deficit

(76,908)

(75,123)

Total stockholders' equity

8,243

9,902

Total liabilities and stockholders' equity

$ 9,032

$ 10,766

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-announces-first-quarter-2017-financial-results-and-provides-corporate-update-300457360.html

Contacts

Media:

Uri Yablonka

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

U.S. dollars in thousands

(Except share data)

Three months ended

March 31,

2017

2016

U.S. $ in thousands

Operating expenses:

Research and development, net

$ 941

$ 986

General and administrative

829

BrainStorm to Present at Two Scientific Conferences in May

Mon, 01 May 2017 12:00:00 GMT

International Society for Cellular Therapy Annual Conference

Date:

Thursday, May 4

Time:

3:30pm - 5:00pm CET

Location:

ExCeL London, London, England

Title:

Safety and Efficacy of Transplantation of NurOwn (Autologous Mesenchymal Stromal Cells Secreting Neurotrophic Factors) in Patients with ALS: a Phase 2 Randomized Double Blind Placebo Controlled Trial

Presenter:

Dr. Yael Gothelf, Chief Regulatory and Scientific Officer, BrainStorm Cell Therapeutics

Date:

Thursday, May 4

Time:

5:00pm - 6.30pm CET

Location:

ExCeL London, London, England

Title:

Poster presentation titled: In vivo modulation of neurotrophic and inflammatory factors in the CSF of ALS patients treated with NurOwn (MSC NTF cells)

Presenter:

Dr. Yael Gothelf, Chief Regulatory and Scientific Officer, BrainStorm Cell Therapeutics

World Advanced Therapies & Regenerative Medicine Congress 2017

Date:

Thursday, May 18

Time:

2:40pm CET

Location:

Business Design Centre, London

Title:

Brainstorm's NurOwn® Treatment for Neurodegenerative Diseases

Presenter:

Chaim Lebovits, Chief Executive Officer, BrainStorm Cell Therapeutics

About the International Society for Cellular Therapy Established in 1992, the International Society for Cellular Therapy (ISCT) is a global society of clinicians, researchers, regulators, technologists and industry partners with a shared vision to translate cellular therapy into safe and effective therapies to improve patients' lives worldwide. ISCT is the global leader focused on pre-clinical and translational aspects of developing cell-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT offers a unique collaborative environment that addresses three key areas of translation: Academia, Regulatory and Commercialization. Through strong relationships with global regulatory agencies, academic institutions and industry partners, ISCT drives the advancement of research into standard of care. Comprised of over 1300 cell therapy experts across five geographic regions and representation from over 50 countries, ISCT members are part of a global community of peers, thought leaders and organizations invested in cell therapy translation. For more information about the society, key initiatives and upcoming meetings, please visit: www.celltherapysociety.org.

About the World Advanced Therapies & Regenerative Medicine Congress 12 years ago when the World Stem Cells Congress was launched, the stem cells sector was one of scientific interest. Focusing on the challenges of how to transform these little precursor cells eventually into new tissues and organs. The first stem cells conference was relatively small with only 80 people attending the first event, but we knew we were on the verge of something huge and exciting. In May 2017 the newly named World Advanced Therapies & Regenerative Medicine Congress, will bring together 800+ attendees and explore the rapidly developing world of ATMPs (Advanced Therapy Medicinal Products). From process development to clinical translation this congress will bring you the most exciting case studies and new data. Experts in every area will help you tackle the process and regulatory hurdles of developing these new therapeutic formats all the way through manufacture and into the clinic.

CONTACTS

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-to-present-at-two-scientific-conferences-in-may-300448600.html

Contacts

Media:

Uri Yablonka

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-to-present-at-two-scientific-conferences-in-may-300448600.html

Brainstorm Cell Therapeutics to Present at ARM's 5th Annual Cell & Gene Therapy Investor Day, April 27 in Boston

Thu, 20 Apr 2017 12:00:00 GMT

In addition, Dr. Ralph Kern, MD, MHSc, Chief Medical Officer & Chief Operating Officer, will participate in a panel titled "Cell Therapy Beyond Oncology: Where Does The Greatest Potential Lie?".

ARM's 5th Annual Cell & Gene Therapy Investor Day Presentation and Panel Details:

Event:

Alliance for Regenerative Medicine's Cell & Gene Therapy Investor Day

Date:

April 27, 2017

Time:

Presentation (Mr. Lebovits): 09:40 AM EDT Panel (Dr. Kern): 10:25 AM EDT

Location:

The State Room, 60 State Street, Boston, MA 02109

A live video webcast of the presentation will be available at: http://www.arminvestorday.com/webcast. The webcast will be posted for further viewing on the event website following the conference.

About ARM's Cell & Gene Therapy Investor Day Organized by the Alliance for Regenerative Medicine (ARM) and co-hosted with Piper Jaffray, this one-day, high impact program provides institutional, strategic and venture investors with unique insight into the financing hypothesis for advanced therapies-based treatment and tools. The event includes clinical and commercial experts who are on-hand to address specific questions regarding the outlook for these products, as well as offer insight into how cell and gene therapies could impact the standard of care in key therapeutic areas such as cardiovascular disease, wound healing and tissue repair, ophthalmology, neurodegenerative diseases, diabetes and oncology. The program will include talks by key opinion leaders in the industry, life science investment experts and analysts covering the sector as well as presentations by more than 30 leading companies from across the globe.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-to-present-at-arms-5th-annual-cell--gene-therapy-investor-day-april-27-in-boston-300442562.html

Contacts

Media:

Uri Yablonka

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Announces Publication of NurOwn® Autism Research Study

Wed, 19 Apr 2017 12:00:00 GMT

The publication reported that transplantation of mesenchymal stem cells (MSC) induced to secrete neurotrophic factors (MSC-NTF cells, NurOwn®) in the BTBR mouse model of autism demonstrated significant long-term improvements in autistic behavior in the BTBR mice compared to MSC treated and to untreated BTBR mice.

A single NurOwn® dose improved social behavior communication skills, and cognitive flexibility, an improvement that was not observed with MSC treatment, and reduced stereotypic repetitive behaviors in the BTBR mice six months post transplantation, a reduction that was only observed for a shorter period (one month) following MSC transplantation.

The authors concluded that NurOwn® treatment markedly reduced autistic behavior in BTBR mice for an extended period after a single cell transplantation, and that NurOwn® is superior to MSC treatment, as demonstrated in its beneficial effect on communication skills and stereotypic behavior. They noted that this was the first study to show an improvement across all autistic like behavioral phenotypes that can be measured in mice and the first to demonstrate a long-lasting effect of a single treatment for six months.

"These findings are especially encouraging because of the lack of effective medical treatments available for autism and the enormous impact this condition has on patients and their families," said Ralph Z. Kern, M.D., Chief Medical Officer of BrainStorm. "We believe that these results represent a strong rationale for pursuing clinical development of NurOwn® as a potential treatment for autism, which we hope to explore further this year."

About Autism

According to the Autism Society, autism spectrum disorder (ASD) is a complex developmental disability; signs typically appear during early childhood and affect a person's ability to communicate and interact with others. ASD is defined by a certain set of behaviors and is a "spectrum condition" that affects individuals differently and to varying degrees. There is no known single cause of autism, but increased awareness and early diagnosis/intervention and access to appropriate services/supports lead to significantly improved outcomes. Some of the behaviors associated with autism include delayed learning of language; difficulty making eye contact or holding a conversation; difficulty with executive functioning, which relates to reasoning and planning; narrow, intense interests; poor motor skills' and sensory sensitivities. In March 2014, the Centers for Disease Control and Prevention issued their ADDM autism prevalence report which concluded that the prevalence of autism had risen to 1 in every 68 births in the United States – nearly twice as great as the 2004 rate of 1 in 125 – and almost 1 in 54 boys.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult mesenchymal stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn® technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn® has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement

Contacts

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-announces-publication-of-nurown-autism-research-study-300441786.html

Contacts

Media:

Uri Yablonka

BrainStorm Cell Therapeutics Inc.

Phone: 646-666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-announces-publication-of-nurown-autism-research-study-300441786.html

BrainStorm Announces Financial Results for 2016 and Provides Business Update

Thu, 30 Mar 2017 12:00:00 GMT

"2016 was a highly successful and pivotal year for Brainstorm, with a number of important achievements and significant progress made on clinical, regulatory and operational fronts," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics. "We announced positive top-line Phase 2 data of NurOwn® in the treatment of amyotrophic lateral sclerosis (ALS), demonstrating the potential of this therapy to halt or reverse ALS disease progression. Following our End of Phase 2 meeting with the FDA, we are making final preparations to begin a Phase 3 clinical trial, which when successful will position us to bring to ALS patients and their families a much needed and innovative ALS disease modifying therapy."

2016 and Recent Clinical Highlights:

2016 and Recent Corporate Highlights:

Financial Results for the Fourth Quarter Ended December 31, 2016 Net R&D expenses for the fourth quarter of 2016 were $323,000, compared with $826,000 for the fourth quarter of 2015. The decrease was primarily the result of decreased U.S. clinical trial expenses. In the fourth quarter of 2016, general and administrative expenses were $327,000, compared with $571,000 in the same period of 2015. This was driven by decreased consultants expenses and decrease in Delaware Franchise Tax. Net loss for the fourth quarter was $624,000 or ($0.03) per share, versus $1.4 million or ($0.07) per share in the same period of 2015.

Financial Results for the Year Ended December 31, 2016 Research and Development expenses for the year ended December 31, 2016 were $2.3 million, compared to $4.9 million in the same period of 2015, primarily as a result of decreased U.S. clinical trial costs and partially offset by in the costs of activities related to the Israeli clinical trials and costs of materials. General and administrative expenses for the year were $2.8 million, compared to $3.6 million in the same period of 2015, primarily due to a decrease in the cost of our investor relations and public relations activities, our Delaware Franchise tax and rent. This decrease was partially offset by an increase in payroll expenses and consultants. Net loss for the year ended December 31, 2016, was $5.0 million, or ($0.27) per share, compared with a net loss of $8.5 million, or ($0.46) per share, for the year ended December 31, 2015.

As of December 31, 2016, BrainStorm had approximately $10.0 million in cash, cash equivalents and short-term deposits, compared with approximately $16.0 million at December 31, 2015.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

December 31,

2 0 1 6

2 0 1 5

U.S. $ in thousands

ASSETS

Current Assets:

Cash and cash equivalents

$ 547

$ 428

Short-term deposit

9,443

15,527

Account receivable (Note 4)

306

759

Prepaid expenses and other current assets

148

Total current assets

10,444

16,788

Long-Term Assets:

Prepaid expenses and other long-term assets

Property and Equipment, Net (Note 5)

297

271

Total Long-Term Assets

322

292

Total assets

$ 10,766

$ 17,080

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities:

Accounts payables

$ 345

$ 1,169

Accrued expenses

152

1,500

Other accounts payable

367

283

Total current liabilities

864

2,952

Total liabilities

$ 864

$ 2,952

Stockholders' Equity:

Stock capital:

Common stock of $0.00005 par value - Authorized: 100,000,000 shares at December 31, 2016 and December 31, 2015 respectively; Issued and outstanding: 18,687,987 and 18,643,288 shares at December 31, 2016 and December 31, 2015 respectively.

Additional paid-in-capital

85,014

84,258

Accumulated deficit

(75,123)

(70,141)

Total stockholders' equity

9,902

14,128

Total liabilities and stockholders' equity

$ 10,766

$ 17,080

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

U.S. dollars in thousands

(Except share data)

Year ended

December 31,

2 0 1 6

2 0 1 5

U.S. $ in thousands

Operating expenses:

Research and development, net

$ 2,250

$ 4,949

General and administrative

2,833

3,587

Operating loss

(5,083)

(8,536)

Financial expenses (income), net

(101)

(48)

Taxes on income (Note 10)

Net loss

$ (4,982)

$ (8,488)

Basic and diluted net loss per share from continuing operations

$ (0.27)

$ (0.46)

Weighted average number of shares outstanding used in computing basic and diluted net loss per share

18,663,162

18,405,610

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-announces-financial-results-for-2016-and-provides-business-update-300431578.html

Contacts

Media:

Uri Yablonka

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

December 31,

2 0 1 6

2 0 1 5

U.S. $ in thousands

ASSETS

Current Assets:

Cash and cash equivalents

$ 547

$ 428

Short-term deposit

9,443

BrainStorm CEO to Present at the Sachs Associates 2nd Annual Neuroscience Biopartnering and Investment Forum

Wed, 22 Mar 2017 12:00:00 GMT

Neuroscience Biopartnering and Investment Forum Presentation Details

Date:

Monday, March 27

Time:

2:20pm Eastern Time

Location:

New York Academy of Sciences, 7 World Trade Center

About the Annual Neuroscience BioPartnering & Investment Forum

The 2nd Annual Neuroscience BioPartnering & Investment Forum to take place on 27th of March at the New York Academy of Sciences. It will focus on key areas of neurodegenerative diseases and pain management with a mix of specialist panels and company presentations. The event is targeted at buy and sell side analysts from investment banks and funds and partnering executives from pharma. For more information, refer to http://www.sachsforum.com/2nbpi-about.html

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

CONTACTS

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-ceo-to-present-at-the-sachs-associates-2nd-annual-neuroscience-biopartnering-and-investment-forum-300427336.html

Contacts

Media:

Uri Yablonka

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com

BrainStorm Strengthens Management Team with Appointment of Ralph Z. Kern, MD, MHSc as Chief Operating Officer and Chief Medical Officer

Mon, 06 Mar 2017 12:00:00 GMT

"We are very excited to have Dr. Kern join our company as we advance our ALS clinical program and prepare for the start of Phase 3 testing of NurOwn®," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics. "Dr. Kern brings to our company a unique combination of program management skills and medical expertise in neuroscience from his tenure as a successful corporate executive at Biogen, Novartis and Genzyme and an effective educator and ALS patient advocate from his service as neurology program director at the University of Toronto. We are very fortunate to have someone of his caliber and record of achievement join our team."

"I am thrilled to join BrainStorm and advance the Phase 3 program for NurOwn to seek an effective solution for ALS patients and their families," said Dr. Kern. "I am confident that BrainStorm will become the world leader in adult stem cell therapies for neurodegenerative disorders."

Dr. Kern is an influential leader, consensus builder, and strategic advisor with expertise translating science into global solutions for patient care. He was most recently Senior Vice President and Head of Worldwide Medical at Biogen, where he was a powerful contributor to Biogen's reputation as a world leader in biopharmaceutical innovation. He helped define the company's therapeutic area and medical/scientific strategies for Alzheimer's disease, multiple sclerosis, spinal muscular atrophy, Parkinson's, neuro-degeneration, and hemophilia.

From 2011 to 2014, Dr. Kern was Vice President and Head of Neuroscience Medical Unit at Novartis, where he developed and directed strategy, budget, and advanced medical-commercial governance model for neuroscience. His team executed the medical and strategic plan for Gilenya®, currently administered to more than 150,000 patients worldwide.

From 2006 to 2011, Dr. Kern was Global Medical Director of Personalized Genetic Health at Genzyme Corporation (now Sanofi Genzyme) where he championed global medical affairs and medical and scientific activities for Fabry disease life cycle management. From 2003 to 2006, he was University Neurology Program Director at the University of Toronto, where he developed the curriculum for post-graduate education in neurology and neurology bioethics, defined and evaluated training requirements for students and faculty, and directed all operations of neurology post-graduate academic programs.

Previously, he was a Neurologist Consultant at Mount Sinai Hospital, where he played a central role in identifying and publishing the first scientific description of central nervous system complications from the West Nile Virus epidemic in 2003. From 1988 to 2001, he was Director, EMG, EEG, and Evoked Potential Laboratory at The Credit Valley Hospital, where he served on the Medicine Executive Committee and facilitated principal-investigator clinical trials for headache, epilepsy, and stroke.

Dr. Kern studied in the undergraduate Neurophysiology program at McGill University, received a Doctor of Medicine from Queen's University, completed post-graduate studies in neurology and neurophysiology at McGill University and a Master of Health Sciences (MHSc in Health Administration) from the University of Toronto.

About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. NurOwn has been administered to approximately 75 patients with ALS in clinical trials conducted in the United States and Israel. In a randomized, double-blind, placebo-controlled clinical trial conducted in the U. S., a clinically meaningful benefit was demonstrated by higher response to NurOwn compared with placebo. For more information, visit the company's website at www.brainstorm-cell.com.

Gilenya® is a registered trademark of Novartis.

CONTACTS

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/brainstorm-strengthens-management-team-with-appointment-of-ralph-z-kern-md-mhsc-as-chief-operating-officer-and-chief-medical-officer-300418226.html

Contacts

Media:

Uri Yablonka,

Brainstorm Cell Therapeutics Inc.

Phone: (646) 666-3188

uri@brainstorm-cell.com

Investors:

Michael Rice

LifeSci Advisors, LLC

Phone: 646-597-6979

mrice@lifesciadvisors.com