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

"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.

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

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)

(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

26

51

Prepaid expenses and other current assets (Note 4)