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 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 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
| September 30, 2 0 1 9 U.S. $ in thousands Unaudited | December 31, 2 0 1 8 U.S. $ in thousands Audited | |
|---|---|---|
| ASSETS | ||
| Current Assets: | ||
| Cash and cash equivalents | $ 2,095 | $ 942 |
| Short-term deposit (Note 4) | 34 | 6,122 |
| Account receivable | 1,924 | 2,009 |
| Prepaid expenses and other current assets (Note 5) | 619 | 1,197 |
| Total current assets | 4,672 | 10,270 |
| Long-Term Assets: | ||
| Prepaid expenses and other long-term assets | 32 | 307 |
| Operating lease right of use asset | 2,443 | - |
| Property and Equipment, Net | 664 | 651 |
| Total long-term assets | 3,139 | 958 |
| Total assets | $ 7,811 | $ 11,228 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current Liabilities: | ||
| Accounts payable | $ 9,144 | $ 4,548 |
| Accrued expenses | 1,975 | 1,042 |
| Other accounts payable | 839 | 622 |
| Total current liabilities | 11,958 | 6,212 |
| Long-Term Liabilities: | ||
| Operating lease liability | 2,630 | - |
| Total long-term liabilities | 2,630 | - |
| Total liabilities | $ 14,588 | $ 6,212 |
| Stockholders' Equity: | ||
| Stock capital: (Note 8) | 11 | 11 |
| Common stock of $0.00005 par value - Authorized: 100,000,000 shares at each of September 30, 2019 and December 31, 2018; Issued and outstanding: 22,606,492 and 20,757,816 shares at September 30, 2019 and December 31, 2018, respectively. | ||
| Additional paid-in-capital | 102,796 | 94,620 |
| Receipts on account of shares | - | 4,408 |
| Accumulated deficit | (109,584) | (94,023) |
| Total stockholders' equity) deficit) | (6,777) | 5,016 |
| Total liabilities and stockholders' equity | $ 7,811 | $ 11,228 |
| Nine months ended September 30, 2 0 1 9 Unaudited | Nine months ended September 30, 2 0 1 8 Unaudited | Three months ended September 30, 2 0 1 9 Unaudited | Three months ended September 30, 2 0 1 8 Unaudited | |
|---|---|---|---|---|
| Operating expenses: | ||||
| Research and development, net | $ 11,018 | $ 4,433 | $ 4,008 | $ 1,975 |
| General and administrative | 4,318 | 4,193 | 1,543 | 1,257 |
| Operating loss | (15,336) | (8,626) | (5,551) | (3,232) |
| Financial expenses (income), net | 225 | (61) | 83 | (56) |
| Net loss | $ (15,561) | $ (8,565) | $ (5,634) | $ (3,176) |
| Basic and diluted net loss per share from continuing operations | $ (0.72) | $ (0.43) | $ (0.25) | $ (0.15) |
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 21,630,007 | 19,754,159 | 22,254,993 | 20,691,900 |
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)