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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 /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, 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).
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 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://ir.brainstorm-cell.com/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: 47908
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 INC. | ||||||
CONSOLIDATED BALANCE SHEETS | ||||||
U.S. dollars in thousands | ||||||
(Except share data) | ||||||
December 31, | ||||||
2022 | 2021 | |||||
U.S. $ in thousands | ||||||
ASSETS | ||||||
Current Assets: | ||||||
Cash and cash equivalents | $ | 772 | $ | 18,856 | ||
Short-term deposit (Note 8) | 2,211 | 3,238 | ||||
Other accounts receivable | 91 | 86 | ||||
Prepaid expenses and other current assets (Note 4) | 32 | 1,100 | ||||
Total current assets | $ | 3,106 | $ | 23,280 | ||
Long-Term Assets: | ||||||
Prepaid expenses and other long-term assets | $ | 23 | $ | 27 | ||
Operating lease right of use asset (Note 5) | 4,389 | 4,781 | ||||
Property and Equipment, Net (Note 6) | 933 | 1,189 | ||||
Total Long-Term Assets | $ | 5,345 | $ | 5,997 | ||
Total assets | $ | 8,451 | $ | 29,277 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||
Current Liabilities: | ||||||
Accounts payables | $ | 6,224 | $ | 3,700 | ||
Accrued expenses | 84 | 83 | ||||
Operating lease liability (Note 5) | 1,427 | 1,461 | ||||
Other accounts payables | 1,065 | 1,073 | ||||
Total current liabilities | $ | 8,800 | $ | 6,317 | ||
Long-Term Liabilities: | ||||||
Operating lease liability (Note 5) | 2,666 | 3,618 | ||||
Total long-term liabilities | $ | 2,666 | $ | 3,618 | ||
Total liabilities | $ | 11,466 | $ | 9,935 | ||
Stockholders' Equity (deficit): | ||||||
Stock capital: (Note 9) | 12 | 12 | ||||
Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at December 31, 2022 and | ||||||
Additional paid-in-capital | 194,910 | 192,990 | ||||
Treasury stocks | (116) | (116) | ||||
Accumulated deficit | (197,821) | (173,544) | ||||
Total stockholders' equity (deficit) | $ | (3,015) | $ | 19,342 | ||
Total liabilities and stockholders' equity (deficit) | $ | 8,451 | $ | 29,277 | ||
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) | ||||||
Year ended | ||||||
December 31, | ||||||
2022 | 2021 | |||||
U.S. $ in thousands | ||||||
Operating expenses: | ||||||
Research and development, net (Note 10) | $ | 13,956 | $ | 15,235 | ||
General and administrative | 10,866 | 9,304 | ||||
Operating loss | (24,822) | (24,539) | ||||
Financial income, net | 545 | 82 | ||||
Net loss | $ | (24,277) | $ | (24,457) | ||
Basic and diluted net loss per share | $ | (0.66) | $ | (0.68) | ||
Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 36,509,060 | 36,181,753 | ||||
The accompanying notes are an integral part of the consolidated financial statements. |
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SOURCE BrainStorm Cell Therapeutics Inc.
