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
Corporate
Financial Results for the Year Ended December 31, 2023
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.
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
Media:
Lisa Guiterman
Phone: +1 202-330-3431
This email address is being protected from spambots. You need JavaScript enabled to view it.
IR:
Michael Wood
Phone: +1 646-597-6983
This email address is being protected from spambots. You need JavaScript enabled to view it.
BRAINSTORM CELL THERAPEUTICS INC. | ||||||
CONSOLIDATED BALANCE SHEETS | ||||||
U.S. dollars in THOUSANDS | ||||||
(Except share data) | ||||||
December 31, | ||||||
2023 | 2022 | |||||
U.S. $ in thousands | ||||||
ASSETS | ||||||
Current Assets: | ||||||
Cash and cash equivalents | $ | 1,300 | $ | 772 | ||
Short-term deposit (Note 8) | - | 2,211 | ||||
Other accounts receivable | 51 | 91 | ||||
Prepaid expenses and other current assets (Note 4) | 548 | 32 | ||||
Total current assets | $ | 1,899 | $ | 3,106 | ||
Long-Term Assets: | ||||||
Prepaid expenses and other long-term assets | $ | 22 | $ | 23 | ||
Restricted Cash | 185 | - | ||||
Operating lease right of use asset (Note 5) | 1,416 | 4,389 | ||||
Property and Equipment, Net (Note 6) | 686 | 933 | ||||
Total Long-Term Assets | $ | 2,309 | $ | 5,345 | ||
Total assets | $ | 4,208 | $ | 8,451 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||
Current Liabilities: | ||||||
Accounts payables | $ | 4,954 | $ | 6,224 | ||
Accrued expenses | 1,240 | 84 | ||||
Operating lease liability (Note 5) | 603 | 1,427 | ||||
Employees related liability | 1,003 | 1,065 | ||||
Total current liabilities | $ | 7,800 | $ | 8,800 | ||
Long-Term Liabilities: | ||||||
Operating lease liability (Note 5) | 672 | 2,666 | ||||
Warrants liability (Note 6) | 594 | - | ||||
Total long-term liabilities | $ | 1,266 | $ | 2,666 | ||
Total liabilities | $ | 9,066 | $ | 11,466 | ||
Stockholders' Equity (deficit): | ||||||
Stock capital: (Note 9) | 13 | 12 | ||||
Common Stock of $0.00005 par value - Authorized: 100,000,000 | ||||||
Additional paid-in-capital | 210,258 | 194,910 | ||||
Treasury stocks | (116) | (116) | ||||
Accumulated deficit | (215,013) | (197,821) | ||||
Total stockholders' equity (deficit) | $ | (4,858) | $ | (3,015) | ||
Total liabilities and stockholders' equity (deficit) | $ | 4,208 | $ | 8,451 | ||
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, | ||||||
2023 | 2022 | |||||
U.S. $ in thousands | ||||||
Operating expenses: | ||||||
Research and development, net (Note 12) | $ | 10,746 | $ | 13,956 | ||
General and administrative | 10,693 | 10,866 | ||||
Operating loss | (21,439) | (24,822) | ||||
Financial income (expense), net | (447) | 545 | ||||
Gain on change in fair value of Warrants liability (Note 9) | 4,694 | - | ||||
Net loss | $ | (17,192) | $ | (24,277) | ||
Basic and diluted net loss per share | $ | (0.40) | $ | (0.66) | ||
Weighted average number of shares outstanding used in | 43,075,938 | 36,509,060 | ||||
The accompanying notes are an integral part of the consolidated financial statements.
| Last Trade: | US$1.25 |
| Daily Volume: | 41,179 |
| Market Cap: | US$99.660M |
November 14, 2024 November 11, 2024 October 28, 2024 October 07, 2024 September 24, 2024 | |
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
CLICK TO LEARN MORE
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
CLICK TO LEARN MORE
