Full Press Release Details
Conference call and webcast rescheduled for8:30 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 endedMarch 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 Phase3btrial, 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
Financial Results for the First Quarter EndedMarch 31, 2025
Conference Call and Webcast
Monday, May 19, 2025, at8:30 a.m.U.S. Eastern Time
Participant Numbers:
U.S. dial in: 888-506-0062
International: 973-528-0011
Participant Access Code: 621608
The replay of the conference call can be accessed by dialing the numbers below and will be available for 14 days.
Teleconference Replay Number:
Toll Free: 877-481-4010
International: 919-882-2331
Passcode: 52457
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 Phase3btrial 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, visitwww.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 athttp://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[email protected]
Media:
Uri Yablonka, Chief Business OfficerPhone: +1 917-284-2911[email protected]
The accompanying notes are an integral part of the consolidated financial statements.
The accompanying notes are an integral part of the consolidated financial statements.
SOURCE BrainStorm Cell Therapeutics Inc.
| BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES | ||||||
| INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||
| U.S. dollars in thousands | ||||||
| (Except share data) | ||||||
| March 31, | December 31, | |||||
| 2025 | 2024 | |||||
| Unaudited | Audited | |||||
| U.S. $ in thousands | ||||||
| ASSETS | ||||||
| Current Assets: | ||||||
| Cash and cash equivalents | $ | 1,644 | $ | 187 | ||
| Other accounts receivable | 67 | 63 | ||||
| Prepaid expenses and other current assets | 621 | 135 | ||||
| Total current assets | $ | 2,332 | $ | 385 | ||
| Long-Term Assets: | ||||||
| Prepaid expenses and other long-term assets | $ | 22 | $ | 22 | ||
| Restricted Cash | 182 | 184 | ||||
| Operating lease right of use asset (Note 4) | 653 | 807 | ||||
| Property and Equipment, Net | 382 | 434 | ||||
| Total Long-Term Assets | $ | 1,239 | $ | 1,447 | ||
| Total assets | $ | 3,571 | $ | 1,832 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||
| Current Liabilities: | ||||||
| Accounts payables | $ | 6,797 | $ | 6,080 | ||
| Accrued expenses | 538 | 619 | ||||
| Short-term loans (Note 7) | 1,200 | 300 | ||||
| Operating lease liability (Note 4) | 443 | 549 | ||||
| Employees related liability | 1,923 | 1,430 | ||||
| Total current liabilities | $ | 10,901 | $ | 8,978 | ||
| Long-Term Liabilities: | ||||||
| Operating lease liability (Note 4) | 127 | 171 | ||||
| Warrants liability (Note 5) | - | 447 | ||||
| Total long-term liabilities | $ | 127 | $ | 618 | ||
| Total liabilities | $ | 11,028 | $ | 9,596 | ||
| Stockholders' Deficit: | ||||||
| Stock capital: (Note 6) | 15 | 14 | ||||
| Common Stock of $0.00005 par value - Authorized: 250,000,000 shares at March 31, 2025 and atDecember 31, 2024 respectively; Issued and outstanding: 7,911,204 and 6,141,762 shares at March31, 2025 and December 31, 2024 respectively (*) | ||||||
| Additional paid-in-capital | 222,144 | 218,974 | ||||
| Treasury stocks | (116) | (116) | ||||
| Accumulated deficit | (229,500) | (226,636) | ||||
| Total stockholders' deficit | $ | (7,457) | $ | (7,764) | ||
| Total liabilities and stockholders' deficit | $ | 3,571 | $ | 1,832 |
| 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, | |||||||
| 2025 | 2024 | ||||||
| Unaudited | |||||||
| Operating expenses: | |||||||
| Research and development, net | $ | 1,304 | $ | 961 | |||
| General and administrative | 1,785 | 1,513 | |||||
| Operating loss | (3,089) | (2,474) | |||||
| Financial income, net | 46 | 13 | |||||
| Loss on change in fair value of Warrants liability (Note 6) | (179) | (940) | |||||
| Net loss | $ | (2,864) | $ | (3,401) | |||
| Basic and diluted net loss per share from continuing operations | $ | (0.45) | $ | (*) (0.75) | |||
| Weighted average number of shares outstanding used in computingbasic and diluted net loss per share | 6,342,002 | (*) 4,315,903 |