Latest news with #BrainStorm
Yahoo
2 days ago
- Business
- Yahoo
BrainStorm to Announce Second Quarter Financial Results and Provide a Corporate Update
Call Scheduled for August 14, 2025, at 8:30 AM Eastern Time NEW YORK, Aug. 8, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that it will hold a conference call and webcast to update shareholders on financial results for the second quarter of 2025, at 8.30 a.m. Eastern Time on August 14, 2025. BrainStorm's President and Chief Executive Officer, Chaim Lebovits, will provide the update. Hartoun Hartounian, PhD, Chief Operating Officer, Bob Dagher, MD, Chief Medical Officer, and Alla Patlis, Interim Chief Financial Officer, will also participate in the call. Following the prepared remarks, there will be a Q&A session with the investment community. Participants are encouraged to submit their questions in advance of the call by sending them to: q@ Questions should be submitted by 10:00 a.m. Eastern Time on August 12, 2025. The investment community may participate in the conference call by dialing the following numbers: Investor dial in:U.S. Toll Free: 877-545-0320 International: 973-528-0002 Participant Access Code: 601260 Webcast URL: 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 until August 28, 2026. Teleconference Replay Number: Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 52831 About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. (OTCQB: 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 Phase 3b trial 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, visit 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 at 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 Investors:Michael Wood Phone: +1 646-597-6983 mwood@ Media:Uri Yablonka, Chief Business Officer Phone: +1 917-284-2911 uri@ Logo - View original content: SOURCE BrainStorm Cell Therapeutics Inc.
Business Insider
18-07-2025
- Business
- Business Insider
BrainStorm announces Nasdaq delisting and transition to OTCQB
BrainStorm (BCLI) Cell Therapeutics announced that it has received a delisting notification from The Nasdaq Stock Market, informing the company that its common stock will be delisted from the Nasdaq Capital Market. Trading of BrainStorm's common stock on Nasdaq will be suspended at the open of trading on July 18. The delisting is a result of the company's non-compliance with Nasdaq Listing Rule 5550(b)(1), pertaining to its minimum shareholder equity requirement. BrainStorm has already secured approval for its common stock to be quoted on the OTCQB Venture Market, a U.S. trading platform operated by OTC Markets Group. The company anticipates its shares will begin trading on the OTCQB under the same symbol, BCLI, beginning at the open of trading on July 18, or as soon as possible thereafter. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with , delivered to your inbox every week.
Malaysian Reserve
17-07-2025
- Business
- Malaysian Reserve
BrainStorm Cell Therapeutics Announces Nasdaq Delisting and Transition to OTCQB
NEW YORK, July 17, 2025 BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) today announced that it has received a delisting notification from The Nasdaq Stock Market LLC, informing the company that its common stock will be delisted from the Nasdaq Capital Market. Trading of BrainStorm's common stock on Nasdaq will be suspended at the open of trading on July 18, 2025. The delisting is a result of the company's non-compliance with Nasdaq Listing Rule 5550(b)(1), pertaining to its minimum shareholder equity requirement. BrainStorm has already secured approval for its common stock to be quoted on the OTCQB Venture Market, a U.S. trading platform operated by OTC Markets Group. The company anticipates its shares will begin trading on the OTCQB under the same symbol, BCLI, beginning at the open of trading on July 18, 2025, or as soon as possible thereafter. Chaim Lebovits, CEO of BrainStorm Cell Therapeutics, stated, 'While this delisting from Nasdaq is a challenging outcome, we want to assure our shareholders and the patient community that it does not alter our core mission or our unwavering commitment to advancing NurOwn for ALS patients. Our pre-arranged transition to OTCQB ensures continuous trading for our shares and allows us to focus entirely on NurOwn's development. We remain fully dedicated to our ongoing scientific and clinical programs, including preparations for our pivotal Phase 3b trial under the Special Protocol Assessment (SPA) agreement with the FDA.' The company confirms that the delisting does not impact its business operations, its ongoing research and development efforts, or its commitment to its shareholders. BrainStorm will continue to provide updates on its progress and financial status in compliance with applicable SEC regulations. 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 Phase 3b trial 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, visit 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 at 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 Investors:Michael Wood Phone: +1 646-597-6983 mwood@ Media:Uri Yablonka, Chief Business Officer Phone: +1 917-284-2911 uri@ Logo – View original content:
Yahoo
08-07-2025
- Health
- Yahoo
FDA Review of Citizen Petition Offers a Fresh Look at NurOwn®'s Evidence of Treatment Effectiveness
BrainStorm to Continue with Planned Phase 3b Trial and Remains Committed to Advancing Access for People Living with ALS NEW YORK, July 8, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today acknowledged that the U.S. Food and Drug Administration's (FDA) consideration of a Citizen Petition requesting a new review of the data supporting NurOwn will provide a critical opportunity to reaffirm its potential as therapy for amyotrophic lateral sclerosis (ALS). A Citizen Petition, submitted to the FDA under the Federal Food, Drug, and Cosmetic Act (21 CFR § 10.30), is a regulatory process that allows any interested party to formally request the Agency to take action on specific matters, such as reviewing data, issuing new guidance, or taking enforcement action. In this case, the Citizen Petition is requesting that the FDA review the data supporting NurOwn. BrainStorm has consistently supported the integrity and scientific validity of its data and believes a comprehensive review of all evidence is essential, especially as the regulatory landscape for rare diseases with unmet needs continues to evolve. Although BrainStorm was not involved in drafting or submitting this petition or its contents, the company welcomes the FDA's willingness to reevaluate existing data. It endorses any process that thoroughly assesses the scientific evidence related to potential treatment options for people living with ALS. "We respect the FDA's independent review process and welcome its consideration of this request," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "We continue to stand firmly behind the scientific integrity of BrainStorm's data and remain committed to working collaboratively with the FDA and the ALS community to advance the development of safe and effective therapies." BrainStorm is committed to continuing alignment with FDA and will proceed with its Phase 3b ENDURANCE trial of NurOwn under an FDA Special Protocol Assessment (SPA), designed to generate additional robust data and confirm the product's efficacy and safety in early stage ALS patients. In parallel, the company supports exploration of potential regulatory pathways that may allow appropriate access to NurOwn for individuals living with ALS today. Bob Dagher, M.D., Chief Medical Officer at BrainStorm, stated, "A new review of the NurOwn data offers an important chance to ensure all available evidence is fully considered. We remain dedicated to rigorous science and to increasing access for ALS patients in need." Mary Kay Turner, Senior Vice President, Advocacy and Public Affairs at BrainStorm, added, "The ALS community has been a powerful voice in advocating for new approaches to treatment. We stand with advocates in supporting efforts that prioritize both data-driven decision-making and urgency for patients facing this devastating disease." ALS is a rapidly progressive neurodegenerative disease that leads to the loss of motor neurons, severely impairing voluntary muscle movement. Despite recent advances in care, effective disease-modifying treatment options remain limited. Peer-reviewed analyses have demonstrated clinically meaningful benefits in individuals with less-advanced ALS: In the subgroup of participants with baseline ALSFRS-R scores of 35 and above, NurOwn showed statistically significant functional improvement versus placebo. Post-hoc analyses revealed NurOwn-treated participants retained an average of two more ALSFRS-R points than placebo recipients - representing meaningful functional preservation. BrainStorm recently announced new survival data from 10 participants who had previously completed the Phase 3 clinical trial and subsequently entered its Expanded Access Program (EAP). Notably, participants survived more than five years from ALS symptom onset – well above published estimates suggesting that only 10% of people diagnosed with ALS reach that benchmark. The median survival in the group was 6.8 years. These results strongly suggest that the observed survival outcomes in the EAP patients are unlikely to be due to chance alone and further underscore the need for continued scientific exploration. BrainStorm will continue to engage transparently with the FDA, clinicians, advocacy groups, and the broader ALS community, and will provide updates as appropriate. 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 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 Phase 3b trial 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, visit 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 at 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 Investors: Michael Wood Phone: +1 646-597-6983 mwood@ Media: Uri Yablonka, Chief Business Officer Phone: +1 917-284-2911 uri@ Logo - View original content: SOURCE BrainStorm Cell Therapeutics Inc.
Business Insider
26-06-2025
- Business
- Business Insider
BrainStorm files to sell 2.76M shares of common stock for holders
16:41 EDT BrainStorm (BCLI) files to sell 2.76M shares of common stock for holders Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
