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BrainStorm Cell Therapeutics Inc. develops autologous adult stem cell therapeutics for neurodegenerative diseases, with news centered on its investigational NurOwn® platform for amyotrophic lateral sclerosis. NurOwn uses bone marrow-derived mesenchymal stem cells expanded and differentiated ex vivo into neurotrophic factor-secreting MSC-NTF cells designed to deliver neurotrophic factors and immunomodulatory cytokines.
Company updates commonly cover financial results, private placements and working-capital actions, regulatory engagement with the FDA, manufacturing readiness and clinical development activities tied to the Phase 3b ENDURANCE study. Corporate updates also address the completed transition of BCLI common stock from Nasdaq listing to OTCQB quotation.
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BrainStorm Cell Therapeutics has appointed Kirk Taylor, M.D. as the new Executive Vice President and Chief Medical Officer, effective May 1, 2023. Dr. Taylor brings over 26 years of biopharma experience, especially in neurology, and will lead global medical affairs and product launches for the company’s innovative therapeutics, particularly NurOwn, aimed at treating ALS. The appointment is viewed as a strategic move to bolster the company's capabilities in anticipation of regulatory review and growth. BrainStorm is preparing for an FDA Advisory Committee meeting regarding NurOwn, underlining its commitment to advancing treatment options for ALS patients. Dr. Taylor’s background includes leadership roles in major pharmaceutical firms, enhancing BrainStorm’s potential for commercial success and regulatory engagement.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced its financial results for FY 2022, reporting a net loss of approximately $24.3 million and cash reserves of $3 million as of December 31, 2022. The company is prioritizing its Biologics License Application (BLA) for NurOwn® for ALS treatment, with an upcoming FDA Advisory Committee Meeting (ADCOM). Previous challenges led to a Refusal to File; however, the FDA plans to review the amended BLA following ongoing discussions. Key presentations at scientific conferences have shown significant clinical benefits of NurOwn, particularly concerning the ALSFRS-R floor effect.
BrainStorm Cell Therapeutics (BCLI) announced that the FDA will hold an Advisory Committee Meeting (ADCOM) to discuss the Biologics License Application (BLA) for NurOwn, aimed at treating amyotrophic lateral sclerosis (ALS). To expedite this process, BrainStorm requested the FDA's File Over Protest pathway and submitted an amendment to the BLA addressing earlier questions from the FDA. The ADCOM will provide a platform for evaluating the clinical evidence supporting NurOwn, which has been highly anticipated by the ALS community. BrainStorm emphasizes the urgent need for new ALS treatment options.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced a conference call on March 30, 2023, at 8:00 a.m. ET to discuss financial results for the fourth quarter and full year ended December 31, 2022, along with corporate updates. The call will feature leaders including President Chaim Lebovits and Co-CEO Stacy Lindborg, PhD. Shareholders are invited to submit questions by March 26, 2023. Call details include toll-free and international participant numbers, with a webcast available at this link. BrainStorm develops therapies for neurodegenerative diseases, notably for ALS using its proprietary NurOwn® technology.
BrainStorm Cell Therapeutics (BCLI) announced the donation of serum and cerebrospinal fluid samples from its Phase 3 ALS trial of NurOwn® to the NEALS biorepository. This initiative is part of a $500,000 grant received from The ALS Association and I AM ALS to support biomarker research. The samples were collected over a 20-week period, enhancing the understanding of ALS progression and treatment effects. The collaboration aims to facilitate new breakthroughs in ALS treatment, with key stakeholders expressing optimism about the research potential.
On January 5, 2023, BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that its management will present a corporate and clinical overview at Biotech Showcase™ 2023 on January 9 at 10:30 a.m. PT in San Francisco. Presenters include President and CEO Chaim Lebovits and Co-CEO Stacy Lindborg. Attendees can join in person or via webcast. The company specializes in adult stem cell therapies for neurodegenerative diseases, with its NurOwn® technology receiving orphan drug designation for treating ALS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has promoted Dr. Stacy Lindborg to Co-Chief Executive Officer as part of a strategic initiative to enhance leadership and expertise. Dr. Lindborg brings over 25 years of pharmaceutical experience and will focus on advancing the regulatory process for NurOwn, a novel stem cell treatment for ALS. Chaim Lebovits retains his role as President and CEO, and Dr. Ralph Kern will retire but continue as a member of the Scientific Advisory Board. This leadership transition aims to position the company for future growth and success.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that the FDA granted a Type A meeting to discuss the refusal to file letter regarding its New Biologics License Application (BLA) for NurOwn® aimed at treating ALS. Scheduled for January 11, 2023, the meeting intends to clarify the next steps in the approval process. CEO Chaim Lebovits expressed optimism about discussing clinical evidence and potentially holding an Advisory Committee Meeting. The Phase 3 trial results indicated a statistically significant clinical response in a specific subgroup of ALS patients, alongside positive biomarker data.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) submitted a Type A Meeting Request to the FDA to address a refusal to file letter regarding its New Biologics License Application for NurOwn® in treating ALS. The meeting is expected within 30 days of receipt. The refusal letter points to issues related to chemistry, manufacturing, controls, and clinical data. CEO Chaim Lebovits emphasizes the importance of this meeting to advance NurOwn and anticipates a clear path toward an FDA Advisory Committee Meeting, which is crucial for therapy approval.