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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.