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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.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced its Q1 2024 financial results and provided a corporate update. The company achieved a key milestone by securing a Special Protocol Assessment (SPA) from the U.S. FDA for its Phase 3b trial of NurOwn for ALS. This SPA validates the clinical trial protocol and statistical analysis, supporting a future Biologics License Application (BLA). Q1 2024 saw research and development expenses decrease to $1.0 million from $2.9 million in Q1 2023, while general and administrative expenses dropped to $1.5 million from $2.2 million. Net loss reduced from $5.1 million in Q1 2023 to $3.4 million. The company has $1.0 million in cash, cash equivalents, and restricted cash as of March 31, 2024. Additionally, BrainStorm will participate in the ALS Drug Development Summit, and management changes include promoting Dr. Bob Dagher to Executive VP and CMO, and Dr. Stacy Lindborg stepping down as Co-CEO but remaining on the Board of Directors.
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