Brainstorm Cell Therapeutics is a clinical-stage biotech developing NurOwn (debamestrocel), an autologous cell therapy for neurodegenerative diseases, primarily ALS. The therapy works by harvesting a patient's own bone marrow, inducing the extracted mesenchymal stem cells to secrete neurotrophic factors, and reinjecting them into the patient's spinal fluid. Because the therapy uses the patient's own cells, there is no immune rejection risk. Brainstorm has no approved products and no commercial revenue. NurOwn failed its Phase 3 ALS trial on the primary endpoint in 2020, and the FDA's advisory committee voted 17-1 against approval in 2023, leading Brainstorm to withdraw its BLA. In 2024, the FDA granted a Special Protocol Assessment for a new Phase 3b trial called ENDURANCE — the first SPA ever granted for an ALS study — and cleared the trial to begin in May 2025. ENDURANCE targets early-stage ALS patients, enrolling roughly 200 patients across ~15 U.S. sites. Brainstorm's secondary pipeline includes progressive multiple sclerosis and Alzheimer's disease, plus early preclinical work on an exosome-based platform that could serve as an off-the-shelf allogeneic therapy. The company is in a precarious financial position, with roughly $1M in cash as of mid-2025 and a need for $20-30M annually to fund ENDURANCE, relying on partnerships and grants to survive. Brainstorm was delisted from Nasdaq in July 2025 and now trades on the OTCQB.
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