BrainStorm Advances NurOwn ALS Program and Highlights Long-Term Survival Data

Mar 31, 2026-

BrainStorm Cell Therapeutics (OTCQB: BCLI) has reported its full-year 2025 financial results while providing an update on the development of NurOwn®, its autologous adult stem cell therapy for amyotrophic lateral sclerosis (ALS). The company also announced that it secured $2.0 million in strategic financing in early 2026, a move that leadership says has helped stabilize operations and reinforce market confidence.

According to BrainStorm CEO Chaim Lebovits, the company’s primary focus remains advancing NurOwn into a Phase 3b confirmatory study, following FDA clearance received in May 2025. The upcoming ENDURANCE Phase 3b trial is designed to enroll approximately 200 ALS patients across leading clinical centers. The study will consist of a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension to evaluate longer-term safety and treatment durability. The primary endpoint will measure change from baseline in the ALS Functional Rating Scale-Revised (ALSFRS-R) at week 24. If successful, BrainStorm believes the data could support a Biologics License Application (BLA) submission.

The company also highlighted encouraging observations from its Expanded Access Program (EAP) cohort. Among the ten ALS patients enrolled in the program, 50% remain alive, with estimated mean survival reaching approximately 84 months. Historically, only about 20% of ALS patients survive beyond five years, yet all ten EAP participants exceeded that milestone. Notably, the five surviving patients were reported to remain tracheostomy-free at the time of a citizen petition submitted to the FDA in July 2025, which requested renewed regulatory review of the NurOwn data.

Researchers believe these observations reinforce the strategy of focusing the Phase 3b trial on earlier-stage ALS patients, where therapeutic effects may be more detectable. Patients in the earlier Phase 3 program who later entered the EAP had relatively high baseline ALSFRS-R scores (~41), suggesting better preserved neurological function at treatment initiation.

NurOwn is based on autologous mesenchymal stem cells (MSCs) derived from a patient’s own bone marrow. These cells are expanded and differentiated ex vivo into MSC-NTF cells, which are engineered to secrete elevated levels of neurotrophic factors (NTFs) and immunomodulatory cytokines. The therapy aims to deliver these protective factors directly to damaged neural tissue, potentially slowing disease progression in neurodegenerative disorders such as ALS.

ALS remains a devastating neurodegenerative disease with limited treatment options, and BrainStorm continues to position NurOwn as a potential regenerative medicine approach designed to address multiple disease pathways simultaneously.