BrainStorm Advances NurOwn ALS Program Toward Phase 3b

New York, United States, August 14, 2026

BrainStorm Prepares Phase 3b ENDURANCE Trial

The company is progressing preparations for the ENDURANCE study, which is planned to enroll approximately 200 patients with ALS. The trial will consist of two 24-week parts. Part A is designed as a randomized, double-blind, placebo-controlled study, while Part B will serve as an open-label extension in which all participants receive NurOwn. The primary endpoint is expected to assess changes on the ALS Functional Rating Scale-Revised (ALSFRS-R). According to BrainStorm, the Phase 3b program is being developed under an FDA Special Protocol Assessment, with the company stating that this is the first SPA granted for an ALS therapeutic candidate. The company intends for results from Part A to support a potential Biologics License Application (BLA). BrainStorm is now focused on completing the operational and regulatory activities required before enrollment begins. The development of NurOwn remains central to the company’s strategy as it seeks to advance an adult stem cell-based therapeutic approach for patients with ALS, a progressive neurodegenerative disease associated with substantial challenges for patients, families, and caregivers.

Leadership and Financing Support Clinical Development

BrainStorm also highlighted a recent change in its executive leadership. In July 2026, the company appointed Peter J. Pitts as Executive Chairman and Chief Strategic Regulatory and Policy Officer. Pitts, who previously served as an FDA Associate Commissioner, joined BrainStorm’s Board in May 2026 and is expected to play an active role in regulatory strategy, operations, partnerships, investor engagement, and preparation for the ENDURANCE study. Professor Jacob Frenkel, who has been involved with BrainStorm’s leadership since 2007 and served as Board Chairman since 2020, is transitioning to the role of Senior Advisor. The company also reported completing private placements totaling $400,000 in May 2026 at a premium to market. Combined with approximately $2.0 million raised in February, BrainStorm said its total capital raised during the first half of 2026 reached approximately $2.4 million.The financing activity comes as BrainStorm prepares for further clinical development and associated regulatory and operational requirements surrounding NurOwn.

Second-Quarter Results Reflect Continued R&D Investment

For the quarter ended June 30, 2026, BrainStorm reported approximately $0.2 million in cash, cash equivalents and restricted cash, compared with approximately $1.03 million at June 30, 2025. Research and development expenses were approximately $1 million, compared with approximately $1.1 million in the second quarter of 2025. General and administrative expenses increased to approximately $2.7 million, compared with $1.5 million in the prior-year quarter. The company reported a net loss of approximately $3.9 million, compared with a net loss of approximately $2.9 million for the second quarter of 2025. Net loss per share was $0.35 for the latest quarter, compared with $0.34 in the prior-year period. BrainStorm also highlighted a June 2026 peer-reviewed publication addressing regulatory approaches for ALS, rare diseases, and regenerative medicine, including areas such as adaptive trial design, Bayesian statistics, biomarkers, genomics, artificial intelligence, and precision medicine.

With preparations for the Phase 3b ENDURANCE trial continuing, BrainStorm’s latest update places NurOwn at the center of its clinical and corporate strategy. The upcoming study is expected to represent an important next stage in the company’s effort to evaluate its cell therapy candidate in ALS and potentially advance the program toward a future regulatory submission.

Source: BrainStorm Cell Therapeutics press relese