#United States #New York #BrainStorm #ALS #NurOwn

BrainStorm Cell Therapeutics: Q2 2025 Financial Results and Corporate Update

On August 14, 2025, BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a pioneer in adult stem cell therapies for neurodegenerative diseases, released its financial results for the second quarter of 2025 and detailed recent corporate advancements.

Clinical Development Update

Chaim Lebovits, President and CEO of BrainStorm, emphasized their commitment to executing the clinical development plan for NurOwn®, their leading stem cell therapy for amyotrophic lateral sclerosis (ALS). A significant milestone was achieved this quarter as the FDA granted clearance for the initiation of the Phase 3b trial named ENDURANCE. This trial will include roughly 200 participants from prestigious academic medical centers and consists of a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension, during which all participants will receive the treatment. The primary endpoint is an improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R) after 24 weeks.

The successful completion of the initial double-blind segment is vital for generating the necessary clinical data to support a potential Biologics License Application (BLA) submission to the FDA. BrainStorm continues to have active discussions with clinical sites and contract development and manufacturing organizations (CDMOs) to ensure clinical drug supply readiness, showing strong interest from the ALS clinical community.

Citizen Petition and Survival Data

Furthermore, a Citizen Petition submitted to the FDA by the ALS community seeks a re-evaluation of NurOwn's data, which may present a new opportunity to highlight the therapy's potential in treating ALS. BrainStorm has not been involved in drafting the petition, but welcomes this chance for an objective review. Recently reported data from the Expanded Access Program (EAP) associated with NurOwn indicated that 100% of participants (10/10) survived for over five years from the onset of ALS symptoms — a stark contrast to published estimates indicating only about 10% survival during this period. Although these figures are promising, it's essential to consider that the EAP cohort had participants who were in earlier stages of their illness.

Manufacturing Partnerships

In preparations for the upcoming Phase 3b trial, BrainStorm has established a Letter of Intent (LOI) with Minaris Advanced Therapies, a globally recognized CDMO that specializes in cell and gene therapies. This partnership is expected to enhance the manufacturing capabilities for NurOwn.

Moreover, BrainStorm's data showcasing the pharmacogenomic implications of the UNC13A genotype in ALS patients treated with NurOwn was recognized at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting. This acknowledgment underscores BrainStorm’s ongoing research efforts and their goal to translate scientific findings into therapeutic applications.

Financial Performance Highlights

Financially, BrainStorm reported around $1.03 million in cash, cash equivalents, and restricted cash as of June 30, 2025. Research and Development expenses for this quarter reached $1.1 million, an increase from $0.9 million during the same period last year. General and administrative expenses also saw a decrease, totaling approximately $1.4 million compared to $2.1 million in Q2 of 2024. However, the company recorded a net loss of roughly $2.9 million, slightly higher than the $2.5 million loss reported the previous year.

While facing these challenges, BrainStorm remains committed to advancing their clinical and operational initiatives, firmly believing in the potential difference NurOwn can make for ALS patients and their families.

Conclusion

BrainStorm’s progress in Q2 2025 signifies a pivotal moment in their ongoing mission to address the needs of ALS patients through innovative stem cell therapies. The forthcoming clinical trials, supported by promising survival data, put the company in a favorable position for potential regulatory success and, eventually, market approval.