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

BrainStorm Cell Therapeutics Reports Q1 2025 Financial Results

In an exciting update from BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), the company has announced its financial results for the first quarter of 2025 while also providing a comprehensive overview of its ongoing initiatives related to neurodegenerative diseases.

Corporate Highlights and Developments

BrainStorm continues to push forward with its innovative therapy, NurOwn®, specifically targeting amyotrophic lateral sclerosis (ALS). The firm's CEO, Chaim Lebovits, expressed optimistic sentiments about the advancements in their Phase 3b trial, intended to evaluate NurOwn's efficacy for early-stage ALS patients. This trial is crucial as it aims to support a new Biologics License Application (BLA) submission, aligning with ongoing expectations and prerequisites set by the FDA through a Special Protocol Assessment (SPA).

In terms of regulatory milestones, BrainStorm has submitted an IND amendment to the U.S. Food and Drug Administration. This submission is essential for updating vital documentation related to regulatory compliance and the integrity of the clinical trial. Such steps are aimed at establishing a solid foundation for clinical success going forward.

The highlights of the upcoming Phase 3b trial include its primary efficacy endpoint focusing on ALSFRS-R score changes after 24 weeks and an expected enrollment of approximately 200 participants. Clinicaltrials.gov has published details about this trial—dubbed ENDURANCE—further detailing the 15 clinical sites contributing to the study.

Furthermore, NurOwn's clinical data gained significant attention, evidenced by its selection for presentation at the International Society for Cell and Gene Therapy (ISCT) 2025 Annual Meeting in New Orleans. Insights presenting how the UNC13A genotype affects clinical outcomes in ALS treatment received praise for their potential impact on future therapeutic strategies. Data unveiled at the 2025 ALS Drug Development Summit emphasized the relevance of cerebrospinal fluid biomarkers relating to NurOwn and its correlated outcomes in ALS patients.

Financial Performance Overview

As for the financial aspect, BrainStorm reported approximately $1.8 million in cash, cash equivalents, and restricted cash as of March 31, 2025. The company reported a net loss of around $2.9 million, showing a decrease when compared to the net loss of approximately $3.4 million during the same quarter in 2024. This improvement highlights the company’s ongoing efforts to manage expenses effectively, with research and development expenditures noted at $1.3 million.

Additionally, general and administrative expenses rose to roughly $1.8 million, compared to $1.5 million the previous year. The loss per share also saw a reduction, indicating a gradual move towards financial stabilization in the context of clinical development.

Upcoming Engagement

In light of these updates, BrainStorm has scheduled a conference call and webcast for May 19, 2025, at 8:30 a.m. U.S. Eastern Time, where participants can join to delve deeper into the financial implications and clinical advancements regarding NurOwn. Interested parties may access this session via a dedicated URL, showcasing the company’s commitment to transparency and engagement with its existing and potential investors.

Conclusion

The first quarter of 2025 has proven pivotal for BrainStorm Cell Therapeutics as it continues to forge its path in neurodegenerative disease treatment, particularly with ALS. The progress on NurOwn, alongside the company’s improved financial metrics, reflects its potential to substantially impact the treatment landscape for patients afflicted by these debilitating conditions. The future of BrainStorm appears promising, with innovative solutions on the horizon rooted in scientific rigor and a strong commitment to addressing neurological health challenges.