BrainStorm Cell Therapeutics Inc. Advances in Stem Cell Therapy Amid Financial Challenges

In the dynamic landscape of biotechnology, BrainStorm Cell Therapeutics Inc., a New York-based company specializing in autologous adult stem cell therapies for neurodegenerative disorders, has recently made significant strides in its clinical development while navigating financial hurdles. The company, listed on the OTC Bulletin Board, focuses on treating conditions such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson’s disease (PD).

On August 14, 2025, BrainStorm announced its second-quarter financial results, revealing both promising clinical developments and ongoing financial challenges. The company reported a quarterly net loss of $2.9 million, or $0.34 per share, compared to a loss of $2.54 million, or $0.60 per share, in the same quarter of the previous year. Despite these losses, BrainStorm’s cash position stood at $1.03 million.

A key highlight from the quarter was the FDA clearance for a Phase 3b trial of its NurOwn® therapy, known as the ENDURANCE trial. This trial is designed to generate confirmatory data to support a potential Biologics License Application (BLA) submission. The company plans to enroll approximately 200 participants, marking a significant step forward in its clinical development efforts.

The NurOwn Expanded Access Program has shown promising survival data, with 100% of participants surviving beyond five years from ALS symptom onset, and a median survival of 6.8 years. This encouraging data underscores the potential impact of NurOwn® in treating ALS.

In addition to clinical advancements, BrainStorm has signed a Letter of Intent (LOI) with Minaris Advanced Therapies for manufacturing support, ensuring readiness for clinical drug supply. The company also presented breakthrough pharmacogenomic data at the International Society for Cellular Therapy (ISCT) 2025, further highlighting its innovative approach to stem cell therapy.

Chaim Lebovits, President and CEO of BrainStorm, emphasized the company’s commitment to executing its clinical development plan for NurOwn®. “We reached an important milestone in Q2 with FDA clearance to initiate our Phase 3b trial,” Lebovits stated. “We are also advancing key operational activities, including discussions with clinical sites and ongoing engagement with our selected CDMO partners to ensure readiness for clinical drug supply.”

The company’s efforts have garnered interest and support from clinicians and the ALS community, reinforcing BrainStorm’s confidence in its mission to develop transformative therapies for neurodegenerative diseases.

As BrainStorm Cell Therapeutics continues to navigate its financial landscape, the focus remains on advancing its clinical programs and bringing innovative therapies to patients in need. The company’s recent developments signal a promising future in the field of biotechnology, despite the financial challenges it faces.