#USA #New York #BrainStorm #ALS #NurOwn

BrainStorm Cell Therapeutics Reports Second Quarter 2026 Financial Results

BrainStorm Cell Therapeutics Inc., listed on OTCQB under the symbol BCLI, has officially released its financial results for the second quarter ended June 30, 2026. The company is renowned for its innovative adult stem cell therapeutics aimed at treating neurodegenerative diseases, particularly amyotrophic lateral sclerosis (ALS).

Corporate Developments

In a recent statement, Chaim Lebovits, President and CEO of BrainStorm, highlighted the company’s advancements in preparations for launching the Phase 3b ENDURANCE study of their flagship therapy, NurOwn. This study will focus on ALS and is conducted under a rigorous regulatory framework, supported by a protocol agreed upon by the FDA under a Special Protocol Assessment. This milestone marks a significant moment for BrainStorm, as it represents the first-ever SPA granted for a therapeutic candidate for ALS.

The company has also appointed Peter J. Pitts as the new Executive Chairman. With a rich history in regulatory affairs as a former senior official at the FDA, Pitts brings invaluable insight that will support the company’s operational, partnership, and capital markets strategies as they advance the NurOwn program.

Progress on NurOwn Trial

The Phase 3b ENDURANCE trial is designed to encompass about 200 patients with ALS, divided into two segments. The first part consists of a randomized, double-blind, placebo-controlled design, while the second part allows all participating patients to receive the NurOwn treatment after 24 weeks. The primary measure of success will be the change in the ALS Functional Rating Scale (ALSFRS-R).

As BrainStorm shifts focus to launching this crucial study, the ALS community is kept in mind, emphasizing the company's commitment to addressing the significant burden that ALS places on patients and their families.

Financial Overview

BrainStorm reported that cash and equivalents totaled approximately $0.2 million as of June 30, 2026, a notable decrease from about $1.03 million at the same time last year. Research and development expenses for the second quarter stood at about $1 million, a slight decrease from the previous year’s $1.1 million.

General and administrative expenses, conversely, increased to approximately $2.7 million from $1.5 million in the second quarter of 2025. The net loss for this quarter was about $3.9 million, higher than the $2.9 million reported in the second quarter of the last year.

The net loss per share for the quarter remained stable at $(0.35), compared to $(0.34) in the previous year’s quarter.

Recent Publications

In June 2026, BrainStorm announced a peer-reviewed publication co-authored by Peter Pitts and CEO Chaim Lebovits, which called for a re-evaluation of FDA regulatory strategies concerning ALS and other rare diseases. This publication addresses the necessity for regulatory frameworks to evolve in line with advancements in genomics, biomarkers, and artificial intelligence, advocating for tools like adaptive trial designs to accelerate the drug development process for these conditions.

Conclusion

As BrainStorm prepares to embark on its most significant trial for NurOwn yet, the recent financial report highlights both the challenges and advancements faced by the company. Leadership changes and the strategic developments in clinical trials underscore BrainStorm’s ongoing commitment to serving the ALS community. Their efforts may pave the way for innovative treatments in neurodegenerative medicine, driving research forward and offering hope to many who are impacted by these diseases.

For further information, please visit BrainStorm Cell Therapeutics.