BrainStorm Cell Therapeutics Reports Q3 2025 Financial Results and Strategic Developments

Introduction
On November 14, 2025, BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), an innovator in adult stem cell therapies for neurodegenerative diseases, disclosed its financial outcomes for the third quarter ending September 30, 2025, along with significant updates about its ongoing projects, particularly the NurOwn® therapy designed to treat amyotrophic lateral sclerosis (ALS).

Financial Overview
BrainStorm's financial position shows a steady yet cautious recovery. The company held approximately $0.23 million in cash and equivalents as of the end of September. Notably, research and development spending slightly decreased to $0.9 million from $1 million in the third quarter of 2024. Administrative expenses also saw a reduction, falling to about $1.1 million from $2 million the previous year. Ultimately, the net loss for the quarter was around $2.1 million, down from $2.7 million in Q3 2024, resulting in a loss per share of $0.19 compared to $0.51.

Key Developments: NurOwn®
BrainStorm is making significant strides in advancing its lead therapeutic candidate, NurOwn®, an investigational therapy aimed at ALS. The company has received FDA clearance to proceed with a Phase 3b clinical trial, dubbed the ENDURANCE study, which is projected to enroll about 200 participants across premier ALS treatment centers. The clinical trial will feature a randomized, double-blind, placebo-controlled phase, lasting 24 weeks, followed by a further 24-week open-label extension. The primary measure of effectiveness will involve assessing changes from baseline to Week 24 using the ALSFRS-R scale, data from which is expected to help with a Biologics License Application (BLA).

Chaim Lebovits, President and CEO, emphasized the company's commitment to supporting the ALS community, stating, “We are making steady progress toward stabilizing our financial situation and initiating our Phase 3b study of NurOwn. We believe that this therapy could provide significant therapeutic benefits for ALS patients.” The company anticipates that the trial results will further substantiate NurOwn's potential to slow disease progression and enhance patient quality of life.

In addition to the clinical advancement, a Citizen Petition was filed with the FDA by ALS advocates, calling for renewed scrutiny of NurOwn's supporting data. While BrainStorm did not take part in this petition, the company views it as a sign of the ongoing interest in the investigational therapy and the hope surrounding its potential.

Future Perspectives
In the next few months, BrainStorm is planning to conduct a conference call and webcast aimed at its investors to deliver further updates regarding the NurOwn Phase 3 program. The company remains optimistic about its ability to navigate the clinical and regulatory landscapes and is focused on strengthening its financial health through prudent management and strategic initiatives.

Conclusion
As BrainStorm Cell Therapeutics moves forward, its dedication to treating ALS through innovative stem cell technologies positions it as a key player in the neurodegenerative therapy domain. With a promising pipeline that includes NurOwn® and a growing intellectual property portfolio, BrainStorm aims to make a significant impact on the lives of millions affected by neurodegenerative diseases. Investors and stakeholders will be watching closely for updates as the end of the fiscal year approaches, with hopes for successful trial results and a potential BLA submission in the near future.