BrainStorm Cell Therapeutics Reports Q1 2024 Financial Results and Corporate Update

BrainStorm Cell Therapeutics Inc., a prominent developer of adult stem cell therapies for neurodegenerative diseases, recently reported its financial results for the first quarter ending March 31, 2024, and provided significant updates on its corporate activities.

A significant advancement in the company's development program for Debamestrocel (NurOwn®) was achieved with the agreement from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA). This agreement pertains to the design of a Phase 3b trial for NurOwn, aimed at treating amyotrophic lateral sclerosis (ALS). The SPA ensures that the trial’s design and statistical analysis are adequate to meet the objectives necessary for a future Biologics License Application (BLA) submission. Chaim Lebovits, the President and CEO of BrainStorm, emphasized that this milestone reduces the regulatory risks of the program, aligning their approach with FDA standards and guidelines. This collaboration with the ALS community is crucial as they work towards introducing this promising treatment to those suffering from ALS.

In April 2024, BrainStorm received written confirmation from the FDA on the SPA, endorsing the Phase 3b trial's clinical protocol and statistical analysis. This validation indicates the trial’s adequacy in supporting a future BLA for ALS. The company plans to initiate this Phase 3b study within the year, following discussions with investigators, securing approval from study site Institutional Review Boards, and engaging with the ALS community.

Additionally, in April 2024, Phase 3 biomarker data on NurOwn in ALS were published in the journal Muscle and Nerve. The data, under the paper titled "Debamestrocel multimodal effects on biomarker pathways in amyotrophic lateral sclerosis are linked to clinical outcomes", showed that NurOwn treatment positively impacted crucial cerebrospinal fluid (CSF) biomarkers relevant to ALS, compared to a placebo. These findings support NurOwn's mechanism of action, complementing the clinical effects observed in ALS patients.

At the MDA Clinical and Scientific Conference in March 2024, BrainStorm presented its proposed design for the Phase 3b trial of NurOwn in ALS. The trial is designed as a two-part, multicenter study to assess the efficacy and safety of NurOwn in individuals with mild-to-moderate ALS. The primary endpoint will be measured using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R).

On the corporate front, BrainStorm promoted Dr. Bob Dagher to Executive Vice President and Chief Medical Officer in April 2024. Dr. Dagher, with over 20 years of experience in clinical research and development, has a proven track record in leading successful clinical trials and fostering innovation in drug development. Additionally, Dr. Stacy Lindborg, after four years in top executive roles, is stepping down from her role as Co-CEO but will continue as a member of BrainStorm’s Board of Directors. These changes are strategic as BrainStorm prepares for the Phase 3b trial for NurOwn.

BrainStorm will also participate in the 3rd Annual ALS Drug Development Summit in Boston, MA, from May 21 to 23, 2024. Dr. Stacy Lindborg will present new data suggesting that longer-term treatment with NurOwn may benefit patients, as evidenced by changes in neurofilament light (NfL), a key biomarker associated with ALS clinical outcomes. Other team members will engage in workshops and panels at the summit.

The company's financial results for the first quarter of 2024 show cash and equivalents totaling approximately $1.0 million as of March 31, 2024. Research and development expenses dropped to approximately $1.0 million from $2.9 million in the same period in 2023. General and administrative expenses decreased to $1.5 million from $2.2 million, and the net loss for the quarter was $3.4 million compared to $5.1 million in the previous year. The net loss per share reduced from $0.14 to $0.05.

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