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BrainStorm's NurOwn® Data at ISCT 2025

BrainStorm Cell Therapeutics Inc. has made headlines with the announcement of new findings regarding its investigational therapy, NurOwn®, which are set to be presented at the upcoming ISCT 2025 Annual Meeting in New Orleans. The conference will take place from May 6-10, 2025, bringing together leaders in the field of cellular therapies.

In collaboration with prominent ALS research centers, BrainStorm's new pharmacogenomic data highlights the influence of the UNC13A genotype on clinical outcomes for patients suffering from amyotrophic lateral sclerosis (ALS). This groundbreaking data received a careful review and selection by the ISCT 2025 Planning Faculty, emphasizing its significance in advancing the field of cell therapies.

Chaim Lebovits, BrainStorm's President and CEO, expressed excitement about sharing the new scientific findings, stating that these results could provide critical insight into predicting treatment responses based on genetic factors. He noted that the feedback from ALS experts has been encouraging as they focus on addressing the medical needs of ALS patients.

The upcoming presentation is particularly timely as the company aims to launch a Phase 3b trial for NurOwn®, which seeks to establish its potential in early ALS treatment. BrainStorm is currently in productive discussions with the FDA, having submitted an IND amendment and committed to implementing a Special Protocol Assessment (SPA) in alignment with regulatory expectations.

Dr. Bob Dagher, BrainStorm's Executive Vice President and Chief Medical Officer, remarked on the impact of the latest findings from the Phase 3 trial. He highlighted the importance of understanding how genetic variations can affect treatment efficacy, stating that this represents one of the first pharmacogenomic analyses in ALS, potentially paving the way for tailored therapies in the future.

Presentation Details

• - Title: Debamestrocel Effect on Clinical and Biomarker Endpoints by UNC13A Genotype in Phase 3 ALS Trial
• - Lead Author: Bob Dagher, MD
• - Session: Mesenchymal Stem/Stromal Cells #1
• - Date & Time: Thursday, May 8, 2025 | 9:00 - 10:00 a.m. U.S. Central Time
• - Location: Ernest N. Morial Convention Center, New Orleans, Louisiana

Following the presentation, a copy of the poster will be made available on the BrainStorm corporate website, which will offer further insight into their research and findings.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics is at the forefront of developing innovative autologous adult stem cell therapies for challenging neurodegenerative diseases. Their proprietary NurOwn® technology utilizes autologous mesenchymal stem cells to create therapeutic cells designed to combat neuroinflammation and foster neuroprotection.

Recognized for its therapeutic potential, NurOwn® has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A completed Phase 3 trial has contributed valuable insights into ALS and has spurred the development of the Phase 3b trial.

As BrainStorm pursues advancements in ALS and other neurodegenerative conditions, they continue to refine their methodologies and expand their understanding of disease biology. Their recent initiatives include a Phase 2 trial for progressive multiple sclerosis, underscoring their commitment to innovative therapies in the realm of regenerative medicine.

To learn more about their initiatives and research, visit BrainStorm's website.