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BrainStorm Cell Therapeutics Full Year Financial Report for 2025

On March 31, 2026, BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a pioneering firm in adult stem cell treatments for neurodegenerative diseases, unveiled its financial results for the fiscal year ending December 31, 2025. This announcement comes amidst a dedicated focus on advancing its lead investigational therapy, NurOwn, for Amyotrophic Lateral Sclerosis (ALS).

Chaim Lebovits, the President and CEO, stated, "Our primary goal remains to progress NurOwn into a Phase 3b confirmatory study, having received FDA clearance in 2025 for this vital undertaking." This study aims to generate the necessary confirmatory data to support a biologics license application (BLA). With crucial regulatory steps already completed, including the Special Protocol Assessment (SPA) and Chemistry, Manufacturing, and Controls (CMC) alignment, BrainStorm is poised for success.

Key highlights from 2025 include:

• - NurOwn for ALS: The company is diligently executing operational, clinical, and manufacturing strategies to advance the Phase 3b ENDURANCE study of NurOwn. This study is expected to enroll approximately 200 participants across top ALS treatment centers and is designed to assess long-term safety and efficacy through a two-part trial: the first part being a 24-week randomized, double-blind, placebo-controlled study, followed by a 24-week open-label extension.

• - Expanded Access Program (EAP): The EAP has reported promising metrics, showcasing that 50% of patients involved remain alive, with an estimated mean survival of approximately 84 months. This far exceeds historical survival rates, highlighting the potential of NurOwn in treating ALS.

In March 2026, BrainStorm also secured strategic financing amounting to $2 million through private placements, reinforcing its financial stability. This funding is intended to support crucial operational activities, particularly in preparation for the Phase 3b ENDURANCE trial.

Financial Overview

In terms of finances, as of December 31, 2025, BrainStorm reported a net loss of approximately $10.3 million, a decrease from the previous year's loss of $11.6 million. Research and development expenses for 2025 totaled $4.2 million, slightly down from $4.7 million in 2024. General and administrative costs also decreased, reflecting a focused effort on managing expenditures amid ongoing developmental commitments.

Looking Ahead

The NurOwn technology platform utilizes autologous mesenchymal stem cells that have the potential to deliver neuroprotective signals directly to areas impacted by ALS. This therapeutic approach is critical for enhancing the survival of patients and providing them with a better quality of life.

BrainStorm's commitment to ALS patients remains unwavering, as it continues to navigate the complex landscape of clinical development, regulatory approvals, and financial sustainability. As the company endeavors to finalize NurOwn and bring this viable treatment to market, continued engagement with the ALS community and regulators will play an integral role in its path forward. The future looks promising as BrainStorm focuses on maximizing the impact of its groundbreaking research and clinical expertise in the realm of neurodegenerative diseases.