BrainStorm Cell Therapeutics Announces Third Quarter 2025 Financial Results and Provides Corporate Update

Core Viewpoint - BrainStorm Cell Therapeutics Inc. is making progress in stabilizing its financial situation and advancing the Phase 3b study of its investigational therapy NurOwn for ALS, with FDA clearance obtained for the clinical study [2][8]. Financial Results - As of September 30, 2025, the company reported cash, cash equivalents, and restricted cash of approximately $0.23 million [7]. - Research and development expenditures for Q3 2025 were $0.9 million, a decrease from $1 million in Q3 2024 [7]. - General and administrative expenses for Q3 2025 were approximately $1.1 million, down from approximately $2.0 million in Q3 2024 [7]. - The net loss for Q3 2025 was approximately $2.1 million, compared to a net loss of approximately $2.7 million in Q3 2024 [7]. NurOwn Therapy Development - NurOwn is designed to deliver neurotrophic factors and immunomodulatory cytokines to slow disease progression in ALS [6][8]. - The upcoming Phase 3b ENDURANCE study will enroll about 200 participants and will include a 24-week randomized, double-blind, placebo-controlled period followed by a 24-week open-label extension [7]. - The primary efficacy measure will be the change from baseline to Week 24 on the ALSFRS-R scale [7]. Regulatory Engagement - The company is actively engaging with regulatory authorities and has received FDA clearance for the planned clinical study [2][8]. - A Citizen Petition was filed with the FDA by ALS community representatives, requesting a renewed review of NurOwn's data, which the company views as a constructive development [7]. Future Communications - BrainStorm plans to host a conference call and webcast for the investment community later in Q4 2025 or early Q1 2026 to provide further updates on the NurOwn Phase 3 program [4].