BrainStorm Cell Therapeutics Announces Full Year 2025 Financial Results and Provides Corporate Update

Core Insights - BrainStorm Cell Therapeutics Inc. reported its financial results for the full year 2025 and highlighted advancements in its clinical programs, particularly for NurOwn, a treatment for ALS [1][2]. Financial Performance - For the year ended December 31, 2025, the company reported a net loss of approximately $10.3 million, an improvement from a net loss of about $11.6 million in 2024 [9][17]. - Research and development expenditures for 2025 were $4.2 million, down from $4.7 million in 2024 [9][17]. - General and administrative expenses decreased to approximately $5.8 million in 2025 from $7.0 million in 2024 [9][17]. - Cash and cash equivalents were approximately $0.3 million as of December 31, 2025, with an additional $2 million secured through private placements in early 2026 [9][3]. Clinical Development - The company is advancing NurOwn into a Phase 3b confirmatory study, having received FDA clearance in 2025 [2]. - The Phase 3b ENDURANCE study is expected to enroll around 200 participants and will consist of a 24-week randomized, double-blind, placebo-controlled portion followed by a 24-week open-label extension [2][4]. - The primary efficacy endpoint for the trial will be the change from baseline to Week 24 on the ALSFRS-R scale [2]. Expanded Access Program (EAP) Results - In the EAP, 50% of patients (5 out of 10) remained alive, with an estimated mean survival of approximately 84 months [4]. - All 10 EAP patients exceeded a 5-year survival rate compared to the historical rate of about 20% [4]. Strategic Financing - The company secured $2 million in strategic financing through two private placement agreements in February 2026, aimed at supporting operational objectives and the Phase 3b trial preparations [3][9]. Technology Overview - NurOwn technology utilizes autologous MSC-NTF cells derived from bone marrow to deliver neurotrophic factors, targeting neurodegenerative diseases [5][6]. - The platform has received Orphan Drug designation from both the FDA and EMA for ALS treatment [7].