Core Insights - BrainStorm Cell Therapeutics Inc. reported financial results for Q2 2025 and provided updates on its clinical development plan for NurOwn, a therapy for neurodegenerative diseases, particularly ALS [1][2] Clinical Development - The FDA has granted clearance for BrainStorm to initiate a Phase 3b clinical trial of NurOwn, named ENDURANCE, which aims to enroll approximately 200 participants at leading academic medical centers [4] - The trial will consist of a 24-week randomized, double-blind, placebo-controlled phase followed by a 24-week open-label extension, with the primary endpoint being the change in the ALS Functional Rating Scale-Revised (ALSFRS-R) from baseline to week 24 [4] - A Citizen Petition has been submitted to the FDA by the ALS community for a new review of NurOwn data, which the company supports as an opportunity to reaffirm the therapy's potential [4] Financial Performance - As of June 30, 2025, BrainStorm reported cash, cash equivalents, and restricted cash of approximately $1.03 million [4] - Research and development expenditures for Q2 2025 were $1.1 million, an increase from $0.9 million in Q2 2024 [4] - General and administrative expenses decreased to approximately $1.4 million in Q2 2025 from approximately $2.1 million in Q2 2024 [4] Survival Data - New survival data from the NurOwn Expanded Access Program indicated that 100% of participants (10 out of 10) survived more than 5 years from the onset of ALS symptoms, compared to an estimated 10% survival rate for ALS patients [4] - The median survival observed in the EAP cohort was 6.8 years from symptom onset, with a range of 6 to 7 years [4] Manufacturing and Partnerships - BrainStorm has signed a Letter of Intent with Minaris Advanced Therapies for the manufacturing of NurOwn for the upcoming Phase 3b clinical trial [4] - The NurOwn data was selected for presentation at the ISCT 2025 Meeting, highlighting the impact of the UNC13A genotype on clinical outcomes for ALS patients treated with NurOwn [4] Company Overview - BrainStorm Cell Therapeutics Inc. specializes in developing autologous adult stem cell therapies for neurodegenerative diseases, with its proprietary NurOwn platform utilizing mesenchymal stem cells to produce neurotrophic factor-secreting cells [6][7]