Brainstorm Cell Therapeutics(BCLI) Prnewswire·2024-11-14 21:30Core Viewpoint - BrainStorm Cell Therapeutics Inc. is advancing its NurOwn® program for ALS, focusing on a Phase 3b registration trial, with updates expected in Q4 2024 [1][6]. Company Updates - The company has refined the Phase 3b trial design based on previous study learnings to enhance the likelihood of demonstrating treatment efficacy [2]. - A Memorandum of Understanding (MOU) was signed with Pluri Inc. for the manufacturing of NurOwn® for the upcoming trial [3]. - The Phase 3b trial is expected to enroll approximately 200 ALS participants, with a two-part structure involving both placebo and NurOwn treatments [4]. Clinical Trial Details - The trial will consist of a 24-week Part A with three doses of either NurOwn or placebo, followed by a 24-week open-label Part B where all participants will receive NurOwn [4]. - Primary efficacy will be measured using the ALSFRS-R score, with additional assessments including survival rates and various clinical measures [4]. Financial Performance - As of September 30, 2024, the company reported cash and cash equivalents of approximately 1.3 million year-over-year [7]. - Research and development expenses for Q3 2024 were 3.3 million in Q3 2023, while general and administrative expenses decreased to 2.7 million [7]. - The net loss for Q3 2024 was 1.2 million in the same quarter of 2023 [7]. Long-Term Benefits and Biomarkers - Promising long-term survival benefits were observed in patients treated with NurOwn, with a median survival time of 46.6 months compared to 41.1 months for matched controls [5]. - Consistent reductions in neurofilament light (NfL) levels were noted, indicating ongoing benefits from extended treatment, which aligns with the understanding of NurOwn's mechanism of action [5].