BrainStorm Cell Therapeutics Announces Full Year 2023 Financial Results and Provides Corporate Update

Core Viewpoint - BrainStorm Cell Therapeutics Inc. is focused on advancing the NurOwn program, particularly through a confirmatory Phase 3b trial aimed at supporting a new Biologics License Application (BLA) for ALS treatment [2][3]. Clinical and Regulatory - The company submitted a Special Protocol Assessment (SPA) request to the FDA for the Phase 3b study of NurOwn, which is currently under review with an expected response soon [3]. - The planned Phase 3b trial will be a two-part, multicenter study assessing the efficacy and safety of NurOwn in ALS patients earlier in the disease [3]. - In October 2023, BrainStorm withdrew its previous BLA for NurOwn after the FDA advisory committee indicated insufficient evidence of effectiveness for mild to moderate ALS [3]. Corporate Developments - In October 2023, BrainStorm announced a strategic realignment, reducing resources and headcount by approximately 30% to accelerate the development of NurOwn for ALS [4]. - The company is committed to conducting the upcoming Phase 3b trial with high scientific standards, reflecting its dedication to the ALS community [2]. Financial Results - As of December 31, 2023, BrainStorm reported cash and cash equivalents of $1.45 million, down from $3 million in 2022 [5]. - Research and development expenses decreased to approximately $10.8 million in 2023 from $14 million in 2022 [5]. - The net loss for the year ended December 31, 2023, was $17.2 million, an improvement from a net loss of $24.3 million in 2022, with net loss per share decreasing from $0.66 to $0.40 [6][15].