Brainstorm Cell Therapeutics I Stock Price, News & Analysis

BrainStorm Cell Therapeutics (NASDAQ: BCLI) has appointed Dr. Haro Hartounian as the new EVP and COO, effective June 18, 2024. Dr. Hartounian brings over 32 years of biopharma experience, notably founding BioCentriq, a cell and gene therapy CDMO, acquired for $73 million in 2022. His expertise encompasses managing large pharmaceutical operations and biotech start-ups. As COO, he will oversee BrainStorm's operational efficiency, CMC, and commercialization strategies, particularly for NurOwn®, their ALS treatment. The appointment aligns with the launch of a Phase 3b ALS study, aiming to enhance the company's therapeutic platforms.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) is advancing its autologous mesenchymal stem cell (MSC) therapy, NurOwn® (debamestrocel, MSC-NTF), targeting neurodegenerative diseases, primarily ALS. Post hoc analysis of Phase III data reveals significant clinical benefits for early-stage ALS patients, prompting the FDA to back a new Phase IIIb trial under an SPA agreement. The Phase IIIb trial aims to enroll ALS patients with ALSFRS-R scores ≥35, focusing on slowing disease progression. Peer-reviewed studies also highlight NurOwn's positive impact on ALS biomarkers, supporting its potential efficacy. BCLI has met the NASDAQ minimum value compliance and anticipates strong valuation growth if the Phase IIIb trial succeeds.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced new biomarker data indicating that ALS patients may benefit from longer-term treatment with their stem cell therapy, NurOwn. This data will be presented at the 3rd Annual ALS Drug Development Summit in Boston from May 21-23, 2024. The data, from the NurOwn Expanded Access Program (EAP) and Phase 3 trial, shows significant reduction in neurofilament light (NfL) levels, a key ALS biomarker. Phase 3 participants on NurOwn saw an 11% NfL decline, while EAP participants saw up to 36% reduction. The company aims to validate these findings in a forthcoming Phase 3b study.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced its Q1 2024 financial results and provided a corporate update. The company achieved a key milestone by securing a Special Protocol Assessment (SPA) from the U.S. FDA for its Phase 3b trial of NurOwn for ALS. This SPA validates the clinical trial protocol and statistical analysis, supporting a future Biologics License Application (BLA). Q1 2024 saw research and development expenses decrease to $1.0 million from $2.9 million in Q1 2023, while general and administrative expenses dropped to $1.5 million from $2.2 million. Net loss reduced from $5.1 million in Q1 2023 to $3.4 million. The company has $1.0 million in cash, cash equivalents, and restricted cash as of March 31, 2024. Additionally, BrainStorm will participate in the ALS Drug Development Summit, and management changes include promoting Dr. Bob Dagher to Executive VP and CMO, and Dr. Stacy Lindborg stepping down as Co-CEO but remaining on the Board of Directors.