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Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a pioneering biotechnology company focused on developing advanced autologous stem cell therapies aimed at treating severe neurodegenerative disorders. These include highly debilitating diseases such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Multiple Sclerosis (MS), and Parkinson’s Disease (PD), which currently have limited treatment options.
The cornerstone of Brainstorm's innovative approach is its NurOwn® technology platform. This proprietary technology involves the propagation and differentiation of autologous Mesenchymal Stem Cells (MSCs) into neurotrophic factor (NTF) secreting cells. These MSC-NTF cells are then transplanted at or near the damaged tissue sites, essentially converting MSCs into a living drug delivery system for NTFs that can target specific neurodegenerative diseases.
Brainstorm has demonstrated proof-of-concept in various animal models for diseases including ALS, MS, Parkinson's, Huntington's, and peripheral nerve injuries. The company's commitment to ALS treatment is underscored by the completion of multiple clinical trials, including a Phase 3 trial, which investigated the safety and efficacy of repeat administration of MSC-NTF cells, supported by grants from the California Institute for Regenerative Medicine (CIRM) and the ALS Association.
Most recently, Brainstorm achieved a significant milestone by securing a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for the design of a Phase 3b trial of NurOwn in ALS patients. This agreement with the FDA validates the clinical trial protocol and statistical analysis, supporting a future Biologics License Application (BLA) for ALS. The Phase 3b trial aims to enroll up to 200 participants and will involve a double-blind, placebo-controlled period followed by an open-label extension period, focusing on patients earlier in the course of ALS.
Additionally, Brainstorm has fortified its intellectual property portfolio with new patents granted in Europe, Australia, and Israel, enhancing its capability to forge global commercial partnerships for NurOwn. The company's efforts in preclinical research, rigorous clinical trials, and strong collaboration with regulatory agencies and the ALS community underscore its dedication to bringing novel treatment options to patients in need.
Brainstorm's financial condition remains robust, supported by diverse grants and collaborative efforts with advocacy groups. The company continues to advance its pipeline with ongoing clinical trials for progressive MS and plans to expand its research into other neurodegenerative conditions.
For the latest updates on Brainstorm Cell Therapeutics Inc. and its groundbreaking developments, visit their official website or follow their news releases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has made significant progress in developing NurOwn®, a stem cell therapy for neurodegenerative diseases, particularly ALS. Key developments include:
1. Resolution of FDA CMC questions
2. Establishment of a commercialization team
3. Raising $4 million to start Phase IIIb rollout
4. Signing a CRO and lining up a commercial manufacturer
These advancements have shortened the Biologics Licence Application timeline. Despite dilution from the recent fundraising, ACF Equity Research maintains a >10x return investment hypothesis. The Phase IIIb trial, focusing on early to mid-stage ALS patients, could provide competitive advantages if successful. BCLI is also exploring non-dilutive grant funding options.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced a mid-year corporate update on its NurOwn® program scheduled for July 8, 2024, at 8:00 a.m. Eastern Time. The update will focus on recent positive developments in NurOwn®, a therapy for neurodegenerative diseases. CEO Chaim Lebovits, COO Hartoun Hartounian, and Chief Development Officer Bob Dagher will present. A Q&A session will follow, with questions to be submitted by July 5, 2024, at 10:00 a.m. Participants can join via conference call or webcast, with replay available until July 22, 2024.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced a $4.0 million registered direct offering with a single institutional investor. The deal includes the sale of 11,111,111 shares at $0.36 each and unregistered warrants for 16,666,667 shares at $0.3912 each, exercisable in six months and expiring in five years. Existing warrants' exercise price will be reduced to $0.3912 and expiration extended to 2029. The offering will close around June 28, 2024, and Maxim Group is the placement agent. The offering is made under a shelf registration statement filed with the SEC.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has reached alignment with the FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of its Phase 3b clinical trial for NurOwn, a therapy for amyotrophic lateral sclerosis (ALS). This development follows the FDA’s Special Protocol Assessment (SPA) agreement granted in April 2024, which provided clarity on the trial design and endpoints. The Type C meeting resolved all outstanding CMC questions, allowing BrainStorm to proceed with the pivotal trial. Chaim Lebovits, CEO, expressed satisfaction with the outcome, emphasizing the importance of alignment in manufacturing complexities and the company's commitment to advancing ALS treatment.
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.
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