Welcome to our dedicated page for Brainstorm Cell Therapeutics I news (Ticker: BCLI), a resource for investors and traders seeking the latest updates and insights on Brainstorm Cell Therapeutics I stock.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) delivers innovative autologous stem cell therapies targeting neurodegenerative diseases through its NurOwn® platform. This dedicated news hub provides investors and healthcare stakeholders with timely updates on clinical developments, regulatory progress, and strategic initiatives.
Access authoritative reporting on key milestones including clinical trial results, FDA communications, manufacturing partnerships, and scientific presentations. Our curated news collection enables efficient tracking of BCLI's progress in advancing treatments for ALS, multiple sclerosis, and Parkinson's disease.
Key content categories include:
- Clinical trial phase updates
- Regulatory submissions and designations
- Research collaborations
- Peer-reviewed publication highlights
- Financial reporting
Bookmark this page for consolidated access to verified BCLI developments. Check regularly for updates on novel cellular therapies addressing critical unmet medical needs in neurology.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has submitted an Investigational New Drug (IND) amendment to the FDA for NurOwn®, their autologous mesenchymal stem cell therapy for ALS. The submission paves the way for a Phase 3b clinical trial designed under a Special Protocol Assessment (SPA).
The upcoming trial will enroll approximately 200 ALS participants in two parts: Part A involves a 24-week double-blind period where patients receive three doses of either NurOwn or placebo. In Part B, all participants transition to an open-label extension, receiving three additional NurOwn doses over another 24 weeks. The primary efficacy endpoint will measure changes in ALSFRS-R scores from baseline to week 24.
NurOwn® technology platform uses autologous MSC-NTF cells derived from bone marrow mesenchymal stem cells, engineered to secrete high levels of neurotrophic factors. The therapy has received Orphan Drug designation from both FDA and EMA for ALS treatment.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has released its full year 2024 financial results and corporate update. The company reported a net loss of $11.6 million ($2.31 per share) for 2024, compared to $17.2 million ($6.00 per share) in 2023. Cash position stood at $0.4 million as of December 31, 2024.
Key developments include advanced preparations for a Phase 3b trial of NurOwn in approximately 200 ALS participants, with FDA agreement on Special Protocol Assessment (SPA). The company secured a strategic partnership with Pluri for manufacturing support and received a patent allowance for exosome platform technology. Research and development expenses decreased to $4.7 million from $10.7 million in 2023, while general and administrative expenses reduced to $7.0 million from $10.7 million.
The company expects to raise approximately $1.64 million through a warrant inducement agreement closing around April 1, 2025.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received an extension from the Nasdaq Hearings Panel until June 30, 2025 to regain compliance with certain continued listing standards of The Nasdaq Capital Market. The extension was granted following the company's presentation at a panel hearing on February 25, 2025.
The biotechnology company, focused on developing autologous cellular therapies for neurodegenerative diseases, is implementing a compliance plan that includes:
- Launching a Phase 3b ALS study for NurOwn®
- Reducing overall debt balance
- Pursuing strategic partnerships to enhance pipeline
CEO Chaim Lebovits emphasized the company's commitment to meeting the requirements within the specified timeframe while focusing on strengthening their financial position and advancing clinical programs.
BrainStorm Cell Therapeutics (NASDAQ: BCLI), a developer of adult stem cell therapeutics for neurodegenerative diseases, has scheduled its Q4 and fiscal year 2024 financial results conference call for March 31, 2025, at 8:30 AM ET.
The corporate update will feature presentations from key executives including CEO Chaim Lebovits, COO Hartoun Hartounian, CMO Bob Dagher, and interim CFO Alla Patlis. Investors can submit questions in advance to q@brainstorm-cell.com by March 28, 2025, at 10:00 AM ET. A replay of the call will be available until April 14, 2025.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) highlights key achievements in 2024, including securing a Special Protocol Assessment (SPA) with the FDA for NurOwn's Phase 3b clinical trial and aligning on Chemistry, Manufacturing, and Controls (CMC) plans. The company entered an MOU with Pluri Inc. for clinical manufacturing and strengthened its leadership team with new appointments.
Biomarker studies showed NurOwn's potential to reduce neurofilament light levels in ALS patients. The company raised approximately $8 million since the previous ADCOM results and is pursuing additional funding. Looking ahead to 2025, BrainStorm plans to execute the Phase 3b trial focusing on early-stage ALS patients and advance its exosome platform development.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has announced two significant upcoming events. The company will host a corporate update conference call on December 30, 2024, at 8:30 AM ET, featuring presentations from key executives including CEO Chaim Lebovits, COO Hartoun Hartounian, and CDO Bob Dagher. Investors can participate through dial-in numbers or webcast, with a Q&A session following the presentations.
Additionally, the company will host a Key Opinion Leader Webinar focused on ALS treatment developments on December 11, 2024, at 10:00 AM ET, featuring Dr. Terry Heiman Patterson from Temple University. Questions for the corporate update call can be submitted in advance to q@brainstorm-cell.com by December 22, 2024.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received a Notice of Allowance from the USPTO for patent application 16/981,757, covering its proprietary exosome technology. The patent protects the composition and method of unique exosomes isolated from MSC-NTF cells, containing specific neurotrophic factors (LIF, VEGFA, GDF-15) and potentially additional proteins or microRNA molecules. The patent is expected to provide protection until April 10, 2039. The company aims to strengthen its position in cellular and exosome-based therapies while focusing on NurOwn development for ALS through an upcoming Phase 3b registrational trial.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announces a KOL webinar scheduled for December 11, 2024, at 10:00 AM ET, focusing on Amyotrophic Lateral Sclerosis (ALS) treatment developments. The event will feature Dr. Terry Heiman-Patterson from Temple University's Lewis Katz School of Medicine, who will discuss the current ALS treatment landscape. BrainStorm's management will provide updates on their planned Phase 3b registrational clinical trial for NurOwn® (autologous MSC-NTF cells) and future development plans. The successful completion of Part A of the Phase 3b trial is expected to support a Biologic License Application (BLA) for NurOwn. The webinar will conclude with a live Q&A session.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced Q3 2024 financial results and updates on its NurOwn® program. The company is preparing for a Phase 3b registration trial of NurOwn in ALS, partnering with Pluri Inc. for manufacturing. The trial will enroll approximately 200 ALS patients in a two-part study. Financial highlights show cash and equivalents of $0.35 million, R&D expenses of $1 million (down from $3.3 million in Q3 2023), and a net loss of $2.7 million ($0.51 per share) compared to $1.2 million ($0.45 per share) in Q3 2023.
BrainStorm Cell Therapeutics has signed a Memorandum of Understanding (MOU) with Pluri to manufacture NurOwn® for the planned Phase 3b trial in amyotrophic lateral sclerosis (ALS). This agreement will enable BrainStorm to transfer its manufacturing technology and start production at Pluri's GMP-compliant facility in Israel upon finalizing a definitive agreement. The collaboration aims to meet the supply requirements for the Phase 3b trial and explore future commercial distribution options, pending NurOwn's approval. The trial will enroll up to 200 participants and is designed in two parts: a 24-week double-blind period followed by a 24-week open-label period. The primary endpoint is the change in ALSFRS-R score from baseline to week 24. BrainStorm will provide further updates in Q4 2024.
