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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) 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.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received written notice from Nasdaq confirming its regained compliance with the minimum closing bid price requirement under Listing Rule 5550(a)(2). The notice, received on October 29, 2024, ensures the company's continued listing on The Nasdaq Capital Market, subject to maintaining compliance with Nasdaq's listing requirements.
BrainStorm Cell Therapeutics presented positive survival data from NurOwn's Expanded Access Program (EAP) at the 2024 NEALS Meeting. The study included 10 ALS patients, showing significant survival benefits with a median survival time of 46.6 months for the debamestrocel group versus 41.1 months for matched controls. Neurofilament light (NfL) biomarker data indicated reduced neurodegeneration in treated patients. The company also presented details of an upcoming Phase 3b trial that will enroll approximately 200 participants to receive either debamestrocel or placebo, followed by an open-label period.
BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a developer of adult stem cell therapeutics for neurodegenerative diseases, announced its participation in the 2024 Maxim Healthcare Virtual Summit. CEO Chaim Lebovits will join a Fireside Chat on October 15 at 9:30 a.m. ET to provide an update on the planned Phase 3b clinical trial for NurOwn®, the company's investigational cell therapy for ALS.
The summit, taking place from October 15 to 17, will feature presentations and discussions led by senior analysts, focusing on critical healthcare trends. The event offers an opportunity for BrainStorm to engage with the investment community and share insights into their upcoming trial. Interested parties can access the conference live on M-Vest by signing up as members.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced the acceptance of two abstracts featuring NurOwn® (MSC-NTF or Debamestrocel) at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting. The company's priority is initiating a Phase 3b clinical trial to confirm NurOwn's efficacy in early-stage ALS patients. Two presentations are scheduled:
1. "Debamestrocel Long-Term Benefits on Survival and Neurodegeneration in ALS Expanded Access Program" by Bob Dagher, MD.
2. "An Overview of The Phase 3b Clinical Trial of Debamestrocel in ALS" by Bob Dagher, MD.
NurOwn® is an autologous MSC-NTF cell therapy targeting neurodegenerative disorders, with ALS as the lead program. The clinical program has provided insights into ALS pathology, disease progression, and treatment.
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