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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) 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.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Alignment with FDA on CMC aspects for planned Phase 3b NurOwn® trial in ALS
2. Special Protocol Assessment (SPA) agreement in place for the trial
3. Appointment of new EVP and COO, and promotion of new EVP and CMO
4. Q2 2024 financial results: Cash position of $3.65 million, R&D expenses of $0.9 million, G&A expenses of $2.0 million, net loss of $2.5 million ($0.04 per share)
5. Successful registered direct offering raising $4.0 million
The company is progressing with preparations for the Phase 3b trial, including CRO selection and engagement with ALS centers for trial sites.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a developer of adult stem cell therapeutics for neurodegenerative diseases, has announced a conference call on August 14, 2024, at 8:30 a.m. Eastern Time. The call will cover financial results for the second quarter ended June 30, 2024, and provide a corporate update. CEO Chaim Lebovits will present, joined by COO Haro Hartounian, CMO Bob Dagher, and Interim CFO Alla Patlis to answer questions. Participants can submit questions in advance to q@brainstorm-cell.com by August 12, 2024. The call can be accessed via toll-free (877-545-0523) or international (973-528-0016) numbers, with access code 308245. A webcast and 14-day replay will also be available.
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.
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