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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 Inc. (BCLI) announced financial results for Q1 2022, reporting a net loss of $5.4 million, down from $6.7 million in Q1 2021. Cash and equivalents decreased to $18.4 million from $22.1 million at the end of 2021. The company is enhancing its leadership team with new appointments, focusing on the advancement of its ALS treatment, NurOwn®. Promising Phase 3 data has been shared, indicating significant effects on ALS biomarkers. BrainStorm continues to engage with ALS experts and plans to present at upcoming conferences.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced senior management appointments on May 12, 2022. Netta Blondheim-Shraga, PhD, is the new VP of Research & Development, tasked with advancing the company's pipeline in cellular therapies. Antal Pearl-Lendner, Adv., joins as Chief Legal Counsel, bringing extensive legal experience. CEO Chaim Lebovits emphasized the importance of these roles in preparing for the company's growth and mission to develop innovative therapies for neurodegenerative diseases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) presented at ISCT 2022 on May 4, 2022, highlighting the superior anti-inflammatory effects of NurOwn-derived exosomes over naïve mesenchymal stem cell-derived exosomes. Preclinical data demonstrated significant reductions in pro-inflammatory cytokines and enhancements in anti-inflammatory cytokines. Notably, treatment with NurOwn-derived exosomes led to a 6.4-fold reduction in MCP-1 and a 3.5-fold increase in IL10. These findings provide critical insights into the potential of NurOwn technology for treating neurodegenerative diseases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced key presentations at scientific conferences in May 2022, focusing on its MSC-NTF exosome technology. New data will be shared at ISCT 2022 in San Francisco (May 4-7) and ISEV 2022 in Lyon, France (May 25-29). Additionally, an analysis of CSF biomarkers from the NurOwn® Phase 3 trial will be presented at the ALS Drug Development Summit in Boston (May 24-26). These insights aim to advance understanding of neurodegenerative disease therapies, particularly ALS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will hold a conference call on May 16, 2022, at 8:00 a.m. ET to discuss first-quarter financial results and provide a corporate update. CEO Chaim Lebovits will lead the call along with key executives, and participant questions will be addressed. Interested parties can submit questions until 5:00 p.m. ET on May 15, 2022. The call can be accessed via phone or webcast. BrainStorm's autologous MSC-NTF technology aims to address neurodegenerative diseases, with recent advances including a completed Phase 3 trial for ALS.
Brainstorm Cell Therapeutics (NASDAQ: BCLI) announced that President and Chief Medical Officer, Ralph Kern, MD MHSc, will present at the 2022 Virtual Growth Conference hosted by Maxim Group LLC from March 28-30, 9:00 a.m. - 5:00 p.m. EDT. This virtual event will feature executives from various sectors and includes presentations, roundtable discussions, and live Q&A sessions. Investors can sign up to attend. Brainstorm focuses on autologous adult stem cell therapies for neurodegenerative diseases.
Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) reported its fiscal year 2021 financial results, highlighting strong momentum in 2022 with positive clinical data for NurOwn® in ALS patients. Although the Phase 3 trial did not meet primary endpoints, further analyses indicated treatment effects in less advanced ALS patients. The company ended 2021 with approximately $22.1 million in cash. R&D expenses decreased to $15.2 million, while the net loss improved to $24.5 million compared to $31.8 million in 2020. Management expressed confidence in advancing NurOwn® and increasing manufacturing capacity.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) will hold a conference call on March 28, 2022, at 8:00 a.m. ET to discuss financial results for Q4 and the full year ended December 31, 2021, along with a corporate update. CEO Chaim Lebovits will lead the session, addressing questions from the investment community. Notably, BrainStorm's NurOwn® technology is the focus of their clinical efforts in treating neurodegenerative diseases like ALS, having completed pivotal trials supported by grants from CIRM and NMSS.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced that its scientific abstract has been accepted for a late-breaking oral presentation at the 2022 MDA Clinical & Scientific Conference, scheduled for March 16, 2022. The presentation, titled 'Relationship of ALS genes and Single-Nucleotide Polymorphisms with Clinical Outcomes in NurOwn Phase 3 ALS Clinical Trial,' will be delivered by Dr. Merit Cudkowicz from Massachusetts General Hospital. This highlights the ongoing advancements in BrainStorm's NurOwn® therapy for neurodegenerative diseases, particularly ALS.
Brainstorm Cell Therapeutics (NASDAQ: BCLI) announced the grant of a new patent by the Brazilian Patent Office for a method to manufacture MSC-NTF cells (NurOwn®), which secrete various neurotrophic factors. CEO Chaim Lebovits emphasized the importance of this patent in enhancing their intellectual property (IP) portfolio, which now includes patents from the US, Canada, EU, Israel, Japan, and Brazil. This development is expected to support future commercial partnerships and regulatory pathways for NurOwn® in South America and globally.
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