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BrainStorm Cell Therapeutics Inc. develops autologous adult stem cell therapeutics for neurodegenerative diseases, with news centered on its investigational NurOwn® platform for amyotrophic lateral sclerosis. NurOwn uses bone marrow-derived mesenchymal stem cells expanded and differentiated ex vivo into neurotrophic factor-secreting MSC-NTF cells designed to deliver neurotrophic factors and immunomodulatory cytokines.
Company updates commonly cover financial results, private placements and working-capital actions, regulatory engagement with the FDA, manufacturing readiness and clinical development activities tied to the Phase 3b ENDURANCE study. Corporate updates also address the completed transition of BCLI common stock from Nasdaq listing to OTCQB quotation.
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.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that Dr. Ralph Kern will present a corporate overview at the 12th Annual California ALS Research Summit on January 27, 2022, at 4:45 p.m. ET. The summit, held virtually on January 27-28, focuses on advancing research in neurodegenerative diseases. BrainStorm's NurOwn® technology, which utilizes autologous MSC-NTF cells, aims to treat conditions like ALS and has received Orphan Drug designation from the FDA and EMA. For more details and registration, visit the official summit page.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will present a corporate and clinical overview at Biotech Showcase™ 2022, scheduled virtually on January 10-12 and 17-18. Ralph Kern, M.D., President and CMO, will lead the presentation, which will be pre-recorded for registered attendees. The company is notable for its NurOwn® technology, targeting neurodegenerative diseases. NurOwn® cells, derived from autologous stem cells, aim to deliver neurotrophic factors to affected areas to combat conditions like ALS. BrainStorm has completed significant trials, including a Phase 3 study in ALS and a Phase 2 trial in progressive MS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has announced an extension of the NurOwn® Expanded Access Protocol (EAP) for patients with neurodegenerative diseases, following FDA recommendations. Eligible participants who completed the Phase 3 NurOwn trial can now receive up to 3 additional doses, increasing the total to 9 doses. The decision was informed by new analysis and biomarkers from the Phase 3 study. This initiative aims to provide more treatment options and gather further data on long-term effects.
BrainStorm Cell Therapeutics (BCLI) announced the peer-reviewed publication of Phase 3 clinical data in Muscle and Nerve for its NurOwn® therapy aimed at ALS treatment. While the trial did not achieve statistical significance in its primary and secondary endpoints, analyses indicate a treatment effect in patients with less advanced disease. Key findings revealed larger treatment effects in these subgroups and significant biomarker improvements in neuroinflammation and neurodegeneration. The study reinforces the potential of NurOwn to provide clinical benefits for ALS patients and emphasizes the need for further evaluation.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) and Catalent (NYSE: CTLT) have finalized the technology transfer for manufacturing the autologous cellular therapy NurOwn® at Catalent's Houston facility. This collaboration began in 2020, aiming to ensure CGMP clinical supply in anticipation of regulatory approval for NurOwn, which targets ALS and other neurodegenerative diseases. Both companies express optimism about the manufacturing process, emphasizing the complexity of cellular therapies and their commitment to advancing the therapy toward commercialization.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the presentation of biomarker data on its therapy NurOwn® at the 32nd International Symposium on ALS/MND from December 7-10, 2021. Dr. Robert Brown will deliver the presentation, focusing on how NurOwn targets multiple disease pathways in ALS. Key findings show significant cerebrospinal fluid (CSF) biomarker changes linked to clinical outcomes. These insights support NurOwn's potential as a novel therapy for ALS, highlighting the importance of targeting various disease pathways to enhance treatment efficacy.