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NurExone Biologic Advances Manufacturing and Regulatory Roadmap with Independent Batch Consistency Results for Exosome Production
TMX Newsfile· 2026-02-10 21:03
Toronto, Ontario and Haifa, Israel--(Newsfile Corp. - February 10, 2026) - NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) ("NurExone" or the "Company"), a biopharmaceutical company developing exosome-based regenerative therapies for central nervous system injuries, today announced results from an independent proteomic analysis conducted at the Technion - Israel Institute of Technology. which evaluated multiple production batches of NurExone's exosomes. The results support the Company's Chemis ...
NurExone Appoints Eyal Gabbai to Board, Adding Large-Scale Healthcare System and Capital Markets Expertise
Globenewswire· 2026-01-30 21:03
Chairman of Meuhedet, Israel’s third-largest health fundTORONTO and HAIFA, Israel, Jan. 30, 2026 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) today announced changes to its board of directors (the “Board”). Effective today, Mr. Eyal Gabbai has been appointed to the Board replacing Dr. Gadi Riesenfeld, who has resigned from the Board. Dr. Riesenfeld will continue to support NurExone as a member of the Company’s Scientific Advisory Board. The C ...
NurExone Reports Anti-Inflammatory Activity of Its Exosomes in Lab Analysis
Globenewswire· 2025-12-19 21:04
Core Insights - NurExone Biologic Inc. has demonstrated that its proprietary exosomes significantly reduce inflammatory activity in the Central Nervous System compared to untreated cells and commercially available exosome products [1][5][6] Group 1: Laboratory Findings - The laboratory results indicate that NurExone's exosomes suppress inflammation more effectively than both untreated cells and commercial alternatives, with stronger effects observed at higher doses [2][5] - NurExone's exosomes reduced levels of IL-6, a key inflammatory signaling molecule, by more than 86% compared to untreated inflamed cells, maintaining this reduction across all tested concentrations [6][9] - For TNF-alpha, another central inflammatory signal, NurExone's exosomes showed a concentration-dependent response, achieving reductions of over 60% at the highest concentration tested [7][9] Group 2: Analytical Framework and Development - The company is building an analytical framework to quantify the biological complexity of exosome-based therapeutics, ensuring consistency and quality for regulatory readiness [4] - NurExone's exosomes, produced from human bone marrow-derived mesenchymal stem cells, exhibit significantly higher biological activity compared to commercially available MSC-derived exosomes [3] Group 3: Market Potential and Product Development - NurExone's lead product, ExoPTEN, has shown strong preclinical data supporting its clinical potential in treating acute spinal cord and optic nerve injuries, which are multi-billion-dollar markets [10] - The company has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy [10]
NurExone Plans Small-Scale of ExoPTEN Clinical Manufacturing in Preparation for FUTURE First in Human USE Pathways
Globenewswire· 2025-12-12 21:04
Core Insights - NurExone Biologic Inc. is making significant progress in its long-term clinical-readiness strategy by evaluating potential Israeli production partners for small-scale GMP-based manufacturing of its lead candidate, ExoPTEN, aimed at treating central nervous system injuries [1][4] Group 1: Product Development - ExoPTEN combines highly active exosomes with targeted siRNA, and the company is preparing for a First-in-Human use submission pending regulatory approval [2] - ExoPTEN is being developed for acute spinal cord injury and optic nerve injury, with the prioritization of indications yet to be determined [2] - New scientific data shows that NurExone's exosomes exhibit significantly higher CD73-associated biological activity compared to commercially available exosomes, reinforcing confidence in the platform [5][6] Group 2: Manufacturing Strategy - NurExone is assessing several Israeli manufacturing organizations for small-scale ExoPTEN production aligned with future clinical requirements [3] - The initial GMP production will take place in Israel, followed by a transition to the United States for scale-up [4] Group 3: Scientific Validation - Recent analytical testing indicates that NurExone's exosomes have a statistically significant higher conversion rate of adenosine monophosphate to adenosine, suggesting stronger regenerative potential [6][7] - The findings validate the potency of NurExone's therapeutic exosomes and support their use as a delivery vehicle in ExoPTEN [7] Group 4: Strategic Engagement - NurExone has engaged Russo Partners LLC for strategic communications support, subject to TSX Venture Exchange approval, for a fixed fee of US$6,600 [8]
NurExone Biologic Inc. Announces Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-28 14:15
Core Insights - NurExone Biologic Inc. reported its financial results for Q3 2025, highlighting significant advancements in its exosome-based therapies for central nervous system injuries [1][24] Financial Performance - Net R&D expenses for Q3 2025 were US$0.70 million, an increase from US$0.50 million in Q3 2024, attributed to higher headcount and service provider costs [19] - G&A expenses decreased slightly to US$0.76 million in Q3 2025 from US$0.78 million in Q3 2024, mainly due to lower service provider costs [20] - The net loss for Q3 2025 was US$1.47 million, compared to US$1.25 million in Q3 2024 [21] Corporate Developments - The company accelerated the expiry of 8.2 million warrants, raising approximately C$3.2 million to support corporate needs [3] - NurExone announced reproducible dose-dependent vision recovery in a glaucoma model, reinforcing the potential of its lead candidate, ExoPTEN [4] - The company secured patent grants in the U.S. and Israel for its exosome production process, enhancing its intellectual property position [11][12] Scientific Recognition - NurExone was named a finalist in two prestigious international award programs, highlighting its innovative approach in regenerative medicine [6] - The company enhanced its scientific visibility through presentations at leading conferences, including the Precision EV Forum 2025 [5] Upcoming Events - An investor webinar titled "Investing in the Future of Exosome Therapeutics" is scheduled for December 10, 2025, to discuss recent achievements and strategic priorities [7] Capital Raising Activities - The company raised C$1.4 million through private placements in August and September 2025, which will be used for working capital and clinical development [8][9][10] Manufacturing Expansion - Plans for a U.S. commercial exosome production facility in Indianapolis were announced, supported by an incentive offer of up to US$0.26 million [13] - NurExone joined the ARMI/BioFabUSA BioFab Startup Lab to strengthen its U.S. biomanufacturing presence [15]
NurExone Secures over C$3.18 Million Through Accelerated Warrant Exercises
Globenewswire· 2025-11-12 21:02
Core Insights - NurExone Biologic Inc. has successfully raised over C$3.18 million through accelerated warrant exercises, enhancing its financial position for ongoing development of its exosome-based therapeutic platform [1][4][5] Financial Summary - The proceeds from the warrant exercises include C$1,207,418.88 from the exercise of 2,515,456 September 2023 Warrants at C$0.48 each and C$1,978,575.55 from 5,653,073 January 2024 Warrants at C$0.35 each [2][3] - The total gross proceeds from the exercises amounted to C$3,185,994.43, which will be utilized for general corporate purposes and working capital [3][4] Management Commentary - The CEO expressed satisfaction with the full participation from warrantholders, indicating that the additional capital will strengthen the company's financial position and support the advancement of its therapeutic pipeline [5] - The CFO noted that the participation reflects investor confidence in the company's strategy and exosome-based platform, allowing for efficient resource allocation towards clinical development [5] Scientific Recognition - NurExone has been nominated as a finalist for the Galien Foundation's inaugural Prix Galien Bridges Awards, recognizing its contributions to life sciences innovation [6][7] - The company was also recognized as a finalist in the Falling Walls Science Breakthroughs of the Year Summit in Berlin, highlighting its leadership in exosome-based medicine [6][7] Company Overview - NurExone is a biotechnology company focused on developing regenerative exosome-based therapies for central nervous system injuries, with its lead candidate, ExoPTEN, showing promising preclinical data [9] - The company has received Orphan Drug Designation from the FDA and EMA, facilitating its path towards clinical trials in the U.S. and Europe [9]
NurExone Accepted into ARMI’s BioFab Startup Lab Strengthening U.S Position in Regenerative Manufacturing
Globenewswire· 2025-11-03 21:04
Core Insights - NurExone Biologic Inc. has been accepted into the BioFab Startup Lab, which is part of the Advanced Regenerative Manufacturing Institute (ARMI) and its BioFabUSA program, aimed at accelerating the commercialization of regenerative innovations [1][2][3] Company Overview - NurExone is a biotechnology company focused on developing regenerative exosome-based therapies for central nervous system injuries, with its lead product, ExoPTEN, showing strong preclinical data for treating acute spinal cord and optic nerve injuries, both of which are multi-billion-dollar markets [6] - The company has established a U.S. subsidiary, Exo-Top Inc., to support its North American growth strategy and plans to create a GMP-compliant facility for naive exosome production [3][6] Industry Context - The BioFab Startup Lab program is federally supported and aims to help early-stage biotechnology companies transition regenerative innovations into scalable manufacturing, reflecting a strategic national capability for the U.S. in biomanufacturing [2][5] - Biofabrication, which involves using living cells and biological materials to manufacture tissues and therapeutic products, is seen as the foundation for next-generation regenerative medicine technologies [4]
NurExone Invited Presenter at Precision EV Forum in Cambridge, UK
Globenewswire· 2025-10-21 20:04
Core Insights - NurExone Biologic Inc. is gaining global recognition for its leadership in developing exosome-based regenerative therapies, particularly through the participation of Dr. Ina Sarel at the Precision EV Forum 2025 [1][2][5] Company Overview - NurExone is a biopharmaceutical company focused on exosome-based therapies for central nervous system injuries, with its lead product, ExoPTEN, showing strong preclinical data for treating acute spinal cord and optic nerve injuries [6] - The company has established Exo-Top Inc., a U.S. subsidiary, to support its North American growth strategy [6] Product Development - ExoPTEN has received Orphan Drug Designation for acute spinal cord injury, facilitating early discussions with the FDA and focusing on innovation and patient safety [3][4] - The product aims to address significant unmet needs in central nervous system repair, demonstrating the ability to restore nerve function and reduce inflammation in preclinical models [4] Regulatory Engagement - Dr. Sarel's presentation at the forum will address regulatory challenges in the clinical development of ExoPTEN, highlighting the company's proactive approach to regulatory approval [2][5] - The invitation to speak at the forum reflects strong international interest in NurExone's lead program and its regulatory strategy [2][5]
NurExone Demonstrates Reproducible, Dose-Dependent Vision Recovery in Preclinical Glaucoma Model
Globenewswire· 2025-10-08 12:30
Core Insights - NurExone Biologic Inc. announced promising preclinical results for its lead candidate ExoPTEN, demonstrating a reproducible, dose-dependent therapeutic effect in an eye model of glaucoma [1][2] Company Developments - The study was conducted in collaboration with the Goldschleger Eye Institute at Sheba Medical Center, showing that ExoPTEN's biological activity increases with higher dosing levels, leading to measurable recovery of visual function in animals with optic nerve injury [2][4] - Prof. Michael Belkin confirmed the potential of ExoPTEN to repair damaged optic nerves, which is crucial for addressing vision loss in patients with conditions like glaucoma [3] - Dr. Tali Kizhner highlighted the significance of the dose-response data as a step towards future clinical trials, emphasizing the dual action of exosomes and siRNA in promoting regeneration [3][4] Research Findings - The optic nerve crush model used in the experiments mimics glaucoma-related nerve damage, with both low and high doses of ExoPTEN showing improved visual signal strength in treated animals [4][5] - High-dose ExoPTEN treatment resulted in response amplitudes comparable to uninjured eyes, indicating substantial functional recovery [5][7] - The study's results align with previous findings from June and December 2024, which demonstrated structural preservation and survival of retinal ganglion cells [2][6] Financial and Corporate Actions - The company is accelerating the expiration date of certain warrants, which could yield approximately C$3.2 million if exercised, to be used for general corporate and working capital purposes [11][12] - The acceleration was triggered by the company's common shares trading above specified thresholds for 20 consecutive days [13] - The agreement with POSITIVE Communications has been extended to July 10, 2026, with additional financial terms [16][17] Market Position - NurExone focuses on developing exosome-based regenerative therapies for central nervous system injuries, with ExoPTEN showing strong preclinical data for treating acute spinal cord and optic nerve injuries, both representing multi-billion-dollar markets [18]
NurExone Demonstrates Reproducible, Dose-Dependent Vision Recovery in Preclinical Glaucoma Model
Globenewswire· 2025-10-08 12:30
Core Insights - NurExone Biologic Inc. announced promising preclinical results for its lead candidate ExoPTEN, demonstrating a reproducible, dose-dependent therapeutic effect in an eye model of glaucoma [1][2] - The study, conducted in collaboration with the Goldschleger Eye Institute, showed that higher doses of ExoPTEN lead to measurable recovery of visual function in animals with optic nerve injury [2][3] - The company is accelerating the expiration of certain warrants, which could yield approximately C$3.2 million if exercised, to support corporate and working capital needs [11][12] Company Developments - ExoPTEN has shown a clear, dose-dependent effect in improving visual signal strength, with high-dose groups achieving response amplitudes comparable to uninjured eyes [5][7] - The optic nerve crush model used in the study mimics damage seen in glaucoma, a leading cause of irreversible blindness [4] - The collaboration with Prof. Ygal Rotenstreich's team is expected to open new treatment avenues for blinding glaucoma and other ophthalmological conditions [6] Financial and Strategic Moves - The company is accelerating the expiration of 2,515,456 September 2023 Warrants and 5,653,073 January 2024 Warrants due to meeting specific trading price thresholds [11][13] - The warrants will now expire on November 7, 2025, and approximately 89% are held by U.S.-based investors [15][14] - The agreement with POSITIVE Communications has been extended to July 10, 2026, with additional financial terms [16][17] Research and Development - The dose-response study is the third independent investigation of ExoPTEN's activity, complementing previous results that showed structural preservation of retinal ganglion cells [3][4] - The findings support the potential of ExoPTEN as a therapeutic option for patients with optic nerve damage, advancing towards future clinical trials [3][18] - NurExone is focused on developing regenerative therapies for central nervous system injuries, with ExoPTEN targeting multi-billion-dollar markets [18]