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NurExone Strengthens U.S. Manufacturing Strategy Through Exo-Top Sublicense Agreement
Globenewswire· 2026-03-26 20:03
Core Viewpoint - NurExone Biologic Inc. has established Exo-Top Inc. as a strategic U.S. subsidiary to enhance its manufacturing, clinical advancement, and long-term value creation in the biotechnology sector focused on exosome-based therapies [1][2]. Group 1: Exo-Top Sublicense Agreement - NurExone Ltd. has granted Exo-Top certain rights under an exclusive worldwide development and commercialization license with Technion Research and Development Foundation Ltd. and Ramot, which is aimed at supporting future manufacturing and commercial activities for naïve exosomes in the U.S. [1][2] - The Exo-Top Sublicense is expected to enhance strategic flexibility in the U.S. market, aligning with NurExone's long-term strategy [2][3]. Group 2: Strategic Importance of Exo-Top - Exo-Top is positioned as a key component of NurExone's North American strategy, focusing on manufacturing, development, and commercialization of exosome-based therapeutics [4][5]. - One of Exo-Top's critical assets is its Master Cell Bank, which ensures batch-to-batch consistency essential for clinical translation and commercial readiness [4]. Group 3: Financial Obligations and Expectations - Under the Tech License, NurExone is obligated to pay certain royalty fees upon reaching Phase II of clinical trials and additional royalties upon commercialization, but no monetary consideration was paid by Exo-Top to NurExone Ltd. for the sublicense [3][5]. - The company does not anticipate any sublicense fees to be payable to TRDF in connection with the Exo-Top Sublicense execution [3].
NurExone to Showcase Its Regenerative Medicine Platform at NANO.IL.2026 and Advanced Therapies Congress in March 2026 and Provides Corporate Update
Globenewswire· 2026-02-27 21:03
Core Insights - NurExone Biologic Inc. is actively participating in two significant international conferences in March 2026, focusing on advancements in nanotechnology and regenerative therapies [1][2][3] Company Updates - Dr. Lior Shaltiel, CEO of NurExone, emphasizes the importance of engaging with scientific and investor communities through participation in NANO.IL.2026 and the Advanced Therapies Congress [2][3] - Mr. Jacob Licht will step down from his roles at NurExone and Exo-Top Inc. at the end of March 2026 for personal reasons, with the management team taking over his responsibilities temporarily [4] Product and Market Focus - NurExone is developing exosome-based regenerative therapies, with its lead product ExoPTEN showing promising preclinical data for treating acute spinal cord and optic nerve injuries, which are part of multi-billion-dollar markets [5] - The company has received Orphan Drug Designation, facilitating its roadmap towards clinical trials in the U.S. and Europe [5]
NurExone Biologic Advances Manufacturing and Regulatory Roadmap with Independent Batch Consistency Results for Exosome Production
TMX Newsfile· 2026-02-10 21:03
Core Insights - NurExone Biologic Inc. announced positive results from an independent proteomic analysis that supports its Chemistry, Manufacturing and Controls (CMC) readiness, which is crucial for potential Investigational New Drug (IND) application and subsequent human clinical trials [1][4] Manufacturing Consistency - The analysis demonstrated batch-to-batch consistency in NurExone's exosome production, with four independent batches showing a highly consistent protein "fingerprint," indicating robustness and reproducibility in the manufacturing process [2][4] Therapeutic Potential - The evaluation revealed several therapeutically potential proteins in NurExone's exosomes that were not present in commercial reference samples, highlighting a distinct biological profile associated with inflammation control, cellular resilience, and nerve repair support [3][4] Development Focus - NurExone's near-term development strategy includes milestones aimed at reducing technical and regulatory risks, alongside establishing small-scale clinical manufacturing capabilities in Israel to transition from research-scale to clinical-grade production [4][11] Engagement with Strategic Communications - The company has reengaged Russo Partners LLC for public and investor relations services for an additional 3-to-6-month term, with a monthly fee of US$15,000, subject to TSX Venture Exchange approval [8][9] Company Overview - NurExone is 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, which are significant market opportunities [11]
NurExone Appoints Eyal Gabbai to Board, Adding Large-Scale Healthcare System and Capital Markets Expertise
Globenewswire· 2026-01-30 21:03
Core Viewpoint - NurExone Biologic Inc. has appointed Mr. Eyal Gabbai to its Board of Directors, replacing Dr. Gadi Riesenfeld, who will continue to support the company as a member of the Scientific Advisory Board [1][4]. Company Developments - Mr. Gabbai's experience in healthcare leadership and capital markets is expected to be valuable as NurExone advances its preclinical programs and evaluates future capital market opportunities [2]. - The appointment reflects the company's focus on engaging with partners who understand patient needs and healthcare economics, with Mr. Gabbai bringing extensive experience in healthcare systems and public company environments [3]. Leadership Background - Mr. Gabbai is currently the Chairman of Meuhedet Health Fund, which has approximately 1.4 million members and an annual turnover exceeding US$3 billion [3]. - He has previously held significant positions, including Director-General of Israel's Prime Minister's Office and Director General of Israel's Government Companies Authority, leading major transactions exceeding US$5 billion [3]. Company Focus and Products - NurExone is 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 [5]. - The company has received Orphan Drug Designation, facilitating its roadmap towards clinical trials in the U.S. and Europe [5]. - NurExone aims to provide solutions for companies interested in quality exosomes and minimally invasive targeted delivery systems [5].
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]