Reducing inflammation helps create a regenerative environment in the Central Nervous SystemTORONTO and HAIFA, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) today announced new laboratory data demonstrating that its proprietary exosomes can significantly reduce inflammatory activity compared to untreated cells and cells treated with a commercially available exosome product. “Inflammation and regeneration are conflicting bi ...

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]

Summary of Capricor Therapeutics FY Conference Call Company Overview - **Company**: Capricor Therapeutics (NasdaqCM: CAPR) - **Focus**: Development of deramiocel for treating cardiomyopathy caused by Duchenne muscular dystrophy (DMD) [1][2] Key Points and Arguments Clinical Data and Efficacy - **HOPE-3 Trial**: Positive results reported from a randomized double-blind placebo-controlled trial involving 106 patients, with 105 completing the study [4][5] - **Primary Endpoint**: Achieved statistical significance with a p-value of 0.03 for the Performance of the Upper Limb 2.0, indicating a clinically relevant 1.2-point change [5][6] - **Secondary Endpoint**: Left ventricular ejection fraction also showed statistical significance with a p-value of 0.04, indicating potential for treating heart disease in DMD patients [6][7] - **Patient Response**: 40% of patients showed improvement in both cardiac and skeletal muscle function, while over 70% had improvement in either [14] Regulatory and Approval Process - **Complete Response Letter (CRL)**: The FDA previously issued a CRL citing insufficient data from earlier studies; however, the new HOPE-3 data is expected to address these concerns [10][11] - **Resubmission Timeline**: Capricor plans to respond to the CRL by the end of the calendar year, anticipating a PDUFA date around July of the following year [11][12] Market Opportunity - **Partnership with Nippon Shinyaku**: Capricor has a sales and distribution agreement, which includes an $80 million milestone payment upon approval and royalties between 30%-50% [16][17] - **Target Population**: DMD affects approximately 15,000 to 20,000 boys and young men in the U.S., presenting a significant market opportunity [17] - **Pricing Strategy**: Capricor aims to price deramiocel competitively within the range of existing exon-skipping therapies, which could lead to a robust revenue model [17] Manufacturing and Expansion Plans - **Manufacturing Facility**: A new commercial-scale facility in San Diego is ready to meet initial demand for about 500 patients, with plans to expand capacity for 2,500 patients annually [21][25] - **Potential for Exosome Development**: Capricor is exploring the use of exosomes for advanced genetic medicine, leveraging their manufacturing capabilities to scale up production [33][34] Future Indications - **Expansion into Becker's Muscular Dystrophy**: Plans to seek accelerated approval for Becker's, which shares similar cardiomyopathy characteristics with DMD, are in development [27][28] - **Broader Neuromuscular Disease Applications**: Capricor is considering expanding deramiocel's application to other neuromuscular diseases with cardiac components [29] Additional Important Information - **Financial Position**: Capricor ended the third quarter with nearly $100 million in cash, with potential additional funding from milestone payments and sales [31] - **Clean Capital Structure**: The company has no debt, positioning it well for future growth and development [31] This summary encapsulates the critical insights from the conference call, highlighting Capricor Therapeutics' advancements, market potential, and strategic plans for the future.

Core Insights - NurExone Biologic Inc. announced that its exosomes outperformed a recognized commercial industry standard in key healing tasks such as nerve repair, wound repair, immune system modulation, and tissue rebuilding, indicating broad potential in therapeutic and aesthetic markets [1][6] Group 1: Exosome Performance - Independent study results showed NurExone's exosomes exhibit approximately 1.8-fold higher neurological potential, nearly double the anti-inflammatory activity, and a two-fold increase in tissue-regeneration and wound-healing signals compared to commercial benchmarks [4] - The exosomes produced by NurExone's U.S. subsidiary, ExoTOP Inc., are expected to deliver more than twice the wound-healing signals than the industry benchmark, suggesting applications in aesthetic skin rejuvenation, wound care, and orthopedic tissue repair [2][4] Group 2: Production and Technology - NurExone's exosomes are produced from a proprietary master cell bank, ensuring high-performance and reproducibility essential for clinical translation and future patient use [3] - The exosomes are enriched with microRNAs that support key healing tasks, as confirmed by a comprehensive analysis performed by TAmiRNA, an ISO13485-certified molecular-diagnostics laboratory [2][7] Group 3: Market Potential and Strategy - The company 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 [8] - ExoTOP is expected to generate multiple revenue streams and provide high-performance exosomes to partners across regenerative medicine as production scales in the U.S. [2][8]

Core Insights - An independent study indicates that exosomes produced by NurExone Biologic Inc. outperform a recognized commercial industry standard in nerve repair, wound healing, immune system modulation, and tissue rebuilding [1][6] - The exosomes are expected to have significant applications in both therapeutic and aesthetic markets, with a focus on regenerative medicine [1][6] Group 1: Exosome Performance - NurExone's exosomes exhibit approximately 1.8-fold higher neurological potential, nearly double the anti-inflammatory activity, and a two-fold increase in tissue-regeneration and wound-healing signals compared to commercial benchmarks [4] - The exosomes are enriched with microRNAs that support key healing tasks, confirming their therapeutic potential [2][4] Group 2: Production and Scalability - The exosomes are produced from a proprietary master cell bank, ensuring high performance and reproducibility across production batches, which is crucial for clinical applications [3] - The U.S. subsidiary, ExoTOP Inc., is set to scale production using a patent-pending 3D process, which is expected to generate multiple revenue streams [2][8] Group 3: Market Potential - NurExone's lead product, ExoPTEN, has shown strong preclinical data for treating acute spinal cord and optic nerve injuries, which are multi-billion-dollar markets [8] - The company aims to provide solutions for other indications through minimally invasive targeted delivery systems, enhancing its market presence in regenerative medicine [8]