Nurexone prepares small-scale manufacturing for ExoPTEN

Executive Summary

• Nurexone Biologic Inc. has initiated the evaluation of Israeli production partners for small-scale, Good Manufacturing Practice (GMP) manufacturing of its lead candidate, ExoPTEN, to support future First-in-Human (FIH) use pathways pending regulatory approval.
• The company reported new scientific data demonstrating that its exosomes, produced from human bone marrow-derived mesenchymal stem cells (MSC), exhibit significantly higher CD73-associated biological activity and AMP-to-adenosine conversion compared to commercially available controls.
• Nurexone has engaged Russo Partners LLC for strategic communications for a fixed fee of $6,600, subject to TSX Venture Exchange approval.

Key Details

• Manufacturing Strategy:
  • Evaluating Israeli manufacturing organizations with expertise in advanced biologics and GMP-aligned systems.
  • Goal is small-scale ExoPTEN manufacturing runs aligned with future clinical requirements.
  • This phase is described as "operational derisking" and process validation.
  • Production will transition to the United States for scale-up after initial Israeli validation.
  • No compassionate-use or clinical manufacturing is being initiated at this stage; all activities are subject to regulatory engagement and approval.
• Scientific Data & Platform Strength:
  • Exosomes produced from human bone marrow-derived MSCs show significantly higher CD73-associated biological activity than a commercially available MSC exosome control.
  • Nurexone’s two manufacturing batches demonstrated meaningfully higher adenosine monophosphate (AMP) to adenosine conversion per particle compared to the control.
  • The difference was statistically significant (t-test, p < 0.01).
  • Findings validate the potency of Nurexone’s therapeutic exosomes and the quality of the Master Cell Bank.
  • Results highlight the efficacy of the company’s patented 3-D shear-force production technology in yielding higher-quality, more potent exosomes.
• Therapeutic Indications:
  • ExoPTEN is being developed for acute spinal cord injury and optic nerve injury.
  • The specific indication prioritized for the First-in-Human program has not yet been determined.
• Strategic Engagement:
  • Engaged Russo Partners LLC (New York-based) for an initial consulting project for up to two months.
  • Fixed fee: $6,600 (U.S.).
  • Engagement is subject to TSX Venture Exchange approval.
  • Russo has no direct or indirect interest in the company’s securities.

Notable Quotes

• Dr. Lior Shaltiel, CEO: "ExoPTEN brings together a powerful synergistic impact with highly active exosomes produced, combined with a targeted siRNA. As we advance our manufacturing plans, small clinical grade batches will position us to prepare a first-in-human use submission in the future, if and when the regulatory pathway supports it."
• Dr. Ina Sarel, Head of CMC, Quality and Regulatory Affairs: "This is a strategically important next phase of operational derisking. Israel is the starting point for our small scale GMP-production of exosomes and process validation, after which exosome production will transition to the United States for scale-up."