NurExone Biologic Advances Manufacturing and Regulatory Roadmap with Independent Batch Consistency Results for Exosome Production

Executive Summary

• Independent proteomic analysis of four NurExone exosome production batches demonstrated high batch‑to‑batch consistency, supporting CMC readiness for a potential IND filing.
• The protein fingerprint revealed several therapeutic proteins absent in commercial reference exosomes, indicating a differentiated biological profile for inflammation control and nerve repair.
• NurExone re‑engaged Russo Partners for an additional 3–6 month PR/IR services term at US$15,000 per month, pending TSXV approval.

Key Details

• Proteomic Findings: Four independent production batches showed a highly consistent protein “fingerprint” across functional categories (EV identity, ECM/guidance, antioxidant, anti‑inflammatory, trophic signaling).
• Differentiation: Proteins detected only in NurExone samples included PDGFRB, LAMA4, ARHGEF1, PEX19, TPST1, BDH2, GALK1, CARS1, PACSIN3, CD320, and IL1R1.
• CMC Implication: Results strengthen evidence of repeatable manufacturing and quality testing, a key milestone toward IND‑enabling activities and clinical‑grade production.
• Operational Outlook: Company pursuing small‑scale clinical manufacturing capability in Israel and evaluating U.S. scale‑up through Exo‑Top Inc., subject to financing and timing considerations.
• Russo Partners Engagement: Extension of services for 3–6 months at US$15,000/month; either party may terminate with 30‑day notice; pending TSXV approval.
• CEO Quote: “Each step towards the clinic is a de‑risking step… This independent assessment provides additional evidence of our manufacturing process control.” – Dr. Lior Shaltiel, CEO.

Notable Quotes

“Consistent exosome production is a core bioengineering milestone that underpins clinical‑grade manufacturing. This independent assessment provides additional evidence of our manufacturing process control.” – Dr. Lior Shaltiel, Chief Executive Officer.