Dr. Lior Shaltiel reports

NUREXONE ANNOUNCES THE TRANSFER OF MANUFACTURING OF THE ACTIVE ELEMENT IN EXOPTEN DRUG TO A COMMERCIAL GMP MANUFACTURER

Nurexone Biologic Inc. has reached an important milestone in its regenerative medicine efforts. The company has transferred the manufacturing of the small interfering RNA sequence for its flagship ExoPTEN nanodrug to a German producer with good manufacturing practice capabilities. A move to a GMP-grade manufacturer is essential for producing a drug for clinical trials and commercial sale.

The siRNA sequence was validated at the new GMP partner, solidifying the company's commitment to advancing regenerative medicine therapies and strengthening its confidence in meeting future clinical manufacturing demands.

Nurexone reports that the siRNA from the new vendor achieved an approximately 80-per-cent reduction in expression of PTEN (phosphatase and tensin homolog), demonstrating potency and effectiveness that are comparable with the siRNA from the company's previous, research-grade producer. Nurexone's ExoPTEN nanodrug, that is still under development, uses PTEN inhibition to facilitate nerve growth and regeneration after injury or damage.

Dr. Lior Shaltiel, chief executive officer of Nurexone, stated: "The tech transfer to a new GMP-compliant vendor for our siRNA sequence is a significant achievement, establishing the foundation for future GMP manufacture of a potent and patented product. Achieving production that meets the strict quality and regulatory standards necessary for clinical trials is a critical step in the development of our ExoPTEN nanodrug."

GMP is a system of regulations, guidelines and procedures intended to ensure that products are produced and controlled according to quality standards.

About Nurexone Biologic Inc.

Nurexone is a TSX Venture Exchange-listed pharmaceutical company that is developing a platform for biologically guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered central nervous system injuries. The company's first product, ExoPTEN for acute spinal cord injury, was proved to recover motor function in 75 per cent of laboratory rats when administered intranasally. ExoPTEN has been granted orphan drug designation by the Food and Drug Administration. The Nurexone platform technology is expected to offer novel solutions to drug companies interested in non-invasive targeted drug delivery for other indications.

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