Dr. Lior Shaltiel reports

NUREXONE PLANS SMALL-SCALE OF EXOPTEN CLINICAL MANUFACTURING IN PREPARATION FOR FUTURE FIRST IN HUMAN USE PATHWAYS

Nurexone Biologic Inc. has made meaningful progress in its long-term clinical-readiness strategy. The company has begun the process of evaluating potential Israeli production partners to support small-scale good-manufacturing-practice-based manufacturing of its lead candidate, ExoPTEN, in order to test the drug in under a first-in-human use program, pending regulatory approval.

Dr. Lior Shaltiel, chief executive officer, noted: "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." He added, "ExoPTEN is being developed for both acute spinal cord injury and optic nerve injury, although it has not yet been determined which indication will be prioritized for a first-in-human program."

In parallel, Nurexone reported new scientific data showing strong biological activity in its exosomes compared with commercially available exosomes, reinforcing confidence in the platform as the company advances toward human studies.

Early manufacturing in Israel: a key step toward U.S. scale-up

Nurexone is currently evaluating several Israeli manufacturing organizations with expertise in advanced biologics and good-manufacturing-practice-(GMP)-aligned systems for small-scale ExoPTEN manufacturing runs aligned with future clinical requirements.

"This is a strategically important next phase of operational derisking," said Dr. Ina Sarel, head of CMC, quality and regulatory affairs. "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."

Nurexone emphasized that no compassionate-use or clinical manufacturing is being initiated at this stage. All such activities would be subject to regulatory engagement and approval.

New scientific data reinforce platform strength

Recent analytical testing demonstrated that Nurexone's exosomes produced from human bone marrow-derived mesenchymal stem cells (MSC) exhibit significantly higher CD73-associated biological activity compared with a commercially available MSC exosome control. CD73 is a surface enzyme linked to extracellular signaling and tissue-repair mechanisms.

As shown in the graph below, the average of Nurexone's two manufacturing batches demonstrated meaningfully higher adenosine monophosphate (AMP) to adenosine conversion per particle compared with the control. The difference was statistically significant (t-test, p less than 0.01), indicating that Nurexone's exosomes possess stronger functional characteristics associated with regenerative potential, or in other words Nurexone's exosomes can send stronger healing or anti-inflammatory signals.

These findings validate the potency of Nurexone's therapeutic exosomes strengthening the biological rationale for their use as a delivery vehicle in ExoPTEN.

These results demonstrate the high quality of the Master Cell Bank acquired by Nurexone and the knowhow held by Nurexone and its patented 3-D shear-force production technology, indicating that the manufacturing approach described in the patent can yield higher-quality, more potent exosomes in practice.

Engagement of Russo Partners

Subject to TSX Venture Exchange approval, Nurexone has engaged Russo Partners LLC, a New York-based strategic communications firm, for an initial consulting project for up to two months for a fixed fee of $6,600 (U.S.).

Either party may terminate the engagement with 30 days of notice. Russo does not currently have a direct or indirect interest in the securities of the company. While Russo has no intention of acquiring any additional securities of the company at this time, it may do so in the future in compliance with applicable securities laws and TSX Venture Exchange policies.

About Nurexone Biologic Inc.

Nurexone Biologic is a TSX Venture Exchange, OTCQB and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multibillion-dollar markets. Regulatory milestones, including obtaining the orphan drug designation, facilitates the road map toward clinical trials in the United States and Europe. Commercially, the company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. Nurexone has established Exo-Top Inc., a United States subsidiary, to anchor its North American activity and growth strategy.

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