Dr. Lior Shaltiel reports

NUREXONE DEMONSTRATES CONSISTENT ANTI-INFLAMMATORY ACTIVITY ACROSS THREE SEPARATE BATCHES OF EXOSOMES

Nurexone Biologic Inc. has released new laboratory results demonstrating consistent anti-inflammatory activity across three batches of its naive exosomes, supporting both its developing commercial supply business through Exo-Top Inc. and continued development of its lead therapeutic candidate, ExoPTEN.

Anti-inflammatory activity is a key biological property attracting interest in exosomes for applications ranging from skin health to tissue repair. Nurexone's latest results showed that three separately produced batches demonstrated similar and substantial anti-inflammatory activity. Two key proteins involved in inflammation, IL-6 and TNF-alpha, showed average reductions of approximately 88 per cent and 57 per cent, respectively. This anti-inflammatory activity shown in the laboratory supports the potential of Nurexone's exosomes for clinical applications, where controlling inflammation is relevant to tissue protection, repair and regeneration.

"The anti-inflammatory properties of our exosomes have potential relevance for both our therapeutic development and commercial strategy," said Dr. Lior Shaltiel, chief executive officer of Nurexone. "For ExoPTEN, these findings support the exosome component of our approach to acute spinal cord and optic nerve injuries. For Exo-Top, they provide additional evidence of product consistency as we begin manufacturing and work toward supplying naive exosomes for applications such as skin and tissue care. Addressing batch-to-batch consistency, a critical unmet challenge in the exosome field, helps distinguish the quality and reliability we expect to bring to the exosome market."

"Manufacturing biological drug substances is an exceptionally complex process governed by strict chemistry, manufacturing and controls (CMC) regulatory requirements," said Dr. Tali Kizhner, director of research and development at Nurexone. "As part of our CMC program for ExoPTEN, we have we have generated data regarding the physical characteristics and the composition of our exosomes and now in their anti-inflammatory activity across production batches. This rigorous approach also supports the quality and reliability of the naive exosomes we plan to supply commercially through Exo-Top."

These achievements provide further positive support for the company's manufacturing foundation as it advances its U.S. production strategy in collaboration with Made Scientific, with a focus on scalability, consistent product characteristics and reproducible biological activity.

About the study

Researchers evaluated the anti-inflammatory activity of three batches of Nurexone's bone marrow-derived mesenchymal stromal cell extracellular vesicles (BM-MSC EVs) using RAW 264.7 macrophages, a laboratory cell model commonly used to study inflammatory responses.

The macrophages were stimulated with lipopolysaccharide (LPS) to induce the secretion of pro-inflammatory cytokines. Cells were then treated with increasing concentrations of Nurexone EVs. IL-6 and TNF-alpha levels in the culture supernatants were measured and expressed as percentages of the LPS-stimulated control, with dexamethasone included as a positive control.

All three tested batches showed dose-dependent suppression of IL-6 and TNF-alpha. At the highest EV concentration, average cytokine reductions reached approximately 88 per cent and 57 per cent, respectively, relative to the LPS-stimulated control.

The overall dose-response patterns were similar across batches, although some variability was observed, particularly for TNF-alpha at intermediate concentrations. These findings support batch-to-batch consistency of the measured biological activity.

All three batches demonstrated similar dose-dependent anti-inflammatory responses, with relatively small variation at the highest concentrations tested. Average reductions reached approximately 88 per cent for IL-6 and 57 per cent for TNF-alpha at the highest concentration. Despite some variation at intermediate concentrations, particularly for TNF-alpha, the results demonstrated consistent biological activity across the three production batches. These in vitro findings do not establish clinical anti-inflammatory efficacy.

About Nurexone Biologic Inc.

Nurexone is a TSX Venture Exchange-, OTCQB- and Frankfurt Stock Exchange-listed biotechnology 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 damage. Regulatory milestones, including obtaining the orphan drug designation from the U.S. Food and Drug Administration and the European Medicines Agency, facilitate the company's road map toward clinical trials in the United States and Europe. Commercially, the company aims to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. Nurexone has established Exo-Top, a U.S. subsidiary, to anchor its North American activity and growth strategy.

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