Dr. Lior Shaltiel reports

NUREXONE DEMONSTRATES SCALABLE EXOSOME PRODUCTION, SUPPORTING ITS MODULAR MANUFACTURING STRATEGY AND COMMERCIAL GROWTH

Nurexone Biologic Inc. has doubled exosome production by operating two bioreactors in parallel while maintaining the same overall production time, process consistency and comparable exosome quality. The achievement marks an important step in Nurexone's strategy to build scalable exosome manufacturing capabilities through its wholly owned U.S. subsidiary, Exo-Top Inc., and its manufacturing collaboration with Made Scientific.

Nurexone is pursuing a modular approach that enables manufacturing capacity to expand by adding standardized production units in parallel (scaling out approach), rather than engineering larger bioreactor vessels (scaling up approach). This strategy has the potential to protect capital investments, accelerate development timelines and allow production to match commercial demand, subject to successful validation and implementation.

"Our goal is to make increasing exosome production straightforward and robust," said Dr. Tali Kizhner, director of research and development at Nurexone. "We have invested hundreds of hours in studying and optimizing our manufacturing process. This run shows that we successfully replicated that process to increase output while ensuring manufacturing of high-quality product, with similar characteristics and critical quality attributes. The achieved milestone provides us a strong foundation for expanding production capabilities even further."

As shown in the table, the exosomes produced in the parallel run retained comparable physical characteristics, the same identifying proteins and anti-inflammatory activity, providing initial evidence that greater output can be achieved while maintaining consistency.

"Scalable manufacturing is critical in positioning Nurexone as a leader in this rapidly evolving exosome-based field. Demonstrating that two bioreactors can operate in parallel to double yield while maintaining process consistency strengthens our ability to respond to future demand and achieve market leadership," said Dr. Lior Shaltiel, chief executive officer of Nurexone. "Through Exo-Top and our U.S. manufacturing collaborations, we are building the high-efficiency capabilities required to support both our internal therapeutic pipeline and potential business-to-business commercial opportunities for naive exosomes."

Supporting therapeutic development and commercial opportunities

Nurexone is pursuing a dual-track strategy that combines the development of regulated exosome-based therapies with commercial opportunities for naive mesenchymal stromal cell-derived exosomes through Exo-Top.

Its lead therapeutic candidate, ExoPTEN, is being developed for acute spinal cord injury and optic nerve damage. In parallel, Exo-Top is advancing manufacturing and commercial collaborations involving naive exosomes for potential applications beyond the company's drug development pipeline.

About Nurexone Biologic Inc.

Nurexone 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 damage. Regulatory milestones, including obtaining the orphan drug designation from the U.S. Food and Drug Administration and European EMA, 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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