Mr. Hugh Rogers reports

BIONXT COMPLETES "FAST-TRACK" US TRACK ONE PATENT FILING FOR SUBLINGUAL DELIVERY OF CLADRIBINE FOR THE TREATMENT OF MULTIPLE SCLEROSIS

Bionxt Solutions Inc. has completed a Track One priority patent filing with the U.S. Patent and Trademark Office (USPTO) for its proprietary sublingual thin-film cladribine formulation (BNT23001), designed for the treatment of multiple sclerosis (MS). The Track One patent filing also covers sublingual drug products for the treatment of many other neurological autoimmune diseases, including myasthenia gravis and lupus nephritis.

Further to the company's press release dated Aug. 20, 2025, the company has completed a fast-track priority patent filing application for its flagship sublingual thin-film cladribine formulation for MS under the USPTO's Track One program. A formal office action from the USPTO is expected within 60 to 90 days and final patent disposition within nine to 12 months. This fast-track status represents a strategic opportunity to secure near-term U.S. patent protection and strengthen the company's IP (intellectual property) position ahead of pivotal bioequivalence studies and commercial partnering discussions.

The patent nationalization process is under way in key global markets, including the European Union, the United States, Canada, Australia, Eurasia, New Zealand and Japan. Both the European Patent Office and the Eurasian Patent Office have issued favourable communications, including notice of intentions to grant. Novelty, inventive step and industrial applicability were fully accepted and only formal non-material adaptations are required for national filings. This is strong validation of the unique scientific and commercial value of Bionxt's proprietary technology.

BNT23001 is an orally dissolvable thin-film formulation of cladribine, a well-established immunomodulatory compound used for the treatment of MS. Delivered sublingually, the formulation is designed for improved bioavailability, faster onset of action and enhanced patient compliance, particularly in populations affected by dysphagia or seeking non-invasive alternatives to traditional tablets or injections.

About Bionxt Solutions Inc.

Bionxt Solutions is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems and active pharmaceutical ingredient development. The company's proprietary platforms -- sublingual (thin-film), transdermal (skin patch), and oral (enteric-coated tablets) -- target key therapeutic areas, including autoimmune diseases, neurological disorders and longevity.

With research and development operations in North America and Europe, Bionxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. Bionxt is committed to improving health care by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.

Bionxt is listed on the Canadian Securities Exchange under the symbol BNXT and on the OTC Markets under the symbol BNXTF and trades in Germany under WKN: A3D1K3.

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