BioNxt Completes "Fast-Track" US Track One Patent Filing for Sublingual Delivery of Cladribine for the Treatment of Multiple Sclerosis

VANCOUVER, BC / ACCESS Newswire / October 9, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in next-generation drug delivery technologies, today announced that it 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 August 20, 2025, the Company has completed a "fast-track" priority patent filing application for its flag-ship sublingual thin-film cladribine formulation for multiple sclerosis (MS), under the United States Patent and Trademark Office's (USPTO) Track One Program. A formal office action from the USPTO is expected within 60-90 days and final patent disposition within 9-12 months. This fast-track status represents a strategic opportunity to secure near-term U.S. patent protection and strengthen the Company‘s IP position ahead of pivotal bioequivalence studies and commercial partnering discussions.

The patent nationalization process is underway 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 favorable 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 Inc. is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems, and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects.