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

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.

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 healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.

BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit www.bionxt.com.

Investor Relations & Media Contact

Hugh Rogers, Co-Founder, CEO and Director
Email: [email protected]
Phone: +1 604.250.6162

Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt

Cautionary Statement Regarding "Forward-Looking" Information

This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities laws (collectively, "forward-looking information"). Such information may include, but is not limited to, statements regarding: the anticipated grant, scope, and timing of European, Eurasian, and other international patent rights; the Company's plans for additional national filings; the development, clinical evaluation, regulatory approval, and commercialization of the Company's Cladribine sublingual thin-film (BNT23001) for multiple sclerosis; the strategic importance of intellectual property protection; the timing, cost, and outcome of preclinical and clinical studies; and the potential application of BioNxt's sublingual thin-film drug delivery platform across additional therapeutic areas.

Forward-looking information is based on management's current expectations, assumptions, estimates, and projections as of the date of this press release. Such statements are subject to inherent risks and uncertainties, many of which are beyond the Company's control, that could cause actual results, performance, or achievements to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to: outcomes of patent examination and prosecution processes; changes in regulatory requirements or legal frameworks; the results, timing, and costs of preclinical and clinical studies; scalability and reproducibility of manufacturing processes; the availability of strategic partnerships and funding; and broader economic, financial, or geopolitical factors.

Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes the expectations and assumptions underlying such information are reasonable, there can be no assurance that they will prove to be correct. Except as required under applicable securities laws, BioNxt undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

F.Tremblay--SMC