BioNxt Solutions Inc. Advances Toward Commercialization with Expanding Global Patent Portfolio

Vancouver, BC – March 24 2026

BioNxt Solutions Inc. (CSE: BNXT, OTCQB: BNXTF, FSE:BXT) announced a significant step in its commercialization strategy. The company has secured a robust, defensible intellectual‑property framework for its proprietary sublingual drug‑delivery platform, positioning it to launch its lead product, BNT23001, a sublingual cladribine orodispersible film (ODF).

Patent Landscape

  • Europe: The European Patent Office granted European Patent No. 4539857 on March 11 2026, covering the ODF technology in up to 39 European Patent Convention member states.
  • Eurasia: Patent No. 051510 was granted on November 14 2025, extending protection to eight Eurasian member states, including Russia and Kazakhstan.
  • United States: BioNxt completed a Track One “fast‑track” filing with the U.S. Patent and Trademark Office, enabling accelerated examination with an expected resolution within 9–12 months.
  • Other Jurisdictions: National phase applications under the Patent Cooperation Treaty are advancing in Canada, Japan, Australia, and New Zealand.

These jurisdictions collectively represent a combined addressable market of nearly one billion people, giving BioNxt the opportunity to secure long‑term exclusivity and explore global licensing prospects.

Product Focus

BNT23001 is a thin, fast‑dissolving sublingual film that delivers cladribine, a therapeutic agent for multiple sclerosis (MS) and myasthenia gravis (MG). The film’s rapid dissolution and sublingual administration aim to improve patient convenience, adherence, and overall therapeutic outcomes.

Strategic Implications

  • Commercialization Phase Entry: By consolidating its intellectual‑property rights across major markets, BioNxt establishes a solid foundation for moving from development to commercialization.
  • Global Reach: The breadth of protection supports potential worldwide launch plans and positions the company to negotiate licensing agreements in key markets.
  • Competitive Advantage: The sublingual ODF platform differentiates BioNxt’s product from existing oral or injectable therapies, potentially offering a superior patient experience.

Market Context

BioNxt’s stock, traded on the Canadian National Stock Exchange, closed at $0.55 CAD on March 22 2026. Over the past 12 months, the share price ranged from a low of $0.38 CAD to a high of $1.10 CAD, reflecting market sensitivity to the company’s developmental milestones. With a market capitalization of $67.4 million CAD and a price‑earnings ratio of ‑10.3, the company remains a high‑risk, high‑potential investment, typical of early‑stage biotechnology firms.

Outlook

The successful patent strategy and the imminent availability of BNT23001 signal a pivotal transition for BioNxt Solutions Inc. As the company prepares to move toward clinical trials and eventual market entry, stakeholders will closely monitor regulatory milestones, clinical efficacy data, and partnership developments that could accelerate the commercialization timeline.