BioNxt Secures European Patent for Sublingual Cladribine Drug Delivery Technology

BioNxt Solutions Inc. (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) announced that the European Patent Office (EPO) has issued a Decision to Grant European Patent No. 4539857 covering the Company's proprietary sublingual cladribine oral thin film (ODF) drug delivery technology. The grant will take effect upon publication of the mention of grant in the European Patent Bulletin on March 11, 2026 (Bulletin 26/11).

Upon assignment in designated jurisdictions, the patent will provide protection in up to 39 European Patent Convention (EPC) Contracting States. The patent term extends through at least June 14, 2043, subject to applicable validation requirements, renewal fees, and national procedures.

The European Decision to Grant follows the Company's previously announced "Intention to Grant" communication from the EPO and represents a significant advancement in securing enforceable intellectual property rights in one of the world's largest pharmaceutical regions.

The CEO stated that Europe is a core component of the long-term commercialization strategy. Securing patent protection in this region strengthens the global intellectual property position and supports ongoing licensing and partnership discussions. The development builds on the recent Eurasian patent grant and aligns with the progress of the cladribine program as the company prepares for planned human bioequivalence studies.

The European patent relates to BioNxt's proprietary sublingual oral thin film formulation designed to deliver cladribine via transmucosal absorption. Unlike conventional oral tablets, the Company's thin film is designed to dissolve rapidly in the mouth, offering a swallow-free, needle-free dosage format intended to improve patient convenience and adherence.

BioNxt's lead candidate, BNT23001, is being developed for the treatment of multiple sclerosis (MS), a chronic autoimmune disease. Swallowing difficulties (dysphagia) affect a meaningful proportion of MS patients during disease progression, highlighting the potential relevance of alternative delivery formats.

The Company's development strategy combines an established active pharmaceutical ingredient with a proprietary drug delivery system designed to enhance usability while leveraging the known safety and efficacy profile of cladribine. Previously reported preclinical pharmacokinetic data in a large-mass animal model demonstrated increased systemic exposure relative to a reference oral tablet formulation, supporting continued clinical development.

The granted European patent is not limited to multiple sclerosis and encompasses the sublingual delivery of cladribine for additional autoimmune and neurodegenerative indications. In addition to MS, BioNxt is evaluating the potential application of its cladribine ODF platform in other autoimmune conditions, including Myasthenia Gravis, which are likewise covered within the scope of the granted patent claims.

The European Decision to Grant builds upon BioNxt's previously announced final patent grant from the Eurasian Patent Organization (EAPO), which provides protection across eight member states.

BioNxt has also completed a "Fast-Track" U.S. Track One patent filing in October 2025 for its sublingual cladribine drug delivery platform, enabling prioritized examination by the United States Patent and Trademark Office (USPTO). In parallel, nationalization efforts continue in Canada and other strategic pharmaceutical markets.

Together, these jurisdictions represent a substantial portion of the global pharmaceutical landscape and form a key foundation of BioNxt's expanding intellectual property estate and long-term commercialization strategy.

With European patent protection progressing toward effectiveness, BioNxt continues preparations for its planned human bioequivalence study for BNT23001. Because cladribine is an already approved active pharmaceutical ingredient, development efforts are expected to focus on demonstrating bioavailability and comparability relative to existing oral formulations, subject to regulatory requirements.

Management anticipates additional intellectual property, development, and regulatory milestones in the coming quarters as the program advances toward clinical execution and potential strategic partnerships.