Berliner Tageblatt - BioNxt Receives Milestone EPO Decision to Grant European Patent for Sublingual Cladribine Drug Delivery Technology for Multiple Sclerosis

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.

A Defining Milestone in BioNxt's European Commercial Strategy

"The European patent decision represents an important milestone for BioNxt," said Hugh Rogers, CEO of BioNxt. "Europe is a core component of our long-term commercialization strategy. Securing patent protection in this region strengthens our global intellectual property position and supports our ongoing licensing and partnership discussions."

Rogers continued, "This development builds on our recent Eurasian patent grant and aligns with the progress of our cladribine program as we prepare for planned human bioequivalence studies. With intellectual property protection advancing across multiple jurisdictions, BioNxt continues to establish a globally defensible platform around our sublingual cladribine technology."

Protecting a Patient-Focused, Needle-Free Drug Delivery Platform

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.

Importantly, 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.

Expanding Global Patent Coverage

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.

Advancing Toward Clinical Validation

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.

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 within the meaning of applicable Canadian securities laws. Forward-looking information includes, but is not limited to, statements regarding the interpretation and significance of the Company's preclinical study results; the potential advantages of BioNxt's sublingual oral dissolvable film (ODF) technology; the planned progression into human pharmacokinetic and bioequivalence studies; the potential applicability of the Company's drug-delivery platforms to additional therapeutic indications; and statements regarding future development, regulatory, commercialization, licensing, or partnering activities.

Forward-looking information is based on management's current expectations, assumptions, and beliefs as of the date of this press release. Such information is subject to a number of risks, uncertainties, and other factors, many of which are beyond the Company's control, that may cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to, scientific and preclinical development risks; the possibility that results observed in animal studies may not be predictive of human outcomes; the timing, cost, conduct, and results of future studies or clinical trials; manufacturing and scale-up risks; reliance on third-party service providers; regulatory and approval risks; intellectual property risks; competitive developments; and general economic and capital market conditions.

Readers are cautioned not to place undue reliance on forward-looking information. Except as required by 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

O.Bulka--BTB