Berliner Tageblatt - BioNxt Solutions Reports Pending Patent Grants in Europe and Eurasia, Strengthening IP Protection for Proprietary Sublingual Cladribine-Based MS Treatment

Advancing Toward Formal Patent Grant

European Patent Office (EPO): The EPO has issued an Office Action with the intention to grant for BioNxt's key patent application. This confirmation signifies that all core claims have met the European requirements for novelty, inventive step, and industrial applicability. Only minor formal amendments were requested, which the Company has already addressed. The next Office Action is expected within the coming weeks.

Eurasian Patent Organization (EAPO): The EAPO, covering eight member countries across Eastern Europe and Central Asia, has issued a formal notice that BioNxt's patent application has likewise been accepted. Minor language modifications were required and have been promptly submitted. The Company anticipates a full patent grant across all member states in the near term.

Global Patent Strategy and Expansion

BioNxt previously filed an international patent application under the Patent Cooperation Treaty (PCT) to establish a coordinated framework for securing patent protection for its sublingual Cladribine thin-film technology and future products in multiple key markets. The Company has entered the national phase of this application in major pharmaceutical jurisdictions, including the United States, Canada, Japan, Australia, and New Zealand.

These national phase applications are currently progressing through local examination procedures. Patent protection in these regions will support BioNxt's long-term strategy for global commercialization, regulatory alignment, and regional partnership development.

Protecting Innovation in Multiple Sclerosis (MS) Treatment

The patents under review are designed to protect a family of products, including BioNxt's Cladribine-based thin-film formulation, developed for the treatment of relapsing-remitting multiple sclerosis (RRMS). The platform uses sublingual administration to optimize drug absorption, improve patient compliance, and avoid first-pass hepatic metabolism, offering a patient-friendly alternative to injectable or conventional oral therapies.

Patent protections include composition of the sublingual film, methods of administration and dosage, use for treating autoimmune diseases, and scalable manufacturing processes.

"Securing intellectual property rights in both Europe and Eurasia marks a critical step forward for our Cladribine program and sublingual delivery platform," said Hugh Rogers, CEO of BioNxt Solutions. "These patents represent significant commercial value by protecting a high-potential product, enabling regional exclusivity, and enhancing our ability to generate future licensing and partnership revenue."

Next Milestones in Patent Issuance and Product Advancement

BioNxt expects formal grant notices and publication from both the EPO and EAPO shortly. In parallel, the Company is preparing for GMP manufacturing and a human bioequivalence clinical study in Europe to support regulatory filings and commercialization. Further updates will be provided as additional national patent offices complete their evaluations.

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: +1 780-818-6422

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"). Forward-looking information includes, but is not limited to, statements regarding the anticipated grant and scope of European and Eurasian patent rights; the Company's plans for additional international patent filings; the development, clinical evaluation, and commercialization of the Company's Cladribine thin-film (BNT23001) for multiple sclerosis; the strategic importance of intellectual property; the timing and outcome of regulatory processes; and the potential expansion of BioNxt's sublingual drug delivery platform to other therapeutic areas.

Forward-looking information is based on management's reasonable assumptions, expectations, estimates, and projections as of the date of this press release. These statements are subject to known and unknown risks, uncertainties, and other factors-many of which are beyond the Company's control-that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking information. These risks and uncertainties include, but are not limited to: patent examination and prosecution outcomes; changes in regulatory or legal frameworks; clinical trial results; scalability of manufacturing processes; strategic partnership risks; and broader economic, financial, or geopolitical conditions.

Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes that the expectations and assumptions reflected in such statements are reasonable, there can be no assurance that they will prove to be correct. 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

K.Brown--BTB