VANCOUVER, BC / ACCESS Newswire / May 23, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to announce that the examining division of the European Patent Office ("EPO") has provided formal notice of the EPO‘s intention to grant BioNxt its core patent without significant changes.

The Company's core patent filing was a comprehensive application for the sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases. This patent family provides numerous proprietary product development and commercialization opportunities, including BioNxt's lead product, BNT23001, a sublingual thin-film formulation of Cladribine for the treatment of multiple sclerosis (MS).

"Confirmation of the Company's flagship intellectual property asset in Europe is a major milestone for BioNxt," stated Hugh Rogers, CEO of BioNxt. "We expect the European patent grant to be finalized and published in the coming weeks. The timing is excellent as we can confidently prepare for the upcoming BNT23001 human bioequivalence study in Europe."

BioNxt continues to advance the nationalization phase of the patent protection process at the European Patent Office and Eurasian Patent Organization, as well as with independent filing nations, such as Australia (AU), Canada (CA), New Zealand (NZ), USA (US), and Japan (JP). Securing nation-level patents around the globe will serve as the foundation for commercial opportunities for the Company's pipeline of sublingual products targeting autoimmune diseases such as multiple sclerosis (MS), myasthenia gravis (MG), lupus nephritis (LN) and rheumatoid arthritis (RA).

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated Tablets)-target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.

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: investor.relations@bionxt.com
Phone: +1 778.598.2698

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 statements within the meaning of applicable securities laws, including statements regarding the development, testing, regulatory approval, and commercialization of BioNxt's sublingual drug products, as well as projected milestones, anticipated partnerships, and potential market opportunities. Forward-looking statements are inherently subject to significant risks, uncertainties, and assumptions, many of which are beyond BioNxt's control. Factors that could cause actual results to differ materially include, but are not limited to, delays in regulatory approvals, negative outcomes from clinical trials, changes in market demand, fluctuations in funding availability, or disruptions in supply chains. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results may differ materially from those expressed or implied. BioNxt undertakes no obligation to update or revise forward-looking statements, except as required by law. Factors that could cause actual results to differ materially from those projected include changes in market demand, regulatory developments, delays in clinical trials, fluctuations in financing availability, supply chain disruptions, and unforeseen competitive pressures.

SOURCE: BioNxt Solutions Inc.