Berliner Tageblatt - BioNxt Enters Commercialization Phase with Global Patent Protection and U.S. Fast Track Strategy for Sublingual Drug Delivery Platform

BioNxt has established a broad and defensible intellectual property position across key global markets, forming the foundation for the commercialization of its lead product, BNT23001, a sublingual cladribine ODF, a thin, fast-dissolving film for oral drug delivery, targeting multiple sclerosis (MS) and myasthenia gravis (MG).

Global Patent Coverage Across Major Markets

In Europe, the European Patent Office granted European Patent No. 4539857 on March 11, 2026, covering BioNxt's ODF technology across up to 39 EPC member states. In Eurasia, Patent No. 051510, granted on November 14, 2025, provides protection across eight member states, including Russia, Kazakhstan, and other strategically important markets. In the United States, BioNxt has completed a Track One "fast-track" patent filing with the USPTO, enabling accelerated examination with an expected timeline of approximately 9 to 12 months to final disposition. In parallel, national phase applications under the Patent Cooperation Treaty are progressing in Canada, Japan, Australia, and New Zealand.

Together, these jurisdictions represent a combined addressable market of nearly one billion people, positioning BioNxt to secure long-term exclusivity and global licensing opportunities.

Strong Intellectual Property and Differentiated Drug Delivery Platform

BioNxt's patent portfolio covers the sublingual delivery of cladribine via thin-film technology, including formulation, manufacturing processes, methods of administration, and therapeutic applications in neurodegenerative and autoimmune diseases such as multiple sclerosis. The technology is designed as an alternative to conventional oral tablets or injectable therapies, with the potential to improve bioavailability, reduce variability, and significantly enhance patient compliance.

The Company's Track One priority filing with the USPTO represents a key strategic milestone, providing accelerated patent review timelines, early visibility on U.S. IP protection ahead of clinical milestones, and strengthened positioning for near-term partnership and licensing discussions. The U.S. filing also extends coverage beyond multiple sclerosis to additional neurological and autoimmune indications, including myasthenia gravis and lupus nephritis, further expanding the commercial scope of the platform.

Transition to Commercialization and Partnering Strategy

With a strengthened global IP position and advancing clinical program, BioNxt is now actively transitioning into the commercialization phase. The Company is pursuing a partnership-driven strategy, including licensing agreements, co-development collaborations, and royalty-based supply arrangements with pharmaceutical partners.

BioNxt's platform is designed to improve bioavailability and pharmacokinetic consistency, enable needle-free and patient-friendly administration, and extend the lifecycle and exclusivity of established drugs. This positions the Company as a high-value innovation partner for reformulating approved therapeutics and unlocking new commercial opportunities.

"We have reached a defining moment for BioNxt," said Hugh Rogers, CEO of BioNxt Solutions Inc. "Our global patent estate, combined with the accelerated U.S. pathway, provides the foundation to move decisively into commercialization. We are now focused on translating our IP strength into strategic partnerships and long-term revenue opportunities."

With global patent coverage, a clear regulatory pathway, and a scalable platform, BioNxt is positioned to become a leading developer and partner in next-generation drug delivery systems targeting high-value markets in neurology, autoimmune diseases, and beyond.

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 news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements are based on management's current expectations, estimates, projections, beliefs, and assumptions as of the date of this release.

Forward-looking statements in this release include, but are not limited to, statements regarding: the negotiation and potential execution of a definitive licensing agreement pursuant to the non-binding letter of intent; the scope, territorial coverage, validity, term, and enforceability of the Company's Eurasian patent; the Company's intellectual property strategy; the continued development of its sublingual cladribine oral thin film (ODF) program; the anticipated timing, design, and conduct of planned human bioequivalence studies; potential regulatory pathways; expansion into additional indications; and potential commercialization, licensing, or partnering activities.

Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the possibility that a definitive agreement may not be executed within the exclusivity period or at all; risks associated with intellectual property protection and enforcement; potential patent opposition or validity challenges; uncertainties relating to regulatory review and approval; scientific, formulation, and development risks; the possibility that preclinical or pharmacokinetic results may not be predictive of human clinical outcomes; risks related to the timing, cost, and results of clinical studies; manufacturing and scale-up risks; reliance on third-party service providers; competitive developments; geopolitical risks in the Eurasian region; and general economic, market, and capital market conditions.

Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by applicable securities laws, BioNxt undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or otherwise.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

G.Schulte--BTB