Mr. Hugh Rogers reports

BIONXT ENTERS COMMERCIALIZATION PHASE WITH GLOBAL PATENT PROTECTION AND U.S. FAST TRACK STRATEGY FOR SUBLINGUAL DRUG DELIVERY PLATFORM

Bionxt Solutions Inc. has made a major advancement in its commercialization strategy, supported by a rapidly expanding global patent portfolio for its proprietary 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 Nov. 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 nine 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 United States 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 life cycle 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, chief executive officer of Bionxt Solutions. "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 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 health care by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.

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