Mr. Hugh Rogers reports

BIONXT SECURES UNITARY EUROPEAN PATENT FOR SUBLINGUAL CLADRIBINE ODF PLATFORM ACROSS 18 COUNTRIES

Bionxt Solutions Inc. has obtained the official registration of unitary effect for European patent No. 4539857 covering the company's proprietary sublingual cladribine oral thin-film (ODF) platform.

The European Patent Office registered the patent's unitary effect on March 31, 2026, with effect from March 11, 2026. The unitary patent provides centralized protection across 18 participating European countries, including major pharmaceutical markets such as Germany, France, Italy, the Netherlands, Sweden and Portugal.

Core patent covers sublingual cladribine film technology

The patent relates to a sublingual pharmaceutical composition containing cladribine, preferably formulated as a cladribine-cyclodextrin complex and embedded in a hydrophilic polymer-based oral thin-film matrix.

The patent-protected technology is designed for transmucosal delivery and is applicable to multiple sclerosis as well as additional autoimmune indications, including myasthenia gravis and neuromyelitis optica spectrum disorders.

With a priority date of June 15, 2022, the patent establishes long-term intellectual property protection for Bionxt's lead drug delivery platform.

Unitary patent unlocks scalable European commercialization

The unitary patent system allows Bionxt to secure and enforce patent protection across 18 EU (European Union) member states under a single legal framework, significantly reducing administrative complexity compared with traditional national validation routes.

This milestone enhances Bionxt's ability to pursue regional licensing agreements, strategic co-development partnerships and efficient market access across Europe and represents a key step in the company's transition toward commercialization of its lead product candidate, BNT23001 (sublingual cladribine ODF).

ODF platform demonstrates strong preclinical and clinical progress

Bionxt's ODF platform consists of a thin, fast-dissolving film administered sublingually, enabling drug absorption through the oral mucosa while bypassing the gastrointestinal tract. This approach is designed to improve bioavailability, reduce variability in drug absorption and enhance patient compliance, particularly in populations with swallowing difficulties.

Preclinical studies supporting the cladribine ODF program have demonstrated comparable systemic exposure to the reference oral product Mavenclad, supporting bioequivalence potential and favourable tolerability with no treatment-related adverse effects observed following repeated sublingual administration.

Bionxt is also advancing a human bioavailability study comparing its ODF formulation with the marketed tablet, representing a key step toward regulatory approval.

Management highlights strategic importance of European patent

"The registration of unitary effect for EP4539857 marks an important milestone in our European IP [intellectual property] strategy," said Hugh Rogers, chief executive officer of Bionxt. "By securing protection across 18 key markets under a single framework, we are strengthening our foundation for commercialization and future partnership opportunities."

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 tumours 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 around the world.

Bionxt is listed on the Canadian Securities Exchange under the symbol BNXT and the OTC Markets under the symbol BNXTF and trades in Germany under WKN: A3D1K3.

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