Bionxt signs LOI for cladribine commercialization

Mr. Hugh Rogers reports BIONXT SIGNS STRATEGIC AGREEMENT FOR EURASIAN COMMERCIALIZATION FOLLOWING CLADRIBINE ODF PATENT GRANT IN EURASIA AND EUROPE Bionxt Solutions Inc. has signed a non-binding letter of intent (LOI) establishing an exclusive negotiation framework for the potential commercialization of its sublingual cladribine oral thin film (ODF) product within one or more member states of the Eurasian Patent Organization (EAPO). The LOI outlines a structured pathway toward a potential regional licensing arrangement and follows recent patent grants and decisions covering Bionxt's proprietary cladribine ODF technology in both the Eurasian region and Europe, significantly strengthening the company's global intellectual property position. Structured commercialization pathway The signed LOI represents a significant step toward regional market entry and outlines a defined pathway toward a potential definitive licensing agreement. The contemplated collaboration framework includes potential regional licensing rights, defined exclusivity during the negotiation period, and financial terms structured around upfront payments, royalties and revenue sharing. The framework also anticipates collaboration across regulatory strategy, manufacturing co-ordination, quality control and commercialization planning within the defined territory. Under the LOI, the parties have agreed to negotiate exclusively for a period of 60 days while working toward finalizing a definitive commercial agreement. While the LOI is non-binding with respect to the final transaction, it reflects the parties' mutual intent to advance commercialization discussions in the region supported by Bionxt's expanding intellectual property footprint and differentiated drug delivery platform. "We believe this strategic agreement marks an important milestone in the commercialization of our cladribine ODF program," said Hugh Rogers, chief executive officer and director of Bionxt Solutions. "Securing long-term patent protection in both the Eurasian region and Europe strengthens our global IP position and underscores the commercial relevance of our platform. We look forward to engaging with potential partners in Europe and Eurasia to pursue licensing and commercialization opportunities that bring patient-centric therapies to market." Strengthened patent protection in Eurasia and Europe Bionxt has received formal patent protection for its sublingual cladribine ODF formulation from the Eurasian Patent Organization (EAPO) and the European Patent Office (EPO). Patent No. 051510, issued on Nov. 14, 2025, by the EAPO, covers sublingual delivery of therapeutic compounds, including Bionxt's lead product candidate, BNT23001. The patent provides protection in all eight EAPO member states (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan and Turkmenistan), representing a combined population of more than 200 million people, and is valid through at least June 14, 2043. In addition, effective March 11, 2026, by way of publication in the European Patent Bulletin, the EPO has granted European Patent No. 4539857 covering Bionxt's proprietary sublingual cladribine ODF technology. Upon national validation, the patent is expected to provide protection in up to 39 European Patent Convention (EPC) contracting states, through to at least June 14, 2043, subject to national procedures and maintenance requirements. These IP (intellectual property) achievements significantly advance Bionxt's global intellectual property strategy and support its continuing pursuit of strategic licensing and partnership opportunities across Europe, Eurasia and other international markets. Access to a more-than-200-million population market and broader European opportunity The Eurasian region's eight member states represent a combined population of over 200 million people, offering meaningful demographic reach for potential commercialization of innovative therapies. In Europe, once nationally validated, the European patent is expected to provide protection across a broad set of jurisdictions covering many of the world's largest pharmaceutical markets. Combined with the Eurasian grant, this positions Bionxt to pursue licensing partnerships spanning major patient populations across Eurasia and Europe. The company is actively evaluating potential licensing partners and commercialization collaborations in European markets, where neurological and autoimmune diseases such as multiple sclerosis (MS) represent a substantial therapeutic and commercial opportunity. Multiple sclerosis affects approximately 2.9 million people globally, with significant patient populations across Europe, Eastern Europe and Central Asia. Patient populations with other autoimmune neuromuscular disorders, such as myasthenia gravis (MG), further expand the addressable market where patient-friendly, swallow-free delivery options may offer meaningful clinical and commercial differentiation. Cladribine is an approved therapy for relapsing forms of MS in major markets, with jurisdiction-specific indications. Bionxt's sublingual ODF formulation is designed as a needle-free and swallow-free alternative to conventional tablet administration, with the goal of improving patient convenience, adherence and real-world usability. Growing global demand for patient-centric drug delivery The global needle-free drug delivery market was valued at approximately $14.39-billion (U.S.) in 2024 and is projected to reach approximately $30.73-billion (U.S.) by 2032. The global oral thin films market is projected to grow at an approximately 8.6-per-cent compound annual growth rate through 2032, reflecting increasing demand for patient-centric dosage forms that enhance compliance, convenience and real-world usability. By combining an approved active ingredient with a differentiated, IP-protected delivery system, Bionxt aims to reduce development risk while enabling an accelerated, partnership-driven commercialization strategy supported by long-term territorial exclusivity. Accelerated development pathway Because cladribine is already an approved active pharmaceutical ingredient, Bionxt's development pathway is primarily focused on demonstrating bioequivalence of its sublingual formulation relative to existing tablet products. Preparations for a human bioequivalence study are under way following successful preclinical pharmacokinetic studies in animal models, which evaluated systemic exposure following administration of the company's ODF formulation. The signed LOI, together with secured Eurasian and European patent protection valid through 2043, positions Bionxt to advance regional commercialization discussions supported by defined territorial exclusivity and long-term intellectual property rights. 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. We seek Safe Harbor.