Bionxt fast-tracks MS drug patent, expands IP

Mr. Hugh Rogers reports BIONXT FAST-TRACKS U.S. PATENT FOR MS DRUG AND SECURES BROAD PLATFORM IP COVERING AUTOIMMUNE NEUROLOGY PIPELINE Bionxt Solutions Inc. has achieved two key milestones in the expansion and protection of its proprietary drug delivery platform targeting neurological autoimmune disorders. The company has formally initiated the prioritized examination process for its United States patent application for BNT23001, a novel sublingual thin-film cladribine formulation for multiple sclerosis (MS), under the United States Patent and Office's (USPTO) Track One program. Simultaneously, Bionxt has received acceptance of core claims for a broad international patent designed as a platform-level umbrella protecting the company's sublingual thin-film delivery technology across a wide range of diseases, drug compounds and applications. Fast-tracked U.S. patent filing via Track One to accelerate clinical development milestones Bionxt is pursuing the USPTO's Track One prioritized examination program to accelerate patent review for BNT23001. Once accepted, this program enables final patent disposition within 12 months, with most applicants receiving a first Office Action in approximately two months and a final decision in under seven months. For Bionxt, this fast-track status represents a strategic opportunity to secure near-term U.S. patent protection and strengthen its IP position ahead of pivotal bioequivalence studies and commercial partnering discussions. BNT23001 is an orally dissolvable thin-film formulation of cladribine, a well-established immunomodulatory compound. Delivered sublingually, the formulation is designed for improved bioavailability, faster onset of action and enhanced patient compliance, particularly in populations affected by dysphagia or seeking non-invasive alternatives to traditional tablets or injections. A strategic path toward superbioavailability and rapid approval Bionxt is advancing BNT23001 for relapsing-remitting MS (RRMS) and primary progressive MS (PPMS), as well as generalized myasthenia gravis (GMG). Merck KGaA is currently conducting a phase 3 clinical trial to evaluate cladribine capsules in GMG, further validating the therapeutic relevance of the compound beyond MS. This clinical activity by Merck reinforces the therapeutic relevance of cladribine in GMG and underscores the opportunity for Bionxt to differentiate and potentially partner or collaborate with its own next-generation, patient-centric delivery format. Bionxt's objective is to confirm that its sublingual thin film offers superbioavailability in comparison with Merck's Mavenclad tablets, which generated more than $1-billion (U.S.) in sales in 2023. If superior bioavailability is demonstrated relative to Mavenclad, Bionxt would qualify for an accelerated regulatory path under Article 10a of the European hybrid application framework, requiring only comparative PK data in healthy volunteers. A preclinical pharmacokinetic (PK) study in pigs, an established translational model for oral and sublingual absorption, will be initiated in the near-term to provide critical bioavailability data to support regulatory positioning and formulation optimization. Bionxt's broad patent: a platform-level umbrella for autoimmune neurology In parallel to its U.S. patent fast-tracking, Bionxt has achieved a major intellectual property milestone with the acceptance of core claims in its broad international umbrella patent protecting its thin-film delivery platform. This foundational patent is not limited to BNT23001, but instead provides platform-level protection for a wide range of drug compounds, therapeutic indications, administration methods and manufacturing processes. The umbrella patent provides long-term exclusivity, extending into the 2040s, not only for cladribine, but for a broad class of drug compounds delivered via Bionxt's proprietary sublingual thin-film technology. This includes protection for composition, manufacturing, administration methods, and use across multiple autoimmune and neuroinflammatory indications. Key disease targets include relapsing-remitting and primary progressive multiple sclerosis, generalized myasthenia gravis, neuromyelitis optica spectrum disorders (NMOSD), autoimmune encephalitis, central nervous system (CNS) vasculitis, optic neuritis, Hashimoto's encephalopathy, cerebral lupus, and Sjogren's syndrome. While Sjogren's is primarily known for its effects on exocrine glands, it is also associated with neurological complications in some patients. The patent has received core claim acceptance from both the European Patent Office (EPO) and the Eurasian Patent Organization (EAPO), and Bionxt has initiated national-phase filings in the United States, Canada, Japan, Australia and New Zealand. This patent framework enables Bionxt to scale its platform across additional indications using the same delivery modality, reducing development timelines and leveraging shared regulatory infrastructure. Targeting global markets and significant unmet need Autoimmune neurodegenerative diseases represent a significant global burden with limited therapeutic options and poor adherence to existing therapies. Bionxt's thin-film delivery technology is designed to improve tolerability and usability across these patient populations. Unlike conventional tablets or injectable formulations, Bionxt's thin-film platform bypasses the gastrointestinal tract, supports rapid absorption and improves dosing convenience, critical in chronic autoimmune disorders where long-term adherence is essential. More than 2.8 million people are living with multiple sclerosis (MS) globally, including nearly one million in the United States alone, according to the National Multiple Sclerosis Society and a 2019 study published in Neurology (Wallin et al., 2019; National MS Society). The U.S. MS drug market was valued at $7.81-billion (U.S.) in 2024 and is forecast to grow to over $17.15-billion (U.S.) by 2034, reflecting a CAGR (compound annual growth rate) of 8.18 per cent (Precedence Research, 2024). Generalized myasthenia gravis affects an estimated 700,000 people globally and remains an area of unmet therapeutic need (ClinicalTrialsArena, 2023). Bionxt estimates that its initial target indications, MS and GMG, represent a combined total addressable market of $42-billion (U.S.) to $46-billion (U.S.) by 2032, based on internal analysis and third party forecasting. The central nervous system therapeutics market is projected to exceed $239-billion (U.S.) by 2032, highlighting the broader opportunity for innovation in neuroimmunology (GMI Insights, 2024). The company expects to report results from its preclinical PK study later this year, supporting its regulatory strategy and partnership discussions. 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 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. We seek Safe Harbor.