Mr. Hugh Rogers reports

BIONXT LAUNCHES 15-DAY SUBLINGUAL CLADRIBINE DOSING OPTIMIZATION STUDY IN PREPARATION FOR HUMAN BIOEQUIVALENCE STUDY

Bionxt Solutions Inc. has launched an important large-mass animal bioequivalence study for its lead product, BNT23001, a proprietary sublingual cladribine formulation for the treatment of multiple sclerosis (MS). This is the final animal study to generate dosing parameters for the company's human-comparative bioequivalence study planned for early 2026.

"The company has already confirmed dosage bioequivalence in small-mass (less-than-20-kilogram) animals; however, a large-mass (greater-than-40-kilogram) animal study will provide valuable insight into the appropriate sublingual drug load for humans," said Hugh Rogers, chief executive officer of Bionxt. "This large-mass animal study is expected to increase the formula precision in our human study and is designed to generate comparative drug absorption results between the company's sublingual formulation versus the name-brand tablet formulation. Optimization of drug load per dose and potential super bioavailability are key pieces of information that will guide the final clinical planning for our upcoming comparative-human bioequivalence study."

The large-mass animal crossover bioequivalence study will commence in the next two to three weeks and will be carried out over the following 15 days. The study is expected to be completed in November, with results available in December.

BNT23001 is an orally dissolvable thin-film formulation of cladribine, a well-established immunomodulatory compound used for the treatment of MS. 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. Preclinical studies, as previously reported, have demonstrated high absorption rates and bioequivalence to existing oral therapies as well as zero indications of toxicity.

The patent nationalization process is under way in key global markets, including the European Union, Canada, Australia, Eurasia, New Zealand and Japan, as well a Track 1 priority filing in the United States. Both the European Patent Office and the Eurasian Patent Office have issued favourable communications, including notice of intentions to grant. Novelty, inventive step and industrial applicability were fully accepted.

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 worldwide.

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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