Mr. Huge Rogers reports

BIONXT ENTERS THE FINAL STRETCH BEFORE HUMAN TRIALS FOR NEXT-GENERATION MS DRUG

Bionxt Solutions Inc. has launched a 15-day dosing optimization study for its lead product BNT23001, a proprietary sublingual cladribine formulation for the treatment of multiple sclerosis (MS).

The study marks the final step before human bioequivalence testing, which is set to begin in early 2026.

A final step before human testing

Following successful small-animal trials that confirmed bioequivalence, Bionxt is now taking the final preclinical step to prepare its sublingual cladribine formulation for human testing. The coming large-mass animal study is designed to fine-tune dosing precision and optimize the formulation ahead of the company's comparative human bioequivalence trial planned for early 2026.

"The company has already confirmed dosage bioequivalence in small-mass (40 kilograms) animal study will provide valuable insight into the appropriate sublingual drug load for humans," said Bionxt Solutions chief executive officer Hugh Rogers.

"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," he added.

The 15-day crossover study is set to begin within the next two weeks and will run for approximately three weeks. Completion is expected in November, with results due in December.

Transforming how MS drugs are delivered

BNT23001 is an orally dissolvable thin-film formulation of cladribine, an established immunomodulatory compound used to treat multiple sclerosis. Delivered under the tongue, the therapy is designed to offer faster absorption, improved bioavailability and greater patient comfort, especially for those who have difficulty swallowing tablets or prefer a non-invasive alternative.

Preclinical testing has shown strong absorption rates, bioequivalence to standard oral treatments and no signs of toxicity, supporting the drug's potential as a more convenient option for MS patients.

Patent protection expanding worldwide

Bionxt Solutions is also advancing its patent nationalization strategy across key markets, including Canada, Australia, the European Union, Eurasia, New Zealand and Japan, along with a Track 1 priority filing in the United States.

Both the European Patent Office and the Eurasian Patent Office have issued favourable communications, including intent-to-grant notices. Novelty, inventive step and industrial applicability have all been accepted, reinforcing the company's IP (intellectual property) position ahead of human trials.

Positioning for 2026 human trials

The coming human comparative bioequivalence study will directly measure drug absorption between Bionxt's sublingual formulation and the existing tablet version of cladribine. The goal: to validate a simpler, faster and more patient-friendly approach to MS treatment.

With dosing optimization under way and patent protections expanding, Bionxt is entering a pivotal phase that could redefine how MS medications are delivered and how patients experience them.

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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