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Bionxt Solutions Inc
Symbol BNXT
Shares Issued 113,402,105
Close 2025-02-18 C$ 0.50
Market Cap C$ 56,701,053
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Bionxt completes patent filings, bioequivalence study

2025-02-19 09:03 ET - News Release

Mr. Hugh Rogers reports

BIONXT SOLUTIONS UNVEILS ACCELERATED 90-DAY PLAN: GLOBAL PATENT ADVANCEMENTS, MS CLINICAL TRIAL, AND ANTI-AGING EXPANSION

Bionxt Solutions Inc. has provided an update on several major milestones for the next 90 days, including the registration of national-level patents, the completion of a human bioequivalence study for its lead multiple sclerosis (MS) treatment, and the development of its longevity and anti-aging product.

Global patent filings -- accelerating commercial pathways for Bionxt's pipeline

Bionxt confirm that all national-level filings pursuant to the Patent Cooperation Treaty (PCT) are complete in key jurisdictions of interest, including the United States, Canada, Australia, Europe and Japan. The company's national-level filings are based on the positive international examination report issued by the European Patent Office (EPO) in Q3 2024 for the company's comprehensive patent application for sublingual delivery of anti-cancer drugs for the treatment of autoimmune neurodegenerative diseases, such as MS. The company is working to accelerate the processing and registration of national-level patents with updates to be provided as they develop.

Securing national-level patents in premier pharmaceutical markets around the globe is a central milestone for Bionxt and will serve as the foundation for commercial opportunities for the Company's pipeline of sublingual products targeting autoimmune diseases such as multiple sclerosis (MS), myasthenia gravis (MG), lupus nephritis (LN) and rheumatoid arthritis (RA).

Human bioequivalence study for lead multiple sclerosis product

Bionxt's lead product, BNT23001, is a proprietary sublingual thin-film formulation of cladribine for the treatment of MS. Preclinical studies, as reported in internal research data and third party evaluations, have demonstrated high absorption rates and bioequivalence to existing oral therapies, with plans under way to commence the first clinical trial in the next 90 days. The bioequivalence study is relatively short and scheduled for less than 30 days from start to finish.

Successful completion of the company's sublingual cladribine bioequivalence study is a major milestone for the company and a proof-of-concept demonstration for Bionxt's lead product and its pipeline of sublingual products targeting autoimmune diseases.

Expansion into longevity and anti-aging

In the next 90 days, Bionxt plans to enter the rapidly growing longevity and anti-aging sector, projected to reach $93-billion (U.S.) by 2027 (Statista). The company is advancing proprietary sublingual (thin film) and oral (enteric-coated tablet) drug products with active pharmaceutical ingredients that show early-stage evidence of benefits such as slowing ovarian aging, extending fertility and promoting healthy aging. These innovative solutions are tailored to meet the growing demand for effective anti-aging therapies.

The company's longevity and anti-aging programs represent a strategic and diversified investment in a large and rapidly growing global market. Bionxt looks forward to providing further details in the coming weeks.

About Bionxt Solutions Inc.

Bionxt Solutions is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems and active pharmaceutical ingredient development. The company's proprietary platforms -- sublingual (thin film), transdermal (skin patch) and oral (enteric-coated tablets) -- target key therapeutic areas, including autoimmune diseases, neurological disorders and longevity.

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 on the OTC Markets under the symbol BNXTF and trades in Germany under the WKN A3D1K3.

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