Sawt Falasteen - BioNxt Solutions Unveils Accelerated 90-Day Plan: Global Patent Advancements, MS Clinical Trial, and Anti-Aging Expansion

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 anticancer 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 nation-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 underway 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 Inc. 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 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. To learn more about BioNxt, please visit www.bionxt.com.

Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
Email: [email protected]
Phone: +1 778.598.2698

Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt

Cautionary Statement Regarding "Forward-Looking" Information
This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the development, testing, regulatory approval, and commercialization of BioNxt's sublingual drug products, as well as projected milestones, anticipated partnerships, and potential market opportunities. Forward-looking statements are inherently subject to significant risks, uncertainties, and assumptions, many of which are beyond BioNxt's control. Factors that could cause actual results to differ materially include, but are not limited to, delays in regulatory approvals, negative outcomes from clinical trials, changes in market demand, fluctuations in funding availability, or disruptions in supply chains. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results may differ materially from those expressed or implied. BioNxt undertakes no obligation to update or revise forward-looking statements, except as required by law. Factors that could cause actual results to differ materially from those projected include changes in market demand, regulatory developments, delays in clinical trials, fluctuations in financing availability, supply chain disruptions, and unforeseen competitive pressures.

SOURCE: BioNxt Solutions Inc.

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O.Mousa--SF-PST