BioNxt Reports "Readiness to Grant" Patent Notification from the Eurasian Patent Organization

Rhea-AI Summary

BioNxt (OTCQB:BNXTF) received a Readiness to Grant notice from the Eurasian Patent Organization for a patent family covering sublingual delivery of anticancer drugs aimed at treating autoimmune neurodegenerative diseases, including BioNxt's lead product BNT23001 (sublingual Cladribine for MS).

The company will pay a publication fee this week to secure formal grant in the EAPO region, which covers 8 countries (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan) representing a combined population of >200,000,000. BioNxt is days away from starting a two-week large-mass animal bioequivalence study to set dosing for an upcoming human bioequivalence study, and is pursuing patent nationalization in the EU, US (Track One), Canada, Australia, New Zealand, and Japan.

Positive

• Readiness to Grant issued by EAPO for core patent family
• Patent coverage spans 8 Eurasian states (>200,000,000 population)
• Two-week large-mass animal bioequivalence study starting in days
• Favorable communications from EPO and EAPO on novelty and inventive step

Negative

• Formal Eurasian patent remains pending until publication fee is paid
• Patent nationalization in EU, US, Canada, Australia, NZ, Japan is ongoing, not granted

VANCOUVER, BC / ACCESS Newswire / October 30, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to announce that the Eurasian Patent Organization (EAPO) has issued a "Readiness to Grant" notification for the Company's comprehensive patent application for sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases. This patent family provides numerous proprietary product development and commercialization opportunities, including BioNxt's lead product, BNT23001, a sublingual thin-film formulation of Cladribine for the treatment of multiple sclerosis (MS).

The EAPO is expected to grant the formal patent to BioNxt upon payment of a publication fee which the Company will provide to the EAPO this week. The EAPO covers Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan. These countries are the members of the Eurasian Patent Convention (EAPC), which provides a single, harmonized patent application process and regulator for the region. The EAPO grants Eurasian patents that are valid in all eight member states with a combined population of over 200,000,000.

"Solidifying patent protection is a critical part of our commercialization strategy," said Hugh Rogers, CEO of BioNxt. "The timing is excellent as the Company is days away from commencing a two-week-long large-mass animal bioequivalence study to determine dosing parameters for our upcoming human bioequivalence study. The coming months are expected to be very exciting for BioNxt as multiple clinical programs advance and our intellectual property portfolio gains international recognition and protection."

The patent nationalization process is underway in key global markets, including the European Union, Canada, Australia, Eurasia, New Zealand, and Japan, as well as a Track One priority filing in the United States. Both the European Patent Office and the Eurasian Patent Office have issued favorable communications including the formal acceptance of novelty, inventive step, and industrial applicability.

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: investor.relations@bionxt.com
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.

View the original press release on ACCESS Newswire

FAQ

What does the EAPO "Readiness to Grant" mean for BioNxt (BNXTF) on October 30, 2025?

It means the EAPO has approved the application and BioNxt must pay a publication fee this week to receive the formal Eurasian patent covering 8 member states.

Which countries will the Eurasian patent cover for BioNxt (BNXTF)?

The Eurasian patent would be valid in Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan.

How does the EAPO action affect BioNxt's lead product BNT23001 (BNXTF)?

The patent family includes protection for sublingual delivery relevant to BNT23001, potentially supporting future product development and commercialization.

When will BioNxt (BNXTF) begin its large-mass animal bioequivalence study and how long will it run?

BioNxt said the study will begin in days and run for two weeks to determine dosing for a planned human bioequivalence study.

Has BioNxt (BNXTF) received similar patent feedback elsewhere besides EAPO?

Yes; BioNxt reported favorable communications from the European Patent Office and EAPO, and is pursuing nationalization in the EU, US (Track One), Canada, Australia, New Zealand, and Japan.