Covering an addressable population of nearly 1 billion people across Europe, Eurasia, and associated validation states, BioNxt’s expanding patent portfolio secures access to some of the world’s largest and most advanced pharmaceutical markets. The EPO “Intention to Grant” complements the Company’s previously announced “Readiness to Grant” from the Eurasian Patent Organization (EAPO) for Eurasian patent application no. 202590051.
Together, these patent filings provide potential protection across up to 54 jurisdictions, including all EPO contracting, validation, and extension states, plus the eight EAPO member countries subject to national validation and maintenance. This extensive geographic and population coverage strengthens BioNxt’s global leadership in oral and transmucosal drug delivery and supports the commercialization strategy for BNT23001, the Company’s lead multiple sclerosis candidate.
### Expanded IP Protection Across Europe and Eurasia
The patents protect BioNxt’s proprietary transmucosal cladribine delivery composition in the form of a sublingual thin film comprising a cladribine-cyclodextrin complex and hydrophilic polymers such as starch and pullulan. This innovative formulation enables rapid absorption through the oral mucosa, which may enhance bioavailability, tolerability, and patient adherence compared to traditional tablets or injectables.
BioNxt is actively expanding its IP portfolio through additional filings, including a U.S. fast-track application, as well as submissions in North America, Japan, and other regions to broaden its global patent coverage.
### Strong Market Opportunity: Europe’s MS Market Moves Toward Oral and Patient-Friendly Therapies
The European multiple sclerosis treatment market is valued at approximately US$7.95 billion in 2024 and is projected to reach US$13.56 billion by 2032, growing at a compound annual growth rate (CAGR) of around 6.9%, according to Stellar Market Research.
The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) estimates that more than 1.2 million people in Europe are living with MS. Oral therapies are expected by Coherent Market Insights to maintain a leading market share of approximately 49% by 2025.
Growth in the oral therapy segment is driven by the rising prevalence of MS, advancements in drug delivery technologies, and increased availability of effective oral disease-modifying therapies. Patients and clinicians increasingly favor oral treatments due to their non-invasive, convenient, and discreet administration, leading to higher treatment adherence and improved quality of life compared to injectable or infusion-based options.
MAVENCLAD® (cladribine tablets), approved by the European Medicines Agency and used by over 100,000 patients globally, has established a strong benchmark for oral cladribine therapies.
BioNxt’s swallow-free, water-free, rapidly dissolving thin-film formulation is designed to simplify administration and further enhance the patient experience, aligning with market trends toward ease of use and self-managed treatment.
### CEO Statement
“Securing patent protection in both Europe and Eurasia marks a major step forward in our global IP and commercialization strategy,” said Hugh Rogers, CEO of BioNxt Solutions Inc. “These patents strengthen our position as a leader in advanced oral drug delivery and support the continued development and partnering of BNT23001.”
### Next Steps and Strategic Significance
BioNxt continues to advance BNT23001, its lead oral cladribine thin-film candidate, through ongoing development and regulatory planning. The Company is currently completing a large-mass animal bioequivalence study to establish dosing parameters for an upcoming human bioequivalence trial.
Additionally, BioNxt is actively pursuing co-development and out-licensing partnerships with both innovator and generic manufacturers seeking patient-friendly formulations of established therapies.
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### About BioNxt Solutions Inc.
BioNxt Solutions Inc. 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 tumors 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 healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.
BioNxt is listed on the Canadian Securities Exchange (CSE: BNXT), OTC Markets (OTCQB: BNXTF), and trades in Germany under WKN: A3D1K3.
To learn more about BioNxt, please visit [www.bionxt.com](http://www.bionxt.com).
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### Investor Relations & Media Contact
**Hugh Rogers**
Co-Founder, CEO, and Director
Email: [email protected]
Phone: +1 604-250-6162
Web: [www.bionxt.com](http://www.bionxt.com)
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### Cautionary Statement Regarding Forward-Looking Information
This press release contains “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian securities laws. Such information includes, but is not limited to, statements regarding anticipated grant, scope, and timing of patent rights; plans for additional filings; development, clinical evaluation, regulatory approval, and commercialization of the Company’s cladribine sublingual thin-film (BNT23001); strategic importance of intellectual property protection; timing, cost, and outcome of studies; and potential application of BioNxt’s delivery platform in additional therapeutic areas.
Forward-looking information is based on management’s current expectations and assumptions as of the date hereof and involves inherent risks and uncertainties. Actual results may differ materially due to factors beyond the Company’s control, including patent examination outcomes, regulatory changes, clinical study results, manufacturing scalability, availability of partnerships and funding, and broader economic or geopolitical factors.
Readers are cautioned not to place undue reliance on forward-looking information. Except as required by law, BioNxt undertakes no obligation to update or revise these statements.
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*© 2025 BioNxt Solutions Inc.*
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