Berliner Tageblatt - BioNxt Reports "Intention to Grant" Patent Notification from the European Patent Office for Its Oral Cladribine Sublingual Thin-Film as the Multiple Sclerosis Market Shifts Toward Patient-Friendly Therapies

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" for European patent application no. 23 729 446.7 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 formulation enables rapid absorption through the oral mucosa, which may enhance bioavailability, tolerability, and patient adherence versus tablets or injectables. BioNxt is expanding its IP portfolio through additional filings, including a U.S. fast-track application, as well as filings 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 MS treatment market is valued at approximately US$7.95 billion in 2024 and is projected to reach US$13.56 billion by 2032 (CAGR ~6.9%) according to Stellar Market Research. The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) notes that more than 1.2 million people in Europe are estimated to be living with MS, and oral therapies are projected by Coherent Market Insights to maintain a leading share of ~49% by 2025. Growth in the oral segment is being driven by the rising prevalence of MS, advancements in drug delivery technologies, and the increasing availability of effective oral disease-modifying therapies. Patients and clinicians increasingly favor oral treatments for their non-invasive, convenient, and discreet administration, resulting in 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 more than 100,000 patients globally, according to public disclosures, 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.

"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 development and regulatory planning. The Company is completing a large-mass animal bioequivalence study to establish dosing parameters for an upcoming human bioequivalence trial, and is actively pursuing co-development and out-licensing partnerships with both innovator and generic manufacturers seeking patient-friendly formulations of established therapies.

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: 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: +1 604.250.6162

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 information" and "forward-looking statements" within the meaning of applicable Canadian securities laws (collectively, "forward-looking information"). Such information may include, but is not limited to, statements regarding: the anticipated grant, scope, and timing of European, Eurasian, and other international patent rights; the Company's plans for additional national filings; the development, clinical evaluation, regulatory approval, and commercialization of the Company's Cladribine sublingual thin-film (BNT23001) for multiple sclerosis; the strategic importance of intellectual property protection; the timing, cost, and outcome of preclinical and clinical studies; and the potential application of BioNxt's sublingual thin-film drug delivery platform across additional therapeutic areas.

Forward-looking information is based on management's current expectations, assumptions, estimates, and projections as of the date of this press release. Such statements are subject to inherent risks and uncertainties, many of which are beyond the Company's control, that could cause actual results, performance, or achievements to differ materially from those expressed or implied. These risks and uncertainties include, but are not limited to: outcomes of patent examination and prosecution processes; changes in regulatory requirements or legal frameworks; the results, timing, and costs of preclinical and clinical studies; scalability and reproducibility of manufacturing processes; the availability of strategic partnerships and funding; and broader economic, financial, or geopolitical factors.

Readers are cautioned not to place undue reliance on forward-looking information. Although the Company believes the expectations and assumptions underlying such information are reasonable, there can be no assurance that they will prove to be correct. Except as required under applicable securities laws, BioNxt undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

SOURCE: BioNxt Solutions Inc.

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R.Adler--BTB