Star Metro - BioNxt Reports Sublingual Cladribine Multiple Sclerosis Drug Milestones Including Large-Animal Study for Validation and Dosing Optimization

Cladribine Sublingual Thin-Film Program: Manufacturing and Development Milestones

BioNxt has successfully completed key technology transfers to its European contract development and manufacturing organization ("CDMO"), including both the process transfer and the analytical method transfer. These achievements represent critical steps toward ensuring reproducibility, scalability, and regulatory compliance in the production of the Company's pharmaceutical-grade sublingual thin-film dosage forms.

In parallel, BioNxt confirms that the active pharmaceutical ingredient (API) for Cladribine has been ordered and is currently in transit to the CDMO for use in the manufacturing of a pilot batch. This batch will be used to produce clinical-grade thin film products, advancing the program toward its next preclinical and clinical phases.

The Company is now preparing for the optimization and validation of analytical methods, together with the final refinement of product and process parameters at its CDMO partner. These activities will enable the production of sublingual thin-film samples for a large-animal (pig) bioavailability study, scheduled to begin in October 2025. Pigs are widely recognized as a translationally relevant model for human gastrointestinal absorption, and this study is specifically designed to confirm and strengthen the highly promising bioavailability results demonstrated in earlier animal studies. A successful outcome will provide robust, clinically translatable evidence of the formulation's performance, establishing the final preclinical validation step and dosage optimization prior to human evaluation.

Building on this foundation, BioNxt plans to manufacture a pilot batch for a first-in-human clinical pilot study, targeted for Q1 2026. This milestone trial would represent a major inflection point in the clinical development of BioNxt's Cladribine sublingual reformulation.

Clinical and Market Impact

BioNxt's Cladribine sublingual thin-film program, BNT23001, represents a novel approach to oral drug delivery in neurological disease, with the potential to improve patient outcomes through enhanced pharmacokinetics and ease of administration. The program also complements BioNxt's growing portfolio of proprietary sublingual thin-film technologies targeting high-value pharmaceutical markets.

"With both our development program and global patent strategy advancing on schedule, BioNxt is steadily building the foundation for clinical translation and commercial success," said Hugh Rogers, CEO of BioNxt. "Cladribine represents a powerful therapeutic option with untapped potential, and our sublingual thin-film reformulation may unlock significant advantages in terms of bioavailability, patient adherence, and market accessibility. The progress we are reporting today reinforces our conviction in the program's importance as a core pillar of BioNxt's commercialization pipeline."

Next Steps

• Completion of analytical optimization and validation at the European CDMO;

• Final process and product optimization, followed by clinical sample production;

• Initiation of a large-animal bioavailability study in October 2025, expected to be the final preclinical study before human trials;

• Preparation for the manufacture of clinical samples for the first-in-human clinical study in Q1 2026; and

• Ongoing patent nationalizations and accelerated US patent review under Track One.

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.

View the original press release on ACCESS Newswire

G.Boudreau--SMC