Berliner Tageblatt - BioNxt Engages Business Development & Licensing Advisors for Commercialization of Patented Sublingual Cladribine ODF

BNT23001 is designed as a differentiated alternative to conventional tablet-based Cladribine therapy, including Mavenclad^®, by offering a thin, dissolvable film placed under the tongue. The Company believes this delivery format may be particularly relevant for MS patients who experience difficulty swallowing, also known as dysphagia. Mavenclad^®, the oral Cladribine MS therapy developed by Merck KGaA, generated reported global revenues of approximately €1.2 billion / US$1.4 billion in 2025, reflecting continued growth and strong demand across major markets including North America and Europe.

Commercialization Initiatives

BioNxt believes the timing is appropriate to advance commercialization planning for BNT23001, the Company's patented sublingual Cladribine ODF program for multiple sclerosis. The initiative will focus on evaluating potential licensing, co-development, regional commercialization, and strategic partnership opportunities.

The BD&L Advisor will support BioNxt in refining the program's commercial positioning, identifying potential pharmaceutical partners, evaluating transaction structures, and preparing for future business development engagement.

"Engaging a BD&L Advisor is an important step in the commercial planning process for our Cladribine ODF program," said Hugh Rogers, CEO and Co-Founder of BioNxt Solutions Inc. "As we prepare for the planned human bioavailability study, our strategy is to ensure that BNT23001 is positioned effectively for potential pharmaceutical partners."

Human Bioavailability Study Preparation

BioNxt has prepared a planned human bioavailability study designed to compare Cladribine ODF 10 mg with the approved reference product Mavenclad^® 10 mg tablets. The study is expected to assess key pharmacokinetic parameters, including total drug exposure, peak plasma concentration, and time to peak concentration, while also monitoring safety and tolerability.

Next Steps

BioNxt continues to prepare for its planned human bioavailability study while working with its BD&L Advisor to develop partnering materials, identify potential pharmaceutical partners, analyze comparable transactions, assess priority territories, and evaluate suitable deal structures.

There can be no assurance that the BD&L Advisor engagement or strategic evaluation process will result in a licensing transaction, co-development agreement, commercialization agreement, or other business arrangement.

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

Email: [email protected]

Wolfgang Probst
Co-Founder, CFO & Director
Phone: +49 151 25284192

Hugh Rogers
Co-Founder, CEO & Director
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 news release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking statements"). Forward-looking statements are based on management's current expectations, estimates, projections, beliefs, and assumptions as of the date of this news release and are subject to risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied herein.

Forward-looking statements in this news release include, but are not limited to, statements regarding the development, advancement, regulatory pathway, and potential commercialization of BNT23001, the Company's patented sublingual Cladribine orally dissolvable film ("ODF") program for multiple sclerosis; the Company's engagement with a Business Development & Licensing ("BD&L") advisor; potential licensing, co-development, regional commercialization, manufacturing, partnering, and strategic collaboration opportunities; the planned human bioavailability study, including its expected design, timing, scope, objectives, pharmacokinetic endpoints, safety and tolerability assessments, and potential results; the potential use of human pharmacokinetic data to support regulatory planning and future business development discussions; the potential benefits, performance, convenience, patient adherence, and commercial viability of sublingual thin-film drug delivery systems; the Company's intellectual property strategy and ability to obtain, maintain, and enforce patent and other proprietary rights in relevant jurisdictions; and the potential applicability of the Company's drug delivery platforms to additional therapeutic programs.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, and other factors, many of which are beyond the Company's control, including but not limited to risks related to research and development activities, scientific and technical challenges, formulation and manufacturing difficulties, clinical study preparation and execution, bioanalytical testing, pharmacokinetic outcomes, safety and tolerability findings, the possibility that preclinical or early-stage results may not be predictive of future clinical results, uncertainties relating to regulatory review and approval processes, intellectual property protection and enforcement risks, reliance on third-party advisors, contract research organizations, manufacturers, development partners and suppliers, competitive technologies, market acceptance, financing availability, and general economic, financial, regulatory, and capital market conditions.

There can be no assurance that forward-looking statements will prove to be accurate, that the BD&L advisor engagement will result in any licensing, co-development, commercialization, manufacturing, strategic collaboration, or other transaction, that the planned human bioavailability study will proceed as anticipated or generate favorable data, that BNT23001 will receive regulatory approval or achieve commercial success, or that the Company's intellectual property portfolio will provide the expected commercial or strategic benefits. Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by applicable securities laws, BioNxt undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Mavenclad^® is a registered trademark that is not owned by, affiliated with, sponsored by, or associated with BioNxt Solutions Inc.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

N.Fournier--BTB