Berliner Boersenzeitung - BioNxt Advances GLP-1 Sublingual Semaglutide ODF Program with Next Stage of Delivery Development Underway

Expanding BioNxt's Thin-Film Platform into GLP-1 Therapeutics

BioNxt's Semaglutide ODF program is designed to evaluate a needle-free, patient-friendly thin-film delivery format for GLP-1 receptor agonists, a class of therapeutics widely used in the treatment of type 2 diabetes, obesity, weight management, and related metabolic disorders. The program builds on BioNxt's expertise in sublingual thin-film drug delivery and expands the Company's platform into one of the fastest-growing therapeutic markets globally.

A Rapidly Growing Market with Significant Delivery Needs

The GLP-1 and incretin drug market has become one of the most significant growth areas in the pharmaceutical industry, driven by rising global demand for obesity and metabolic disease treatments. Morgan Stanley Research estimates that the global market for GLP-1 drugs could reach $190 billion by 2035, more than double the $79 billion in total sales recorded in 2025, with growth supported by oral treatment formats, broader insurance coverage, international market expansion, and new therapeutic use cases. Current GLP-1 therapies are primarily delivered by injection, while first-generation oral tablet formats may involve strict administration requirements. BioNxt believes that sublingual ODF delivery may represent a next-generation approach designed to improve convenience, portability, ease of administration, and patient experience.

Sublingual ODF: A Needle-Free Delivery Approach

Oral dissolvable films are thin, flexible films that dissolve in the mouth and can be designed for transmucosal absorption through the oral mucosa. Sublingual administration is intended to bypass the gastrointestinal tract and hepatic first-pass metabolism, which may be particularly relevant for peptide-based therapeutics that are vulnerable to gastrointestinal degradation. BioNxt's development strategy focuses on applying this delivery approach to established, high-value active pharmaceutical ingredients where improved administration formats may address important limitations of injectable and conventional oral dosage forms.

Addressing Long-Term Treatment Convenience

The Company believes that patient-friendly delivery formats may become increasingly important as GLP-1 therapies expand into broader populations for long-term metabolic health and weight management. Market adoption of injectable GLP-1 therapies has also highlighted practical challenges associated with self-administration, dose timing, injection burden, and treatment adherence. In parallel, industry research points to oral delivery formats as a key driver of future GLP-1 adoption, particularly among patients who prefer to avoid injections and in markets where broader access and affordability may support wider utilization. BioNxt's sublingual ODF program is being developed to explore whether a compact, needle-free film format can provide a more convenient alternative for future GLP-1 therapy delivery.

"GLP-1 therapies have transformed the treatment landscape for obesity, weight management, and type 2 diabetes, but delivery format remains a major area of opportunity," said Hugh Rogers, CEO of BioNxt Solutions Inc. "Our Semaglutide ODF program is focused on advancing a patient-friendly, needle-free thin-film approach that aligns with the next phase of GLP-1 delivery development."

Next Stage of Pharmaceutical Development

BioNxt has advanced the Semaglutide ODF program through feasibility evaluation and early formulation work and is now progressing the program into its next stage of pharmaceutical development. Current activities include formulation optimization, analytical method work, compatibility testing, placebo and active thin-film development, and preparation for additional proof-of-concept, preclinical, and formulation validation activities.

Broader Platform Potential for Peptide-Based Therapeutics

The program also supports BioNxt's broader strategy to establish a scalable sublingual ODF platform for complex, high-value molecules, including peptide-based therapeutics and other complex molecules. In addition to metabolic disease applications, oral thin-film technologies are increasingly being evaluated across multiple therapeutic areas, including central nervous system disorders, rescue medications, pain management, migraine, and other indications where rapid, convenient, and predictable administration may offer clinical and commercial advantages. GLP-1 therapies are also being explored for use cases beyond diabetes and obesity, including cardiometabolic, inflammatory, neurological, and other conditions, which may further support long-term interest in innovative delivery approaches for this therapeutic class.

Building on BioNxt's ODF Development Expertise

BioNxt's GLP-1 ODF initiative builds on the Company's growing expertise in sublingual thin-film drug delivery, including its lead Cladribine ODF program for multiple sclerosis and related autoimmune neurodegenerative indications. Through its German R&D operations and development partnerships, BioNxt continues to advance its pipeline of next-generation drug delivery technologies across high-value therapeutic markets.

The Company cautions that its Semaglutide ODF product candidate remains under development and has not been approved by any regulatory authority. There can be no assurance that the program will achieve its intended technical, clinical, regulatory, or commercial objectives.

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 more selectively to tumors with the goal of reducing systemic exposure.

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.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

(K.Lüdke--BBZ)