Announcement • Jul 11

BioNxt Solutions Advances GLP-1 Sublingual Semaglutide Oral Dissolvable Film Program With Next Stage Of Delivery Development Underway

BioNxt Solutions Inc. has announced continued progress in its sublingual Semaglutide oral dissolvable film program, marking the next stage of development for the Company’s GLP-1 delivery platform. 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. 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. 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. 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. 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. 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. 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.

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BioNxt Solutions Advances GLP-1 Sublingual Semaglutide Oral Dissolvable Film Program With Next Stage Of Delivery Development Underway

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