Mr. Hugh Rogers reports

BIONXT ADVANCES SEMAGLUTIDE AS FIRST APPLICATION OF BROAD GLP-1 ODF PLATFORM STRATEGY

Bionxt Solutions Inc. has provided an update on its semaglutide oral thin-film (ODF) program and its broader strategy to develop a scalable platform for GLP-1 receptor agonists and peptide-based therapeutics.

Semaglutide as lead candidate for GLP-1 platform validation

Bionxt is currently in early stage development of its semaglutide ODF program, with initial formulation work under way, including preliminary feasibility and exploratory proof-of-concept evaluations. Semaglutide, a leading GLP-1 receptor agonist widely used in the treatment of Type 2 diabetes and obesity, has been selected as the company's lead candidate to support the development of a next-generation sublingual oral thin-film (ODF) approach for peptide therapeutics.

The company believes that semaglutide represents an ideal model compound due to its strong clinical profile, large and rapidly growing global market, and well-established regulatory pathway. By exploring feasibility with semaglutide, Bionxt is establishing the foundation for potential broader application of thin-film delivery approaches to peptide-based therapeutics.

The program remains in an early stage of development, and further work is required to validate formulation performance, bioavailability and delivery characteristics.

Expansion toward a GLP-1 and peptide delivery platform

Bionxt's strategic focus extends beyond a single-product development model. The company is advancing a next-generation ODF formulation approach designed to enable the sublingual delivery of complex peptide drugs, including GLP-1 receptor agonists.

Building on its early work with semaglutide, Bionxt is evaluating the potential to expand this approach to additional compounds within the GLP-1 class, including next-generation therapies such as tirzepatide and established molecules like liraglutide. These compounds share structural and pharmacological characteristics that may be compatible with Bionxt's formulation strategy.

The company's development efforts are focused on identifying and optimizing carrier systems and film compositions capable of supporting the delivery of large, sequence-based peptide molecules. This program is expected to generate new intellectual property covering formulation, carrier systems and peptide delivery mechanisms.

Upon further validation, Bionxt intends to pursue a broader intellectual property strategy targeting delivery technologies and potential multicompound applications within the GLP-1 category and other peptide-based therapeutic areas.

Large and rapidly expanding market opportunity

The global market for GLP-1 receptor agonists is one of the fastest-growing segments in the pharmaceutical industry, driven by rising prevalence of obesity and Type 2 diabetes, as well as expanding clinical use in cardiometabolic care. According to Fortune Business Insights, the global GLP-1 receptor agonist market was valued at $62.83-billion (U.S.) in 2025 and is projected to grow to $254.19-billion (U.S.) by 2034, representing a 16.8-per-cent CAGR (compound annual growth rate).

Semaglutide remains the leading commercial benchmark in the category. In its 2024 annual report, Novo Nordisk reported Ozempic sales of approximately $17.4-billion (U.S.) and Rybelsus sales of approximately $3.4-billion (U.S.) in 2024, while total obesity care sales, including Wegovy and Saxenda, reached approximately $9.4-billion (U.S.).

Bionxt believes that alternative, patient-friendly delivery formats such as sublingual oral thin films may play an important role in the next phase of market evolution, particularly by improving convenience, adherence and accessibility compared with injectable therapies.

Platform strategy and commercial outlook

Bionxt is positioning itself as a platform developer focused on drug delivery innovation rather than active pharmaceutical ingredient discovery. The company's development approach is designed to enable life cycle management opportunities for established drugs, support new formulations for approved compounds, and facilitate potential licensing and partnership agreements with pharmaceutical companies.

By combining a non-invasive, needle-free delivery approach with formulation-driven intellectual property, Bionxt aims to create a scalable and commercially attractive platform that can be applied across multiple therapeutic areas, with an initial focus on metabolic and peptide-based indications.

Semaglutide represents the first step in this strategy, serving as an initial validation candidate for the broader platform concept.

About Bionxt Solutions Inc.

Bionxt Solutions 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 tumours 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.

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