Bionxt finishes semaglutide ODF proof-of-concept trials

Mr. Hugh Rogers reports BIONXT ADVANCES SEMAGLUTIDE ORAL DISSOLVABLE FILM (ODF) PROGRAM WITH SUCCESSFUL PROOF-OF-CONCEPT AND PROTOTYPE DEVELOPMENT Bionxt Solutions Inc. has successfully completed proof-of-concept trials for its semaglutide oral dissolvable film (ODF) program at Vektor Pharma TF GmbH, the company's wholly owned German subsidiary. Over the past several weeks, multiple proprietary film platforms were evaluated at Vektor Pharma. One of these in-house platforms achieved highly promising results, generating first prototypes of semaglutide ODF formulations with strong performance characteristics. The prototypes demonstrated rapid disintegration, homogeneous film quality, good processability during manufacturing and favourable mechanical properties. These results confirm the suitability of Bionxt's thin-film technology for complex peptide formulations and provide a solid foundation for further development. This achievement marks a key advancement in the program and provides positive momentum as the project advances into its next stage. "Achieving positive proof-of-concept results with first prototypes in hand represents an important milestone for Bionxt," said Hugh Rogers, chief executive officer of Bionxt Solutions. "These results validate our approach and allow us to proceed with greater confidence as we optimize the formulation, secure intellectual property and prepare for preclinical testing." Patent filing and next-stage development Building on the successful prototypes, Bionxt is preparing to file a patent application for the semaglutide ODF in the coming months. Under the supervision of Vektor Pharma, development will now transition toward refining the formulation to optimize performance and absorption potential while also initiating stability studies, advancing scale-up work and preparing the product for preclinical evaluation. These efforts are expected to continue through late 2025 and will culminate in a preclinical animal study anticipated to begin in early 2026. The study will evaluate the pharmacological performance and overall suitability of the product. Looking further ahead, Bionxt intends to manufacture an investigational medicinal product (IMP) to support a pilot clinical study targeted for the second half of 2026. Addressing the expanding GLP-1 market Semaglutide, currently marketed under the brand names Ozempic and Rybelsus, is a GLP-1 receptor agonist approved for Type 2 diabetes and obesity. Global demand for GLP-1 therapies is expanding rapidly, with semaglutide alone generating more than $29.3-billion (U.S.) in sales in 2024. Bionxt's oral-thin-film delivery format is designed to offer patients a non-invasive, accessible and compliance-friendly alternative to existing injectable and tablet-based options. Semaglutide represents the lead candidate in Bionxt's GLP-1 ODF portfolio, which is expected to include additional GLP-1-based therapies developed on the company's proprietary thin-film platform. 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 health care by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide. Bionxt is listed on the Canadian Securities Exchange under the symbol BNXT and the OTC Markets under the symbol BNXTF and trades in Germany under WKN: A3D1K3. We seek Safe Harbor.