Bionxt Solutions receives semaglutide API

Mr. Hugh Rogers reports SEMAGLUTIDE API DELIVERY ENABLES START OF LAB-SCALE ODF DEVELOPMENT AT BIONXT Bionxt Solutions Inc. has received the semaglutide active pharmaceutical ingredient (API), enabling the initiation of laboratory-scale formulation and testing of the Company's oral dissolvable film (ODF) delivery system. In collaboration with its qualified supply partners, Bionxt has secured high-purity semaglutide as the central compound for its proprietary ODF formulation program. The API's fundamental physical and chemical properties -- such as solubility, molecular stability and loading capacity -- are foundational to formulation design and product performance. With the API now in hand, Bionxt's formulation team is executing preformulation and lab-scale trials to optimize delivery parameters. Initial research and development efforts will focus on optimizing drug incorporation within the sublingual thin-film matrix, characterizing disintegration time, testing peptide stability under formulation conditions, and developing analytical methods to ensure uniformity, controlled release and shelf-life performance. "Having the API in-house allows us to translate theory into practice," said Hugh Rogers, chief executive officer at Bionxt Solutions. "We're focused on generating reliable data to inform formulation refinement and position the project for patent protection in the coming quarter." Gen-Plus: Bionxt's European drug development hub All laboratory development activities for the semaglutide oral film are being conducted at Gen-Plus GmbH, Bionxt's German drug development partner, located in Munich, Germany. Gen-Plus is a licensed drug developer and manufacturer specializing in pharmaceutical thin-film formulations and novel dosage forms. Gen-Plus provides GMP-aligned (good manufacturing practice) laboratory infrastructure, in-house expertise in polymer science and peptide formulation, and regulatory readiness for clinical development in the European Union. The Munich facility serves as Bionxt's core technical centre for thin-film research, formulation prototyping and early-stage product development. The semaglutide program builds on Gen-Plus's proven experience in oral and transdermal delivery technologies for both small molecules and complex biologics. Advancing toward prototype and patent With laboratory work now under way, the next milestones in the development timeline include completion of formulation trials, characterization of peptide stability, and production of first-generation film prototypes. These efforts will generate the technical foundation required to support a provisional patent filing planned for the third quarter of 2025. Semaglutide, currently marketed under the brand names Ozempic and Rybelsus, is a leading GLP-1 receptor agonist approved for the treatment of Type 2 diabetes and obesity. Global demand for GLP-1 therapies is growing rapidly, with semaglutide accounting for more than $29.3-billion (U.S.) in sales in 2024. Bionxt's oral thin-film version is intended to improve accessibility and patient compliance through a non-invasive delivery format. Semaglutide is the first in a planned series of GLP-1-based therapies being developed using Bionxt's proprietary ODF 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 (symbol: BNXT) and the OTC Markets (symbol: BNXTF) and trades in Germany under WKN: A3D1K3. We seek Safe Harbor.