Voyageur Pharmaceuticals Ltd. (TSX-V: VM)(OTC Pink: VYYRF) announced independent laboratory test results confirming that its barium sulfate active pharmaceutical ingredient (API) from the Frances Creek barite property meets pharmaceutical-grade purity, achieving an average of 98.8% BaSO4, exceeding the USP monograph requirement of 97.5%. The testing, conducted by SGS Laboratories in Mississauga, Ontario, included full USP compliance for identification, pH, loss on drying, limit of soluble barium salts, acid-soluble substances, sulfides, and microbiological requirements. Heavy metal levels were significantly below USP specifications. The barite was successfully micronized to 1-micron and 10-micron particle sizes using pharmaceutical-grade equipment at Sturtevant Inc., with d50 values of 1.1-1.9 µm and d90 values as low as 2.5 µm. All micronized samples met USP criteria, exhibited good flowability and 100% yield, with no discoloration or contamination.
These results mark the completion of the first stage of the Alberta Innovates AICE-Market Access Program, unlocking additional non-dilutive funding for stage two. Voyageur will now manufacture batches of its barium contrast agents for an upcoming clinical trial in patients, designed by Chief Scientific Officer Dr. Iryna Saranchova in accordance with Health Canada standards. The trial will compare Voyageur’s contrast products with current standard-of-care options for gastrointestinal Computed Tomography and fluoroscopic imaging. Brent Willis, CEO, stated, 'These results are promising and represent a major de-risking milestone. We believe we have proven that our natural barite resource delivers high chemical purity, ideal particle size after micronization, and full USP compliance. The upcoming clinical trial in patients is the final bridge to using our Frances Creek API in our Health Canada-approved contrast products.'
Successful study outcomes are expected to validate clinical performance, strengthen regulatory positioning, and accelerate market adoption. Full study completion is targeted for the fourth quarter of 2026. The results will also support the Company's FDA licensing applications, beginning in the first quarter of 2026, and contribute to the prefeasibility and final feasibility study for the Frances Creek project, expected by the fourth quarter of 2026. By developing this domestic resource, Voyageur aims to build a fully integrated supply chain from quarry to finished contrast media, reducing reliance on imported materials and improving cost efficiency.
In addition, Voyageur announced the issuance of 378,651 Deferred Share Units (DSUs) to directors and a consultant, and granted 4,300,000 stock options to directors and officers, with an exercise price of $0.1125 per share for 10 years. Options for 500,000 common shares at $0.18 per share were also granted to a contractor. The Company also plans to issue units totaling $100,000 to settle debt with an arm's length third party, subject to TSX Venture Exchange approval.
This disclosure has been reviewed and approved by Bradley Willis, P.Eng, a non-Independent Qualified Person as defined by National Instrument 43-101.
