Voyageur Pharmaceuticals Ltd. (TSX-V: VM)(OTC Pink: VYYRF) announced independent laboratory test results confirming that its barium sulfate active pharmaceutical ingredient (API) sourced from the Frances Creek barite property in British Columbia meets pharmaceutical-grade purity standards. The testing, conducted by SGS Laboratories in Mississauga, Ontario, showed %BaSO4 assay results ranging from 98.1% to 99.4%, exceeding the USP monograph requirement of 97.5%, with an average purity of 98.8%. All samples passed full USP monograph tests, including identification, pH, loss on drying, limit of soluble barium salts, acid-soluble substances, sulfides, and microbiological requirements. Elemental impurities testing found heavy metal levels significantly below USP specifications. The processed barite achieved particle sizes of 1 micron and 10 microns, with d50 values of 1.1–1.9 µm and d90 values as low as 2.5 µm, demonstrating efficient micronization using pharmaceutical-grade equipment at Sturtevant Inc. All micronized samples met USP particle size criteria, exhibited good flowability, 100% yield, and no discoloration or contamination. The acid-wash procedure was performed in a cGMP-compliant environment at SGS, and final processing and packaging were completed under Good Manufacturing Practices (GMP).
These results mark the successful completion of the first stage of the Alberta Innovates AICE-Market Access Program, as previously announced. Voyageur will now advance to stage two, which involves manufacturing batches of new product using Frances Creek barium sulfate for an upcoming Health Canada-approved clinical trial. The trial will compare Voyageur's barium contrast agents with current standard-of-care options for gastrointestinal Computed Tomography and fluoroscopic imaging. CEO Brent Willis 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." The clinical trial, designed by Chief Scientific Officer Dr. Iryna Saranchova in accordance with Health Canada standards, is expected to provide comprehensive assessment of the products' performance. Successful outcomes are anticipated to validate clinical performance, strengthen regulatory positioning, and accelerate market adoption. Full study completion is targeted for the fourth quarter of 2026. The trial 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.
Voyageur also announced the issuance of 378,651 Deferred Share Units (DSUs) to directors and a consultant under its equity compensation plan, with a deemed value of approximately $0.17573 per DSU based on weighted average share prices. Additionally, the Company granted 4,300,000 stock options to directors and officers, with 1,075,000 vesting immediately and the remainder subject to time-based vesting. The options have an exercise price of $0.1125 per share for 10 years. Options to purchase 500,000 common shares at $0.18 per share were also granted to a contractor, vesting fully on January 11, 2027. All securities are subject to Exchange approval and a four-month hold period. Furthermore, Voyageur intends to issue units to an arm's length third party at a deemed value of $100,000 in connection with debt incurred for financial advisory services. Each unit will consist of one common share and one warrant exercisable at $0.15 for five years. The issuance is subject to TSX Venture Exchange approval. By developing its domestic barite 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 for hospitals and patients.
