Voyageur Pharmaceuticals Ltd. (TSX-V: VM)(OTC Pink: VYYRF) announced that independent laboratory testing of its barium sulfate active pharmaceutical ingredient (API) from the Frances Creek barite property in British Columbia has achieved pharmaceutical-grade purity, exceeding USP monograph requirements. The testing, conducted by SGS Laboratories in Mississauga, Ontario, as part of the Alberta Innovates AICE-Market Access Program, confirmed %BaSO4 assay results ranging from 98.1% to 99.4%, with an average of 98.8%, surpassing the USP requirement of 97.5%. All samples passed the complete suite of USP monograph tests, including identification, pH, loss on drying, limit of soluble barium salts, acid-soluble substances, sulfides, and microbiological requirements. Heavy metal levels were significantly lower than USP specifications under USP <232> elemental impurities testing. The processed barite achieved 1-micron and 10-micron particle sizes, with excellent particle size distributions (d50 values of 1.1-1.9 µm, d90 values as low as 2.5 µm) after micronization at Sturtevant Inc. All micronized samples met USP particle size and performance criteria, exhibiting good flowability, 100% yield, and no discoloration or contamination. The barium sulfate underwent a controlled acid-wash procedure in a cGMP-compliant environment at SGS, with final processing and packaging under full Good Manufacturing Practices.
With this milestone, Voyageur is set to advance to stage two of the Alberta Innovates AICE-Market Access Program, unlocking additional non-dilutive funding. The upcoming clinical trial will compare Voyageur's barium contrast agents against current standard-of-care options for gastrointestinal Computed Tomography and fluoroscopic imaging. Designed by Chief Scientific Officer Dr. Iryna Saranchova in accordance with Health Canada standards, the trial will evaluate both barium-based and iodinated oral contrasts. Successful outcomes are expected to validate clinical performance, strengthen regulatory positioning with Health Canada and the FDA, and accelerate market adoption. Full study completion is targeted for the fourth quarter of 2026.
Brent Willis, CEO of Voyageur, 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. This brings us significantly closer to a fully integrated, secure, and cost-effective North American supply chain for barium contrast media." By developing this domestic resource, Voyageur is building a fully integrated supply chain, from quarry to finished contrast media, reducing reliance on imported or synthetic materials while improving cost efficiency. Currently, most pharmaceutical barium sulfate is synthetically produced, which management believes results in less effective imaging quality. Voyageur's vertically integrated model aims to replace synthetic products with higher quality, lower cost imaging products.
In addition to the clinical progress, Voyageur announced the issuance of 378,651 Deferred Share Units (DSUs) to directors and a consultant under its equity incentive compensation plan. The DSUs, with a deemed value of approximately $0.17573 per DSU, are subject to TSX Venture Exchange approval. The Company also granted 4,300,000 stock options to directors and officers, with 1,075,000 vesting immediately and the remainder vesting over time, exercisable at $0.1125 per share for 10 years. Additionally, 500,000 options were granted to a contractor at $0.18 per share, vesting fully on January 11, 2027. Furthermore, Voyageur intends to issue units to an arm's length third party to settle $100,000 in debt, subject to Exchange approval. Each unit will consist of one common share and one warrant exercisable at $0.15 for five years. These corporate actions align with Voyageur's strategy to advance its pharmaceutical operations and secure necessary funding for its clinical and commercial objectives.
