Voyageur releases Frances Creek barite purity results

Executive Summary

• Voyageur Pharmaceuticals confirmed that its Frances Creek barium sulphate Active Pharmaceutical Ingredient (API) meets pharmaceutical-grade purity standards (98.8% average BaSO4) and fully complies with USP monograph requirements, including heavy metal limits and particle size specifications.
• The company is advancing to Stage 2 of the Alberta Innovates AICE market access program, which involves manufacturing batches for an upcoming Health Canada-approved human clinical trial comparing its contrast agents against standard-of-care options.
• The release also details significant corporate actions, including the issuance of stock options and Deferred Share Units (DSUs) to directors/officers, and a proposed issuance of securities to settle $100,000 in debt for financial advisory services.

Key Details

• API Purity & Testing:
  • Independent testing by SGS Laboratories confirmed BaSO4 assay results ranging from 98.1% to 99.4%, with an average of 98.8%.
  • All samples passed the complete suite of USP monograph tests, including identification, pH, loss on drying, limit of soluble barium salts (NMT 0.001%), acid-soluble substances, sulphides, and microbiological requirements.
  • Heavy metal levels were significantly lower than USP specifications.
  • Processed barite achieved one-micrometre and 10-micrometre particle sizes.
• Micronization Results:
  • Processing trials at Sturtevant Inc. demonstrated efficient processing into ultrafine particles.
  • Optimal conditions produced d50 values of 1.1 to 1.9 micrometres and d90 values as low as 2.5 micrometres.
  • All micronized samples met USP particle size/performance criteria, exhibited good flowability, 100% yield, and showed no discolouration or contamination.
  • Processing occurred in a current good manufacturing practice (cGMP) compliant environment.
• Clinical Trial & Regulatory Path:
  • The company is moving to Stage 2 of the Alberta Innovates AICE program to unlock additional non-dilutive funding.
  • Clinical trial will compare Voyageur's contrasts with current commercial standards for gastrointestinal CT and fluoroscopic imaging.
  • Evaluation includes comparison against both barium-based and iodinated oral contrasts.
  • Study completion is targeted for Q4 2026.
  • FDA licensing process is expected to begin in Q1 2026.
  • Prefeasibility and final feasibility study for the Frances Creek project is expected by Q4 2026.
• Stock Option and DSU Grants:
  • Issued 378,651 Deferred Share Units (DSUs) to directors and a consultant.
  • DSU starting value: ~17.573 cents per DSU (based on weighted average share price for quarters ended Sept 30, 2025, and Dec 31, 2025).
  • Granted 4.3 million stock options to directors and officers.
    • 1,075,000 options vest immediately on grant date.
    • Remainder subject to time-based vesting.
    • Exercise price: 11.25 cents per share.
    • Term: 10 years.
  • Granted 500,000 options to a contractor.
    • Exercise price: 18 cents per share.
    • Expiration: 60 months from issuance.
    • Vesting: Fully on Jan 11, 2027.
  • All options/DSUs subject to a four-month hold period.
• Proposed Issuance of Securities for Debt:
  • Intends to issue units to an arm's-length third party to settle $100,000 in debt for financial advisory services.
  • Unit composition: One common share and one common share purchase warrant.
  • Deemed price: 11.25 cents per unit.
  • Warrant terms: Exercisable at 15 cents per share for five years.
  • Hold period: Four months and one day from issuance.

Notable Quotes

• "These results are promising and represent a major derisking 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." — Brent Willis, CEO