Avicanna applauds U.S. reclassification of cannabis

Executive Summary

• Avicanna Inc. publicly supports President Trump’s executive order to reclassify cannabis from Schedule I to Schedule III, highlighting the potential for increased clinical research, innovation, and investment in cannabinoid-based therapies.
• The company provided a comprehensive scientific update for 2025, detailing progress in clinical trials, patent acquisitions, and commercialization efforts across its Rho Phyto and MyMedi.ca platforms.
• Key operational milestones include the commencement of a Phase II randomized controlled trial for arthritic pain and the enrollment of approximately 450 patients in a real-world evidence study with the University Health Network.

Key Details

• Regulatory Stance: Avicanna applauds the reclassification of cannabis to Schedule III, stating it reinforces the commitment to standardized, evidence-based approaches and may facilitate further clinical research and reimbursement opportunities.
• Clinical Development:
  • Real-World Evidence Study: Collaboration with University Health Network (UHN) has enrolled approximately 450 patients to date, evaluating outcomes related to pain, sleep, anxiety, and depression.
  • Phase II Trial: The company commenced its first Phase II randomized controlled trial in December, evaluating arthritic pain using proprietary cannabinoid formulations.
• R&D and Intellectual Property:
  • Achieved the granting of a new USPTO patent.
  • Translated proprietary products and technologies, including PwdRx, from the lab to the commercial stage.
  • Optimized the Rho Phyto medical cannabis portfolio.
• Medical Affairs and Commercialization:
  • Expanded engagement through the Avicenna Academy educational initiatives and the MyMedi.ca medical cannabis care platform.
  • Enhanced patient support programs, clinical guidance resources, and insurance reimbursement initiatives to improve patient access.
• Business Pillars Overview:
  • Rho Phyto: Commercial-stage medical cannabis formulary available nationwide in Canada and expanding internationally, offering oral, sublingual, topical, and transdermal deliveries.
  • MyMedi.ca: Operated by Northern Green Canada Inc., providing bilingual pharmacist-led support, specialty services for veterans, and collaboration with payers for adjudication.
  • Pharmaceutical Pipeline: Proprietary, indication-specific candidates targeting dermatology, chronic pain, and neurological disorders.
  • Active Pharmaceutical Ingredients: Majority-owned subsidiary Santa Marta Golden Hemp SAS (SMGH) supplies high-quality CBD, THC, and CBG for global partners and internal supply chains.

Notable Quotes

• "As a biopharmaceutical company focused on cannabinoid-based medicines, this development represents an important milestone that reinforces our long-standing commitment to standardized, evidence-based approaches to cannabinoid products," stated Aras Azadian, chief executive officer of Avicanna.
• "We are encouraged by the recognition of the growing body of scientific evidence supporting the medical potential of cannabinoids and by the administration's emphasis on advancing research in this field, including real-world evidence. We believe this regulatory direction may facilitate further clinical research, support innovation and encourage investment into the development of rigorously validated cannabinoid-based therapies, with longer-term implications for reimbursement and patient access."