Optimi passes inspection, gains GMP certification

Executive Summary

• Optimi Health Corp. received a favorable Drug Establishment Licence (DEL) inspection from Health Canada with no critical observations, achieving GMP-compliant status for the fabrication and distribution of psychedelic pharmaceutical products and APIs.
• The company entered into a market making service agreement with Independent Trading Group (ITG) to improve share liquidity on the Canadian Securities Exchange (CSE), pending CSE approval.
• The company confirmed that its finished psychedelic drug products (MDMA for PTSD and psilocybin for TRD) are currently being prescribed to patients in Australia under the authorized prescriber scheme.

Key Details

• Regulatory Status: Passed Health Canada DEL inspection with a "good-manufacturing-practice-compliant" rating.
• Authorized Activities under DEL:
  • Fabricate API and pharmaceutical products.
  • Label API and pharmaceutical products.
  • Package API and pharmaceutical products.
  • Distribute pharmaceutical products.
  • Wholesale Prescription Drug List, Schedule G, Narcotics, or cannabis-containing drugs.
• Product Pipeline & Market Access:
  • MDMA capsules for the treatment of posttraumatic stress disorder (PTSD).
  • Psilocybin capsules for the treatment of treatment-resistant depression (TRD).
  • Products are currently prescribed to patients in Australia under the authorized prescriber scheme.
  • Products are accessible in Canada through the special access program.
• Market Making Agreement:
  • Counterparty: Independent Trading Group (ITG).
  • Date: September 30, 2025.
  • Status: Subject to approval by the Canadian Securities Exchange (CSE).
  • Objective: Maintain an orderly market and improve liquidity of Optimi's common shares on the CSE and other trading venues.
  • Compensation: $6,500 per month.
  • Term: Initial one-month term, automatically renewing for successive one-month periods unless terminated with 30 days' notice.
  • Terms: No performance-based factors; ITG receives no shares or options as compensation.
  • Relationship: ITG and Optimi are unrelated and unaffiliated; neither holds any direct or indirect interest in the company's securities at the time of the agreement.

Notable Quotes

• No direct quotes from management were included in the provided text.