Mr. Dane Stevens reports

OPTIMI HEALTH EXPANDS CLINICAL PROGRAM WITH PHASE 3 TRIAL EVALUATING MDMA-ASSISTED THERAPY FOR POST-TRAUMATIC STRESS DISORDER

Optimi Health Corp. plans to initiate a Health Canada-authorized phase 3 clinical trial evaluating MDMA (3,4-methylenedioxymethamphetamine)-assisted therapy for individuals with posttraumatic stress disorder. The trial is expected to begin in 2027.

The phase 3 clinical trial is intended to enroll up to 100 participants across multiple sites in Canada, with enrolment focused on veterans and current or former front line workers, including military, police, paramedics, firefighters and health care workers. Participants will receive the company's synthetic MDMA HCl, supplied in two dosage formats, during two supervised sessions combining MDMA and psychotherapy, spaced several weeks apart, with follow-up evaluations after the final session. The primary efficacy end point will be change in the clinician-administered PTSD scale (CAPS-5), the standard clinician-rated instrument for assessing PTSD severity.

"On the heels of announcing our phase 2 trial of natural psilocybin for the treatment of major depressive disorder, we are preparing to advance our synthetic MDMA into an approved phase 3 trial in PTSD, with the goal of submitting both products for registration," said Dane Stevens, Optimi's chief executive officer and co-founder. "PTSD and major depressive disorder are large, underserved markets. Millions of patients around the globe continue to struggle despite existing treatments, and veterans and front line workers carry a disproportionate share of that burden. Psychedelic-assisted therapies have shown promise in helping patients find relief."

Posttraumatic stress disorder is a mental health condition that can develop after experiencing or witnessing a terrifying, life-threatening or deeply traumatic event. People with PTSD typically experience severe, persistent distress that significantly disrupts daily functioning. Worldwide, an estimated 70 per cent of people will experience a traumatic event during their lifetime, with an estimated 3.9 per cent of the global population developing the disorder. Many people with PTSD see limited benefit from first line treatments such as trauma-focused psychotherapy and antidepressants, leaving a pressing need for new therapeutics.

The safety and efficacy of MDMA-assisted therapy to treat PTSD are still under investigation, and none of Optimi's MDMA drug products have received market authorization from Health Canada. Clinics in Australia have been prescribing MDMA manufactured by Optimi since October, 2024.

About Optimi Health Corp.

Optimi Health is a commercial-stage pharmaceutical company focused on manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies. As a Health Canada-licensed pharmaceutical manufacturer, Optimi produces validated MDMA and botanical psilocybin drug products at its GMP-compliant facilities in British Columbia, Canada. Optimi supplies both active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally, with products currently prescribed to patients in Australia under the country's authorized prescriber scheme and accessible in Canada through the special access program.

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