The APEX Strategy

APEX is redefining mental health, one dose at a time.

Advance multiple clinical programs evaluating the safety and efficacy of APEX's dual drug assets for PTSD and depression in Canada, US, and Israel.

Commercial Strategy

Psilocybin remains a controlled substance not yet approved for general medical use by Health Canada. However, it has demonstrated significant potential in clinical research for mental health. APEX is advancing two distinct, patent-pending drug assets toward commercial approval, optimized across disease severity:

  • APEX-52 (Microdose): Designed for take-home use targeting moderate depression and PTSD
  • APEX-90 (Macrodose): Intended for in-clinic dosing with assisted psychotherapy, targeting severe cases

Both drug candidates have been used to dose Veteran patients in clinical and early access settings, achieving all endpoints without adverse events.

Regulatory Strategy

Upon completion of Phase 2b trials in Canada and Israel, APEX will initiate Phase 3 trials and pursue full regulatory approval. In parallel, APEX is advancing clinical development and regulatory engagement in the US, Israel, EU and Australia, positioning for global market access.

Patient-Centric Approach

PTSD and trauma-related mental illness continue to grow globally, with Veterans disproportionately affected as documented by multiple international Veteran Affairs agencies.

As a Veteran-founded company, APEX is committed to addressing the unmet mental health needs of both the general population and Veteran communities. Through a trusted network of Veteran-focused clinics and access to thousands of qualified patients, APEX will expedite recruitment and optimize trial outcomes across jurisdictions.