Investors

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Critical Path

  • 1

    CTA Approval

    APEX has an approved CTA with Health Canada by way of a No Objection Letter (NOL) for a phase 2a randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability and efficacy of psilocybin in Veterans with Post-traumatic stress disorder using drug product APEX-002.

  • 2

    Product Sourcing

    APEX has sourced API from Dealer Licenced (DL) Psygen’s 17,000 square foot Calgary, AB facility under GMP-compliance with the ability to produce large-scale synthesis of psychedelic compounds. Psygen’s DL site is built to Compliance with Level 9 of the Security Directive*, allowing ample storage of controlled substances to secure North American supply.

  • 3

    Launch

    APEX will launch multiple clinical trials with Veterans in Canada and the US. APEX has assembled a clinical team that has successfully conducted both phase 2 and phase 3 clinical trials with psychedelic compounds.

* Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis

Revenue Model

  • 1
  • 2
  • 3
  • 4
  • SAP Micro

    Pricing model exercise for take home micro-dose product with physician oversight.

  • SAP Macro

    In clinic macro-dose with psycho-therapy through Apex Therapy Manual instructions.

  • Pre-DIN

    Pre-DIN (Drug Identification Number) revenue created by insurance coverage for Veterans and retired RCMP Officers.

  • DIN

    Achieve DIN by developing a psilocybin drug product, a botanical extract and/or synthetics through established regulatory processes.

* Drug Enforcement Administration
1

SAP Micro

Pricing model exercise for take home micro-dose product with physician oversight.

2

SAP Macro

In clinic macro-dose with psycho-therapy through Apex Therapy Manual instructions.

3

Pre-DIN

Pre-DIN (Drug Identification Number) revenue created by insurance coverage for Veterans and retired RCMP Officers.

4

DIN

Achieve DIN by developing a psilocybin drug product, a botanical extract and/or synthetics through established regulatory processes.

* Drug Enforcement Administration

Intellectual Property

Genetic Registration & Rights

APEX has filed provisional US patent Application, which relates to extraction methods for tryptamines via Cooley LLP.

APEX intellectual property development plan prioritizes patent protection of development genetics, compositions, formulations and target indications for drug products. We combine these aspects together to bolster and diversify our patent claims, particularly in formulations prepared from extracts of botanical biomass and synthetic forms.

There is an incredible opportunity for developing and securing intellectual property rights in the psilocybin, psilocin and psychedelic space. APEX is working in conjunction with our intellectual property counsel at Cooley LLP, DLA Piper (USA) LLP and R-Group Legal, identifying the assets that can be protected and effectively captured to capitalize on.