Investors

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Critical Path

  • 1

    CTA Approval

    APEX filed a CTA with Health Canada for a 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
  • Exemptions

    APEX has filed and is actively pursuing further subsection 56(1) exemptions for Veteran medical access through TheraPsil.

  • SAP

    Now with broadened SAP regulations, APEX will engage its Veteran patient base for access to APEX-002 product.

  • Sales

    APEX has the ability to sell controlled substances to other Dealer’s Licences and federal Drug Enforcement Administration (DEA) licence holders for profit.

  • DIN

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

* Drug Enforcement Administration
1

Exemptions

APEX has filed and is actively pursuing further subsection 56(1) exemptions for Veteran medical access through TheraPsil.

2

SAP

Now with broadened SAP regulations, APEX will engage its Veteran patient base for access to APEX-002 product.

3

Sales

APEX has the ability to sell controlled substances to other Dealer’s Licences and federal Drug Enforcement Administration (DEA) licence holders for profit.

4

DIN

Achieve Drug Identification Number (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.