Demo

Market Opportunity

  • 322 Million

    People globally deal with depression

  • 280 million

    People globally suffer from PTSD

  • $19.5 Billion USD

    Forecasted size of the anxiety disorder and depression treatment markets by 2028

The APEX Strategy

Develop and commercialize pharmaceutical assets that address significant unmet need across many established patient segments through phased clinical trial pipelines and a robust early access program (EAP).

Commercial strategy

APEX is currently evaluating two unique drug assets seeking Health Canada Approval that will be optimized for all relevant disease states:

  • Microdose drug candidate (APEX-52) optimized for take-home dosing targeting mild to moderate disease severity
  • Macrodose drug candidate (APEX-90) positioned for in-clinic dosing with assisted psychotherapy targeting more severe disease

Regulatory Strategy

Following Canadian phase 2b study completion with demonstrated outcomes, APEX will pursue a regulatory pathway towards commercial approval in the US, Europe and Australia.

Patient Focus

As a Veteran-founded organization, APEX will prioritize Veteran patient communities that represent very high unmet need in clinical trial recruitment and the EAP. APEX will leverage access to a network of thousands of Veteran patients and strong relationships with Veteran-focused practitioners to expedite recruitment to the most qualified patient candidates.

Clinical Pathway

1 Q1 2023

Phase 2b “STEP-52” study completed. Working collaboratively with Health Canada APEX completed patient dosing in a proof-of-concept take home microdose risk mitigation study using APEX-52 drug product, the first of its kind. The trial completed March 29th 2023 and met all endpoints over a two month period with no adverse events.

2 Q1 2023

World’s largest take home microdose psilocybin clinical trial “PATHFINDER-52” approved by Health Canada January 3rd 2023. 294-patient phase 2b study designed as a randomized double-blind placebo-controlled trial evaluating safety, efficacy and tolerability of APEX-52 in treating depression and anxiety within diagnosed PTSD. Recruitment and trial launch Q4 2023.

3 Q2 2023

“SUMMIT-90” statistically powered 160 patient phase 2b clinical trial approved by Health Canada April 14th 2023 using APEX-90 macrodose drug product in-clinic with assisted psychotherapy. Pre-screening in progress and trial launch Q4 2023.

4 Commercialization

Following Canadian phase 2b study completion with demonstrated outcomes, APEX will challenge regulatory agencies for pre-phase 3 conditional approval expanding towards commercial approval in Canada, US, Europe and Australia.

Drug Asset Optimization

There is not one size-fits all when it comes to psilocybin therapies. Some patients are best suited to in-clinic macro-dose treatments with assisted psychotherapy, while others are best suited for take-home microdose psilocybin treatment options.

APEX’s two unique drug assets have the potential to be optimized for severity across indications, supporting unmet need in many patient cohorts.

APEX-52 microdose take home treatment

Potential to be optimized for mild to moderate disease severity.

STEP-52 Risk mitigation study completed: First patient with PTSD dosed with APEX-52 in take home microdose phase 2b stability study in January 2023. The trial completed March 29th 2023 and met all endpoints over a two month period with no adverse events.
World largest take home psilocybin clinical trial (PATHFINDER-52) approved by Health Canada January 2023. Phase 2b double-blind, placebo controlled clinical study to evaluate safety, efficacy and tolerability, recruiting 294 patients and beginning Q4 2023.
APEX-90 macrodose drug for in-clinic dosing with assisted psychotherapy

Potential to be optimized for severe disease.

SUMMIT-90 statistically powered 160 patient macrodose phase 2b clinical trial using APEX-90 drug product approved by Health Canada April 14th 2023. Pre-screening underway and recruitment to begin Q4 2023.
Robust Early Access Program to provide treatment to patients with highest immediate unmet need

Patient Recruitment

The best way to optimize clinical trial costs, speed and outcomes is to expedite recruitment to the most qualified patient candidates.

A Veteran-First Approach

As a Veteran-founded organization and in alignment with our mission to address the highest areas of unmet need, APEX’s research team will be initially focused on Veteran communities in trial recruitment who have the most severe mental health disease burden. APEX has access to a network of thousands of Canadian Armed Forces and RCMP Veteran patients and strong relationships with Veteran-focused practitioners sufficient to support swift clinical trial enrollment and our Early Access Program.

APEX aims to secure clinical indications for the general population, including Veterans.

Early Access Program

The strategy behind early access is to provide the most vulnerable patients in need access to a medication prior to full commercial approval.

Currently the primary mechanism through which Health Canada allows psilocybin access to patients is the Special Access Program (SAP) which now includes psilocybin and MDMA.

In addition to the clinical development program, APEX Labs is pursuing an Early Access Program for Canadian Armed Forces and RCMP Veterans leveraging Canada’s SAP program for the APEX-90 macrodose drug candidate.

The APEX Labs EAP will achieve two primary objectives:

Broader access to emerging therapeutic treatments where the current standard of care has failed
The generation of pre-DIN revenue while facilitating the collection of real-world evidence to further support our clinical program under strict physician oversight

SAP Experience

On March 21st, 2022, Dr. Valorie Masuda MD received authorization under the SAP to treat six patients experiencing end-of-life distress with psilocybin and psychotherapy. GMP synthetic psilocybin was donated by Psygen Labs Inc., and Apex Labs Ltd. provided access to its psilocybin investigators’ brochure, in support of the SAP application. This is the first known case of psilocybin being accessed through Canada’s SAP since the Food and Drug Regulations were amended on January 5th, 2022, to allow access to psilocybin and other restricted drugs through the SAP. The six patients were treated in early April of 2022 by Roots to Thrive, co-led by Dr. Masuda.

This is the first legal medical access to psilocybin outside of a clinical trial in Canadian history.

Why APEX?

1 First Mover in Take Home Psilocybin

APEX is the first to launch and dose a take home microdose psilocybin clinical trial, with the largest of its kind approved and beginning recruitment Q4 2023.

2 8-Year Data Exclusivity

Following first commercial approval, APEX drug assets have data protection for 8 years in Canada.

3 Optimized Dosing Options and Clinical Pipeline

Two drug assets in the pipeline have the potential to be optimized for severity across indications.

4 Unmatched Team

Decades of healthcare, clinical and pharmaceutical experience, executing 190 clinical trials, bringing 20 drugs to market in 70 countries with representation from the Veteran community in the C-suite and past corporate experience with Johnson & Johnson, Roche, GSK, Lilly, McKesson, Tilay, Sharp, and Canaccord.

Directors and Officers

Apex Labs Ltd. Photograph

Tyler Powell

Chief Executive Officer & Director

Tyler Powell is an experienced entrepreneur with over 15 years of experience in the financial services sector. As a leader, Tyler identifies areas with substantial unmet need and builds collaborative teams with diverse experience that believe in the mission.

Tyler has deep expertise in venture capital, initial public offerings, secondary financings, mergers and acquisitions, public vehicles, and operations as well as in media and investor relations. While running a financial services consulting company for a decade, Tyler supported promising companies with infusions of capital, management and restructuring to maximize the value of their core business.

Connect with Tyler on LinkedIn here.

Apex Labs Ltd. Photograph

Arron Victory

Chief Strategy Officer & Director

Arron Victory is a purpose-built entrepreneur, corporate strategy leader, Canadian Armed Forces Veteran and advocate with robust experience in health care, emerging therapeutics, and community engagement.

Arron is also an Ambassador for Veteran advocacy group, Wounded Warriors Canada, Board Member of the Heroic Hearts Project, a charity providing access to psychedelic therapies for Veterans, and an Advisory Board Member for the Chronic Pain Centre of Excellence, a research centre improving the understanding of Veteran-specific chronic pain and how best to manage it.

Connect with Arron on LinkedIn here.

Apex Labs Ltd. Photograph

Orion Lekos

Chief Science Officer & Director

Dr. Lekos is an industry-leading green entrepreneur and engineer, specializing in the extraction of valuable phytochemicals from plants, renewable energy, water, biomass derived chemicals, and micro-organisms.

With a PhD in Bioengineering and a master’s degree in environmental chemistry, Dr. Lekos has led global clinical trials while being instrumental in the development & design of the extractions and formulations for a top three global cannabis company. He also served as the Chief Science Officer of a biotechnology company developing poppy genetics to produce non-addictive opiate alkaloids.

Dr. Lekos also has robust experience in Technology Commercialization, Environmental Management, Life Cycle Analysis, Industrial Plant Design, Plant Commissioning, Green Chemical Design, and Good Manufacturing Practices.

Connect with Dr. Lekos on LinkedIn here.

Clinical Advisors

Raashid is the Senior Director of Medical Cannabis at Shoppers Drug Mart, Canada’s largest pharmacy chain. He currently heads all aspects of the medical cannabis business unit, previously holding roles in eHealth, Pharmacy Operations and Business Development at the company, helping spearhead a new pharmacy dispensing system that is currently implemented across the enterprise.

Prior to joining Shoppers Drug Mart, Raashid worked in the pharmaceutical industry at Janssen Ortho in Sales Analytics and at Eli Lilly Canada in Government and Economic Affairs. Raashid holds a pharmacy degree from the University of Toronto and is a licensed pharmacist.

Dr. Rampakakis has over 20 years of experience in scientific research, has contributed to the conception, design, analysis and interpretation of more than 100 large scale, national and international, pre-approval and observational studies, and has contributed to 8 market approvals. He is an adjunct member of the department of pediatrics of McGill University and an author on over 100 peer-reviewed publications and over 300 presentations at international conferences.

Dr. Rampakakis received his Ph.D. from the Department of Biochemistry in McGill University and the McGill Cancer Centre, and obtained post-doctoral training in Pharmacoepidemiology at McGill University and the Jewish General Hospital.

Dr. Kevin Lutz is a Registered Psychologist in BC, with more than 20 years of clinical experience in a variety of areas ranging from addictions to general mental health to forensic psychiatry. Since 2014 Dr. Lutz has focused his practice toward individual trauma treatment and the facilitation of educational and treatment group programs for trauma and PTSD clinically. Dr. Lutz has also participated in clinical research as a sub-investigator and therapist examining the effectiveness of psychedelics to support mental health since 2015, and since 2022 as a trainer internationally to therapists from around the world who are interested in delivering psychedelic psychotherapy. Currently much of Dr. Lutz’s work is dedicated to supporting military and first responder populations.

Franklin King MD is a psychiatrist at the Massachusetts General Hospital and an Instructor in Psychiatry at Harvard Medical School. He is a graduate of the University of Massachusetts Medical School, after which he completed residency in adult psychiatry at the MGH/McLean program, followed by a fellowship in Consult Liaison Psychiatry and a research fellowship at the Cardiac Psychiatry Research Center.

Dr. King is currently the Director of Training and Education at the MGH Center for Neuroscience of Psychedelics. He is actively involved in research into psychedelic-assisted therapies, and in addition practices clinically at MGH.