The Golden Age of Psychedelic Medicine

Apex Labs is the most differentiated drug development company in psychedelics, unleashing the power of psilocybin in treating mental health with two drug assets in human clinical trials and a path to early revenue.

Let’s change the world together.

Download your investor package now for more information on our pre-IPO round.

APEX is is a patient-driven pharmaceutical company that develops and commercializes clinically-evaluated psilocybin-derived treatments to tackle the most critical unmet need in depression and PTSD among Veterans and the general public.

APEX is the first-mover in take-home microdose psilocybin treatments and has a macrodose drug asset as well, blazing the trail for stand-alone use, combination and maintenance therapy. Both assets are optimized across mild, moderate and severe disease states. The company has completed a human clinical trial, has two trials actively recruiting for a total of over 450 patients, and their robust Early Access Program is running in parallel to support Veterans and collect real world data.

“From Day 1, our mission has been focused on first serving the Veteran community that is suffering at an alarming rate. We know that treating them successfully represents the first step in far broader access for tens of millions of potential patients for our therapies. Our team mission has informed our “we are in this together” ethos which has led to hitting one key benchmark after another – and at a fraction of standard industry cost.”

–Tyler Powell, APEX Co-Founder & CEO.

From its inception, APEX has had strong financial support from a premier group of investment banks, broker dealers, and leading VC investors including:

And it is now pursuing a Reg D raise of $15 million to complete multiple phase 2 clinical trials and then, subsequently, funding its big board US IPO in Q1/Q2 2024.

This broad social challenge is exacerbated by the fact that currently dispensed pharmaceutical antidepressants are the standard of care, but the side effects can be brutal and studies estimate these drugs improve symptoms in around half of patients, a coin toss at best.

“The drug effect of antidepressants is not clinically significant. If they are to be used at all, it should be as a last resort.”
–Dr. Irving Kirsch, Associate Director, Placebo Studies at the Harvard Medical School

In addition, current anti-depressants often lead to addiction and related health and lifestyle decline. This level of suffering is tragic, not necessary and is screaming to be addressed.

Recent clinical psilocybin studies have shown positive benefits.

HOW APEX IS LEADING THE INDUSTRY

Most psychedelic companies only pursue large doses of drug that have to be taken in a clinic with a healthcare professional present, costing a fortune and preventing broad access. APEX is disrupting the industry by developing a microdose treatment that can be taken in the comfort of your home just like traditional home medications – the first of its kind in a phase 2b clinical trial.

This is a game-changer for treatment, a game-changer for the industry and most importantly, a game changer for the millions who are currently suffering.

Because of this innovation and APEX’s substantial market differentiation the financial and medical communities are paying close attention to the company’s rise:

Psychedelics are at the forefront of mental health research globally. APEX drug assets are in advanced clinical testing stages, and our first mover advantage with take -home microdose psilocybin and unmatched network of Veteran patients and clinics has set APEX years ahead of competitors.

Depression and PTSD plague all age groups, all ethnicities and all economic classes.

PTSD prevalence in North America alone is estimated to be 21.8 million. Depression prevalence at a staggering 39.2 million individuals.

Globally, we are looking at bringing patient relief for depression (322 million people) and PTSD (280 million people) with a drug asset that has been shown in studies to be non-addictive with minimal side effects.

Given the breadth of this suffering, it comes at no surprise then that the global mental health market is estimated to exceed $380 billion dollars.

Even though antidepressants have harsh side effects and are only estimated to improve symptoms in around 50% of patients, medical professionals and patients don’t have better options. Spending for antidepressants has been rising YOY:

APEX will seek conditional approval in Canada following phase 2b trials, opening the door to prescribed federal access for 3mm+ Canadian patients as phase 3 trials continue to open up the global market.

We can get quickly to market due to our Early Access Program pre-approval drug sales via Special Access Program with unmatched access to Veteran patients with pathway to seek insurance coverage. There are over 460,000+ Canadian military Veterans alone. (460 ref – https://www12.statcan.gc.ca/census-recensement/2021/ref/98-20-0002/982000022021001-eng.cfm)

Our Early Access Program is projected to produce sales growing from $9M in 2024 to $125M in 2028, representing a CAGR of 163%.

With Conditional Drug Approval, those estimates rise to $255 by 2028, representing a CAGR of 1860%

Traditional Drug Approval is projected to grow to $133M by 2028, representing a CAGR of 167%

As a pioneer in psilocybin treatment for depression, anxiety and PTSD Apex Labs has been covered 40+ times pre-launch due to our extensive and strategically-cultivated relationships with key. Journalists. APEX press releases have been picked up over 1,000 times with a potential reach in the high hundreds of millions.

In short, Apex is making news! And for very good reasons. For example:

1. https://bc.ctvnews.ca/first-of-its-kind-psilocybin-trial-approved-in-vancouver-1.6134639
2. https://www.benzinga.com/markets/cannabis/22/11/29552007/first-take-home-psychedelics-clinical-trial-in-north-america-will-target-ptsd
3. https://globalnews.ca/video/9249346/health-matters-evaluating-the-safety-and-efficacy-of-take-home-psilocybin/
4. https://mugglehead.com/apex-gets-health-canada-approval-for-Veterans-take-home-psilocybin-drug-trial/?utm_source=rss&utm_medium=rss&utm_campaign=apex-gets-health-canada-approval-for-Veterans-take-home-psilocybin-drug-trial
5. https://invesbrain.com/tdrs-top-5-psychedelic-developments-for-the-week-of-october-31/
6. https://www.bcbusiness.ca/Apex-Labs-is-using-a-take-home-psilocybin-based-drug-to-treat-PTSD-and-depression-in-Veterans
7. https://hightimes.com/news/non-profit-organization-marches-on-canadian-capital-to-fight-for-therapeutic-mushrooms/
8. https://www.benzinga.com/markets/cannabis/23/02/30677938/canadian-psychedelics-company-launches-take-home-psilocybin-trial-for-some-300-participants
9. https://www.msn.com/en-us/money/other/canadian-psychedelics-company-launches-take-home-psilocybin-trial-for-some-300-participants/ar-AA170Av8
10. https://www.nxtpsychedelics.com/?p=35504 – Apex Labs Pioneers Take-Home Psychedelic Treatment
11. https://www.benzinga.com/markets/cannabis/23/04/31642724/psyched-canadas-case-for-psilocybin-access-and-microdose-trial-us-reform-update-battle-with-dea-
12. https://www.benzinga.com/markets/cannabis/23/04/31906086/exclusive-canada-takes-center-stage-with-large-scale-psilocybin-macrodose-trial
13. https://www.nxtpsychedelics.com/news/articles/psychedelics/news-you-might-have-missed-april-24th-2023/
14. https://www.nxtlifescience.com/life-sciences/news-you-might-have-missed-april-24th-2023/
15. https://markets.businessinsider.com/news/etf/psyched-lsd-for-major-depression-canada-s-psilocybin-macrodose-trial-treatments-for-multiple-sclerosis-and-more-1032255420
16. https://www.benzinga.com/pressreleases/23/07/n33367906/apex-labs-cbd-launches-pico-iv-the-worlds-first-sterile-cbd-iv-solution
17. https://www.msn.com/en-us/health/other/psilocybin-api-import-from-us-to-canada-approved-here-s-what-you-need-to-know/ar-AA1csiMP

APEX labs was born in the face of a glaring need: PTSD and depression have been destroying the lives of millions of people across demographics, and especially plaguing military Veterans costing lives and placing a huge financial burden on healthcare systems. In order to address this unmet need, our founders from clinical, research, and Veteran communities came together to move change forward with a treatment option that has strong potential benefits with minimal side effects.

Each of our four co-Founders, bringing a unique specialty:

• Tyler Powell, Chief Executive Officer is a longtime financial leader who handles all financings and anything numbers-related while quarterbacking the team
• Dr. Orion Lekos, Chief Science Officer – is an expert biologist who oversees drug development
• Dr. Peter Tomlinson, Chief Technical Officer – Peter drives the clinical program bringing extensive international trial experience
• Arron Victory, Chief Strategy Officer – and Canadian Armed Forces Veteran leads Apex’s Early Access Program and all elements relating to Veterans and patient engagement.

Riding the clinical successes and deregulation of other efficacious psychedelic treatments, especially medical cannabis and ketamine and now increasingly psilocybin, our roadmap has been clear from the start: to develop and commercialize pharmaceutical assets that address significant unmet need through a clinical trial pipeline and robust Early Access Program.

On March 21, 2022, Apex Labs participated in the first known case of psilocybin being accessed through Canada’s Special Access Program, the first legal medical access to psilocybin outside of clinical trial in Canadian History .

Now in Q4, APEX is proceeding with a 294 patient clinical trial for APEX-52 and 160 patient clinical trial for APEX-90 – both of its lead drug assets in phase 2b studies. Once completed with demonstrated outcomes, we will accelerate revenue by challenging regulatory agencies for pre-phase 3 conditional approval expanding toward commercial approval in Canada, US, Europe and Australia.

Additionally, by prioritizing Veteran patient communities via our network of thousands of Veteran patients, 13 Veteran-focused clinics and psilocybin-trained therapists, APEX will accelerate public awareness, proof of concept, public acceptance and revenue.

In H2 2024, with positive phase 2b data, APEX will file New Drug Submissions (NDS) for conditional approval with health Canada, initiating 8 years of data exclusivity once approved, and inform multiple pivotal phase 3 commercialization study designs on the path toward commercial approval in US, Canada, Europe and Australia.

This current round of financing allows APEX to launch all clinical trials, dose patients through the SAP and then file our IPO registration for an early 2024 listing.

APEX is a build to acquire model. Once APEX is public and clinical trial readouts are positive, we will be in a highly advantageous position to sell the company.

Dr. Emmanouil Rampakakis – Clinical Trial Protocols Specialist
Dr. Kevin Lutz Psychiatrist -Specializing in Veterans and PTSD
Dr. Bal Kang – Synthetic Chemist and Drug Design
Dr. Franklin King – Psychiatrist and Experienced Psychedelic Clinical Investigator
Dana Nohynek – Clinical Development and Regulatory Affairs
Raashid Naik – Pharmacist and Senior Director at Shoppers Drug Mart
Alysa Langburt – Clinical Program Manager

Dr. David Wood – Intellectual Property and Regulatory Attorney
Bob Cross – Capital Markets and Corporate Structure
Martin Cronin – Veteran Advocate
Victoria Dekker – Public Relations
Max Monahan-Ellison – Corporate Affairs
Dennis LeBlanc – Veteran Advocacy

First 500 investors will become part of The APEX Inner Circle – including monthly online gatherings, exclusive AMA with the doctors, C-suite and Veterans experiencing success stories. Contribute your ideas, wisdom and support and be part of this needed revolution.