Drug Development – 3 Phase Approach

1

Research & Development

Dr. Orion Lekos oversees Research and Development (R&D) alongside Dr. Bal Kang to lead exploration of Intellectual Property (IP) formulations for APEX’s synthetic psilocybin-derived drug product APEX-52 used in upcoming clinical trials and medical access.

2

Clinical Trial Planning

Dr. Peter Tomlinson, Dr. Emmanouil Rampakakis, Greg Rutherford and Dana Nohynek will oversee regulatory efforts and manage the Clinical Trial Application (CTA) and Investigational New Drug Application (IND) for all clinical trials.

3

Clinical Trial Execution

Dr. Enrique Carazzana and Dr. Peter Tomlinson combined clinical and GMP expertise will allow APEX to develop, protect and commercialize drug products manufactured under GMP standards for Canadian, US and International markets.

Patient Recruitment & Access Channels

APEX is working with Key Opinion Leaders (KOL) in Canadian and US markets to further identify how Veterans can benefit from medical access and psychedelic-supported psychotherapy based on clinical evidence.

Veterans

APEX’s Veteran-focused research team will be studying depression in PTSD, traumatic brain injury and chronic pain in Canadian and American Veteran communities. We have exclusive access to a network of thousands of Veteran patients and strong relationships with Veteran-focused practitioners sufficient to support clinical trial enrollment and our early access program.

SAP

Currently the primary mechanism through which Health Canada allows psilocybin access to patients is the recently revised Special Access Program (SAP). APEX believes that the SAP will support our staged clinical trial program with additional, real-world evidence, and can give an expedited path to medical access and revenue in specific cases.

Special Access Program

On March 21st, 2022, Dr. Valorie Masuda MD received authorization under the Special Access Program (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 pharmaceutical-grade GMP psilocybin outside of a clinical trial in Canadian history.