Apex Labs Granted Approval for 160 Patient Macrodose Multi-Dose Psilocybin Clinical Trial by Health Canada

SUMMIT-90 statistically powered phase 2b study to evaluate APEX-90 macrodose synthetic psilocybin in-clinic with assisted psychotherapy

VANCOUVER, BC, April 20, 2023 /CNW/ - Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with clinically proven psilocybin treatments, is pleased to announce approval of SUMMIT-90. SUMMIT-90 is a landmark double-blind, placebo controlled phase 2b study evaluating multiple doses of APEX-90 administered in-clinic with assisted psychotherapy for the treatment of severe depression within diagnosed PTSD. The 160 patient trial approval comes by way of a no objection letter received from Health Canada on April 14th, 2023 and the company aims to begin recruitment Q2 of 2023.

"This approval validates the urgent need for expanded healthcare options and ultimately gives physicians another tool to support patients struggling with depression and PTSD," says Tyler Powell, APEX Co-Founder and CEO. "We already have first movers advantage in take home microdose psilocybin treatment and SUMMIT-90 expands the APEX drug portfolio to address the current inadequate standard of mental health care."

SUMMIT-90's primary indication being studied is severe depression within diagnosed PTSD and secondary indications include standalone PTSD symptoms, chronic pain, and anxiety. APEX-90 will be administered multiple times during the study period in-clinic alongside assisted psychotherapy guided by the APEX proprietary therapy manual.

Currently it is estimated that over 8 million Canadians suffer from depression and 3.1 million navigate PTSD. Despite being the primary treatment for these conditions, studies estimate antidepressants only improved symptoms in around 20% of people, marking an important need for expanded therapeutic options.

"The APEX-90 dosing schedule was optimized for sustained efficacy based on gaps in the current market, focused on patients with the highest disease severity," says Dr. Peter Tomlinson, Chief Medical Officer at APEX. "With two unique drug assets in the pipeline, APEX is able to address critical unmet need across mild, moderate and severe disease states."

APEX has a microdose take home synthetic psilocybin drug asset, APEX-52 optimized for mild-to-moderate depression. The company recently completed a proof-of-concept trial meeting all clinical endpoints with no adverse events, and subsequently received approval for a 294 patient statistically powered phase 2b study, PATHFINDER-52, the largest of its kind in the world.

SUMMIT-90 and PATHFINDER-52 will be conducted through Centricity Research across five sites in Canada. APEX began patient pre-screening and recruitment in Q2 of 2023. Those interested in participating in clinical trials can sign up for updates at apexlabs.com/contact.

About Apex Labs Ltd.

APEX is a patient-driven pharmaceutical company focused on revolutionizing the standard of mental health care for patients with clinically proven psilocybin treatments. By bringing data supported, clinically evaluated drugs to market for depression and anxiety in PTSD, APEX's strategy is focused on developing pharmaceutical products through phased clinical programs evaluating safety and efficacy across multiple indications, alongside a robust early access program.

APEX sees Veterans as a patient base with the severest unmet need and strong mental healthcare infrastructure. APEX is supporting Veteran patients first and expanding to broader global patient communities.

Visit apexlabs.com for more information and follow APEX on LinkedIn, Twitter and Instagram

Forward-Looking Statement

This release contains certain "forward looking statements" and certain "forward-looking information" as defined under applicable Canadian securities laws. Forward-looking statements and information can generally be identified by the use of forward-looking terminology such as "may", "will", "expect", "intend", "estimate", "anticipate", "believe", "continue", "plans" or similar terminology. Forward-looking statements and information are based on forecasts of future results, estimates of amounts not yet determinable and assumptions that, while believed by management to be reasonable, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out here in, including but not limited to: Health Canada's non-objection letter; the Company administering the first take home multi-dose psilocybin clinical trial in Canada; the Company evaluating the safety and efficacy of APEX-52 (psilocybin) and APEX-90 in treating depression in Veterans with depression in post-traumatic stress disorder; statements related to APEX-52 and APEX-90, including manufacturing, dosing, and trial details; statement's made by the Company's CEO with respect to the Company's efforts as a first mover in synthetic psilocybin, addressing an inadequate current standard of care,; statements from the Company's CMO relating to the dosing of APEX-90 and gaps in the current market; statement's made relating to Canadian Veteran patient's taking APEX-52 in the comfort of their own home; the potential impact of epidemics, pandemics or other public health crises, including the current outbreak of the novel coronavirus known as COVID-19 on the Company's business, operations and financial condition, the successful integration of technology, the inherent risks involved in the general securities markets; uncertainties relating to the availability and costs of financing needed in the future; the inherent uncertainty of cost estimates and the potential for unexpected costs and expenses, currency fluctuations; regulatory restrictions, liability, competition, loss of key employees and other related risks and uncertainties. The Company undertakes no obligation to update forward-looking information except as required by applicable law. Such forward-looking information represents managements' best judgment based on information currently available. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place undue reliance on forward-looking statements or information.

SOURCE Apex Labs Ltd.

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