Wake Network Receives Approval for Phase 2b Psilocybin Microdosing Trial

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TORONTO, May 12, 2021 /CNW/ - Wake Network Inc. ("Wake" or the "Company"), a global leader in psilocybin and medicinal mushroom production and developer of genomics-based integration therapies, is pleased to announce that the company has received conditional ethics board approval from the Ministry of Health and Wellness (Jamaica) to conduct a Phase 2b psilocybin microdosing clinical trial together with the University of the West Indies. The receipt of this ethics board approval marks the completion of the final step towards receiving conditional approval to begin the study.

Wake Network, Inc.Logo (CNW Group/Wake Network, Inc.)
Wake Network, Inc.Logo (CNW Group/Wake Network, Inc.)

Today's announcement marks a significant industry milestone towards the commencement of the world's first psilocybin microdosing trial to be conducted using a randomized, placebo-controlled, double-blind method with mushroom-based psilocybin. To date, no known studies have documented the effects of psilocybin microdosing in structured clinical trials. In this trial Wake will use naturally-derived psilocybin mushroom material produced in its facility, distinguishing it from all previous trials with psilocybin that have been conducted using synthetic substances only. This trial, as with all other trials in the Wake pipeline, will be registered at the clinicaltrials.gov database and pre-registered at Open Science to improve the quality and transparency of its research.

Wake's mission is to produce pharmaceutical-grade psychedelics for clinical research and clinical access from biological sources. Quality data on psilocybin microdosing is currently non-existent. This study aims to provide the industry and the psychedelic research community with insights into the effects of psilocybin microdosing on anxiety and depression. Greater research will provide regulators with greater data on psilocybin microdosing efficacy to increase the availability of products over time.

"Microdosing psilocybin is increasingly becoming a popular practice worldwide. Wake is committed to exploring the potential effects that microdosing has on anxiety and depression through controlled clinical research. Our goal is to bring these medicines to a larger group of users in a safe and compliant manner," stated Dr Olga Chernoloz, Chief Medical Officer of Wake Network.

ABOUT WAKE NETWORK, INC.

Wake Network Inc. is a fungi bioscience company focused on advancing, through research, the field of psychedelic and fungi-based therapeutics. To address the growing need for psychedelic-assisted mental health support in medicine and society at large, Wake has partnered with academics, governments and best-in-class mycologists around the world. Wake is currently developing fungus-derived psilocybin and medicinal mushroom products and is making advancements in the engineering of novel psychedelic biologics, while working on proving out their safety through proprietary genetics-based integration therapies.

Caution Regarding Forward-Looking Information

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance, are "forward-looking statements." Forward-looking statements can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements.

Forward looking statements are based on certain assumptions regarding the Company, including but not limited to expected growth, results of operations, performance, industry trends and growth opportunities. While the Company considers these assumptions to be reasonable based on currently available information, they may prove to be incorrect. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including but not limited to dependence on obtaining and maintaining regulatory approvals, including federal, provincial, municipal, local or other licences, to operate and expand the Company's facilities; the Company's limited operating history and lack of historical profits; reliance on management; the Company's requirements for additional financing and the effect of capital market conditions and other factors on the availability of capital; competition, including from more established or better financed competitors; the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers; the development and implementation of medical protocols and treatment standard operating procedures for the use of psychedelic therapies; the Company's ability to successfully withstand the economic impact of COVID-19; the medical benefits, safety, efficacy, dosing and social acceptance of psychedelics; and the cultivation and harvest of psilocybe mushrooms; and any other factors or developments that may hinder the market or the Company's growth.

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.

SOURCE Wake Network, Inc.

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