R&D Program Developing 100% Optimi-Owned Psychedelic Capsule for Human Clinical Trial Dosing Study
VANCOUVER, BC (GLOBE NEWSWIRE – May 4, 2021) — Optimi Health Corp. (CSE: OPTI) (OTC: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated functional mushroom brand focused on the health and wellness sector, is pleased to announce that its previously announced lab services agreement with Numinus Wellness Inc. (“Numinus”) (TSXV: NUMI) is progressing forward with an initial candidate for clinical trials, subject to Health Canada approvals.
Recognized as a global leader in supporting and expanding the safe, accessible, and evidence-based use of psychedelic-assisted psychotherapies (PAP), Numinus is aiding Optimi’s mission to further the research and development of all-natural, Canadian-grown psilocybin-producing mushrooms and related product formulations.
Optimi Chairman of the Board JJ Wilson notes, “Today’s news is another step forward as we prepare for our first all-natural proprietary psychedelic mushroom formulation for human trial. We recently noted several advancements at our substantial facilities in Princeton, BC which are ultimately designed to meet or exceed GMP standards for production. This commitment to cultivation, production and processing excellence is reflected by our dedication to “all-natural” formulations. This approach, combined with early-stage research aimed at quickly moving into human trials is all part of a multi-faceted strategic plan aimed at ensuring we have advanced stage product formulations in readiness for timely regulatory review and approval. Optimi’s strategy to generate revenue and sell functional mushroom products is all about laying the groundwork to develop world-class processes to support and build our all-natural mushroom brand. The heavy lifting we are doing today with Numinus will scale into multiple development projects and revenue streams aimed at an array of future commercial opportunities focused on treating a variety of human health conditions naturally and safely.”
As part of the research and development agreement with Numinus, Optimi gained near immediate access to services encompassing laboratories, equipment, and expert talent specifically related to Psilocybe mushrooms, psychedelic compounds, and formulations within Numinus’ licensed facilities. The pre-submission for Optimi’s first candidate whole psilocybe mushroom extract will be fully documented in readiness for applicable Health Canada review in preparation for entry into the proposed clinical trial with IMPACT at the University of Calgary. Optimi believes several additional candidates may be forthcoming and could join the initial candidate profile, thereby jumpstarting the research clinicians’ efforts through access to multiple options for study. All resulting intellectual property (IP) will be 100% owned by Optimi.
Optimi’s CEO, Mike Stier concludes, “The relationship with Numinus has rapidly delivered right out of the gate with what we trust will be a very significant collection of all-natural formulations for study. Attention to detail and rigorous documentation are critical at this stage as we must be prepared to validate the work to the clinical trial team. Accelerated advancement is critical for us to capture sector leadership in order to create tangible returns to our shareholders. This is very important to us. So, I’m truly pleased by today’s news and thank everyone involved for the collaborative approach and eagerness to move forward. The path ahead is getting clearer every day.”
President, Chief Executive Officer and Director
ABOUT OPTIMI (CSE: OPTI) (OTC: OPTHF) (FRA: 8BN)
Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also applied for a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production.
Find out more at: https://www.optimihealth.ca/.
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This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to the dealer’s license application, activities proposed to be conducted under the Company’s research exemption and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Final Prospectus dated February 12, 2021. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement. Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
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