VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets, is pleased to provide an operational update on the progress of its planned year of commercialization.
Initiated in Q1 of 2022, the year of commercialization is a strategic growth initiative designed to scale all aspects of Optimi Health’s revenue generation in relation to market demand for natural psychedelic and functional mushrooms and synthetic psychedelic substances.
Recent disclosure by the Biden administration that FDA approval for psychedelic therapy is anticipated within 24 months, and an August 25thmeeting between Canadian Health Minister Carolyn Bennet and members of the Oregon Psilocybin Advisory Board, shows encouraging signs that the regulatory landscape in psychedelics is poised for rapid advancement.
“With policymakers increasingly aligning around psychedelic therapy and a robust commercial sector developing to meet the challenge of delivering better health outcomes with these substances, Optimi is building a global distribution pipeline and is positioned to be the leader in psychedelic drug supply,” said Optimi Health CEO Bill Ciprick.
“With hundreds of active clinical trials, we are keeping a keen eye on jurisdictions that are loosening supply regulations and are in active discussions with Health Canada on how to further supply Canadians with homegrown medicine,” Ciprick added.
Since the May 2022 inauguration of its Princeton, B.C. cultivation and processing facility, Optimi Health has secured five domestic psilocybin supply agreements with Halucenex Life Sciences, Filament Health, ATMA Journey Centers, SABI Mind, and Bloom Psychedelic Therapy and Research Centre.
Additionally, the Company has signed retail and e-commerce distribution agreements for its Optimi Life line of functional mushroom formulations and supplements with Well.ca, Healthy Planet, and Vitasave.
In preparation to meet the diverse needs of the psychedelic sector, Optimi received an amendment to its Health Canada Controlled Substances Dealers Licence, allowing it to manufacture synthetic psychedelics, with the Company’s specific commercial focus to be on MDMA. Large scale production of MDMA is scheduled to begin in October 2022 under the supervision of Chief Science Officer Justin Kirkland, with domestic and international supply agreements with validated clinical researchers anticipated for later this year and into 2023 shortly thereafter.
By October 2022, Optimi will be the only publicly listed company in the psychedelics sector growing natural psilocybin and producing MDMA for clinical research and patient trials in-house, an accomplishment Ciprick says the Company has worked hard to achieve and is an example of how the company has delivered on top of their prospectus.
“The existing MDMA deal structures we have observed to date give us every confidence that there is plenty of room for Optimi to occupy a significant piece of the clinical research market,” said Ciprick. “Our fully integrated, on-site production and analytical facilities will be able to improve upon the logistical efficiency of current offerings, in which clinicians and drug developers have difficulty obtaining consistent products synthesized, tested, and brought to market in-house by a single supplier. As such, we look forward to being the first company to supply an all-Canadian made MDMA product to a Canadian MDMA trial.”
Finally, the Company is pleased to share that it is currently preparing to harvest what it believes will be the largest crop of EU-GMP psilocybin cultivated in North America to date, to be used in the fulfillment of the aforementioned domestic and international supply agreements, approved SAP applications, and upcoming clinical trials.
Optimi Health products are not available to the public and are still being investigated through a clinically validated development program for the purpose of applying for market authorization. The safety and efficacy of our products has not been formally established.
