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, and
Numinus Wellness Inc. ("Numinus") (TSXV: NUMI), a mental health
care company advancing innovative treatments and safe,
evidence-based psychedelic-assisted therapies, have met another
early milestone in the development of an initial all natural
psilocybin extract.
Optimi and Numinus, through Impact Clinical
Trials Accelerator at the University of Calgary (“Impact”), have
submitted a pre-clinical trial application to Health Canada for
review and comment. Meanwhile, cultivation, research, formulation,
and continuous validation studies to produce the investigational
psilocybin extract for trial continue at the Health Canada-licensed
Numinus lab in British Columbia, Canada.
Key information submitted in the information
package provided to Health Canada includes the investigational
product’s chemical constituents, genotype, and formulation as well
as procedures and processes to produce a consistent dosage from
Psilocybe mushrooms.
With Health Canada’s feedback and anticipated
regulatory approvals, Numinus plans to use the candidate mushroom
clone to develop a uniform all-natural psilocybin capsule for use
in Optimi’s human clinical trials, initially for a dosing study and
then expanding into trials for a variety of human health
conditions.
Optimi will retain 100% ownership of the
resulting all-natural psilocybin capsule and full intellectual
property rights to its use.
Optimi Chairman of the Board JJ Wilson comments,
“This is another important step for our commitment to the
development of naturally sourced, evidence-based product
formulations. As a cornerstone of our brand positioning, we believe
that future consumer demand will be based on efficacy, cost, and
source integrity. By using natural products, we seek to unlock the
full value potential in this sector. With the work we are embarking
on today with the teams at Numinus and Impact, we are aiming for
what we hope will become blockbuster candidates able to
significantly transform the mental health therapeutic landscape,
while remaining true to historic principles and natural organic
origins.”
“Numinus is pleased to partner with Optimi on
this important work and provide the expertise, licensed facility
and specialized equipment required to quickly develop, formulate
and rigorously test products derived from natural Psilocybe sources
and prepare them for Health Canada submissions and approvals,” said
Sharan Sidhu, Science Officer and General Manager, Numinus
Bioscience. “We look forward to continuing our work with Optimi to
develop safe, standardized and reproducible products that provide
meaningful and accurate clinical trial data.”
Numinus Bioscience recently received amendments
to its federal license to allow the possession, production,
assembly, sale, export, and delivery for a wide variety of
psychedelics including – for the first time – Ketamine and Lysergic
acid diethylamide (LSD). The amendment also supports Numinus
Bioscience’s role in activities related to Mescaline, N,
N-Dimethyltryptamine (DMT), N-Methyl 3,4, methylenedioxyamphetamine
(MDMA), Psilocin and Psilocybin.
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://optimihealth.ca/.
ABOUT NUMINUS WELLNESSNuminus
Wellness (TSX-V; NUMI) empowers people to heal and be well through
the development and delivery of innovative mental health care and
access to safe, evidence-based psychedelic-assisted therapies. The
Numinus Wellness model - including psychedelic production, research
and clinic care - is at the forefront of a transformation aimed at
healing rather than managing symptoms for depression, anxiety,
trauma, pain and substance abuse. At Numinus, we are leading the
integration of psychedelic-assisted therapies into mainstream
clinical practice and building the foundation for a healthier
society. Learn more at numinus.ca, and follow us on Facebook,
Twitter, and Instagram.
FOR FURTHER INFORMATION CONTACT:
Investor RelationsEmail: investors@optimihealth.ca Phone: +1
(778) 930-1321Web: https://optimihealth.ca/
FORWARD‐LOOKING STATEMENTSThis 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.
The CSE does not accept responsibility for the
adequacy or accuracy of this release.
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