Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
(“Optimi”), a Health Canada licensed drug researcher and formulator
specializing in controlled psychedelic substances such as natural
psilocybin and MDMA, proudly announces a significant milestone in
the granting of its Precursor Licence for
3,4-Methylenedioxyphenyl-2-propanone (“MDP2P”), the precursor used
in the chemical synthesis of MDMA.
Approved in December 2023 by Health Canada under
Section 16 of the Precursor Control Regulations, the licence allows
Optimi to import MDP2P for the purpose of formulating and verifying
MDMA drug candidates at the Company’s research and analytical
facility in Princeton, BC.
This achievement comes in the wake of a recent
facility visit from Health Canada, serving as additional evidence
of Optimi's firm commitment to regulatory compliance and
operational excellence.
"Securing our precursor licence represents a
pivotal advantage for Optimi, offering a compelling edge in
producing MDMA at significantly reduced costs," said Optimi Chief
Financial Officer Jacob Safarik. “This strategic move aligns with
our intent to address market demand for GMP MDMA in 2024,
especially amid the heightened anticipation surrounding the recent
New Drug Application (NDA) submission by the Multidisciplinary
Association for Psychedelic Studies Public Benefit Corporation
(“MAPS PBC”) to the U.S Food and Drug Administration (“FDA”).”
Safarik also acknowledged another interesting
development announced by the American Medical Association (“AMA”)
yesterday, which Optimi is closely monitoring.
"With the AMA’s current procedural terminology
("CPT") III codes for psychedelic-assisted therapies now officially
in effect, this underscores the goal of obtaining our precursor
licence. With potential FDA approval, physicians and other
qualified healthcare providers seeking coverage and reimbursement
for delivering psychedelic-assisted therapy will now have a
reliable partner who can formulate and encapsulate the most
cost-effective, high-quality, and accessible MDMA solutions in the
market,” he added.
Encapsulation Milestone
Achieved
With the Company’s precursor licence secured,
Optimi Chief Science Officer, Dr. Preston A. Chase, is pleased to
report the successful encapsulation of MDMA into 40mg and 60mg
dosage formats after verification through its High-performance
Liquid Chromatography (HPLC) methodology. This milestone further
aligns Optimi strategically with the MAPS PBC published protocol
and recent NDA.
“This milestone is more than formulation. It
symbolizes our dedication to achieving scientific uniqueness in
alliance with industry pioneers such as the MAPS PBC who are paving
the road ahead,” said Dr. Chase. “Our innovation journey is
grounded in advancing the safety and validity of our MDMA drug
candidate, and I am happy to say that we’re just hitting our stride
in becoming the premier provider of fully verified, encapsulated
MDMA in 2024 and beyond.”
To prepare for the Company's Australian supply
agreements, continuous stability testing will be conducted to
guarantee consistency and reliability. Optimi is set to obtain a
Certificate of Analysis (COA) from a Third-Party laboratory,
confirming the purity and offering an extra layer of assurance to
clients.
The Company also announces it has issued 50,000
common shares, at a deemed price of $0.245 per share, subject to a
hold period expiring May 3, 2024, in consideration of services
provided.
For media inquiries, please contact Michael
Kydd:michaelk@optimihealth.ca
For investor inquiries, please
contact:investors@optimihealth.ca
www.optimihealth.ca
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA:
8BN)
Optimi Health Corp. an end-to-end drug
researcher and formulator licensed by Health Canada to produce and
supply, for clinical research purposes, psychedelic substances such
as 3,4-Methylenedioxymethamphetamine (“MDMA”), natural GMP-grade
psilocybin, as well as functional mushrooms that focus on the
health and wellness markets. Built with the purpose of producing
scalable psychedelic formulations for transformational human
experiences, the Company’s goal is to be the number one trusted,
compassionate supplier of safe drug candidates throughout the
world. Optimi’s products are grown and manufactured at its two
facilities comprising a total of 20,000 square feet in Princeton,
British Columbia.
FORWARD‐LOOKING
STATEMENTS
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.
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 Annual Information Form dated
January 9, 2023, and other continuous disclosure filings available
under Optimi’s profile at www.sedarplus.ca. 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.
Optimi Health (TG:8BN)
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