Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a
leading Health Canada licensed psychedelics pharmaceutical
manufacturer, specializing in controlled substances such as natural
psilocybin and MDMA, is pleased to announce that three validation
batches of its Natural Psilocybin Extract have undergone full
release testing and have been issued the Certificate of Analysis
(COA) by a third-party, confirming compliance with Good
Manufacturing Practice (GMP) specifications. Additionally, the
Company has successfully completed the in-house encapsulation of
psilocybin drug candidates in 5mg and 10mg dosage formats.
The third-party COA confirms critical
information regarding potency, water content, microbial content,
and heavy metal content, ensuring that the Natural Psilocybin
Extract meets the predetermined specifications. The completion of
both extract validation and finished product testing aligns with
Optimi's goal of advancing the drug candidate, marking significant
progress toward its eventual release for human consumption.
“This is an exciting development for Optimi,”
said CEO Bill Ciprick. “Obtaining successful results on the
validation batches of psilocybin extract speaks to Optimi’s
dedication to developing a repeatable, quality focused
manufacturing process. This documentation provides important data
and helps Optimi ensure patients receive an extract backed by
evidence,” added Ciprick.
Ciprick also stated, “We are able to create
stable GMP inventory in-house and at scale which showcases Optimi’s
unique position in the psychedelic supply chain. We’ve worked hard
to secure the end-to-end production advantage.”
After six months of accelerated data collection,
Optimi confirms that its Natural Psilocybin Extract maintained its
original potency level without any degradation during stability
testing. Furthermore, the Psilocybe cubensis mushrooms used in
creating the extract were cultivated in-house under Good
Agricultural Collection Practice (GACP) conditions, as highlighted
in a recent video from earlier this year.
As the Company prepares to meet its Australian
supply commitments with Mind Medicine Australia, Karina Lahnakoski,
Optimi's Director of Quality and Commercial Strategies, assures
patients and therapists of the reliability and quality of Optimi's
drug candidates.
“Our drug development program for the Natural
Psilocybin Extract has established a robust process which has been
validated and confirmed through the COA testing and the stability
program,” said Lahnakoski. “By conducting our program in accordance
with guidelines established by organizations like the International
Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use (ICH) and the requirements of Good
Manufacturing Practice (GMP), we further emphasize our commitment
to patient safety and high-quality products.”
Dedicated to fostering collaborations and
advancing the scientific understanding of the potential therapeutic
benefits of psilocybin, Optimi welcomes inquiries from principal
investigators and research groups interested in learning more about
the Company’s validated GMP Natural Psilocybin Extract and other
drug candidates.
For media inquiries, please contact Michael
Kydd:
michaelk@optimihealth.ca902.880.6121
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 31, 2024, 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.
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