Key Highlights:
- Optimi is officially a GMP-compliant pharmaceutical drug manufacturer after receiving the internationally recognized Drug Establishment Licence for MDMA and psilocybin capsules, and for the fabrication of Active Pharmaceutical Ingredients (API's) extracted from plant sources.
- The Company will now prioritize the registration of both drugs with the
U.S. Food and Drug Administration through the implementation of Mutual Recognition Agreements (MRAs). - Psychiatrists in
Australia who are authorized by theTherapeutic Goods Administration (TGA) can request the importation of Optimi's MDMA and psilocybin capsules for use in patients. The available drugs include:- MDMA Capsules (40mg and 60mg) for PTSD; and
- Psilocybin Capsules (5mg) for Treatment-Resistant Depression.
- Optimi was recently issued an import certificate to supply 160 doses of MDMA and psilocybin to fulfill initial patient prescriptions by Mind Medicine Australia.
- The pre-authorized Australian Psychiatrist Portal is expected to launch on
June 24th, 2024 to approximately 2,800 psychiatrists. - The Company can now provide comprehensive GMP psychedelic drug solutions for worldwide drug commercialization, covering manufacturing, export, and distribution.
A Message from
Dear Shareholders,
Obtaining a Drug Establishment Licence (DEL) from
It has been imperative for us to deliver on our promise to build the necessary infrastructure, obtain the required licenses, and develop our business to be ready to participate in the global psychedelics market. Optimi possesses capabilities that very few companies in the world have—the ability to commercialize our pharmaceutical-grade psychedelics, starting with
On a global scale, with the acquisition of the DEL, Optimi can now provide comprehensive GMP psychedelic drug solutions for worldwide drug commercialization, covering manufacturing, export, and distribution. This achievement firmly establishes Optimi as the leader in the rapidly growing psychedelic supply market.
As a shareholder in Optimi, you have helped us bring two drugs to a prescription market for patient use imminently. We believe this licence has tremendous value going forward as markets around the world open, and we thank you for your continued support and confidence in our vision.
Everyone at Optimi looks forward to sharing more successes with you as we advance our mission to be a global leader in psychedelics.
Thank you,
On Behalf of the Board of Directors
JJ Wilson
Chairman of the Board
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. forward-looking statements made in this news release include the proposed use of the proceeds of the Offering. 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. 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.
Neither the Canadian Securities Exchange nor the
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