Optimi Health Announces First PTSD Patients Treated with MDMA Capsules in Australia

Additional 700 Doses Ordered by Mind Medicine Australia as Demand Surges

Vancouver, British Columbia–(Newsfile Corp. – October 23, 2024) – Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) (“Optimi” or the “Company“), a Health Canada-licensed manufacturer of psychedelic pharmaceuticals specializing in botanical psilocybin and MDMA, is proud to announce that the first group of patients with post-traumatic stress disorder (PTSD) in Australia has successfully received treatment with its GMP-certified MDMA capsules under the Authorised Prescriber Scheme. In response to growing demand, the Company has received an additional order for 700 doses after its initial shipment of 160 doses was fully allocated in under eight weeks.

Key Highlights:

• First Patient Dosing: Patients in Australia are being treated with Optimi’s GMP-certified MDMA capsules for PTSD, positioning Optimi as one of the few companies with in-market products actively treating real patients.
• Additional Orders: An additional 700 doses of MDMA capsules have been ordered to meet demand after the initial 160 doses were fully allocated in less than eight weeks.
• Real World Data: The Patient Reported Outcomes (PROs) being gathered through the patient registry at Australian National University will provide data on the effectiveness of MDMA treatments across a diverse range of Australian patients. The data collected from thousands of patients using Optimi’s MDMA will be one of the most comprehensive and valuable data sets in the history of psychedelic-assisted therapies.

“This is a major advancement for Optimi and our investors,” said Dane Stevens, CMO and CEO of Optimi. “We’re not just talking about potential-we’re actively treating patients today. The fact that our first shipment is fully allocated with an additional order placed proves the need for MDMA-assisted therapy is real, and Optimi is meeting that demand.”

Stevens added, “Despite the recent setback in the U.S. with the FDA delaying the approval of MDMA-assisted therapy, we believe the progress being made in Australia will accelerate the push to treat Americans suffering from PTSD. Right now, Americans can actually travel to Australia to receive these life-changing treatments through the Authorised Prescriber Scheme. While the situation in the U.S. continues to unfold, we’ll continue to prioritize doses to patients in Australia today.”

Optimi’s close collaboration with Mind Medicine Australia-a leading non-profit focused on expanding access to psychedelic-assisted therapies-has been instrumental in bringing these treatments to market. Mind Medicine Australia advocates for the safe integration of psychedelics into mental health treatments and has been a key partner in connecting Optimi’s MDMA with Australian healthcare providers.

Peter Hunt, Chairman of Mind Medicine Australia, commented, “The partnership with Optimi is delivering real solutions for patients today. The successful dosing of the first patients in Australia is just the beginning. We’re excited about the future impact this collaboration will have on mental health treatments globally.”

Global Context:

PTSD affects approximately 3.9% of the global population, with higher prevalence rates in conflict-affected areas and among certain demographics (BMJ Global Health). In the United States, about 6% of adults experience PTSD at some point in their lives (PTSD.va.gov). The economic burden of PTSD in the U.S. is substantial, estimated at $232.2 billion annually as of 2018 (ScienceDaily). These statistics underscore the critical need for effective PTSD treatments and the significant impact that Optimi’s MDMA-assisted therapies could have on a global scale.

The MDMA capsules were exported under Optimi’s recently awarded Drug Establishment Licence (DEL) from Health Canada, which allows the Company to manufacture and export GMP MDMA capsules to regulated markets globally. With this DEL, Optimi’s MDMA capsules can be prescribed by healthcare professionals in regulated markets for the treatment of PTSD.

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. These statements may involve estimates, assumptions, and uncertainties that 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. 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 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 Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/227511