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Optimi Health Corp. (OPTHF) is a leading Health Canada-licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as botanical psilocybin and MDMA. The company recently obtained a Drug Establishment Licence (DEL) from Health Canada, confirming compliance with Good Manufacturing Practices (GMP). This allows Optimi to supply MDMA and psilocybin capsules to patients with PTSD and Treatment-Resistant Depression under Australia's Authorized Prescriber Scheme and export to regulated jurisdictions globally. Optimi aims to be the trusted global supplier of safe drug candidates by producing proprietary formulations in its 20,000 square feet facilities in Princeton, BC.
Optimi Health has been granted a Drug Establishment Licence (DEL) from Health Canada, allowing the company to manufacture and sell MDMA and psilocybin capsules. This accreditation confirms their compliance with Good Manufacturing Practices (GMP) and enables the global distribution of these drugs, pending export documentation. Optimi plans to register these drugs with the U.S. FDA through Mutual Recognition Agreements (MRAs). The company will provide 160 doses to Australia under the Therapeutic Goods Administration's Authorized Prescriber Scheme. This milestone is expected to enhance Optimi's position in the global psychedelics market, offering comprehensive GMP psychedelic drug solutions for manufacturing, export, and distribution.
Optimi Health has successfully closed the final tranche of its $1,500,000 non-brokered private placement. The third tranche raised CDN$544,990 on May 29, 2024, adding to the CDN$400,000 raised on May 10, 2024, and CDN$555,010 raised on February 23, 2024. Each unit in the Offering was priced at CAD$0.30, comprising 1 common share and 1/2 transferable common share purchase warrant. Warrants allow for the purchase of one common share at CAD$0.40 within two years, subject to an accelerated expiry if shares trade above CAD$0.50 for 20 consecutive days.
Proceeds from the Offering will be used to obtain a Drug Establishment License, facilitate commercialization, and for general working capital. The issued securities are subject to a hold period of 4 months and 1 day as per Canadian regulations.
Optimi Health has secured an import permit from Mind Medicine Australia to export MDMA and psilocybin capsules to Australia under the Authorized Prescriber Scheme. The initial shipment will include 160 doses for approved psychiatrists, marking a significant milestone for the company. Optimi has also developed a secure Prescriber Portal, launching in June 2024, to support over 2,800 Australian psychiatrists. Mind Medicine Australia has trained over 350 professionals in psychedelic-assisted therapies and aims to increase the number of Authorized Prescribers substantially. This partnership focuses on making psychedelic therapies affordable and accessible.
Optimi Health, a Health Canada licensed psychedelics pharmaceutical manufacturer, has signed a Letter of Intent (LOI) with ATMA Journey Centers to supply GMP natural psilocybin for ATMA's Phase II clinical trial targeting Major Depressive Disorder (MDD). The LOI outlines a future definitive agreement within 45 days, making Optimi the sole supplier of psilocybin drug candidates for ATMA, with shared revenue from future net sales.
Optimi will also support product development for ATMA's Phase III clinical trial in 2025. The collaboration includes territories such as Canada, the US, the UK, and the EU, aiming to provide cost-effective psilocybin-assisted therapy. This partnership is expected to generate significant clinical data and improve accessibility and affordability of psychedelic therapies.
Both companies emphasize the cost-saving benefits of group therapy protocols, which reduce clinician demand and enhance patient access. By 2024-2025, Optimi aims to complete Phase II and III trials, potentially securing breakthrough therapy status.
Optimi Health Corp announced the receipt of a Certificate of Analysis (COA) confirming that its 40mg and 60mg MDMA capsules meet Good Manufacturing Practice (GMP) specifications. The capsules have a purity level of 99.95% and have passed stability testing for up to three months. The company has also completed GMP process validation for up to 1,000 capsules per batch. In a corporate update, Optimi announced plans to close a final tranche of its private placement offering, aiming to raise CAD$1,500,000 at CAD$0.30 per unit. Proceeds will be used for obtaining a Drug Establishment License and commercialization efforts.
Optimi Health Corp., a Health Canada licensed GMP psychedelics pharmaceutical manufacturer, is closing the final tranche of its non-brokered private placement to raise up to CAD$1,500,000. The Company has already raised CAD$555,010. Each Unit consists of a Common Share and a Warrant. The net proceeds will be used to obtain a Drug Establishment License, facilitate commercialization, and for general working capital. Optimi has entered into a services agreement with Very Polite Agency Inc. to provide public and media relations services. The Company has completed its Drug Establishment License inspection for GMP compliance.
Optimi Health Corp. receives an Export Permit from Health Canada to ship MDMA to Tel Aviv University's Institute for Psychedelic Research, marking its first international export. This collaboration signifies a significant milestone for Optimi, showcasing its ability to produce GMP psychedelic pharmaceuticals and support global psychedelic research and innovation.
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