Optimi Health Stock Price, News & Analysis

Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) has announced a strategic partnership with PsiloThai, marking its entry into the Asian medical market for psilocybin research. This collaboration follows Thailand's recent regulatory change permitting psilocybin for medical treatment and research. Optimi will supply its GMP-approved natural psilocybin extract capsules for observational studies focusing on patients with addiction and end-of-life distress.

The studies will be conducted in conjunction with Government Hospitals and Rajamangala University, pending formal approval from Thai health authorities. This partnership not only expands Optimi's global footprint but also aligns with Thailand's progressive stance on psychedelic research, potentially paving the way for broader acceptance in Asia.

Optimi Health has announced the launch of OptiMed, an online portal aimed at assisting Australian psychiatrists in prescribing psychedelic medicines like psilocybin and MDMA. Developed in collaboration with Mind Medicine Australia, the portal offers a centralized, secure hub for essential information, resources, and support related to psychedelic drug manufacturing and training. The platform ensures compliance with Australia's Authorised Prescriber Scheme, providing insights into Good Manufacturing Practices (GMP) and facilitating secure communication.

The user-friendly interface allows psychiatrists to easily access comprehensive resources, including multimedia content showcasing Optimi's GMP-compliant facility. Currently, OptiMed is available solely to Australian psychiatrists, with plans for future international expansion. Psychiatrists can register for access through the portal's website.

Optimi Health has received three export permits from Health Canada to supply MDMA and psilocybin capsules to Australian psychiatrists for treating PTSD and Treatment-Resistant Depression. With a shipment of 160 doses, this marks the company's first commercial entry into Australia. The capsules will be used under the Authorised Prescriber Scheme, facilitated by Mind Medicine Australia. This initiative aims to gather Real World Evidence and Patient-Reported Outcomes to support the therapeutic potential of these substances. Optimi's export is made possible by its GMP-compliant production facility and newly awarded Drug Establishment Licence.

Optimi Health has completed its first international shipment of MDMA to Israel's Institute for Psychedelic Research at Tel Aviv University, facilitated by an export permit from Health Canada. This marks a significant milestone for Optimi, emphasizing its ability to manufacture and export controlled substances globally. Additionally, Optimi has received the CERS and CBSA Exporters Authorization ID, ensuring compliance with international trade regulations.

Optimi has also engaged Oak Hill Financial for investor relations, aiming to enhance communication with potential investors. Recent achievements include obtaining a Drug Establishment Licence from Health Canada, enabling production and distribution of MDMA and psilocybin capsules. Optimi can now supply GMP-compliant psychedelic drug solutions from its Princeton, BC facility for global distribution.

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.