Optimi Health Stock Price, News & Analysis

Optimi Health (OPTHF) has completed its second shipment of GMP-certified MDMA capsules to Australia and increased its 2025 production forecast to support over 5,000 patients globally. The company, which manufactures psychedelic pharmaceuticals under Health Canada license, is working in partnership with Mind Medicine Australia to distribute the products through a regulated pharmacy network.

The initiative includes collecting patient-reported outcomes via the Australian National University's registry, creating one of the largest Real World Evidence datasets on MDMA-assisted therapy. The company's expanded production capacity aims to ensure consistent access to high-quality GMP-certified products for healthcare providers in Australia while supporting ongoing and future clinical trials.

The partnership with Mind Medicine Australia focuses on making these therapies accessible at optimal pricing, promoting equitable access. This development is significant given that PTSD affects 6% of U.S. adults during their lifetime, with an estimated economic burden of $232 billion annually in the U.S. alone.

Optimi Health Corp (OPTHF) has entered binding agreements with Psyence Biomedical to become their exclusive supplier of GMP-certified psilocybin for clinical research and drug development programs. The partnership focuses on Psyence's Phase IIb trial for Adjustment Disorder and future commercialization initiatives in Palliative Care.

Optimi will provide GMP-certified, nature-derived psilocybin extract capsules and Chemistry, Manufacturing, and Control (CMC) support for regulatory submissions. This ensures Psyence's access to consistent psilocybin supply for current programs, Phase III trials, and potential commercialization. The agreement supports Psyence's Investigational New Drug (IND) application with the FDA.

Optimi Health announces successful treatment of first PTSD patients in Australia using its GMP-certified MDMA capsules under the Authorised Prescriber Scheme. Following high demand and full allocation of initial 160 doses in under eight weeks, an additional 700 doses have been ordered. Patient Reported Outcomes are being collected through Australian National University's patient registry, creating valuable data on MDMA treatment effectiveness. The company's Drug Establishment Licence from Health Canada enables manufacturing and export of GMP MDMA capsules to regulated markets globally. Despite FDA delays in the U.S., Optimi continues prioritizing treatment access in Australia, where Americans can travel to receive therapy.

Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN), a GMP-compliant, Health Canada-licensed manufacturer of psychedelics specializing in botanical psilocybin and MDMA, has announced a leadership transition. Mr. William (Bill) Ciprick is stepping down as Chief Executive Officer due to personal reasons after three years of leading the company.

The Board of Directors has appointed Mr. Dane Stevens, Co-Founder of Optimi, as Interim Chief Executive Officer, effective immediately. Mr. Stevens will focus on advancing key initiatives, including business development, expanding revenue opportunities, and maintaining the company's strategic direction. Mr. Ciprick will continue to support the company in an advisory capacity during this transition period.

Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) has received a No Objection Letter from Health Canada for a Phase 2 clinical trial using their GMP natural psilocybin extract capsules. The trial, conducted with ATMA Journey Centers, will study Major Depressive Disorder in 200 frontline mental healthcare workers affected by COVID-19. This approval marks a significant step in Optimi's clinical validation efforts in Canada, complementing their ongoing Real World Evidence collection in Australia.

The study aims to assess the safety, efficacy, and therapeutic potential of psilocybin-assisted psychotherapy. It will also explore how psilocybin might enhance the professional capacities of healthcare workers, particularly in psychedelic therapy. This research could provide important insights into new treatment options for those most affected by the pandemic's mental health challenges.

Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) has achieved several significant milestones:

• Completed the first export of GMP-validated MDMA capsules to Australia for PTSD treatment under the Authorised Prescriber Scheme
• Received permits for psilocybin shipment to New Zealand for a pilot study
• Influenced Australian regulatory framework for MDMA and psilocybin manufacturing requirements
• Closed the first tranche of a non-brokered private placement, raising CAD$538,999.80

These developments position Optimi as a leader in the psychedelics pharmaceutical industry, with a focus on MDMA and psilocybin for mental health treatments.

Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN), a GMP-approved, Health Canada licensed psychedelics pharmaceutical manufacturer, has announced a non-brokered private placement of up to 16,666,666 units at CAD$0.30 per unit, aiming to raise up to CAD$5,000,000. Each unit consists of one common share and half a warrant, with each full warrant allowing the purchase of an additional share at CAD$0.40 for two years.

The company plans to use the proceeds for business development in Australia and globally, commissioning new equipment for GMP production and analytical laboratory, and general working capital. Insiders may participate for up to CAD$500,000. The offering includes an accelerated expiry provision and a potential 4% finder's fee for qualified non-related parties.

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.