Company Description

We are a Canadian Good Manufacturing Practices (“GMP”) compliant, pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. We specialize in controlled substances with our products being 3,4-Methylenedioxymethamphetamine hydrochloride (“MDMA”) and psilocybin derived from botanical sources. With a vertically integrated approach, we own two 10,000-square-foot production facilities in Princeton, British Columbia and operate under a Drug Establishment Licence (“DEL”) awarded by Health Canada. Our DEL certifies that our facilities and quality management systems comply with GMP for the formulation of designated drug products and the manufacture of certain active pharmaceutical ingredients (“API”) from plant sources. Additionally, we hold a Dealer’s Licence (“DL”) under Canada’s Narcotic Control Regulations, allowing us to possess, produce, assemble, sell, and deliver psilocybin and other psychedelic substances within the regulated framework set forth by Health Canada. The DL allows us to possess up to 20kg of psilocybin and 200g of psilocin (equivalent to approximately 2,000kg of dried full-body psilocybin-containing mushrooms) and 2kg of MDMA. We also hold a Precursor Licence under Canada’s Precursor Regulations allowing us to import 3,4-Methylenedioxyphenyl-2-Propanone if used in the synthesis of MDMA. The legal status of psychedelic drugs varies by country and our various licenses allow us to supply markets where it is legal and position ourselves for new markets. Our products are currently available in Australia where psilocybin and MDMA have been rescheduled to allow prescription by an Authorized Prescriber only for treatment-resistant depression (“TRD”) and post-traumatic stress disorder (“PTSD”). In Canada, our products are available via the Special Access Program (“SAP”), which we are authorized to supply as a provision of our DL whereby sale or provision to the holder of a Controlled Drugs and Substances Act subsection 56(1) exemption is not prohibited for licensed dealers to provide psilocybin and MDMA in relation to an SAP authorization. The SAP patient authorization process has been successfully achieved for MDMA products. Our psilocybin product is currently in phase 2b clinical trials in Canada conducted by third parties. In all other countries, access is restricted to approved clinical trials, including in Israel, one of our planned target markets, where our MDMA product is currently in phase 2 clinical trials conducted by third parties. We are currently restricted from selling our products in the United States, another one of our planned target markets, where psilocybin and MDMA are considered Schedule I “controlled or “scheduled” substances, meaning their manufacture, importation, exportation, domestic distribution, storage, sale and legitimate use is subject to a significant degree of regulation by the U.S. Drug Enforcement Administration (the “DEA”). While our MDMA and botanical psilocybin products are currently being accessed in Canada and Australia, in any new market, a regulatory approval would be required for our products – be that a clinical trial application approval, a marketing authorization approval or access via a change to regulatory access for these products. Our DEL enables us to supply validated psilocybin API, psilocybin drug products and MDMA drug products to patients in Australia under the Authorised Prescribers Scheme. Through strategic collaborations and ongoing compliance with global regulatory authorities, we aim to expand our product availability to additional jurisdictions where psychedelic-assisted therapies are gaining regulatory approval. The key differentiator of a DEL is that it enables our MDMA and psilocybin capsules to be prescribed by authorized physicians in Australia for the treatment of PTSD and TRD. Unlike most companies in the psychedelic sector that remain in clinical or pre-commercial phases, we are currently supplying regulated medicines under prescription in certain markets – supported by a DEL that also permits the legal manufacture and international export of both products. As part of our commitment to innovation and broadening accessibility to psychedelic-based therapies, we continuously refine our production methodologies, invest in advanced extraction technologies and enhance our regulatory compliance frameworks to remain ahead of industry standards. By prioritizing sustainable and responsible production practices, we are dedicated to becoming a global leader in the psychedelic pharmaceutical sector. Our research initiatives focus on optimizing extraction efficiency, improving formulation stability and ensuring scalable manufacturing techniques that align with future market expansion plans. Although we do not currently own any patents, nor do we have any pending patent applications related to our MDMA and botanical psilocybin products, the design, formulation, and large-scale manufacture of these products are founded on—and would be materially impaired without—a comprehensive body of proprietary know-how, specialized production methodologies, and rigorously safeguarded trade secrets that we protect through internal controls and confidentiality agreements. --- Our principal executive offices are located at 269 David Brown Way, Princeton, British Columbia, V0X 1W0. Our telephone number at this address is (778) 761-4551. Our registered and records office is located at 2054 Dowad Drive, Squamish, British Columbia, V8B 0Y8. Our agent for service of process in the United States, Cogency Global Inc., is located at 122 East 42nd Street, 18th Floor, New York, NY 10168. Our principal website is www.optimihealth.ca.