Last month, when Optimi Health kicked off (PDF) an initial public offering (IPO) of 2.5 million shares, the timing couldn’t have been better for the Vancouver-based manufacturer of psychedelic drugs.
With President Donald Trump recently signing an executive order to accelerate research and ease the restrictions on psychedelics—and doing so at the reported prompting of podcast giant Joe Rogan—there is unprecedented buzz around the potential of the drugs to treat mental disorders.
And it’s an opportune time for an early entrant like Canada’s Optimi to attract investors, too.
“You have the most popular person in the world—for better or worse—Donald Trump and probably the second-most popular, Joe Rogan, standing behind him talking about it,” Dane Stevens, the CEO of Optimi, said in an interview last week. “It’s a huge step, a big catalyst. Since then, the phone's been ringing non-stop.”
In the nascent industry, there aren’t many companies like Optimi, which Stevens classifies as a “specialty CDMO.” Optimi produces natural psilocybin and MDMA. Both have been designated as breakthrough therapies by the FDA.
Optimi, which was established six years ago, has two 10,000-square-foot manufacturing facilities in Princeton, British Columbia, which is roughly three hours east of Vancouver.
Unlike many companies in the psychedelic arena, which both develop and produce their drugs, Optimi is solely a manufacturer. It supplies capsules of psilocybin and MDMA for clinical trials around the world and for commercial use in Australia, which reclassified the psychedelics in 2023, taking them off the Schedule 9 banned substances list and making them Schedule 8 controlled drugs.
Physicians there can prescribe psilocybin for treatment-resistant depression (TRD) and MDMA for post-traumatic stress disorder (PTSD) in the country. Veterans in Australia are covered for PTSD treatment by the government, a model that Stevens anticipates will be adopted in the U.S.
As Optimi considers the potential surge in demand for its products, thanks to the sudden support of psychedelics in the U.S., it already has a head start, as it has received its Good Manufacturing Practice (GMP) certification from Health Canada.
Optimi has the ability to produce two million capsules per year, serving more than 200,000 patients. The individual capsules are priced at $33.33 for MDMA and $20 for psilocybin.
As for its sales in Australia, Stevens says that Optimi has an advantage over competitors because it is unique in that it both manufactures and ships its drugs directly to pharmacies, not using a middleman. Operating in this way allows Optimi to offer its treatments at a lower cost than larger-scale manufacturers, who use distributors, according to the CEO.
At its manufacturing complex, Optimi has four fruiting rooms, which are enclosed environments that simulate optimal humidity, temperature and fresh air exchange conditions to grow mushrooms. Optimi has one of the world’s largest genetic banks, with the ability to grow more than 200 varieties of psychedelic mushrooms.
A Drug Establishment License (DEL) from Health Canada allows the company to produce nearly 20 types of mushrooms that can be sold commercially. Optimi handles end-to-end manufacturing of the psilocybin at its facility. The process includes extraction, encapsulation, packaging and export.
“We had to develop all the SOPs, the testing methods,” Stevens said. “When we first started, we just started with the facilities. We purpose-built them, one-way airflow, clean-room technology, all automated systems to manage the environment. And when you can control the environment, you can control the outcome, consistently.”
Optimi also revealed last month that it is seeking to manufacture the psychedelic alkaloid ibogaine, which is under investigation for opioid use disorder, traumatic brain injury (TBI) and PTSD. Ibogaine was included in Trump’s executive order to hasten the development of psychedelics. The drug is a naturally occurring alkaloid from the bark of the African Tabernanthe iboga shrub.
Optimi will not attempt to cultivate the plant itself. It is working with a supplier to curate the extracted organic compound. The company will handle the standardization, encapsulation, packaging and export of the drug.
Johnson & Johnson’s Spravato (esketamine) offers an example of a rescheduled drug finding a therapeutic niche. J&J's nasal spray is a tweaked version of ketamine, a synthetic drug that was created in a laboratory more than six decades ago and was rescheduled by the FDA in 1999 for medical use as a controlled substance. Spravato, which reached the market in 2019 and is approved for major depressive disorder (MDD) and TRD, generated sales of $1.7 billion last year.
Further, the FDA two weeks ago awarded priority vouchers to psychedelics specialists Compass Pathways, Transcend Therapeutics and the Usona Institute. The vouchers are designed to accelerate research, approval and access to the compounds being developed by the companies.
“We feel like we’ve got a really unique opportunity here to supply the market, whether it’s from the white-labeling CDMO side of things or, actually, in the rescheduled framework where these drugs can be available at a really competitive cost,” Stevens said. “We reached the Australian patients before everybody else, which was great, and now we’re looking at a similar situation where we can be a direct competitor to the drug development companies.”