When Optimi Health launched its 2.5 million-share initial public offering (IPO) last month (PDF), the timing couldn’t have been better for the Vancouver-based maker of psychedelic drugs.
President Donald Trump recently signed an executive order accelerating research and loosening regulations on psychedelic drugs, reportedly at the urging of podcast mogul Joe Rogan, sparking an unprecedented conversation about the potential of psychedelic drugs to treat mental illness.
And it’s the perfect time for early entrants like Canada’s Optimi to attract investors.
“Donald Trump, who is, for better or worse, the most popular person in the world, and probably the second most popular person, Joe Rogan, are standing behind him talking about it,” Optimi CEO Dane Stevens said in an interview last week. “This was a big step, a big trigger. The phone has been ringing non-stop ever since.”
In the emerging 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 treatments by the FDA.
Optimi, founded six years ago, has two 10,000-square-foot manufacturing facilities in Princeton, British Columbia, about three hours east of Vancouver.
Unlike many companies in the psychedelic space that develop and manufacture pharmaceuticals, Optimi is simply a manufacturer. The company supplies psilocybin and MDMA capsules for clinical trials around the world and for commercial use in Australia, where psychedelics will be reclassified in 2023, taking them off the list of Schedule 9 prohibited substances and making them Schedule 8 controlled substances.
Doctors in the country can prescribe psilocybin for treatment-resistant depression (TRD) and MDMA for post-traumatic stress disorder (PTSD). Veterans in Australia are being targeted for PTSD treatment by the government, and Stevens expects this model to be adopted in the US as well.
Optimi believes demand for its products could soar thanks to the sudden popularity of psychedelics in the United States, and it already has a head start as it has Good Manufacturing Practice (GMP) certification from Health Canada.
Optimi has the capacity to produce 2 million capsules per year and serves more than 200,000 patients. Individual capsules cost $33.33 for MDMA and $20 for psilocybin.
Regarding sales in Australia, Mr Stevens said Optimi had an advantage over its competitors because it was unique in that it manufactured medicines and shipped them directly to pharmacies, bypassing intermediaries. The CEO says that by operating this way, Optimi can provide treatments at a lower cost than larger manufacturers that use distributors.
Optimi’s production facility has four fruiting rooms, an enclosed environment that simulates optimal humidity, temperature and fresh air exchange conditions for mushroom cultivation. Optimi has one of the world’s largest gene banks and can grow over 200 types of psychedelic mushrooms.
A Drug Establishment License (DEL) from Health Canada allows the company to produce approximately 20 types of mushrooms that can be sold commercially. Optimi performs end-to-end manufacturing of psilocybin in its own facilities. This process includes extraction, encapsulation, packaging, and export.
“We had to develop all our SOPs, testing methods,” Stevens says. “When we first started, we started with facilities. We built them purpose-built, one-way air flow, clean room technology, all automated systems to manage the environment. And if you can control the environment, you can consistently control the results.”
Optimi also announced last month that it aims to produce ibogaine, a psychedelic alkaloid that is being investigated as a treatment for opioid use disorder, traumatic brain injury (TBI), and PTSD. Ibogaine was included in President Trump’s executive order to accelerate the development of psychedelic drugs. This drug is a natural alkaloid obtained from the bark of the African tabernante iboga shrub.
Optimi does not attempt to grow the plants themselves. We work with our suppliers to manage extracted organic compounds. The company is responsible for standardization, encapsulation, packaging and export of pharmaceutical products.
Johnson & Johnson’s Supravat (esketamine) provides an example of a shelved drug that has found a therapeutic niche. J&J’s nasal spray is a tweaked version of ketamine, a synthetic drug created in a lab more than 60 years ago and rescheduled for medical use as a controlled substance by the FDA in 1999. Spravato, which hit the market in 2019 and is approved to treat major depressive disorder (MDD) and TRD, generated sales of $1.7 billion last year.
Additionally, the FDA granted priority vouchers two weeks ago to psychedelic experts Compass Pathways, Transcend Therapeutics, and Usona Institute. The vouchers are designed to facilitate research, approval and access to compounds that companies are developing.
“We feel there’s a really unique opportunity here to supply the market, even from the white-label CDMO side, and indeed within a rescheduled framework where we can get these medicines at a very competitive cost,” Stevens said. “We were able to get it to Australian patients faster than anyone else, which was great, and now we’re seeing a similar situation where we could be a direct competitor to drug development companies.”
