In this edition of "Rising High," The Fly conducted an exclusive interview with Dane Stevens, Co-Founder and Chief Marketing Officer of Optimi Health Corp. (OPTHF), a Canadian-based drug manufacturer and formulator of psychedelic substances. Here are some highlights:
PSYCHEDELIC PRODUCTION: Optimi Health is an end-to-end drug manufacturer licensed by Health Canada to produce and supply psychedelic substances such as MDMA and natural GMP-grade psilocybin, as well as functional mushrooms that focus on the health and wellness markets. The company aims to be the number one trusted, compassionate supplier of safe drug products throughout the world. "What really makes us stand out is our end-to-end manufacturing," Stevens said. "When you break it down, the first thing you really need is a facility. It is super tough without it, and we built ours from the ground up in Princeton, British Columbia. The clean space and the GMP standard are required to really make these drugs available at scale."
Licensing is the second factor that plays an important role in making these drugs available to patients, he said. "We have that from Health Canada to actually do the work that needs to be done to manufacture these drugs to high specifications," the CMO said. "We're optimized much differently than anybody else and we don't have to pay anybody to do any of this work on our behalf. We actually do it all with our team."
Optimi has spent the last couple of years working with its science team, building out operational procedures and raising funds, he said. "A lot of the founders have chipped in along the way," Stevens said. "We have done it with the support of Health Canada, which has really helped make our joint vision come together. They're on our side and they're showing a belief in what we are up to with the licensing. That is what is going to be really important as international markets open up. In order to ship these drugs internationally, they have to be safe, pure and we have to show that we are able to do that consistently to a very high standard."
Manufacturing expertise, quality and compliance are a few of the key differentiators that set Optimi apart from competitors in the field, he said. "We're also willing to provide these drugs at the lowest possible price," the CMO said. "I don't actually see a lot of competition when it comes to scalable manufacturing capabilities to get these medicines into the right hands."
He noted there has been a lot of money going into the space around patents and clinical trials, and there have been a lot of studies and testimonial evidence that has brought psilocybin and MDMA to the forefront. "But we asked the question to ourselves, 'Who is really set up to supply this industry?'," Stevens said. "And that's us. We have the ability to create all the inventory we need in our facility to meet our contract obligations to date and going forward, we feel like we have such an advantage by being the manufacturer ourselves with the support of Health Canada to bring those medicines to all the companies that are doing that treatment and clinical development work."
LICENSE AMENDMENT: In January, Optimi announced it had been granted an amendment to its Health Canada Controlled Drugs and Substances License, allowing for substantial increases in the quantities of MDMA, MDA, and 2CB. "The primary objective of that was to make sure we were able to fulfill our contracts at a larger scale," the CMO said. "We are anticipating, not immediately in the next quarter, but throughout the year, having an exclusive supply partnership with Mind Medicine Australia (MNMD), which just finished dosing its first patients under the Authorized Prescriber Scheme. Health Canada was able to increase our limits on what we can create onsite under that license, meaning we are able to deliver more at scale and fulfill the objectives of the business."
He added Optimi's partnership with Mind Medicine was a milestone for the company. "Peter Hunt, the founder of Mind Medicine Australia, has been a huge champion for getting these medicines rescheduled," Stevens said. "To be working with Mind Medicine, you get direct access to various clinics and we feel like that is the right partnership for us to grow with. It's going to be important for us to have that partner in Australia, so people that are in connection with the government and have had a hand in getting those drugs rescheduled can handle the roll out of those drugs. It's a great fit for us."
PRECURSOR LICENSE: Additionally in January, Optimi announced it was granted a Precursor License for MDP2P, the precursor used in the chemical synthesis of MDMA, allowing the company to import MDP2P for the purpose of formulating and verifying MDMA drug candidates. Optimi also reported the successful encapsulation of MDMA into 40mg and 60mg dosage formats at the time. "Optionality is really important for us and different precursors and starting materials are used specifically to manufacture the MDMA," the CMO said. "For us to be able to add a precursor means we can manufacture MDMA with the Multidisciplinary Association for Psychedelic Studies' published recipe. The precursor allows us to enter cost amendments as well and cheaper starting material should parlay into cheaper medicines for the people that are going to be using these drugs."
Optimi hopes to be rewarded from the move as MAPS looks to fulfill their supply commitments, he said. "For us to do the same doses, the 40 mg and the 60 mg, and make sure we are doing everything on our end to be prepared for what that partnership could look like pending approval is the right call," Stevens said. "They are going to be the biggest player in the space, they are going to be the ones that are rolling out the MDMA in therapy and ensuring that we make a product that fits within that is really important."
DRUG MASTER FILE, DRUG ESTABLISHMENT LICENSE: In Optimi's 2023 Annual Review, the company said it was poised to achieve a significant milestone in 2024 with the completion and submission of its Drug Master File in Canada and the U.S. "These are records that are really important for our psilocybin extract, our MDMA drug candidates and active pharmaceutical ingredients," the CMO said. "It is essentially the backend information for each of those drugs and it falls within the compliance of what we have to do to be able to present it to any groups interested in acquiring those drugs from us."
The company also said it had embarked on a journey to obtain a Drug Establishment License in 2024, representing a verification of GMP compliance from Health Canada. "It's a fluid situation," Stevens said. "We did apply for it some time last year, there's a process and there's an automatic waiting period. But at the end of the day what that does for Optimi is that brings us into a different category of compliance, where we are officially a Health Canada-registered drug manufacturer, meaning that product that we are making can go to patients. With the DEL, we can export to pretty much anywhere in the world and have it be GMP-recognized pending the acceptance."
Optimi believes the DEL will be a game changer for the company. "Optimi will be one of the only publicly-traded psychedelics company with that license and it is so important because the regulations in the European Union around harmonization and the European medical agencies," the CMO said.
MAPS NDA: The MAPS Public Benefit Corporation recently submitted a New Drug Application to the FDA for MDMA-assisted therapy for post-traumatic stress disorder. If approved, the treatment would be the first psychedelic-assisted therapy for PTSD. "It's a really big step," Stevens said. "It's what the industry has been waiting for and it is the first big catalyst for psychedelics to hopefully become a legitimate and regulated form of therapy for those with PTSD. It has got genuine and meaningful support from both Republicans and Democrats and the trials show overwhelmingly positive results, so MAPS has an amazing opportunity to roll it out."
He added he believes the therapy has the potential to change the game in terms of treatment options. "It has the potential to bring people back into the workforce and become functioning members of society again," the CMO said. "It opens the door to psilocybin hopefully next, but I think it really has the opportunity to get people off SSRIs and make a positive impact in communities."
FDA DRAFT GUIDANCE: In June, the FDA published its first draft guidance on clinical trials with psychedelic drugs highlighting fundamental considerations for researchers investigating the use of these drugs for potential treatment of medical conditions. "It's the first big step towards building a strong regulatory framework," Stevens said. "It has laid the foundation for some of the criteria expected in order to ensure the clinical trial results could provide the purest possible data."
SCHEDULING: Several psychedelics are listed as Schedule I drugs under the Controlled Substances Act, including MDMA and psilocybin, but the CMO said he believes public awareness is changing as more clinical data emerges. "The data is starting to speak for itself," he said. "We've seen a lot of clinical trials now that seem to be showing a lot of promise. There are plenty of companies in the space doing really meaningful work. All this anecdotal evidence over the past hundreds of years, if not thousands, was always lacking that clinical support and the data to lead the way and make it more mainstream."
He said there are also more people now who feel passionately about psychedelics to rally behind the space and make meaningful change. "It is an interesting time," he said. "This is the moment where you will get some change as the data begins to mesh with the testimonial and the anecdotal evidence. It just feels like now could be that time where it really breaks through to the mainstream."
CHALLENGES: When asked about the largest hurdles facing the psychedelic space, Stevens pointed to the capital side of the industry as one of the biggest challenges. "On the pubco side, a lot of companies came and went, a lot of money was raised and a lot of investors had a tough couple of years here," he said. "And I think there are some of the issues with patents and how that is going to play out in the legal sense."
However, Optimi has an advantage with its own production, the CMO said, allowing the company to work with businesses who hold the patents. "We like to ask the question, 'Who is going to be making these psychedelics once they are ready to be commercialized?,'" he said. "I think that is going to be us with the licenses, the facility and the team in place ready to do it."
OPPORTUNITIES: As the psychedelic industry develops and matures, Stevens said he sees the biggest potential in the commercialization of these drugs. "Companies that get their clinical trials done first and have the positive results are going to have the biggest opportunity to take the market share when it comes to the actual IP and the patent side of development," he said. "There is a lot of room for growth and excitement on the clinic side as well."
The CMO added Optimi is uniquely positioned for the future as the company's overhead is out of the way and its focus is on scaling up the medicine, getting inventory and exporting. "We're in a position here where we are ready to be commercialized and there's so much meat left on the bone for Optimi to grow going forward," he said. "We're excited for our group and we're excited for our patients. When you own a share of Optimi, you own a piece of the market potential to supply. You own the building, you own the license, you own the inventory with us. We feel that is a pretty special situation."
CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Acreage (ACRHF), Audacious (AUSAF), Atai Life Sciences (ATAI), Aurora (ACB), Avant Brands (AVTBF), Ayr Wellness (AYRWF), BZAM (BZAMF), Cannara Biotech (LOVFF), Canopy Growth (CGC), Chicago Atlantic (REFI), Clearmind (CMND), Clever Leaves (CLVR), Cresco Labs (CRLBF), CordovaCann (LVRLF), Cronos (CRON), Columbia Care (CCHWF), Compass Pathways (CMPS), CURE Pharmaceutical (CURR), Curaleaf (CURLF), CV Sciences (CVSI), Cybin (CYBN), Delic Holdings (DELCF), Delta 9 (DLTNF), Entourage Health (ETRGF), Enveric Biosciences (ENVB), Fire & Flower (FFLWF), Flora Growth (FLGC), Trees Corporation (CANN), Goodness Growth (GDNSF), Greenlane (GNLN), Green Thumb (GTBIF), GrowGeneration (GRWG), Hemp (HEMP), High Tide (HITI), India Globalization Capital (IGC), Indiva (NDVAF), IM Cannabis (IMCC), Innovative Industrial Properties (IIPR), InterCure (INCR), Wellbeing Digital (KONEF), Khiron Life Sciences (KHRNF), Lotus Ventures (LTTSF), Lowell Farms (LOWLF), Lucy Scientific Discovery (LSDI), MediPharm (MEDIF), MedMen (MMNFF), MindMed (MNMD), NewLake Capital (NLCP), Numinus (NUMIF), Organigram (OGI), Planet 13 (PLNHF), Red White & Bloom (RWBYF), Reunion Neuroscience (REUN), Revitalist (RVLWF), RIV Capital (CNPOF), Relmada (RLMD), RYAH Group (RYAHF), Safe Harbor Financial (SHFS), SNDL (SNDL), Sproutly (SRUTF), Skye Biosciences (SKYE), Stem Holdings (STMH), Sunniva (SNNVF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Tilray (TLRY), Trulieve (TCNNF), Tryp Therapeutics (TRYPF), Verano (VRNOF), Village Farms (VFF), Wesana Health (WSNAF), Zynerba (ZYNE) and 4Front Ventures (FFNTF).