Rising High: Exclusive talk with mental healthcare company Numinus

In this edition of “Rising High,” The Fly conducted an exclusive interview with Payton Nyquvest, Founder and CEO of Numinus Wellness (NUMIF), an integrated mental healthcare company advancing evidence-based psychedelic-assisted therapies. Here are some highlights:

PSYCHEDELIC-ASSISTED THERAPIES: Numinus offers an assortment of mental wellness services through its integrated healthcare model, which includes 13 client wellness clinics, proprietary practitioner training programs, a network of five clinical research sites and one Health Canada-licensed research lab.

“We are a mental health services company that at its core is focused around psychedelic therapy,” Nyquvest said. “We do offer a range of traditional mental health services as well as psychedelic-assisted services and the main component of that would be our clinical network.” Numinus has five corporately-owned wellness clinics in Canada and one Numinus Network-affiliated site in the country, as well as seven corporately-owned clinics in the U.S., he said. “As we anticipate more of these psychedelic therapy products becoming available, we have also focused on building a robust training platform for people who want to be able to offer psychedelic therapy to be prepared to do that,” the CEO said. The company continues to develop training programs for both internal and external practitioners, he added, noting Numinus recently launched the Numinus Certification Pathway for psychedelic-assisted therapy.

“We also have a contract research organization that is really focused on being the clinical trial sites for pretty much all the major psychedelic clinical studies that are happening at the moment,” Nyquvest said. “That gives us the opportunity to engage with a number of those products within our own clinical infrastructure so that we can continue to innovate and ideate our clinical care model based off of the research.” He noted Numinus offers a differentiated approach from others in the space as the company provides an assortment of mental wellness treatments for a variety of mental health needs. “That is a model that we believe is successful and has been very successful for us,” the CEO said. “And as we look towards the future, Numinus has really aligned itself very closely with the organizations that will be bringing the next round of psychedelic therapy products to market.”

CEDAR CLINICAL RESEARCH: Cedar Clinical Research, or CCR, is a wholly-owned subsidiary of Numinus offering clinical research management services to a range of academic institutions and biotech companies. In May, the company announced CCR had begun studying Compass Pathway’s (CMPS) COMP360 psilocybin therapy for treatment-resistant depression. “COMP360 is a product that we do anticipate being in market and Compass has actually put out some guidance that they anticipate that being available in 2027,” Nyquvest said. “Our clinical trial site management organization is a business line for us and a very healthy one, but it also gives us the opportunity to deepen the relationship with Compass and inform our clinical care model for when COMP360 gets approved.”

Additionally in June, Numinus announced CCR’s Draper, Utah clinic as a top enrolling site for MindMed’s (MNMD) Phase 2b study of MM-120 for general anxiety disorder. “What has really made CCR successful and the premier clinical trial site for a lot of these companies is our depth and breadth of expertise in psychedelics,” the CEO said. “Our opportunities to be involved in this research continue to hone and refine that expertise as well.”

MAPS PARTNERSHIP: Numinus announced a partnership with the Multidisciplinary Association for Psychedelic Studies, or MAPS, in June to support psychedelic experiential opportunities for practitioners as part of a clinical study. The company has submitted a Clinical Trial Application to Health Canada to enable MDMA-assisted therapy Experiential Opportunities for practitioners as part of an investigational Phase 1 clinical trial. If the CTA is approved, MAPS will provide Numinus with permission to use its protocol as part of this Experiential Opportunity, the first such permission granted by MAPS. “We view training as really the biggest bottleneck to access,” Nyquvest said. “MAPS anticipates MDMA being available this time next year. There is a lot of work to do in getting people trained so that once that approval is in place, there’s people who can offer that therapy in the most informed way possible.”

The clinical trial, if approved, will initially be conducted at Numinus’ clinics in Vancouver and may be expanded to include additional clinic locations in the future. “There are a lot of practitioners that are looking to get access to the opportunity to gain experience with MDMA in an above-the-board way that can be considered credential training,” the CEO said.

NUMINUS NETWORK: Numinus recently launched the Numinus Network to facilitate licensing and practitioner partnerships as well as accelerate the expansion of the company’s clinical footprint. In May, the company welcomed its first Practitioner Partner in Toronto, Ontario, who will be able to provide Numinus’ psychedelic-assisted therapies to her existing client base. “We anticipate that over the coming couple of years there is going to be a need for hundreds, if not thousands, of these locations as different psychedelic compounds become available,” Nyquvest said. “Launching the Numinus Network was really a way for us to be able to provide scale and access to locations in a way that offered something very robust and tailored to the needs of a number of different locations.” The company also partnered with Healing Commercial Real Estate to provide Numinus Network licensees with the option of leasing a fully-functioning clinic location. “It is also a much less resource-intensive way to expand than us building and opening up purpose-built facilities,” the CEO said. “We will still look to expand through purpose-built and owned locations, but this offering gives us the opportunity for expansion through that licensing model.”

Looking at expansion plans, he added Numinus will seek continued growth within North America on both sides of the border. “We’ve seen a lot of interest through the Numinus Network already,” Nyquvest said. “But the one thing we are trying to stay in line with as much as possible is the anticipation of MDMA being available. There are certain states in the U.S. that are legally going to be the first adopters through the FDA process, so we try to focus on the states that we know will be the ones to convert as soon as that process is complete.” He noted the company is also hoping to achieve a U.S. listing this fall. “We’ve put a pretty considerable amount of time and effort into it, so we’re hoping to be listed on a major U.S. exchange,” the CEO said.

FDA DRAFT GUIDANCE: The FDA recently 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, including psychiatric or substance use disorders. “Overarchingly, it just continues to show the support that is there from the regulators,” Nyquvest said. “We’ve seen nothing but significant support from regulators and what is really exciting about that is there are a lot of organizations that are looking to do research in the space. Research is necessary, but it is also expensive and cumbersome. The fact that the FDA is putting out guidance and helping provide pathways for companies, shows that it does have intentions of being able to approve these products.”

SCHEDULING: Several psychedelics are listed as Schedule I drugs under the Controlled Substances Act, including MDMA and psilocybin, which the CEO said underscores the importance of research and clinical trials. “The main criteria of being a Schedule I drug is potential for abuse and no known therapeutic benefit,” he said. “Clinical trials are showing significant therapeutic benefit and a very, very low potential for abuse.” While scheduling has created barriers in the past, Nyquvest said he believes those barriers are starting to erode.

“Scheduling and an appropriate regulatory structure for these compounds is important,” he said. “We do not believe that there will be a recreational market for psychedelics in the foreseeable future, so regulation and monitoring will be important. But certainly there will be a rescheduling process with those compounds as these clinical trials complete.”

CHALLENGES: When asked about the largest hurdles facing the psychedelic space, the CEO pointed to regulatory uncertainty as well as the immense global need for better mental health services. “Any time you are working with regulation change, there are a lot of factors that go into that,” he said. “But the biggest challenge is that the problem we’re hoping to solve for is massive. It’s going to take a lot of effort from everybody to come together and collaborate to make this paradigm shift. The need for many people working together and resources to support that is significant, because the problem is far, far greater.”

OPPORTUNITIES: As the psychedelic industry develops and matures, Nyquvest said he believes the space is at a seminal moment with the upcoming availability of MDMA. “That is something we’re extremely excited about,” he said. “Over the coming couple of months is getting prepared for that approval and really just seeing the integration. With MDMA coming online, the impact which it continues to show for post traumatic stress disorder and the burden on the health care system is massive. The potential for that to really be an intervention with curative intent, we really believe can help make a massive change systematically and societally.”

CANNABIS/PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Aleafia Health (ALEAF), Acreage (ACRHF), Atai Life Science (ATAI), Audacious (AUSAF), Aurora Cannabis (ACB), Avant Brands (AVTBF), Awakn Life Sciences (AWKNF), Ayr Wellness (AYRWF), Body and Mind (BMMJ), BZAM (BZAMF), Cannara Biotech (LOVFF), Canopy Growth (CGC), Chicago Atlantic (REFI), Clearmind (CMND), Clever Leaves (CLVR), CordovaCann (LVRLF), Cresco Labs (CRLBF), Cronos Group (CRON), Columbia Care (CCHWF), Curaleaf (CURLF), CURE Pharmaceutical (CURR), CV Sciences (CVSI), Cybin (CYBN), Delic Holdings (DELCF), Delta 9 (DLTNF), Entourage Health (ETRGF), Fire & Flower (FFLWF), Flora Growth (FLGC), General Cannabis (CANN), Greenlane (GNLN), Green Thumb (GTBIF), GrowGeneration (GRWG), Goodness Growth (GDNSF), Hemp (HEMP), HEXO (HEXO), High Tide (HITI), India Globalization Capital (IGC), Indiva (NDVAF), Innovative Industrial Properties (IIPR), InterCure (INCR), IM Cannabis (IMCC), Wellbeing Digital (KONEF), Khiron Life Sciences (KHRNF), Lowell Farms (LOWLF), Lotus Ventures (LTTSF), MediPharm Labs (MEDIF), MedMen (MMNFF), NewLake Capital (NLCP) Organigram (OGI), Planet 13 (PLNHF), Reunion Neuroscience (REUN), Revitalist (RVLWF), RIV Capital (CNPOF), Relmada (RLMD), RYAH Group (RYAHF), Safe Harbor (SHFS), Small Pharma (DMTTF), 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).