In this edition of "Rising High," The Fly conducted an exclusive interview with Daniel Carcillo, founder and chief executive officer of Wesana Health (WSNAF), a data-driven life science company focused on developing the novel therapies of tomorrow and delivering new care paradigms today. Here are some highlights:
TRANSCENDING BARRIERS: Wesana Health’s drug development program looks to utilize combination therapy to address migraine and symptoms of Traumatic Brain Injury, like depression and anxiety. Using psilocybin and cannabidiol, Wesana’s lead drug candidate SANA-013 targets the improvement of neuroplasticity while acting as an anti-neuroinflammatory.
“Wesana was born out of a need for traumatic brain injury survivors after I recovered my brain health and quality of life using high and low dose forms of psilocybin over a two and a half year/three-year period,” Carcillo said. “There is no approved pharmaceutical treatment for traumatic brain injury, which has an incidence rate over 5.6M new cases a year. TBI is severely underreported and over half of those cases deal with long-term, lifetime issues.”
The CEO, who played professionally in the NHL for nine years and won two Stanley Cups, retired in 2015 after his seventh concussion and became an advocate for concussion survivors and psychedelic treatments. “When I found this technology, it was five years into my brain health journey and I was almost bankrupt by going to traditional clinics and doing the standard treatments,” he said. “When I found this alternative treatment, it saved my life. It helped me recover my brain health, I began to feel more creative and more present, and right now my mental and intellectual performance is the best it has ever been.”
Wesana was born in drug development, Carcillo said, and went public on the CSE within about eight months. “In the beginning, we were focusing on drug development first,” he said. “I quickly realized it would be important to be able to get into the actual care delivery and so that’s when we acquired PsyTech.”
The PsyTech deal resulted in Wesana owning two clinics in Illinois, which have conducted over 4,000 ketamine infusions since inception, the CEO said. “I liked the approach that these clinics were bringing to the care delivery model because I believe strongly in pharmacogenetics testing, hormone testing, advanced diagnostics and cognitive testing--all of which they were offering” he said. “And they were using psychiatry, which is insurance renumerated, and combining that with patients that qualified for ketamine.
COMPETITIVE EDGE: When asked about the company’s key differentiators, the CEO cited psychiatrist oversight at Wesana Clinics, in addition to their insurance renumerated services. In terms of partnerships, the company has professional athletes, like Mike Tyson and Juliana Pena, using these diagnostics and tracking their mental health and brain health.
“We need to be able to bust through the stigma of mental health and these medicines,” Carcillo said. “Our competitive advantage right now is using an athlete-focused platform to really communicate the message that we want to send.” He added the company also uses a third-party independent lab for research and data analysis as well as a world-renowned CRO guiding drug development and regulatory pathway overseen by a world-class in-house team. “Everything that we do from a drug development standpoint is steeped in using the best of the best,” the CEO said. “I just feel lucky that I have a championship winning team around me to do things the right way.”
DEPRESSION TREATMENT PROTOCOL: In January, Wesana announced positive results of an animal study on a novel depression treatment protocol. Combining psilocybin and cannabidiol, the animal study demonstrated considerable and sustained improvement in depressive behaviors. Wesana’s novel and proprietary depression treatment protocol includes a single high dose of psilocybin followed by a maintenance regimen of a microdose of psilocybin combined with cannabidiol. In a validated preclinical animal model of depression, the maintenance regimen demonstrated up to 64% further improvement than those observed with a single high dose of psilocybin alone. Furthermore, the maintenance regimen provided a sustained antidepressant effect after the single high dose of psilocybin.
“The positive results of this study align with my individual experience and the improvements that I observed in my personal journey with depression,” the CEO said. “It’s thrilling to see our scientific data support Wesana’s mission to find more effective treatments for the millions of individuals suffering from the symptoms of traumatic brain injury including depression.”
PRE-IND MEETING: In January, Wesana announced that the U.S. Food and Drug Administration granted the company’s request for a pre-IND meeting in March to discuss the novel therapy and proprietary protocol of SANA-013 for the treatment of TBI-related major depressive disorder. The company expects to receive feedback on its toxicology program and research to date.
“We will get more information about what we need to do to satisfy the FDA and prove to them that our proprietary novel protocol and composition of matter is safe and efficacious for TBI-related major depressive disorder,” Carcillo said. “We look forward to the opportunity to sit in front of the FDA and really plan that out.” Wesana is looking to ensure that it is on the best path forward for IND clearance, he said. “They got back to us, I believe it was in sixteen days, so that tells me that they’re extremely amenable to the functional animal data and human data that we provided them,” the CEO said. “A lot of the people in this space say that they’re going to replace SSRIs and antidepressants and that they are against big pharma. That’s not us, we want to integrate into it.”
MAPS NEGOTIATIONS: In December, Wesana announced it has received a commercial viability analysis conducted by Boston Consulting Group which validated and will expedite partnership talks with the Multidisciplinary Association for Psychedelic Studies and MAPS Public Benefit Corporation. The parties are proceeding with negotiations of a definitive agreement to study MDMA-assisted therapy to treat symptoms associated with TBI.
“Right now, we’re just going through the different business aspects and speaking about the revenue share that we will have with a new IND with the FDA to use MDMA to treat a TBI-related symptom,” Carcillo said. “Those discussions are moving along nicely.” He added Wesana and MAPS struck up the discussions based on a small cohort of data MAPS collected in a Phase 2 study on people that had a TBI diagnosis as well as a PTSD diagnosis. “They actually did better than the 67% of the cohort for PTSD, so that’s a signal,” the CEO said. “We commissioned a BCG report to look at the feasibility of using MDMA for TBI and the results were extremely favorable so now we’re moving forward.”
Wesana is very excited about that partnership, Carcillo said, adding he is looking forward to working with good friend Rick Doblin, MAPS executive director. “We aim to really shepherd along an ethical clinical expansion and the way that these medicines are going to get delivered,” he said. “We’re moving along in those conversations. We expect to get to a term sheet in the near future, work to a definitive agreement and have, with MAPS, the exclusivity to be able to deliver MDMA for TBI in our clinical network.”
STRATEGIC RESTRUCTURING: In January, the company announced a strategic restructuring program including a reorganization and simplification of the operating structure and a reduction in workforce. The program, aimed at streamlining operations and driving efficiency, reduces corporate overhead annual commitments by $1.1M. “We run a lean team and I have a very specific vision,” the CEO said. “From the beginning, we’ve been executing everything ahead of timeline and below budget. Operationally, when you can save $1.1M and reallot these funds to patents and protecting the SOPs, novel protocols, and functional animal work, it’s prudent to make those decisions.”
He added sometimes tough decisions have to be made and Wesana appreciates everything that his former colleagues have contributed. “There has been a change of business strategy,” Carcillo said. “We’ve already gotten into discussions licensing our SOPs and scaling as quickly as possible.” He said he feels confident in Wesana’s plan and extremely confident in the team he has assembled. “I have complete trust in every single person on the C-level to execute and that is why we made these decisions,” the CEO said
CORONAVIRUS: Coronavirus has impacted many companies in the mental healthcare industry globally and Carcillo said the isolation and fear has affected the general public. “We’re human beings, we want to connect and when you can’t do that, you get depressed and you get anxious,” he said. “We’ve seen the uptick, specifically in a state like Illinois, we’ve seen the effects of that within our clinics. We’re just happy that we can be there to support people in their mental health journeys.” The CEO noted Wesana has a digital front door and has done about 57% of its work intake through telemedicine, saw a record number of patient visits and ketamine infusions in the month of December. “It’s not affecting people coming into the clinics for treatment,” he said.
CHALLENGES: When asked about the largest hurdles facing the mental health space, the CEO pointed to the narratives surrounding the sector. “Investors are going to have to place their bets strategically because there are a lot of people in this industry that are not necessarily on the same path,” he said. “Many have no real novel way forward, so I would caution investors to do due diligence and dive deep into these companies.” He added Wesana Health is always more than happy to open its doors to investors.
OPPORTUNITIES: As the mental health industry develops, Carcillo said Wesana is most excited about the opportunity to integrate into big healthcare by progressing discussions on the company’s IP protected SOPs, clinics, and drug development program. “Obviously, we’re extremely excited about sitting down with the FDA to push that along,” he said. “We’re also extremely excited about our partnership discussions with MAPS. We’re just blessed to be able to have boots on the ground and to be able to deliver care right now.”
OTHER CANNABIS/PSYCHEDELIC STOCKS: Other publicly-traded companies in the space include Acreage (ACRHF), Akerna (KERN), Aleafia (ALEAF), Atai Life Sciences (ATAI), Awakn Life Sciences (AWKNF), Audacious (AUSAF), Aurora Cannabis (ACB), AYR Wellness (AYRWF), BC Craft (CRFTF), Body and Mind (BMMJ), CanaFarma (CNFHF), Canopy Growth (CGC), RIV Capital (CNPOF), Clever Leaves (CLVR), Columbia Care (CCHWF), Compass Pathways (CMPS), CordovaCann (LVRLF), Cresco Labs (CRLBF), Cronos Group (CRON), CV Sciences (CVSI), Curaleaf (CURLF), CURE Pharmaceutical (CURR), Delic Holdings (DELCF), Delta 9 (DLTNF), Emerald Health (EMHTF), Fire & Flower (FFLWF), Flora Growth (FLGC), FluroTech (FLURF), Gage Growth (GAEGF), General Cannabis (CANN), Goodness Growth (GDNSF), Greenlane (GNLN), Green Thumb (GTBIF), GrowGeneration (GRWG), Harborside (HBORF), Hemp (HEMP), HEXO (HEXO), High Tide (HITI), IM Cannabis (IMCC), India Globalization Capital (IGC), Indiva (NDVAF), Inner Spirit (INSHF), Innovative Industrial Properties (IIPR), InterCure (INCR), Ketamine One (KONEF), Khiron Life Sciences (KHRNF), Lowell Farms (LOWLF), Lotus Ventures (LTTSF), MediPharm Labs (MEDIF), MedMen Enterprises (MMNFF), MJardin Group (MJARF), Neptune Wellness (NEPT), Thermic Science (ENDO), Organigram (OGI), Planet 13 (PLNHF), Relmada Therapeutics (RLMD), RYAH Group (RYAHF), Skye Bioscience (SKYE), SLANG Worldwide (SLGWF), Sproutly (SRUTF), Stem Holdings (STMH), Small Pharma (DMTTF), Sundial Growers (SNDL), Sunniva (SNNVF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Tilray (TLRY), Trulieve (TCNNF), Valens (VLNCF), Village Farms (VFF), Entourage Health (ETRGF), Zynerba (ZYNE) and 4Front Ventures (FFNTF).
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