In this edition of "Rising High," The Fly conducted an exclusive interview with Anthony Tennyson, chief executive officer of Awakn Life Sciences (AWKNF), a biotechnology company focused on developing and delivering psychedelic therapeutics to treat addiction. Here are some highlights:

PSYCHEDELIC THERAPEUTICS: Awakn is a biotechnology company developing psychedelic therapeutics to treat addiction and an operator of clinics to administer those treatments. “We’re a cutting-edge biotech company developing and delivering psychedelic therapeutics, a combination of therapy and drugs to be used together to better treat addiction,” the CEO said. “Not only that we’re also going to be delivering those treatments and those therapeutics in clinics across the UK and the EU.” Awakn currently has two clinics open, plans for another 18 by the end of 2024 and expects to deliver therapeutics through franchise and licensing partnership arrangements on a global level starting next February, he said. “The real core reason that we’re set up that way is biotech companies are expensive businesses to build and run,” Tennyson said. “Typically they tend to be about seven and a half years away from revenue and we believe that’s just not good enough. Revenue means treating people and waiting seven and a half years to treat people given the mental health and addiction crisis that society is currently faced with right now just isn’t bloody good enough.”

Awakn is building clinics in order to treat people now, earn revenue and reinvest it back into the biotech business, he said. “That enables us to actually help more people, better, quicker, faster in the longer run,” the CEO said. “And the focus on addiction is because we have built a team which is the best team in the world in the use of psychedelics to treat addiction.” He noted chief research officer David Nutt, head of department in the Imperial College of London and a former advisor to the UK state on drug policy reform and head of ketamine research Celia Morgan, head of department in the University of Exeter and leader of the world’s only trial for ketamine-assisted psychotherapy to treat alcohol use disorder. Dr. Ben Sessa also serves as the chief medical officer, Tennyson said, and he led the world’s only trial for MDMA to treat alcohol use disorder. “The approach that were taking to treat addiction, it’s radical, it’s revolutionary and it hasn’t been tried by anyone else before,” he said. “What we’re doing is we understand how addiction influences changes in the circuits of the brain and we’re using that combined approach to therapies and drugs together to address that. We’re using drugs like MDMA and ketamine in the near-term to disrupt those connections and then bringing in psychotherapy to enable these patients a permanent change in how they view themselves and how they view their addictions.”

COMPETITIVE EDGE: As competition rises in the psychedelic space, Tennyson pointed to the company’s focus, team, assets and business model as key differentiators for Awakn. “Our focus is on using psychedelic therapeutics and the approach that we’re taking focuses on circuitry disruption,” he said. “It’s a multi-site drug targeting approach so it enables us treat indications across substance and behavior addiction.” Substance addiction affects 20% of the global population, the CEO said, and Awakn can also treat behavioral addictions like gambling addiction, compulsive sexual behavior, eating disorders and internet usage disorders. “Our leading differentiator is the focus that we’re taking on the use of psychedelic drugs and therapies to treat both those broad categories,” he said. “No one else is coming at it with the same approach that we are.” The second factor that sets Awakn apart from competitors is its team, Tennyson said. “We have the world-class team of Prof. Nutt, Prof. Morgan, Dr. Sessa, Dr. Laurie Higbed and Dr. Shaun McNulty all on staff,” he said. “And our advisory team, Prof. Harriet de Wit, Prof. Kevin Fone, Prof. Steve Husbands and Prof. Barbara Mason are all world leaders in small molecule drug discovery and development and addiction treatments.” The CEO added the company’s approach toward drug discovery in acquiring assets and partnering with world leaders also acts as a key differentiator. “It enables us to accelerate towards an end goal,” he said. “Working with ketamine, MDMA and our own drugs, we’ve acquired assets that are unique and compelling in each of those three categories.” For ketamine, the company acquired the IP and the team for the world’s only trial of ketamine-assisted psychotherapy to treat alcohol use disorder. “We will be publishing news and potentially a publication on the results of a Phase 2 trial of ketamine to treat alcohol use disorder in the coming weeks,” Tennyson said. “That will propel us to the top of the industry and we are partnering with the University of Exeter and other state-level bodies in the UK to bring that research forward into a Phase III.”

For MDMA, Awakn acquired the IP, assets, team and data from the world’s only trial using MDMA in alcohol use disorder and is working to bring that research forward from Phase IIa into Phase IIb, he said. “We’re also then developing our own drugs and we’ve acquired six years of proprietary research from Professor David Nutt including details of newly discovered modes of action for MDMA,” the CEO said, adding the company has partnered with Evotec to accelerate the development of next-generation MDMA.

Lastly, Awakn differentiates itself through its business model, he said. “We’re a biotech company, developing a very, very deep, relevant, highly-commercializable IP portfolio to use psychedelics to better treat addiction,” Tennyson said. “We also have near-term revenue streams that provide us with the ability to fund the business on an ongoing, non-relative basis and we have two clinics open, Bristol and Oslo. We will have another clinic open for the end of the year in London and we will have 20 clinics open by the end of 2024.” Each clinic will be capable of generating GBP4M topline, or about $110M topline for all 20, the CEO said. “We think we can do that at a significant margin and that gives us the ability to reinvest on an annual basis to support our biotech business,” he said. “We will be able to fund investments and research from free cash flow from our clinics’ business but not only that, we will also be licensing our IP under our franchise model in North America.”

AXON ACQUISITION: In October, Awakn announced the closing of its acquisition of Axonklinikken, a ketamine-assisted psychotherapy clinic in Norway. Axon will be renamed Awakn Clincs Oslo and Dr. Lowan Stewart will be appointed regional director for the Nordics and managing director, Awkn Clinics Oslo. Awakn Clinics Oslo AS Clinic will serve as the Nordic hub from which Awakn plans to expand its clinical network across the region. “Stewart is a leading European authority on ketamine-assisted psychotherapy,” the CEO said. “There are a limited number of people in Europe that will be experts in ketamine infusions, but he’s actually one of the few experts in ketamine-assisted psychotherapy.” He noted Stewart set up the first ketamine-assisted psychotherapy clinic in New Mexico before moving to Norway and knocking down doors with the Norwegian Health Authority. “He has established a framework at the Norwegian policy level for the use of ketamine-assisted psychotherapy to treat instances of depression and addiction so it was a natural conversation for us to have a discussion with him,” Tennyson said. He added Stewart is active in research and is going to be one of the MAPS researchers for the MAPS clinical trial for MDMA in Norway. “It’s a really good beachhead for us into the Nordics region, which is a 40M person territory and a $2.5T a year territory,” the CEO said. “Highly wealthy, high disposable income and high concentration of population in urban centers, so it works well for us from an expansion plan perspective.”

MDMA RESEARCH RIGHTS: In September, Awakn announced that it acquired exclusive rights to the data from the phase IIa Bristol Imperial MDMA in Alcoholism Study from Imperial College London. “You typically have a 75% failure rate with alcohol use disorder treatments in the first twelve months,” Tennyson said. “Those people that have been through MDMA psychotherapy, there was a 30%-20% relapse rate after six and nine-month observations so groundbreaking results.” He said Awakn’s vision and purpose is to secure marketing authorization for MDMA to treat alcohol use disorder in the UK and the EU. “Essential to that is having access to the data from that clinical trial in order to accelerate our Phase IIb clinical trial but also to facilitate more detailed discussions with the MHRA and the EMA when it comes time to move Phase IIb into pivotal trial,” Tennyson said. “After pivotal trial, if we are successful in securing our primary and secondary endpoints, we will seek to secure marketing authorization for MDMA to treat alcohol use disorder in those territories. It gives us a significant advantage and an ability to accelerate our research program.”

CORONAVIRUS: The coronavirus pandemic has impacted many companies globally and the CEO said on a micro level, it threw a monkey wrench into renovations for Awakn’s Bristol clinic as the area was in level 3 lockdown. However, on a broader scale, the outbreak had a significant negative impact on the mental health of adolescents, adults and front-line workers, he said. “It’s going to manifest itself in increased cases of PTSD in our frontline practitioners, a significant increase in addiction, anxiety and depression with our adults and a significant increase in anxiety and depression with our adolescents,” Tennyson said. “A purely commercial venture would be rubbing its hands in glee because this pandemic has just created a significant increase in commercial opportunities. I view it as being terribly sad.” Individuals, families and communities have been so negatively affected by the conditions brought about by coronavirus, he said, and the current methods meant to be helping them are relatively ineffective. “It’s beholden upon a company like Awakn, who knows how to treat these conditions in a more effective manner, to do more quicker, better, faster,” the CEO said. “We could help those individuals and provide hope for those individuals, their families and the community to help alleviate the suffering that they’re going through.”

CHALLENGES: When asked about the largest hurdles facing the psychedelics space, Tennyson pointed to the number of firms in the industry as one of the biggest challenges. “There’s a lot of noise in the system and it’s attracting quite a lot of companies,” he said. “There’s a bit of a race and I’m not sure of the quality of all the companies that are operating in the industry.” The CEO said the noise is having an impact on capital markets as they have not been performing as ideally as they could be. “Our purpose as a company is to democratize psychedelics so that we can help as many people as possible,” he said. “Democratization means seeking to secure regulatory approval and therefore labeled use reimbursement and engagement with the health care system. The only way that we can do that is to run the drugs and therapies that we’re developing through the full spectrum of regulatory checks and trials.” Regulatory trials require capital however, Tennyson said, and Awakn will need investor and capital market support throughout that process. “The capital markets have not really performed that well for various reasons,” he said. “Some of that is because there’s a bit too much noise in the system and there are perhaps questions over how many companies are operating in the space.” The CEO added he also sees a potential future challenge in the distinction between medical and recreational use of psychedelics. “Medical cannabis has got huge potential, but it’s been held back by the lack of clarity between recreational and medical,” he said. “Although not currently an issue, I really hope and my desire for the psychedelics industry is that these are really viewed as medical and delivered in clinical and medical settings as opposed to there being any confusion coming into the system with a recreational offering.” Tennyson said he believes the lack of division between a medical offering and recreational offering will hinder regulatory approval.

OPPORTUNITIES: As the psychedelic industry develops, the CEO said democratization is the main opportunity companies in the space should be focused on. “Not everyone has disposable income to pay for these solutions and treatments out of their own pockets,” he said. “We have to have these treatments available in the UK and the EU through the public healthcare system, in Canada through the public healthcare system and in the U.S. through the reimbursed insurance payer model. To me, that is what the psychedelic industry should be seeking to secure.” Awakn is focused on that goal as a company, Tennyson said, and is investing money to secure a label in order to democratize psychedelics and help as many people as possible. “We’re those most excited about actually being able to democratize psychedelics in a way that it is currently not democratized.”

OTHER CANNABIS/PSYCHEDELIC STOCKS: Other publicly-traded companies in the space include Acreage (ACRHF), Akerna (KERN), Aleafia (ALEAF), Atai Life Sciences (ATAI), Ayr Wellness (AYRWF), Audacious (AUSAF), Aurora Cannabis (ACB), 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 (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), 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), Sundial Growers (SNDL), Sunniva (SNNVF), TerrAscend (TRSSF), Tetra Bio-Pharma (TBPMF), Tilray (TLRY), Trulieve (TCNNF), Valens (VLNCF), Village Farms (VFF), WeedMD (WDDMF) Zynerba (ZYNE) and 4Front Ventures (FFNTF).