This article highlights the clinical-stage research Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat addiction, is currently undertaking; its development of a chain of therapy-assisted treatment clinics; and the huge revenue potential the Company is well on its way to achieving. In summary, this article is a wakeup call for any investor who wants to get in on the ground floor of the fledging psychedelic drug industry and is looking for a company with exceedingly high potential.

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The Global Addiction Treatment Industry Revenue Opportunities

Awakn estimates that more than 20% of the global adult population, of which North America accounts for 40% and Europe for 30%, suffer from alcohol, drug and tobacco abuse and behavioral addictions, such as gambling which currently affects an estimated 10 million gambling addicts in the U.S. alone and, with the rise in legalized sports betting, it is likely addiction per capita metrics will continue to rise in the future. 

The private global addiction treatment industry is currently valued at US$17.5 billion per year and forecast to increase to US$31.5 billion per year by 2027.

• Were Awakn to realize just a 1% share of that market it would amount to revenue of US$5.0B per annum. That would turn Awakn into a major pharmaceutical company in its own right and of major interest to Big Pharma as a possible acquisition.
• Even a miniscule 0.1% market share would equate to US$500M per annum and make Awakn the fifth largest psychedelic drug company after Atai, Compass Pathways,, GH Research and Mind Medicine.

The company expects to have 20 psychotherapy clinics in operation by the end 2024 with each clinic forecast to generate £4m top line in revenue, for a total forecast of £80m in revenue by then, licensing partnership revenue commencing in 2022 and therapeutic commercialization revenue being realized by 2025. ]

Awakn is developing a pipeline of next-generation therapeutics to treat addiction, with a near-term focus on ketamine, a medium-term focus on MDMA, and a long-term focus on Awakn’s own developed drugs (New Chemical Entities).

Clinical-Stage Research

Awakn is one of 36 clinical-based companies researching 10 different psychedelic substances for the treatment of mental health conditions (see article here) and, as mentioned above, has a near-term focus on ketamine and a medium-term focus on MDMA.

Ketamine-Based Research

Ketamine, which is primarily used as an anesthetic in accident and emergency rooms around the world, is the only
psychedelic drug that is broadly legal today and 6 of the 36 companies mentioned above are involved in mental health research using ketamine of which Awakn is one. This gives ketamine a unique advantage in the psychedelic industry as it already has regulatory approval due to its decades of use in hospitals.

For its part, Awakn has initiated a ketamine research program designed and led by, Celia Morgan, PhD., an internationally respected expert in the therapeutic use of ketamine and Awakn’s Head of Ketamine-Assisted Psychotherapy for Addiction. The program will demonstrate the effectiveness of ketamine-assisted psychotherapy against multiple addictions, initially focusing on treating AUD and gambling addiction and will consist of, amongst other activities:

• a completed phase I Iab clinical trial focused on AUD, the only company in the world providing evidence-backed ketamine-assisted psychotherapy for AUD,
• a mechanistic study focused on gambling addiction, the world’s first ketamine treatment study for gambling
  addiction, 
• and intellectual property development activities.

MDMA-Based Research

MDMA refers to 3,4-methylenedioxymethamphetamine (its street drug name is "Ecstasy" or "Molly") which has a strong safety profile, produces feelings of emotional warmth, an increase in self-awareness and an increase in empathy which makes it an excellent adjunct to psychotherapy. 5 of the 36 companies mentioned above are involved in MDMA research of which Awakn is one.

For its part, Awakn has acquired the exclusive rights to the data from the phase IIa Bristol Imperial MDMA in Alcoholism Study (BIMA) from Imperial College London, which was a safety, tolerability and proof-of-concept study to investigate the role of MDMA-assisted psychotherapy in treating the 5% of the world's adult population with AUD.

The study indicated that MDMA has the potential to be effective in treating the 5% of the world's population affected by AUD as there was only a 20% relapse rate with such treatment within the first nine months compared to the 75% relapse rate within the first 12 months with traditional treatments. AUD accounts for 30% of the treatment market of which only 16% of those suffering from it seek treatment.

The BIMA data will assist Awakn's progress by enabling it to design a more efficient execution of its clinical program enabling Awakn to accelerate its clinical research into a phase IIb Randomized Controlled Trial in the U.K.. The acquisition of the BIMA data is part of Awakn's strategy to secure marketing authorization for MDMA to treat AUD in both the U.K. and the European Union, a 400-million-person territory.

New Chemical Entity (NCE) Research

Awakn reported in its Q2 2021 (3-months ending July 31, 2021) financial results (see here) and business highlights that it intends to build on its position and experience as a clinical phase biotechnology company to develop a range of innovative and targeted new candidates to treat several poorly addressed addictions where the consequences for the patient, their family, and society, are quite severe.

To that end, Awakn has filed provisional patent applications in the U.S. for two next-generation novel MDMA-derived new chemical entities, AWKN001 and AWKN002, as part of their New Chemical Entity drug discovery program will further strengthen the Company's intellectual property portfolio and pipeline for the treatment of substance and behavioural addictions placing Awakn as a global leader in the psychedelic-biotechnology industry. Awakn has appointed Evotec who are renowned as the world’s leading drug discovery company as their contract research organization. Results from the first stage are due in early Q$ 2021 early Q4 2021.

Professor David Nutt, Awakn’s Chief Research Officer, commented that,

“The candidates we are developing will bring together the best therapeutic characteristics of MDMA, with more rapid onset of activity, and a shorter half-life, in a research space that is undiscovered. These improved candidates will enable us to treat more patients at a reduced cost and with the potential to increase both efficacy and the range of disorders we can treat.  This, together with our teams of partner organizations and in-house drug discovery and development experts will enable us to make rapid progress towards treating addiction, a condition with huge unmet medical needs.”

Anthony Tennyson, Awakn’s CEO added:

“Our ambition is to fully integrate effective psychedelic-based treatment into mainstream healthcare to better treat addiction. We are fortunate to have many of the world’s leading researchers, drug discovery experts and preclinical data that all support our vision at Awakn to provide those with addiction, next-generation psychedelic medicine as a treatment option. Our clinical team has unparalleled experience in treating addiction, and now with the development of a world class psychedelic-drug discovery pipeline, it has strategically placed Awakn as a global leader in this space.”

Clinic Roll Out

Norway

Awakn has acquired Axonklinikken AS ("Axon"), a leading ketamine-assisted psychotherapy clinic in Norway which will be renamed 'Awakn Clinics Oslo AS, and will serve as the Nordic hub from which Awakn plans to expand its clinical network across the region. The acquisition is part of Awakn's larger strategy to open 20 addiction and mental health clinics across Europe by the end of 2024.

According to Anthony Tennyson, Awakn's CEO:

"This acquisition will enable Awakn to demonstrate the depth of our three-pronged revenue generation strategy: clinics in the U.K. and Europe, licensing partnership beyond the U.K. and Europe, and therapeutics commercialization. We look forward to opening more clinics across the Nordic region and globally as we aim to become the leading authority in the development and delivery of psychedelic therapeutics."

U.K.

Awakn has signed a 10-year lease to open Awakn Clinics London, a 5,000 square-foot, 8 treatment room clinic which will be owned and operated by Awakn and led by on-site psychiatrists to deliver psychedelic-assisted psychotherapy treatments for addiction and other mental health conditions.

Awakn Clinics London will deliver ketamine-assisted psychotherapy in the near term and will utilize MDMA therapies as, and when, marketing and regulatory authorization is granted. Awakn Clinics London will be the second of three Awakn clinics to open this year in the UK. The first was Awakn Clinics Bristol and the Manchester clinic is scheduled to open in late Q4.

CEO Tennyson commented:

"A significant majority of people globally have been either directly or indirectly affected by Addiction or mental health conditions. Suffering themselves or having family or friends whose lives have been upended by these conditions. The opening of Awakn Clinics London marks a significant milestone not only for Awakn, but for the people of London who have been suffering with Addiction and mental health conditions."

Awakn has entered into an agreement with Mind Cure Health Inc. for Mind Cure to become a distributor of its ketamine-assisted psychotherapy for Alcohol Use Disorder (AUD) protocol in the U.S. and Canada via Mind Cure's iSTRYM digital therapeutics platform. Mind Cure forecasts 75 partner clinics in Canada upon commercialization beginning in Q1 of 2022 and anticipates 150 additional clinics across Canada, the U.S., the U.K., and Europe by Q4 2022.

A Proven Team of Executives, Directors and Advisors

Awakn's management team, as outlined below, has extensive psychedelic, biotech and capital markets expertise:

• Anthony Tennyson, CEO; Prof. David Nutt, Chief Research Officer; Dr. Ben Sessa, Chief Medical Officer; Prof. Celia Morgan, Head of Ketamine-Assisted Psychotherapy and Dr. Shaun McNulty, Chief Science Officer.

In addition, Awakn has highly regarded individuals acting as non-executive directors and advisors as follows:

• Stephen Page (Former CEO of the Priory - UK); Prof. Barbara Mason (Director of the Pearson Center for Alcoholism and Addiction Research); Prof. Harriet de Wit (Department of Psychiatry and Behavioral Neuroscience at the University of Chicago); Prof. Stephen Husbands (Department of Pharmacy and Pharmacology at the University of Bath); Prof. Kevin Fone (Department of Neuroscience at the University of Nottingham) and Prof. Matt Johnson (Department of Psychiatry and Behavioral Sciences at Johns Hopkins University).

More information On Awakn

• Go here to hear Tennyson, explain what makes Awakn’s model so compelling in a sector where most are targeting Post Dramatic Stress Disorder (PTSD).
• Go here for Awakn's latest (September) Corporate Presentation and
• Go here to access the company's web site.

Stock Performance

Awakn's stock began trading on the Canadian NEO stock exchange on June 23rd (AWKN), on the OTCQB Venture Market on August 8th (AWKNF) and on the Frankfurt stock Exchange (FWB:954) later in August with CEO Tennyson commenting that:

"The uplisting to the OTCQB is a significant achievement in our strategy to broaden our reach and access into the institutional and retail investment community in the United States. We look forward to introducing Awakn to both the U.S. institutional and retail investment community as we continue move forth our strategy of researching, developing and delivering psychedelic medicine to better treat Addiction." 

Initially, the stock traded on the OTCQB at US$1.48, rose to $1.91 on September 22nd. settled out, and is currently trading around $2.30/share.