Awakn Life Sciences Corp.

Overview

Awakn Life Sciences (NEO:AWAKN,OTCQB:AWKNF) is a revenue-generating biotechnology company conducting research, development and commercialization of therapeutics to treat addiction. With a near-term focus on alcohol use disorder (AUD), Awakn is the first company in the world to provide evidence-backed ketamine-assisted therapy for AUD. In the medium-term, the company will generate revenue or create value through out-licencing or sale of R&D assets.

Approximately 1 in 8 people in the world are living with a mental disorder, according to data from the World Health Organization. Canada’s Centre for Addiction and Mental Health says people with a mental illness are twice as likely to have a substance use disorder, compared to the general population, and at least 20 percent of those living with a mental illness have a co-occurring substance use disorder.

About 400 million globally are affected by AUD, and yet it remains one of the biggest unmet medical needs today. Awakn is working to disrupt this underperforming industry — currently valued at $25 billion per year — by advancing next-generation drugs and therapies, through preclinical research and clinical stage trials.

The company’s business model focuses on two things: 1) research and development, by combining existing drugs with Awakn’s proprietary therapies to treat AUD; 2) commercialization, through Awakn-owned clinics throughout Europe and through licensing partnerships with third-party addiction treatment clinics in North America.

Project Kestrel is the lead clinical development program of Awakn Life Sciences. Project Kestrel is supported by Awakn’s Phase II a/b ‘KARE’ clinical trial which examined ketamine-assisted therapy for the treatment of alcohol use disorder (AUD). The trial resulted in patients experiencing on average 86 percent abstinence at six months post-treatment versus 2 percent before the trial, which means study participants went from being sober on average seven days a year to being sober on average 314 days a year. The company was recently successful in securing funding for Phase III clinical trial for Project Kestrel from the UK’s National Institute for Health and Care Research (NIHR). The NIHR grant will cover 66 percent of the approximately $3.75 million cost of the clinical trial.

Research and Development

Awakn’s research and development team repurposes existing drug treatments for AUD and combines them with Awakn’s proprietary therapy to develop effective treatment protocols. The goal is to expand these treatments to other forms of addiction over time, including a range of behavioral addictions.

The company is currently pursuing three types of therapies, in varying stages of development: ketamine-assisted therapy for AUD; MDMA-assisted therapy for AUD; and ketamine-assisted therapy for behavioral addictions.

Commercialization

Awakn operates three clinics in Europe: two in the UK (London and Bristol) and one in Oslo, Norway. These clinics use Awakn’s proprietary therapy treatment programs for patients with addiction and mental health conditions and collect clinical data for further research and development.

Awakn-owned clinics also generate revenue for the company, growing 34 percent during the first half of 2022. The company plans to grow the number of clinics to between 15 and 20 sites, with each clinic generating C$4.5 million annually.

Licensing

Part of Awakn’s commercialization strategy is licensing its proprietary ketamine-assisted therapy for treating AUD to third-party addiction treatment centers in the US and Canada. In addition to providing access to Awakn’s proprietary therapy package, the licensing agreement also includes training, systems support and clinic design and new-site activation support.

Company Highlights

• Awakn Life Sciences is a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder
• Phase III clinical trial of Awakn’s proprietary ketamine-assisted therapy treatment for AUD has received 66 percent grant funding from the UK state National Institute for Health and Care Research (NIHR)
• Completed world’s first ketamine treatment study for behavioural addictions
• Three operational clinic locations: London and Bristol in the UK, and Oslo in Norway
• Licensing agreements with Revitalist in the US and Wellbeings in Canada for use of Awakn’s proprietary ketamine-assisted therapy for AUD treatment.
• Awakn has a world-leading scientific team with decades of experience researching, developing and commercializing therapeutics to treat addiction

Management Team

George Scorsis - Chairman of the Board

George Scorsis has 15 years of experience leading companies in highly regulated industries to rapid growth, including alcohol, energy drinks; and, most recently, medical cannabis. He was the former president of Red Bull Canada and was instrumental in restructuring the organization and growing the business to a revenue of C$150 million.

Anthony Tennyson - Co-founder and Chief Executive Officer

Anthony Tennyson is an experienced financial services industry executive with 10 years of experience in international strategy and commercial leadership roles with Aon, five years with Merrill Lynch and the Bank of Ireland. He holds a master’s of business administration in strategy and finance and a master’s of science in technology from UCD Smurfit, Ireland's top-ranked business school.

Jonathan Held - Co-founder and Chief Financial Officer

Jonathan Held is a chartered professional accountant with CFO-level experience for private and public companies. He has worked in several sectors, including technology, biotech, and natural resources. Held has experience in both domestic and international markets and has been involved in numerous successful public market transactions, including initial public offerings, reverse takeovers, and financings.

James Collins - Chief Operating Officer

James Collins is a senior business leader and mental health champion with 17 years of experience. His tenure includes working with Accenture Strategy, spending seven years as managing director, and designing and delivering corporate, digital, and operating model strategies. Collins holds a bachelor of science and master’s of philosophy in psychology degrees from the University College London.

Professor David Nutt - Chief Research Officer

Professor David Nutt is currently the Edmond J. Safra professor of neuropsychopharmacology and director of the neuropsychopharmacology unit in the division of brain sciences. After entry to Bristol Grammar School, Nutt received an open scholarship to Downing College Cambridge. He then completed his medical training at Guy's Hospital, London, continuing in neurology to magnetic resonance cholangiopancreatography (MRCP). In 1988, Dr. Nutt established the psychopharmacology unit at Bristol University, an interdisciplinary research group spanning the departments of psychiatry and pharmacology. Nutt moved to Imperial College London in December 2008, leading a similar group with a particular focus on brain imaging, especially positron emission tomography (PET). He is currently chair of DrugScience, formally the Independent Scientific Committee on Drugs (ISCD). Dr. Nutt was previously president of the European Brain Council, the European College of Neuropsychopharmacology (ECNP), the British Neuroscience Association (BNA), and the British Association of Psychopharmacology (BAP).

Professor Celia Morgan - Head of Ketamine-Assisted Therapy

Professor Celia Morgan is a professor of psychopharmacology at the University of Exeter in the UK, where she was given a chair in 2015. She completed her undergraduate and doctoral degrees at University College London (UCL). After earning her doctorate, Morgan worked at the University of Melbourne as a visiting research fellow, returning to UCL for a fellowship and then a lectureship.

Dr. Arun Dhandayudham - Chief Medical Officer

Dr. Arun Dhandayudham has been a consultant in addictions psychiatry since 2005 and trained in Oxford and Cambridge. He currently works Part time as Executive Medical Director of WDP which is a large third sector organization. He was previously Clinical Director of the NHS Addictions services across Bedfordshire and Northamptonshire as well as Clinical Lead within CRI. Arun has extensive experience in setting up community drug and alcohol services, prison services and dual diagnosis services. He has an interest in online shopping addiction, PTSD and chronic arousal states such as pain and anxiety. Previous roles include being part of the Royal College of Psychiatry Addictions Faculty serving as Coordinator for the Regional Representatives network as well as Chair of the Addictions Faculty Patients and Carers group. Arun also has a keen interest in supporting addiction research and patient advocacy.

Dr. Laurie Higbed - Lead Psychologist

Dr. Laurie Higbed is an experienced clinical psychologist who has worked as a lead therapist on clinical trials using MDMA and psilocybin-assisted psychotherapy. Dr. Higbed has a special interest in working with complex trauma, addictions, and the use of psychedelic therapy to treat a range of mental health difficulties. Higbed is registered with the Health and Care Professions Council (HCPC) and is a member of the Association of Clinical Psychologists (ACPUK).

Kevin Lorenz - US Head of Commercial Development

Kevin Lorenz brings deep commercial biotech experience to Awakn, having spent two decades in the pharmaceutical sales industry, particularly in the US addiction treatment market. Previously, he worked at Alkermes as senior regional sales director, where he directed a team of leaders and their representatives, covering 32 states for Vivitrol, an FDA-approved medication for the treatment of Alcohol Use Disorder and Opiate Use Disorder. During his time with Alkermes, Lorenz was responsible for half of the US sales of Vivitrol, which was worth US$170 million per annum. Before Alkermes, he worked at Cephalon and Janssen Pharmaceuticals, amongst others. Lorenz received his degree from Lambuth University.

Gordo Whittaker - Chief Marketing Officer

Gordo is a senior marketing and communications industry leader with over 10 years of experience, building, protecting, and growing some of the world’s most famous brands, including Volkswagen and Land Rover, where he led their global advertising functions.

Dr. Ben Sessa - Co-founder and Head of Psychedelic Medicine

Dr. Ben Sessa has specialist training as a child and adolescent psychiatrist and is interested in the developmental trajectory from child maltreatment to adult mental health disorders, including addictions. Sessa's interests in psychotherapy, pharmacology, and trauma have led him towards researching the subject of drug-assisted psychotherapy using psychedelic adjuncts. In the last 15 years, he has been part of scientific and clinical studies administering LSD, psilocybin, ketamine, MDMA, and DMT to patients and volunteers.

Shaun McNulty - Chief Scientific Officer

Shaun McNulty is an experienced biotechnology executive with over 20 years of experience in drug development with Pfizer, GSK, Syntaxin, ImmBio, Biosceptre and Inflection Biosciences. McNulty holds a doctorate of philosophy degree from the University of York and researched central nervous system (CNS) biology and signaling at the University of Cambridge, UK.

Martyna Kabia - Human Resources Lead

Martyna is a highly motivated and career-driven human resource (HR) professional with over 20 years of proven ability gained in the NHS, higher education, private and public sector, and through a faith-based approach. She is experienced in key areas of strategic HR management including recruitment and selection, employee relations, employment law, analysis and reporting, remuneration, job evaluation, project work, training, coaching, mentoring, and HR consultancy.

Steve Page - Non-Executive Director

Stephen Page has worked in chief executive- and board-level positions in the UK healthcare industry for over 30 years. During his tenure, Page led Priory Healthcare, the largest network of mental healthcare hospitals and clinics in the UK, through a period of rapid expansion and market dominance. Page has led, and successfully grown, organizations in public and private sectors, including Oxleas NHS Trust in London, Nestor, and Acorn Care and Education.

Paul Carter - Independent Non-Executive Director

Paul Carter is a seasoned international BioPharma leader with an outstanding and proven track record. He has over 25 years of senior executive experience, specializing in commercialization, regional leadership, and mergers and acquisitions. Carter is currently a board director and committee chair of four US-listed BioPharma companies: HutchMed, Mallinckrodt Pharmaceuticals, Immatics, and VectivBio. Prior to this, Carter served as executive vice-president and chief commercial officer of Gilead Sciences, where he was responsible for the company's worldwide commercial activity, including US$33 billion of revenue in 2015, and for launching several of the biggest selling prescription drugs of all time. Before that, he had senior leadership roles in GSK, and its legacy companies, including head of GSK China, SmithKline, and Beecham, now GlaxoSmithKlineRussia.

Professor John Papastergiou - Non-Executive Director

Professor John Papastergiou is a highly regarded pharmacist and clinical research scientist who has served as an advisor to several leading pharmaceutical organizations, including Bayer, Pfizer, GSK, and AstraZeneca.

Dennis Purcell - Special Advisor to the CEO

Dennis Purcell is the Founder of Aisling Capital LLC, a major life sciences venture capital firm based in New York City and has previously served as the Fund’s Senior Managing Partner and Advisor. Prior to the formation of Aisling Capital, Purcell served on the Executive Committee and as Managing Director of the Life Sciences Investment Banking Group at Chase H&Q, formerly Hambrecht and Quist. During his time in the industry, he has invested in, raised capital for, and advised hundreds of life sciences companies. He currently serves on the board of directors of Real Endpoints, Ichnos Pharmaceuticals, Summus Global, Shorla Oncology, and Embera Pharma. He is also an advisor to Better Health, Cellevolve and xCellerate. He has previously served on the Boards of public and private Life Sciences companies.

Scientific Advisors

Professor Barbara Mason - Advisor

Barbara J. Mason, PhD, is director of the Pearson Center for Alcoholism and Addiction Research and of the Laboratory of Clinical Psychopharmacology. Dr. Mason works as a Pearson Family professor in the department of molecular medicine at The Scripps Research Institute, La Jolla, California. Dr. Mason's work in medication development for the treatment of substance use disorder has been recognized with the Smithers Distinguished Scientist Award from the American Society of Addiction Medicine, and a MERIT Award from the National Institutes of Health (NIH). Additional accolades include receiving the Dean's Senior Clinical Research Award from the University of Miami School of Medicine and the Andrew W. Mellon Foundation Teacher-Scientist Award from Weill Cornell University Medical College.

Professor Harriet de Wit - Advisor

Harriet de Wit is the professor and director of the human behavioral pharmacology laboratory in the department of psychiatry and behavioral neuroscience at the University of Chicago. In addition to her role as principal investigator for several NIH-funded research projects, Dr. de Wit serves as field editor for the journal Psychopharmacology. She is also a consultant to the Food and Drug Administration (FDA).

Anne Mithoefer - Advisor

Ann Mithoefer has a bachelor of science in nursing degree and is a registered nurse, focused primarily on training and supervising therapists conducting Multidisciplinary Association for Psychedelic Studies (MAPS)-sponsored clinical trials, as well as continuing to conduct some MAPS research sessions. Between 2004 and 2018, she and her husband, Michael Mithoefer, a medical doctor, completed two of the six MAPS-sponsored Phase II clinical trials testing MDMA-Assisted Therapy for PTSD. The pair also conducted a study providing MDMA-Assisted sessions for therapists who have completed the MAP therapist training. Mithoefer was instrumental in the pilot study treating couples with MDMA-assisted therapy combined with cognitive-behavioral conjoint therapy.

Dr. Michael Mithoefer

Dr. Michael Mithoefer began collaborating with MAPS in 2000 on the first U.S. Phase 2 clinical trial of MDMA-assisted psychotherapy. He has since conducted two of the six MAPS-sponsored Phase 2 clinical trials testing MDMA-Assisted Psychotherapy for PTSD, as well as a study providing MDMA-assisted sessions for therapists who have completed the MAPS-sponsored MDMA Therapy Training Program, and a pilot study treating couples with MDMA-Assisted Psychotherapy combined with Cognitive-Behavioural Conjoint Therapy. He is now the Senior Medical Director for Medical Affairs, Training and Supervision at MAPS Public Benefit Corporation (MAPS PBC). He is a Grof-certified Holotropic Breathwork Facilitator, is trained in EMDR and Internal Family Systems Therapy, and has nearly 30 years of experience treating trauma patients.

Professor Stephen Husbands - Advisor

Stephen Husbands is a professor of medicinal chemistry in the department of pharmacy and pharmacology at the University of Bath. His research has focused on the development and therapeutic potential of central nervous system-targeted ligands, particularly those interacting with multiple receptors.