Fighting Opioid Dependency with Plant-Based Medicine
Universal Ibogaine (TSXV:IBO) is a Canadian company working to develop the gold standard for addiction treatment.
The company is developing an ibogaine based drug franchise to treat addiction and related mental health issues. These treatments will be administered within a global network of owned and franchised state-of-the-art holistic treatment clinics.
Addiction doesn't just affect 1 in 5, it affects everyone.
Addiction and the underlying mental health challenges are the true epidemic of our time. No family has not been touched by the problem of addiction. The pointed end of the addiction crisis is opioid related overdose death. Opioid overdose has become the leading cause of accidental death in North America. Approximately 150 people die every day in North America. In Vancouver BC, the center of the opioid problem in Canada, one person dies from opioid overdose every two hours.
Opioids can be found in methamphetamine licit and illicit forms. Several opioid medications, including codeine, fentanyl, morphine, oxycodone and diacetylmorphine are produced and used most often to treat pain. Problematic opioid use generally occurs when a patient finds they are unable to discontinue use upon the completion of their prescription. The patient is then forced to turn to illicit sources.
What is Ibogaine?
Ibogaine is a psychoactive alkaloid extracted from the root bark of Tabernanthe iboga, a Central West African rain forest shrub called iboga. Iboga has been used by local cultures as a rite of passage for centuries.
Ibogaine has been shown to provide rapid detox from opioid use by regenerating opioid receptors in the brain, thereby resetting the brain to a pre-addicted state. Ibogaine also converts to a long-acting metabolite which continues to support brain development for 2 to 4 months post treatment. This time, along with an aftercare program, provides the patient an opportunity to establish healthy new habits and rebuild their lives.
Universal Ibogaine Co-Founder Dr. Alberto Sola has provided ibogaine detox treatment to over 3700 patients, more than any other doctor in the world. Universal Ibogaine is leveraging the treatment data developed by Dr. Sola to advance a clinical trial in Canada for the use of ibogaine in opioid detox.
Universal Ibogaine also owns and operates a traditional addiction recovery center where it will develop a state-of-the-art holistic pretreatment, detox and aftercare programs into which the ibogaine treatment protocol will be inserted upon successful completion of the human proof of concept study.
Studies have shown the potential for opioid detoxification with ibogaine, with evidence that suggests a lack of withdrawal symptoms after a single dose. “Individuals typically do not go back into withdrawal following opioid detoxification with single doses of ibogaine despite opioid abstinence, suggesting a persistent modification of neuroadaptations associated with opioid tolerance or dependence," said Tamara Antonio in the study “Effect of Iboga Alkaloids on µ-Opioid Receptor-Coupled G Protein Activation." Ibogaine is currently a Schedule I substance according to the US Drug Enforcement Agency.
In Canada, ibogaine sits on the Prescription Drug List, meaning the pathway to medicalization faces significantly less barriers. With the addition of the real world treatment data, Universal Ibogaine is confident in their ability to bring this medicine to market in a timely fashion.
Universal Ibogaine Inc. has completed a reverse-takeover Qualifying Transaction with P Squared Renewables (TSXV:PSQP), a Capital Pool Company, allowing the company to list on the TSX Venture Exchange.
In concert with the Qualifying Transaction, Universal Ibogaine has completed a C$6 million financing.
Universal Ibogaine's Company Highlights
- The only pure-play public ibogaine company in the world
- Focused on Ibogaine drug development plus state-of-the-art treatment clinics
- Co-Founder Dr. Alberto Sola has administered over 3700 ibogaine treatments, more than any other doctor in the world.
- CEO Dr. Rami Batal has a 25-year successful track record in developing experimental medicines.
- De-Risked bio-tech drug development backed by real world treatment data set.
- Treatments to occur in a safe clinical environment, through the development of gold-standard addiction treatment clinics
- Arranging for clinical trials to medicalize ibogaine in Canada, including securing contract research organization (CROs), drug supply, and institutional partners
- Acquired an active addiction treatment center in Canada to perfect the wrap around treatments and roll out ibogaine once approved in Canada.
- Partnering with Canadian First Nations to investigate treatment possibilities on sovereign indigenous territories.
- Acquired land in Belize with an eye toward co-development of an addiction aftercare treatment center.
Kelburn Addiction and Mental Health Treatment Center
The Kelburn Clinic is an established and respected conventional addiction treatment center located near Winnipeg Manitoba in Canada. The center was acquired through the financing and qualifying transaction with P Squared Renewables. The center will be re-branded as Clear Sky Recovery and will host the research and development side of Universal Ibogaine's Canadian operations.
Having an operating treatment center makes Universal Ibogaine revenue positive will in clinical trials, it offers the team a development platform for the creation of its state of the art addiction treatment models.
The pre and post ibogaine treatment protocols can be expanded into a network of owned and franchised facilities during the ibogaine drug development process. The network of clinic will then provide the runway to deliver the approved ibogaine medicines according to the treatment protocols developed in the original Clear Sky Clinic.
The Kelburn clinic also sits on a 50-acre development parcel which holds promise to further expand research and treatment facilities in the near term.
Clear Sky Recovery Clinic
Universal Ibogaine Inc. has acquired the exclusive worldwide licensing rights as well as a purchase option from Clear Sky Recovery Cancun, the world leading ibogaine treatment center based in Cancun, Mexico.
The facility has provided over 3700 ibogaine treatments using a proven protocol designed to ease the withdrawal symptoms associated with a variety of addictive drugs including opioids such heroin, OxyContin & Oxycodone, methadone, buprenorphine (Subutex and Suboxone), methamphetamines, cocaine, and alcohol.
According to the company, ibogaine has the potential to eliminate 95 percent of symptoms associated with opioid withdrawal. Ibogaine seems to produce a flood of neurotrophic growth factor which targets and repairs damaged receptors in the brain. During the treatment the opioid receptors are repaired to a pre-addicted state. Certain psychological experiences during the treatment also help to reveal and heal underlying trauma that may have contributed to substance abuse and addictive behaviors.
After the treatment, opioid receptors are rendered “naive". It is as though the brain has never taken an opioid. Ibogaine also produces a long-acting metabolite which helps to reduce cravings and continues neurogenic growth for up to 4 months after the treatment. This allows the patient time to create healthy new habits and rebuild their lives through an effective aftercare program.
The facility's treatment protocols are designed to meet the specific needs of individual patients and their unique medical background. The facility is an oceanfront private hospital located in the Punta Sam resort area of beautiful Cancún that aims to provide a safe and effective setting for ibogaine treatment for interrupting drug dependency disorders. Clear Sky provides a comprehensive pre-care and aftercare package that can be customized to cater to a patient's unique needs.
Over the last 13 years, Dr. Alberto Sola has treated thousands of patients at Clear Sky Recovery. He believes ibogaine has significant potential in combating drug dependency issues. “We have a once in a lifetime to help the sufferers of a modern-day epidemic, the opioid crisis, by bringing them a safe and effective, seven-day treatment with ibogaine. It's an opportunity to save lives, change paradigms in the addiction industry and pioneer a brand-new market."
Universal Ibogaine's Management Team & Board of Directors
Dr. Rami Batal, PharmD/PhD - Chief Executive Officer
Dr. Rami Batal is a seasoned biopharmaceutical industry executive and a healthcare professional who has a passion for, and expertise and experience in, neuropsychiatry and mental health/behavioral health illnesses, including substance use disorders. Dr. Batal has occupied leadership and influencing roles in research and development, strategic marketing and business development at Antibe Therapeutics, Canopy Growth, Beckley-Canopy (now Beckly-Psytech), Purdue Canada, and Yumanity Therapeutics. Dr. Batal holds a doctorate in Experimental Medicine from McGill, and an MBA from Concordia. He is a Canada Board certified Pharmacist and is licensed to practice in Quebec.
Greg Leavens, CPA - Chief Financial Officer
Greg Leavens, CPA CA - is a financial executive, CFO and Controller with 30 years of experience in public accounting and industry, including the oil & gas exploration / production and service sectors. Greg started his career with KPMG, and has extensive experience in leadership, strategic planning, due diligence reviews, financing, forecasting, financial reporting, treasury and risk management, and regulatory compliance.
Dr. Ian Rabb - Chief Clinics Officer
Dr Ian Rabb is one of the most recognized and respected leaders in Addiction Treatment in Canada today. Dr. Ian Rabb is a certified Interventionist and addictions specialist who has helped thousands of people overcome addiction. In his 20 years of sobriety, he has founded Two Ten Recovery and Destiny House — Winnipeg's only sober living housing organization. Ian was the visionary founding member of Aurora Recover Centre in Gimli Manitoba and most recently held the position of Director of Business Development at Edgewood Health Network, Canada's only national addiction treatment center brand. Prior to his work in addiction treatment Ian was a practicing Doctor of Optometry.
Dr. Glenn Copeland - Senior Medical Advisor
Dr. Copeland is internationally recognized for his work as the former founder, chairman and CEO of the renowned Cleveland Clinic Canada. He also established the Rehab and Wellbeing Centre and Sports Medicine Centre at Mount Sinai Hospital in Toronto.
Chief Ian Campbell, MBA - Chairman (Independent)
Chief Ian Campbell (Xalek) is a hereditary chief of the Squamish Nation located in Vancouver, British Columbia. He has served as an elected member of council since 2005 and was appointed as a Political Spokesperson in 2008. Since 1999 he has been the Cultural Ambassador and Negotiator for the Intergovernmental Relations Department of the Squamish Nation, advancing Aboriginal rights and title, while invigorating substantive economic opportunities through negotiations, collaboration, and partnerships. Ian graduated from Simon Fraser University with an MBA in Aboriginal Business and Leadership.
Dr. Alberto Sola, BSc, MD
Clear Sky Addiction Solution's President, Dr Sola is a thought leader in entheogenic treatment. He has the distinction of having treated more patients with ibogaine than any other person in the world and is head of operations at Clear Sky Recovery. Dr. Sola graduated from Universidad Anahuac. As the Medical Director of Amerimed, he opened four emergency hospitals for tourists in Puerto Vallarta, Cancun, and Cabo San Lucas.
Robert Turner, ICD.D, MBA - Director (Independent)
Mr. Turner is President of his own incorporated consulting firm and a Principal within Western Management Consultants. His consulting focus is providing guidance to boards on their governance including proper CEO oversight. Mr. Turner brings experience as a CHRO in both the private and public sectors. Subsequently, he joined Mercer Canada as a Partner focused on consulting within Canadian health care. Robert has served on Universal Ibogaine's Advisory Board since December 2018. Robert has an ICD.D certification from Rotman Business School, an MBA from the Ivey Business School and a BSc (Biochemistry) from the University of Toronto. He serves on the Boards of two other corporations – one private and one not-for-profit.
Marilyn Loewen Mauritz, ICD.D, JD - Director (Independent)
Marilyn Loewen Mauritz is a senior corporate executive with over 25 years of experience in diverse industries. From 2015 to January 2021, Ms. Mauritz held several senior executive positions at Central 1 Credit Union, a leading provider of financial, digital banking and payment solutions, including serving as the interim Chief Executive Officer. Most recently, she served as Central 1's Chief Transformation & Legal Officer, where she led the Legal, Compliance, Governance, Strategy, Information Technology and Government Relations teams. Prior to joining Central 1, she was General Counsel and Corporate Secretary at Interfor Corporation. She currently serves on the Board of YWCA of Greater Vancouver, chairing the Governance and Nominating Committee. Marilyn obtained her Bachelor of Law degree from the University of Calgary and holds a Bachelor of Arts degree from McMaster University. She is a graduate of the Institute of Corporate Directors, ICD.D.
Anthony DeCristofaro - Director
Mr. DeCristofaro is currently CEO of Qnext Corp., a global developer of disruptive apps and private cloud technologies, and his extensive experience includes thirty years in the computer industry and three M&A transactions valued at more than $600 million. Over the course of his career, DeCristofaro has been sought out as a member of several high-profile public Boards, including Hartco, Delrina, Synchronica, and TransGaming. He also currently serves on the Board of Directors of Jack Nathan Medical Corp.
David Danziger, CPA, CA - Director
David Danziger is Senior Vice President, Assurance & National Leader, Public Companies of MNP LLP, Chartered Professional Accountants ("MNP"), Canada's fifth largest accounting firm. He is a member of the firm's management team and responsible for providing leadership and direction to MNP's Assurance practice across Canada. David has extensive experience in both Canada and USA public market transactions and leverages significant expertise, having served as a director on many public companies listed on the TSX, the TSX Venture, the CSE and the New York Stock Exchange.
Near Term Goals and Milestones
The team at Universal Ibogaine is currently expanding, with notable hires in Clinic Operations, Drug Development, and additions to the board in Corporate Finance and Governance expected through Q4 2021.
Concurrent OTC and FSE listings completed through Q4 2021.
Drug development program with initial Canadian Clinical Trial expected to be underway by Q1 2022 with the goal to launch into Phase 2 Human Proof of Concept.
Additional revenue producing clinic acquisitions through 2022.
Transforming the Traditional Landscape of Mental Health, Addiction Treatment and Pain Management Treatment Across Multiple Verticals
Shifting legal frameworks and regulatory changes have made psychedelic medicine one of the most promising solutions to mental health and addiction treatment in the modern age. Strong demand from therapists and patients for treatments involving psychedelic drugs like psilocybin has pushed the market to new heights, including a projected market size of over US$10.75 billion by 2027.
Globally, the market for functional mushrooms was US$5.8 billion in 2018 and could grow to a CAGR of 8.0 percent by 2024. Early-movers in the space can expect exceptional growth and economic success as the psychedelic space continues to gain traction as an increasingly positive remedy to limited responses to mental health, substance use and chronic pain crises around the world.
Levitee Labs (CSE:LVT,OTCPK:LVTTF) is an emerging leader in the integrative wellness space. The company will be the world's first psychedelic company with significant revenue and cash flow by year end 2021. Levitee Labs revealed that its M&A team has been tremendously successful in structuring transactions that will define the future of the company. Its acquisition pipeline is deep with a focus on pain & addiction clinics, specialized pharmacies, regulated telehealth, therapeutic psychedelic compound accessibility, and novel nutraceuticals.
Levitee Labs has established a profitable platform of integrative wellness assets through internal development and a regimented acquisition strategy. It operates a robust portfolio of revenue streams, including platform acquisition verticals of addiction and pain clinics, pharmacies and supplement & nutraceutical brands. The company also operates its divisional Sporeo Supply, which offers the gold standard of picks & shovels for mushroom cultivation.
Levitee's acquisition strategy includes a focus on addiction clinics & pharmacies. Recent acquisition ACT Medical Centres serves as a base for future clinic acquisitions and already has a patient base of 35,000 visits yearly, positioning Levitee as the largest non-government provider of addiction services in Alberta with 70% percent currently conducted via telemedicine. It provides Levitee with a platform for future research opportunities and allows for the future delivery of psychedelic medicine to addiction and chronic pain patients. The LTM revenue of this vertical is approximately C$7.5 million.
Additionally, Levitee's nutraceutical rollup and strategy are focused on a significant acquisition pipeline with over $50 million in revenue, which includes Earth Circle Organics. This acquisition already involved an executed LOI with an omni channel superfoods brand.
The company's Project Outback seeks to acquire a late stage applicant for a Health Canada sanctioned Controlled Drugs and Substances Dealer's License. This would allow Levitee Labs access to compounds such as psilocybin, MDMA, ketamine, LSD and DMT. The provisions surrounding the application would involve possession, production of base materials, delivery and import/export, which would widely expand the company's mission of traditional mental health and addictions treatment disruption and overall integrative wellness verticals.
Levitee Labs anticipates C$22.8 million in revenue in 2021. About C$13.2 million of the projected revenue comes from the company's ACT Medical Centres composed of five addiction clinics and three pharmacies. Levitee's major distribution partnership with My Green Planet is expected to have a year-end run-rate revenue of C$6 million while it expects C$3 million or 300% growth for its Earth Circle Organics acquisition.
The next steps for Levitee Labs include a psychedelic blueprint, which outlines an increased integration of alternative medicines and psychedelic therapies across its wellness platforms as regulations and shifting legal frameworks develop. Additionally, the company's R&D strategy is progressing sustainably, focusing on a rollout of alternative medicines to underserved patients.
The Levitee Labs management team comprises a diverse and complementary group of professionals across related fields in clinical research, public venture capital, M&A and operations. Together, they prime the company for exceptional growth potential, established key partnerships and positive financial valuations.
Levitee Labs' Company Highlights
- Levitee Labs is a multidisciplinary company dedicated to redefining traditional mental health and addiction treatments through integrating evidence-based complementary medicines and novel psychedelic therapies into the traditional infrastructure of mental health treatment
- The company's current major assets include addiction clinics, specialized pharmacies, a proprietary addiction-focused platform, an omnichannel nutraceuticals company as well as having internally developed a mushroom feedstock manufacturing facility
- The company acquires and operates healthcare and nutraceutical assets through a vertically integrated M&A model, leveraging medical expertise, technology and resources
- The company's nutraceutical and superfoods acquisition pipeline could bring over $50 million in revenue through Earth Circle Organics and others
- Its Sporeo Supply mushroom cultivation asset offers exceptional internally developed picks & shovels and involves a major distribution partnership with My Green Planet.
- Its Superfoods and Nutraceuticals vertical involves brands like Earth Circle Organics, OJIO, Earth Shift Products, Project Buddha and MONKE Nutraceuticals.
- Levitee Labs has a market cap of approximately C$37.5 million, an enterprise value of C$26 million, and a tight capital structure.
- Levitee Labs completed the acquisition of BlockMD Telemedicine Platform, three specialised pharmacies and five addiction clinics in Alberta.
- The company's management team is a strategically diverse and robust group of professionals with experience across an array of related fields including psychedelics, clinical research and strategic alliance.
- Levitee Labs added superfoods to its portfolio by completing the acquisition of all the issued and outstanding shares of Earth Circle Organics Chain Inc.
Levitee Labs' Integrated Wellness Portfolio
Clinic and Pharmacy Acquisition Strategy
Levitee's acquisition strategy focused on addiction clinics, pharmacies and pain management clinics serves as a platform for addressing the burden of inefficiencies prevalent within current clinical treatments, particularly those available to underserved patient populations. Levitee has acquired five clinics, three specialized pharmacies and a telemedicine platform, which the company intends to add additional services to treat underserved patients through innovative digital drug delivery avenues as the market expands.
The ACT Medical Centres acquisition has an estimated enterprise value hovering around C$5.9 million with a C$7.5 million LTM revenue and C$1.1 million EBITDA. The roll-up strategy would also include research into psychedelic medicine and trials of novel psychedelic compounds.
Nutraceutical Acquisition Rollup
Levitee's division of nutraceutical strategy focuses on acquiring brands that are established but lack an e-commerce presence with little to no marketing expenditure. These brands offer the company a first-mover advantage with early-stage positioning in growth, high search volume and limited established competitors. These companies also have proprietary products with exceptional economic volume but high barriers to entry. Levitee's main brands include MONKE Nutraceuticals and executed LOI involving Project Buddha and Earth Circle Organics.
- MONKE Nutraceuticals is an internally developed, premium functional mushroom company, which offers expansive distribution opportunities across Levitee's larger acquisitions.
- Earth Circle Organics is an omnichannel superfoods and supplements brand with a 300 percent growth rate in the last two years and contains over 180 SKUs across three encompassed brands.
Sporeo Supply – Mushroom Cultivation
Sporeo Supply centralizes all sterilization operations and offers cultivators high yield growth formulas for mushroom spawn and substrate. The company is currently building a production facility near Vancouver, British Columbia that will address the market fragmentation for mushroom cultivators, increase standardization of manufacturing practices for future psilocybin production and advance its production of ready-to-grow mushroom kits for consumers.
Its products will be available through retail, wholesale and e-commerce channels and aim to defragment the mushroom cultivation ecosystem. The company has secured a strategic partnership with My Green Planet to expand its reach and provide cultivators with the full range of growing materials required for the cultivation of all mushrooms.
Levitee Labs' Management Team
Pouya Farmand – CEO & Co-Founder
Pouya Farmand is an experienced financier and entrepreneur with over ten years in the financial markets, primarily in investment banking and venture capital. He has been involved in over 35 transactions ranging from C$1 million to C$50 million.
Kelly Abbott – COO & Director
Kelly Abbott has over ten years of experience in entrepreneurship and software development. He was the former founder and CEO of ParcelPal Technologies, overseeing over 400 employees at its peak.
Mason M. Darabi – CFO
Mason M. Darabi is an experienced CPA with a long history of working in various accounting roles in Canadian accounting firms including MNP, Imperial Oil, RSM Canada and PwC. In his most recent role, he led Ag Data from an idea to a thriving initiative, at the national level for MNP LLP.
Ken Osborne – CFA, Head of M&A, Co-Founder
Ken Osborne is a capital markets professional with diverse experience in both public and private markets covering over 20 capital raises and C$500 million in M&A activity.
Dr. Mohammed Mosli – Chief People Officer (Levitee Clinics, Alberta)
Dr. Mosli is a multilingual Public Health and Preventive Medicine physician specialized in Addictions Health, health services improvement, health promotion, environmental public health, and health policy. Throughout his career, Dr. Mosli served, or currently serves as a director, educator, or senior level manager for an array of organizations, including those in provincial, institutional, and private segments. He is a valuable physician member of the Opioid Addictions Medicine team for Levitee Clinics™ and Levitee Pharmacies™ in Alberta.
Marc Momeni – Executive VP
Marc is a finance professional with over 10 years of experience in financial services and banking. With a key competency in building and managing teams, Marc has been able to scale multiple businesses from start-up to over 7 figures.
Fady Hannah-Shmouni – Chief Medical & Scientific Officer
Dr. Hannah-Shmouni was a clinician scientist in neuroendocrinology, hypertension, and biochemical genetics at NIH (Maryland, USA) since 2015. He served as Director of the Office of Education's Graduate Medical Education (GME) with the National Institute of Child Health and Human Development; Chief of the Internal Medicine, Endocrinology, and Genetics Inpatient Ward; Associate Program Director of NIH's Inter-Institutes Endocrinology & Metabolism Fellowship Program; and Principal Investigator of neuroendocrine genetic and hypertension disorders.
Dr. Hannah-Shmouni specializes in neurohormonal dysregulation of the stress system, with a clinical focus on studying the effects of psychedelic therapies on endocrine conditions and different hormone axes. This specialization in stress hormones uniquely positions Dr. Hannah-Shmouni to provide clinical insights on the prolonged effects of stress that can lead to mental health disorders.
Azim Qazi – Head of Ecommerce and Consumer Packaged Goods
Azim Qazi has over 20 years of experience with broad expertise in dynamic retail marketplaces, business development and supply chain management to oversee Company-wide CPG operations, beginning with the recently launched product lineups of MONKE Nutraceuticals, and Earth Circle Organics. Prior to Levitee Labs,he has worked with Cymax Stores and Cymax Group in multiple leadership positions including Category Manager at Cymax Stores during which he developed objectives and key results for key categories representing 50 percent of total revenue, managed 32 separate $1 million vendors, negotiated marketing promotions, analyzed PPC campaigns and grew category revenue by 39 percent.
Noha ElSayed - Executive Director Levitee Clinics & Levitee Pharmacies, Alberta Region
Mrs. ElSayed brings a wealth of expertise gained through a variety of clinical and managerial positions held in retail pharmacies, hospitals, and primary care settings while working as a pharmacist for the last 20 years, including 11 years as a pharmacy manager. Mrs. ElSayed earned her Bachelor of Science degree in Pharmacy and obtained her Additional Prescribing Authorities from The Alberta College of Pharmacists. She is an active member of several specialized health care networks as the International Society of Travel Medicine and The Canadian Obesity Network. Mrs. ElSayed has a passion for mental health care, addiction treatment, custom compounding, and travel health, as well as diabetes and chronic disease management education. She prides herself on staying up-to-date with the latest pharmacy practices and procedures and is an expert in custom compounding techniques and knowledge.
INN does not provide investment advice and the information on this profile should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.
The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with Levitee Labs and seek advice from a qualified investment advisor.
Developing Psychedelic Medicine to Treat Addiction
Awakn Life Sciences (NEO:AWAKN,OTCQB: AWKNF) is a biotechnology company with clinical operations researching, developing, and delivering psychedelic medicine to treat addiction. It is the only company in the world providing evidence-backed ketamine-assisted psychotherapy for alcohol use addiction (AUD) through its near term Ketamine for Reduction of Alcoholic Relapse (KARE) protocol.
“For the sake of the millions of people in the world who could be helped, it's time to say there should be no limits to the therapeutic research we do with these drugs," says Prof. David Nutt, Head of Research at Awakn, in his TEDx Talk, “How can illegal drugs help our brains".
Addiction and mental health currently stand as the fifth leading cause of illness worldwide, affecting 20 percent of the global population and rising by 13 percent in the last decade. In treating these conditions, science and medical professionals are looking for a more robust form of therapy in psychedelics.
With positively shifting legal frameworks surrounding research and development of revolutionary psychedelic and biotech-based treatments, investors could see significant market growth in the upcoming years. The global substance addiction treatment industry is valued at US$17.5 billion per annum and is forecast to increase to US$31.5 billion per annum by 2027. The US and Europe combined, account for 70 percent of this market.
Awakn who are focused in this area, have a dual strategic focus of researching and developing psychedelic drugs, therapies, and enabling technologies to treat addiction and delivering psychedelic treatments for addiction in clinics in the UK and EU, and through licensing partnerships beyond the UK and EU.
In early 2021, as part of its Development division, the company initiated a new chemical entity (NCE) program with its research partner, Evotec SE (FSE:EVT, OTCBB:EVTCY) and leading the program is the world's expert on psychedelic research, Prof. David Nutt. Prof. Nutt is currently the Edmund J Safra Professor of Neuropsychopharmacology and Head of the Centre for Neuropsychopharmacology in the Division of Brain Science in Imperial College London, and Chair of DrugScience. Prof. Nutt is also Chairman of Awakn Life Sciences' Advisory Board and their Head of Research.
Awakn Life Sciences is focused on becoming a prominent clinical biotech company with its Delivery division set to stand as the dominant psychedelic medical clinics platform in the UK and the EU. This business model aims to generate revenue while providing access to patients and ensuring that the company has a deep and relevant data set.
“Awakn Life Sciences is uniquely positioned to take a leadership role in this emerging industry. We've got an incredibly strong drug development and therapy development pipeline, specifically targeting addiction," commented Awakn Life Sciences CEO Anthony Tennyson.
The following steps for the company include exciting first stages of NCE drug development programming and Awakn Digital's advanced analytics program. Additionally, the company intends to open the doors of several strategically positioned clinics in Bristol, London and Manchester, UK this year, with the aim of having 20 clinics throughout the UK and Europe by 2024.
Awakn Life Sciences' Company Highlights
- Awakn Life Sciences is a biotechnology company positioned to become a leader in clinical research, development and delivery of psychedelic medicine to treat addiction and other mental health conditions.
- Awakn's strong partnerships with notable players in the biotech and psychedelic space enable the company to expand its global reach through licensing and engagement with addiction treatment practitioners.
- Its clinic platform is set to become the leading UK and EU medical psychedelic clinic platform where there is a population of 400M and GDP over C$25 trillion.
- Awakn has initiated a new chemical entity (NCE) program with its research partner, Evotec, with the world's expert on psychedelic research, Prof. David Nutt, leading the program, having acquired six years of proprietary data from Prof. David Nutt.
- Awakn Life Sciences has a strong management and scientific team with years of combined experience in related industries, including technology, healthcare and psychedelic research.
- Acquire Axonklinikken AS (“Axon"), a leading ketamine-assisted psychotherapy clinic in Norway, which will be renamed Awakn Clinics Oslo AS. Dr. Lowan Stewart will be appointed as Regional Director for the Nordics and Managing Director Awakn Clinics Oslo AS.
- Awakn Clinics Bristol received Care Quality Commission's (CQC) formal approval to begin treatments.
Awakn Life Sciences' Complementary Divisions
Awakn has two divisions, Development and Delivery, each of which has two business areas within.
The company operates a portfolio of New Chemical Entity drug development and clinical trials planned and focused on the treatment of Addiction. Awakn's drug and therapy development team consists of leading experts in drug development, psychotherapy and scientific research who specialise in mental health and addiction. Its near and medium-term clinical trials aim to secure marketing authorization for ketamine and MDMA to treat Alcohol Use Disorder (AUD) in the UK and EU.
Long-term plans include New Chemical Entity drug development of the next generation of patentable psychedelic medicines focusing on the treatment of addictions such as AUD, opiates and other behavioural addictions.
Awakn Development works to enable technologies to improve the effectiveness of psychedelic-assisted psychotherapy in treating Addiction. 2021 plans include data capture to track identity transformation during psychological therapy using advanced data analytic techniques.
The future plans for Awakn Digital involve natural language processing to understand variables that lead to identity transformation and predictive & supportive analytics to develop and commercialize analytic data to support psychedelic-assisted psychotherapy practitioners.
Providing hope for those for whom the status quo is not working by combining the proven therapeutic potential of psychedelics with psychotherapy to treat Addiction and other mental health conditions.
Each Awkan Clinic will be owned and operated by Awakn, will be led by a consultant psychiatrist, will deliver ketamine-assisted psychotherapy in the near term, and will utilize MDMA when Awakn secures marketing authorization.
Awakn intends for extensive clinical expansion across the UK and EU, with a target of 20 clinics by the end of 2024.
Awakn utilizes strategic partnerships to scale its reach beyond core territories through licensing agreements and branching networks, which enable addiction treatment practitioners to deliver the Awakn methodology. These partnerships utilize protocols & therapy manuals, training, clinical best practices and data & analytics to create better patient outcomes at every level.
Awakn Life Sciences' 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 CAD$150 million in revenue.
Anthony Tennyson – CEO
Anthony Tennyon is an experienced financial services industry executive with ten years in international strategy, commercial leadership roles with Aon plc and five years with Merrill Lynch and Bank of Ireland. He holds an MBA in Strategy and Finance and an MSc in Technology from UCD, Ireland's top-ranked business school.
Dr. Ben Sessa – CMO
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 adult addictions. Sessa's joint 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.
Stephen Page – Non-executive Director
Stephen Page has worked as chief executive and board level in the UK healthcare for over 30 years, most noticeably leading Priory Healthcare, the largest network of mental healthcare hospitals and clinics in the UK, through a period of rapid expansion and market dominance. He has led and successfully grown organizations in public and private sectors, including Oxleas NHS Trust in London, Nestor plc and Acorn Care and Education.
Prof. 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.
Jonathan Held – CFO
Jonathan 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, both domestic and international and has been involved in numerous successful public market transactions, including initial public offerings, reverse takeovers and financings.
James Collins – COO
James Collins is a senior business leader and mental health champion with 17 years of experience with Accenture Strategy, seven years as MD, designing and delivering corporate, digital and operating model strategies. Collins holds a BSc and MPhil in Psychology from University College London (UCL).
Shaun McNulty – CSO
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 D. Phil from the University of York and researched CNS biology and signaling at the University of Cambridge, UK.
Prof. Celia Morgan – Ketamine Lead
Celia is a Professor of Psychopharmacology at the University
of Exeter in the United Kingdom. Prof. Morgan completed her undergraduate degree and Ph.D at University College London (UCL) . After her Ph.D Prof. Morgan worked at University of Melbourne as a visiting research fellow, returning to UCL for a fellowship and then Lectureship. She joined University of Exeter as a Senior Lecturer in 2013 and was given a Chair in Psychopharmacology in 2015
Dr. Laurie Higbed – Lead Psychologist
Laurie is an experienced clinical psychologist. Laurie has worked as a lead therapist on clinical trials using MDMA and psilocybin-assisted psychotherapy and has a special interest in working with complex trauma, Addictions and the use of psychedelic therapy to treat a range of mental health difficulties.
Laurie is registered with the Health and Care Professions Council (HCPC) and is a member of the Association of Clinical Psychologists (ACPUK).
Prof. David Nutt – Chief Research Officer, Chair of Preclinical and Clinical Advisory Boards
Prof. David Nutt is currently the Edmond J. Safra Professor of Neuropsychopharmacology and Director of the Neuropsychopharmacology Unit in the Division of Brain Sciences. After 11+ entry to Bristol Grammar School David was awarded an Open Scholarship to Downing College Cambridge and then completed his medical training at Guy's Hospital London, continuing in neurology to MRCP. In 1988, he set up the Psychopharmacology Unit in Bristol University, an interdisciplinary research grouping spanning the departments of Psychiatry and Pharmacology, before moving to Imperial College London in December 2008 where he leads a similar group with a particular focus on brain imaging especially PET. He is currently Chair of DrugScience (formally the Independent Scientific Committee on Drugs (ISCD)). He 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).
Prof. Barbara Mason – Advisor
Barbara J. Mason, Ph.D. is Director of the Pearson Center for Alcoholism and Addiction Research, Director of the Laboratory of Clinical Psychopharmacology, and Pearson Family Professor in the Department of Molecular Medicine at The Scripps Research Institute, La Jolla, CA. 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, a MERIT Award from the National Institutes of Health (NIH), 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.
A Tri-vertical Health and Wellness Company
CANBUD Distribution Corp. (CSE:CBDX, FSE:CD0) is a science and technology-based health and wellness company that operates a trinitarian enterprise model in the plant-based protein, psychedelic pharmaceutical and non-psychedelic nutraceutical, and hemp cannabinoids (CBD) spaces. (www.canbudcorp.com)
— Canbud Distribution Corp, CSE:CBDX (@canbudcorp) March 10, 2021
The company’s vision and mission is to become a world leader in science and technological innovations through plant and mushroom-based disruptive wellness and environmental solutions. CANBUD’s business model includes its premium plant-based nutraceuticals, psychedelic, and hemp-derived products and services.
CANBUD leverages on timely and methodical execution of its revenue generating plan across its three verticals.
Canbud announced that it has completed the acquisition of Molecular Science Corp. through a “three-cornered” amalgamation, whereby a newly-formed wholly-owned subsidiary of the Corporation amalgamated with MSC under the Business Corporations Act (Ontario) to form MSC Corp., a wholly-owned subsidiary of the Corporation.
CANBUD’s Management Team
Steve Singh – CEO & Co-Founder
Steve Singh is a seasoned investor with more than 35 years of experience in the financial sector. Over the years, he has built a significant global investment network and has provided consulting and advisory services to numerous publicly listed companies and has been involved in financings of over CAD$500 million throughout his career. He is the founder of Thinking North, a National Investor Network and the founder of Tekgenz, a full spectrum tech incubator. Singh is very passionate about helping entrepreneurs and companies attain their full potential. Using his vast global investment network, he helps companies raise capital, develop their messaging, amplify their marketing and devise corporate strategies.
Robert Tjandrar, BSc, MBA – President, COO & Co-Founder
Robert Tjandra started his career with BP Petroleum in Indonesia and BP UK in Aberdeen, Scotland. Later, he ventured into entrepreneurship, where he has developed a unique mixture of professional management and entrepreneurship skill sets across various international companies. Tjandra has co-founded and grown several companies generating millions of dollars in revenue in Indonesia with over 25 years of combined experience working, consulting, and developing businesses in construction, trading, oil, and gas, fintech, cleantech and agrotech. He has served on public and private Boards as a director and an audit committee member. Currently, he is a director at Electrum Charging Solutions.
Tjandra earned a BSc in Geology Specialist and Mathematics Minor from the University of Toronto and an MBA from the Philippines School of Business Administration.
Raj Ravindran, MSc, MBA, Ph.D., CFA – CFO & Co-Founder
Raj Ravindran is an entrepreneur and investor with diversified international experience and a passion for innovation, technology, and capital markets. He has held senior roles across a breadth of start-ups and small-cap companies in North America and Europe. Ravindran has co-founded numerous companies, including Thinking North, Canbud Distribution Corp. and is currently the UDP and director for Florence Wealth Management.
Ravindran holds a Master’s degree in Chemical Engineering, Ph.D. in Industrial-Organizational Economics, MBA in Finance and a Charter Financial Analyst designation.
Adrian Burke – VP of Marketing
Adrian Burke is a serial entrepreneur with over 24 years of brand development, marketing, and business execution experience. Burke’s previous focus in the nutraceutical space and his insight into the current state of attention and distribution aids in company efforts in differentiating consumer packaged goods (CPG) offerings. Likewise, his focus on the plant-based space and empathic approach to environmentally sustainable packaging will help build out and scale CANBUD’s intellectual property (IP) portfolio.
Dr. Jane Wright-Mitchell – Director
Based in California, Dr. Jane Wright-Mitchell is an experienced healthcare and life sciences attorney with more than 20 years working with pharmaceutical and medical device companies. She is currently General Counsel, Chief Compliance Officer and Corporate Secretary with Vaxcyte, Inc., a vaccine development company. Prior to joining Vaxcyte, she was Chief Legal Officer with Steep Hill, Inc., a state-licensed cannabis testing laboratory. She previously served as Chief Legal Officer at AcelRx Pharmaceuticals, Inc. where she also served as Chief Compliance Officer and Corporate Secretary. Earlier in her career, she served in legal roles of increasing responsibility at Mesoblast, Actelion, Purdue Pharma, and Neurogesx.
*Disclaimer: This profile is sponsored by CANBUD Distribution Corp. (CSE:CBDX, FSE:CD0). This profile provides information which was sourced by the Investing News Network (INN) and approved by CANBUD Distribution Corp. in order to help investors learn more about the company. CANBUD Distribution Corp. is a client of INN. The company’s campaign fees pay for INN to create and update this profile.
INN does not provide investment advice and the information on this profile should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.
The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with CANBUD Distribution Corp. and seek advice from a qualified investment advisor.
Establishing a Library of Novel Psychedelic Derivatives
In recent years, the psychedelic market has been heating up, increasing investor interest and capital flow into this growing sector. In terms of the market size of psychedelic medicine, it is estimated that it could be as high as US$100 billion. Developing cultural movements, extensive research and policy changes are pushing this rapidly emerging market forward, which is gaining tremendous global and real investor traction.
One unique company in this growing space is MagicMed Industries, a biotechnology company focused on the discovery and early development of novel drug candidates, structurally related to the classic psychedelics but with vastly improved pharmaceutical characteristics and commercial potential. The company intends to establish its flagship molecule derivatives library, the Psybrary™, as an essential building block from which industry partners can develop new patented products.
Psybrary™ is a particularly exciting project considering the resurgence of interest and investment in psychedelics as an alternative mental health therapy in recent years. In 2017, the US Food and Drug Administration (FDA) recognized the potential benefits of MDMA by assigning a Breakthrough Therapy Designation to an MDA-assisted therapy to treat post-traumatic stress disorder (PTSD). Notable government investment and shifting regulatory policy will allow MagicMed to leverage significant institutional support and a growing patient base to explore psychedelic use in a medical capacity.
With a vast library of individual molecules covered by several different chemical compound categories, MagicMed is pursuing partnerships with innovators in the industry to develop newly patented products. These products will help tailor drug candidates to patients’ needs and unlock the healing power of psychedelics. MagicMed has finished its initial derivative portfolio based on the structures of psilocybin and N,N-dimethyltryptamine (DMT). Research efforts continue to create additional patents and derivative portfolios based on MDMA, mescaline, LSD and ibogaine.
To create the novel derivatives contained in the Psybrary™ , the MagicMed team combines synthetic biology and traditional chemistry techniques. This combination allows MagicMed to create a library of molecules that is larger and more diverse than what chemistry techniques alone can achieve. MagicMed analyzes, catalogues, and stores the molecules to find desired characteristics, such as an improved safety profile. Screening a vast library of drug candidates generates a sizeable amount of data that can be processed and used to improve future generations of the Psybrary™.
The company’s diversified approach to molecule manufacturing and market outreach works to de-risk its business model. Making multiple molecules for multiple indications broadens MagicMed’s exposure to numerous specific drug treatments and sectors of the overarching psychedelic market. It’s strategic partnership with the University of Calgary has also benefited the company by providing access to state-of-the-art equipment that the team has been able to utilize.
Next steps for MagicMed include the exciting announcement of a pending public listing on the Canadian Security Exchange in the first or second quarter of 2021. Likewise, the company has been working on new derivatives, patents and first partner engagements since 2020.
MagicMed Industries’ Company Highlights
- MagicMed Industries is a biotechnology company focused on its flagship Psybrary™ project, a library of novel derivative molecules based on classic psychedelics like psilocybin, DMT, mescaline, ibogaine, MDMA and LSD.
- The company’s main objective is advancing the discovery and early development of novel drug candidates structurally similar to classic psychedelics.
- MagicMed has finished it’s initial derivative portfolio based on the structures of psilocybin and N,N-dimethyltryptamine (DMT).
- MagicMed’s diverse approach to molecule manufacturing, revenue generation and market exposure has reduced the company’s business model risk while positioning it for significant economic growth.
MagicMed Industries’ Key Projects
MagicMed’s Psybrary™ focuses on developing into the world’s foremost library of psychedelic derivatives. The library is designed to become one of the leading providers of novel drug candidates for the biotechnology and pharmaceutical industries.
The project combines synthetic biology and chemistry to enable its ever-expanding portfolio of psychedelic derivatives. Likewise, the library’s extensive, robust patenting is intended to cover composition and manufacturing for potentially millions of possible drug candidates.
The Psybrary™ would allow MagicMed partners to search, select and test from the psychedelic molecular derivatives in the project’s library and use them to develop pharmaceuticals for the indication they intend on targeting. MagicMed is constantly working with partners and its world-class science team to further refine and improve selected derivative molecules to advance final products and expand its fully patent-protected portfolio.
MagicMed Industries’ Management Team
Dr. Joseph Tucker—CEO
Dr. Joseph Tucker is a seasoned executive who has built several publicly traded biotechnology companies. He was a founder and CEO of Stem Cell Therapeutics, which he took public on the TSX. Trillium Therapeutics acquired Stem Cell Therapeutics in 2013. Dr. Tucker has also held the position of Co-Founder and CEO of Epimeron Inc., a University of Calgary start-up acquired in the creation of Willow Biosciences Inc. At Willow, he served as executive chairman and COO. Prior, Dr. Tucker was a healthcare analyst with two investment banks and worked in technology commercialization for a university technology transfer office. Dr. Tucker received his Ph.D. in Biochemistry and Molecular Biology from the University of Calgary.
Dr. Jillian Hagel—CTO
Dr. Jillian Hagel is the CTO for MagicMed Industries Inc. Jill leads the science team in delivering milestones and science program coordination. Dr. Hagel has over 19 years of experience in plant biochemistry and natural product biosynthesis. Before co-founding MagicMed Industries, Dr. Hagel held the position of vice president, Applied Science and co-founder of Willow Biosciences Inc. She was COO of Epimeron Inc. before the acquisition of Epimeron by Willow. Dr. Hagel has co-authored over 35 peer-reviewed publications and is the co-inventor on many patent applications. Dr. Jillian Hagel received her Ph.D. in natural products biochemistry in 2010 from the University of Calgary.
Dr. Peter Facchini—CSO
Dr. Peter Facchini is the CSO of MagicMed Industries, Inc. He has been a Professor of Plant Biochemistry in the Department of Biological Sciences at the University of Calgary for 25 years. Dr. Facchini held the Canada Research Chair in Plant Metabolic Processes Biotechnology and is currently a Parex Resources Innovation Fellow in the Faculty of Science. Dr. Facchini also co-founded and was CSO of Willow Biosciences Inc. and Epimeron Inc. Dr. Facchini has published over 160 scientific papers and co-invented over 30 patents. He is an international leader in the biochemistry and biotechnology of natural product metabolism.
A Leader in Transformational Medicine
Lobe Sciences Ltd. is a life sciences company focused on the research and development of psychedelic medicines. The Company focuses on clinical development of devices and medicines to treat neurological disorders and brain trauma. The Company’s mission is to identify and develop transformative new methods, medicines and devices to improve brain health and provide new pathways for treating brain injuries and neurological disorders. The Company undertakes the development of innovative medicines and devices to treat mental health disorders and improve well-being while building a growing a portfolio of intellectual property to protect our technologies. The Company is working to develop psychedelic compounds as therapeutics.
Psychedelics (serotonergic hallucinogens) are powerful psychoactive substances that alter perception and mood and affect numerous cognitive processes. They are generally considered physiologically safe and do not lead to dependence or addiction. NAC is a dietary supplement derived from the amino acid L-cysteine. Taking NAC increases the level of glutathione, a potent antioxidant and anti-inflammatory molecule, in cells. Glutathione’s function is to protect cellular compounds such as DNA and prevent damage to them from reactive oxygen species and inflammatory cytokines. It is also used as an antidote for acetaminophen overdose.
Studies indicate that no proven treatment modality currently exists for the sequelae/long term effects of either mTBI with PTSD or either condition alone. The Company’s vision is to administer the compounds of psilocybin and N-acetylcysteine (“NAC”) in doses that will be administered at home, the emergency department or clinic. The Company plans to develop psilocybin-based therapeutics in combination with NAC for the treatment of mild traumatic brain injuries (“mTBI”) and post-traumatic stress disorder (“PTSD”) and devices for the efficient application of these medications
The first focus is on micro-dosing psilocybin in combination with NAC for the treatment of mTBI and PTSD and other neurological disorders. Additionally, they may be paired with odorants to create memory odor imprint pairing. The second is micro-dosing MDMA, where MDMA is combined with NAC for the treatment of mTBI and PTSD and other neurological disorders. Likewise, pairing them with odorants in an attempt to create memory odor. Third, Lobe Sciences has been evaluating the development of a medical device for immediate delivery of medicines directly to the olfactory bulb[, the structure located in the forebrain of vertebrates that receives neural input about odors detected by cells in the nasal cavity, for best therapeutic outcomes. Finally, a virtual reality (“VR”) is often shown to be used in enhancing the therapeutic outcomes of patients. We are evaluating the use of a VR headset or a fully immersive pod combined with a nasal mist transducer device (“NMT”) to improve efficiency and raise response to treatment.
The Company has submitted a provisional and PCT patent applications and launched a preclinical research study to examine a strategy that combines two products for the treatment of PTSD and mTBI with PTSD. The proposal will use a well-established rodent model to test the use of a combination of NAC and psilocybin in animals that have been subjected to mild-moderate traumatic brain injury with PTSD induced through an established rodent PTSD paradigm.
Cowlitz County Cannabis Cultivation Inc., was another subsidiary of Lobe Sciences. Cowlitz, based in Washington State, is a Tier 2 licensed cannabis processor. Washington is one of the states where medical and recreational use of cannabis is legal and is one of the most mature cannabis markets in the country. As a top producer in the state, Cowlitz has a range of innovative products and brands it brings to the market. Lobe divested Cowlitz to a multistate cannabis operator called Ionic Brands.
On March 8, 2021 the company completed the sale of Cowlitz County Cannabis Cultivation Inc. to Ionic Brands Corp.
- Strengthened Lobe’s balance sheet with C$1.75 million cash on closing
- Lobe Sciences received 100,406,701 series E non-voting preferred shares of CNSX:IONC which convert on a one-to-one basis and carry an annual dividend of 13% for a period of two years
- Lobe Sciences also received 4,000,000 five year C$0.30 Ionic Brand warrants
Lobe Sciences’ Company Highlights
- Headquartered in Canada with North American Operations
- Currently developing psychedelic therapeutics as an integrated biotech company
- Therapeutic development focused mild traumatic brain injury(mTBI)and posttraumatic stress disorder (PTSD) associated with head trauma
- Lobe Sciences is currently prosecuting several provisional patents to treat PTSD or mTBI with PTSD
- Additional provisional patent for methods and compositions for treating mTBI PTSD alone with 3,4 MDMA plus NAC
- patent pending for a medical device for delivery of medicines to the olfactory bulb
- Lobe Sciences is collaborating with a multidisciplinary team of scientists and physicians from the University of Miami where Dr. Michael Hoffer is conducting a large preclinical study on the effect of the treatment of mTBI with PTSD or PTSD alone based on the combination of psilocybin and NAC
Lobe Sciences’ Future Outlook
Moving ahead, Lobe Sciences has a range of catalysts on the horizon.
The company is gearing up to conduct pre-clinical studies, which includes GLP toxicology, ADME in addition to forming and manufacturing, to file an investigational new drug application (IND). Lobe Sciences, together with its subsidiary Eleusian Biosciences, will partner with the University of Miami to conduct the study on rodents to prove the efficacy of the molecules.
With successful results following the study and regulatory approval, Lobe Sciences aims to file its IND with the US Food and Drug Administration (FDA) by March 2022 to be able to move the candidate of psilocybin and NAC into a Phase 3 Clinical Trial by July 2022 on humans for the treatment of mTBI with PTSD or PTSD alone in collaboration with investigators at the University of Miami and other clinical research institutions. The company aims to look at what proper dosing will look like with these trials.
Pending any FDA approval, Lobe Sciences will consider bringing its products to other global markets.
Lobe Sciences’ Management Team
Philip J. Young – CEO & Director
Philip Young is an accomplished CEO and innovative professional with 25 years of expertise in senior executive management and board roles, with significant mergers and acquisitions and equity financing experience. He has a proven track record in the biotech, medtech and pharmaceutical industries with expertise in dealing with FDA/regulatory frameworks as well as new device and therapeutics development. From 2015 until 2019, Mr. Young was the Founder, Chairman, and CEO of Exactus Inc. (“Exactus”), an OTCQB listed company he successfully transitioned from a medical technology company to a farming focused hemp-derived CBD company.
Prior to Exactus, Mr. Young was the president, CEO, and Director of AmpliPhi Biosciences Corp. (now Armata Pharmaceuticals Inc.), a global biopharmaceutical company. He was also previously the President, CEO and a director of Osteologix Inc., where he was responsible for directing and managing all facets of the global pharmaceutical development company. He is the former Chief Business Officer and Executive Vice President of Insmed Inc., where he directed all financing, corporate and commercial communications activities. Prior thereto, he was the Vice President and General Manager of Neurex Corp., where he was involved with the negotiations for its US$700 million acquisition by Elan Corporation. Mr. Young holds a Bachelor’s of Science from James Madison University.
Brian Zasitko – CFO
For over 13 years, Brian Zasikto has worked in a number of private and public companies in sectors such as cannabis, agriculture, manufacturing, and utility industries. Mr. Zasitko is well versed in financial reporting and corporate governance and the capital markets.
Dr. Maghsoud Dariani – Chief Science Officer
Dr. Dariani has extensive experience working with a wide range of life science companies. He is the current president and CEO of Semorex Inc., a privately held company focused on novel therapeutics for cancer. Mr. Dariani was previously the president of Focus Pharmaceuticals, Inc., where he managed the development and approval of drug products and notched an FDA approval for another clinical evaluation stage.
Jonathan Gilbert – Executive Director
Jonathan Gilbert was the founder and CEO at Tassili Life Sciences Corp., a biotech firm conducting research with psilocybin. Gilbert is also the founding CEO of Eleusian Biosciences, which Lobe Sciences acquired in June 2020, and will play an integral role in the company’s growth strategy moving forward.
Leighton Bocking – Director
Leighton Bocking has worked in the capital markets for over a decade. Primarily, his role has been as an independent corporate development consultant as well as other various director roles. Mr. Bocking has been particularly focused on financing and structuring companies.
Dr. Mark A. Geyer Ph.D – Scientific Advisor
Dr. Geyer is Distinguished Professor of Psychiatry and Neurosciences Emeritus at the University of California San Diego (UCSD) and directs the Neuropsychopharmacology Unit of the VISN 22 Veterans Administration Mental Illness Research, Clinical, and Education Center. He is respected internationally for his research on the psychophysiology, neurobiology, and pharmacotherapy of schizophrenia and bipolar disorder. Dr. Geyer’s broad experience as a researcher, grant reviewer, journal editor, and teacher lends invaluable scientific and professional expertise to several organizations, as he provides leadership to develop strong programs in the behavioral psychopharmacology and clinical applications of psychedelic agents.
Charles S. Grob, MD – Scientific Advisor
Charles S. Grob, M.D. is Professor of Psychiatry and Pediatrics at the UCLA School of Medicine. He previously held faculty positions at the Johns Hopkins School of Medicine and the University of California at Irvine. He has conducted approved clinical research with psychedelics since the early 1990s. From 2004-2008 he was the Principal Investigator of the first study in several decades to examine the use of a psilocybin treatment model for patients with advanced-cancer anxiety. He has also conducted research into the range of effects of MDMA, in both normal volunteers and in a selected subject population of adult autistics with severe social anxiety. And, he has conducted a series of ayahuasca research studies in Brazil. Over the last thirty years Dr. Grob has published numerous articles on psychedelics in the medical and psychiatric literatures and he is the editor of Hallucinogens: A Reader (Putnam/Tarcher, 2002), co-editor (with Roger Walsh) of Higher Wisdom: Eminent Elders Explore the Continuing Impact of Psychedelics (SUNY Press, 2005) and co-editor (with James Grigsby) of the recently published Handbook of Medical Hallucinogens (Guilford Press, 2021). He is a founding board member of the Heffter Research Institute.
Benjamin Kelmendi, MD – Scientific Advisor
Benjamin is a psychiatrist and an Associate Professor in the Department of Psychiatry at the Yale University School of Medicine. His primary clinical expertise is in PTSD, Depression, OCD, and the endocannabinoid system. He is the co-founder of the Yale Psychedelic Science Group. He leads a research program focused on the therapeutic potential of psychedelic medicines, across a range of psychiatric diagnoses. He is currently investigating the effects of psilocybin on the neurocircuitry implicated in the development, maintenance, and treatment of patients with OCD. He is also exploring the effects of MDMA on brain activation and neural network organization in PTSD to understand the relationship between MDMA-induced neural changes and the acute cognitive and behavioral effects of the drug.
Albert “Skip” Rizzo, Ph.D – Scientific Advisor
Albert “Skip” Rizzo is a clinical psychologist and Director of Medical VR at the University of Southern California Institute for Creative Technologies. He is also a Research Professor with the USC Dept. of Psychiatry and School of Gerontology. Over the last 25 years, Skip has conducted research on the design, development and evaluation of Virtual Reality systems targeting the areas of clinical assessment, treatment, and rehabilitation across the domains of psychological, cognitive and motor functioning in both healthy and clinical populations. This work has focused on PTSD, TBI, Autism, ADHD, Alzheimer’s disease, stroke and other clinical conditions. He has also driven an extensive research program on the use of intelligent virtual human agents for clinical training, healthcare information support, and clinical assessment. In spite of the diversity of these clinical R&D areas, the common thread that drives all of his work with digital technologies involves the study of how Virtual Reality simulations can be usefully applied to human healthcare beyond what’s possible with traditional 20th Century methods.
Ilan Hayman – Advisor
Ilan has played a pivotal role in the General Management of healthcare businesses including a private cosmetic surgery chain and the commercialisation of a breakthrough skincare range. He successfully led the development of these products from concept through to production commercialization. Most recently Ilan oversaw a group of national medical centers. His career into operations management was triggered by his valuable experience as part of the Risk and Controls Solutions practice at PricewaterhouseCoopers (PwC). Specifically, Ilan’s passion is assisting the medical fraternity in their practice management and business administration functions. Ilan’s ambition is to work in a role that utilises his analysis expertise enriched by his exposure to the commercial side of business. Ilan has a passion for assisting community organizations and sits on several boards of not for profit organizations. He also holds Bronze and Silver Duke of Edinburgh awards and brings along a unique set of community and industry related experience.
Bart Oates — Advisor
Bart Oates Esq. is a three-time Superbowl Champion, who graduated magna cum laude with a Juris Doctor degree from Seton Hall during his off season. Prior to his NFL career, he earned a BS in Accounting from the Marriott School of Business at BYU and was inducted into their athletic Hall of Fame in 1992. Bart was selected to five Pro Bowls during his NFL career and to the UPI All-NFC team three times. Bart is now the President of the NFL Alumni Association which offers former players a diverse package of medical, business, and legal services to help keep them and their families healthy, productive, and connected to their former teammates.
Gilberto Jesús Mendoza – Advisor
Gilberto Jesús Mendoza is currently the President of the World Boxing Association. Mr. Mendoza began his career as a lawyer and an engineer and has been working with the WBA since 2015. His priority has always been to give opportunities to the most vulnerable regions of the world. He has spent time in close contact with athletes since he was a child and has actively participated in the intention to rescue amateur boxing. Mr. Mendoza is the proud creator of “Un Solo Boxeo” (Only One Boxing), a program that promotes the integration of professional boxing. He also created the Future WBA Champion, a project that has given space to thousands of boxers in their preparation stage for the Tokyo Olympic Games. Mr. Mendoza’s goal is the growth and development of boxing, as well as its adaptation to change.
Innovative Research into Psychedelic Therapies
Numinus (TSXV:NUMI, OTC Pink: NUMIF) is a healthcare company at the forefront of addressing the growing prevalence of mental health issues and desire for greater wellness. The company offers an integrated therapeutic model to create lifelong relationships with people seeking physical, mental and emotional health with a focus on treating mental illness, trauma and substance abuse.
In addition to services including counselling, neurofeedback, physiotherapy and other therapies, Numinus aims to conduct psychedelic-assisted therapies to help people heal, connect and grow — when approved by Health Canada, Colleges and other regulators. Numinus put a value chain in place that will be key to the company's growth and success. Numinus Bioscience is licensed by Health Canada to test, sell and distribute psychedelic substances. Numinus Wellness plans to establish physical locations where psychedelic-assisted therapies can take place once approved by regulators. Lastly, Numinus R&D is where partnerships with leading research groups will take place to advance practice and understanding in the space.
Numinus Bioscience is making a name for itself in analytical testing for psychedelic substances and as a place of excellence for product research and development. Numinus Bioscience's 7,000 square foot analytics and research laboratory handles a range of psychedelic substances and analytical methods and uses for the psychedelics space. In October 2020, Numinus announced it had harvested the first legal flush of Psilocybe mushrooms in Canada by a public company under its Health Canada-issued Controlled Drugs and Substances Dealer's Licence.
Numinus was founded by Payton Nyquvest and Stacey Wallin, who both have a passion for developing holistic therapies that deal with the root causes of mental illness, addictions and trauma. The two founders have a wealth of experience in bringing innovative companies to the capital markets. Nyquvest, for example, has raised over C$100 million for public and private companies alike and has facilitated numerous IPOs, including Numinus' pending RTO with Salvation Botanicals and Rojo Resources Ltd. Joining the team as Chief Operating Officer is Michael Tan, who was the first director for the British Columbia Liquor Distribution Branch's (BCLDB) cannabis division. He also has a track record of driving profitable revenue growth.
Numinus' Company Highlights
- RTO with Salvation Botanicals and Rojo Resources Ltd. completed in Q2 2020.
- When approved by Health Canada and Colleges, Numinus aims to conduct psychedelics-assisted therapies to help people heal, connect and grow. These therapies will be conducted in safe, controlled therapeutic environments when approved by regulators.
- Has a 7,000 square foot laboratory that is licensed by Health Canada to test, possess, buy and sell various controlled substances.
- In October 2020, the company harvested the first legal flush of Psilocybe mushrooms in Canada by a public company under its Health Canada-issued Controlled Drugs and Substances Dealer's Licence.
- Revenue from the company's existing cannabis testing operations provides a foundation for growth, differentiating Numinus from others in the psychedelics space.
- The cannabis portion of the business has the potential to bring in C$25 million, dependent on timing of receiving Health Canada processing licence and production facility operating at capacity.
- The company's long-term plans are to build a network of healing centres across North America, staffed with professional therapists and integrative health professionals.
- Research partnerships in place with MAPS and Together We Can and Memorandum of Understanding signed with the BC Centre on Substance Use (BCCSU).
- Numinus has closed its acquisition of the Neurology Centre of Toronto (NCT), a leading Canadian provider of clinical neurologic care.
Regulators Turning to Psychedelic Therapies to Treat Mental Illness and Addiction
In 2017, psychedelic therapies were designated as a breakthrough therapy by the FDA due to the growing need for solutions for mental health-related issues across the globe. According to the World Health Organization, mental health disorders affect one in four people at some point in their lives, and approximately 450 million people currently suffer from mental health issues, making it a leading cause of ill-health and disability worldwide.
If left untreated, mental health disorders can cost Canadians C$51 billion per year in health care costs, lost productivity and reductions in health-related quality of life, according to the Centre for Addiction and Mental Health (CAMH).
Leading organizations such as the FDA and Johns Hopkins are helping to position the use of psychedelic assisted therapies in regulated, safe, controlled therapeutic environments as accepted therapeutic options. Many research organizations, such as BCCSU, have been testing the efficacy of treating mental health disorders with various psychedelics.
Numinus' Management Team
Payton Nyquvest – Founder, Chairman and CEO
Payton Nyquvest founded Numinus out of a lifelong interest in health, wellness and personal development, triggered by mental health and chronic autoimmune problems in his earlier years. Transformational therapies helped to save his life, and he is driven to provide public access to these therapies.
He is a former Director, VP and Head of Sales at Mackie Research Capital, with 15 years of experience focusing on early-stage companies in multiple industries including technology, healthcare, biotech, cleantech and cannabis. He has raised over $100 million for more than 100 public and private companies and facilitated numerous IPOs.
Stacey Wallin – Founder and Chief Strategy Officer
Stacey Wallin founded Numinus with a passion for holistic wellness after a series of near-death experiences in 2015 related to illness and misdiagnosis, which inspired her to begin studying and advocating awareness for mind-body health. She previously founded and was CEO of LifeBooster, a tech startup now helping Fortune 100 clients detect and proactively respond to workplace injury risks. She most recently was the Director of Venture Programs at the BC Tech Association with a mandate of solving the largest ecosystem and policy-related challenges facing growth and scale-stage technology companies.
Dr. Evan Wood – Chief Medical Officer
Dr. Evan Wood is a recognized researcher with 20+ years of experience in addiction research, most recently as Executive Director of the British Columbia Centre on Substance Use (BCCSU). A professor of medicine at the University of British Columbia. Work on psychedelic-assisted psychotherapy, his work includes involvement with the Multidisciplinary Association for Psychedelics Studies (MAPS) trial of MDMA-assisted psychotherapy and examining the potential of psilocybin-assisted psychotherapy for a range of mental health disorders.
Dr. Devon Christie – Medical Director
Dr. Christie, a clinical instructor with the UBC Department of Medicine, is also a family physician with a focused practice in Multidisciplinary Pain Management. She is a Registered Therapeutic Counsellor emphasizing Relational Somatic Therapy for trauma resolution and she is also trained to deliver both MDMA-assisted psychotherapy for PTSD (MAPS USA) and ketamine-assisted psychotherapy, in a research setting. She is a recognized speaker and expert on the potential for incorporating psychedelic assisted therapies in an improved health care model for the future.
Michael Tan – Chief Operating Officer
Michael Tan is the former and first executive director of the BCLDB's Cannabis Division, where he successfully launched cannabis operations in British Columbia. Michael has 20 years of strategic planning and execution with national and multinational corporations. He is a high-impact product development, marketing and operations executive with a track record of driving profitable revenue growth.
Kraig Docherty – Chief People Officer
Kraig Docherty has over 20 years of experience growing and scaling tech and creative companies such as EA, Activision Blizzard, Indochino, Invoke and Eventbase.
John Fong – Chief Financial Officer
John Fong is a professional accountant with over two decades of experience in financial and operational management. He provides stability and growth solutions to public natural resource companies and technology start-ups.
Dennis McKenna – Advisor
McKenna brings over 40 years of experience conducting research in ethnopharmacology. He is a Founding Board Member of the Heffter Research Institute and a former key investigator on the Hoasca Project, the first biomedical investigation of ayahuasca. McKenna has taught courses on Ethnopharmacology and Plants in Human Affairs for 17 years as an adjunct Assistant Professor in the Center for Spirituality and Healing at the University of Minnesota . In collaboration with colleagues in Canada and the US, he incorporated a new non-profit, the McKenna Academy of Natural Philosophy.
Jamie Wheal – Advisor
Wheal is a bestselling author, Pulitzer Prize nominee and founder of the Flow Genome Project, an international organization dedicated to research and training of ultimate human performance. Since its inception in 2011, the organization has become the leading voice of evidence-based peak performance. Wheal is an expert on peak performance and leadership, specializing in the neuroscience and application of Flow states.
Ben Nemtin – Advisor
Nemtin is the #1 New York Times bestselling author of What Do you Want to Do Before You Die?, co-founder of the Buried Life movement and a mental health advocate. Nemtin was forced to drop out of university due to depression and in an effort to feel more alive, he and his three friends made a list of “100 things to do before you die" and for every list item they accomplished, they helped a complete stranger cross something off their bucket list. Oprah Winfrey declared their mission “truly inspiring." Nemtin is recognized as one of the “World's Best Motivational Speakers" as well as “World's Top Organizational Culture Thought Leaders" by Global Gurus and regularly speaks to Fortune 100 leadership teams and business conferences around the world.
Pamela Hadfield – Advisor
Hadfield is an entrepreneur and thought leader in the cannabis space. She became a cannabis advocate after finding relief from debilitating migraines using medical cannabis. After cannabis transformed her health, she dedicated her time and efforts to helping others with alternative healthcare approaches, including cannabis. Hadfield is the co-founder of HelloMD, a digital telehealth and educational platform for cannabis consumers and people seeking complementary care.
Nichol Bradford – Advisor
Bradford is CEO of the Willow Group and Executive Director of the Transformative Technology Lab. She is a former senior executive in the video game industry responsible for strategy, operations and marketing for major brands, including Disney, Vivideni and Activision Blizzard. Bradford is also a fellow of the British American Project, a former term member of the Council on Foreign Relations and served on the board of the Brandon Marshall Foundation for Mental Health.
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NeonMind Biosciences Inc manufactures Medicinal Mushroom products under the brand NeonMind which are for sale through e-commerce on its website. It is also in the early stages of development of a product with the goal of using such product to promote and cause weight loss using a compound found in psychedelic mushrooms. The company’s product …