January 3, 2023
Kelowna, British Columbia, Canada — (January 3. 2023) – Tryp Therapeutics, Inc. (CSE: TRYP) (OTCQB: TRYPF) (“Tryp” or the “Company“), a clinical-stage biotechnology company focused on developing intravenous-infused psilocin (the active metabolite of psilocybin) for diseases with high unmet medical needs, today announced the signing of a letter of intent with Massachusetts General Hospital (MGH), the largest teaching hospital of Harvard Medical School, to fund and conduct a Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS). IBS is a common, chronic, and often debilitating condition with an estimated prevalence in the general population ranging from 4-5%. Industry research has demonstrated that a large percentage of IBS patients and gastroenterologists are dissatisfied by current treatments. The market for IBS treatments is estimated to grow to $4.7 billion by 2030*.
The planned study will evaluate the effect of psilocybin-assisted psychotherapy in patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms. Many of these patients also suffer from fibromyalgia, anxiety and fatigue. The primary efficacy endpoint of the study will be improvement in abdominal pain. The study will also explore changes in brain connectivity and responses to pain at baseline, at four weeks, six months and twelve months, post-the psychedelic session, along with numerous other secondary endpoints.
Dr. Erin Mauney, the pediatric gastroenterology fellow at Massachusetts General Hospital leading the proposed study, said “We are delighted to be partnering with Tryp Therapeutics, a recognized leader in the development of psilocybin-assisted therapies. There is tremendous potential for the treatment of debilitating IBS and other disorders of gut-brain interaction by utilizing the combined administration of psilocybin and psychotherapy. Our clinical study will examine how psilocybin-assisted psychotherapy may alter important brain networks involved in chronic pain and gastrointestinal-specific anxiety in IBS to bolster the neural flexibility in these patients and thereby reduce visceral hypersensitivity.”
Jim Gilligan, PhD, Chief Executive Officer of Tryp Therapeutics, commented, “MGH is an ideal partner for Tryp to expand on its strategy of utilizing TRP-8802 (oral psilocybin) to explore the clinical potential of psilocybin-assisted psychotherapy in new indications. With positive results in this study, Tryp would look to continue clinical development in IBS with TRP-8803, our proprietary formulation of IV-infused psilocin, that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe. Our ultimate goal is providing even more favorable outcomes and relief to the millions of patients currently suffering from IBS and its associated disorders. With this agreement in place, we will be in a position to submit the relevant IND.”
*Asburn & Meera, Nature 2006; Rangan et al, Gastroenterology 2020; Acumen Research and Consulting 2022
About Tryp Therapeutics
Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. Tryp’s lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.
The Company has an ongoing Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida and an upcoming Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia, both of which are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Where a preliminary clinical benefit has been demonstrated, subsequent studies are expected to utilize TRP-8803 which has the potential to further improve efficacy, safety and patient experience. For more information, please visit www.tryptherapeutics.com.
About Massachusetts General Hospital
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. In July 2022, Mass General was named #8 in the U.S. News & World Report list of “America’s Best Hospitals.” MGH is a founding member of the Mass General Brigham healthcare system.
Forward-Looking Information
Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans,” “targets,” “expects” or “does not expect,” “is expected,” “an opportunity exists,” “is positioned,” “estimates,” “intends,” “assumes,” “anticipates” or “does not anticipate” or “believes,” or variations of such words and phrases or state that certain actions, events or results “may,” “could,” “would,” “might,” “will” or “will be taken,” “occur” or “be achieved.” In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.
Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct.
The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
Contact Information
Peter Molloy
Chief Business Officer
pmolloy@tryptherapeutics.com
Chief Financial Officer
Mr George is a Director at Bio101 Financial Advisory (‘Bio101’), a financial services firm providing outsourced CFO, taxation and company secretarial solutions to the biotechnology and healthcare sector. He has over 10 years of finance and commercial experience working with public and private companies in Australia and abroad. Mr George currently serves as CFO and Company Secretary for several ASX-listed, private companies and not-for-profits.
He holds a Bachelor of Commerce from the University of Melbourne, a Masters Degree in Professional Accounting from RMIT, a Certificate in Governance Practice from the Governance Institute of Australia and is a qualified Chartered Accountant.
Scientific Advisor
Professor Philippa Hay is a renowned academic psychiatrist with international recognition for her research on eating disorders and obesity. With over 500 scientific papers and significant contributions to clinical practice and treatment guidelines, she has influenced national and international standards.
Notably, she led the development of the Royal Australian and New Zealand College of Psychiatrists’ national guidelines and the EDP framework for Medicare-supported recovery in Australia. Awarded the ANZ Academy for Eating Disorders Lifetime Leadership Award and the RANZCP Senior Research Award, she is also the founding Editor-in-Chief of the Journal of Eating Disorders and a past-President of the Australian Academy for Eating Disorders.
Her current research includes clinical trials for anorexia nervosa, public health interventions, and the exploration of psychedelics in treatment. She serves as a principal reviewer for the Cochrane Library and frequently contributes to leading journals and publications.
Scientific Advisor
Professor David Castle is a distinguished psychiatric scholar, who most recently was appointed by the Tasmanian Government as Professor of Psychiatry at the University of Tasmania’s Centre for Mental Health Service Innovation, launched in partnership with the Tasmanian Department of Health.
Previously, he served as the Inaugural Scientific Director at the Centre for Complex Interventions and the Centre for Addictions and Mental Health at the University of Toronto, and as Professor of Psychiatry at the University of Melbourne. With a focus on mental health conditions such as schizophrenia, bipolar disorder, and OCD, he is known for his research on psychedelic treatments and body dysmorphic disorder.
Professor Castle has published over 900 works, reviews for numerous scientific journals, and has a strong track record in securing significant research funding.
Scientific Advisor
William Schmidt, PhD is a Scientific Advisor to Tryp Therapeutics.
Dr. Schmidt serves as an expert on pain medicine pharmaceutical development with pharmaceutical and biotech companies throughout North America, Europe, Asia, Latin America and Australia. He currently sits on the Scientific or Medical Advisory Boards of five biotech companies. Dr. Schmidt has received many awards throughout his career including the John J. Bonica award for the development of new analgesics and for his sustained contributions to the educational efforts of the Eastern Pain Association in 2014. He joined DuPont Pharmaceuticals where he helped to develop nalbuphine (Nubain®), naltrexone (Trexan®, ReVia®) and the oxycodone-ibuprofen formulation used in Combunox™. He also led the clinical teams in the development of alvimopan (Entereg®) and polmacoxib (Acelex®).
Dr. Schmidt earned a BA from the University of California, Berkeley and a PhD from University of California, San Francisco.
Scientific Advisor
Derek Ott, MD is a Scientific Advisor to Tryp Therapeutics.
Dr. Ott is an Associate Clinical Professor of psychiatry at the UCLA School of Medicine, Director of the UCLA Pediatric Neuropsychiatry Clinic and a psychiatric consultant for Westside and Frank D. Lanterman Regional Centers in Los Angeles. He is a board-certified physician in child, adolescent and adult psychiatry. Dr. Ott has particular expertise in the areas of neuropsychiatry, developmental disabilities, attention-deficit hyperactivity disorder and childhood psychosis. His private practice focuses on psychopharmacology in children, adolescents and adults.
Dr. Ott earned a BS in human biology from Stanford University. He then attended the University of Illinois Urbana-Champaign, where he earned an MS in neuroscience and an MD.
Scientific Advisor
Rachel Wevrick, PhD is a Scientific Advisor to Tryp Therapeutics.
Dr. Wevrick is a Professor in the Department of Medical Genetics at the University of Alberta. Her research is focused on the genetic, molecular and physiological basis of abnormal neurodevelopment, growth and metabolism in developmental disorders affecting children. Her specific areas of interest include Prader-Willi syndrome, Schaaf-Yang syndrome and other neurodevelopmental disabilities that are caused by genetic mutations.
Dr. Wevrick earned a PhD from the Department of Molecular and Medical Genetics, University of Toronto and completed post-doctoral fellowships in the Department of Genetics at the Hospital for Sick Children Research Institute and at the Howard Hughes Medical Institute, Stanford University School of Medicine.
Scientific Advisor
Joel Castellanos, MD is a Scientific Advisor to Tryp Therapeutics.
Dr. Castellanos is an Associate Professor in the Department of Anesthesiology at the UC San Diego School of Medicine. He also serves as Medical Director of Inpatient Rehabilitation. Dr. Castellanos has specific clinical interests in pelvic pain, complex regional pain syndrome, phantom limb pain and post-spinal cord injury pain syndromes. His research interests include altering nutrition as a means of treating chronic pain, neuromodulation for chronic painful conditions and the potential use of psychedelics for these conditions.
Dr. Castellanos completed residency training in physical medicine and rehabilitation at University of Michigan Medical School, where he also completed a two-year program in healthcare administration. Dr. Castellanos earned his medical degree from University of Toledo College of Medicine in Ohio. He is board-certified in physical medicine and rehabilitation and pain medicine.
Scientific Advisor
Daniel Clauw, MD, is a Scientific Advisor to Tryp Therapeutics.
Dr. Clauw is a Professor of anesthesiology, medicine (Rheumatology) and psychiatry at the University of Michigan. He serves as Director of the Chronic Pain and Fatigue Research Center. He joined the faculty at Georgetown University in 1990, and while there, founded the Georgetown Chronic Pain and Fatigue Research Center, and served as the Division Chief of Rheumatology, Immunology and Allergy, and Vice Chair of the Department of Medicine. Since moving to UM in 2001, Dr. Clauw has continued his commitment to the clinical care and research into overlapping conditions such as Fibromyalgia, Gulf War Illnesses, and Interstitial Cystitis, just to name a few. Dr. Clauw has become an internationally known expert in chronic pain, and especially the central nervous system contributions to chronic pain states, performing past or ongoing work in conditions such as low back pain, osteoarthritis, vulvodynia, endometriosis, irritable bowel syndrome and temporomandibular joint disorder.
Dr. Clauw attended the University of Michigan for both undergraduate and medical school studies and then completed his Internal Medicine residency and Rheumatology Fellowship at Georgetown University.
Chairman, Scientific Advisory Board
Robin Carhart-Harris serves as Chairman of the Scientific Advisory Board for Tryp Therapeutics.
Dr. Carhart-Harris is the Ralph Metzner Distinguished Professor in Neurology and Psychiatry at the University of California, San Francisco. He is also the Director of the Psychedelics Division within the translational neuroscience center, Neuroscape, at UCSF. Dr. Carhart-Harris founded the Centre for Psychedelic Research at Imperial College London in April 2019, the first of its kind. He has designed human brain imaging studies with LSD, psilocybin, MDMA and DMT; a clinical trial of psilocybin for treatment-resistant depression; a double-blind randomized controlled trial comparing the effects of psilocybin and the SSRI escitalopram on depression that was published in the New England Journal of Medicine; and a multimodal imaging study in first-time users of psilocybin.
Dr. Carhart-Harris earned a BSc in applied psychology and computing from Bournemouth University, an MA in psychoanalysis and contemporary science from Brunel University, and a PhD in psychopharmacology from the University of Bristol. He has published over 100 scientific papers and in 2021 was listed in Time Magazine’s “100 Next,” a list of 100 rising stars shaping the future.
Non-Executive Director – B.Comm, MAICD
Clarke is a Financial Adviser and Capital Markets Specialist with over 20 years’ experience in the Financial Services Industry in Australia and the United Kingdom.
Clarke has experience in structuring, operations and risk management of institutional exotic derivatives in the United Kingdom with Morgan Stanley International Limited and has been a Derivatives Manager, responsible for establishing and managing derivatives trading desks for several Australian based stockbroking firms.
Clarke brings to Exopharm his extensive experience providing corporate advisory services for companies listed on the Australian Securities Exchange (ASX) across a variety of industries, with a particular focus on growth opportunities in the Biotechnology, Technology, Industrial and Resource industries, providing them with advice on business models & strategy, structuring of pre-IPO and IPO fund raisings, reverse takeovers, capital raisings, mergers and acquisitions, investor relations and capital markets advice.
Clarke also services institutional, wholesale and retail clients, advising on ASX investments, share portfolios, derivatives, and identification of early-stage opportunities across a variety of industries and sectors.
Clarke is a Founding Director of AMG Acquisition Corp, a publicly listed company on the Toronto Venture Exchange.
Clarke holds a Bachelor of Commerce degree from the University of Western Australia and is a Member of the Australian Institute of Company Directors (AICD).
Chairman
Mark is Founder and Managing Director at 1861 Capital and has been an investor in Exopharm since the IPO in 2018. Mark has a Bachelor of Commerce from the University of Western Australia and is Non-Executive Chairman of Neurotech International (ASX: NTI), a drug development company focused on utilising NTI164 in the treatment for paediatric neurological disorders including Autism Spectrum Disorder (ASD).
Non Executive Director – B.Comm
Mr Ntoumenopoulos is the Managing Director at Twenty 1 Corporate, an Australian-based corporate advisory firm.
He has extensive experience in financial markets, with over 20 years of raising capital and providing corporate advisory services. Additionally, he has served as a director of ASX listed companies for more than 7 years.
Mr Ntoumenopoulos was a founding director of both ResApp Health Ltd (ASX:RAP), which was acquired by Pfizer, and Race Oncology (ASX:RAC). Currently, he serves as a non-executive director at TrivarX Limited (ASX:TRI).
If elected, Mr Ntoumenopoulos will be considered by the Board (including the incoming Directors with Mr Ntoumenopolous abstaining) to be an independent Director. Mr Ntoumenopoulos is not considered by the Board to hold any interest, position or relationship that might influence, or reasonably be perceived to influence, in a material respect his capacity to bring an independent judgement to bear on issues before the Board and to act in the best interests of the entity as a whole rather than in the interests of an individual security holder or other party. Mr Ntoumenopoulos does not currently hold any other material directorships, other than as disclosed in this Prospectus.
Non Executive Director
Gage Jull serves as a Chairman of Tryp Therapeutics.
Gage is Executive Chairman of Arrow Exploration, a TSX-V and London AIM listed oil and gas exploration and production Company (TSX-V; AIM: AXL). Arrow has grown production, cleaned up its balance sheet and is growing its cashflow. Prior to Arrow, Gage was a Co-Founder and Chairman of Bordeaux Capital Inc., a Toronto-based mergers & acquisitions advisory firm focused on emerging companies in the natural resources and other sectors. Before Bordeaux Capital, Mr. Jull was a Managing Director, Corporate Finance at Mackie Research Capital Corp., an investment banking and securities brokerage firm. Mr. Jull has acted as lead underwriter on numerous cross border equity and debt offerings involving energy assets around the world, with capital sourced in Canada, the U.S. and the U.K. At Prudential Bache, Mr. Jull was the lead banker on the $40 million cross border IPO of Quadra Logic Technologies, a Vancouver based pharmaceutical company. He has completed over 200 financings and M&A transactions in the course of his career.
Mr. Jull holds a BSc degree from the University of Toronto, an MBA from the University of Western Ontario, and holds both PEng and CFA designations.
Company Secretary
David is a Director and Principal of the Automic Group. As a Senior Executive, Company Secretary and Director of ASX Listed Entities and Professional Services organisations, David has over 25 years of experience within this field, in a diverse range of industries.
David is a Chartered Accountant, Fellow of the Financial Services Institute of Australasia, Fellow of the Governance Institute of Australia, Justice of the Peace, Registered Tax Agent and holds a Bachelor of Economics (Finance and Accounting) from Macquarie University.
With over 25 years in finance and accounting, initially qualifying with Price Waterhouse in their Business Services and Corporate Finance Divisions, David has been CFO, Company Secretary and/or Director for numerous ASX listed and unlisted public and private companies, in a range of industries including energy retailing, software as a service, transport, financial services, mineral exploration, technology, automotive, software development wholesale distributions, retail, biotechnology and healthcare.
VP, Drug Development
Peter Guzzo, PhD serves as Vice President of Drug Development at Tryp Therapeutics.
Pete served as Director of Drug Discovery at Curia (formerly AMRI) for nearly 20 years where he led drug discovery teams from project conception through clinical trials. While at Curia, Pete developed products and intellectual property in the areas of CNS, oncology and gastrointestinal diseases. Pete co-founded and served as CEO at ConSynance Therapeutics, a clinical-stage drug development company pursuing treatments for rare diseases.
Pete earned a BS in chemistry from Assumption College and a PhD in organic chemistry from the University of Notre Dame. He is an inventor on 43 patents, has co-authored 47 scientific publications, and has presented nearly 30 invited lectures.
President & Chief Scientific Officer – Ph.D., MSIB.
Jim Gilligan currently serves as Chief Executive Officer, President and Chief Scientific Officer of Tryp.
Jim received his Ph.D in pharmacology and Toxicology from the University of Connecticut. He pursued his post-doctoral fellowship at the Roche Institute of Molecular Biology. Later in his career he returned to Seton Hall University where he earned an MBA in International Business.
Jim is a scientist, entrepreneur, executive, and business development specialist who has over 35 years in the pharmaceutical industry and co-founded and helped lead multiple bio-pharma and bio-tech companies, including Tryp, Tarsa Therapeutics, Herborium Inc., and Unigene Labs, where he oversaw the entire spectrum of drug development activities, including pharmacology and preclinical activities, CMC, clinical Phase I-III, as well as US and international regulatory strategies. Jim is a co-author on several manufacturing and formulation patents and has been featured in journal articles on novel therapeutic peptides and their clinical utility. He has executed numerous feasibility and licensing deals within the pharmaceutical industry, working frequently with investment bankers, venture capitalists, and brokers.
Chief Medical Officer
Michael Silverman, MD serves as the Chief Medical Officer of Tryp.
Michael has over 30 years of experience in clinical development in biotech including product development strategy, clinical/regulatory planning and operations, business strategic analysis and planning, and technical assessment and recommendations. Additionally, Michael has served as President of BioStrategics Consulting Ltd. since 1999.
Michael received his BS from the University of Illinois and his MD from the University of Chicago Pritzker School of Medicine.
Chief Business Officer
BA (Hons), CFA (UK)
Mr Molloy has 25 years of experience creating, advising and investing in private and public companies, with a particular focus on the healthcare sector. He was previously the founder and CEO of Edison Group where he spent 15 years building the company into an international brand with a global team in excess of 100 people, recognized for its world class equity research platform, advisory services, and deep sector expertise. He remains a Director and principle shareholder of Edison.
Mr Molloy is also the co-founder of various other companies including, most recently, Tarus Therapeutics, an immune-oncology company which was acquired by a NASDAQ listed biotech in July 2022. Mr Molloy’s earlier career includes a successful period as an institutional investor, most notably at Hermes Investment Management in London, managing a healthcare and technology focused small/mid-cap portfolio, and with a close involvement in Hermes’ shareholder activism initiatives.
Mr Molloy graduated from Exeter University (UK) with a degree in Economics and is an alumni of London Business School. He holds the CFA (UK) and FINRA Series 7.
Chief Financial Officer
Jim O’Neill – BBA, CPA and CA
Jim O’Neill currently serves as Chief Financial Officer of Tryp.
Jim has over 30 years of experience as a finance executive with publicly listed and private multi-national businesses. Most recently, he founded and serves as president of O’Neill & O’Neill Services Corp. providing financial consulting services including CFO and corporate secretarial services to TSXV and CSE listed companies.
Jim received his bachelor’s in business administration from Wilfrid Laurier University and holds a CPA and CA from the Chartered Professional Accountants of Ontario.