Psychedelics (also called hallucinogens) are powerful mind-altering substances that can temporarily induce hallucinations by affecting the serotonin receptors in the brain responsible for controlling the senses. Popular psychedelics include lysergic acid diethylamide (LSD/acid), psilocybin (magic mushrooms), and ketamine.
Psychedelics have been used in religious settings for thousands of years, but developed a social stigma in the 1960’s due to widespread recreational use by “hippies” and youth involved in counter-cultural and anti-war movements in the US and beyond. These substances were finally made illegal in the US in 1970. Fifty years later, psychedelics are re-entering the mainstream as a potential breakthrough for various hard-to-treat mental health conditions, including depression and post-traumatic stress disorders (PTSD).
A May 2019 approval by the US Food and Drug Administration (FDA) of a ketamine-derivative substance (in therapeutic settings) has raised the possibilities of more widespread commercialization of psychedelics. Since then, the nascent industry—still mostly in the research stage—has garnered significant investor interest, some of whom are anticipating a cannabis-like boom.
Heightened demand for mental health treatments:
In June 2020:
- 4X higher rates of depression (vs Q2 2019)
- 3X higher rates of anxiety (vs Q2 2019)
- 2X higher rates of suicidal ideation (vs 2018)
Pandemic restrictions forced psychedelic clinics to adopt telemedicine:
Field Trip: Launched virtual psychedelic therapy services through its online platform.
Mindbloom: Launched fully virtually administered ketamine therapy sessions.
A majority of the businesses in the psychedelic industry focus on research and development (R&D), studying the benefits of psychedelic substances and conducting preclinical and clinical research. Other segments—such as cultivation, clinics, and delivery platforms—have started to evolve only recently, driven by the advancements in R&D and positive developments in the regulatory landscape. So in addition to R&D focused leaders Compass Pathways and MindMed, the industry is now seeing growth in vertically integrated psychedelic players such as Field Trip, Numinus, New Wave, and others listed in the table below.
Having advanced their lead drugs to Phase 2b clinical trials, Compass Pathways and MindMed can be safely considered the for-profit pioneers in psychedelic research. And in some cases, it could be said that psychedelic medicine companies might prioritize financial stability over groundbreaking research with a majority of the companies covered in this industry hub having pursued relatively early-stage listings, following a strategy employed by cannabis companies.
Looking at the industry as a whole, capital is concentrated with the four Nasdaq-listed companies: Compass and MindMed as well as their relatively younger peers ATAI Life sciences and GH Research. Other disruptors like Field Trip, Core One Labs, Silo Pharma, and Bright Minds are also eyeing Nasdaq-listings or uplistings with the hope of accelerating growth via enhanced investor visibility.
Among the privately held companies, Beckley Psytech and Gilgamesh Pharmaceuticals—which develop psychedelic-inspired medicines for neuropsychiatric conditions, have raised the most cash within the range of USD 30-40 million in venture funding.
Toronto-based Field Trip is a mental wellness company developing and delivering psychedelic therapies to treat mental disorders such as depression, post-traumatic stress disorder (PTSD), and anxiety. The company has three divisions: Health (clinics), Discovery (research and development), and Digital (virtual therapy). As of June 2021, Field Trip Health operates in six locations: New York, Los Angeles, Toronto, Atlanta, Chicago and Houston. The company also has near-term plans to open six new clinics in San Diego, San Carlos, Seattle, Washington DC, Fredericton, and Amsterdam. These clinics support ketamine-assisted therapies with plans to add other substances, including psilocybin, when permitted. Through its Discovery segment in research labs at the University of West Indies in Jamaica, the company is developing FT-104, its first drug candidate similar to psilocybin in potency. The research is at the preclinical evaluation stage and Field Trip is planning to launch its Phase I clinical trials in 2021. A provisional patent has been filed for FT-104 with the US Patent & Trademark Office.
In August 2020, Field Trip launched its digital app which provides a framework and tools to support meditation and breathwork. The company also has a digital portal that provides users with information and tools related to psychedelic therapies to enhance and optimize the therapeutic experience provided via its clinics.
Field Trip’s key strategy is to use the clinic model for immediate revenue generation while also making them an integral part of the company’s R&D structure. It plans to expand its clinic network to 20 by the end of 2021 and 75 by 2023.
The company went public on the Canadian Securities Exchange in October 2020 after a reverse takeover of Newton Energy Corporation. The company is also awaiting final approval for a Nasdaq listing under the ticker symbol “FTRP” after received conditional approval in July 2021. It recorded revenue of nearly CAD 1 million (USD 0.8 million) for the year ended March 2021 and earned a net loss of CAD 23 million (USD 19 million).
Cultivation/ Synthesis :
Research and Development:
The psychedelic industry has not yet attracted major interest from conventional pharmaceutical companies. This reluctance could be due to psychedelic therapies’ tendency to require a single round of treatment as well as financial, legal, and reputational risks. Partnerships and acquisitions are highly likely in the near future, however, as psychedelic companies progress toward latter stages of drug development.
In May 2019, Johnson and Johnson, through its pharmaceutical unit Janssen Pharmaceutica, was the first in the industry to receive US Food and Drug Administration (FDA) approval for a psychedelic-like nasal spray, named Spravato, to treat depression. Spravato contains esketamine, a chemical derivative of ketamine, and is intended to be used in conjunction with oral antidepressants. Spravato prescriptions are limited to patients who have tried and failed at least two different antidepressants.
The FDA granted Breakthrough Therapy status to Spravato twice: for treatment-resistant depression in 2013 and for major depressive disorder with imminent risk for suicide in 2016. The company claims Spravato to be the only approved medicine able to reduce depressive symptoms within 24 hours. The treatment’s clinical trials showed a 16-point decrease on the Montgomery-Asberg Depression Rating Scale after the first dose of the drug, compared to approximately 12 points in the standard care group.
As the first Breakthrough Therapy approved for depression in three decades, industry analysts predicted Spravato to be a blockbuster drug for Johnson and Johnson. However, the treatment received criticism for not being cost effective from industry watchdogs, the Institute for Clinical and Economic Review (ICER) in the US, and the National Institute for Health and Care Excellence (NICE) in the UK. ICER concluded that Spravato would cost USD 198,000 per quality-adjusted life year, above the usual USD 150,000 threshold used to evaluate cost-effectiveness. NICE also claimed the true efficacy of the drug was difficult to determine due to issues in clinical trial design, and rejected the use of the nasal spray for National Health Service (NHS) for treatment of major depressive disorder.