Introduction

You may know Psychedelic Invest for our trackable index of public companies. You may know us for our constant stream of informative content surrounding the financial side of this growing industry. You might even know us from the epic parties we got to throw in-person again this year.

However you may know us now, the value that we deliver to readers like you is about to expand exponentially in 2022.

Over the past few months, we’ve been working on ways to deliver more content, more data, more insights, and more opportunities to engage with the companies operating in this space. On January 18th, the next chapter of Psychedelic Invest will be unveiled.

This 2021 report is merely the start of the adventures ahead. Like the industry itself, we’re gearing up for an exciting ride of opportunity and uncertainty. All we can hope is that you stay on board for the journey. It’s not only going to be a memorable road ahead, but we can guarantee it will offer more opportunities to learn, participate, and profit from everything this industry has to offer.

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2021 was an expansive year for the psychedelics industry, topping the previous year of immense growth, with funding to psychedelic medicine companies surpassing $730M across 61 total deals, up from 42 in 2020–in what some are calling “The Psychedelic Renaissance.”

Public and private organizations are driving the psychedelic reform movement internationally, with companies and lawmakers sponsoring legislation and research into psilocybin, MDMA, ketamine, LSD, DMT, and other psychedelic substances. A host of companies are developing psychedelic-based drugs, supportive tools, and therapies for conditions including treatment-resistant depression, anxiety, addiction, PTSD, ADHD, autism spectrum disorder, eating disorders, and more. Research is happening parallel to the decriminalization movement, which continues to gain momentum. In 2020, voters in Oregon made the historic vote to pass Proposition 109, decriminalizing all drugs, legalizing psilocybin for medical use, and investing in substance misuse treatment. Washington also decriminalized all medical uses of psychedelics in December of 2020. Washington D.C. and Denver have both moved forward with decriminalization efforts and on December 13th, 2021 a New York lawmaker filed a bill to legalize medical psilocybin with a focus on first-responders and veterans. Similar decriminalization efforts are in action in Massachusetts, Connecticut, Texas, Virginia, and California.

Summary

2021 was a year of big public listings and saw the first several billion-dollar IPOs in the space. Compass Pathways became the first company to be publicly traded north of $1 Billion, an indicator of the industry’s rapid expansion and a larger paradigm shift in our approach to mental health care–soon followed by MindMed, GH Research, and atai Life Sciences. Atai is now the largest company in the psychedelic space, with a market cap of $1.2B and partial ownership of the second largest company in the space, Compass Pathways (CMPS) at $947M, followed by GH Research, capped at $1.2B, and Mind Medicine (MNMD) at $535M. Celebrity investor Peter Thiel’s backing of atai, the third psychedelic biotech to go public in the US, made news in June. In December, it was announced that atai would be added to the Nasdaq’s prestigious biotechnology index.

The COVID-19 pandemic has been linked to a sharp rise in mental health disorders–already a major global issue before COVID-19, with 1 billion people affected worldwide. As the pandemic continued into its second year with subsequent lockdowns, roughly 40% of US adults reported symptoms of anxiety or depression, according to KFF. These growing concerns exposed the weaknesses of traditional health care systems to address and heal mental health disorders at the root–and also amplified the demand for real, healing solutions. With consumers increasingly open-minded to alternative therapies (after the success of cannabis legalization efforts) and seeking solutions to unmet medical needs–the record $730M invested across the sector shows optimism among investors, and increasingly, the general public–around psychedelic medicines’ potential to transform traditional mental health therapies and address the root cause of persistent or “untreatable” issues–such as treatment-resistant depression, anxiety, PTSD, ADHD, addiction, eating disorders and more.

Because of the urgent nature of conditions such as treatment-resistant depression, reporting on these issues requires sensitivity and a nuanced understanding of these conditions, which by their nature engage with grave conditions including self-harm and suicide. These inherent risk factors must be taken into consideration when reading and evaluating clinical data related to conditions such as PTSD and TRD. After all, the hope of “solving” hopelessness–or such high risk, high priority conditions as treatment-resistant depression and PTSD–may be the Trojan horse that paves the way for much more research in the space.

Covid-19 Perpetuated More Illness

The mental health treatments currently available are ineffectual–and ready for disruption.

Before the COVID-19 pandemic hit, mental health was the #1 public health crisis in the developed world, with 1 billion people suffering worldwide from mental health issues, and 13% of the world population directly affected by substance abuse and mental health issues.

Since the pandemic hit, 43% of Americans have reported that their mental health has been seriously affected by COVID-19.

These numbers have devastating personal effects ranging from self-harm, suicide, and substance abuse issues. Mental health problems also have a large financial impact on our societies–costing approximately $1T in annual lost productivity.

As these growing concerns expose the weaknesses of traditional mental health care solutions to address and heal mental health disorders at the root–they also amplify the demand, and the opportunity–for real, healing solutions.

A Paradigm Shift in Care

Unlike traditional pharmaceuticals, psychedelic medicines help people address the root cause of their mental health concerns, rather than just managing symptoms. Learning more about oneself, and touching one’s pain is the way to healing. Psychedelic medicine offers the opportunity to dive deep within oneself and do just that. In many cases, the therapies being developed combine a scientific compound with a therapeutic protocol, guiding the patient safely into deeper levels of self-awareness that have the potential to heal the root cause of emotional pain.

Psychedelic substances also have the ability to unlock creative thinking, re-wire the brain, release addictions, disrupt the pharmaceutical industry–and, have a great positive impact on our society if practiced safely, and at large.

Investment Growth in 2021

A RECORD AMOUNT OF MONEY IS BEING INVESTED INTO THE DEVELOPMENT OF PSYCHEDELIC MEDICINE

2021 began on the tails of Oregon’s historic Proposition 109, which was passed in December 2020, decriminalizing psychedelics for all purposes, and legalizing psilocybin for medical use.

More cities across the US have moved forward with decriminalization, including Denver, Washington D.C., Oakland, Santa Cruz, Arcata, and Port Townsend, WA. As the reform movement continues to gain momentum, investors see growing opportunities in the space.

2021 SAW THE FIRST SEVERAL BILLION-DOLLAR IPOS AND/OR VALUATIONS IN THE SPACE

Compass Pathways became the first company to be publicly traded north of $1 billion, followed by atai Life Sciences, GH Research, and MindMed. While MindMed didn’t IPO at $1 billion, it became worth $1 billion in 2021, a major indicator of growth in the space.

PSYCHEDELIC MEDICINE HAS GONE MAINSTREAM

With unicorns in the market, popular shows on the topic gaining mass popularity and media attention, and a quickly growing reform movement…celebrities are aligned with the movement, too–including Hamilton Morris (of Hamilton’s Pharmacopeia) who was hired by Compass Pathways in September 2021, Lamar Odom who is working with KetaMD (recently acquired by Braxia Scientific), and Mike Tyson, who is an advisor for Wesana.

More than ever, people are willing to shatter the stigma around mental health disorders and are interested in the solutions that psychedelic medicines might provide.

Which Companies Received All That Funding?

he $730 million investment into the industry is being funneled into a few different categories.

Investment Funds and Venture Capital Firms

he four most active investors in the psychedelic space are: Noetic, The Conscious Fund, Palo Santo, and Able. Below is where they put their money in 2021:

Noetic is a venture fund launched by Grey House Partners GP Inc. They invest in emerging and early-stage wellness, therapeutic and pharmaceutical companies around the globe, including:

  • Gilgamesh – $27,000,000
  • Beckley Psytech – £14,000,000
  • Delix – $70,000,000
  • Sana Health
  • Cybin CA – $45,000,000
  • Also, Compass Pathways, MindMed, Numinous, Psybio.

The Conscious Fund invests in early stage ventures in plant-powered medicine, including:

Palo Santo is a “psychedelic therapeutics investment firm” targeting high growth opportunities within biotech & drug development, health care services, and digital health solutions.

Able Partners is focused on supporting visionary, early-stage brands in positive living, including:

  • Compass Pathways – $80M
  • Atai Life Sciences – $43M
  • Goop – $50M
  • MUD/WTR – Undisclosed amount
  • Synthesis – Undisclosed amount

New Investors are Entering the Space

er Investments invests in the mental health sector-primarily in early-stage private companies operating across the psychedelic ecosystem. Their investments include:

  • Awakn Life Sciences – $ 838.29k
  • Psytechedelitech, Inc. – $ 428.75k
  • Wesana Health Holdings – $100k
  • Apex Labs – $ 120.61k
  • Beckley Psytech Limited – $ 1000
  • Nucleus Holdings – $750k
  • Psilera Biosciences – $925k

Vine Ventures is partnering with MAPS on the first Special Purpose Vehicle or “SPV” which marks a collaboration of the nonprofit and for-profit sectors to accelerate MDMA Therapy research.

Neo Kuma is Europe’s first venture capital firm to focus solely on investments into psychedelic healthcare companies. With ten investments already executed, more are in the pipeline.

  • Tripp – $11M
  • Journey Clinical – $3M
  • Wavepaths – $4.5M

PsyMed Ventures is an investment syndicate that invests in early-stage psychedelics companies.

  • TRIPP – $11M
  • Journey Clinical – $3M
  • Delix Therapeutics – $70M
  • TRIPP (separate round) – $70M

JLS Fund invests at the intersection of psychedelics and technology.

There are More Psychedelic Companies Than Ever Before

The psychedelic renaissance is fueled by firsthand experiences of the transformative effects of these compounds. Public and private companies, nonprofits, and educational organizations each play a significant role in moving the reform movement forward.

Of the 1,692 organizations listed in the Neuly database working to progress this movement forward…

Industry Collaborations and Partnerships

Traditional pharmaceutical companies are partnering with psychedelic companies.

  • Pharmaceutical companies like Merck are partnering with psychedelic medicine startups (like Novamind) to gain access to the emerging industry. These companies are working together to develop a drug to address treatment-resistant depression.
  • The surge in psychedelic research is partially motivated by a decrease in ROI for traditional pharmaceuticals that has occurred over the last ten years, which has prompted pharmaceutical companies to seek new revenue channels in the development of psychedelic medicine.

The non-profit and for-profit sectors are working together in new ways:

The First SPV–Special Purpose Vehicle–marks a collaboration of the nonprofit and for-profit sectors to accelerate MDMA Therapy research. On December 2, 2021, MAPS and Vine Ventures announced they will work together to inject $70M into research for MDMA-assisted therapy for PTSD, and Patient Access infrastructure with what they are calling the “Regenerative Financing Vine.”

  • Traditional pharmaceutical companies like Otsuka are investing in psychedelic companies, too. Otsuka invested in Compass Pathways in 2020, before they went public.
  • Drug companies like Compass, who were awarded Breakthrough Therapy designation by the FDA for their psilocybin product and combined therapeutic protocol COMP360, are following a traditional pharmaceutical pathway by seeking patents and gaining regulatory approval for their product.
  • Compass plans to sell COMP360 to clinics and healthcare providers in the US and Europe. However, they have faced some resistance in the form of nonprofits such as The Heffter Institute and Usona Institute, which have helped fund some of the legal efforts against Compass’ efforts to patent COMP360.

Organizations by Drug Focus

Of all the startups in the space, the ones receiving the biggest investment are those companies developing and researching their own drugs–and developing pipeline treatments for indications where there is an opportunity to disrupt traditional pharmaceutical medicines.

However, new drugs require FDA approval, and a handful of companies are racing to secure patents on unique chemical derivatives and running clinical trials on those substances, in hopes of receiving FDA approval.

2021 saw a massive amount of money invested into drug development–R&D accounts for 48% of the total amount invested into the sector this year. As many companies pursue clinical trials for FDA approval, the only ones currently generating revenue are the ones–like Field Trip, and Numinous–using ketamine (which is currently legal in the United States) for the off-label treatment of PTSD and depression. Until FDA approval is obtained, investors should expect volatility as these companies work through their trials–which could take time. With psychedelic stocks currently low, these companies are still high-risk investments. However, investing in new industries with promising potential often rewards early investors.

Psilocybin Organizations

Psilocybin – of 178 organizations in the psilocybin space, 119 are privately held (including Beckley Psytech, Cybin Therapeutics, Havn Life), 47 are public (ATAI, Compass Pathways, Cybin, Mydecine, Field Trip Health), 9 are nonprofits, and 2 are educational organizations.

Compass Pathway is leading the development of psilocybin for commercial use. They have applied for patents for COMP360–a protocol derived from a psilocybin-derived compound they are developing to be sold to clinics in the USA and Europe and combined with a therapeutic protocol. The results of their COMP360 trial on Treatment-Resistant Depression released in November showed substantial promise at treating TRD with a 10mg dose. Atai made an additional $12 million investment in Compass, increasing its stake in the company from 19.4% to 20.8% soon after the results were released.

Despite working toward the same goal, the relationship between the for-profit and nonprofit sectors isn’t always supportive-organizations like Usona may undermine Compass’ potential market by providing a comparable psilocybin-based product to providers for free or at a lower cost.

LSD Organizations

LSD – of 14 organizations working with LSD, 6 are privately held (Beckley Psytech, Mycrodose, MagicMed Industries), 5 are public (Astra Zeneca, MindMed, BetterLife Pharma), 3 are nonprofits (SPORE).

Mindmed is currently developing LSD-treatment protocols for generalized anxiety disorder, and adult ADHD (currently in Phase 2a of clinical trials)–they have partnered with Liechti Lab at University Hospital Basel, NYU Langone Health and Maastricht University in the Netherlands to conduct research.

Mindmed is also conducting the first clinical study exploring the effects of LSD combined with MDMA, and developing an LSD-neutralizing compound to reduce the hallucinatory effects of LSD. Mindmed is also developing 18-MC, derived from ibogaine, and exploring its potential to cure addiction.

MDMA Organizations

DMA – of 20 organizations, 9 are privately held (ATMA, MagicMed Industries, Mycrodose), 6 are public (ATAI Life Sciences, CURE Pharmaceutical (CURR)) Lobe Sciences, Merck) 5 Nonprofit organizations (MAPS, Spore).

Awakn Life Sciences is developing an IP portfolio of therapeutics aimed at treating addiction. Currently in Phase IIa of a study that explores the ability of MDMA to address alcohol abuse disorder, they are also looking at the effectiveness of ketamine and new chemical entities at curing substance addictions, gambling, and other behavioral addictions.

CURE Pharmaceuticals has developed CUREFilm, a sublingual and buccal film allowing direct absorption of the active substance into the bloodstream, which is placed in the oral mucossal tissue, and is passed directly into the bloodstream, for rapid release that bypasses the metabolism and avoids potential negative side effects.

Ketamine Organizations

Ketamine – Of 61 organizations in the Neuly database, 46 are privately held (Gilgamesh Pharmaceuticals, Ember Health, mindbloom) 9 are public (atai Life Sciences, Field Trip Health, Novamind) 6 are nonprofits (SPORE, Kriya Institute).

The legality of ketamine means the research being conducted on it is far more substantial than non-legal psychedelic substances–and the vast sum of research on ketamine is not exclusive to its psychedelic properties. However, an impressive amount of educational organizations are exploring ketamine’s potential for treating mental health conditions as varied as OCD, Bipolar disorder, depression–in multiple forms, anxiety, and PTSD.

There are over 100 ketamine clinics currently operating in the USA, with many more to come. Companies including Field Trip Health are using ketamine therapeutically, combined with talk therapy, to address treatment-resistant depression and PTSD.

Companies including Field Trip Health are using ketamine therapeutically, combined with talk therapy, to treat treatment-resistant depression and PTSD.

Mycrodose is developing transmucosal ketamine lozenges, which claims to deliver a sustained and controlled dose of medicine into the body, to treat mental health disorders.

DMT Organizations

DMT – of 20 organizations focused on DMT in the Neuly database, 14 are privately held (Beckley Psytech, Psilera Biosciences, CB Therapeutics, GH Research, MagicMed) 3 are public (Algernon Pharmaceuticals, atai Life Sciences, XPhyto) and 3 are nonprofit (Limina Foundation, SPORE)

Small Pharma is currently in stage I/IIA of the world’s first clinical trial studying the effects of SPLO26 DMT on major depression–a double-blind, placebo-controlled study combining DMT with therapy to explore the safety and efficacy of the compound. They are also in the preclinical stage of a Deuterated DMV IV study. Small Pharma is working to develop a drug pipeline using their proprietary deuterium-enriching technology, re-engineering the pharmacokinetic profile of tryptamine-based compounds which allows them to control how a drug travels through the body, as well as the duration of the psychedelic experience.

GH Research is in clinical trials for their DMT formulation GH001, studying it for its potential to treat depression and their DMT formulation GH002 which is in preclinical R&D for undisclosed indication.

Algernon Pharmaceuticals is studying DMT for its non-psychedelic potential to promote healing and recovery in the brain from a stroke. They recently announced they have completed manufacturing a clinical-grade supply of DMT (AP-188) which they will use to complete their trials studying the effects of DMT on strokes.

Growth in Nonprofits

“The foundations for the ecosystem or industry that’s emerging is built on nonprofits and research organizations that have depended on philanthropy for the last 30 years arguably, with The Heffter Institute and MAPS, just as two that have raised significant amounts of capital and made significant amounts of progress for what we all have this significant opportunity to play in.” – Psygen founder Danny Motyka (:28 mins)

The commercial investment into psychedelic research is enabled by nonprofit organizations which have paved the way for the decriminalization and legalization movement with independently funded research. Organizations like MAPS, The Heffter Institute and The Beckley Foundation have each played a significant role in moving psychedelic research forward–creating a foundation of research on which legislation, newer research and commercial developments may progress. These nonprofits often work in partnership with educational organizations to design and implement clinical studies.

MAPS was founded by Rick Doblin in 1986 to help develop legal contexts for the beneficial uses of psychedelics and marijuana. Their research output is substantial and has mostly focused on MDMA but now also includes LSD, ayahuasca and ibogaine.

The Heffter Research Institute is a non-profit organization based in New Mexico, incorporated in 1993. Heffter has helped to design, review, and fund leading studies on psilocybin at prominent research institutions in the US and Europe. Their research explores psilocybin for the treatment of cancer-related distress, and addiction. They also investigate the relationship between the psychedelic experience and spirituality, and psilocybin’s effect on the physiology of brain activity, cognition, and behavior.

The Beckley Foundation is a non-profit based in Oxford, UK, and incorporated in 1998. Focused on drug policy reform and scientific research into psychoactive substances, founder Lady Amanda Feilding created Beckley Psytech in 2019 to increase the scale and ambition of the NGO’s work. The foundation exists separately from the for-profit company.

Educational Organizations

Universities and other educational organizations play a crucial role in collecting research, generating data, and ultimately, moving the reform movement forward. With most research clustered in the United States and Canada, certain universities have established schools dedicated to researching psychedelic compounds. Johns Hopkins launched their Center on Psychedelic and Consciousness Research with $17 million in funding. The UC Berkeley Center for the Science of Psychedelics launched in 2020 with a $1.25 million donation from an anonymous donor. Also worth noting is the Imperial College of London’s Centre for Psychedelic Research (psychedelic advocate Tim Ferris has provided support to both Imperial College and Johns Hopkins.)

A selection of educational organizations conducting clinical studies on psychedelic medicine can be found on the subsequent pages of this report.

Johns Hopkins Clinical Trials:

Charite University in Berlin Clinical Trials:

Columbia University: Clinical Trials:

University of Chicago Clinical Trials:

Yale Clinical Trials:

Increase in Job Opportunities

One indicator of the industry’s growth is the abundance and breadth of available jobs. An uptick in clinical trials means more research jobs, and more data means more data and engineering jobs. As more tech is built, there are more programming jobs. Simply put, as the psychedelic industry becomes a more mature marketplace, the need for talent expands horizontally.

With many concentrated in the USA (NYC, San Francisco, and San Diego) and Canada, many are remote. Below are some of the companies and research organizations currently hiring. There are 382 total jobs currently listed in the Neuly database.

Mindleap Health: (Jobs are based in Vancouver, Canada) Integration Specialist

For more information on jobs available in psychedelic medicine, please visit our jobs report HERE and visit Neuly’s database.

Psychedelics as Medicine

The use of psychedelic substances including psilocybin, MDMA, LSD, DMT, ketamine, and ibogaine to treat mental health conditions is progressing with great momentum parallel to the decriminalization movement.

Urgent conditions such as treatment-resistant depression and PTSD are furthest along in clinical trials, as researchers and companies alike strive for solutions for those not helped by existing therapies.

Treating Depression

Psilocybin holds great promise to heal the root of depression rather than just its symptoms. In November, Compass Pathways announced the findings of their comprehensive, double-blind study of COMP360, where they found that a 10mg dose of COMP360 was effective at treating depression in a TRD population. Numerous other studies have found psilocybin to be effective when treating depression. GH Research is studying DMT (they are testing their derivative, GH001) for treatment-resistant depression. Naurex is testing their compound GLYX-13 for its ability to treat difficult-to-treat depression, as well as NRX-1074 for the treatment of major depressive disorder. MAPS has conducted numerous studies on MDMA’s application for depression.

Treating PTSD

PTSD has been one of the biggest areas of study for MAPS–as MDMA quiets the amygdala, or the fear response center of the brain, allowing people with PTSD to experience and release painful or fearful memories without being overwhelmed. MAPS recently conducted a phase 3 multi-site study of MDMA-assisted psychotherapy across 16 cities. Ketamine is also being studied for PTSD, for antidepressant-resistant symptoms of PTSD, and for comorbid PTSD combined with chronic pain. Atai and EmpathBio are conducting a study using EMP-01, an MDMA derivative, currently in its preclinical stage.

Treating Addiction

Ibogaine is one substance that holds unique promise in the treatment of addiction. Derived from a shrub grown in Africa, ibogaine has anecdotally cured opiate addictions in a single treatment. One of atai Life Science’s platform companies, DemeRx, is currently in Phase 1 of a study to evaluate DMX-1002/Ibogaine on Opioid Use Disorder. MindMed is entering Phase 2 on an opioid withdrawal study using LSD, and also developing their ibogaine-derivative 18-MC, for its potential to treat addiction. Psilocybin, MDMA, and LSD are all being analyzed for their ability to treat alcoholism and other forms of addiction.

Treating Anxiety

Anxiety can impact many aspects of life–one aspect of life that conjures anxiety in most people is facing the inevitable reality of death. There are multiple studies being conducted to analyze the effects of psilocybin on integrating the reality of mortality. These studies are being conducted on populations approaching the end of their lives–many of whom have received a diagnosis of cancer or a terminal illness. Studies include Psilocybin Cancer Anxiety Study, Psilocybin-Assisted Psychotherapy for Anxiety in People With Stage IV Melanoma, Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety, Psychopharmacology of Psilocybin in Cancer Patients, Psilocybin for Psychological and Existential Distress in Palliative Care, and MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer. MDMA is also being studied for social anxiety in autistic adults.

Clinical Trials in 2021

Psychedelic research is now a global effort, with the majority of research occurring in the United States, where over 1,000 FDA-sanctioned clinical trials involving psychedelic substances have been, or are currently being conducted.

Of those, the most researched substances include MDMA and Psilocybin–both of which have received the FDA’s “Breakthrough Drug” designation, as well as ketamine, which is already legal in the US. Furthest along are the studies focusing on hard-to-treat conditions like treatment-resistant depression and PTSD. It is worth noting that since ketamine is already legal in the USA and has anesthetic properties beyond its mental health applications, the research into ketamine does not solely reflect the research being done on ketamine’s application as psychedelic therapy.

A record amount of clinical studies began in 2020. In 2021, the research has continued, lead by organizations including MAPS and Compass Pathways, who announced in November the conclusion of the most comprehensive double-blind study to date, into the therapeutic effects of psilocybin on treatment-resistant depression. They found promising results from a 10 mg dosage of their drug COMP360, combined with guided therapy.

Numerous other studies are being conducted, exploring the therapeutic effects of substances including GHB, DMT, LSD, and ibogaine to treat conditions including addiction, PTSD, autism spectrum disorder, and more.

In the Neuly database, there are…

…moving the dial forward to progress the psychedelic movement.

Some current psychedelic studies (experimental and clinical) in the fields of psychology, psychiatry and neuroscience include, but are not limited to:

Psilocybin Clinical Trials

One of the most studied compounds this year, psilocybin, is being analyzed for its ability to treat a wide range of mental health disorders–including depression, anxiety, PTSD, addiction, end of life anxiety associated with cancer, and terminal illness, and eating disorders. Research into urgent and hard-to-treat conditions such as treatment-resistant depression are some of the furthest along.

MAPS Clinical Trials

Select Clinical Trials from MAPS:

Clinical Trials for Depression

According to the World Health Organization, depression affects approximately 280 million people worldwide or an estimated 5% of adults. DIt is is a leading cause of disability worldwide and a major contributor to the overall global burden of disease. Depression can have tragic consequences for families and individuals–the reality of the condition is a deeply painful one that can result in death by suicide.

The first selective serotonin reuptake inhibitor (or SSRI) released to the US market was Fluoxetine, in 1987. By the 1990s, SSRIs had become the leading treatment for depression in North America, and usually the first line of treatment for depression and other mood disorders. However, in recent years, concerns have been raised about their safety and efficacy, as studies have shown a possible increased risk of suicidal behavior among those treated with SSRIs, especially among adolescent populations.

There is significant hope that psychedelic medicines, combined with supportive therapies, may help resolve the root cause of depression and therefore heal its most tragic symptoms.

Clinical Trials for Addiction

Harmful patterns of substance use affect an estimated 35 million people worldwide. (WHO) It is estimated that about 0.5 million death annually are attributable to drug use. Opioid-related deaths, largely due to synthetic opioids, have recently changed the mortality trends in some high-income countries. The Opioid epidemic alone is estimated to cost the USA $78.5 Billion annually. Research organizations are exploring the potential of psilocybin, MDMA, Ibogaine and LSD to treat addiction at the root. Government organizations like NIDA (National Institute for Drug Abuse) are sponsoring studies at research organizations across the US,

Clinical Trials for PTSD

PTSD is a psychiatric disorder which may stem from the witnessing or being victim of a traumatic event but may also occur through indirect exposure to a traumatizing event, resulting in intrusive thoughts which have a serious impact on one’s lived experience.

Though most commonly associated with soldiers or victims of a violent event, “PTSD affects approximately 3.5 percent of U.S. adults every year, and an estimated one in 11 people will be diagnosed with PTSD in their lifetime. Women are twice as likely as men to have PTSD. Three ethnic groups – U.S. Latinos, African Americans, and American Indians – are disproportionately affected and have higher rates of PTSD than non-Latino whites.” (Source: Psychiatry.org)

Here are a selection of current clinical studies focused on PTSD:

Clinical Trials for Anxiety

There are numerous studies analyzing the effects of psilocybin and MDMA to assist in end of life integration therapies. In August of 2020, Canada legalized the use of psilocybin as a part of end-of-life care for terminally ill patients. The legislation was assisted by the non-profit TheraPsil. Following a similar trajectory as marijuana, it is likely that high-risk indications such as end-of-life therapies may help push legalization forward so that psychedelic substances will be accepted as valid treatments for less “grave” forms of anxiety.

Clinical Trials for Eating Disorders

Clinical Trials for Bipolar Disorders

The Decriminalization of Psychedelics in 2021

As the reform movement gains traction and more states work to decriminalize plant medicines, entheogens like psilocybin seem poised to follow the same pathway as marijuana, with states in the US like Oregon, Washington, and California leading the way on decriminalization.

One big player driving reform in the United States is the Decriminalize Nature movement. Multiple chapters have popped up across America, which have been successful in educating people about entheogens and leading legislative change through decriminalization. The Decriminalize Nature organization provides resources for those interested in creating their own local chapters, uniting those who believe in plant and fungi medicine around a “movement to heal our relationship with nature and each other through a partnership with these entheogens.

The U.S. Legal Landscape

Below are a select few states which are moving forward with decriminalization efforts.

Psychedelic Research in Texas

In Texas, the Department of State Health Services will collaborate with the Texas Medical Board to study MDMA, psilocybin, and ketamine to treat a variety of medical conditions, including depression, anxiety, PTSD, bipolar disorder, chronic pain, and migraines.

Psychedelic Research in New York

In New York, the legislation proposes to establish a psychedelic research institute to study the efficacy of using psychedelics to treat addictive disorders, depression, PTSD, and end-of-life anxiety among others.

Psychedelic Research in Connecticut

Connecticut’s proposed research program is the most limited because it will only study psilocybin. Unlike Texas and New York’s research program of treating various specific ailments, Connecticut’s plan is broader, stating they will study whether using psilocybin “may be beneficial to the person’s physical or mental well-being.”

To follow the decriminalization movement, and view our full guide on psychedelic legalization, visit us here.

Psychedelic Industry Events in 2021

The MDMA Conference was a virtual conference organized by Microdose on June 15th, which brought together experts from the business side of MDMA, psychotherapists, healthcare professionals and regulatory experts to approach the topic of MDMA from a range of perspectives. Keynote was delivered by Ben Sessa, the Chief Medical Officer of Awakn Life Sciences, who discussed the role that MDMA can play in helping people heal from alcohol dependence and addiction, and by Charles Wininger of MAPS, and author of “Listening to Ecstasy: The Transformative Power of MDMA.”

Beyond Experience took place from October 6-10 in Amsterdam Beyond Experience is a 5-day intensive group workshop on psychedelic integration that teaches people to learn from extraordinary psychedelic experiences and embody those insights in everyday life. The event teaches participants how to integrate their own psychedelic experiences and support others in their journeys.” Based on the principles of ACT – Acceptance and Commitment Therapy, the course offers a collaborative experience as well as a variety of tools, including creative expression, automatic writing, bodywork, working with self-aspects and biography, hypnotherapeutic trances, music journeys, and mindfulness meditation practices. Organized by the MIND Foundation, which also offers training in their ACT protocol of Augmented Psychotherapy Training. No psychoactive substances are consumed during the workshop.

The Fantastic Fungi Global Summit took place on October 15-17th, riding the wave of enthusiasm from the Netflix hit film by the same name. Appropriately multidisciplinary, “Voices from the Underground” joined legendary mycologists such as Paul Stamets with psychedelics and mental health experts such as Michael Pollan, Andrew Weill and Rick Doblin, as well as artists and visionaries, food experts and foragers, environmentalists, growers, spiritual leaders, and many other innovators to discuss the giant topic of mushrooms–and the many ways that fungi stand to impact the world in a positive way.

DELIC – On November 6-7, Delic Holdings, a psychedelic wellness platform, hosted Meet DELIC in Las Vegas. Described as “Burning Man meets CES” the Meet Delic Festival took place at Las Vegas’ Area15. The weekend-long extravaganza explored the idea of psychedelic wellness through a blend of educational and entertaining events, covering topics such as “How Big Money is (Already) Playing Psychedelics,”Psychedelic Activism,” “Aphrodisiacs and Psychedelics: A History of Medicine for Love,” and “How Psychedelics Can be Effectively Used for Physical Optimization,” combined with dance parties, music, and the world’s largest psychedelic business expo. Speakers included Duncan Truseel, Aubrey Marcus, and Jason Silva. For more information and to purchase tickets for next year, visit their website here.

Wonderland by Microdose took place from November 8 to 9, 2021 in Miami, FL. Microdose has hosted virtual events all year, including Psychedelic Capital, The MDMA Conference, and the Molecular Masterclass series–but Wonderland Miami was the industry’s largest event to date, showcasing the latest advancements in emerging technologies within the psychedelic industry. With over 2,000 attendees and an impressive lineup of founders, industry researchers thought leaders, and CEOS among them, Wonderland presented a unique opportunity to network with industry leaders and executives from top companies and research organizations, including Robin Carhart-Harris and Matthew Johnson of Johns Hopkins, Rick Doblin from MAPS, and celebrity advocates like Mike Tyson and Lamar Odom. Psychedelic Invest hosted the official afterparty for the event–it was awesome.

The 14th-annual Horizons: Perspectives on Psychedelics took place from December 1 to 5, 2021 in New York City. The longest-running annual conference on psychedelic medicine, Horizons is dedicated to providing an in-depth, educational experience to participants—and while they addressed psychedelic medicine from multidisciplinary perspectives (addressing science, medicine, culture, community, spirituality, and economy) they also offered in-depth introductions to psychedelic therapy in small group learning environments, many of which were geared toward practitioners.. The conference offered live and digital forums, classes, and films. Some of their offerings included an Introduction to the Art & Science of Psilocybin Therapy; Introduction to MDMA Therapy for Clinicians, and The Psychedelic Business Forum. The event took place in historic NYC buildings including The New York Academy of Medicine. For more information and to visit next year, visit their event website.

Accomplishments in Q1 2021

2020 Ended on a high note, as psychedelics were historically decriminalized in Oregon–and 2021 has only gained momentum since then.

Below are some of the highlights from the year:

January

  • Horizons Psychedelic Stock Index ETF launched (PSYK)
  • Senate Bill S1284 was introduced in New York by Sen. Gustavo Rivera (D) to “[Eliminate] criminal and civil penalties for possession of controlled substances; [establish] the drug decriminalization task force to develop recommendations for reforming state laws, regulations and practices so that they align with the stated goal of treating substance use disorder as a disease, rather than a criminal behavior.” The bill is still under analysis.
  • Novamind goes public
  • January 15 – Somerville, MA approves decriminalization measure

February

  • Core One Labs began their biosynthetic psilocybin production trials.
  • Canada’s Red Light Holland has received regulatory approval to import its psilocybin truffles to Brazil.
  • Optimi Health, the Vancouver-based health, and wellness company completed a $20.7 million IPO.

March

Accomplishments in Q2 2021

April

May

June

Accomplishments in Q3 2021

July

August

Accomplishments in Q4 2021

October

November

December

…an exciting year for the psychedelic industry!

What should we expect in 2022?

We are witnessing the beginning of a whole new industry–the psychedelic industry still in its infancy.

And while it’s growing quickly, companies are still early in their processes of developing pipelines for therapeutic development. Larger investments will continue to give companies the power they need to continue research and testing, to eventually turn anecdotal evidence into robustly-assessed clinical data which permits FDA approval. Simultaneously, the reform movement is picking up pace.

Making bets in the early stages of an industry has the potential to reward early adopters with a significant return on their investments–but time will tell which companies stand out and lead the ship forward toward new horizons of healing previously unknown to our mental healthcare landscape.

Until many of these companies have clear revenue channels, stocks are bound to fluctuate and remain high-risk, especially amid macro-financial concerns such as inflation. But as large investments continue to roll in for these companies, and as research and reform initiatives continue–there is no sign that the industry’s growth will slow down until there are valid mental healthcare solutions to address our collective needs.

To stay abreast of new developments in the psychedelic industry, to view our extensive industry-leading database, and our Projections for the Psychedelic Industry in 2022, follow along at www.neuly.com, www.psychedelicinvest.com, and www.withnucleus.com.