The Psychedelics As Medicine Report 3rd Edition

PSYCH:
THE
PSYCHEDELICS
AS MEDICINE Third Edition
REPORT OCTOBER 2021
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Psychedelic substances remain illegal in most countries so please reference your local laws in relation to medical or recreational use. This report has been compiled for Psychedelic substances remain illegal in most countries so please reference your local laws in relation to medical or recreational use. This report has been compiled for
informational purposes only. It should not be construed as a research report for investment, legal, medical, health or tax advice. © 2021 Psych Capital Plc. informational purposes only. It should not be construed as a research report for investment, legal, medical, health or tax advice. © 2021 Psych Capital Plc.
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The Psychedelics as Medicine Report | Table of Contents The Psychedelics as Medicine Report | Table of Contents
Table of
Contents
1 27
INTRODUCTION LEGISLATION
AND REGULATION
5 29
DEFINITIONS CONSUMER
AND SCOPE ATTITUDES
9 41
EXECUTIVE HEALTHCARE
SUMMARY PROVIDERS’
ATTITUDES
15 53
KEY TRENDS SPOTLIGHT
ON HEALTH
19 63
MARKET VALUE PSYCHEDELICS -
TIMELINE OF KEY
DEVELOPMENTS
The Psychedelics as Medicine Report | Table of Contents The Psychedelics as Medicine Report | Table of Contents
67 145
COUNTRIES PSYCHEDELICS
TO WATCH PER COUNTRY
75 155
PSYCHEDELIC PSYCHEDELICS
PROFILES AND THE LAW
83 159
KEY PSYCHEDELIC PATENTS AND
DEEP DIVES INTELLECTUAL
PROPERTY
129 163
OTHER THERAPY
PSYCHEDELICS PRACTITIONERS
OF NOTE
137 173
PSYCHEDELICS PSYCHEDELIC
AS MEDICINE: RESEARCH
POTENTIAL
THERAPIES
141 187
PSYCHEDELICS GLOSSARY
AND TECHNOLOGY
The Psychedelics as Medicine Report | Introduction The Psychedelics as Medicine Report | Introduction
Introduction
William Potts,
CEO
Psych Capital Plc.
PSYCH is proud to bring you the third edition Now, 50 years later, we are in the midst of a
of The Psychedelics as Medicine Report, pro- psychedelic renaissance. A wave of high-qual-
filing all major psychedelic drugs, both nat- ity research has prompted renewed interest in
urally derived plant-based varieties such as psychedelics as medicine. Whereas psyche-
psilocybin, ibogaine, ayahuasca and mesca- delics may have never left the general public,
line, along with those synthetically manufac- they are now being rediscovered by research-
tured in laboratory settings, such as LSD (ly- ers, entrepreneurs, investors, and before too
sergic acid diethylamide), ketamine, MDMA long, patients.
(3,4-Methylenedioxymethamphetamine) and
novel second-generation psychedelics. Our fully updated report will present you with
an expert overview of the market opportunity
A year after the release of the second edition that psychedelics as medicine offer. It iden-
in September 2020, the world is still grappling tifies the regulatory landscape and provides
with the COVID-19 pandemic. All of us have unique insights into consumer and healthcare
collectively lived through unprecedented times providers’ attitudes, and outlines which psy-
as the world has stood still for more than a chedelics are poised to disrupt convention-
year. Not only was our physical health in dan- al treatments for a wide array of debilitating
ger, but the looming threat and months-long mental health conditions, affecting hundreds
lockdowns has also had a severely negative of millions of people worldwide.
impact on our collective mental health. At the
same time, the immensely quick development Finally, it offers key insights into the extraor-
of effective vaccines has offered us hope for dinary opportunities that psychedelics will
the future. A future where we will not only be present to early movers in this nascent in-
able to tackle threats from outside but will also dustry, including interviews with pioneering
be able to improve the mental health of billions. experts already operating in the therapeutic
psychedelics’ space.
Once given to more than 40,000 patients,
psychedelics were banned from the psychi- We hope you enjoy reading the latest edition
atrist’s office in the Convention on Psycho- of The Psychedelics as Medicine Report.
tropic Substances of 1971. These political
decisions were a result, not of the danger of
psychedelics, but as a response to the ‘hip-
pie’ counterculture of the 1960s. Soon after
they were banned, research into psychedelics
became all but impossible.
informational purposes only. It should not be construed as a research report for investment, legal, medical, health or tax advice. © 2021 Psych Capital Plc. \ 1 informational purposes only. It should not be construed as a research report for investment, legal, medical, health or tax advice. © 2021 Psych Capital Plc. \ 2
The Psychedelics as Medicine Report | Lead Sponsor Foreword The Psychedelics as Medicine Report | Lead Sponsor Foreword
LEAD SPONSOR
FOREWORD
Florian Brand
Co-founder and CEO
atai Life Sciences
It’s been a memorable year for our team at Pharma with a licensing deal between atai’s
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globally (particularly on the mental health and Otsuka, an industry leader in innovative
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we have been buoyed by atai’s stellar growth in our strategic partnership with IntelGenx
and successful IPO. We are continuing to build on novel transmucosal delivery technologies,
a diverse portfolio in an industry with potential EmpathBio’s partnership with Bionomics
for growth, and I believe that we are well situ- on PTSD and, most recently, the launch of
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to 93,000 in 2020. COVID-19 was known to chedelic compounds, have been overlooked
impact the most vulnerable, but the stats or underused. Like all those who have con-
bring new meaning to that fact. tributed to this year’s Psychedelics and Med-
icine report, we believe that it’s high time
Growth & recognition: patients had access to more innovative treat-
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we are proud of numerous accomplishments
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led to the first major partnership between a
company developing psychedelics and Big
The Psychedelics as Medicine Report | Definitions and Scope The Psychedelics as Medicine Report | Definitions and Scope
Definitions
and Scope
DEFINITIONS
The psychedelic substances profiled in this Serotonin (5-HT)

report are either naturally occurring, such as Serotonin is a crucial hormone found in the
psilocybin, ayahuasca and ibogaine; or, like brain, gut, and throughout the central nervous
LSD and MDMA, are (semi-)synthetically man- system (CNS). In the brain, it serves a role as
ufactured in a laboratory setting. Naturally a neurotransmitter, or neuromodulator, and is
occurring psychedelics, such as psilocybin, involved in functions related to mood, cogni-
can also be synthetically manufactured. Novel tion, learning, memory and happiness. Many
psychedelic compounds can also be synthe- conventional antidepressant drugs work by se-
sised based on existing substances. lectively inhibiting the reuptake of serotonin
(SSRIs). Through that process, there is more
serotonin available to improve the transition
of messages between neurons. Many psyche-
delics work by agonising, binding to serotonin
receptors, especially in neocortical pyrami-
dal cells, and through that mechanism chang-
ing how the serotonergic system works. The
complex effects of serotonin are mediated
through 7 receptor types and at least 14 sub-
types. Psychedelics usually influence either
the 5-HT2a or 5-HT1a receptors.
Indole alkaloid
An alkaloid is a naturally occurring, organic,
nitrogen-containing compound found in more
than 4,000 species of plants, which has
diverse physiological effects on humans.
An indole alkaloid is a particular classifica-
tion of alkaloid that has a chemical structure
containing a ring system called indole. Ex-
amples of indole alkaloids include serotonin,
and psychedelics such as psilocybin mush-
rooms, iboga, LSD and tryptamines such as
DMT (dimethyltryptamine). Codeine and mor-
phine (as well as nicotine) are well-known
commonplace examples of pharmaceuticals
derived from plant alkaloids.
The Psychedelics as Medicine Report | Definitions and Scope The Psychedelics as Medicine Report | Definitions and Scope
Psychedelics Mescaline (peyote) LSD

Psychedelics, or hallucinogens, are psychoac- Mescaline is a naturally occurring psycho- LSD belongs to a chemical group named ly- cal research has been undertaken with salvia.
tive substances that powerfully alter percep- active substance derived from the flowering sergamides, which have both phenethylamine It has psychedelic effects when consumed
tion, mood, and a host of cognitive process- heads of the peyote cactus and is found in and tryptamine (such as psilocybin) groups by chewing, smoking, or when drunk as tea.
es. They are considered physiologically safe Mexico and in southwestern United States. embedded within their structure. The chemical structure of salvia is distinct
and do not produce dependence or addiction. San Pedro and Peruvian Torch are examples of from other psychedelics, and it is a potent
Psychedelics can cause changes in percep- other cacti that contain mescaline. Mescaline MDMA k-opioid receptor, so not a serotonin recep-
tion, thought and feeling, ranging from visual is an alkaloid that has psychedelic properties. MDMA is a synthetic stimulant of the central tor agonist. Revixia Life Sciences, an entity of
distortions (illusions) to imagining things that The mescaline molecule is of similar struc- nervous system (CNS) derived from amphet- clinical-stage biopharmaceutical company atai
are not there (hallucinations). Psychedel- ture to two hormones produced in the human amine. It is closely related in structure to Life Sciences, is developing a proprietary for-
ics heighten sensory inputs (bottom-up) and adrenal gland, adrenaline and noradrenaline. another stimulant, methamphetamine. MDMA mulation of Salvinorin A, RLS-01, as a medica-
lower the influence of preconceived ideas Mescaline can also be synthetically manu- shares a similar chemical structure to mesca- tion for TRD.
(top-down). Most psychedelics profiled in factured. It was first isolated from the peyote line, which is found in the peyote cactus and is
this report are serotonergic psychedelics, plant in 1896. referred to as an ‘entactogen’ (this translates Breakthrough Therapy
exerting their influence via the serotonergic as ‘touching within’) and as an ‘empathogen’ Designation
pathways in the brain. MDMA (an empatho- Ayahuasca (which means it can generate empathy). If the United States FDA awards a substance/
gen), ibogaine, ketamine, and salvinorin A Ayahuasca is a brew made from a blend of treatment Breakthrough Therapy designa-
being notable exceptions that mainly work via different plants, primarily the Banisteriopsis Ketamine tion (BTD), this means the FDA will expe-
changing other systems. caapi (ayahuasca or yagé) vine and Psycho- Ketamine was first synthesised in 1962 and dite the substance’s development and review
tria viridis (chacruna) shrub, which contains is used most commonly in veterinary prac- process because clinical evidence has shown
Psilocybin DMT. So, unlike DMT, which is most common- tice as an animal tranquilliser. However, it has that it may offer a substantial improvement
(‘magic’ mushrooms) ly smoked, ayahuasca is a liquid preparation, practical medical applications as a general an- over existing therapies. BTD has been given to
Psilocybin is a psychoactive substance consumed orally as a ‘tea’. Ayahuasca con- aesthetic and sedative in human patients, es- COMPASS Pathways and Usona Institute to
derived from psilocybe mushrooms (such as tains chemicals (MAOIs - monoamine oxidase pecially in children and in patients who have develop psilocybin to treat depression, to the
Psilocybe Mexicana). It is an indole alkaloid inhibitors) that prevent the stomach from compromised respiratory systems. Ketamine Multidisciplinary Association for Psychedel-
that, when converted to psilocin, has psyche- breaking down DMT and which prolong the is also a powerful psychoactive substance and ic Studies (MAPS) which is developing MDMA
delic properties. It is thought that psilocin effect of DMT. If ayahuasca is synthesised it is antidepressant. It is available in liquid-soluble to treat post-traumatic stress disorder (PTSD),
acts mainly by activating the 5-HT2a recep- sometimes named pharmahuasca. form as ketamine hydrochloride and is mar- and to Janssen & Janssen for the treatment of
tors. Psilocybin can be synthetically manufac- keted in both Europe and North America by TRD with Spravato.
tured and was first isolated in a laboratory in DMT numerous companies, including Endo Pharma-
the 1950s. The mental health care company DMT (dimethyltryptamine) is a naturally oc- ceuticals and Pfizer, under the brand names
COMPASS Pathways has successfully patent- curring chemical found at low concentrations Ketalar/Ketanest.
ed a synthetically derived psilocybin derivative in many plants, animals and humans. When
known as COMP360. taken in concentrated doses, it is a powerful Esketamine
psychedelic. It is ordinarily the central active Esketamine is the S(+) enantiomer of ket-
Ibogaine ingredient in ayahuasca. DMT is thought to act amine, which is one half of the two mirror
Ibogaine is a psychoactive substance ex- by activating 5-HT2a receptors. It can also be images that make up (racemic) ketamine. It
tracted from the bark of the root of an African synthetically manufactured. is currently unknown if esketamine is supe-
rainforest shrub called Tabernanthe Iboga. rior to ketamine or arketamine (R(-) enantio-
Ibogaine is an indole alkaloid that has psyche- 5-MeO-DMT mer) for the treatment of depression. A sub-
delic properties. Ibogaine was isolated from 5-MeO-DMT is a tryptamine alkaloid that was sidiary of Johnson & Johnson has received
the plant in 1901 and was synthesised in 1966. first synthesised in 1936. The compound is FDA (Food and Drug Administration) approval
In small doses, it acts as a general stimulant. found in both plant and animal sources, includ- to manufacture a nasal spray to treat treat-
A synthetically derived substance similar to ing high concentrations in the parotid gland ment-resistant depression (TRD) under the
ibogaine, called 18-MC, is also being investi- secretions of the Colorado River toad, Bufo al- brand name Spravato.
gated for its anti-addictive properties. varius. The psychedelic effects of oral inges-
tion are both fast-acting and short-lived. A UK- Salvia divinorum
based company, Beckley Psytech, is exploring Salvia divinorum is a species of plant native
the use of 5-MeO-DMT for the treatment of a to Mexico. Little is known about the toxicolo-
variety of neuropsychiatric disorders. gy, adverse events, and safety, as little clini-
The Psychedelics as Medicine Report | Executive Summary The Psychedelics as Medicine Report | Executive Summary
Executive
Summary
Psychedelics as medicine are at a crucial in- sections dedicated to profiling each sub-
flexion point. A growing number of studies are stance and identifying its legality around the
adding evidence to the astounding effective- world, as well as clinical trials or academic re-
ness of psychedelics to treat mental health search underway to ascertain the potential
and substance use disorders. Tireless work by benefits of these substances for treating
daring researchers and relentless non-govern- a broad list of mental health conditions.
ment organisations (NGOs) have made possi-
ble the renaissance of psychedelic research a Psilocybin, the psychoactive substance
that we find ourselves in. (when metabolised as psilocin) in over 200
species of fungi, has shown promise, when
Exactly 50 years ago, most psychedelics were combined with psychological support such
classified as controlled substances (Sched- as talk therapy, in the treatment of a variety
ule I) under the Convention on Psychotropic of mental health disorders. Most research
Substances. The backlash against the ‘hippie’ has been done to treat so-called treat-
culture also made it nearly impossible to study ment-resistant depression or TRD (depres-
psychedelics, which showed initial success- sion that does not respond to convention-
es in the treatment of alcoholism, anxiety, and al antidepressants - estimated to affect
other mental health disorders. 77 million people worldwide). Two sepa-
rate providers, COMPASS Pathways and
Forward-thinking investors and entrepreneurs the Usona Institute have received Break-
now recognise the growing body of academic through Therapy designation (BTD) from the
research. They, often with scientists advising US Food and Drug Administration (FDA) for
them, are laying the groundwork for psyche- synthetic versions of psilocybin for use as
delic-assisted therapy (PAT) at scale. As you part of psychedelic-assisted psychothera-
will learn in this report, there are many areas py for TRD and major depressive disorder
where psychedelics are showing promise. Psy- (MDD), respectively. COMPASS Pathways
chedelics are on course to become the next recently finished its phase IIb trial and will
major paradigm shift. This blossoming indus- publish results later in 2021. The FDA des-
try marks the first significant innovation in ignation is a step closer to licensing ap-
mental healthcare since 1987 when antide- proval for this therapy in the US, which may
pressants were first introduced. be granted as early as 2025.
This report examines six psychedelic sub- b LSD has shown tremendous early poten-
stances in depth. These are: psilocybin tial in treating depression, anxiety, PTSD,
(‘magic’ mushrooms), LSD, MDMA, ketamine, attention deficit hyperactivity disorder
ayahuasca and ibogaine. The report includes (ADHD), and cluster headaches, among
The Psychedelics as Medicine Report | Executive Summary The Psychedelics as Medicine Report |
others. Although less intensely studied ent in a nasal spray patented by Johnson
since the turn of the century, LSD has & Johnson under the name Spravato - the
played a pivotal role in early research and only FDA and EMA approved psychedelic
even discovering serotonin (a neurotrans- medicine for the treatment of TRD.
mitter) in the brain. The practise of mi-
crodosing psychedelics (taking regular, e Ibogaine, which originates from West
sub-perceptual doses of a psychedelic, in Africa, has been used for decades to treat
fractional quantities not strong enough to substance use disorders (SUDs) in coun-
result in hallucinations), which, anecdotal- tries such as Mexico. It has shown effica-
ly, is believed by many to enhance produc- cy in reducing a patient’s misuse of stim-
tivity and stimulate creativity, is beyond the ulants, opiates and alcohol, and reducing
scope of this report, due to a lack of scien- symptoms of withdrawal (from opiates)
tific evidence proving its efficacy. after administering a single dose. Several
‘second generation’ (novel compounds
c MDMA-assisted psychotherapy is showing based on existing psychedelics) psyche-
incredible promise for the treatment of delics are being developed to harness the
We think
PTSD; so much so that it is expected to anti-addictive effect of ibogaine without
receive FDA approval by 2023, having re- the relatively high health risks, specifically
ceived BTD in 2017. The therapy has been heart rhythm disturbances, associated with
differently
so effective that a phase III clinical trial the substance.
conducted by the Multidisciplinary Associ-
ation for Psychedelic Studies (MAPS) found f Ayahuasca, which has been in use for
about mental
that two-thirds of the study participants millennia, is a psychoactive brew that
who completed a course of MDMA-assisted combines several ingredients, DMT and
psychotherapy no longer met the criteria for MAOIs, that one consumes as tea. Al-
health so you
a PTSD diagnosis. Earlier studies showed though less well studied in clinical trials,
that these effects held for up to 12 months the mixture and the isolated psychedelic
after treatment. MDMA could be treating DMT show promise in treating depression,
can too
patients within six months after approval in anxiety, eating disorders, and could even
the US and Israel, with European Medicines help those with strokes to recover better.
Agency (EMA) approval following a phase III Many have sought ayahuasca experienc-
trial in Europe. es through partaking in ayahuasca retreats
- particularly common across South and
d Ketamine is the only psychedelic profiled Central America. Find out more at
compasspathways.com
in this report that features on the World
Health Organisation (WHO) List of Essential Other psychedelics also show promise in the
Medicines. Ketamine is widely available as treatment of mental health and substance
a general anaesthetic. It can also be used use disorders. These include Salvia Divino-
‘off-label’ (for purposes other than anaes- rum, mescaline (from the peyote cactus), DMT,
thesia, which have not been approved) to 5-MeO-DMT, kratom, 2C-X, nitrous oxide and
treat conditions as varied as depression, novel compounds (also called ‘second genera-
anxiety, suicide ideation (SI), chronic pain tion’ psychedelics). The future approval of the
and fibromyalgia. It is currently available in major psychedelics will probably clear a path
clinics throughout the US for these purpos- for further clinical research and development
es and is starting to be offered in Europe. of these other psychedelics into medicines.
Ketamine clinicsmay prove to be a success-
ful prototype for other psychedelic-assist- There is significant support among sections
ed therapies for patients once approval of society to allow researchers to examine the
has been granted to psilocybin or MDMA, potential benefits of psychedelics. PSYCH &
for example. Esketamine, one half of the Blossom’s proprietary consumer data shows
ketamine molecule, is the primary ingredi- that 69% of adults in the US, the UK, Canada,
The Psychedelics as Medicine Report | Executive Summary The Psychedelics as Medicine Report | Executive Summary
France and Germany would consider psyche- These figures, highlighting the total address- ed therapy and collect data that will improve
delic-assisted therapy. Two-thirds support able market, are an attempt to broadly illus- the therapeutic process. Many of the com-
the legalisation of psychedelics for research trate the potential economic and societal panies positioning themselves as the ‘go-to’
purposes. Six out of ten participants from a benefits that could be wrought from psyche- providers of psychedelic-assisted therapy are
representative sample in each country (3,050 delic drugs if the success in preliminary clin- already opening ketamine clinics to sharpen
respondents total) were curious to learn more ical studies was replicated on the medici- their protocols and grow their customer base.
about psychedelics as medicines. nal market once legalised and scaled up. The
precision of these calculations is necessari- Not more than 18 months after MindMed
To date, conventional pharmaceuticals have ly limited due to the preliminary nature of the became the first publicly listed psychedel-
had limited success in treating certain condi- clinical data. ic-focused pharmaceutical company, there
tions such as TRD, which does not respond to are now over 40 companies listed on stock ex-
typical courses of antidepressants, or SUDs, The majority of psychedelics are classified changes, from the innovative Candian Stock
most starkly illustrated by the opioid epidemic as controlled substances under the United Exchange (CSE) to the well-respected Nation-
in the US. Pharmaceutical companies are now Nations (UN) Convention on Psychotropic al Association of Securities Dealers and Auto-
looking elsewhere for solutions, and there is a Substances. However, with the recent approv- mated Quotations (Nasdaq). The biggest listed
growing appetite for new plant-based medi- al of esketamine on both sides of the Atlantic company, atai, currently trades around US$16
cines. Psychedelic substances, more than any and the likely approval of MDMA, and psilocy- a share and is valued at US$2.4 billion (as of
other substance explored in the past 50 years, bin-assisted psychotherapies in the next three September 2021). We expect this number to
have the potential to address this crisis. to five years, it is likely that the status of these keep growing into 2022 as more investors and
substances will come under review. Regulato- companies position themselves in the right
The psychedelics industry is a blossoming ry changes are already happening at the local places for when psychedelics as medicines
market that is on an exponential path, with level, particularly in the US; for example, the become available at scale.
investments quintupling, on average, in each recent decriminalisation of psilocybin in six
of the last four years. With depression on the cities and the start of a legal and regulato-
rise, fuelled even more by the COVID-19 pan- ry framework in Oregon. Other states such as
demic, increasing awareness of the detrimen- California and over 100 cities are advancing
tal impact of mental health disorders, and the regulatory changes.
emergence of new treatment therapies, the
global market for alternatives to conventional The massive market potential of psychedel-
antidepressants is sizable. ics has led to a flurry of investments into this
space. Many investors and entrepreneurs from
The prospect of ‘one-and-done’ psychedelic pharmaceuticals, cannabis and general invest-
options, such as ibogaine, to provide medium- ment groups are getting involved. The ones
to long-term relief from addictive substances, who will be successful in offering psychedel-
with a considerable reduction in the likelihood ic-assisted therapy (PAT), along with the key
of relapse; or one-to-two doses of psilocy- infrastructure solutions to enable the indus-
bin for the effective treatment of TRD within try, at scale, will reap the rewards and fuel the
a short course of treatment (six-to-eight ses- impactful healthcare businesses of the future.
sions) will radically disrupt the existing market Some companies are already generating rev-
for conventional treatments. To get an idea of enues by offering ketamine in clinics, often
how valuable these drugs could be to our so- without much therapeutic guidance. Johnson
cieties, we have calculated their potential to & Johnson has capitalised on the rapid ap-
relieve some of the economic burdens of treat- proval of Esketamine, though it is also finding
ing the conditions for which they are showing stiff competition from private ketamine clinics.
promise. We estimate that psychedelic-as-
sisted therapies could provide relief in costs The converging trends of digital therapeutics
to society in the region of US$230 billion in and psychedelics have enticed some groups
relation to SUDs (opioid and alcohol), US$330 to make significant investments in technology
billion in relation to depression, and US$120 to bring about the best therapeutic outcomes.
billion in relation to PTSD, for just the US and Atai has built a portfolio of a dozen companies
the European Union (EU). that promise to both offer psychedelic-assist-
The Psychedelics as Medicine Report | Key Trends The Psychedelics as Medicine Report | Key Trends
Key Trends
Research is Psychedelics poised

at a tipping point to treat many disorders
Clinical evidence is accumulating at an in- Mental health and substance use disorders
creasing rate. Not only is academic research affect more than 900 million people around
into psychedelics going through a renaissance the globe. Somewhat paradoxically, the more
presently, but dozens of companies are also affluent countries are the ones who are dealing
now sponsoring research to bring psychedel- with the most immense burden. The costs as-
ics as medicines to market. With several com- sociated with mental health care and the lives
panies boasting valuations in the hundreds of lost from substance use disorders are enor-
millions or even billions, the research budget mous. Making a sizable dent in this market
has grown exponentially in the last few years. by improving the mental health of millions is
where the opportunity for psychedelics exists.
Whereas in the early 2000s it was near-im-
possible to do psychedelic research with
humans, there are currently more than 50
Watching my best
ongoing clinical trials. Studies are happen- friend and business
ing at prestigious universities with several partner suffer, being
opening psychedelic research centres at
Johns Hopkins, Imperial College London (ICL),
let down by existing
Harvard and Massachusetts General Hospi- treatments and fi-
tal. These trials have progressed from phase nally finding comfort
I studies that proved the safety of psyche-
delics to phase III; the final step before FDA in psychedelic ther-
approval, and beyond. One psychedelic, ket- apies, was all the in-
amine, is being employed to treat a variety of
mental health disorders. It will soon be joined
spiration I needed
by many other psychedelics in the coming ten to commit my life to
years, of which MDMA will be the first. this cause.
Florian Brand,
Co-founder & CEO of atai Life Sciences
The Psychedelics as Medicine Report | Key Trends The Psychedelics as Medicine Report |
Psychedelics are being investigated and ex- Legislation and

plored to treat many significant disorders; regulation moving
from various forms of depression to alcohol- in the right direction
Working with
ism. What sets psychedelics aside from con- Six states and six cities in the United States
ventional treatments is that a few sessions have moved to decriminalise psychedelics;
with a high dose of a psychedelic can usually 100 more cities and several states are working
lead to long- term effects measured in months
or years. The upfront costs of psychedel-
ic-assisted therapy (PAT) will need them to be
on similar legislation. Public opinion favours
psychedelics, and legislators are, for the first
time in 50 years, loudly speaking out against
Patients in Mind
treated differently from current medications restrictions on research and the freedom to
Our mission is to help patients suffering from
which may cost less but are turning out to be take psychedelics for recreational use.
neuropsychiatric disorders by developing a
ineffective for the majority of patients. pipeline of psychedelic compounds into
Psychedelic research will initially have to licensed pharmaceutical medicines
Instead of numbing someone to their circum- complete more phase III trials for approval as
stances, psychedelics offer the possibility to medicines. This is expected as early as 2023
engender long-lasting changes in behaviour for MDMA regarding PTSD and within two
and mental health. Not only will this save years after that for psilocybin regarding TRD;
money for insurers, hospitals and caretakers, both designated as breakthrough therapies
and handsomely reward those who will bring by the FDA. If the decriminalisation efforts
these medicines to market, it will also give continue at a similar pace as in the last few
back valuable qualitative years of life to those years, more than a dozen states are expected Our Heritage 1
helped by psychedelics. to stop the enforcement of laws against psy-
chedelic use.
Pioneering psychedelic science, medicine
Therapy will be and drug development for over 20 years
the name of the game Patients and doctors
are ready for change
2
Therapy is an integral part of how psyche-
delics lead to improvements. As will be More than two-thirds of medical profession- Our Approach
detailed later in this report, psychedelics als support the easing of restrictions on re-
Advancing a diversified pipeline to bring
enable active coping through which patients search barriers. If approved by a governing
innovative and clinically differentiated
are able to resolve past trauma or addiction. medical body, six out of ten would like to
Psychedelics have also been described as provide PAT to their patients. Doctors and
medicines to patients
‘non-specific amplifiers’ enhancing the ef-
fectiveness of therapy.
nurses are ready to accept PAT as an option
in their toolbox. Many are closely following Our Team 3
the research, with psychiatrists being most Combining world-renowned psychedelic
Types of talk therapy which work best for aware of recent developments. researchers and best-in-class drug developers
psychedelic and mental health disorders
are currently being investigated. Most pub- Patients are similarly ready for change; two-
lished studies have used either cognitive
behavioural therapy (CBT), acceptance and
thirds of the people we’ve surveyed strongly
supported personal consideration for psyche-
Our Research 4
commitment therapy (ACT) or forms specifi- delic medicine where it is shown to be safe Utilising the benefits of low dose and high dose
cally adapted to PAT. and effective. When we presented them with psychedelics to treat neurological and
information about the level of scientific re- psychiatric disorders
MAPS, COMPASS Pathways, California Insti- search conducted, the support numbers in-
tute of Integral Studies (CIIS), MIND Foun- creased further.
dation, and many others are currently train-
ing therapists to give PAT. The number of Psychedelics have moved from the fringes of
qualified therapists, excluding those who society to the front page of the New York Times,
provide ketamine, sits at no more than a few and it will not be long before they become an
hundred. The expectation is that this will accepted treatment for a wide variety of mental
scale up to more than 50,000 therapists health and substance use disorders. Follow our journey: www.beckleypsytech.com/our-news/
within the next ten years.
The Psychedelics as Medicine Report | Market Value The Psychedelics as Medicine Report | Market Value
Market Value
KEY TAKEAWAYS A GROWING MARKET
1. Medical psychedelics companies

are valued at over US$10 billion.
The market opportunity in the nascent and
growing psychedelics’ space is being har-
nessed by a growing base of institutional in-
2. The market value of medical

psychedelics is valued at US$190
million and expected to exceed
vestors seeking to establish and scale busi-
nesses in a landscape showing scientific and
commercial promise.
US$2.4 billion by 2026.
While capital invested in psychedelic compa-
3. The pandemic has great potential

to rattle the mental health
landscape, and psychedelic
nies is over US$2 billion, the current value of
medical businesses surpasses US$10 billion,
with atai Life Sciences’ initial public offering
therapy offers another tool to (IPO) earlier this year making it the most valu-
support the alleviation of a growing able publicly-traded business among the 47
global epidemic. publicly-traded businesses in the sector, cur-
rently valued at US$2.4 billion (as of Septem-
ber 2021).
Biotech and pharmaceutical companies con-

tinue to dominate businesses within the
sector, though there is a growing base - and
appetite for - research clinics, therapy pro-
viders and software infrastructure. Canada’s
capital markets remain a popular choice for
psychedelic companies.
There are over 100 ketamine clinics in op-

eration in the USA with many more in the
pipeline. Despite gaining regulatory approv-
al in the UK, Johnson &Johnson’s Sprava-
to (esketamine) did not receive approval by
Note to the reader: NICE (National Institute for Health and Care
The value estimates contained within this Excellence, which approves drugs for use
report are top-level and for information by the National Health Service) twice, citing
purposes only. For a more detailed market the cost-effectiveness estimates for esket-
value forecast, please contact our team at amine to be much higher than the cost-effec-
info@psych.global. tive use of National Health Service (NHS) re-
The Psychedelics as Medicine Report | Market Value The Psychedelics as Medicine Report | About Us
sources, and would like to better understand II trials with commercialisation goals, Usona
the long-term use of esketamine in patients, and COMPASS Pathways are investigating psi-
and whether the improvement in symptoms locybin therapy for the treatment of depres-
and quality of life can be sustained follow- sion. The research path for many aspirational
ing treatment. Spravato costs about £10,000 researchers will take years to go through the
(US$14,000) per course of therapy. In the various stages of clinical trials, analysis and
USA, it was suggested that the price of Spra- reviews, and as such, we have focused pri-
vato needs to be reduced by 40% in order marily on ketamine, psilocybin and MDMA,
to be cost-effective for the management of as these compounds are either being used
treatment-resistant depression (TRD). for treatment already or are close to being re-
viewed for widespread therapeutic purposes.
Approval landscape
While ketamine has been available as an Based on estimates around MAPS’ therapy
off-label drug for depression for many years, it goals during their data exclusivity period
wasn't until 2019 when Spravato (esketamine, from 2023-2029, we forecast total healthcare
a ketamine derivative) got FDA approval, and savings to be rather substantial for patients -
the following year approval by the European at least US$18 billion, and revenue gains from
Medicines Agency (EMA), for TRD, or for use providing therapy and training to be in the
in psychiatric emergencies. Currently, MAPS' region of $7 billion. Assuming a linear growth
MDMA-assisted therapy for PTSD is the only rate for ketamine clinics, at US$600 per
psychedelic therapy undergoing phase III trials course of treatment, the revenue of ketamine
with commercialisation goals; globally, there clinics could be upwards of US$3 billion over
are 82 active phase II trials with psychedelics, the same period, with healthcare cost savings
of which 45% are completed. Among the phase on a par with revenue gains.
Projected growth of medical psychedelics

market revenues
MDMA PSILOCYBIN KETAMINE
$2,500,000,000
$2,000,000,000
$1,500,000,000
$1,000,000,000
$500,000,000
$0
2021 2022 2023 2024 2025 2026
Source: Blossom
Note: The above is an estimated, forecasted value of psychedelics as medicine sales in Europe and North America,
subject to regulatory changes. MDMA- and psilocybin-assisted therapies are undergoing clinical trials and our model
assumes approval with implementation within six months of approval. It should be noted that approval in Europe will
take longer and may be subject to further study requirements.
The Psychedelics as Medicine Report | About
MarketUs
Value The Psychedelics as Medicine Report | Market Value
Projected growth of aligned to their goals, though it will be en- ECONOMIC

medical psychedelics couraging to see more government subsidies HEALTH MODEL
market and universities embed psychedelic therapy
In modelling the medical psychedelics market, training, to increase access - both in terms of Potential savings on costs brought about by psychedelic-
we focused on therapy training and services, knowledge and resources - and widen ther- assisted therapies compared with costs of mental health
to encapsulate the current market condition. In apist potential for the growing demand, with conditions to society in the US and EU, in millions
2021, with ketamine the only compound used more PATs expected to be approved in the
off-label widely for the treatment of mental near future.
USA
health conditions, and esketamine for TRD,
ketamine-assisted-therapy dominates the The cost of illness COST OF ILLNESS BENEFIT TOTAL COST
market. We expect compassionate use to in- Mental health conditions are very costly
creasingly include psilocybin and MDMA, with and wide-ranging for society, affecting the
policy and health advocates being strong pro- quality of life for patients and their support PTSD $116,300 $174,500
ponents of such therapies. MDMA is currently networks, as well as the economy at large.
available for compassionate use in Israel, Swit- Outside of healthcare spending, economic
zerland and Canada. Compassionate use ex- losses are primarily caused by impaired levels AUD $143,000 $365,900
ception is expected in 2022 for psilocybin-as- of labour participation from those affected by
sisted therapy in Europe, with Canada's section mental health conditions. Mental health in-
56 exceptions being another route to early novation can impact society at all levels - so- OUD $55,400 $227,000
access before Health Canada’s consideration. cially and economically.
Our model is dependent on the exact dates The burden of mental health conditions across MDD $249,500 $366,600
of approval by the FDA or equivalents in other Europe and America was quantified through
countries. Nonetheless, the model incorpo- understanding the healthcare costs - direct
rates data on therapists’ availability (both and indirect - that are being used to treat
$0 $100,000 $200,000 $300,000 $400,000
who is trained and how many patients they these conditions; together with the economic
can serve), consumer willingness, and adja- loss which ensues from impaired productivity
cent revenues such as therapist training and levels, affecting businesses and the economy EUROPE
other complementary therapy services (e.g. at large. By investing in new, effective treat- COST OF ILLNESS BENEFIT TOTAL COST
Wavepaths’ music service). Underground and ment tools, we explore the extent to which
non-medicinal revenues are not modelled. these costs can be alleviated through model-
ling current trial efficacies (and the likelihood PTSD $7,100 $11,900
Psilocybin therapy (and specific training proto- of these trials successfully gaining approval),
cols) will grow in sales through clinical access together with the interest consumers have in
being granted to practitioners (beginning in receiving such treatments. The potential of AUD $88,500
$31,100
early 2023) - and we expect this to be a key PAT, as shown in the graph on the next page,
driver in societal education and contributor are vast and promising.
to wider reforms across America. We predict
OUD $1,000 $4,700
MDMA-assisted therapy to take a strong In particular, the cost-saving to employers
market share from 2024, owing in large part (such as through gaining back sick days or
to the later trial stage, plans to create therapy employer productivity), has the potential to
MDD $79,900 $130,400
opportunities, and MAPS’ head start to thera- provide US$64 billion to European countries,
pist training and US$270 billion to America - where costs
are attributed at a greater expense to health-
$0 $100,000 $200,000 $300,000 $400,000
There are many companies researching best care (more than 4-times for opioid use disor-
practice for the training of psychedelic ther- der (OUD) - a national epidemic in America
apists, who have distilled these into training - and over 6-times for major depressive disor-
programmes, such as the MIND Foundation der (MDD)). Source: Blossom / Our World in Data / YouGov / Marseille et al. 2020
and COMPASS Pathway. Diversity in the offer-

ings provides aspiring therapists with options
from which they could choose training most
The Psychedelics as Medicine Report | Market Value The Psychedelics as Medicine Report | Market Value
Mental health during There has been much discussion around the
the COVID-19 pandemic scale of the trauma caused by the pandem-
While symptoms of depression and anxiety ic; an event that imposed lengthy restrictions
were particularly heightened at the start of the upon people's ability to travel, interact with
pandemic, the uncertainty surrounding future one another, and experience life in ways to
restrictive measures and the medium-/long- which they were accustomed. Parallels have
term effects of the conditions in which people been drawn between the two most traumat-
lived during this period is yet to be under- ic events that Americans have recently faced:
stood. Using data modelled by the UK's Na- the COVID-19 pandemic, and the 9/11 terrorist
tional Health Service, we could extrapolate ex- attack, where with the latter, the repercus-
pectations of new or additional mental health sions on people’s wellbeing is still being felt.
support that could be required for patients Unlike the targeted experience of the terror-
with depression and PTSD. In Europe, this ist attack, the COVID-19 pandemic has per-
could mean 139% more cases of depression and meated all homes, across geographies and
21% more patients being treated with PTSD - at varying severities. Far more than a health
costing Europe's healthcare system an addition- crisis, the pandemic has exacerbated so-
al US$41 billion to treat. Similarly, the health- cio-economic inequalities, and the extent to
care costs in America could amount to US$185 which this will continue is strongly dependent
billion for new and additional mental health upon global responses to health, economic
support for depression, and US$33 billion for and social mobilisation of support. A longitu-
PTSD patients - a total of 29 million people. dinal study found that those who had worked
I believe that psyche- on the scene of the 9/11 attack, and those
who had physically witnessed it, had the
delics represent one highest rates of PTSD and depression for 15
of the best shots we years following the event. However, residents
of the area were also similarly affected, and
have in combatting the in order to exemplify the pervasive nature in
mental health crisis. which the pandemic's trauma could influ-
So now it’s all about ence new mental health conditions following
a traumatic incident, we applied the research
execution, transform- to our model. It was revealed that PTSD
ing the prior evidence cases could rise by 28 million, and depres-
sion cases by 29 million, among Americans;
we have on psyche- totalling over US$1 trillion in illness costs.
delic compounds into
FDA compliant, mod-
ern, rigorous scien-
tific data, so that we
can bring new treat-
ments to the people
who really need them.
Christian Angermayer,
Founder and Chairman of atai Life Sciences
The Psychedelics as Medicine Report | Legislation and Regulation: An Overview The Psychedelics as Medicine Report | Legislation and Regulation: An Overview
Legislation
and Regulation:
An Overview The United Nations (UN) Convention on Psy-
chotropic Substances framework for the inter-
national control of psychotropic substances
(those which affect how the brain works and
Psilocybin, MDMA, DMT and LSD are listed as
Schedule I substances under the convention.
Ketamine, which is on the WHO List of Essen-
tial Medicines, is not a controlled substance.
cause changes in mood, awareness, thoughts, Ayahuasca is not specifically controlled, al-
feelings, or behaviour) lists the substances in though the individual components that make
one of four Schedules (I to IV) or leaves them up the brew are controlled, including DMT,
unlisted if no harm is perceived (e.g. for caf- which sits in Schedule I. Individual countries
feine). The ones perceived as least harmful have also placed restrictions on some, or all,
and with a medical application, such as midaz- of these substances.
olam, are listed in Schedule IV. The ones where
the UN perceived no medical benefits and the
greatest harm, were listed in Schedule I.
Legal classification of psychedelics
DRUG UN STATUS* US STATUS CANADA STATUS
Ayahuasca Uncontrolled Schedule I/ Schedule III/

Exemptions Exemptions
Cannabis Schedule I Schedule I Schedule VIII
DMT Schedule I Schedule I Schedule III
Ibogaine Uncontrolled Schedule I Controlled
Ketamine Uncontrolled Schedule III Schedule I
LSD Schedule I Schedule I Schedule III
MDMA Schedule I Schedule I Schedule I
Peyote/ Schedule I/ Schedule I/ Schedule III/

Mescaline Exemptions Exemptions Exemptions
Psilocybin Schedule I Schedule I Schedule III
Source: Blossom
*A small number of UN member states are not party, or acceded, to the treaty with conditions such as provisions
for the rights of indigenous peoples to make use of traditionally used substances.
The Psychedelics as Medicine Report | Consumer Attitudes The Psychedelics as Medicine Report | Consumer Attitudes
Consumer
Attitudes
KEY TAKEAWAYS
1. We discovered that approximately

two thirds of Europeans and
Americans support legalisation of
In June 2021, PSYCH and Blossom conducted
a nationally representative consumer survey
in five countries. The aim of which was to
psychedelics for medicinal use. gauge awareness of, and attitudes towards,
the potential use of psychedelics for the treat-
2. Two in three individuals are aware

of the use of psychedelics for
mental health conditions and
ment of a variety of mental health conditions.
The survey was conducted between 10 and
17 June, among 3,050 adults living in the US,
would consider psychedelics for Canada, the UK, France and Germany. Each
therapeutic use. sample consisted of at least 600 respons-
es which were proportionally filled out, by age
3. Consumer knowledge about

specific psychedelics varies,
presenting an opportunity for
group and sex, representative of each individ-
ual country. This section offers a topline anal-
ysis of the survey results. Raw data cuts and a
education from trusted sources. more detailed analysis of the consumer senti-
ment towards psychedelic therapies are avail-
4. Results show that 38% of

consumers know of someone who
could benefit from psychedelic-
able on request via info@blossomact.com.
assisted therapy.
CONSUMER'S TAKE When presented with a scenario in which psy- French consumers showed the least agree-
ON PSYCHEDELICS chedelics were shown to be safe and effective ment across all the geographies surveyed, with
AS MEDICINE in the treatment of certain mental health con- regard to all four questions. After being given
ditions such as PTSD and depression, where more context on psychedelic medicines, there
Consumers were asked about their views on Last year’s survey encompassed only 18-66 their respective country’s drug regulators ap- was a stark increase in agreement - with the
several statements relating to the use of psy- year olds, so for the purpose of the follow- proved certain psychedelics as medicines (in highest increase being seen (versus the other
chedelic-assisted therapy to treat mental ing comparison, we focused on those aged conjunction with talk therapy), we observed countries) with regard to health insurance
health conditions. Five out of ten respon- between 18-64. Support for legalisation a noticeable increase in agreement across support in the case of knowing someone who
dents were in favour of medical legalisation, reduced in 2021 among Americans by 6% (to all four questions. This result shows us that could benefit from PAT. This strongly demon-
with four out of ten unsure, and one in ten 50%) for the legalisation of psychedelics for consumers are in favour of safe and effective strates that people are amenable to trust-
who disagreed with legalisation. The majori- medical use. Similarly, fewer Americans knew treatment options – regardless of the associat- ing new treatment options in circumstances
ty of consumers surveyed were in agreement someone who could benefit from psychedel- ed stigma which psychedelic compounds have where drug regulators and evidence demon-
with seeing psychedelic therapy covered by ics in 2021, though as you can see from the faced in previous years. strates efficacy and safety.
insurance providers (59%), and they strong- diagram below, contextual information makes
ly supported personal consideration for psy- a difference. UK respondents in 2021, on the
chedelic medicine where it is shown to be other hand, were more supportive of legalisa-
After being presented with a scenario where PAT was shown
safe and effective (65%). A third of respon- tion for medical use (increase of 7% to 43%),
dents knew of someone who could benefit
to be safe and effective to treat mental health conditions
and more were aware of someone who could
from psychedelic-assisted therapy (PAT). benefit from PAT (increase of 9% to 53%). STRONGLY DISAGREE DISAGREE NOT SURE/ DON'T KNOW
AGREE STRONGLY AGREE
Considering the use of PAT to treat mental health I SUPPORT THE LEGALISATION OF PSYCHEDELICS FOR MEDICINAL USE
conditions, to what extent do you agree with each
of the following statements?
STRONGLY DISAGREE DISAGREE NOT SURE/ DON'T KNOW I SUPPORT THE COVERAGE BY HEALTH INSURANCE OF PSYCHEDELICS FOR MEDICINAL USE
I SUPPORT THE LEGALISATION OF PSYCHEDELICS FOR MEDICINAL USE IF FACED WITH A MEDICAL CONDITION FOR WHICH A PSYCHEDELIC MEDICINE WAS SHOWN
TO BE SAFE AND EFFECTIVE, I WOULD CONSIDER USING THIS TREATMENT OPTION
I SUPPORT THE COVERAGE BY HEALTH INSURANCE OF PSYCHEDELICS FOR MEDICINAL USE

I KNOW SOMEONE WHO WOULD BENEFIT FROM PSYCHEDELIC THERAPY
IF FACED WITH A MEDICAL CONDITION FOR WHICH A PSYCHEDELIC MEDICINE WAS SHOWN
0% 25% 50% 75% 100%
Source: Blossom
I KNOW SOMEONE WHO WOULD BENEFIT FROM PSYCHEDELIC THERAPY
The education opportunity

Familiarity with psychedelics for the treat- treatment consideration for themselves (if
ment of mental health conditions was the faced with a mental health condition where
highest among those aged between 18 and psychedelic therapy has shown to be effec-
0% 25% 50% 75% 100%
44. Despite the 45+ cohort being less knowl- tive) remained high among all age groups –
edgeable on the topic, support for legalisa- even prior to being given more context on
Source: Blossom tion for medical use, health insurance, and psychedelic treatments. However, those aged
over 65 were the least likely to agree on these When we look at the differences between the
issues, particularly with regard to legalisa- different countries surveyed, Germany had the
tion (where only 34% agreed), and the major- most people informed about psychedelics, as
ity did not have an opinion. When given more well as the most who claimed to be well-ed-
contextual information, opinions were further ucated (along with the UK) about the treat-
cast, and 59% of this cohort were in favour. ment potential of psychedelics. The familiar-
ity of medical psychedelics was the lowest in
Considering the extent to which mental health France, where respondents also expressed
conditions have been experienced – either the least interest in learning more. There are
directly or indirectly – by the large majori- also fewer research groups and clinical trials
ty during the pandemic, and with the greater ongoing in France than in some of the surveyed
focus on mental health in the media and counterparts, which could also be contributing
general culture, the openness to supporting to the initially lower rates of support given to
new forms of treatment comes as no surprise, insurance coverage, legalisation and personal
posing an opportunity for the medical psyche- therapeutic use. Overall, women and men were
delics industry to use this momentum. broadly aligned with both their curiosity in psy-
chedelics, and knowledge on the topic.
Which statement best describes your awareness of

the use of psychedelics for the treatment of mental
health conditions?
HAVE HEARD & HAVE HEARD & CURIOUS HAVE NOT & CURIOUS
WELL-EDUCATED
HAVE HEARD & NOT CURIOUS HAVE NOT & NOT CURIOUS
100%
75%
50%
25%
0%
UNITED STATES CANADA UNITED KINGDOM FRANCE GERMANY
Source: Blossom
Psychedelics of choice same degree as many of the other psychedel- INFLUENCE OF PRIOR DRUG demonstrates that prior experience yields
Consumers were given the opportunity to ics, those who were inclined to try salvia were USE ON OPENNESS TO further interest in psychedelics – particularly
select each psychedelic compound which people who had used psychedelics in the past. PSYCHEDELIC-ASSISTED among those who have used psychedelics for
they would be willing to consider during PAT THERAPIES spiritual or creative reasons.
- should it be shown to be safe and effective, While 31% of respondents stated that they
and be approved by drug regulators. The most were likely or very likely to try LSD, it was also Respondents who had previously tried psyche- While those who have had no prior experi-
popular options were psilocybin and salvia – the drug that was the least popular among delic drugs for recreational, creative, or ther- ence with psychedelic drugs were less likely to
where 35% of respondents expressed an inter- respondents (with 33% stating they were un- apeutic purposes, were more likely to demon- demonstrate the same strong levels of inter-
est. Psilocybin, in particular, has been at the likely to try it) - illustrating quite a mixed view strate openness to trying psychedelics as est, they weren’t entirely opposed either – with
forefront of consumer’s minds, in part due to among respondents. Consumers ranked phy- a treatment option, alongside talk therapy, 54% stating that they were neutral or didn’t
strong media coverage - reflecting clinical trial sicians and scientists as the topmost trusted should they receive approval from their respec- know, and 27% expressing that they were un-
results in the treatment of mental conditions, sources surrounding the benefits of medical tive country’s drug administration. This finding likely or very unlikely to demonstrate interest.
cultural discourse around microdosing for cog- psychedelics (with religious leaders and poli-
nitive enhancement or creativity, and its use ticians ranking the lowest). By participating in
in psychedelic-assisted retreats in locations consultations with physicians to understand
Psychedelic experience and interest in various PATs
such as the Netherlands and Central Ameri- personalised treatment options, and further
can countries. In November 2020, Oregon was media coverage of clinical trial results, use VERY UNLIKELY/ NEUTRAL/ VERY LIKELY/
UNLIKELY DON'T KNOW LIKELY
the first state to decriminalise psilocybin and cases and reviews of various psychedelic ther-
100%
approve it for therapeutic purposes. Interest- apies, decision-making around treatments will
ingly, while salvia has not been at the forefront become clearer for those interested in under-
of news reporting or clinical research, to the standing their options.
PSYCHEDELIC-ASSISTED THERAPIES
75%
INTEREST IN VARIOUS
How likely would you consider using the following
psychedelics as a treatment option if you could
benefit from PAT? 50%
VERY UNLIKELY/ NEUTRAL/ VERY LIKELY/

UNLIKELY DON'T KNOW LIKELY
100%
25%
75%
0%
RECREATIONAL SPIRITUAL CREATIVE THERAPEUTICS NO PRIOR
PRACTICE INSPIRATION EXPERIENCE
50% REASON FOR SEEKING PSYCHEDELIC DRUG USE
Source: Blossom
It’s interesting to see the large curiosity and fa- Novamind. ‘The pandemic has further highlight-
25% miliarity exhibited by consumers towards psy- ed the urgent need for better solutions. We’re
chedelics for the treatment of mental health starting to see less stigma towards mental
conditions. We see this as being really import- health and more widespread acceptance of
ant in driving legalisation of these treatments psychedelics as a therapeutic option.’
0% and in receptiveness toward businesses emerg- Psychedelics have borne the brunt of adverse
LSD PSILOCYBIN DMT MDMA KET IBO MESCAL SALVIA ing to be part of the wider wellness solution. media coverage for years, and our findings
‘The mental health revolution that we are cur- suggest the importance in appropriately com-
Source: Blossom
rently in is long overdue’, commented Dr Reid municating with the wider public, to drive a
Robison, Director and Chief Medical Officer at better awareness of this emerging market.
The Psychedelics as Medicine Report | Expert Interview The Psychedelics as Medicine Report | Expert Interview
EXPERT INTERVIEW
Dr Reid Robison
Chief Medical Officer,
Novamind
Can you tell us how you got on the path of Novamind is operating a unique and success- Another innovation I’m especially looking Novamind as being that doorway to a trans-
psychedelic medicine? ful business model focused on our growing forward to is our Park City location in Utah. formative healing path. The significant growth
Early in my career as a psychiatrist, I was dis- network of psychiatry clinics and our contract It will offer unique intensive treatment in demand for mental health services can be
couraged by the limitations of available treat- research organization that serves leading drug programs outside daily routines and environ- seen at our clinics: we are forecasting 65,000
ment options, and it became my quest to find developers. Our clinics deliver both main- ments, which can contribute significantly to visits to our clinics in 2021, a 225% increase
better solutions. Many conventional medicines stream and newer treatment modalities like positive outcomes. from 2020.
work slowly with potentially little to no thera- ketamine-assisted psychotherapy and tran-
peutic effect. And unfortunately, funding for scranial magnetic stimulation. Our research How do psychotherapy and ketamine What excites you about the future
research and innovation in this space has not sites are co-located with our clinics to enable work together? of psychedelics?
kept pace with the increasing need for effective patient recruitment from a large, diverse Ketamine-assisted psychotherapy generally I’m excited to see the mainstream adoption of
treatment options. Today mental illness is one population. Patients benefit from access to consists of three sessions. The preparatory psychedelic medicine. The momentum of the
of the world’s leading causes of disability and new treatments options and a highly skilled, session involves screening, consent, discus- public saying this is something we want and
over a million lives are lost each year to suicide. multidisciplinary clinical and research team. sion of treatment goals, and education about believe in, is powerful. We’re seeing positive
We are currently scaling our network of the medicine. Dosing begins with intention policy shifts towards greater access. And the
I studied and ran clinical trials for ketamine clinics and research sites with a multi-state setting and ends with processing of the field is starting to embrace new therapies as
around the time it started gaining attention expansion plan across the United States. In experience. When administered, psychedelics potentially game changing. We can start to
in the psychiatry community in 2011. It was a anticipation of FDA-approvals for MDMA and act on the serotonin receptors that are linked address root causes of mental illness, not just
paradigm shift in treating mental health condi- psilocybin, we are uniquely positioned with our to cognitive flexibility, enhanced imagination the symptoms, supported by evidence-based
tions because of its anti-depressant capabili- clinical infrastructure and research expertise and creative thinking. It provides a window of medicine. We’re proud to be hosting clinical
ties, psychedelic properties and what it could to provide those treatments to our clients. opportunity to disrupt patterns in the brain. trials that will help to bring those medicines
mean for therapeutic practice. I haven’t looked The integration session is where we can make to market. Novamind has been selected as a
back. Since 2016, we’ve administered over What are some Novamind innovations that lasting change. It allows individuals to explore key research site for neuropsychiatric clinical
7,000 ketamine treatments. are solving problems in the sector? their psychedelic experience and discover trials with leading drug developers like Merck,
Our model enables us to create cost-effective insights and meaning that can be incorporated Otsuka, Bionomics, and our pipeline of clinical
Where does Novamind fit in the industry? treatment options that address specific needs into day-to-day life. trials continues to grow.
Novamind is on a mission to bring innovative within unique patient populations, then use
mental health treatments to market and to our research capabilities to study outcomes in What has surprised you about the mental The opportunity before us at Novamind and
expand access to those treatments for all peo- real-time. A great example that hits home for health revolution to date? in fact, the entire industry, is to responsibly
ple. Psychedelic-assisted therapy, in partic- me is our clinical pilot for frontline healthcare The mental health revolution that we are shape this new era. Novamind’s contribu-
ular, is a departure from the current standard workers (Frontline Ketamine Assisted-Psy- currently in is long overdue. The pandemic has tions are focused on developing the clinical
of mental healthcare. It requires a specialized chotherapy). The risk of burnout in healthcare further highlighted the urgent need for better infrastructure required to safely administer
infrastructure that most mental health prac- professions is high, especially as mental health solutions. We’re starting to see less stigma MDMA and psilocybin following FDA-approval.
titioners don’t have. Add to that an explosion needs have become even more urgent in the towards mental health and more widespread Novamind is leveraging its years of experience
of new therapeutic candidates in the pipe- pandemic. I’ve also personally seen some of the acceptance of psychedelics as a therapeutic treating thousands of patients to deliver best-
line that require research sites, patients and most severe cases of PTSD in this population. option. There’s an inextinguishable light in in-class treatments. Every day I get to help
people who have specialized training to deliver In this pilot, we are delivering ketamine-assist- everyone, no matter where they are on their expand access to mental health treatments
psychedelic therapy. ed psychotherapy in a group setting that uses journey or struggle. Everyone has the potential and create a new standard of care.
the power of social connection. to heal and recover, and we see our role at
The Psychedelics as Medicine Report | The Psychedelics as Medicine Report |
The Psychedelics as Medicine Report | Healthcare Providers’ Attitudes The Psychedelics as Medicine Report | Healthcare Providers’ Attitudes
Healthcare
Providers’
Attitudes KEY TAKEAWAYS
1. Healthcare professionals are

well-informed on research sur-
rounding psychedelics for mental
Given that healthcare professionals, in the
coming years, will be working with patients
undergoing psychedelic-assisted therapy
health, speaking from personal (PAT), we conducted a survey measuring UK
experience - with four out of ten health professionals' views around mental
having used psychedelic drugs, health solutions, and their understanding
and over half having experienced and opinions of psychedelics. The 440 re-
mental health conditions. spondents were comprised of; nurses (55%),
doctors (24%) and various other health-
2. There is strong agreement about

the therapeutic benefits of psy-
chedelics, along with receptive-
care workers (21%) – 79% of the cohort were
females, 20% male and 1% non-binary. The
survey captured quite a diverse set of health-
ness for the challenges psychedel- care workers, including those who work in
ic experiences pose. general practice (16%), surgery (12%), psychia-
try (8%), public health and policy (6%), paedi-
3. Two-thirds of healthcare providers

are excited about the prospect of
psychedelics as medicines.
atrics (6%), anaesthesia (5%), among others –
with two thirds who have been practising for
under ten years.
STATE OF MENTAL HEALTH:

HEALTHCARE WORKERS
More than half of the healthcare workers exhibiting symptoms, 16% within the last year
have been affected by a mental health con- (but not currently) and 11% within the last
dition and are intimately familiar with the five years, with a further 7% who have had a
impact these experiences have had on their pre-existing mental condition at some other
lives. Of our respondents, 21% are currently point in their lifetimes.
Do you have a pre-existing mental health condition?
NO
21%
I DID, IN MY LIFETIME,
BUT NOT IN THE LAST 5 YEARS
45%
I DID IN THE LAST 5 YEARS,
BUT NOT IN THE LAST YEAR ALL
I DID IN THE LAST YEAR, 16%
BUT NOT IN THE LAST MONTH
YES, AND CURRENTLY

EXPERIENCING SYMPTOMS
11%
7%
Source: Blossom
Healthcare workers’ atti-

tudes towards current men-
tal health and substance
use disorder treatments
When asked about their views on the effica- terms of their perceived treatment efficacies,
cy of current treatments for various mental which could be due to the high relapse rates
conditions, most healthcare professionals and complex layers of other mental health
stated that they believe the current treat- disorders which underlie reasons for addic-
ment options for PTSD, depression, eating tion. Common treatment options for depres-
disorders and drug and alcohol addiction are sion currently include talk therapy, antidepres-
‘somewhat effective’. sant medications (such as serotonin reuptake
inhibitors (SSRIs)/serotonin and norepineph-
Interestingly, more healthcare profession- rine reuptake inhibitors (SNRIs)), and for PTSD
als believed our current treatment options are could consist of antidepressants, cognitive
‘somewhat effective’ for depression, higher behavioural therapy and eye movement de-
than of any of the other conditions (45%). Drug sensitisation and reprocessing.
and alcohol addictions scored the lowest in
How effective do you perceive the current treatment To what extent do you agree with the following
options for the following mental health disorders? statements?
EXTREMELY EFFECTIVE SOMEWHAT EFFECTIVE NOT SURE /
I am familiar with research regarding psychedelic-
SOMEWHAT INEFFECTIVE EXTREMELY INEFFECTIVE
DON’T KNOW assisted therapy for the treatment of ...
100%
KNOWLEDGEABLE I HAVE SOME UNDERSTANDING OF THE RESEARCH
I HAVE NEVER COME ACROSS SUCH RESEARCH
75%
DEPRESSION
50%
PTSD
25%
ALCOHOL ADDICTION
0%
PTSD DEPRESSION EATING DRUG ALCOHOL DRUG ADDICTION
DISORDERS ADDICTION ADDICTION
Source: Blossom
EATING DISORDERS
PSYCHEDELIC EXPERTISE
OF HEALTHCARE
WORKERS
0% 25% 50% 75% 100%
To gauge the current level of knowledge health- tion – areas in which we expect more target-
care workers had of PAT, we asked them how ed clinical research in forthcoming years.
familiar they were with research regarding PAT Source: Blossom
for the treatment of PTSD, depression, eating Doctors were the most informed profession sur-
disorders, drug addiction and alcohol addiction. veyed, where on average, eight out of ten were
familiar with psychedelic research surround-
Overall, familiarity was the greatest with re- ing mental health disorders, and just under half
search regarding depression and PTSD, fol- self-reported to be 'knowledgeable' in contrast
lowed by alcohol addiction – which is in align- with seven out of ten nurses expressing famil-
ment with recent advancements in clinical iarity, and three out of ten identifying them-
trials surrounding these conditions. Strong selves as ‘knowledgeable’. While doctors were
knowledge regarding developments into the the most knowledgeable about research on
research of depression involving psychedel- PTSD and drug addiction, nurses were the most
ics could be attributed to the high prevalence informed about PTSD and depression. Those
of the condition; the treatment of which has working in psychiatry were more knowledgeable
not seen similar innovative advancements for about research on drug addiction and eating
decades. The least recognised research areas disorders, though it is worth noting that they
were around eating disorders and drug addic- only formed a small cohort in our study group.
THERAPY: THE BENEFITS Healthcare workers'

AND CHALLENGES views on medical and
recreational psychedelics
Responses to statements around whether
psychedelics can provide therapeutic ben-
efits, or be detrimental toward users was Psychedelics can provide therapeutic benefit to
surveyed, and the results were rather mixed users/be detrimental to users’ health in a medical/
– signifying an opportunity for healthcare
professionals to be provided with more re-
recreational setting
sources and training to inform their views,
STRONGLY DISAGREE DISAGREE NOT SURE/ DON'T KNOW
which will of course be further bolstered
with growing research and clinical trials, use AGREE STRONGLY AGREE
cases and training initiatives. The most popu-

larly held view was that psychedelics provide
PROVIDE THERAPEUTIC BENEFIT TO USERS IN A MEDICAL SETTING
therapeutic benefit to users in a medical
setting, followed by a strong view claim-
ing that psychedelics can be detrimental to
users’ health in a recreational setting – illus-
PROVIDE THERAPEUTIC BENEFIT TO USERS IN A RECREATIONAL SETTING
trating that healthcare professionals are in
agreement around the therapeutic benefits
available to patients in a controlled setting,
with trained professionals.
BE DETRIMENTAL TO USERS’ HEALTH IN A MEDICAL SETTING
Interestingly, more than half of the respon-
dents agreed that users can receive thera-
peutic benefits of psychedelics in a recre-
ational setting, 48% also agreed that this BE DETRIMENTAL TO USERS’ HEALTH IN A RECREATIONAL SETTING
could, in fact, be detrimental to users’ health
(while 17% disagreed with this statement).
Broadly a third remained unsure about their
views. While research has shown psychedel-
ic compounds to have lower addictive and 0% 25% 50% 75% 100%
physiological risks to users, versus other
commonly used recreational drugs, harm re-
duction still remains top priority, and in par- Source: Blossom
ticular, with regard to psychological risks
(commonly stemmed from lack of prepared-
ness, and nonconstructive ‘set’ and ‘setting’).
As more states look to decriminalise and le-

galise psychedelic compounds in the USA,
earlier this year the Psychedelic Peer Support
Line was launched by the Fireside Project. It
is a hotline which psychedelic users (or their
accompanying friends) can call to receive
guidance from trained facilitators around the
holistic psychedelic experience – from prepa-
ration through to integration.
The Psychedelics as Medicine Report | Healthcare Providers’ Attitudes The Psychedelics as Medicine Report |
INFLUENCE OF Treatment and

PSYCHEDELIC USE ON research support
PRACTITIONER VIEWS
We questioned mental health providers re-
Healthcare professionals who had used garding their support for psychedelics as
psychedelics for therapeutic and spiritual medicines, with some questions similar to
reasons, were the strongest supporters of those posed earlier to consumers, in order to
the therapeutic benefits of psychedelics for get a sense of the variety of perspectives.
medical (with 83% of both groups agreeing)
and recreational use (73% and 70%, respec- Medical professionals were asked: ‘Consider-
tively). This could be due to the more inten- ing the use of psychedelic-assisted therapy
tional approach these groups had to their to treat mental health conditions, to what
psychedelic practice. Those who had tried extent do you agree with each of the follow-
psychedelics recreationally and for cre- ing statements?’ These statements centred
ative inspiration also agreed with the bene- around 1) easing restrictions on research
fits far more than those who had no expe- barriers, 2) coverage by healthcare services,
rience with psychedelics – in which only 3) openness to personal use of PAT, and 4)
55% agreed with therapeutic benefits in a desire to refer or provide patients for PAT.
medical setting, and 45% agreed with thera-
peutic benefits, recreationally. Medical professionals strongly supported the
easing of restrictions on research barriers,
Stronger opinions were once again seen with to drive medical research, with 70% agree-
those who had tried psychedelics therapeuti- ing. While not directly comparable, we asked
cally or for spiritual reasons, with the majority healthcare workers if they would like to refer
(63% and 57%, respectively) agreeing on the or provide PAT to their patients, and we asked
detrimental effects psychedelics can have in consumers if they would know someone who
a medical setting. Only 44% of those with no could benefit from PAT. Six out of ten medical
prior experience agreed with this statement, professionals were open to providing or re-
and 41% weren’t sure. In fact, those with no ferring patients to PAT, whilst only a third of
prior psychedelic experience were under- consumers knew someone who could benefit
standably the most uncertain about these from PAT. We attribute the stronger support
statements. Majority agreement around the by healthcare providers to them being closer
detrimental effects of psychedelics taken to larger cohorts suffering from mental health
both recreationally and medically among all conditions, as well as the ongoing research,
cohorts – and particularly among those who and empathy, towards the various implica-
have tried psychedelics – speaks toward the tions for their patients and their ability to
appreciation of both the challenges and ben- support them.
efits which could be experienced.
Similarly high interest was found among both
Practitioner experience is clearly important groups when asked if faced with a medical
in facilitating the understanding and expos- condition for which a psychedelic medicine
ing the stronger viewpoints around the thera- was shown to be safe and effective, whether
peutic benefit and challenges of these drugs, they would consider using this treatment
something which MAPS has been vocal in option. About two-thirds of both groups re-
driving among their MDMA therapy providers. sponded positively, showing again that, even
at this stage with research predominantly in
phase II trials, people are receptive to PAT.
Considering the use of psychedelic-assisted therapy Two-thirds of medical professionals are

to treat mental health conditions ... excited about psychedelics as medicines -
STRONGLY DISAGREE DISAGREE NOT SURE/ DON'T KNOW
which is unsurprising given their strong incli-
nation to provide, or refer, patients to receive
PAT, when possible. It has been interesting
to see the high levels of familiarity among
I SUPPORT THE EASING OF RESTRICTIONS ON RESEARCH BARRIERS,
TO DRIVE MEDICAL RESEARCH AND THERAPEUTIC BEST PRACTICE healthcare professionals regarding psyche-
delic therapy for mental health disorders, and
more so, to note their shared positive outlook
for the future. As the ones who will be inti-
I SUPPORT THE COVERAGE OF PSYCHEDELICS FOR MEDICINAL USE BY THE NHS
mately involved in the delivery of PAT, this
level of support is fundamental to the scaling
up of psychedelics as medicines.
IF FACED WITH A MEDICAL CONDITION FOR WHICH A PSYCHEDELIC MEDICINE WAS SHOWN
SHOULD PSYCHEDELIC-ASSISTED THERAPY BE APPROVED BY MHRA, I WOULD LIKE TO

REFER, OR PROVIDE IT, TO MY PATIENTS TO ASSIST WITH THEIR PSYCHOLOGICAL THERAPY
0% 25% 50% 75% 100%
Source: Blossom
THE SHARED SENTIMENT:

EXCITEMENT
How excited are you about the prospect

of psychedelics as medicines?
4% 2%
19%
VERY EXCITED
SOMEWHAT EXCITED 29%

INDIFFERENT ALL
UNEXCITED
REALLY UNEXCITED
46%
Source: Blossom
The Psychedelics as Medicine Report | Spotlight on Health The Psychedelics as Medicine Report | Spotlight on Health
Spotlight
on Health
KEY TAKEAWAYS
1. According to Our World in Data,

the share of the population with
mental health and substance use
disorders stands at nearly 1 billion
people, or 15% of the world popu-
lation, a proportion that has been
stable or rising since 1990.
2. There have been no significant

changes in mental health treat-
ments in the last 30 years; up to a
third of those suffering from de-
pression do not respond adequate-
ly to a course of appropriate anti-
depressant medication.
3. The societal burden of depression

amounts to more than US$490
billion per year for the US alone,
eclipsing the societal costs of
cancer or diabetes.
PSYCHEDELICS COMING chedelic researchers are now making it to the Total number of clinical trials (since 2000)
OUT OF THE CLOSET front page of the New York Times.
Psychedelics have long been something that

one only spoke about, in intimate circles, with NOVEL WAY OF TREATING
reference to alternative healing and tradition- PERSISTENT PROBLEMS
al medicine. The banishing of psychedelics
as medicines, after they became synonymous Psychedelics belong to a category of substanc-
with the counterculture of the 1960s, has led es (mainly plant-based) that possess power-
to collective amnesia, with many people today ful psychoactive properties, meaning that they 14
unaware of the rich history of psychedelics change someone's state of consciousness. 198 89
prior to their ostracism. Not only were psyche- Most psychedelics, especially the classic psy-
delics the focus of more than 1,000 studies, chedelics, LSD and psilocybin, achieve their 14
but they were also used by psychiatrists and mind-altering effects through interaction with
relationship councillors with great success. the serotonergic system. By changing how se-
rotonin, dopamine, and other neurotransmitters
1
Now, over 50 years after psychedelics have are either released or absorbed, psychedelics
left the public consciousness, they are re- change activation patterns in the brain. 9
joining the conversation. That is the medical
conversation; psychedelics have never left These neurological changes also emerge at 3
the public arena. In the US alone, 32 million the psychological level where this altered
people, which is nearly 10% of the popula- state allows one to tackle old problems with
tion, have used a psychedelic in their lifetime. renewed vigour. One way psychedelics can be
Among those aged 30 to 34, 20% have tried a viewed is that they allow someone to break
psychedelic. It is not only that psychedelic use free from old patterns or tracks. Imagine a ski
is commonplace, but large scale surveys have slope where, after an intense day of skiing,
also shown that classic psychedelic use is as- your next run down the mountain is already NORTH LATIN EUROPE AFRICA
sociated with reduced psychological distress. predetermined. The grooves are deep and
AMERICA AMERICA
small moguls force you to take one, of only a MDD 83 MDD 3 MDD 23 TRD 1
TRD 31 TRD 6 TRD 16
In 2009, the young, eager researcher, now Dr few routes, down. Wait a night and for some PTSD 27 SUD 1 PTSD 5
Robin Carhart-Harris, told his colleagues he fresh snow to fall, and novel ways down the ANXIETY 9 ANXIETY 2
SUD 10 SUD 5
wanted to focus his research on psychedel- mountain become available again. A fresh ski EATING DISORDERS 4 EATING DISORDERS 1
ics and study them using functional magnet- slope, just like a brain influenced by psyche-
ic resonance imaging (fMRI). Many advised delics, offers a mountain of possibilities. MIDDLE ASIA OCEANIA
him against this path. In the 40 years prior, no EAST
other researcher had administered psychedel- It is this process that happens both at the MDD 8 MDD 11 MDD 2
TRD 1 TRD 1 TRD 1
ics in the UK. Yet, he persisted and under the neurological and psychological level. Psyche- PTSD 3
guidance of Professor David Nutt and building delics by themselves do not solve any prob-
on the work by the Beckley Foundation, their lems, they only allow one to take action and
team at Imperial College London became the broaden the options available, especially in Source: Blossom/Clinicaltrials.gov
first to study psychedelics in the UK. combination with psychotherapy. Where tra-
ditional medications such as antidepressants
Now just 12 years later, there are more than a aim to relieve the symptoms of the suffering
hundred psychedelic studies being conduct- one experiences (passive coping), psychedel- that normally detects serotonin (antagonis- covering the different ways in which psyche-
ed each month. Established drug researchers ics allow one to see problems with a fresh set ing the 5-HT2a receptors). Ketamine, on the delics work in the brain. Recent research by
such as Matthew Johnson and Roland Griffiths of eyes (active coping). other hand, works by activating AMPA (a-ami- Awakn Life Sciences points towards previous-
at Johns Hopkins Medicine are joined by a slew no-3-hydroxy-5-methyl-4-isoxazolepropion- ly unknown receptor activation by MDMA.
of younger researchers from all over the world. Even after more than 300 clinical trials, we ic acid) receptors and strengthening synap-
Psychedelic research centres are growing like are still discovering the many processes tic connections. MDMA increases the activity What we do know is that the mental health
mycelium across the world and from what was through which psychedelics work. Classical of at least three neurotransmitters; serotonin, outcomes are significant and promising. The
originally perceived to be ‘career suicide’, psy- psychedelics work by binding to a receptor dopamine and norepinephrine. We are still dis- most prominent study to date has been done
by the Multidisciplinary Association for Psy- two courses of antidepressant treatment. This these and other mental health conditions, have
chedelic Studies (MAPS). The latest data from equates to roughly 77 million people suffering had varying success to date and companies are
their phase III clinical trial, the last step before from TRD worldwide. It is likely that this figure now looking elsewhere for solutions.
Food and Drug Administration (FDA) approval, is a conservative estimate given that many
is showing that 67% of the participants in the people suffering from mental health problems, The widespread and long-term use of tradi-
MDMA group no longer met the diagnostic cri- such as depression, choose not to seek help tional antidepressants has been dubbed as
teria for post-traumatic stress disorder (PTSD); for their condition. a ‘public health experiment on a large scale’
participants who had previously been suffer- according to Dr Daniel Engle, as nobody
ing for 15 years on average. Substance use disorders (SUDs), including de- truly knows what the impact will be on public
pendence on opioids, for conditions such as health or on those individuals who have spent
The promising results before prohibition, chronic pain, have reached epidemic propor- many years on antidepressants. Already we
combined with the resurgence of research, tions, particularly in North America, where are seeing many conventional pharmaceutical
show the untapped potential that psychedel- even conservative estimates place the cost to products experience a backlash from the nega-
ics offer. This is not only as a replacement of the US economy at tens of billions of dollars tive side effects of long-term usage and/or ad-
often ineffective and life-long conventional in lost earnings every year. The US stands out diction, with opioids – the bedrock of the phar-
therapies, but as a curative model when com- from the global average of 1% of the population maceutical industry – being a key example of
bined with psychotherapy. The next step that with SUDs with 3.5% of the population being this. There is a definite appetite for alternatives
is required is validation by the FDA and the im- addicted, and almost 1 in 10 people between to conventional medicines among patients.
plementation of psychedelic-assisted therapy 20 and 30 addicted to various substances. In
at scale. Psychedelic medicines, both natural- 2019, 50,000 people in the US alone overdosed Mental health disorders also lead to a sig-
ly occurring and those synthesised, have the on opioids, either from prescribed medications nificant number of indirect deaths through
potential to redefine how mental health condi- or their street alternatives. Other substance suicide and self-harm. Our World in Data
tions will be treated. misuse conditions, such as alcoholism and finds that up to 90% of suicides in high-in-
nicotine addiction, exacerbate the problem. come countries can be attributed to underly-
Conventional pharmaceuticals, prescribed for ing mental health or substance use disorders.
KEY CONDITIONS
Psychedelics as medicines are being inves-

tigated for the treatment of a wide range of
mental health disorders such as depression
(MDD, TRD), suicidal ideation, PTSD, eating
disorders, anxiety and substance use dis-
orders (SUD), such as addiction to alcohol,
opioids and nicotine. THE NON-PSYCHEDELIC
This is needed now, more than ever before, as, PSYCHEDELICS
according to Our World in Data, 1 billion people
are suffering from mental health and sub- COMPANY
stance use disorders. This amounts to 15% of
the world population, a number that has surely
risen during the COVID-19 pandemic. For every
year that is lost due to early death or disabili-
ty (DALYs - disability-adjusted life year), 7% is
caused by mental health and substance use
disorders. The cost to society of depression
has surpassed that of cancer and doesn’t look
to be going down without finding new solutions.
Up to 30% of people with depression are treat-

ment-resistant (TRD), meaning their condi-
tion has not responded positively to at least
Percentage of mental health and substance Facts about mental health conditions:
use disorders (2017)
NUMBERS MENTAL HEALTH
(millions) CONDITIONS
970 Number of people with mental health or substance abuse disorders
282 Number of people with anxiety disorders

12.6%
17.2% 14.1% 258 Number of people with major depressive disorder (MDD)
15.2% 77 Number of people with a treatment-resistant form of depression (TRD)
269 Number of people with post-traumatic stress disorder (PTSD)

13.2%
105 Number of people with alcohol use disorder (AUD)
12.6%
70 Number of people with other substance use disorder (SUD)
18.5%
Source: Blossom/Our World in Data/WHO
NORTH LATIN EUROPE AFRICA PSYCHEDELIC HISTORY

AMERICA AMERICA AND FUTURE
MDD 4.8% MDD 2.8% MDD 4.0% MDD 3.8%
TRD 1.6% TRD 0.9% TRD 1.3% TRD 1.3% Using psychedelics to treat mental health con- Pygmy communities of Gabon, specifically in
ANXIETY ANXIETY ANXIETY ANXIETY
(including PTSD) 6.5% (including PTSD) 4.6% (including PTSD) 6.6% (including PTSD) 4.3% ditions is a new development in Western and Bwiti religious ceremonies and as an aide to
SUD 5.4% SUD 3.1% SUD 2.8% SUD 1.6%
industrialised countries. After briefly being healing. Certain peoples of Gabon and the
EATING DISORDERS 0.5% EATING DISORDERS 0.3% EATING DISORDERS 0.6% EATING DISORDERS 0.2%
used in the 1960s and 70s, psychedelics have Congo region have also used iboga extracts,
not had a place in modern-day health care. or chewed the root of the plant, in order to
MIDDLE ASIA OCEANIA But, their role in society and their potential remain calm, but alert, whilst hunting animals.
EAST to heal, has been documented over millennia
MDD 4.2% MDD 3.4% MDD 4.5% and is recognised by many diverse indigenous The word ‘peyote’, the name given to the
TRD 1.4% TRD 1.1% TRD 1.5%
ANXIETY ANXIETY ANXIETY
communities around the world. cactus from which the psychedelic substance
(including PTSD) 5.1% (including PTSD) 3.2% (including PTSD) 6.8% mescaline is derived, comes from an ancient
SUD 1.8% SUD 1.8% SUD 3.8%
EATING DISORDERS 0.3% EATING DISORDERS 0.2% EATING DISORDERS 0.9%
Psilocybin mushrooms have a long history of Aztec word, which translates as ‘Divine Mes-
traditional use – from indigenous Australians senger’. Under the Native American Religious
over 10,000 years ago, to the ancient native Freedom Act, 1994, Native American peoples
Source: Blossom/Our World in Data
peoples of Central America (particularly in living in the US have a legal right to use peyote
Mexico), who believed that psilocybe mush- as part of religious ceremonies. One Native
rooms were sacred. The Aztec people re- American congregation successfully peti-
In addition, those suffering from mental health In a world that is spinning around ever faster, ferred to mushrooms as teonanácatl or ‘flesh tioned the US Supreme Court in 2006, to allow
disorders face double the chance of dying the health care system isn’t able to keep up. of the gods’. Healing ceremonies are still its members to use ayahuasca as part of its
from cardiovascular diseases. The risk of dying Spending on medical care has gone up 6-fold held in Mexico today, led by native shamans religious sacraments.
at an early age is highest for those suffering in the United States over the past 50 years. known as curandera.
from eating disorders, such as anorexia. In that time, the rate of depression and other DMT, one of the main components of ayahuas-
mental health disorders hasn’t budged or has In West and Central Africa, ibogaine has ca, can also be found in cohoba, a hallucino-
slightly risen. It is time for a new way forward. traditionally been used by the Bantu and genic snuff used by the Indians of Trinidad
The Psychedelics as Medicine Report | The Psychedelics as Medicine Report | Spotlight on Health
and by the Llanos in northern South America patients suffering from a broad range of mental
during the earliest explorations of the conti- health conditions, while also respecting the
nent by the Spanish. DMT has been dubbed cultural, spiritual and historical importance of
‘the spirit molecule’, a nickname taken from these substances to indigenous communities.
the popular book of the same title, by Dr Rick
Strassman, who examined how DMT produced
mystical and near-death experiences in study WHY PSYCHEDELICS
volunteers in the early to mid-1990s. ARE DIFFERENT
The Centre for Psychedelic and Conscious- The jury is still out on how effective psy-
ness Research at Johns Hopkins University chedelics will be in the treatment of mental
has also undertaken research to examine the health and substance use disorders. Early
importance of spirituality among participants studies on everything from smoking cessa-
in psychedelic studies. A number of these tion to PTSD show the significant and often
studies have found that subjective mystical lasting impact of psychedelics. But, not in all
experiences (for example during monitored cases does depression stay away and without
sessions while using psilocybin) were an accu- changing their environment, how long can we
rate predictor of sustained positive respons- expect treatment effects to last? What will
es among participants. Currently, a debate is prevent psychedelics from becoming the next
ongoing within the scientific community, to ineffective treatment?
understand in what ways mystical experienc-
es contribute to the positive long-term effects The key difference between psychedelics
that psychedelics engender. Where some re- and other treatments is that the methods and
searchers argue that such experiences of awe goals are completely different . Whereas many
are the key driver of mental health benefits, treatments are aimed at helping someone live
others are researching ways to separate the with a condition and making life liveable again,
mental health and anti-addictive effects from psychedelics aim to cure. Psychedelics are ac-
the mind-altering perceptions. tivating and can help, in combination with psy-
chotherapy, someone to ‘face the music’.
The latter group is also investigating if we can
separate the hallucinogenic and therapeutic This also means that psychedelic therapies
effects of psychedelics. Blasphemy to some; are not a pill or treatment that someone has
separating these effects could lead to a wider to take every day for the rest of their life.
acceptance of psychedelics as medicines and Some early psychedelic studies have shown
for them to be used by those who would rather that participants were free from anxiety
not experience changes in their conscious- for up to five years. More studies will have
ness. If found to work in humans, as studies to show if these effects are sustained or
with non-hallucinogenic analogues have only whether psychedelic treatments need to be
been completed in mice, these could also save repeated months or years later.
costs where a qualified medical professional
does not have to sit with a patient for several These effects have been found in early clinical
hours anymore. trials and for the classical psychedelics that
are detailed in this report, but this is not for all
The challenge going forward will be to utilise psychedelics, such as ketamine. The cost-ef-
the healing properties of psychedelics, some- fectiveness to society needs to be carefully
thing indigenous communities have been doing examined, as the upfront costs of psychedel-
for hundreds, if not thousands of years, to ic treatments are often much higher than that
develop modern psychedelic-assisted thera- of other therapies. Only if PAT is able to help
pies and medicines, while also scaling up the a large proportion of those treated, and for
process to meet global demand. Psychedelics a long period of time, can we expect them to
as medicine should benefit a new generation of find widespread adoption.
The Psychedelics as Medicine Report | Psychedelics - Timeline The Psychedelics as Medicine Report | Psychedelics - Timeline
of Key Developments of Key Developments
Psychedelics -
Timeline of Key
Developments Year Month Event Location
1896 Arthur Heffter isolates mescaline for the first time Germany
1901 Dybowsky and Landrin isolate ibogaine for the first time France
1912 Anton Köllisch synthesises MDMA for the first time Germany
1938 November Albert Hofmann synthesises LSD for the first time Switzerland
1947 LSD is introduced as a commercial medication to Global

psychiatrists under the trade-name Delysid
1958 Albert Hofmann isolates psilocybin for the first time Switzerland
1962 Calvin Stevens synthesises ketamine for the first time US
1962 April Walter Pahnke and colleagues conduct the Good US

Friday Experiment
1966 May California bans LSD US
1968 October Staggers-Dodd Bill passes, banning possession of US

LSD and other stimulants and depressants without
a prescription
1971 February UN publishes the Convention on Psychotropic Global

Substances; psychedelics including LSD, DMT and
MDMA are now internationally controlled substances
1971 May US Controlled Substances Act comes into effect US

moving most major psychedelic drugs to Schedule I
1971 May UK passes Misuse of Drugs Act 1971, placing controls UK

on most known psychedelics
1977 MDMA will be used by a small group of US

psychotherapists for the next eight years
The Psychedelics as Medicine Report | Psychedelics - Timeline The Psychedelics as Medicine Report | Psychedelics - Timeline
of Key Developments of Key Developments
Year Month Event Location Year Month Event Location
1985 June MDMA joins other psychedelics and is added to US 2020 April A number of ballot initiatives to decriminalise / US
Schedule I under an emergency ban by the Drug legalise psychedelics in states in the US are impeded
Enforcement Agency (DEA) by the spread of COVID-19 - US
1996 June Canada moves many psychedelics, including LSD and Canada 2020 May MAPS preparing for FDA approval after positive US
psilocybin, to Schedule III interim analysis of phase III trials of MDMA for PTSD
2000 November World’s first clinical trial of MDMA-assisted Spain 2020 July Oregon Psilocybin Service Initiative (IP34) succeeds US
psychotherapy begins in Madrid; it will be shut down in placing legal psilocybin for treatment in a medical
before completion - Spain setting on the state ballot for November 2020
2001 July Personal possession of all drugs decriminalised Portugal 2020 August Health Canada grants four exemptions for use of Canada
in Portugal psilocybin in palliative care
2014 September The results from an open-label pilot study show 80% US 2020 September Ann Arbor, Michigan becomes third US city to US
of participant smoking-free 6 months after psilocybin- decriminalise psychedelic substances including
assisted therapy psilocybin, ayahuasca and peyote
2017 August MDMA-assisted psychotherapy granted Breakthrough US 2020 October Numinus Wellness harvests Canada’s first legal Canada
Therapy designation (BTD) from US FDA psilocybin mushrooms
2018 October COMPASS Pathways receives BTDfrom US, FDA for US 2020 November Washington DC decriminalises psychedelic substances US
psilocybin synthetic derivative, COMP360 including psilocybin, ayahuasca and peyote
2019 March Esketamine approved in the form of Spravato by FDA, Global 2020 November Oregon decriminalises psychedelics and creates US
followed by European Commission approval psilocybin-assisted therapy framework with the
in December passing of Measures 109 and 110
2019 May Denver, Colorado votes to decriminalise psilocybin US 2020 December UK approves clinical trial for DMT to treat depression UK
mushrooms
2021 March UK's first ketamine-assisted psychotherapy clinic UK
2019 June Oakland, California votes to decriminalise psilocybin US opens in Bristol
mushrooms
2021 March Australian government invests AU$15 million into Australia
2019 November Usona Institute receives US FDA BTD for psilocybin US research of psychedelic medicines - Australia
treatment for MDD
2021 May MAPS publishes results from phase IIIa clinical trial, US
2020 January COMPASS Pathways announces US patent approval US showing potential for MDMA to combat PTSD
of COMP360, its synthetically derived psilocybin for
the treatment of TRD 2021 June California Senate approves bill to legalise possession US
of psychedelics
2020 February Santa Cruz, California votes to decriminalise US
psychedelic substances including psilocybin, 2021 June COMPASS Pathways completes phase IIb clinical trial UK
ayahuasca and peyote for psilocybin derivative to treat TRD
2020 March MindMed becomes the first publicly listed Canada 2021 July Health Canada approves real-world open-label trials Canada
psychedelics company for MDMA-assisted therapy to treat PTSD
The Psychedelics as Medicine Report | Countries to Watch The Psychedelics as Medicine Report | Countries to Watch
Countries
to Watch
KEY TAKEAWAYS
1. Canada has resisted the harsh

classification of drugs and was
the first G8 country to legalise
cannabis. The same route through
which cannabis found medical use,
Section 56 exemptions, is now also
being explored with psychedelics.
2. The Canadian Securities Exchange

has become the place for for-
ward-thinking companies that work
with psychedelics to list, with over
US$330 million being raised on the
exchange, in the first half of 2021.
3. China has historically been averse

to psychedelics and has even tried
to add ketamine to the list of con-
trolled substances. Yet, in the last
few years, a dozen studies have
been done to generate evidence
for ketamine’s effectiveness in this
country of 1.4 billion people.
4. Switzerland has allowed psyche-

delic-assisted therapy through
compassionate use exemptions
and has also had an outside
impact on psychedelic research
with 35 clinical trials being
conducted in the country, surpass-
ing any other country, bar the US.
CANADA In October 2020, Numinus Wellness harvested searchers and healthcare professionals to
Canada’s first legal flush of psilocybe mush- obtain banned compounds for treatment-re-
Canada has a history of embracing novel rooms, with the favourable regulatory climate sistant disorders.
healthcare policies, as an early adopter of as- encouraging the relocation of burgeoning psy-
sisted dying and medicinal cannabis. In 2020, chedelic companies abroad. The Canadian Se- With a history of embracing progres-
the federal regulator, Health Canada, granted curities Exchange became the ‘de facto’ trading sive health policies, and by demonstrating
over 20 exemptions to access psilocybin and platform for US cannabis operators to connect support for psychedelic medicines by provid-
this year approved a clinical trial to combat with investors. Psychedelic companies, such as ing legal exemptions for patients and through
treatment-resistant PTSD with MDMA. The Braxia Scientific, are following a similar route, the revival of the Special Access Programme,
study within the patient population hopes to with over US$330 million being raised on the many psychedelic companies and inves-
identify best practices for its medical applica- exchange in the first half of 2021 alone. tors are venturing that Canada may be the
tion, and obtain safety and efficacy data for first country to enact federal legislation au-
its regulatory approval. In addition to significant steps towards the thorising psychedelic medicines. If correct,
regulation of psilocybin, in 2021, Health this could provide these stakeholders with a
Politicians in Canada have long supported Canada made a momentous decision on MD- crucial first-mover advantage.
drug decriminalisation, even when it put the MA-assisted therapy, approving a clinical trial
country at odds with the international commu- to investigate the compound’s safety and effi-
nity. At the same time as the UN published the cacy in combating treatment-resistant PTSD.
Convention on Psychotropic Substances, the The study not only hopes to identify MDMA’s
US passed the US Controlled Substances Act suitability for regulation but also opportunities
and the UK enacted the Misuse of Drugs Act to streamline treatments to reduce costs and
1971, Canada’s Le Dain Commission were rec- promote their adoption. The demand for novel
ommending that regulations be loosened and treatments and restricted drugs is so high
that drugs be gradually decriminalised. that Health Canada has restored its Special
Access Programme, to make it easier for re-
Alas, in 1996 the Controlled Drugs and Sub-
stances Act was passed, which classified
drugs into eight schedules, I to VIII, similar to
the US framework. In 2018, Canada federally
legalised cannabis, the first G8 country to do
so, setting a trend that resulted in a UN Com-
mission voting to declassify the drug in 2020. Experienced legal and patent advice
As the world caught up with Canada’s progres-
sive drug policy, Health Canada granted over for your psychedelics business
20 exemptions from the Controlled Drug and
Substances Act for researchers, drug devel-
Aird & Berlis LLP is a prominent Canadian law firm and a recognized leader
opers, medical practitioners and patients to
access psilocybin.
in the psychedelics industry.
Aird & Berlis is at the forefront of the psychedelics industry with our team
The four initial Section 56 exemptions were
permitted to palliative care patients to ease
of more than 200 lawyers, patent agents and business advisors providing
end-of-life distress, with studies having demon- strategic legal and patent advice in all principal areas of business law,
strated psilocybin’s potential to treat depres- including Capital Markets, Mergers & Acquisitions, Intellectual Property
sion and anxiety for this patient population. and Tax, to serve the entire suite of legal and patent needs of private and
Since the landmark decision, the reasons for public psychedelics companies.
Section 56 exemptions have been expanded,
enabling for-profit and non-profit companies to
Aird & Berlis LLP | Lawyers
cultivate, harvest, process and study psilocybin Brookfield Place, 181 Bay Street, Suite 1800, Toronto, Canada M5J 2T9
producing fungi. If these exemptions show ex- T 416.863.1500 F 416.863.1515 | airdberlis.com
ceptional results, it is hoped psilocybin’s ther-
apeutic use may be recognised and legalised.
CHINA
Although the vast majority of research and de- In an effort to develop medicines for treat-
velopment of psychedelic medicines has taken ment-resistant depression, Wuhan General
place in North America and Europe, China has Group is exploring the therapeutic potential
conducted a dozen clinical trials to investigate of psilocybin through its subsidiary M2BIO.
the potential of ketamine and more recently The subsidiary looks to create new therapies
psilocybin. These are critical to global adop- for mental disorders, including anxiety, PTSD,
tion with studies in China recruiting partici- and addiction, by disrupting neuroactivity. The
pants of ethnicities underrepresented in the company is well-positioned to collaborate with
western hemisphere. legislative bodies and once created, these
novel treatments could be regulated in China
China has strict illicit drugs laws, with death and further afield, for large patient populations,
sentences handed out in severe cases. The with the healthcare policies of many Asian
country has also repeatedly asked the UN to countries echoing the regional superpower.
add ketamine to the Convention on Psychotro-
pic Substances of 1971 Act; thereby removing
its designation as an essential medicine.
However, China is also running clinical trials to

explore the benefits of the same compounds
that it rigorously denounces. In tightly con-
trolled environments, the country has conduct-
ed as many clinical trials with psychedelics as
Israel and nearly as many as the UK, with ket-
amine being the principal focus of its investiga-
tions, alongside a solitary study into psilocybin.
The results of these studies have wide-reach-

ing implications for researchers and regula-
tors, as they have been conducted outside the
western hemisphere with local patient popu-
lations. This is important as patient diversity
in clinical trials is essential, as a better repre-
sentation of society globally, with researchers
being able to access a wider data set and to
therefore better generalise the outcomes.
China has hosted clinical trials to observe

the long-term safety of ketamine in the treat-
ment of depression. A 2015 study involved
over 120 patients dependent on the drug, to
identify correlations with psychotic and de-
pressive disorders and the concerns raised. In
2018, research was published by neuroscien-
tists at the Zhejiang Chinese Medical Univer-
sity, who detected instances where ketamine
impacted on brain activity and as a result
identified molecular targets to manufacture
ketamine-based antidepressants with greater
safety and efficacy.
SWITZERLAND
Switzerland became synonymous with psy- On the back of these results, the Swiss regula-
chedelic research following Albert Hofmann’s tor has granted authorisations for over a dozen
synthesis of LSD and isolation of psilocybin. patients to access MDMA and LSD in a thera-
Despite its small size, the country has con- peutic setting. Initially, protocols were devel-
ducted the second largest number of clinical oped for individual therapy, to promote regu-
trials into psychedelic medicines. Home to a latory approval, however, group therapy trials
number of prestigious scientific organisations, were also approved in 2017, enabling research-
studies have been conducted on a wide range ers to benefit from the data collected nearly
of psychoactive substances including aya- thirty years earlier.
huasca, DMT and mescaline.
In 2018, Switzerland conducted fMRI scans on
Swiss chemist, Albert Hofmann, first syn- subjects to observe changes in brain activi-
thesised LSD in 1938 and was the first to ty - pioneering research into how LSD impacts
consume the compound five years later. neuron activity to disrupt mental disorders. De-
Fifteen years later he isolated psilocybin and creased functional connectivity was observed
psilocin, cementing himself in the foundations within the default mode network with be-
of psychedelic research. tween-network connectivity intensifying, par-
ticularly in the thalamus and cerebral cortex.
In 1951, Switzerland passed the Narcot-
ic Drugs and Psychotropic Substances Act, In 2020, MindMed acquired data and patent
to prevent unauthorised consumption and rights for research into psychedelic medicines
to regulate the availability of psychedelics conducted at the University Hospital Basel
for medical and scientific purposes. In 1972, over a 10 year period. Later that year, Switzer-
Zurich recorded its first fatal heroin over- land approved MindMed’s phase IIa clinical
dose, leading the government to adopt a trial into LSD’s efficacy to treat ADHD and a
progressive public health approach to drug phase I trial into the application of LSD and
policy, centred around harm reduction. MDMA in combination. The firstever clinical
trial, using both together, started in 2021, with
Switzerland legalised psychedelic-assisted the results expected to be published in 2022.
therapy in 1988, with medical practitioners au-
thorised to prescribe LSD and MDMA. A group With an extensive history of research into psy-
setting approach was applied to the therapy, chedelic-assisted therapy, Switzerland has
which would reduce the resources associated developed the framework, institutions and
with the treatment, to increase its accessibility expertise to continue pioneering new treat-
and adoption. Between 1988 and 1993, when ments. Over 35 clinical trials have been con-
the programme ended, almost 200 patients ducted in the nation, with a conducive regula-
had been seen in a group setting, in studies tory environment attracting drug developers to
that would inform trials in future populations. establish and invest in future studies.
From 2007, Switzerland restarted examina-

tion of the potential of LSD-assisted therapy,
under an expanded compassionate use pro-
gramme, and in 2012 conducted a study with
MDMA to combat treatment-resistant PTSD.
Subsequent studies investigated optimal
dosages in therapeutic settings and the bene-
fits of LSD in palliative care; sponsored by the
Swiss National Science Foundation.
The Psychedelics as Medicine Report | Psychedelic Profiles The Psychedelics as Medicine Report | Psychedelic Profiles
Psychedelic
Profiles
This section provides detailed profiles of each tion is either being studied in a clinical trial,
psychedelic and the mental health and sub- usually in combination with psychotherapy, or
stance use disorders for which they can offer it is soon to be studied.
compelling novel treatments. Each combina-
List of health conditions and the psychedelic

substances with the potential to treat them:
HEALTH PSYCHEDELIC SUBSTANCE

CONDITION
Psilocybin LSD MDMA Ketamine Ibogaine Ayahuasca DMT/5- Mescaline/ Salvinorin
MeO-DMT Peyote A/Salvia
Depression
(MDD) (TRD)
Bipolar
disorder
Suicidal
Ideation
Anxiety
Autism
(Social
Anxiety)
PTSD
Eating
Disorders
Alcohol Use
Disorder
The Psychedelics as Medicine Report | Psychedelic Profiles The Psychedelics as Medicine Report | Psychedelic Profiles
HEALTH PSYCHEDELIC SUBSTANCE

CONDITION
Psilocybin LSD MDMA Ketamine Ibogaine Ayahuasca DMT/5- Mescaline/ Salvinorin
MeO-DMT Peyote A/Salvia
Opioid Use
Disorder
Chronic Pain
ADHD
Cluster
Headaches
Stroke
OCD
Inflammation
Note: This is an indicative list for illustrative purposes only and should not be regarded as exhaustive.
Source: Blossom/Clinicaltrials.gov
EXPERT INTERVIEW
George
Goldsmith
CEO and Co-founder,
COMPASS Pathways
What is psilocybin therapy and why is health care system did not provide the care providers and clinic networks directly; we will
everyone talking about it? he so desperately needed. not be building our own clinic network. Any
Psilocybin therapy is one of the most promising business model will have to include digital
innovations in psychiatry today and has the Along our journey we talked to many, many solutions to complement and augment our psi-
potential to transform the lives of millions of people who told similar stories of feeling help- locybin therapy protocol. Digital technologies
people suffering with mental health challenges. less and frustrated by the inability to access can help to collect and measure behavioural
effective mental health care. Some of these information that will enable us to provide
We are in the middle of a global mental health were people we had known for years, who personalised care pathways that could help
crisis. One person dies from suicide every 40 were opening up to us for the first time. We predict and prevent deterioration and relapse.
seconds and in that same timeframe another realised that “everyone has a story” – and we
20 attempt it. More than 320 million people of started COMPASS so that we could do some- What else is in your portfolio?
all ages around the world suffer with depres- thing to bring innovation and help to patients. We work with leading academic institutions
sion and up to a third of them are diagnosed and researchers around the world, and provide
with “treatment-resistant depression” (TRD) In 2018 we received Breakthrough Therapy our COMP360 psilocybin, free of charge, to
and not helped by current treatments. designation from the FDA for COMP360, our selected investigator-initiated studies (IISs) in
proprietary formulation of synthetic psilocybin. areas of high unmet need. These are sig-
Psilocybin is an active ingredient in some And we are currently in the final stages of a nal-generating, exploratory studies covering
species of mushrooms, often referred to as large-scale, randomised, controlled phase IIb indications such as anorexia nervosa, bipolar
“magic mushrooms”. Early studies have shown study of psilocybin therapy for TRD, taking disorder II, body dysmorphic disorder, depres-
that a single high dose of psilocybin could im- place in 22 sites across 10 countries. This is sion in cancer, and PTSD. If these studies pro-
prove outcomes for patients with depression, the world’s largest psilocybin therapy trial. vide signals that merit further investigation, we
anxiety, addiction and other mental health ill- Data is expected by the end of 2021 and if all will consider moving them into late stage trials.
nesses, when administered with psychological goes well, we’ll begin phase III next year and
support from specially trained therapists. hope to apply for regulatory approval after that. We also have an active preclinical research
programme. The hub of this is our Discovery
So we have a therapy that could make a dif- If this therapy gets approved, how will Center, anchored at University of the Sciences
ference in areas of significant unmet medical people access it? What does your business in Philadelphia, and with a network around
need. That’s why people are talking about it. model look like? the US. The teams here are developing many
Access is central to our mission at COMPASS. new, optimised psychedelic compounds that
What is COMPASS’s part in this? We are in active discussions with regulators, target the 5HT2A receptor, which is believed
I co-founded COMPASS Pathways with my payers and insurers about the data we need to to mediate the potential therapeutic effects
wife, Ekaterina Malievskaia, after we expe- generate in order to ensure that this therapy is of psychedelics. We plan to have a couple
rienced the pain of mental health illness reimbursed and made available to patients in of these enter clinical trials over the next 18
in our own family. Our son became very need, regardless of their ability to pay. months to two years.
ill when he went to college. We thought it
would be easy to fix – it wasn’t. Each new If COMP360 psilocybin therapy is approved,
medication made him worse and the mental we plan to target public and private healthcare
The Psychedelics as Medicine Report | Expert Interview The Psychedelics as Medicine Report |
Clinical development programme
How have you seen this field change over

Phase I Phase IIb Phase III
the last few years?
There are been growing excitement around
Completed Dose-ﬁnding study To follow in
psychedelic therapies in recent years, with
2019 2022
COMP360 psilocybin therapy pending phase
administration completed much talk of the “psychedelic renaissance”,
89 IIb results
healthy participants July 2021 Large-scale numerous psychedelic companies and retreats
pivotal trials,
World’s largest prior to emerging, and a rising interest from politicians
application for
psilocybin therapy study
marketing
approval
in legalising substances including psilocybin.
Data expected in
late 2021
We are a mental health care company, which
means our priority is to help people with
22 sites serious mental health challenges. Develop-
10 countries ing psychedelic therapies is, for us, a way of
achieving this goal, it is not the goal.
Newcastle
Aalborg
This means that evidence is our friend. We
Toronto
New York City
Dublin
Bristol
Groningen
Utrecht Berlin
need to generate data, through rigorous clini-
Baltimore London Leiden
Stanford
San Diego
Klecany
cal trials, that demonstrate quality, safety and
Atlanta
Houston
efficacy of psilocybin therapy. Only then can
Barcelona
Lisbon
it be approved by regulators, reimbursed, and
made available to as many as possible who
233 TRD patients
(exceeding target recruitment of 216) might benefit.
What progress do you anticipate making in

the next 12 months?
>300 people involved in the trial Data from our phase IIb trial will be shared in
including:
late 2021; if all goes well, we aim to move into
phase III in 2022. We will also be expanding our
portfolio with studies in new indications, based
Principal and Study co-ordinators Study nurses Therapists
sub-investigators on the signals we see from our IIS partners.
We are building a strong digital team, with

Pharmacists Raters Clinical research organisation
partners and suppliers experts from Mindstrong, Tesla, Stanford,
and Google-sister company Verily, working
together to build apps and tools that will be
Randomised, controlled, double-blinded study
able to quickly measure and track behavioural
change, and improve patient outcomes.
Dose-ﬁnding study comparing
25mg and
10mg with 1mg of COMP360,
administered with psychological support The promise of psilocybin therapy is signifi-
cant. To make sure we realise this promise, we
Patients followed up for 12 weeks need to generate data that will demonstrate
the safety and efficacy of psilocybin therapy
and enable its widespread rollout and accessi-
Making psilocybin therapy accessible to bility to all. The promise is big but we must be
patients with serious mental health illnesses patient for a little while longer.
Additional
indications for
Reimbursement Widespread
Large-scale Pivotal psilocybin
Regulatory and integration access for
phase IIb trial – phase III trials – therapy, as well
approval into health patients
data generated data generated as new
systems with TRD
compounds
developed
The Psychedelics as Medicine Report | Key Psychedelic Deep Dives The Psychedelics as Medicine Report | Key Psychedelic Deep Dives
Key
Psychedelic
Deep Dives
The psychedelic deep dives presented here
offer detailed information on clinical trials
and research being conducted and the legal
framework surrounding the following psyche-
delics, as well as a breakdown of conditions
for which each substance has potential cura-
tive properties. Featured in the key psychedel-
ic deep dives are:
Psilocybin
LSD
MDMA
Ketamine
Ibogaine
Ayahuasca
PSILOCYBIN
KEY TAKEAWAYS
1. Psilocybin-assisted therapy for

depression (MDD and TRD) is
finishing phase II clinical trials and
may become a licensed therapy as
early as 2025.
2. Academic studies conducted

around the world using psilocybin
with accompanying psychologi-
cal support (PAT) are demonstrat-
ing rapid and long-lasting positive
effects on patients suffering from
depression and anxiety. In one study
the positive effects were still evident
up to four and a half years later.
3. Next to health care reimbursed

therapies, decriminalisation
efforts are opening another
avenue through which psilocybin,
‘magic mushrooms’, can become
a tool for the improvement of
mental well-being.
Psilocybin is a psychedelic that can be derived locybin-assisted treatment of alcohol depen- I have smoked health care company COMPASS Pathways,
from over 200 varieties of fungi. Since its iso-
lation in 1958 by Albert Hofmann, a variety of
dence. Most of these studies are either taking
place in the US or Europe, as is the case for
for a number of which began in 2019.
synthetic methods for producing psilocybin the other key psychedelics. years, and I have The phase II study, which was also conducted
have been found. A human body quickly me- attempted to at 21 other sites in Europe and North America,
North America
tabolises psilocybin into psilocin which is the
pharmacologically active agent which interacts Several studies with psilocybin for relieving
quit on numerous of psilocybin-assisted therapy for TRD, was
completed in June 2021. COMPASS Path-
with several serotonin receptors in the brain. anxiety in those suffering from life-threatening occasions, and I ways will publish the results of this trial in
Specifically, it is best known for being a 5-HT2a
agonist, meaning it can change serotonin activ-
diseases were the impetus for studying psilo-
cybin in the US. This is also where, in 2020, a
always would go late 2021. The trial is the largest of its kind to
date and has treated 216 patients. At this time,
ity in the human brain and disrupt dysfunction- long-term follow-up study was done with par- through withdrawal. COMPASS Pathways is furthest along with
al brain connectivity. Through these and other ticipants from the New York University School I didn’t with making psilocybin, specifically their propri-
mechanisms, psilocybin thus offers a potent
new alternative for the treatment of a wide
of Medicine study. The researchers found that
among 15 cancer patients who participated, up
psilocybin. etary COMP360, into a medicine.
variety of mental health conditions. to 80% were still feeling the positive effects In continental Europe, the MIND Foundation
from one dose of psilocybin, up to four and a has set up a comparable study. Since March
Clinical trials and research half years later. 2021 they have been recruiting 144 patients
Psilocybin is, after ketamine, the second most to study the effects of one or two psilocybin
studied psychedelics to date. There have been Several studies carried out by researchers Study participant, Johns Hopkins University, doses on TRD. The EPIsoDE study is funded
64 clinical trials to date of which 26 are phase from the Centre for Psychedelics and Con- psilocybin for smoking cessation trial by the Federal Ministry of Education and Re-
II studies. The trials with psilocybin are for the sciousness Research at Johns Hopkins Uni- search, marking the first time direct federal
widest range of mental health disorders. The versity have concluded that not only does psi- funding has been allocated to such a study
following is a list of conditions for which psilo- locybin have long-term, positive effects on the in Germany.
cybin has potential therapeutic benefits based depression and anxiety scores of study partic- Europe
on clinical trials and academic studies con- ipants and on the relapse rates of participants In 2017, Imperial College London conducted Oceania
ducted to date: suffering from substance misuse conditions, a psilocybin study with 16 patients suffering In Australia, Mind Medicine Australia (MMA)
but also the abuse potential of psilocybin from TRD, using fMRI technology to measure and St Vincent’s Hospital, Melbourne, are co-
• Depression (MDD, TRD, and bipolar); compares favourably with other substances changes in brain function in the subjects operating on a psilocybin study on anxiety in
such as opioids. In other words, patients are before and after doses of psilocybin were ad- terminally ill cancer patients. MMA is a reg-
• Anxiety and depression in patients with at minimal risk of developing a dependence ministered. The study found that psilocybin, istered charity that aims to support safe and
life-threatening disease; on psilocybin relative to other drugs which are with accompanying psychological support, effective psychedelic-assisted treatments, via
used as medicines. produced rapid and sustained antidepressant clinical research. MMA focuses specifically on
• Social anxiety for those with autism; effects, with the potential to ‘reset’ the brain, the clinical application of medicinal psilocybin
Researchers at the University of New Mexico offering a potential new treatment for TRD. and medicinal MDMA for mental health condi-
• Substance misuse, including alcohol, opioid Health Sciences Centre have instigated a pilot The College’s Centre for Psychedelic Research tions, such as PTSD and anxiety.
and nicotine dependence; study for the treatment of alcohol dependence is positioning itself to serve as a model re-
with psilocybin. The study with ten participants search clinic that serves as a prototype for the This effort is greatly assisted by the recent
• Eating disorders such as anorexia nervosa; showed that up to nine months later they had licensed psychedelic care facilities set to be a AU$15 million competitive grant that was
significantly reduced their alcohol intake after feature of mental health services in the future. launched in March 2021, only weeks after the
• Demoralisation in long-term AIDS survivors; two high dose psychedelic treatment sessions. Therapeutic Goods Administration (TGA) had
The Centre for Affective Disorders at King's rejected access for mental health profession-
• Cluster headaches/migraines; and Also widely reported is another pilot study College London established a psychedelic als to use psychedelics. The money will be
from Matthew Johnson and colleagues at trials group, which received funding from the used to fund clinical trials in Australia with
• Symptoms of obsessive-compulsive disor- Johns Hopkins that found that 12 of the 15 National Institute for Health Research (NIHR) psilocybin, MDMA and other psychedelics.
der (OCD). participants in a smoking cessation trial were in 2017, to investigate the safety and efficacy
not smoking up to six months later. A fol- of psilocybin for patients with TRD, coupled
In these 64 clinical trials, nearly 2,100 patients low-up study 2.5 years after the trials showed with a suite of psychological supports and
have been enrolled, as of July 2021. Among that 60% were still smoking abstinent. These medical supervision, through a randomised,
the active trials are those investigating psilo- numbers compare favourably versus other, placebo-controlled trial. The centre, which is
cybin for the treatment of migraine headache, often much longer, treatments that achieve up headed up by Professor Allan Young, is cur-
psilocybin for the treatment of OCD, and psi- to 35% smoking abstinence. rently involved in trials sponsored by mental
Number of clinical trials to date, using psilocybin Legality of psilocybin

as an intervention, by condition treated mushrooms worldwide
The UN Convention on Psychotropic Substanc-
es (the ‘Vienna’ Convention), 1971, identifies
PHASE I PHASE II psilocybin as a Schedule I substance, a cate-
gory of illicit drugs deemed to offer no medical
benefit and with a high potential for abuse.
DEPRESSION (MDD, TRD, BIPOLAR)
7
The Vienna Convention lacks clarity in relation
13 to the legal status of organic materials con-
taining psilocybin (i.e. so-called ‘magic’ mush-
SUBSTANCE USE DISORDERS rooms). The result is that not all countries
2 have adopted a strict interpretation of the
7 convention rules governing psilocybin mush-
rooms. The Netherlands is one example of a
ANXIETY country that has created exemptions for its
5 cultivation, sale and supply.
1
North America
The Controlled Substances Act, 1971, which
CLUSTER HEADACHES / MIGRAINES
provides a legal framework for the US federal
4
drugs policy, prohibits the manufacture, sale,
1 possession or use of psilocybin in the US.
While this may be the case at the federal level,
OCD a number of initiatives at the state level have
3 resulted in the decriminalisation of the sub-
1 stance. Some cities in Colorado and California
approved the decriminalisation of psilocybin
EATING DISORDERS in 2019, with the citizens of Denver becoming
2 the first in the country to vote to decriminalise
psilocybin mushrooms on 7 May 2019. The city
2
council of Oakland, in the state of California,
followed a month later, on 5 June. In January
PTSD
2020, Santa Cruz, also in the state of Califor-
1
nia, became the third city in the country to
decriminalise psychedelic mushrooms. As of
July 2021, more than seven cities and as many
AIDS DEMORALIZATION states, have implemented legislation sur-
1 rounding the decriminalisation of psilocybin.
According to the grassroots movement, De-

0 5 10 15 criminalise Nature, there are as many as 100
other initiatives at various stages of develop-
ment in cities across the US. On 6 July 2020,
*Studies with healthy participants (usually phase I studies, are excluded from this overview, thus the total number activists in Washington DC seeking to decrim-
of studies is lower than the total number of clinical trials conducted.
Source: ClinicalTrials.Gov / Blossom (correct as of 01/07/2021) inalise psychedelics submitted a sufficient
number of signatures to successfully peti-
tion for inclusion on the November ballot. The
Psilocybin Service Initiative of Oregon (PSI
Oregon 2020) is a 2020 ballot initiative that
led Oregon to become the first state to legalise
psilocybin-assisted therapies and to decrimi- than 100 days to be granted and as of July 2021 Map of cities, states and countries where psilocybin-
nalise personal possession of drugs (Measures TheraPsil is urging, via their lawyers, the Minis-
containing mushrooms are legal or decriminalised for
109 and 110). A two-year development process ter of Health to respond within 14 days.
is currently ongoing to establish rules and reg-
personal possession and use.
ulations. The start of 2023 is the earliest date Europe
LEGAL UNENFORCED DECRIMINALISED PENDING
when applications related to the manufacture, In 1976, the Netherlands was one of the first
sale and purchase of psilocybin products and countries to decriminalise possession of ‘small
services is set to commence in Oregon. amounts’ of any drug for personal use. In De-
cember 2008, the government of the Nether-
California, the most populous state in the US, lands specified threshold limits on the amount
has been working on decriminalisation legis- of fresh and dried psychoactive mushrooms a
lation since Oakland’s victory. Senator Scott person could be in possession of, for personal
Weiner is leading this charge and has success- use. To date, it is legal to possess up to 5 grams
fully secured the decriminalisation of several of fresh mushroom or 0.5 grams of dried mush-
psychedelics (notably excluding peyote for room for personal use, but not for the purpose
conservation reasons) through the Senate and of sale or supply. Psilocybin truffles can be cul-
several committees. A vote on the Assembly tivated legally for these purposes because of a
floor and the Governor's desk awaits. legislative loophole as the truffle is a different
part of the mushroom, which grows beneath
Finally, a federal bill was introduced to US the earth rather than above ground. The pro-
Congress to decriminalise drug possession in duction, possession and sale of truffles in
June 2021. The Bill is still in the early stages ‘smart shops’ are legal in the Netherlands.
and will go through several revisions that will
take at least several months. Still, this marks Oceania
the first significant signal of change for drug In August 2020, the Green Party in the Austra-
policy at the federal level. lian Capital Territory (ACT) committed to sup-
porting the introduction of regulated psyche-
In Canada, an advocacy group made up of delic therapies as part of its drug law reform
healthcare professionals, called TheraPsil, election platform. Although the changes to the LEGAL UNENFORCED DECRIMINALISED PENDING
was established in 2017; its mission being to Therapeutic Goods Administration (TGA) at NEPAL CAMBODIA PORTUGAL CALIFORNIA
promote compassionate use of psychedelics. the start of the year were not honoured, more BRAZIL CHILE CZECH REPUBLIC TEXAS
NETHERLANDS** INDIA AUSTRIA MISSOURI
The group successfully challenged the illegal- money is going towards research that could BAHAMAS INDONESIA CROATIA IOWA
ity of psilocybin by petitioning Health Canada provide evidence for allowing the therapeutic BRITTISH VIRGIN ISLAND LAOS CYPRUS NEW YORK
SAMOA MEXICO* ISRAEL VERMONT
to allow access to mushrooms in a medical use of psilocybin in Australia. OREGON RUSSIA ITALY NEW HAMPSHIRE
setting for those patients in palliative care TAIWAN SPAIN CONNECTICUT
THAILAND URUGUAY MAINE
who were experiencing psychological distress VIETNAM ANN ARBOR DENVER
DISTRICT OF COLUMBIA
due to their terminal diagnoses. On 4 August
SOMERVILLE
2020, in a landmark case, the Health Minis- OAKLAND
SANTA CRUZ
ter of Canada, Patty Hajdu, approved the use
of psilocybin therapy for four patients with
anxiety resulting from terminal cancer. It is the
Mushroom spores are not included in this list
first exemption for the use of a psychedelic *In Mexico, mushrooms are tolerated by authorities for use in religious rituals only.
treatment in Canada since 1974. **In the Netherlands, magic mushrooms are illegal, but, due to a legal loophole, magic truffles are not.
Source: Blossom/Psilocybin Alpha/Talking Drugs
Since then, 17 healthcare professionals have

also been granted exceptions to possess and
ingest psilocybin themselves in training to
learn what processes their patients go through.
After the initial four patients, 24 more have
been granted section 56 exemptions. Still,
these approvals are sometimes taking more
LSD
KEY TAKEAWAYS
1. LSD was widely studied in the

1960s and generated over 1000
scientific papers. These studies
showed positive developments in
reducing anxiety during ‘end-of-life’
care, depression and alcoholism.
2. Modern-day studies using fMRI

are enlightening researchers about
the way everyday consciousness
functions and how the hierarchy of
the brain is ‘flattened’ or ‘segregat-
ed’ under the influence of LSD.
3. The duration of an LSD trip makes

it a less likely candidate to be
developed as a medicine. Its micro-
scopic effective dose and wide-
spread use in recreational microdos-
ing do still show opportunities for
the further study of this psychedelic.
Lysergic acid diethylamide (LSD, LSD-25, acid) • Depression (MDD);

is a serotonergic psychedelic. LSD binds to se-
rotonin receptors, specifically the 5-HT2a re- • Anxiety and depression in patients with
ceptor, as well as dopamine receptors (which life-threatening disease;
psilocybin doesn’t bind to). The effects of
LSD are noticeable at dosages measured in • Substance misuse, including alcohol, opioid
the millionths of a gram. Research studies and nicotine dependence;
use between 50 and 200 micrograms, which
can produce effects for upwards of 12 hours. • Alzheimer’s disease (low-dose LSD);
The study of LSD played a pivotal role in the
discovery of the function of serotonin in the • Cluster headaches/migraines; and
brain. Although widely studied in the 1960s,
LSD is trailing behind psilocybin in terms of • Symptoms of OCD.
scientific interest.
In the 19 clinical trials, 530 patients have
Clinical trials and research been enrolled as of July 2021. Among the
LSD was the most studied psychedelic around active trials are those investigating LSD for
60 years ago. Trials were conducted to study the treatment of anxiety, LSD for the treat-
the effect of LSD on mood, alcohol depen- ment of depression, and LSD as a treatment
dence and, unfortunately also on patient pop- for cluster headaches.
ulations with schizophrenia or autism, who
hadn’t given consent to being administered a Europe
psychedelic. These questionable practices, Researchers in Basel, the city in which Albert
in a time before ethics review boards, and the Hofmann discovered LSD, are now testing the
lack of any control groups who were given a effects of this psychedelic on the human fear
placebo, means that much of the research was response. Researchers have shown that 100
not up to today’s standards. The promising micrograms of LSD are sufficient to reduce
results from that time were also swept under the fear response in healthy subjects who are
the carpet when the counterculture adopted shown pictures of others in a fearful state.
LSD as a recreational drug. The freeze on re- They observed reduced activity in the amyg-
search has held back our understanding of dala (emotional centre), which was mirrored
mental health disorders for decades. by the subjects’ reports that those who re-
ceived the LSD dose experienced less fear
In the current era of research, 19 clinical trials than those who did not.
have been conducted with LSD. Of those,
four are phase II studies. The trials with LSD How LSD specifically, and psychedelics in
not only focus on mental health disorders but general, are metabolised in the body has a
also serve a purpose for better understand- direct influence on the intensity of the ‘lived’
ing how our brains work. For instance, one experience. Researchers found that people
study investigated the role of dopamine and who lacked copies of the CYP (Cytochrome
serotonin after LSD administration and how P450) gene, which codes for an enzyme that
this affected emotional processing. Studies breaks down LSD, had up to 75% more ex-
like this can then inform those which more di- posure, as measured by their blood plasma
rectly study mental health disorders in which levels, of LSD. These participants had more
emotional processing is disturbed. intense and longer-lasting trips. Information
on genetic differences could lead to the devel-
The following is a list of conditions for which opment of more personalised medicines or to
LSD has potential therapeutic benefits based more personalised dosing.
on clinical trials and academic studies con-
ducted to date:
Another study in Switzerland, one of the few A neuro-pharmaceutical company, MindMed, Oceania for abuse. The possession of LSD was made
double-blind, placebo-controlled studies with is also funding research into the effects of In January 2020, the Ministry of Health ap- illegal in the US in 1968, but research con-
LSD in patients, was conducted with 11 people microdosing LSD and its impact on creativi- proved the first LSD microdosing study in New tinued until the late 1980s. Stringent govern-
who were suffering from life-threatening dis- ty and focus, with a view to developing a new Zealand. Researchers at the Centre for Brain ment rules that prevented easy access for
eases. The patients underwent two sessions treatment for the symptoms of ADHD. In April Research at the University of Auckland had research purposes, in combination with less
with either 200 microgram or 20 microgram 2020, MindMed filed a patent in the US (pre- previously engaged in other multidisciplinary stellar results than hoped, ended any further
(active placebo) LSD. The study found a signif- serving worldwide rights) for a neutraliser research projects using LSD, including the research after that time.
icant decrease in anxiety and a trend towards technology intended to shorten or eliminate same brain imaging study conducted by re-
lower scores on a measure of depression. the effects of an LSD trip during a therapy searchers from ICL. The push for decriminalisation, as mentioned
session. If sufficiently developed, this tech- in our section on psilocybin, partly applies to
In 2019, the Beckley Foundation, in collabora- nology could effectively act as an ‘off-switch’ Legality of LSD worldwide LSD. The possession of small amounts of LSD
tion with Maastricht University, concluded one to an LSD trip. This research is a collabora- The UN Convention on Psychotropic Sub- (40 units or less) is decriminalised in Oregon
of the first double-blind, placebo-controlled tion between MindMed and the University of stances (the ‘Vienna’ convention), 1971 iden- as of February 2021. Some countries, includ-
studies on microdosing LSD and its effects on Basel's Liechti Laboratories. tifies LSD as a Schedule I substance, a cating Mexico and Portugal, have decriminalised
pain management, mood and cognitive func- egory of illicit drugs deemed to offer no the possession of (small quantities) of drugs,
tion. Currently, the foundation is research- At Imperial College London (ICL), the Centre medical benefit and with a high potential including LSD.
ing the impact that a fixed microdose of LSD for Psychedelic Research (CPR) was set up
can have on amplifying brain plasticity. It is last year, backed by five founding investors
hoped that the results of these studies will who contributed £3 million to get the project
lead to LSD becoming a possible treatment for off the ground. The stated purpose of this re- Number of clinical trials to date, using LSD
a range of conditions such as mood disorders, search centre is two-fold: to investigate the
as an intervention, by condition treated
age-related cognitive decline/mild impairment, potential of psychedelics in treating mental
chronic pain, brain rehabilitation and addiction. health disorders and secondly to probe the
basis of human consciousness using the PHASE I PHASE II
most modern imaging techniques available.

The present data One of the first studies conducted by the
DEPRESSION (MDD)
suggests low doses Psychedelic Research Group at ICL, prior to
the establishment of the CPR, was a study
1
of LSD could con- on the effects of LSD on brain activity, using 1
stitute a useful brain imaging techniques.
pain management North America

ANXIETY
1
treatment option Researchers at the Eleusis Benefit Corpora- 2
that is not only tion in New York are seeking to leverage the
anti-inflammatory activity of low doses of LSD
effective in patients to stave off Alzheimer’s disease. The company
CLUSTER HEADACHES / MIGRAINES
but is also devoid so far has been successful in stage I clinical

1
of the problematic trials, which demonstrated the safety of doses
up to 20 micrograms in geriatric populations.
consequences asso- Next, the researchers will investigate whether
ciated with current the anti-inflammatory activity of LSD is neuro- 0 2
protective against Alzheimer’s.

mainstay drugs, *Studies with healthy participants (usually phase I studies) are excluded from this overview, thus the total number
such as opioids. In June 2020, MindMed announced a phase

of studies is lower than the total number of clinical trials conducted. This is especially true for LSD trials where
healthy participants are often studied.
IIb commercial drug trial, for the treatment of Source: ClinicalTrials.Gov / Blossom (correct as of 01/07/2021)
anxiety disorders, officially known as Project

Lucy. The trial will focus on experiential
doses of LSD, administered by a therapist.
The company’s aim will be to submit an appli-
Amanda Feilding, Beckley Foundation, cation for an investigational new drug (IND)
on LSD microdosing for pain trial with the US FDA.
MDMA
KEY TAKEAWAYS
1. MDMA is not regarded as a classic

psychedelic; it is classified as an
empathogen. It is an outlier among
the other substances profiled
in this report as there are no or
fewer hallucinogenic effects. The
potential for abuse in recreation-
al use is also higher than with
classical psychedelics.
2. MDMA-assisted psychothera-
py for the treatment of PTSD has
completed the first part of phase III
clinical trials. After receiving Break-
through Therapy designation from
the US FDA in 2017 it is expected to
get final approval in 2023.
3. It may then take up to six months

after FDA approval for MDMA-as-
sisted psychotherapy to be admin-
istered to the first patients. A re-
al-world trial underway in Canada
and other ‘compassionate use’
trials may give earlier access to a
small number of patients.
MDMA (3,4-Methylenedioxymethamphet- • Eating disorders, such as anorexia nervosa compared to 32% in the placebo group. An ad- The resurgence
amine, ecstasy) is a psychedelic that was
first discovered in 1912, whilst finding a novel • Chronic pain.
ditional 21% of those who received MDMA had
a clinically meaningful response.
of research into
chemical route towards making another com- using drugs such as
pound, by Merck. MDMA works primarily by In these 47 clinical trials, nearly 1,900 patients The data, which represents half of the par- MDMA to catalyse
increasing the availability of serotonin, dopa-
mine and noradrenaline. A sense of general
have been enrolled as of July 2021. Among the
active trials are several investigating MDMA
ticipants that will be treated in the full phase
III trial, mirrors that of earlier phase II trials.
psychotherapy is
well-being and happiness, increased self-con- for the treatment of PTSD, MDMA for the The results of the current cohort were only the most promising
fidence, and increased empathy towards
others are some of the subjective effects of
treatment of eating disorders, and MDMA for
the treatment of alcoholism.
measured up to five weeks later. What earlier
studies show is that, even 12 months later,
and exciting
MDMA. These effects are also what may facili- those treated with MDMA were as likely, or development
tate psychotherapy efficacy. PTSD even more likely, to not meet the diagnostic I’ve seen in my
Unlike with classical psychedelics, many rec-
PTSD is a stress-related, debilitating con-
dition that may occur following a traumatic
criteria for PTSD as they were at the point the
study ended.
psychiatric career.
reational users experience a slump in their event such as war, disaster, sexual abuse, vi-
mood a few days after MDMA use. This neg- olence, terrorism, or from accidents resulting In August 2017, the FDA granted Breakthrough
ative side-effect has not been observed in in traumatic brain injury (TBI). From the limited Therapy designation to MDMA-assisted psy-
clinical research where the dose is lower data available it has been suggested that up chotherapy for PTSD. The second half of the
and patients are not dancing throughout the to 327 million adults may suffer from PTSD phase III trial is expected to be completed
night; two factors that possibly contribute and/or major depression worldwide. In the US next year, in 2022. Full approval from the FDA Michael Mithoefer, Acting Medical Director
to the slump. Although most ecstasy tablets alone, an estimated 6.8% of the population is expected in 2023 and depending on the for MAPS PBC
contain MDMA, it is not uncommon for them will experience PTSD at some point in their point in the year when this takes place, pa-
to contain adulterants. Similar to LSD, MDMA lives (equates to over 22 million Americans). tients with PTSD may, during that same year,
was used by therapists before it became Currently, in the US approximately 870,000 be able to get treated with MDMA. If treatment North America
illegal - particularly in couple therapy - and is veterans are in receipt of disability payments is approved, it will only be available following In 2018, the University of California, Los
still being used by underground practitioners for PTSD from the Department of Veterans referral from a doctor and only in supervised Angeles (UCLA) conducted a small feasibil-
to aid in the therapeutic process. Affairs, which costs the US government an es- therapeutic settings from certified clinicians. ity study (12 participants) on the impact of
timated US$17 billion a year. MDMA on the social anxiety of adults with
Clinical trials and research The clinical trials have been conducted at autism. All of the participants in the study,
MDMA is being researched as a potential MAPS more than 15 sites in the US, Canada and even those who took a placebo, displayed
treatment, in combination with talk therapy, MAPS is a non-profit research and education- Israel. On 3 February 2019, the Department some improvement, but patients who took
for a variety of mental health disorders. There al organisation established in the US in 1986 for the Treatment of Mental Trauma, housed the MDMA experienced a significant drop
have been 47 clinical trials to date of which and it has raised over US$100 million for psy- within the Israeli Ministry of Health, an- in their anxiety after the first session and
19 are phase II studies and three phase III chedelic therapy, medical cannabis research nounced the approval of the compassion- another reduction after the second dose.
studies. The following is a list of conditions and education since its founding. Its sister ate use for MDMA-assisted psychotherapy Even six months after the treatment ended,
for which MDMA has potential therapeutic organisation, MAPS Public Benefit Corpora- for PTSD, which will also allow 50 patients they continued to feel considerably less
benefits based on clinical trials and academic tion (MAPS PBC) conducts the clinical trials to receive the treatment. Patients with PTSD anxious about social encounters.
studies conducted to date: and, as a wholly-owned subsidiary of MAPS, are eligible to receive treatment at four sites
will aim to make MDMA-assisted therapy as throughout Israel. Further north, at the Ryerson University in
• PTSD; widely available as possible whilst reinvesting Toronto, researchers have conducted the first
profits to achieve this. MAPS Europe is pursuing phase III trials on modern-day studies on MDMA and couple
• Depression, Major Depressive Disorder the continent which will allow MDMA-assisted therapy. Of the six couples in the study, one
(MDD) and Treatment-resistant Depression Worldwide therapy to also be approved by the European of the partners was suffering from PTSD
(TRD). MAPS has led the effort towards making Medicines Agency (EMA). Money is currently but both partners underwent cognitive be-
MDMA, when used in conjunction with psy- being raised to get EMA approval as quickly as havioural conjoint therapy (CBCT). Both part-
• Anxiety; chotherapy, a medicine. This has culminated possible after FDA approval. ners were happier, in a better relationship with
in the publication of the results of the suc- each other, and the partner suffering from
• Social anxiety for those with autism; cessful phase III trial. The 90 participants re- PTSD also felt relief regarding the symptoms
ceived 12 therapy sessions of which three were related to PTSD.
• Substance misuse, specifically alcohol; with either placebo or MDMA. Of those who
received MDMA, 67% no longer had PTSD,
MDMA has also been investigated as a treat-

ment for anxiety and other psychological dis-
tress related to life-threatening illnesses. A
small 2018 study at the Harbor-UCLA Medical
Centre found improvements in scores of
anxiety, but these results didn’t reach signif-
icance. A larger trial, with more participants,
may find that MDMA can be beneficial for this
patient population too.
An ongoing study, that is recruiting patients,

will investigate the safety and feasibility of
treating eating disorders with MDMA-assist-
ed therapy. Specifically, the study will inves-
tigate those with anorexia nervosa restrict-
ing subtype (AN-R) and binge-eating disorder
(BED). This study is also being supported by
MAPS and is a phase II study that will take
place in the coming year in the US and Canada.
Europe
Researchers from Imperial College London
(ICL), some of which are also associated with
Awakn Life Sciences, have published the
first results of MDMA-assisted therapy for
those with alcohol use disorder (AUD). The
study was an open-label trial, meaning all
patients knew they were getting MDMA, and
involved two sessions with MDMA and then
eight further therapy sessions. Patients went
from drinking an average of 131 to 19 units of
alcohol per week from before the study to
one year after completion. Although there
was no head-on comparison, other treat-
ments for AUD rarely, if ever, find results of
this magnitude.
Legality of MDMA five grams of MDMA for personal use is per- Number of clinical trials to date, using MDMA
worldwide mitted. In Peru, on the other hand, posses-
A number of countries worldwide have decrim- sion of any amount greater than 0.25 grams
inalised the possession of small amounts of of MDMA will result in sanctions. Further-
any drug, so long as it can be proven that the more, Peruvian national police continue to PHASE I PHASE II PHASE III PHASE IV
drug is intended for personal use. Some of make arrests for drug possession, which, in
these countries have explicitly legislated for 2018, accounted for almost half of all arrests
DEPRESSION (MDD, TRD, BIPOLAR, PPD)
threshold amounts of MDMA. for drug offences. Internationally, MDMA
1
remains a Schedule I controlled substance,
These countries vary greatly in terms of what meaning it is considered to have a high po-
ANXIETY
constitutes acceptable threshold amounts. tential for dependence and abuse.
1
In Germany, for example, possession of up to
3
Map of cities, states and countries with thresholds PTSD
4
for MDMA possession
13
ALCOHOL USE DISORDER (AUD)
EATING DISORDERS
0 3 6 9 12 15
**Studies with healthy participants (usually phase I studies) are excluded from this overview, thus the total number
of studies is lower than the total number of clinical trials conducted.
Source: ClinicalTrials.Gov / Blossom (correct as of 01/07/2021)
COUNTRY / AMOUNTS OF MDMA YEAR

STATE / CITY PERMISSIBLE DECRIMINALISED
<5g GERMANY 5g 1992
SPAIN 2.4g 1983
<2g CZECH REPUBLIC 1.2g 1990
PORTUGAL 1g 2001
OREGON 1.2g 2021
<1g NETHERLANDS .5g 1976
<.5g RUSSIA .3g 2004
PERU .25g 1991
MEXICO 40mg 2009
Source: talkingdrugs.org / Blossom
Timeline: MDMA as Medicine
Year Developments
2008 First MDMA-assisted psychotherapy open-label study for PTSD completed by MAPS
2013 Phase II trials begin
2017 MAPS applies to the US FDA for BTD for MDMA-assisted psychotherapy for PTSD
2017 FDA grants BTD for MDMA-assisted psychotherapy for PTSD
2019 The Ministry of Health in Israel approves compassionate use of MDMA for treatment-
resistant PTSD
2020 MAPS receives approval from the US FDA for expanded access programme for
MDMA-assisted psychotherapy for up to 50 patients across 10 sites in the US
2020 MAPS raises $30 million with the Capstone Challenge organized by Tim Ferriss and
the Psychedelic Science Funders Collaborative (PSFC)
2021 Phase IIIa trials completed in the US
2022 Phase IIIb trials expected to be completed in the US
2023 MDMA-assisted psychotherapy is expected to receive FDA approval and to be

available to patients in the US from certified clinicians, upon referral from a doctor
2024 MAPS expects EMA (Europe) and MHRA (UK) approval by the end of the year
2029 MAPS has the goal to treat 500,000 patients before the end of data exclusivity
Source: Blossom / MAPS
KETAMINE
KEY TAKEAWAYS
1. Unlike other psychedelics,

ketamine has been available as
a medicine (general anaesthet-
3. Esketamine, a subtype of
ketamine, in the form of a nasal
spray (Spravato) has been
ic) for decades. For this reason, it patented by Johnson & Johnson
is on the World Health Organisa- and has been approved for the
tion’s List of Essential Medicines. treatment of TRD with accompa-
It is also used as an ‘off-label’ nying suicidal ideation. The costs
treatment for depression, anxiety of Spravato are significantly higher
and suicidal ideation. than that of ketamine which has
led the UK’s National Institute for
2. There has been a proliferation of

ketamine therapy clinics through-
out the US and to a lesser extent
Health and Care Excellence (NICE)
and Health Canada to not approve
it as a medicine.
in Europe. These clinics may well
become a prototype in the market,
occupying a prime position to take
advantage of future expansion
4. Ketamine is the only psychedelic
substance, among those profiled
in this report, to be the focus of
into psilocybin and MDMA assist- clinical trials in Asia. In China, spe-
ed-therapy, when these substanc- cifically, clinical trials are focused
es receive FDA and EMA approval. on ketamine as an intervention,
The sector is relatively unregulated to study the impact of ketamine
and ketamine infusion therapy is on health conditions such as
often not administered in conjunc- postnatal depression, autism in
tion with talk therapy. children and arthritis.
Ketamine was first synthesised in 1956 and is • Inflammation; A review of studies of ketamine in the treat- Asia
used most commonly in veterinary practice as ment of depression in patients with a history Asia, as a region, is proving to be a ‘late
an animal tranquilliser. It is also a human an- • Cluster headaches/migraines; and of psychosis or current psychotic symptoms adopter’ in terms of clinical research into the
aesthetic and a powerful psychoactive sub- showed that the available literature does not potential health benefits of psychedelics.
stance and is available in liquid-soluble form • Symptoms of OCD. support the assumption that ketamine exacer- Only a single clinical trial, out of a total of over
as ketamine hydrochloride. Ketamine was bates psychotic symptoms in those patients. 16,000 registered in China, involves the use of
granted US FDA approval for medical use as a In these 140 clinical trials, nearly 11,000 pa- The review was limited in sample size (41 pa- any psychedelic substances as interventions,
general anaesthetic and sedative back in 1970 tients have been enrolled as of July 2021. tients) but it stands out because psychotic pa- with one exception: ketamine. Nine clinical
and has been classified as ‘safe to use’ as an Among the active trials are those investigat- tients are excluded in nearly every other trial trials have originated in China, two of these
anaesthetic because it does not reduce blood ing ketamine for the treatment of depression in with psychedelics in order to limit risks. studies investigate PPD; ‘baby blues’ after
pressure or compromise a patient’s respirato- veterans, ketamine for the treatment of depres- childbirth. Administering one dose of ketamine
ry system. Ketamine may be injected into the sion in teenagers and late-life depression, and Ketamine has been shown to be effective in after childbirth may be able to prevent PPD.
muscle (IM), passed through an intravenous a head-to-head comparison of ketamine versus the treatment of several substance use dis-
(IV) drip, taken orally, or absorbed via an oro- electroconvulsive therapy for depression. Some orders. One double-blind, placebo-controlled Product development
mucosal (nasal) spray. studies are taking place in China, Israel, the study in December 2019 investigated the Most recently the benefits of ketamine for
United Kingdom, Canada and Mexico; most effects of ketamine in combination with moti- treating severe TRD have been recognised.
Clinical trials and research studies however are being done in the US. vational enhancement therapy to treat alcohol Having become the first company to patent
Ketamine is the most widely studied psyche- use disorder. A single administration of ket- one half of the ketamine molecule, esket-
delic to date. Excluding studies that look at North America amine, in combination with talk therapy, im- amine, Janssen Pharmaceutica, a subsidiary
the anaesthetic effects of ketamine, there More than 100 clinical trials have investigated proved the number of days the participants of Johnson & Johnson, has developed a nasal
are 140 clinical trials of which 22 are phase the effectiveness of ketamine for the treatment weren’t drinking and also reduced the number spray to treat TRD under the brand name
III trials and 32 are phase IV trials. Phase IV of mental health disorders. The overwhelming of heavy drinking days. Spravato, which received FDA approval in
trials observe the real-world application of conclusion states that ketamine is effective March 2019 and authorisation from the EMA in
approved medicines in large patient popu- in the acute treatment of all forms of depres- In March 2020, a study from Louisiana State December of the same year. It is the first new
lations to monitor the effectiveness, after sion (MDD, TRD, bipolar disorder, postpar- University examined the comparative efficacy drug introduced (as part of a broader treat-
it has been approved. Ketamine has been tum depression (PPD)), suicidal ideation, and of psilocybin and ketamine in rodent models. ment regimen) for the treatment of depres-
shown to be effective, starting almost imme- PTSD. The effects are usually noticeable in the The study found that a single administration of sion in over 35 years and the only psychedelic
diately and then for up to seven days or more, first few hours and persist at a high level up to psilocybin, or LSD, produced persistent anti- substance with marketing approval to treat a
for a wide range of mental health disorders. seven days later. The effectiveness of ketamine depressant-like effects in the rodent model. In mental health condition.
The following is a list of conditions for which wears off in the days afterwards and some contrast, ketamine produced only a transient
ketamine has potential therapeutic benefits studies find that patients are back to baseline antidepressant-like effect. The results of the There are two phases within the treatment
based on clinical trials and academic studies in 28 days. The lack of long-term effectiveness study indicate that classic psychedelics may regimen:
conducted to date: could be to do with the different way ketamine have therapeutic efficacy that is more per-
interacts with the brain, the lack of talk therapy sistent than ketamine. • The induction phase (weeks one to four): a
• Depression, major depressive disorder in many trials, and other factors. However, patient receives treatment twice a week at
(MDD), treatment-resistant depression ketamine’s benefit also extends to those who Europe either a 56 milligrams (mg) or 84 milligrams
(TRD), and bipolar disorder; require immediate relief, and may prefer to gain Several studies in Europe are comparing the (mg) dose.
an alleviation of symptoms, without engaging in effectiveness of ketamine with that of elec-
• Suicidal ideation; the process of talk therapy. troconvulsive therapy (ECT). ECT is a pro- • The maintenance phase (weeks five to
cedure whereby small electric currents are eight): the frequency of administration is
• Anxiety; Two studies at the start of 2021 have added ev- passed through the brain to induce a gener- reduced to once a week. Clinicians may
idence for the long-term effectiveness of ket- alised seizure. Although the treatment has extend the maintenance phase if required.
• Social anxiety for those with autism; amine when administered repeatedly. The first been shown to be effective, it also comes with
study, from the Washington University School side effects and patients need to be under Spravato is administered in tandem with an
• Substance misuse, including alcohol, of Medicine, found that a 96-hour infusion general anaesthesia during the treatment. The oral antidepressant. In February 2020, NICE
cocaine, and opioid dependence; of intravenous ketamine lowered depression comparative studies are still ongoing, but early in the UK rejected the use of Spravato, based
scores for those with TRD, up to eight weeks results show that those undergoing ketamine on efficacy and cost-effectiveness grounds.
• Eating disorders such as anorexia nervosa; later. The second study gave six weekly oral treatment experience fewer side effects and There has been some controversy surround-
doses of ketamine for those suffering from sui- the antidepressant effects are visible quicker.. ing the approval of Spravato by the FDA, given
• Chronic pain; cidal ideation and found significant reductions the likely expense associated with its admin-
up to four weeks after the end of the study. istration, as well as questions about its abuse
potential and safety concerns (six participants Ketamine has been legal for medical use by Number of clinical trials to date, using ketamine
died while on the trial, three of whom commit- medical professionals and veterinarians for
ted suicide). Despite this, Spravato was ap- decades in most parts of the world. In 1985,
proved by the FDA for treatment of a second ketamine was placed on the WHO List of Es-
PHASE I PHASE II PHASE III PHASE IV
mental health condition in August 2020, sential Medicines and is currently one of the
namely for the treatment of suicidal ideation. most widely used sedatives in the world.
DEPRESSION (MDD, TRD, BIPOLAR, PPD)
Ketamine therapy clinics A WHO expert committee has repeated- 48
On 4 March 2020, Field Trip Health, a subsidi- ly recommended against placing ketamine
38
ary of Field Trip Psychedelics, announced the on international controlled substance lists,
opening of its first psychedelic-assisted psy- as controlling the drug could make access- 15
chotherapy clinic in Toronto, which uses ket- ing it for medical purposes more difficult. In 29
amine-assisted therapy as part of a broader 2015, following the most recent review of its
psychotherapy protocol to treat depression. efficacy, the organisation stated ‘the medical SUICIDAL IDEATION
Similarly, in July 2020, Novamind closed the benefits of ketamine far outweigh the poten- 5
acquisition of a chain of clinical research tial harm from recreational use.’ The WHO has 1
sites and psychiatry clinics specialised in ket- also stated that, in its view, ketamine does not
3
amine-assisted psychotherapy operating in pose a sufficient health risk to warrant sched-
Utah since 2016. uling under the 1961 and 1971 conventions. 1
Dr Reid Robison, Director and Chief Medical ANXIETY
Officer at Novamind, explained the treatment 1

protocol, ‘dosing begins with intention setting 1
and ends with processing of the experience.
When administered, psychedelics act on the SUBSTANCE USE DISORDERS
serotonin receptors that are linked to cognitive 2
flexibility, enhanced imagination and creative
2
thinking. It provides a window of opportuni-
2
ty to disrupt patterns in the brain. The inte-
gration session is where we can make lasting
change. It allows individuals to explore their
psychedelic experience and discover insights PTSD
and meaning that can be incorporated into 1
day-to-day life.’ 2
1
Ketamine Therapy USA, an online commu-
nity resource for patients seeking ketamine
therapy in the US, lists approximately 140 ket-
amine treatment centres nationwide.
0 10 20 30 40 50
Legality of ketamine
worldwide
Ketamine is something of an outlier among the
other psychedelics presented in this report in
that it is not classified as a Schedule I drug. *Studies with healthy participants (usually phase I studies) or those studying ketamine as an anaesthetic are excluded
It is a Schedule III drug under the Controlled from this overview.
Substances Act in the US and is categorised
as a Class B drug in the UK. The exception to
this is in Singapore, where ketamine is classi-
fied as a Schedule I narcotic.
EXPERT INTERVIEW What sets Braxia Scientific apart in the effective treatments. We exceeded our IV Ket-
psychedelics industry? amine infusion targets every month since Jan-
We have created an efficient organisational uary 2021. In our latest quarter, we reported
structure that saves time and resources by op- year-over-year revenue growth from ketamine
erating our own licensed clinics. These clinics treatments of more than 80%.
provide direct access to patients and other
facilities that significantly expedite our ability Investors should also be excited about how
Dr Roger to develop and test drugs without compromis- quickly we were able to get our latest expan-
McIntyre ing on the high clinical standards to which we sion clinic up and running, and the potential
CEO, adhere. We also aim to develop new chemical implications as we pursue our clinic growth
Braxia Scientific entities that could ultimately be acquired by strategy, which aims to add as many as 50 new
large pharmaceutical companies, rather than clinics over time throughout North America.
market the drug ourselves. This shortens the
standard R&D timeline, which usually runs Most of Braxia Scientific’s current
Dr Roger McIntyre, CEO of Braxia Scientific, Considering the serious nature of de- seven to nine years, to only one or two years. portfolio seems to be related to
is a Professor of Psychiatry and Pharmacol- pression and suicidality you are seeking ketamine. Are you working with any other
ogy at the University of Toronto (and holds to treat, are psychedelics treated with We believe that our outstanding personnel psychedelics at the moment?
professorships at universities in New York, enough gravitas? also gives us a considerable advantage. Yes! In fact, at the end of August, we an-
California, Korea and China), Head of the Absolutely not! Suicidality is the tenth leading Personally, I have more than 25 years of nounced we would be commencing a land-
Mood Disorders Psychopharmacology Unit cause of death overall in the United States, experience treating depression. During this mark clinical trial to conduct Canada’s first
at the University Health Network, Executive claiming the lives of over 47,500 people time, my program has seen more than 100,000 multiple-dose psilocybin study for treat-
Director of the Brain and Cognition Discov- annually. In 2020 nearly 1.4 million Americans patients. Our team members have a long, ment-resistant depression (TRD), which
ery Foundation, and Chair of the Scientific attempted suicide. More than 300 million peo- successful track record of quality research will take place at Braxia Health’s clinics. It
Advisory Board of the Depression and ple worldwide suffer with depression, and the and development, and have established will be the broadest study of its kind, and
Bipolar Support Alliance. He has also been currently approved treatments fail to adequately themselves as world leaders in depression what’s unique about it is that we will not limit
listed among “The World’s Most Influential relieve symptoms for more than one-third of research, based on more than 740 published participation based on how many potential
Scientific Minds” by Clarivate Analytics for them. Moreover, the existing treatments for de- articles in peer-reviewed journals. remedies patients have previously attempted,
the past seven years and counting. pression do not adequately address the issue of whereas most other TRD studies do impose a
suicidality of which depression is the most com- With these bona fides, our supremely qualified maximum. We will even include patients that
What is Braxia Scientific’s mission? mon diagnosis in people who commit suicide. staff have been able to secure federal gov- have endured dozens of unsuccessful medical
We have a vertically integrated business mod- ernment funding for various clinical trials, and trials, including IV ketamine and/or electro-
el with three units focusing on three strategic Psychedelics, like ketamine, can offer rapid are positioned to capitalise on the extensive convulsive therapy.
priorities. Braxia Scientific seeks to identify and significant symptom relief in adults with relationships they have cultivated with large
new, IP-capable ketamine and psychedelic depression, and have also been demonstrat- international pharmaceutical companies, like Integrating psilocybin provides immense
derivatives, as well as novel delivery systems ed to rapidly reduce suicidality. However, Pfizer, AstraZeneca, Lundbeck and Otsuka. opportunity for benefit for those dealing with
for those treatments. We then aim to capi- we are doing them no favours when we play treatment-resistant depression, which is a
talise on these innovations by implementing into stigma-promoting stereotypes of what What should excite investors most about very large market that disproportionately
them within Braxia Health’s multidisciplinary they are and do, such as calling them “magic Braxia Scientific? dominates the majority of mental health ser-
clinics. These clinics currently provide various mushrooms,” and talking about users going on While there is a long list, we are very excit- vices. By including everyone with more than
ketamine treatments, including intravenous a “psychedelic trip.” ed and motivated by the discussions we are two failed medical trials, we are increasing
(IV). We will expand our offerings to other having with major drug manufacturers as to the degree to which the results can be ap-
psychedelics as the research and regulatory That is why at Braxia Scientific, we focus our how we can move the needle for ketamine and plied to a larger population, making our find-
environments progress. Finally, there is the attention on the science and medical research psychedelic derivatives. Through our relation- ings much stronger. Furthermore, we will have
Braxia Institute, which trains new clinicians involved with treatments that can be imple- ships we are refining our therapeutic research less exclusion criteria and are even including
to administer psychedelic-assisted therapy mented for depression, post-traumatic stress priorities in developing new products that patients with bipolar depression – a huge first
based on the International Guidelines pub- disorder, suicidality and other mental diseases, could be ultimately acquired by large pharma. for the field – or comorbid disorders, which
lished in the American Journal of Psychiatry such as ketamine and psilocybin. We certainly were excluded in psilocybin studies done by
by myself and other members of the Braxia welcome the excitement, hope and activity In terms of our clinics, we are growing! As other companies.
Scientific leadership. in the psychedelic space broadly but we also one of few IV Ketamine clinics in Canada, our
think the area requires thoughtful experienced referrals are increasing rapidly for patients
leadership, which Braxia Scientific represents. with depression in need of rapid-acting and
IBOGAINE
KEY TAKEAWAYS
1. Ibogaine is not listed as a

scheduled substance by the
United Nations but is a con-
trolled or illegal compound in
many Western countries, with the
notable exception of New Zealand.
2. Ibogaine has the potential to

decrease a patient’s misuse of
opioids, cocaine and alcohol, and
reduces symptoms of withdrawal
after the administration of
a single dose.
3. Ibogaine treatment is being

offered in several countries
around the world with costs
ranging from US$5,000 to
US$8,000 per treatment.
Ibogaine is a naturally occurring psychoactive Ibogaine therapy has been proposed for other Delix, which spun out of the Olson Laborato- Ibogaine therapy clinics
compound that is found in several plants such mental health conditions, such as depression ry, has developed a completely non-hallucino- An established model of ibogaine treatment
as the roots of the iboga tree (Tabernanthe and PTSD. Its psychological effects have been genic psychedelic analogue, tabernanthalog. centres exists for the treatment of SUD in
iboga); it can also be chemically synthesised. reported to help people view difficult experi- The compound has been shown, in rats, to countries where ibogaine is legal or unreg-
The traditional use of ibogaine stems from the ences in an objective way, and to help facilitate have anti-addictive properties and to promote ulated, predominantly in Latin America.
Bwititribe of Gabon where it has been used for ‘closure’ of unresolved emotional conflicts or neural plasticity. An ongoing debate between Ibogaine is an illegal substance in the US and
over 100 years. It has particular spiritual sig- trauma. Ibogaine has also shown some early psychedelic researchers discusses if the throughout most of Europe (with the exception
nificance for practitioners of the Bwiti religion signs of promise in the treatment of neuro- non-hallucinogenic nature of tabernanthalog of a few countries, such as Portugal and the
in West Africa and has an established history degenerative disorders such as Parkinson’s will undermine its long-term effectiveness in Netherlands) and occupies something of a
as a treatment for substance use disorders, disease (in rodents), and it may also help to humans or if this is not necessary to achieve ‘grey’ legal area in Canada, although a number
particularly in South American countries such support the growth of new neurons in the brain. positive results. of treatment centres are located there. More
as Mexico and Guatemala, where ibogaine treatment centres have been established in
operates in a grey area, not illegal, but unreg- One reason why only a few researchers are First synthesised in a laboratory in 1996, South America. Patients living elsewhere and
ulated. The relatively unsafe profile, leading actively studying ibogaine is the cardiovas- 18-Methoxycoronaridine (18-MC) is a deriva- who suffer from a SUD are required to travel;
to at least 20 deaths in the past 30 years, has cular risks that are associated with its use. A tive of ibogaine. It was developed to remove if they wish to take advantage of ibogaine
prompted researchers to research alternatives Dutch study at Radboud University showed the undesirable side effects of ibogaine, in- therapy. Some of the more successful clinics
that offer the benefits without the cardiac that nearly half of the patients in their study cluding a slowed heartbeat and tremors. The have been running for decades, such as Clear
dangers of ibogaine. showed a delay in ventricular repolarisation, hallucinogenic effect of ibogaine is absent Sky Recovery in Mexico. More and more
meaning the time it takes for the heart muscle from 18-MC. In 2014, Savant HWP filed an clinics are operating in Europe, for example,
Clinical trials and research to recharge between beats, of more than 450 IND application with the FDA. However, this the Iboga Tree clinic in Portugal.
Two clinical trials list ibogaine as an interven- milliseconds for over 24 hours. stalled in review for a number of years until
tion. These trials, which are taking place in the psychedelic pharmaceutical company The sector is unregulated, so the quality
Spain and Brazil and are recruiting patients, Ibogaine analogues MindMed acquired the patent in September varies considerably; reputable clinics offer
examine ibogaine’s potential to treat sub- Several companies are exploring ibogaine 2019. In April 2020, MindMed began dosing patients access to trained medical profes-
stance use disorder (SUD). The conditions for its anti-addictive properties. DemeRx, in the first patient in an additional phase I sionals in a medicalised setting with accom-
treated were: partnership with atai, is developing both ibo- human safety trial of 18-MC for opioid with- panying psychological support such as talk
gaine and noribogaine as oral, non-addicting drawal and opioid use disorder. therapy, both before and after treatment,
• methadone detoxification (1); and treatments for opioid dependence. The latter to integrate the psychedelic experience
has a greater affinity for opioid receptors than and maximise effectiveness. In September
• alcoholism (1). ibogaine. DemeRx has received approval from 2015, the Global Ibogaine Therapy Alliance
the MHRA in the UK to conduct clinical trials (GITA) published clinical guidelines for ibo-
In research conducted by pioneering advo- with ibogaine. gaine-assisted detoxification, which outline
cates of the substance, such as Dr Deborah clinical risk management protocols in detail.
Mash, it has been shown that ibogaine has This measure may be due in part to a small
the potential to decrease a patient’s misuse of Given the limitation number of deaths among detox patients who
stimulants, opiates and alcohol, and reduces experienced cardiac arrest while receiving
symptoms of withdrawal (from opiates) after in currently available ibogaine treatment; mostly as a result of un-
the administration of a single dose. Similar treatments, ibogaine derlying but undetected heart conditions.
findings have been recorded in observational
studies funded by MAPS at independent treat-
represents an Cost to patients
ment centres in Mexico and New Zealand. enormous leap Ibogaine treatment therapy is not covered by
forward for OUD health insurance providers in the US so its
Other research studies have shown:
(opioid use disorder) cost may be prohibitive to some; the therapy
can cost between US$5,000 and US$8,000
• a reduction in users’ tolerance of opiates sufferers. per course of treatment when paid for pri-
and alcohol; and vately. GITA offers ‘low’-rate unsecured loans
to patients from the US or Canada seeking
• a significant decrease in cravings for opi- ibogaine therapy anywhere in the world, while
ates and cocaine for an extended period of the majority of private ibogaine clinics offer
time after treatment. financing options to prospective patients.
Deborah Mash, CEO DemeRx
Legality of ibogaine Number of clinical trials to date, using ibogaine

worldwide as an intervention, by condition treated
Although ibogaine is not listed as a sched-
uled substance on the United Nations List of
Psychoactive Substances under International PHASE I PHASE II
Control, its legality varies from country to

country. The map below illustrates the status
OPIOID USE DISORDER
of ibogaine (for medical use or personal use
1
outside a clinical setting) by country
of relevance. 2
ALCOHOL USE DISORDER
Legal status of ibogaine, around the world in 2021 1
ILLEGAL UNREGULATED DECRIMINALISED
PRESCRIPTION-ONLY MEDICINE LEGAL

0 2
*Studies with healthy participants (usually phase I studies) are excluded from this overview.
ILLEGAL UNREGULATED PRESCRIPTION LEGAL

-ONLY MEDICINE
BELGIUM COSTA RICA AUSTRALIA NEW ZEALAND
FINLAND GABON BRAZIL URUGUAY
FRANCE GERMANY CANADA
IRELAND MEXICO DENMARK
ISRAEL NETHERLANDS HUNGARY
ITALY SOUTH AFRICA
SWEDEN
SWITZERLAND
DECRIMINALISED
UNITED KINGDOM
UNITED STATES PORTUGAL
Source: Blossom / GITA
AYAHUASCA
KEY TAKEAWAYS
1. Ayahuasca has been used in Latin

America for over 1000 years and
has been found to be helpful for
treating a variety of mental health
and substance use disorders. The
setting often involves elaborate
rituals which can add to the thera-
peutic effects of ayahuasca.
2. Only a few clinical trials have

been done with ayahuasca, one
of which showed improvements
in treatment-resistant depres-
sion. The lack of clinical studies is
holding back the wider adoption of
this psychedelic.
3. Ayahuasca is not a scheduled drug

under the United Nations conven-
tions, but its main component DMT
is. This has allowed the plants,
and their use, to escape regulation
based on their natural occurrence.
Other exemptions have been made
on religious grounds in the US,
Canada and beyond.
Ayahuasca is served as tea, made from a Clinical trials and research cant improvements in depression and suicid- I am on methadone
blend of different plants, usually the Banis-
teriopsis Caapi (ayahuasca or yagé) vine and
Ayahuasca is the topic of more than 160
papers in Blossom’s research database, but
al ideation. A follow-up, five years later, re-
ported that participants found the experience
and that did not
Psychotria Viridis (chacruna) shrub, which at this time there have only been three clini- valuable, but no long-lasting effect on mental work…after that
contains DMT. Pharmahuasca is the name cal trials completed with the brew. The varying health was reported. [retreat] I had no
for the pharmaceutical version, which com-
bines an MAOI (which prevents the stomach
amounts of the different ingredients in the
brew make it difficult to study in controlled Adverse events during and after the use of
desire…I do not
from breaking down DMT) with DMT. Because settings. The setting itself is also, just like with psychedelics is a valid concern that deserves know what it is
the name ‘ayahuasca’ denotes the brew used
in traditional settings, some variations of it
traditional psilocybin use, a big part of aya-
huasca’s healing power and something not
much attention if psychedelics are to become
medicines. Because of the observational
about that but it
work via other compounds and do not contain suitable for controlled clinical studies. That nature, often without a screening of partici- really is very life-
DMT. Ayahuasca has been used for more than being said, ayahuasca has been studied for pants on pre-existing mental health disorders, changing.
a thousand years and many observational a wide range of mental health disorders. The research in this area is still limited. Research-
studies have found positive effects on mental following is a list of conditions for which aya- ers at the Universitat Rovira found this year
health and substance use disorders, though huasca has potential therapeutic benefits that up to 17% of first-time ayahuasca users
clinical studies are severely lacking. based on clinical trials and academic studies had experienced acute psychological adverse
conducted to date: events. Some of these were ascribed to an
unsafe environment. On average, even these
• Depression, MDD and TRD; participants had improved mental health
scores six months after the study. Study participant, University of Victoria,
• PTSD; ayahuasca for addiction study
North America
• Substance misuse, including alcohol, opioid, An observational study conducted by the
cocaine and nicotine dependence; and University of Victoria researchers followed toration and possibly growth of new neuronal
12 participants who participated in two aya- cells. Although these studies are still in the
• Eating disorders such as anorexia nervosa. huasca ceremonies with the goal of reduc- early phases, now being conducted in mice,
ing addictions. The self-reported problematic they may have large implications for those
While ayahuasca has been in use for at least use of cocaine, alcohol and tobacco de- suffering from Alzheimer’s and traumatic
a thousand years and is commonly taken in creased significantly in the six months after brain injury (TBI).
modern ritual settings, there is very little clin- treatment. These and several other studies
ical data on the substance. The only phase II have found positive effects of ayahuasca on
clinical trial, with 29 patients and completed in a variety of addictions.
2019, investigated ayahuasca for the treatment
of TRD. The double-blind controlled study con- Europe
ducted at the Onofre Lopes University Hos- Researchers at Maastricht University have
pital in Brazil, found significant reductions in recently completed an interesting study on
depressive symptoms one day after treatment. the effects of ‘set and setting’ in ayahuas-
The response rate of patients was significant- ca retreats throughout Europe. As in other
ly higher in the ayahuasca group (64% versus studies, they found improvements in the
27% in the placebo group). Most studies of mental health of the participants but found
ayahuasca are taking place in Latin America. that on most measures the participants in the
placebo group, who did partake in the cere-
Latin America mony, received similar benefits. This high-
A 2016 study followed a group of 17 partic- lights the importance of non-pharmacological
ipants with recurrent depression who were factors, not only in research on ayahuasca
given ayahuasca in a medical setting (leaving but also in the ‘set and setting’ in which other
out many of the characteristics of the ‘set’ psychedelics are administered.
and ‘setting’). The researchers at the Univer-
sity of São Paulo thus investigated the phar- Several studies, one of which by a Spanish
macological effects of ayahuasca outside the research group, has found the components of
traditional context. The study found signifi- ayahuasca, specifically DMT, lead to the res-
Legality of ayahuasca
worldwide
The principal component of ayahuasca, DMT,
is a Schedule I drug under the Convention on
Psychotropic Substances, but the plants that
contain DMT are not subject to internation-
al control. This exemption, which also applies
to peyote and psychoactive mushrooms that
contain mescaline and psilocybin respective-
ly, means that there is less top-down regula-
tion regarding the use and distribution of aya-
huasca. Throughout Latin America, there is
little to no enforcement of any restrictions on
the use of ayahuasca.
Another route through which ayahuasca is

available is through religious exemptions.
The Religious Freedom Restoration Act has
allowed groups like the União do Vegetal to
import and use ayahuasca as their sacrament.
The Santo Daime church has won similar
cases and can use ayahuasca in both the US
and Canada for religious purposes.
Number of clinical trials to date, using ayahuasca

PHASE I PHASE II
DEPRESSION (MDD & TRD)

1
0 1 2
*Studies with healthy participants (usually phase I studies) are excluded from this overview.
The Psychedelics as Medicine Report | Other Psychedelics of Note The Psychedelics as Medicine Report | Other Psychedelics of Note
Other
Psychedelics
of Note
The psychedelics we have covered above;
psilocybin, LSD, MDMA, ketamine, ibogaine
and ayahuasca are the clear leaders when it
comes to developing psychedelics as med-
icines. This section of the report highlights
other psychedelics of note that are ready to
become medicines in their own right. Mes-
caline has found itself on the research menu
once again and a handful of studies are
already pointing towards the use of 5-me-
thoxy-N,N-dimethyltryptamine (5-MeO-DMT)
for the treatment of PTSD.
The Psychedelics as Medicine Report | Other Psychedelics of Note The Psychedelics as Medicine Report | Other Psychedelics of Note
SALVIA DIVINORUM NITROUS OXIDE
Salvia divinorum is the most psychoactive other psychedelics, not against any particular the Church of the Tree of Life used 5-MeO- Nitrous oxide, also known as laughing gas, is a
compound known to man, working in similar condition, but as they affect a broad range of DMT as a sacrament. A UK-based company, chemical with significant medical uses. Simi-
quantities as LSD. Salvinorin A is the prin- psychometric measures. Beckley Psytech, is exploring the use of larly to ketamine, it is used for its anaesthetic
cipal compound of salvia, a dose of 200 mi- 5-MeO-DMT for the treatment of a variety of and pain-reducing effects. Both compounds
crograms is enough for psychoactive effects. neuropsychiatric disorders, including depres- are on the World Health Organisation's List of
Salvia divinorum is part of the salvia genus DMT sion and substance misuse. Essential Medicines. When nitrous oxide gas
(Lamiaceae) of which mint is also a species. is inhaled, it can lead to dissociative effects
Little is known about the toxicology, adverse DMT is a powerful yet short-lived hallucino- through its effect on gamma-aminobutyric
events and safety, as little clinical research genic drug, which is a natural component of KRATOM acid type A and N-methyl-D-aspartate recep-
has been undertaken with salvia. It has psy- many living plants and animals and is found tors in the brain. A small number of clinical
chedelic effects when consumed by chewing, in high concentrations in some plants used Kratom is a species of tree (Mitragynia specio- trials have found favourable effects of nitrous
smoking, or being drunk as tea. The chemical for psychedelic purposes, such as Mimosa te- sa) that grows in Southeast Asia and Africa. In oxide on scores of depression. A recent
structure of salvia is distinct from other psy- nuiflora and Banisteriopsis caapi (one half of low doses, kratom leaves act as a stimulant. phase II study found that a 25% nitrous oxide
chedelics and it is a potent k-opioid receptor, the ayahuasca brew). Similar to psilocybin and In high doses, it has analgesic effects. It is not mixture, versus a 50% mixture, had compara-
so not a serotonin receptor agonist. Revixia LSD, DMT produces a visual and hallucino- a classic psychedelic and it is unclear how ble therapeutic effects with fewer side effects.
Life Sciences, an entity of clinical-stage bio- genic experience, yet at a much more intense much, if any, the serotonin 5-Ht2a receptor is
pharmaceutical company atai Life Scienc- and shorter duration. DMT is also listed as a involved in the effects of kratom compounds.
es, is developing a proprietary formulation Schedule I controlled substance under the It is likely that the combination of effects from NOVEL COMPOUNDS
of Salvinorin A, RLS-01, as a medication for UN Convention on Controlled Substances several different types of receptors is respon-
treatment-resistant depression. 1971. The chemical structure of DMT is similar sible for benefits from the compound, which During his lengthy career as a profession-
to the anti-migraine drug sumatriptan, and it include relief from symptoms of opium with- al tinkerer, Alexander Shulgin created almost
acts as a non-selective partial agonist at most drawal, anxiety and depression. More than a 200 psychedelics. Now some years after his
MESCALINE or all of the serotonin receptors, particular- dozen countries have made kratom a con- death, a new group of researchers is taking
ly at the serotonin 2a receptor. There exists trolled substance, limiting the sale, use, im- over the discovery of novel compounds. Many
Mescaline, which can be derived from cacti anecdotal evidence that DMT can be used to portation, and production of kratom. Neither novel compounds will be made by making
such as peyote and San Pedro or chemical- treat conditions such as chronic migraines. the UN nor the US has currently scheduled small changes to existing psychedelics, to
ly synthesised, has been used by humans for While research is now beginning to probe into kratom, the latter is considering scheduling it improve their effectiveness, shorten the du-
millennia for its effects ranging from anti-in- the mechanisms of DMT, notably at Imperial as of July 2021. The FDA did ban the importa- ration of a trip, or make a compound that is
flammatory and pain-relieving properties to College London, there is virtually no modern tion of kratom in 2014; until then it was pro- patentable. Known examples of novel com-
healing wounds and in ritual ceremonies. Al- clinical data on the use of pure DMT for any moted as a dietary supplement. pounds are 18-MC and tabernanthalog; both
though currently a Schedule I drug, peyote and medical purposes. A low dosage of DMT is from ibogaine. A manifold other second-gen-
San Pedro are legal for use in some regions in considered to be between 0.05 and 0.1 milli- eration psychedelics are in progress that will
the Americas for religious contexts in native gram/kilograms body weight. The ‘psychedel- 2C-X modify the effects of psilocybin, MDMA and
communities owing to a longstanding tradi- ic’ threshold for DMT is believed to be 0.2 mil- LSD. Many of the compounds that are being
tion of use amongst indigenous peoples. As ligram/kilograms body weight. 2C or 2C-x is the general name for a group developed will need to go through all the
a Schedule 1 drug, however, it is regarded as of psychedelic compounds first synthesised safety steps and can take a long time to get
having no recognised medical benefits and by Alexander Shulgin in the 1970s and 80s. to market. Novel developments, including the
is deemed to present too much of a risk of 5-MEO-DMT Not all of the 2C compounds are psychedelic, recent open-sourcing of Google’s DeepMind
physical and/or psychological abuse for it to some of the most popular psychedelic com- database on the building blocks of life (how
be legally available for purchase or prescrip- 5-MeO-DMT is a tryptamine alkaloid found pounds are 2C-B, 2C-E, and 2C-I. Several ther- proteins fold), mean that there is ample room
tion. There are anecdotal reports of mescaline in both plant and animal sources, including apists explored 2C-x as therapeutic agents for novel compounds to be developed.
being used for a wide range of purposes, in- high concentrations in the parotid gland se- as they offered a middle road between the
cluding analgesia and headache relief, yet no cretions of the Colorado River toad and the warm embrace of MDMA and the psychedelic
evidence exists for these yet. Only three clini- Sonoran Desert toad. The psychedelic effects effects of LSD; 2C-x are controlled substanc-
cal trials list mescaline as an intervention, one are fast-acting and short-lived, similar to DMT es in most countries, 2C-B is a schedule I drug
of which will investigate mescaline for alcohol yet still very distinct in character. The legality in the US since 1995.
use disorder. The other trials are investigating of 5-MEO-DMT is similar to DMT apart from a
the effects of mescaline in comparison with period between 1971 and the late 1980s where
EXPERT INTERVIEW
Cosmo Feilding
Mellen
CEO,
Beckley Psytech
Unlocking the therapeutic potential of psy- research and operations, what we have done core programmes which balance and com- This programme is an example of our intention
chedelic medicine is not just a business for really well and continue to do, is combine plement each other. The aim was to identify to use psychedelics as a pharmacological
us, it is an intergenerational family mission our deep knowledge and expertise of psy- development programmes that not only made intervention, and therefore as an outpatient
stretching back over 50 years. My mother chedelic science with a best-in-class drug sense from a psychedelic science perspective, treatment without concomitant psychothera-
and co-founder, Amanda Feilding, is one development team. as well as from a feasibility and a commercial py. The advantage of demonstrating that the
of the world’s most renowned pioneers in viability perspective but also differentiated our compound can be self-administered safely,
psychedelic science and, in 1998, she set Best-in-class drug development team pipeline versus what competitors were doing. without the need for a psychotherapist, is that
up the Beckley Foundation, a non-profit Our Chief Scientific Officer, Dr Steve Wood- the treatment can be taken at home which
focused on scientific research into psyche- ing, is a trained physician but subsequently We are looking at utilising low doses and high makes it more affordable and less resource
delics and their medical potential. Back spent a life in research and development. His doses of psychedelics in different ways, for intensive for health systems.
then, this subject was not nearly as fashion- last role was Head of Global Commercial and different categories of disease. This involves
able as it is today, in fact it was shrouded Market Access Strategy in Johnson & John- two treatment models, the first combines high We have already begun a clinical trial in a
in stigma, and the Beckley Foundation has son’s pharmaceutical division, Janssen. Our doses of psychedelics with psychotherapy to small group of patients to examine how differ-
been a major driver in the renaissance of Chief Medical Advisor, Dr Fiona Dunbar, was create psychedelic-assisted therapy and is ent doses of psilocybin impact SUNHA, with
psychedelic research and been involved in Head of Global Medical Affairs at Janssen too, primarily focused on psychiatric conditions. the data expected in the coming months. Un-
many ground-breaking studies over the last so is also very experienced in drug develop- The second is looking at low sub-hallucino- derstandably, given the nature of this disease,
couple of decades. ment and pharmaceutical commercialisation. genic doses of psilocybin administered several we are targeting an orphan drug designation
Similarly, our Chief Operating Officer was the times over a period of days or weeks. This has which could not only offer an accelerated
Given our longstanding involvement in this CEO and President of Otsuka Europe. no psychotherapy component and is intended route to market, but also provide us with ex-
field of science and the global network of to be brought to market as an outpatient treat- tended market protections through additional
researchers that has been established, There are very few institutes in the world that ment model for neurological conditions. data and marketing exclusivity.
Amanda and I decided we could increase have had the Beckley Foundation’s influence
the impact of what we were doing by setting in shaping this field of science or shown Near-term opportunity The mid-term opportunity
up focussed drug development companies commitment at a time when psychedelic med- The first drug development programme, and The second programme, and what we term our
to bring new, effective treatments to the icine was neither fashionable, nor profitable. Beckley Psytech’s near-term opportunity, is mid-term opportunity, involves 5-MeO-DMT,
patients. The aim is to translate the promis- This adds credibility to the integrity of our exploring how low doses of psilocybin can which is naturally occurring in a variety of
ing academic evidence surrounding psy- approach and has helped attract a commit- treat an exceptionally rare headache condition plant species and the Sonoran Desert toad.
chedelics into large-scale pharmaceutical ted mission driven team with incredible drug known as short-lasting unilateral neuralgi- Despite extensive use in informal and ritual-
research and development programmes, to development expertise. The team knows not form headache attacks or SUNHA. SUNHA is istic settings, 5-MeO-DMT has been under
create licensed medicines. just how to develop a drug so that it receives an extremely debilitating condition whereby researched from a scientific perspective. So,
regulatory approvals, but also how to position patients may experience up to 200 headaches while there is currently little clinical data on
Beckley Psytech is now the second biotech it so that it is commercially viable and reaches a day. At the moment there is no approved 5-MeO-DMT, there is an extensive body of an-
company we have started, having success- the patients it is intended to help. treatment for the disease, so patients suffer ecdotal and real-world evidence that indicates
fully sold the first in 2019, and it is focussed enormously with insufficient medical interven- the drug’s potential as a medicine and our aim
exclusively on investigating and, hopefully, We have taken a multi-platform approach to tion available to them. now is to prove this therapeutic potential in a
commercialising psychedelic medicines drug development, with multiple programmes controlled clinical setting.
for patients in need. As we have scaled our running in parallel. Currently, we have three
The Psychedelics as Medicine Report | Expert Interview The Psychedelics as Medicine Report |
We landed on 5-MeO-DMT as an ideal candi- and refine them to bring about the treatment
date for psychedelic-assisted psychotherapy outcomes we are looking for.
for two main reasons, the first is that it is
very potent and known to produce profound Future opportunities
subjective psychedelic experiences. In psy- With the near, mid and long-term opportuni-
chedelic-assisted therapy subjective expe- ties, we are following a rigorous pharmaceuti-
riences correlate with positive outcomes, cal drug research and development approach,
and 5-MeO-DMT is reported to induce these going through phased clinical trials to hopeful-
kinds of experiences more reliably than any ly achieve regulatory approval from regula-
other psychedelic. tory bodies such as the FDA and EMA. It is a
well-established pathway and it takes time,
In addition, the drug experience is very short, but the closer you get, the more confidence
normally lasting under an hour. This is import- you can have that these medicines will reach
ant because a major challenge facing psyche- their potential.
delic-assisted therapy with drugs like MDMA,
psilocybin and LSD is that those drugs are long We recently sought to raise US$50m to
acting, so essentially a therapist has to sit with support these development programmes and
a patient for six to ten hours. This is resource the response was incredibly positive. Due to
and cost intensive and potentially limits the enormous demand we decided to upsize the
number of patients you can reach with these funding round to US$80 million and have
treatments. We already have a shortage of now raised over $100m since the company
psychotherapists, so requiring them to spend was founded in 2019. It has helped that we
a whole day with a single patient may become previously founded and grew a very success-
a bottleneck for patient access. ful company that made investors significant
returns, but we have also attracted new and
With 5-MeO-DMT assisted psychotherapy, very well-respected institutional investors
the goal is to produce similar levels of effica- from healthcare and breakthrough science,
cy to those seen with MDMA and psilocybin, alongside several psychedelic-focussed funds.
but with a treatment session that takes an
hour instead of a day. By improving resource In the next couple of years we believe there is
utilisation and therefore the cost and acces- going to be substantial progress made in this
sibility of the treatment, it would in theory al- field of science and the industry more broadly.
low us to help many more patients. A Phase What is particularly exciting about this oppor-
I clinical trial of our intranasal 5-MeO-DMT tunity is that it is emerging rapidly, and that it
formulation is currently underway in healthy has the potential to make a meaningful differ-
volunteers and we plan to move quickly into ence for a large number of patients worldwide.
studies with patients. It is not only an incredible growth opportunity,
but it also marries up with having a positive
The long-term opportunity impact for a lot of people.
Our third programme, and our longer-term op-
portunity, is looking at developing brand new
psychedelic compounds. This is the classic
drug development approach with the stron-
gest IP protection whereby you take known
compounds and change their molecular
structure to refine their effects by dialling up
or down certain receptor binding profiles. This
is the furthest away from market, as we are
effectively creating and researching a brand-
new drug, but in the long term it affords us
the ability to learn from existing psychedelics
The Psychedelics as Medicine Report | Psychedelics as Medicines: The Psychedelics as Medicine Report | Psychedelics as Medicines:
Potential Therapies Potential Therapies
Psychedelics
as Medicine:
Potential
Therapies 1.
KEY TAKEAWAYS
Conventional medications, such

as antidepressants, can have
numerous negative side effects
3. During a psychedelic-assisted
therapy session, ‘set’ and ‘setting’
are of central importance to the
and evidence is emerging on their patient’s experience. ‘Set’ refers
longer term effects. Converse- to the patient’s mind-set, while
ly, psychedelic-study participants ‘setting’ refers to the context or
have consistently reported fewer environment in which the therapy
negative side effects from psyche- session takes place. Following the
delic treatments, and psychedel- supervised psychedelic ‘trip’, in-
ics are acknowledged to have a low tegration of the experience via
potential for abuse or dependence. further talk therapies is vital to the
success of the treatment.
2. The challenges involved in de-

veloping psychedelic therapies
involves converting an unstable
plant-based medicine into a con-
sistent and replicable pharma-
ceutical drug that can secure FDA
approval so as to be covered by
insurance. Otherwise, the costs
associated with the treatment and
the accompanying psychological
support from trained therapists
could be prohibitive.
The Psychedelics as Medicine Report | Psychedelics as Medicines: The Psychedelics as Medicine Report | Psychedelics as Medicines:
Potential Therapies Potential Therapies
Pharmaceutical drugs may have several Psychedelic Semantics netic parameters and also whether continu- attendance. The patient can sit or lie on a
adverse side effects. Selective serotonin re- As regulatory landscapes emerge and evolve, ous intravenous infusion extends the com- couch and is often encouraged to wear an
uptake inhibitors (SSRIs), a class of antide- the psychedelics industry is subjected to a pound’s efficacy. eye mask, and/or listen to a relaxing playlist
pressants, can be particularly detrimental to series of semantics. This report frequent- of music. Oral ingestion of a capsule of syn-
a patient in the short term with little being ly references both psychedelic-assisted Available on prescription thesised psychedelic compound (e.g. psilo-
known about the consequences of long-term therapy and psychedelic treatments, with the Although psychedelic medicines are not cur- cybin) is the most common route of adminis-
consumption. Opioids, although a godsend latter encompassing medications that can be rently widely available through pharmacies tration, and the session will typically last for
for pain relief, have proven to be addictive and self-administered and used in combination or dispensaries, several companies are de- up to eight hours.
more deadly than heroin in the US. Psychia- with talk therapy. veloping products patients can self-adminis-
trists need novel treatments with higher safety ter at home. During the COVID-19 pandemic, ‘Dose’ refers to the amount of psychedelic
profiles, and studies have shown psychedelic We have categorised these treatments into several ketamine providers shipped patients that is taken. In many trials, a high-dose psy-
medicines to have a low risk of dependence. three subsections: their ketamine at home and they provided a chedelic session or two to three high-dose
video link in order to still provide guidance for sessions (usually 20–30 milligram psilocy-
The challenges associated with developing 1. Psychedelic-assisted psychotherapy; their patients. bin or 35 milligram ketamine per 70 kilogram
psychedelic medicines are similar to those for body weight) are conducted. Several studies
medicinal cannabis: the obstacle of convert- 2. Infusion therapy; Making psychedelics available on prescrip- are showing no difference between men and
ing a psychoactive plant into a consistent and tion would substantially reduce the cost of women in their reaction to psychedelics,
replicable pharmaceutical product. This is es- 3. Available on prescription. treatments and subsequently increase their besides the difference in average weight, and
sential for treatments to be covered by insur- adoption. MindMed is conducting clini- some genetic factors have been found that
ance providers, with the resources required Psychedelic-assisted psychotherapy cal trials for its LSD microdosing treatment, influence the reaction to a dose.
for psychedelic-assisted therapy beyond the The term psychedelic-assisted psychothera- which it hopes will be available over-the-
reach of many patients. py, or psychedelic-assisted therapy, refers to counter for ADHD. Immediately after the psychedelic session
the consumption of a psychedelic substance and in the following days, a process of ‘inte-
In psychedelic-assisted therapy, ‘set’ and in combination with several sessions with gration’ is facilitated by the therapist. During
‘setting’ are central to the patient’s experience a therapist. The number of sessions with a THE IMPORTANCE these conversations, the patient has the op-
and outcomes. ‘Set’ refers to the patient’s psychedelic, usually lasting a full day, varies OF SET, SETTING portunity to process, make sense of, and give
mind-set, while ‘setting’ refers to the context between one and three, with two sessions AND INTEGRATION meaningful expression to their psychedelic
or environment in which the therapy session being the most commonly used regimen. experience. This is a vital part of the therapy
takes place. Although critical components to The total number of supporting therapy ses- As previously stated, ‘set’, ‘setting’ and ‘dose’ and is employed in nearly all studies with the
the experience itself, subsequent integration sions, both before and after, usually number are key to a patient’s experience of a therapy notable exception of many ketamine studies.
through talk therapies is vital to the success between six and ten. session involving psychedelics.
of the treatment.
Examples of this treatment include COMPASS ‘Set’ refers to mind-set, a complex mix of ex-
Pathways’ protocol for major depressive disor- pectation and mood, personality and past
der, which the FDA designated a breakthrough experience. If someone comes into a psyche-
therapy. Clinical trials are also being conduct- delic session with a lot of grief, the session
ed to develop MDMA-assisted psychotherapy will unfold quite differently from when
for PTSD, with the FDA expected to approve someone comes well-rested, regardless of
the treatment in 2023. the setting and dose.
Infusion therapy ‘Setting’ refers to the context in which the

Infusion therapy involves the intravenous session takes place, including basic factors
administration of psychedelic substances, like the comfort and aesthetic of the room,
either in combination with talk therapy or as and more complex factors like the quality of
a stand-alone treatment. Ketamine infusions the relationship with the clinicians and the
were recently approved in the US and EU, but atmosphere they help to create. Even though
must occur in controlled medical settings. In most clinical trials take place in hospitals or
2021, several companies started clinical trials research institutes, the session rooms are
to investigate the potential of intravenous made as comfortable and homely as pos-
DMT, to investigate the drug’s pharmacoki- sible. There are typically two therapists in
The Psychedelics as Medicine Report | Psychedelics x Technology The Psychedelics as Medicine Report | Psychedelics x Technology
PSYCHEDELICS X TECHNOLOGY
EXPERT INTERVIEW
Zach Haigney
The Trip Report
Why is the intersection of technological tient care and monitoring will also benefit from There are, rightly, concerns about tracking feedback and through technology before,
innovation and psychedelic medicine real-time tracking and data analytics. all this information. The privacy of a patient during, and after PAT.
so important? needs to be protected from leaks and hacks.
There are two parts to this answer, one prac- Outside PAT, companies are already using pas- Privacy concerns are already heightened when DHT is up for a challenge in all of these areas
tical, the other technical. Practically, there is sive data from smartphones and wearables, it concerns data on mental health and will be to prove that it works better than what is out
a massive unmet need in mental healthcare, such as steps and heart-rate variability, to even more so when psychedelics, legal or not, there already. There is a narrow band in which
and psychedelics seem to offer a transdiag- relay health information. Digital phenotyping, are involved. The current conversation about PAT and DSCP can exist. They will need to
nostic treatment option. This means that in coined only in 2016, is another name for this who owns medical data is a big ball of confu- offer advantages over traditional treatments
combination with therapy, the same molecules type of data collection, and the goal is to make sion that needs untangling before successfully without compromising the privacy of patients.
show promise in treating symptoms across behavioural and mental health more objective. implementing PAT with DSCP.
health indicators, from PTSD to substance We are already seeing the first psychedelic Psychedelics as medicines are very novel
use disorders. The technical challenge is the applications that support and help people with What exciting developments do you when viewed through the lens of the FDA -
massive constraint on the scalability of psy- their psychedelic journeys. see happening with psychedelics and so are digital therapeutics, such as the video
chedelic-assisted therapies (PAT). At this time, technology in the next 5 to 10 years? game for the treatment of ADHD approved
two costly therapists have to be with a patient In your reporting for The Trip Report, Technology could allow for more objective only last year. How do you think PAT, in
for at least eight hours, usually two to three of you've described drug-software measures of mental health and well being combination with DSCP, can go to market?
these sessions. Next to the therapy session combination products. Can you tell us how than is currently captured by surveys or the There are multiple different routes to market.
with psychedelics, most protocols also include this applies to psychedelics as medicines? perception of clinicians. If this technology The critical difference between the different
four to twelve preparation and integration Drug-software combination products (DSCP) delivers on the promise we would see an over- routes turns on the question of who pays. The
meetings. The hurdle before us is making PAT combine the strengths of a specific drug and a haul of psychiatric disease classifications with difficult and potentially most lucrative route
safe, accessible, and deployable at scale. technology like a mobile application, to create greater emphasis on objective biometric mark- is through FDA approval. MAPS, Compass,
better treatment outcomes. For instance, to ers. This is the premise of the US National Usona and others are currently pursuing this
If we take a broader view, we already see reduce A1C levels in diabetic patients through Institute of Mental Health’s (NIMH) Research route for PAT. If approved as medicines they
technological innovation and mental health monitoring software and the release of drugs. Domain Criteria (RDoC). The latter provides a could then be reimbursed by insurance, and
care intersect. Digital Health Tech (DHT), or Another example of DSCP is the combination multivariable, biologically-based, rather than psychedelics could become part of main-
digital therapeutics (DTx), is at an inflexion of an Apple Watch and biometrics-based in- symptom-based, framework for understanding stream healthcare.
point where the technology is good enough to sights, which can help lower blood pressure. mental disorders, and the vision is that the
become a viable option. A silver lining of the research framework will be able to offer per- EndeavorRx is the game you mentioned that
COVID-19 pandemic is that it has shown tele- This combination will offer possibilities for sonalised mental health care at scale. the FDA approved in June 2020. It is marketed
medicine to be a tool in the physician's toolbox. psychedelic companies to create combination to improve attention function in children with
Beyond telemedicine, we're seeing the quality products that they can patent. A whole slew of There are four areas where psychedelics and ADHD, and I find it fascinating. The game
and adoption of trackers in smartphones and biometrics may go into formulating the optimal technology are intersecting: diagnosis and adjusts the difficulty level based on input from
wearables such as the Apple Watch and Fitbit dose, or the optimal moment, when someone symptom management; care delivery, with the participant and thereby improves attentive
increase exponentially over the last few years. takes a dose of psilocybin. Or conversely, increased precision in the administration function significantly. Sensory stimuli and
The rise in real-world data and real-world when not to engage in PAT if biomarkers are and observation of patients; preparation and simultaneous motor challenges are designed
evidence in drug development and discovery showing raised blood pressure. integration, by offering anything from health to target areas of the brain that play a crucial
enables better research and development. Pa- checklists to personalised questions and role in attention function. About half of the
The Psychedelics as Medicine Report | Psychedelics x Technology The Psychedelics as Medicine Report | Psychedelics x Technology
children in the studies on EndeavorRx see perspective of the caregiver, there will be mas- render to the experience, a crucial part of PAT. tives. I wonder how many more molecules there
clinically significant improvement in ADHD-re- sively more information. The patient will have To hammer this point home, the combination are to create and if those can get FDA approval.
lated impairments within two months. a place to continuously connect and have an of VR and psychedelics could allow people
application that supports them during PAT. to learn skills the same way as athletes who Another area that I think is interesting is the
The FDA recognises DSCP and is being proac- are getting feedback on their movements, development of legal frameworks outside of
tive with the Digital Health Innovation Action Some people may find going into a in real-time. The feedback loop allows for a FDA approval. From California and Oregon all
Plan. According to the FDA, this is the first psychedelic experience a bit much. You've much more robust training ground than was the way down to Australia, initiatives are fight-
step to ‘assuring that all Americans, including written before about VR and psychedelics. previously possible. ing for greater access outside the established
patients, consumers and other health care Do you think that VR could play a role to medical route. Although here, we should keep
customers have timely access to high-quality, let people experience psychedelics from a One group that is incredibly forward-looking in mind that psychedelic legalisation will cre-
safe and effective digital health products.’ more comfortable position? in this space is Neuroscape. The laborato- ate a very different market from cannabis.
One part of this plan most interesting to PAT is People much more familiar with virtual reality ry could be the foremost space using this
the pre-certification that could allow for faster than me are saying that the current genera- branch of translational neuroscience, mod- Tools that help either psychedelic research
review and approval of DSCP. tion of VR headsets is at an inflexion point. ulating the experience based on biomarkers. and ancillary technology to support PAT are
The Oculus Quest 2 is for VR, where the Now that Robin Carhart-Harris, one of the another area of interest that we've already
Another route to market is providing assisting iPhone 1 was for smartphones. The technolo- leading psychedelic researchers, is continu- touched upon. Companies like Wavepaths,
technology to companies that work with PAT. gy behind VR is maturing to a point where the ing his research there, we can expect more which provides music to accompany the thera-
Applications that support preparation, music, experience becomes seamless. integration of DTx and PAT. peutic benefit of psychedelics, can offer tools
monitoring (mental) health metrics and inte- to make PAT more effective, safe and scalable.
gration of psychedelic experience are poised There are shared characteristics between VR At this time, we're flying relatively blind. PAT
to help clinicians offer better treatments. and psychedelics. Both can alter the con- consists of talk therapy and during the psy- This report talks a lot about psychedelics
sciousness of the person who's using these chedelic experience most participants listen as medicines, so let's switch gears a
Finally, there is the route directly to consum- tools. They can change the perception of to music and there is very little interaction little bit and talk about psychedelics for
ers. Although the price you can charge is what is 'real' and augment our perception of with the therapists. Only, after a session, is neurological enhancement. Can you tell us
probably much lower, a much vaster pool of space and time. Both are leveraging experien- there space to reflect and provide feedback. a bit about what you see happening there?
customers is available. Several psychedelic tial medicine. This would be akin to a weightlifter only get- Just like psychedelics can help those with
applications are currently testing these waters. ting feedback a week after training. We want mental health disorders, they can also lead
VR can help with PAT in three distinct ways. to have immediate feedback, a recording that to the betterment of well people. Of course,
An example of DSCP is in development Firstly by using VR to prepare someone for what we can look back and study, and technology these categories are not set in stone, and it
by Psyber, an atai Life Sciences portfolio they can experience during a psychedelic trip. that assists in shaping the path. What if we would be amiss of me to say that people fall
company. They are working on electroen- Showing people how perceptions can change can upgrade the psychedelic experience to be in either one of these categories. Still, I think
cephalography, or EEG, brain-computer in- which will do a lot to ease worries and gently like weightlifting is now? That way we can use there is a huge opportunity beyond treating
terface technology for use in combination introduce people to a psychedelic experience. the pliable state one is in during, and after, a mental health disorders and substance use
with psychotherapy. How do you see this psychedelic experience optimally. disorders for psychedelics.
implemented in the next few years? Secondly by offering VR experiences instead
This brain-computer interface technology will of chemically induced ones. An exciting pos- How can investors identify emerging The way PAT can be improved, with the help
allow mental healthcare professionals and sibility here is that neuroplasticity could be trends and opportunities in the space? of DSCP, also applies to other domains of life.
patients to access real-time interpretation of achieved through a VR experience with lower That's the million-dollar question. From a For instance, a professional athlete may use
emotional, behavioural and mental states. This physiological risks. chemicals and drug development perspective, psychedelics to overcome a fear that is hold-
technology will create a much shorter feed- many apparent opportunities are already being ing them back. Becoming better attuned to
back loop from weeks to mere minutes. Thirdly by combining VR and psychedelics. I pursued. Maybe ‘set’ and ‘setting’ is where the their body, or seeing a mental blockage from
think this is one of the most interesting appli- next phase of development and investment a different angle, could mean the difference
The use-case here for atai will be to integrate cations of psychedelics and technology. will happen. Enhancing the effectiveness of between first and second place.
this technology into their other portfolio com- PAT through DSCP may become the next place
panies for marketing and improved efficacy of This combination could allow for closed-loop where investors can make outsized returns. It may be a long time before we see robust
treatments. Positioning this as a DSCP will also human-computer interfaces. The VR headset evidence for cognitive enhancement through
allow them to patent their specific protocols. and other tools can collect where someone is The public markets have been introduced to psychedelics. At the same time, microdosing
looking, their heart-rate variability and then the recent development with the major psyche- has taken over Silicon Valley and coaches who
Eventually, technologies like this will be com- feed that back into the system. This infor- delics since the second half of 2019. And for work with psychedelics can be found from
bined with PAT so that patients’ health can mation then augments the experience, for most of the major psychedelics, companies are Austin to Amsterdam. There will be a lot of
be tracked throughout treatment. From the instance, to make it easier for someone to sur- already developing second-generation alterna- developments in this space too.
The Psychedelics as Medicine Report | Psychedelics per Country The Psychedelics as Medicine Report | Psychedelics per Country
Psychedelics
per Country
Pyschedelic Clinical Standout Valuation of
medicines studied trials Companies companies
in country
AUSTRALIA DMT, ketamine, N2O, 2 Creso Pharma entered the psyche- $171m
MDMA psilocybin delics industry in July 2021, through the
acquisition of Canadian psychedelics
company Halucenex Life Sciences.
Mind Medicine Australia (not affiliat-

ed with MindMed) is the registered
charity supports clinical research into
psychedelic-assisted therapies.
The Psychae Institute is headquart-

ed in Melbourne, the global collobo-
ration between universities received
AU$40m in initial funding.
BRAZIL ayahuasca, DMT, 3 Brain Institute in the Federal Univer-

ketamine, ibogaine, sity of Rio Grande do Norte, are the
MDMA, psilocybin researchers from the institute who
studied neural plasticity, inflamma-
tion and neurodegeneration triggered
by 5-MeO-DMT.
Núcleo de Estudos Interdisciplinares

sobre Psicoativos is an organisation
predominantly focused on ayahuasca,
its application and anthropolical im-
portance.
University of São Paulo, the universi-

ty hosted a clinical trial to investigate
ayahuasca's potential as an antide-
pressent, in 2015.
Pyschedelic Clinical Standout Valuation of Pyschedelic Clinical Standout Valuation of

medicines studied trials Companies companies medicines studied trials Companies companies
in country in country
CANADA ayahuasca, ibogaine, 18 Braxia Scientific owns and operates $2.1bn DENMARK psilocybin 3 Octarine Bio is backed by private inves- $6m
ketamine, psilocybin multidisciplinary clinics, with an ini- tors including Oskare Capital and for-
tial focus on ketamine treatments. In mer Canopy Growth CEO Bruce Linton,
July 2021, the CEO and CMO received Octarine Bio developed in-cell enzy-
C$918,000 in funding from the Cana- matic platforms expanding the chemi-
dian government. cal diversity of tryptamine derivatives
Cybin Corp. focuses on developing GERMANY psilocybin, ketamine 1 atai Life Sciences is a the biopharma- $2.3bn
drugs and drug delivery systems. The ceutical company increased its IPO tar-
company is currently conducting clini- get to US$225m, to become the largest
cal trials on propreitary psilocybin-de- publicly traded psychedelics company,
rivitive CYB001 to treat major depres- with underwriters including CitiGroup,
sive disorder. Berenberg and RBC Capital Markets.
Havn Life Sciences supported by institi- MIND Foundation is a non-profit sci-

tional investors, in March 2021 the com- ence and education organization that
pany raised US$95m in a single funding promotes psychedelic research and
round. Three months later Havn became therapy. Every second year they organ-
the first psychedelic company to list on ise their widely attended INSIGHT in-
Nasdaq’s Global Select Market. dustry conference.
Numinus Wellness announced Health IRELAND 5-MeO-DMT 3 GH Research - The company's 5-MeO- $1b
Canada had approved its study into DMT deritive has compeleted its phase
MDMA's efficacy to treat PTSD, in July I clinical trial. In April 2021 the compa-
2021. Between 2020 and 2021, Numi- ny announced it had raised US$125m
nus' share price rose 266%. to progress these trials to phase II and
has since listed on the Nasdaq.
TheraPsil, the non-profit which advo-
cates for the legalisation of psilocybin Alvarius - In 2021, psychedelic start
therapy, submitted its proposal for the up Alvarius announced it had recieved
psilocybin regulation to Health Canada €2.7m from a fund associated with
in August 2021. Christian Angermayer, founder of atai
Life Sciences. The company hopes to
CHINA ketamine, psilocybin 12 The Zhejiang University School of leverage the funds to run clincial trials
Medicine identified the the anatomical into 5-MeO-DMT.
and molecular targets of ketamine's
fast-acting antidepressant properties, NETHERLANDS 5-MeO-DMT, MDMA, 4 Blossom is a web platform which pro- $8m
to enable manufacturers to develop psilocybin vides insigts on research, companies,
ketamine-based antidepressants with public and governmental atittudes to-
greater safety and efficacy. wards psychedelics as medicines.
M2BIO is a subsidary of Wuhan Gen- Synthesis Institute provides for med-

eral Group researching the potential ically-supervised psychedelic experi-
of psilocybin therapies to disrupt neu- ences, psychedelic research facilities,
roaxtibity to treat mental health disor- and education provider. Synthesis has
ders. The company also develops CBD raised over $4m.
products, leveraging the cannabinoid's
thereputic properties.
Pyschedelic Clinical Standout Valuation of Pyschedelic Clinical Standout Valuation of

medicines studied trials Companies companies medicines studied trials Companies companies
in country in country
OPEN Foundation is a non-profit NGO April 19 is an AI-powered platform re-
promoting academic research and ed- searching novel psychedelic drug com-
ucation of Psychedelics in Europe. pounds with minimal side effects.
SPAIN ibogaine, MDMA 3 International Center for Ethnobotani- UNITED DMT, ibogaine, ketamine, 171 Maya Health is a developing software $1.8bn
cal Education, Research, and Service STATES kratom, LSD, MDMA, for psychedelic practitioners and clin-
(ICEERS) is a non-profit organization psilocybin, salvinorin A ics to manage their practice, measure
dedicated to transforming society’s re- progress, and illustrate health out-
lationship with psychoactive plants. comes. They have raised $2m to date.
SWITZERLAND ayahuasca, DMT, ketamine, 36 Heffter Research Institute is large Journey Colab, a startup which raised
LSD, MDMA, mescaline, funder of psychedelic research, the in- $3m, are researching and develop-
psilocybin stitute focuses on driving scientific re- ing new treatment compounds for the
search on psilocybin, for mental health treatment of mental health conditions,
conditions, including addiction. including synthetic mescaline.
University Hospital, Basel, specifically Tactogen is a public benefit corpora-

Leichti Lab, has been active in driving tion developing the next generation of
research across various psychedelics, mental wellness medicines - starting
including studies around the altered from entactogens (like MDMA), and
state of consciousness between LSD raised $1.5m earlier this year.
and psilocybin.
TRIPP uses interactive VR and mobile
University of Zurich's department of experiences to companies, wellness
psychedelic research and therapy is clinics and directly to consumers, to
developing safe and sustainable thera- manage mental health conditions, and
pies for mood conditions. is also participating in clinical trials
for anxiety reduction, depression and
UNITED ibogaine, ketamine, 11 Awakn Life Sciences operates treat- $1.8bn substan ce use disorder.
KINGDOM MDMA, psilocybin ment clinics and is undertaking re-
search to develop new treatments for Wesana Health is publicly-traded life
the treatment of addictions, and is sciences company (market cap of
trading on the NEO Exchange. $33m) working on the development
and delivery of personalised therapies,
Beckley Psytech is a biotech company including psychedelic compounds, to
researching first and second genera- treat traumatic brain injury and related
tion psychedelic compounds, including conditions. Wesana have raised ap-
the advancement of 5-MeO-DMT into proximately $17m.
a licenced pharmaceutical medicine
for the treatment of conditions such as
depression and addiction. Beckley has Source: Blossom
received over $102m in investment.
COMPASS Pathways is the second larg-

est publicly-traded medical psychedelics
company (market cap $1.35bn as at Aug
21), conducting clinical trials and develop-
ing practitioners to administer PAT.
EXPERT INTERVIEW
Florian Brand
Co-founder & CEO,
atai Life Sciences
In 2018, we embarked on this adventure at On the opposite side, there’s a community of into objective endpoints, finding measurable potential for a differentiated treatment effect
atai Life Sciences—to pioneer the devel- psychedelic advocates who see them through changes such as a decrease in depressive for each candidate in an area of unmet patient
opment of highly effective mental health the lens of the spiritual or the mystical; for symptoms, anxiety, suicidality, etc. need, and they must have significant commer-
treatments that address the unmet needs many in this community, pharma, Wall Street, cial potential, which we see as complementary
of patients. Recognizing that the existing and the medical establishment are unwel- In summary, developing drugs is tough to those already in our pipeline.
toolbox of psychiatric medicines has proven come intruders. work, and mental health, especially using
inadequate, we set out on this journey, which psychedelic compounds, presents a multi- A wholistic view of our pipeline illustrates this
has always been a personal one. Many on We walk clear eyed into this maelstrom of tude of challenges and uncertainties. These careful, disciplined approach. Since 2018, we
our team have spoken openly about direct strong and heartfelt opinions with a single challenges are evidenced by the lack of new have grown our platform to five psychedelic
and indirect experiences with mental health goal: to use scientific methods to establish approvals, the small number of compounds and five nonpsychedelic drug development
issues. Many have been failed by existing how these compounds can be of best service with novel mechanisms that enter the programs and six enabling technologies,
therapies, and some have personal expe- to patients living with mental health chal- space, and a negative feedback loop where focusing on differentiated and potentially
rience with, or have observed the healing lenges. But this mission presents challenges investment in mental health has been rela- disease-modifying mental health treatments.
potential of, psychedelics. beyond changing minds or correcting out- tively sparse for years. But we are encour- Treatment-resistant depression (TRD) is a
dated notions: Pharmaceutical development aged by recent news and trends. We see a key indication for us, as is opioid use disorder
These experiences are central to our is extremely challenging across all disease brighter future, and know we have the sup- (OUD), and we also have programs pursuing
founding. Our shared experience is a tie that areas. Every year thousands of compounds port of our investors, who have continued to cognitive impairment associated with schizo-
binds our mission. As we’ve grown our team must pass through rigorous preclinical test- invest in our future success, most recently phrenia (CIAS), generalized anxiety disorder
significantly in the past year, we continue to ing, clinical trials, and regulatory approvals, through our June IPO. We are encouraged (GAD), mild traumatic brain injury (mTBI), and
bring on board individuals who are commit- resulting in just a few dozen reaching market by the accumulating scientific evidence for post-traumatic stress disorder (PTSD).
ted to our mission — almost everyone has a in any given year. Oncology, for example, has these drugs, by the fact that psychedelics
story to tell. massive investment approaching $100 billion as a class have earned approvals and re- To further illustrate our methodology selecting
spent on R&D a year, spanning thousands of ceived breakthrough status from regulatory and developing compounds with our enabling
We strive to be bold in our ambition, but we candidate drugs. Despite this huge influx of bodies, and by increased acceptance and technology platforms, we’ll highlight one of
must not downplay the challenges ahead of capital and effort, since 2015, fewer than 100 interest from patients and physicians. our more recently added drug candidates,
us. Though regulatory bodies and the general new products have been approved. RLS-01, a buccal formulation of Salvinorin A
public are starting to recognize the potential What makes us different? What are we (SalA), which is a naturally occurring psyche-
medical benefits of psychedelics, we’re still Within this same time frame, mental health doing at atai to select compounds, de-risk delic compound derived from the Salvia divi-
working against decades of negative public has seen just 7 new drugs gain FDA approval. development, and ultimately bring them to norum plant. This compound doesn’t have the
opinion. Fueled by political parochialism, old Not surprisingly, the challenges in mental the market? same level of notoriety as other psychedelic
narratives interfered with scientific rigor and health are complex because we’re dealing Our process is designed for effective program compounds, but it’s been essential in cere-
subsequent innovation. And legislation con- with the human brain. Oncology is tough, but selection, drug development, and value cap- mony and traditional healing for the Mazatec
trolling or banning the use of many of these ultimately, candidates in clinical trials are turing. For compound selection, we have a dis- people of southern Mexico for centuries. We
psychedelic substances largely remains in measured against endpoints that are rela- ciplined approach to evaluating and selecting believe initial research on SalA suggests po-
place as a hurdle declaring in no uncertain tively definable, such as “did the tumor grow new programs, which requires prior evidence tential benefits as a therapeutic, which is why
terms that they have no potential benefit. or shrink?”. In contrast, in mental health we in humans to increase probability of success. we launched Revixia Life Sciences, to pursue
must render what is inherently subjective We must also be able to demonstrate the TRD as an initial indication for SalA.
Certain aspects of SalA remain mysterious, Our intent is to continue to strategically grow er of gel at the roof of the nasal cavity, where
namely its unusual mechanism of action our business and to aid in the development it stays for an extended period, releasing ac-
(MoA). It’s classified as an atypical kappa and indication expansion of our various pro- tive ingredient via the nose-to-brain route. We
opioid receptor (KOR) agonist and has a com- grams to maximize the potential of our pipe- think that the technology has the potential to
plex pharmacological profile. The unique MoA line, while we incubate, acquire, and invest in offer a painless and non-invasive administra-
shows no interaction at the 5-HT2A serotonin other promising companies that share our goal tion route and may offer additional advantages
receptor, as with classical hallucinogens like of advancing transformative treatments for such as increased patient compliance, lower
psilocybin and LSD. In addition, SalA may people who live with mental health disorders. dose requirements than oral administration,
indirectly influence the cannabinoid system, rapid onset of action, and minimized systemic
and is a negative allosteric modulator of the Our enabling platform companies are set up exposure, which may reduce the risk of pe-
mu opioid receptor (MOR). Though we’re still with the goal of driving efficient drug discov- ripheral toxicity.
learning about its MoA, we believe that the ex- ery and improving treatment outcomes. To
isting evidence from human exposure de-risks continue using Revixia as an example, the We believe that this novel approach to the
it for further development. pharmacologic intervention of SalA will be delivery of medicines to the brain has revolu-
paired with a digital technology, developed tionary potential. atai announced the launch
In one prior third-party study, subjective by our enabling company, Introspect Digital of InnarisBio in July 2021, and SalA represents
effects from SalA were demonstrated to be Therapeutics. The companies will collaborate the first compound in the pipeline to be for-
similar to classical psychedelics. The study in efforts to deliver high-quality psychological mulated using the technology.
showed the ability of the S. divinorum leaf to care supporting the therapeutic that poten-
effect hallucinogenic states of consciousness tially streamlines preparation, integration, and These pairings, complementing SalA with
beyond serotonergic mechanisms. Notably, all patient engagement in trials. digital therapeutics and a novel formulation,
six Hallucinogen Rating Scale (HRS) clusters are just two examples across our pipeline
were significantly elevated for participants Introspect has a novel approach to digital where compound and enabling technology
given the active S. divinorum leaf. Crucially, no therapeutics (DTx), which we intend to inte- are intended to cross-pollinate. We are also
significant adverse events were observed or grate across atai’s architecture. Introspect is developing an EEG-based brain-computer
reported by the participants of the third-party committed to the idea that high-quality DTx interface technology with an initial application
study. And lastly, five patients reported posi- combinations have the potential to increase to help patients prepare for their experiences
tive changes in relationships with living family the safety and effectiveness of many men- (i.e., their “set and setting”) leading up to and
members. Based in part on the initial results tal health drugs, providing personalized and during psychedelic treatments. And again
of this study and others, we have plans to scalable treatment to those who might not meshing digital and molecular, we intend to
initiate a Phase 1 clinical trial of RLS-01, which otherwise be able to access high-quality psy- bolster the atai pipeline with novel drug dis-
we anticipate will start in mid 2022. chological care. covery through an AI-enabled computational
biophysics platform.
Our subsidiary structure and enabling The development of SalA for mental health
technologies treatments will also benefit from our recent- To summarize, the atai platform approach is
Building on our program selection process, ly launched enabling technology company, built to support a broad range of compounds
we operate our business in a decentralized InnarisBio. InnarisBio is focused on one of the and multiple technologies, aimed at support-
model to enable scalable development at biggest challenges of developing medicines for ing them from early discovery, through formu-
our atai companies, which we have either mental health disorders—getting drugs to the lation, trial design, and clinical trials. Through
acquired a controlling or significant interest brain. The blood–brain barrier, which serves each step, atai, through our platform approach
in or incubated de novo. We believe that this to protect the brain, also restricts drug entry. is “loosely coupled but tightly aligned”, and
model provides our development teams the We believe that this biological impediment is in step on our objectives and values, giving
support and incentives to rapidly advance partially to blame for the stunted innovation in freedom for decentralized decision mak-
their therapeutic candidates or technologies mental health. ing. Our approach is designed to maintain a
in a cost-efficient manner. Together with this common theme optimizing our development in
decentralized model, our process incorporates Taking on this challenge, InnarisBio is develop- arenas of medicine that have been extremely
impactful capital allocation and strategic ing a sol-gel, intranasal, drug delivery plat- challenging. We are strident in our approach
value capture, as illustrated by our ability to form. Sprayed into the nose like a standard and committed to our mission to redefine how
increase shareholder value via our strategic nasal spray, the sol-gel formulation solidifies the world treats, prevents, and heals mental
investment in COMPASS Pathways. at body temperature and adheres as a thin lay- health disorders.
The Psychedelics as Medicine Report | Psychedelics and The Law The Psychedelics as Medicine Report | Psychedelics and The Law
Psychedelics
and The Law
KEY TAKEAWAYS
1. Psychedelics have been classified

under the most stringent rules for
50 years and counting. Through
research showing the effective-
ness of psychedelics as medicines,
the first real changes in legislation
have started happening over the
last two years.
2. Psychedelics have been decrim-

inalised in six US cities and just
as many states have active leg-
islation that either decriminalis-
es, making it the lowest priority
of law enforcement, or provides a
legal framework around psychedel-
ics with Oregon leading here with a
framework for offering legal psilo-
cybin-assisted therapy.
The Psychedelics as Medicine Report | Psychedelics and The Law The Psychedelics as Medicine Report | Psychedelics and The Law
This year, 2021, marked the fiftieth anniver- 1971 - 1985 | Becoming MA-assisted therapy with no reports of sub- begins to swell, interest in psychedelics is
sary of President Nixon’s infamous ‘war on controlled substances sequent drug abuse or neurocognitive decline. also ramping up globally. With the UK ap-
drugs’ speech, following a surge in recre- MDMA was originally excluded from this This not only validated the therapy’s effica- proving its first clinical trial into DMT and the
ational consumption throughout the coun- wide-reaching list of regulated compounds, cy but also its safety, achieving a milestone Australian government committing AU$15
tercultures of the sixties. The impassioned although close analogue MDA was designat- for the psychedelic and instigating further re- million for psychedelic research.
speech on public safety prompted the UN to ed as a scheduled drug. As a result of anec- search into other psychedelic medicines.
schedule a wide number of substances, im- dotal reports of MDMA’s effects and poten- Fifty years on from Nixon’s ‘war on drugs’
plementing controls on common tryptamines tial efficacy in psychiatry, American chemist 2017 - now | speech, in 2021, MAPS published the results
and abandoning research into the therapeutic Alexander Shulgin, who first synthesised the Making psychedelics from its FDA approved phase IIIa clinical trial,
potential of psychedelic medicines. compound in 1965, began testing the drug into medicines demonstrating MDMA-assisted therapy’s ca-
in 1976 and in 1978 reported ‘an easily con- One of the psychedelics to benefit from the pacity to combat PTSD; 67% of patients in
trolled altered state of consciousness’, indi- reassessment of MDMA was psilocybin. An the randomised placebo-controlled trial no
cating its capacity for clinical application. open-label study into psilocybin-assisted longer met the criteria for PTSD at the end of
therapy for smoking cessation confirmed the the treatment, with little to no side effects.
Despite this promise, in 1985, MDMA was treatment’s success over other therapies, ig- As a result of these impressive safety and ef-
subjected to an emergency ban by the DEA, niting renewed interest in the compound from ficacy results, MAPS is expected to receive
and added to the controlled substanc- drug developers and regulators. regulatory approval for MDMA-assisted
es act alongside MDA, psilocybin and LSD. therapy in 2023.
This ended studies into the compound with In 2017, the FDA designated MDMA-assist-
patient populations, but the results of the ed psychotherapy a breakthrough therapy, Psychedelics are still far removed from com-
initial research gave rise to the re-emergence recognising its benefits over treatments cur- plete legalisation or from becoming widely
of psychedelic medicines. rently available. A year later COMPASS Path- accepted medicines. The first proposals have
ways received the designation for its psilocy- found their way to the US Congress where
2000 - 2011 | bin-derivative COMP360, signalling a seismic an amendment by representative Alexandria
Resurgence of research shift in policy towards psychedelic medi- Ocasio-Cortez to remove barriers for federal
At the dawn of the twenty-first century, re- cine. With public support backed by a shift in research on the therapeutic potential of psy-
searchers began to re-examine MDMA’s re- federal policy, US states began to decriminal- chedelics has been rejected. Still, groups like
ported ability to control states of conscious- ise psychedelic medicines, mirroring the le- the Plant Medicine Coalition are hoping for
ness in the treatment of mental health. The galisation of medicinal cannabis, with Denver federal reform with them specifically aiming
world’s first clinical trial of MDMA-assisted and Oakland passing legislation in 2019, and at US$100 million in federal funding for psy-
psychotherapy began in Spain in 2000 but Santa Cruz, Washington D.C and Ann Arbour chedelic research.
was closed in 2002 before completion. Four following suit in 2020.
patients had completed the groundbreaking The long road ahead for psychedelics mirrors
trial, but the study was not extensive enough Following a successful ballot initiative in No- that travelled by cannabis. Although still
to supply data to inform regulation. vember 2020, Oregon became the first state illegal at the federal level in the United
to legalise psychedelic-assisted therapy States, they have become widely accepted
The study was sponsored by MAPS, with the (PAT), specifically with psilocybin. Measure both for their medical benefit and for rec-
non-profit psychedelic research organisa- 109, also known as the ‘Oregon Psilocybin reational use. It was in 1996 that California
tion championing the compound’s efficacy Services Act’ will allow the Oregon Health approved cannabis for medical use, now 25
to combat treatment-resistant PTSD. Follow- Authority (OHA) to license and regulate PAT years later it has become one of the biggest
ing continuous advocacy campaigns by the with psilocybin starting as early as January industries in several US states.
groups, and increasing medical and main- 2023. At this time Oregon is the only state of-
stream support, in 2004 the FDA approved two fering this unique framework, which show-
MAPS-sponsored MDMA-assisted psychother- cases another way to state-level legalisation.
apy studies, one of which was to treat PTSD.
North of the border, Canada is also investi-
The results of the study were published in gating PAT on a national level, with the coun-
2011, with encouraging results. The research, try’s regulator granting a number of exemp-
which involved 19 subjects, who each received tions, under Section 56, to access psilocybin
MDMA in conjunction with psychotherapy, in palliative care. As the body of research
demonstrated the sustained benefits of MD- on psychedelic medicines in North America
The Psychedelics as Medicine Report | Patents and Intellectual Property The Psychedelics as Medicine Report | Patents and Intellectual Property
Patents and
Intellectual
Property KEY TAKEAWAYS
1. Patents are not possible on the first

generation of psychedelics which
have all expired. Therefore novel
formulations of these compounds
or second generation psychedelics
will need to be made to create an
intellectual property (IP) moat. The
former being easier to create but
considerably less innovative.
2. Data exclusivity is an overlooked

opportunity where one would
be able to protect a specific
compound for a specific mental
health or substance use disorder
combination. MAPS will use this
data exclusivity period of five to ten
years to build a network that serves
500,000 patients and positions
them as the provider of choice for
PAT with MDMA for PTSD.
3. Producing psychedelics at scale, with

good manufacturing practice (GMP)
levels of purity, is another frontier
where more than a dozen companies
are competing to offer both
natural psilocybin, extracted from
mushrooms, and synthetic versions
to be produced at large scale.
The Psychedelics as Medicine Report | Patents and Intellectual Property The Psychedelics as Medicine Report | Patents and Intellectual Property
Many of the traditional psychedelics were with companies exploring how compounds can build a moat before others will also be able
synthesised many decades ago and the be modulated for shorter durations and to mit- to offer MDMA-assisted psychotherapy for
patents governing their use have long since igate the reliance on healthcare professionals. PTSD. In that time MAPS will scale up to over
expired. MDMA was first patented in 1914, 1 million sessions in 2029, which means that
LSD in 1957 and psilocybin in 1963. As a One way this could possibly be achieved is they will be able to serve at least 500,000 pa-
result, companies are creating novel psyche- reducing the hallucinatory experience, with tients between 2023 and 2029.
delic compounds based on classic trypt- non-hallucinogenic analog tabernanthalog en-
amines that can be patented. gineered as a non-toxic ibogaine derivative. In In the meantime, other organisations will still
an attempt to dominate the emerging industry, be able to generate their own data to get a
In the UK, US and Canada, new drugs are pat- drug developers are filing dozens of patents on treatment with MDMA approved. This can
ented upon discovery, rather than regulation, psychedelic-compounds, long before they are even be for MDMA-assisted psychotherapy for
with a patent term of 20 years. Patenting med- thoroughly researched or subjected to clinical PTSD, but that would entail them generating
ications provides drug manufacturers with a trials. Some stakeholders see the application the same level of data and efficacy as MAPS
period of market exclusivity in order to incen- of over broad patents as strangling industry has done so far.
tivise the development of new treatments by innovation, whereas others believe it is crucial
enabling the company to monopolise sales. to protect and futureproof a business model. Making psychedelics
at scale
Patenting ketamine To prevent patents being applied that will Another area where patents are playing a role
Johnson & Johnson successfully secured a stifle research and using information that is in the production or extraction of psyche-
patent, and regulatory approval, for its esket- has been known to the public, which is called delics. Whereas natural production costs
amine nasal spray to treat treatment-resistant ‘prior art’; two different organisations are US$10-US$15 per effective dose, a novel
depression. Although Spravato was approved challenging overreaching patents and col- yeast-based production method may, if scaled
by the FDA, it fell short of regulation in the UK lating earlier work. Freedom to Operate, a up, provide psilocybin at a much lower cost.
due to its prohibitive cost and a failure to sig- non-profit led by Carey Turnbull, the founder Already in the year 2000, without wanting to
nificantly improve patient outcomes, above of the Heffter Research Institute, and Porta be involved in psychedelics as medicines, the
and beyond existing medications. Health Sophia, supported in part by Usona Institute, Royal Dutch DSM, applied for a patent, that
Canada did approve Spravato as a treatment, are fulfilling these respective roles. This work was granted in 2007, for the improvement of
but has recently rejected its patent claim. should help patent reviewers to better judge the yield of psilocybin. To prevent others from
This signalled muted success for Johnson & if the work detailed on a patent is not already patenting known ways of producing psilocy-
Johnson, as it restricted Spravato’s use to a in the public domain. bin, and to advance Open Science, Usona In-
specific jurisdiction and a limited patient pop- stitute has published all their psilocybin pro-
ulation, despite the company heavily investing Data exclusivity for MAPS duction methods without patenting them. In
in the drug’s development. In addition to a patent to secure market ex- August 2021, Filament Health became the
clusivity, organisations can also apply for data first company to be issued a patent for the ex-
While the FDA’s approval of Spravato was an exclusivity to secure ownership and confi- traction of natural psilocybin.
important milestone for the psychedelic indus- dentiality of data provided to regulators. This
try, the failure to gain accreditation in other typically includes the data generated through Still, in the last few years, many companies
countries is a warning lesson for other man- clinical trials, so it cannot be used to obtain have filed patents on different proprietary
ufacturers. It is not enough to develop new regulatory approval for a similar medication. In manufacturing processes for making psilocy-
treatments with better patient outcomes, the the US data exclusivity lasts five years, eight bin, DMT, MDMA, and many novel psychedel-
treatments need to provide far greater efficacy in Canada, and ten in Europe and the UK. ics. The same can be said about the different
than medications currently available and also delivery methods which range from soft gels to
be cost-effective for healthcare providers. MAPS will get data exclusivity for its clinical small films that sometimes extend the period
trials to treat PTSD with MDMA, as MDMA over which a psychedelic is released. It will be
Novel psychedelics was originally patented in 1914 and its patent up to the patent reviewers to judge the innova-
under patent has long expired. Consequently, MAPS re- tive nature of each of these applications.
This is one of the main challenges facing the quired data exclusivity to achieve returns on
psychedelic industry, as the majority need to its investment, when the treatment is expect-
be applied in controlled settings and followed ed to be regulated by the FDA in 2023. This
up with sessions with a trained therapist. This will give them five to ten years, depending
significantly adds to the cost of treatments, on the continent, to scale up treatments and
The Psychedelics as Medicine Report | Therapy practitioners The Psychedelics as Medicine Report | Therapy practitioners
Therapy
practitioners
KEY TAKEAWAYS
1. More than 50,000 therapists will

be trained to administer psyche-
delic-assisted therapy within the
next ten years. MAPS, COMPASS
Pathways, CIIS and many other or-
ganisations have already started
scaling up training programmes.
2. Therapists in the ongoing clinical

trials work in dyads and a full
treatment can take upwards of 42
hours. New ways of administrat-
ing therapy through groups or with
novel shorter-lasting compounds
could drastically lower the time re-
quirements and related costs.
The Psychedelics as Medicine Report | Therapy practitioners The Psychedelics as Medicine Report | Therapy practitioners
Therapists and clinicians are the backbone of ly linked to mobilising more trained thera-
psychedelic therapy delivery, and the capaci- pists. Considerations such as shorter in-person
ty to fund and provide training, plus ensuring therapy, group therapy, or use of technology, as
that a steady supply of therapists are consis- detailed earlier in the report, could be options
tently being trained, upskilled, and retained, is to enhance accessibility to more people, but the
of utmost importance in the wider distribution efficacy of such methods remains to be tested.
of psychedelic therapies. It will be a key piece
of the puzzle when scaling up psychedelic-as- While therapists who want to work with MDMA
sisted therapy (PAT), both for non-profit and will need to undergo the MAPS' training pro-
for-profit organisations who are delivering gramme, there is a common desire to be trained
these training courses. as a general psychedelic therapist, in order to
customise treatments (for instance, by pro-
PAT is generally available for mental health providing a sequence of psychedelic compounds)
fessionals who are seeking to work with clients for their clients. Currently, there are 310 ther-
who are receiving therapy, in conjunction with apists being trained by MAPS, with another
a psychedelic supplement. This could range 500 expected to begin training in September.
from training specifically in integration services, Physicians prescribing MDMA will also require
through to becoming a practitioner of PAT. training, though their limited involvement in the
Training equips health professionals with the therapeutic setting means their training could
tools they need for supporting the experiences be completed in around 2-4 hours.
of their clients and integrating these into their
lives, as well as harm reduction techniques. There are many training programmes emerging,
Many therapists also choose to train in other seeking to build the next generation of therapy
complementary modalities, such as breathwork. providers. Among psilocybin training provid-
ers, Canadian organisations such as ATMA
Therapy training providers Journey Centres recently completed train-
Several non-profit and for-profit companies ing with 35 professionals, and the non-prof-
are currently training psychedelic therapists. it, Therapsil launched its beta training pro-
We expect more than 50,000 therapists to be gramme in March, earlier this year. US-based
trained to administer PAT within the next ten Fluence provides integration training, as well
years. Here we highlight the work being done as ketamine-assisted psychotherapy training
by MAPS who have been transparent about to aspiring practitioners. Access to a ketamine
their training goals. prescriber is a common bottleneck for inde-
pendent practitioners who want to provide ket-
MAPS wants to train 24,000 therapists in the amine-assisted therapy. A US-based start-up,
six years that they expect to have data exclusiv- Journey Clinical, is providing in-house trained
ity following successful New Drug Application ketamine prescribers to independent therapy
(NDA) approval in the USA for MDMA-assisted practitioners, and has partnered with Fluence
therapy (2023-2029), for the treatment of PTSD; for their therapist training programmes. Aspir-
data exclusivity is much longer in Europe. Their ing psychedelic clinical researchers can also
training is formed from online modules (100 take a post-graduate training course at the
hours), plus therapists can expect to be super- California Institute of Integral Studies.
vised and receive feedback on their first PTSD
patients. The 100-hour training costs US$5,000 In a bid to increase therapy providers, collab-
but does not include the voluntary option to orations between experienced training prac-
partake in MDMA-assisted therapy themselves. titioners and education systems will be key
in providing more aspiring therapists to gain
Considering that each patient currently, in psychedelic therapy training, and encourage
the PAT clinical trials, undergoes 42 hours of a diverse set of therapists to consider psy-
therapy with a male/female co-therapy team, chedelic therapy as a specialisation - to help
increased therapy delivery will be intrinsical- the expanding groups of beneficiaries.
EXPERT We consider psychedelic-assisted therapy to the dosing session, the after care/integration
INTERVIEW be psychotherapy - not an exceptional and and follow-up activities. All of the therapy ses-
mysterious thing. The embedding into the sions are important, it is not some kind of mag-
mental health care context, the screening and ic pill therapy or psychedelic pharmacotherapy
treatment planning, the preparation sessions, with a little bit of preparation and integration.
Dr sc. hum.
Henrik Jungaberle Components of a mental health system integration
MIND Foundation & of psychedelics, including factors to be considered
OVID Health Systems
in Health Technology Assessment (HTA) and future
formulation of REMS criteria.
Since the turn of the century, there in a larger patient collectives and/or special 1. REFERRAL • Check consent and education of co-treatment (liaison) system for
has been a resurgence of research into patient groups to determine the therapeutic SYSTEMS interaction pre-, during, and post-treatment
psychedelics as medicines. In 2021, significance with more practical relevance in
MAPS published the first results from "naturalistic environments". This is to identify • Availability of emergency care facilities
its phase IIIa clinical trial to treat PTSD if a drug really holds the promise in the field
with MDMA-assisted psychotherapy, that it was approved for. 2. SCREENING & • Ensure application only after the psychiatric screening procedure
and COMPASS Pathways’ completed its INDIVIDUALIZED
phase IIb study into psilocybin’s efficacy If we train a lot of unreliable therapists who TREATMENT • Check patients' social support systems
against treatment-resistant depression. misleadingly think psychedelic therapy con- PLAN
As companies position themselves to sists of giving a drug to a person or “tripping” • Check substance co-treatment regime: interactions with classic
treat patients with psychedelic-assisted it could derail the whole process. To avoid this, psychotropic drugs, concomitant medication
psychotherapy, what do you see are the we need to ensure that training is done at high
biggest roadblocks to the widespread quality and that we assess therapist’s capabil- • Ensure process diagnostics: decide whether a self-directed salutogenic
accessibility of psychedelics? ities properly before they enter the trainings, process is underway or whether intervention by the help system is
I think that the last part of the journey can be especially before they embark on short online necessary and who will carry this out
the hardest. From phase II to phase III and training programmes. I am personally scepti-
everything that happens after phase III, when cal that these courses will provide the skills • Screen for an understanding of and willingness for integration
companies are negotiating with regulators. people need in the first generation of modern (defined as engaging in adaptive learning processes)
That is when the authorities will talk about risk psychedelic therapists.
mitigation strategies, setting up the criteria on • Define treatment plan
how the medicines will be applied. This is the To bring psychedelics to market, therapists
challenge that will soon be faced by MAPS, will need to be trained to offer new forms • Ensure drug is administered only in the context of a minimum of
COMPASS Pathways’ and all those that try to of therapy. How do you think we can train psychotherapeutic embedding
gain approval for psychedelics as medicines. these therapists, and what kind of training
do they need? The MIND Foundation is • Define qualifications of multi-professional teams
The second bottleneck or challenge that I see training therapists through its Augmented (medical responsibility in relation to treatment responsibility)
is the training of psychedelic therapists. Rick Psychotherapy Training (APT). Can you
Doblin of MAPS recently said that he wants elaborate on this two-year programme and • Test quality of screening
to train 24.000 therapists. I think the strategy what skills therapists will obtain?
or the goal to train a lot of therapists in a very The MIND Foundation has worked hard in 3. PREPARATION • Check accuracy and understanding of patient consent information
short timeframe could be very challenging to the last few months to build a curriculum
not only MAPS but the whole field. I hope that that is different from what we currently see • Include information about sociocultural risk factors in patient consent
we will be able to keep the quality of training in the field. The APT curriculum is a two-year
high because there could be a real big back- 400-hour training in-depth programme. Our
lash when we finally get to real life implemen- concept was to build the long version of the
tion and phase IV studies, which serve the curriculum first and then develop medium and
purpose of further risk-benefit assessment five-day intensive versions of the training.
on the latest therapy models such as Accep- group without the correct approach could
4. DOSING SESSION • Ensure application under the supervision of a physician tance and Commitment Therapy (ACT). We have dire repercussions and nobody wants
are applying an integrative psychotherapy that. Having qualitative screening procedures
• The drug is administered only in certified health care facilities that can theory and teach the so-called general change in place will ensure that we reach a large
observe patients for at least 3 hours after drug effects wear off and mechanisms, as they have been shown to be group, but also that treatments are successful.
provide the medical care necessary in case of an adverse event effective by psychotherapy research in the
last 50 years. This is the work of Jerome Frank Our experience at OVID, MIND Foundation’s
• Define rules for individual treatments, parallel individual treatment, and in the US, but much more the work of the clinical sister organisation that today is
group treatment dosing sessions groups around Klaus Grawe, a German-Swiss providing ketamine- and breathwork-as-
psychotherapy researcher who worked at the sisted psychotherapy, is that turning down
• Epistemic narratives and regime: Creating a shared system of ideas University of Basel. They have shown that unsuitable patients builds trust within our
about psychedelic treatments and assessing their effect (limiting independent of certain schools of therapy, referral system. By having a good screening
irrationality and esotericism) there are five common underlying factors procedure, referring doctors know that we are
present in effective psychotherapies, and this not here just to “drop acid” into somebody’s
5 AFTER-CARE/ • Check existence of a system for co-treatment with non-psychedelic is the theoretical basis that we are building the organism and hope that it magically works.
INTEGRATION practitioners APTtraining upon. It does help, but you really have to build the
context and care for the long-term perspec-
• Check epistemic narratives In your latest research article, co-authored tive of the patients.
with Prof. Dr med. Gerhard Gründer, titled
• Check existence of rational community building systems ‘The Potential Role of Psychedelic Drugs We do not know yet if psychedelic therapies
in Mental Health Care of the Future’ you make healing processes faster though. This
6. FOLLOW-UP • Monitoring of symptom reduction, suicidality, well-being, and recognise the different aspects needed to is not what the studies show yet and will
substance use patterns integrate psychedelics in mental healthcare. be the terrain of comparative and phase IV
Can you elaborate on the role of screening in studies. Current studies show that for a large
• Consider digital technologies in follow-up strategies this process? Will psychedelics be available proportion of study participants, psilocybin
to most patients or only a small group? has been very effective and that the effects
• Investigate post-treatment patient group therapy (online and on-site) In our paper, we describe a six-step model endure for some months, but not for all
and patient community systems in their role for sustaining positive (see above), not only the three most known patients. Building on our psychiatric and psy-
treatment effects - preparation, dosing and integration. When chotherapeutic experience, we believe that
you look at how things are already done in psychedelic therapists and psychotherapists
• Evaluate and discuss possible post-treatment self-administration of real-life therapy within an existing mental largely play the same role in the treatment.
psychedelic drugs by subjects health system it gets a little bit more complex. Outside of the therapists’ office, both con-
For example, before a patient arrives at our nect the patients to a social ecosystem that
OVID Clinic in Berlin, the first two steps have helps her or him to get better.
Source: Gründer, G., & Jungaberle, H. (2021). The Potential Role of Psychedelic Drugs in Mental Health Care of the Future. already taken place as a lot of our patients are
Pharmacopsychiatry, 54(04), 191–199.
referred by other doctors, psychotherapists, or Psychedelic-assisted therapy (PAT) has
even other patients. shown some incredible results in clinical
Instead, the APT training is looking at how the ing people in non-pharmacological methods studies. Some follow-up studies have found
psychotherapy process is intensified, expand- and for atypical psychedelics like ketamine Future psychiatric therapists will have to build lasting positive effects up to five years later.
ed or sometimes accelerated. We are training - as well as for serotonergic psychedelics like referral systems and train non-psychedelic At the same time, other studies, mainly
people either to become certified psychedelic psilocybin. We want therapists to be familiar therapists so that they know who to send and with ketamine, find acute positive effects
therapists or co-therapists that can work along- with a broad pharmacopoeia and a diversified who not to send. And following the end of which seem to dissipate within the first
side other therapists in a coherent team. These toolset to alter consciousness. Then, in the psychedelic therapy, some patients will still be month. Do you think that psychedelics will
therapists could come from a broad spectrum outcome-based training (OBE) that we created vulnerable and some will have setbacks, so a be something a person with a mental health
of alternatively trained disciplines, too. we involve techniques like patient actors, non-psychedelic psychotherapist will have to disorder should go back to periodically, or is
mentoring and mindfulness meditation - next continue with the therapy or provide a stabilis- it a one-treatment and done deal?
Other things stand out in our training program. to a sound introduction into ing role because it is simply not the reality that This is one of the extremely thrilling compo-
The first is that we believe in training thera- people all get magically better forever. nents of PAT that need to be worked out much
pists to become group players - with medical The last characteristic of APT is its deep focus more. It is very likely that a number of patients
doctors and psychotherapists working closely on integration. We are basing the curriculum, Keeping that in mind, we do want to reach a will have to return to psychedelic therapy
together. The second is that we are also train- and the whole therapeutic process, not only large group of patients. But reaching a large from time to time. The phase IV studies will
show who will have to come back and at what can afford to pay for it themselves or can be We also want to make the German medical Our educational programmes, such as
intervals. People will also come for different enrolled in our diversity programs. and psychotherapy system aware that this Footsteps and BEYOND EXPERIENCE help
reasons, with psychopathology and self-devel- kind of therapy can be performed safely a wider audience gain an understanding of
opment being disparate scenarios. We do not only have to show that PAT has a within the system. There is a lot of resistance altered states of consciousness, and how
slight advantage compared to talk therapy, but and if you want to overcome resistance, you they can use these altered states of con-
A patient who has struggled with depression also that it is better than electroconvulsive have to do it on a country by country level sciousness to create a better life. We want to
for 30 years may find great relief after one or therapy (ECT) for example - as that is what it in the EU. We are aware of the impressive expand that these programs for everyone by
two psychedelic sessions like our colleagues is being compared to. This is the reality of the results from US-American and multi-nation- training more facilitators so that switching in
are already beginning to see in the German EP- medical system and we need to do head-to- al studies, but their outcomes are largely and out of altered states of consciousness is
IsoDE study (Efficacy and Safety of Psilocybin head comparison studies with the current gold confined to the psychedelic bubble still, and normalised and integrated into a framework
in Treatment-Resistant Depression in Mann- standards, such as ECT, behavioural therapy is not knowledge shared by mainstream psy- of integration.
heim and Berlin with 144 patients). But the and antidepressants. chiatrists and psychotherapists. They either
psychosocial system around them that stabi- do not know about it or they are not taking it Additionally, this year we will hand out sev-
lises their pathologies will not just go away for In the long-term though, in order for people seriously. If you want to get novel treatments eral awards at the INSIGHT conference, our
everybody. For many patients, we may need to have access to these therapies, we need to to patients, you have to convince those who bi-yearly psychedelic research conference
another session, two or more each year. bring them into public health care systems. work in the traditional system.ÖL and on November 26th, the fifth anniversary
This is different in the EU from the United of MIND. The goal is to raise awareness and
For self-development, we are at an even earlier States. Here in Germany, the Netherlands, This takes us back to the six-step process create recognition for the junior and senior
stage. The MIND Foundation is beginning to Switzerland, and the Mediterranean coun- around psychedelic therapies that we talked pioneers in the field. And to help them being
have conversations with legal authorities and tries, we need to get it covered by public about earlier. The referral system needs to be taken seriously in the wider scientific commu-
politicians. Which systems of law, legal regula- health care systems. We need to talk to in- informed. At OVID, we have monthly referral nity. This is also why we are providing en-
tion or architecture need to be created around surers, public health officials, and learn from system meetings, online and onsite, for col- dowed awards. The MIND Foundation Award
psychedelic use for healthy people? In medi- other experts to set up these studies so they leagues from Berlin and globally. Colleagues will come with a €4.000 grant, and the Willy
cine, we have the term ‘prophylaxis’, meaning are done well. in the US and Canada, where ketamine Schweitzer Young Researchers Award comes
treatment given or action taken to prevent dis- clinics are already more prolific, still seem to with € 1.000 due to generous donors.
ease. Part of these processes could be seen Your colleague Prof. Dr med. Gerhard face a lot of resistance and medical profes-
as prophylaxis, with psychedelic therapy for Gründer is leading the phase IIb Efficacy sionals are not referring patients for these Finally, our aim is to change the perspective
personal growth preventing the deterioration and Safety of Psilocybin in Treatment- types of therapies at a large scale yet. from a drug-centred model, which is also
of mental health. The study of psychedelic use Resistant Depression (EPIsoDE) study, very present in the psychedelic field, and
for personal growth and insights should also which has received more than €2 million In Blossom’s survey, featured earlier on includes the magic pill narrative, to an inte-
become part of the fields in the years to come. from the German government. Why is it in the report, 65% of participants were gration-centred model. Integration is about
necessary to undertake this study as others aware of the use of psychedelics for the transforming experience into health and
OVID, MIND’s sister organisation, is offering such as COMPASS Pathways’ and the treatment of mental health conditions. happiness related behaviours. Integration is
augmented psychotherapy, meaning you Usona Institute are doing similar studies? This is already an amazing number, at all about creating a better life beyond altered
augment psychotherapy either with non- The EPIsoDE study serves several societal and the same time much more education is states of consciousness. , We are not there
pharmaceutical methods or with ketamine, scientific goals. Our study is unique in that it needed. Can you highlight how the MIND yet as a field, but putting a little bit more
and in the future with other psychedelics. provides two 25 mg doses of psilocybin and it Foundation and OVID are filling this role? focus on integration in the next ten years will
Is this treatment currently supported by is being tested against two different placebos. We are currently in the fifth year of the serve everyone well - those looking for heal-
insurance? From your perspective, what This will give us much more information about MIND Foundation’s existence and year two ing and those looking for growth.
evidence is needed for insurance to pay for which placebo we can best use going forward of OVID. In these first five years, MIND has
these treatments? in future studies. focussed a lot on the academic system. We cannot do it alone, a lot of organisations
Public health insurance companies do not pay Now, we have ten programmes in place will need to work together and steer the field
for PAT in Germany at the moment, but we We will also train our MIND and OVID staff that help educate and connect everyone, into the next generation. Not only by replicat-
have some private health insurance compa- with this study, prepare them to work on stud- from established researchers to therapists, ing scientific results but also by translating
nies that have begun to pay for it, which is ies with other psychedelics or mental health students and junior academics. The empha- science into real-life practices and using all
great progress already. The effectiveness of disorders and involve them in the APT training sis for the next five years will be translating our creativity to build up-to-date, secular
PAT has never been demonstrated in Ger- for future psychedelic therapists. We have academic knowledge into public awareness, spiritualities that invite people to steer out
many, nor in many other countries, so we do not talked about it publicly yet, but we are so people have the information to build a of esoteric self-referral. Thereby, we have a
need to generate this data for insurers to currently negotiating cooperations between critical assessment of the results that psy- chance to build a place for psychedelics in
justify paying for PAT. That way the treatments OVID and public universities to conduct future chedelic treatments can produce. modern societies.
become available to more than only those who studies together.
The Psychedelics as Medicine Report | Psychedelic Research The Psychedelics as Medicine Report | Psychedelic Research
Psychedelic
Research
KEY TAKEAWAYS
1. Ketamine is currently the only psy-

chedelic in widespread clinical use.
MDMA for the treatment of PTSD
is currently in phase IIIb and is
expected to be approved by 2023.
Psilocybin for depression has just
finished the data collection on
a large phase IIb trial, of which a
total of 26 have been conducted or
are currently ongoing.
2. Universities and hospitals

commonly sponsor trials;
companies have sponsored an
average of 10 trials annually over
the last three years, which will rise
to 40 annually in 2024. More than
30 companies have indicated an
intent to run clinical trials.
3. We can expect MDMA-assist-

ed psychotherapy for PTSD to be
approved by the FDA in 2023. Psi-
locybin for depression, both major
depressive disorder (MDD) and
treatment-resistant depression
(TRD), will probably be approved by
2025. Other approvals for ibogaine,
LSD, DMT and ketamine could
follow soon afterwards.
Psychedelic research is pushing ahead at a On the other side of the pond, the Imperial Founding of dedicated psychedelic research centres
pace never seen before. Where in the early College London (ICL) team has been the first
2000s, you were lucky to find a handful of re- to study psychedelics with brain imaging tech-
searchers doing animal studies with mind-al- niques. After more than a decade of research, Year University Research Seed
tering substances; nowadays, more than 100 the Centre for Psychedelic Research at ICL Centres Funding
exciting papers on psychedelics are published was launched with the explicit goal to develop
every month. psilocybin-assisted therapy into a licensed 2019 APRIL Centre for Psychedelic Research at Imperial $4 million
treatment for depression. College London
These papers detail the results of clinical
trials, of which a new one is started every These pioneering centres are not the only 2020 SEPTEMBER Center for Psychedelic and Consciousness $17 million
week, observational studies often in tradition- places where research is taking place. Ev- Research at Johns Hopkins University
al settings, new hypotheses, and reviews that erywhere from Maastricht University in The
bring together what we currently understand Netherlands to the University of São Paulo 2020 SEPTEMBER UC Berkeley Center for the Science of $1,25 million
about psychedelics as medicines. in Brazil, individual researchers and re- Psychedelics
search groups have studied psychedelics,
Psychedelic each through their own unique lense. We can 2021 JANUARY Center for Psychedelic Psychotherapy and $2,1 million
Research Groups expect more research centres to join those Trauma Research at Mount Sinai
The astronomical rise of research into psy- already established.
chedelics is a result of the work from several 2021 FEBRUARY Center for the Neuroscience of Psychedelics
research groups that have found the balance In the last two years, many new research at Mass General
between the multidimensional world of psy- centres have joined the two original groups.
chedelics and the rigorous demands of sci- Researchers, including the author Michael 2021 MARCH UCSF Neuroscape Psychedelics Division $6,4 million
entific inquiry. This work has also been made Pollan, have launched the UC Berkeley Centre
possible by foundations that have paid for for the Science of Psychedelics in Septem- 2021 APRIL Translational Psychedelic Research Program $3,4 million
much of the early research, specifically the ber 2020 with the aim of educating the public, at UCSF
Heffter Research Institute, the Beckley Foun- training therapists and conducting more re-
dation and MAPS. search. Mount Sinai, which launched the 2021 JULY Project on Psychedelics Law and Regulation
Centre for Psychedelic Psychotherapy and at Harvard Law School*
The new wave of research arguably started Trauma Research at the start of 2021, will
with the study of DMT experiences by Rick also research MDMA, psilocybin, and other *Undisclosed amount of funding received from the Saisei Foundation, led by Tim Ferriss (podcast host, author,
philanthropist) with funds also provided by Matt Mullenweg (WordPress)
Strassman in the 1990s. At that time, as far as psychedelics for the treatment of those with Source: Blossom
we know, his group at the University of New complex mental health issues.
Mexico was the only place doing research with
psychedelics on humans. Although the study In February this year, Mass General launched
didn’t investigate psychedelics as medicines the Center for the Neuroscience of Psyche- CLINICAL TRIALS
‘per se’, it showed others that, with enough delics, where neuroimaging will be leveraged WITH PSYCHEDELICS
persistence against wider discourse, research to better understand how psychedelics work.
could be done. The University of California San Francisco Of all the research that has been done with Over the years, we can clearly see a strong
(UCSF) has launched The Translational Psy- psychedelics, psilocybin and MDMA get to upwards trend in the number of patients that
The Johns Hopkins research group got per- chedelic Research, which will investigate psi- share the limelight. But it’s actually ketamine have participated in clinical trials. Where
mission in 2000 to reinitiate research with locybin for hard-to-treat mental health disor- that has generated the most amount of re- an average of 1,100 patients per year were
psychedelics, this time in patients who were ders such as bipolar depression. Finally, UCSF search. As of July 2021, 140 clinical trials have studied between 2016 and 2018, this more
psychedelic-naive, not having taken psyche- has also set up a psychedelic section within been conducted with ketamine for the treat- than doubled to 2,450 patients in clinical trials
delics before. The Centre for Psychedelic and its Neuroscape laboratory, where Robin Car- ment of mental health and substance use dis- between 2019 and 2021. The average number
Consciousness Research at Johns Hopkins, hart-Harris serves as a director. orders. As detailed earlier in the report, this of participants in each trial is 52, which is
founded in September 2020, marks the next had led to the approval of Spravato for TRD higher than one might expect. The numbers
phase of research intensification as the group and for the widespread use of ketamine for the increase from 36 on average in phase I trials,
expands and investigates psilocybin for many treatment of MDD and suicidal ideation. up to 96 per phase III trial. Looking at the data,
different mental health disorders. without ketamine trials, lowers the average in
phase I trials to 30 patients per trial.
The Psychedelics as Medicine Report | Psychedelic Research The Psychedelics as Medicine Report |
Clinical Trial locations

Looking at geographic trial activity, America is Not only are most of the studies in Western To heal mental health disorders so that
the most active when it comes to running clin- Educated Industrialised Rich Democratic everyone, everywhere can live a more fulfilled life
ical trials, with Switzerland, mostly the Liechti countries but the patient populations are cur-
Laboratory, coming in second place. The UK rently not that diverse. A review in 2018 found
takes the fourth spot after Canada and has re- that 82% of patients are white and only 2% are NASDAQ: $ATAI Over $600m raised to date including the sector's largest IPO in June
cently been ramping up the number of trials in of Asian origin – a startling discovery, given
the country. Surprising to note is a dozen trials that this is where 60% of the world lives. Other
in China, one of our profiled countries, where ethnic groups are similarly underrepresent-
Our current pipeline
ketamine has been researched since 2012. ed. Studies on dosing, efficacy, genetics and
China has also conducted a study on psilocy- differing attitudes towards health services
OUR PROGRAMS
bin for the treatment of migraines. should be aimed at a more diverse and repre-
sentative group for society to better generalise Lead Lead
the results of the current body of research. Company Compound Indication Type Ownership Preclinical Phase 1 Phase 2 Phase 3
PCN-101
R-ketamine TRD VIE 58.9%
Location of clinical trials conducted from 2000 to 2021

RL-007/
Compound CIAS VIE 51.9%
DMX-1002/
Ibogaine OUD VIE 59.5%
NN-1001/
N-acetylcysteine mTBI
VIE 56%
13 KUR-01/
198 89 Deuterated OUD VIE 54.1%
Mitragynine
14 GRX-917/ Majority
Deuterated GAD Owned Equity 53.8%
etifoxine Interest
1
EMP-01/ Wholly
MDMA PTSD Owned 100%
9 derivative
3 VLS-01/ Wholly
TRD Owned 100%
DMT
RLS-01/ Wholly
TRD Owned 100%
Salvinorin A
ENTITIES LIMITED TO EQUITY INTEREST

Source: ClinicalTrails.Gov / Blossom Developing COMP360 therapy, with
psychological support from specially trained 19.4%
therapists for TRD. Phase 2b trial is ongoing.
Developing DMX-1001, a formulation of

noribogaine, as a potential at-home 6.3%
maintenance therapy for OUD. Preclinical stage.
Any questions? Join the atai #insightnetwork

info@atai.life @atai Life Sciences @atai_life @atai.life
Number of Clinical Trials Psychedelic trials

The number of trials that have been spon- is readily available. News from Germany and sponsored by industry
sored has shot up in the last three years, with Australia indicate that more government The commercial interest in research with Many more companies are running or
an average of ten trials being sponsored each funding is on the way. psychedelics has only recently been ignited. planning to run clinical trials.
year. Most of the current studies are being There are more than 30 companies that are
conducted by universities, which have recently Projecting the current numbers into the future, either running a clinical trial, have run a trial In alphabetical order:
also significantly increased their output. we can expect the number of trials to contin- or have indicated that they plan to pursue a
ue to rise quite quickly. Not only should many trial with a psychedelic. Although some of Algernon, Alvarius, Awakn, BMORE,
The data for 2021 does include some trials that companies actually deliver on their plans to these press releases may not materialise as Beckley Psytech, BetterLife Pharma,
haven’t started yet, but we can expect some run trials, but we can also expect more studies completed studies, many well-funded compa- Bexson, Bright Minds, CaaMTech, Ceruvia,
more to be registered before the year is over. to be sponsored by governments – such as the nies are on track to start clinical trials in the COMPASS, Cybin, Delix, DemeRx, Diamond
At this time the biggest sponsors of research German government who is sponsoring the next few years. Therapeutics, Eleusis, EmpathBio,
are COMPASS Pathways, MindMed, Johnson & MIND Foundation’s psilocybin trial. EntheogeniX, Entheon Biomedical,
Johnson, atai and its various subsidiaries. There are currently tens of companies pursu- Field Trip Health, Filament Health, GH
ing trials, of which the most certain are listed Research, Gilgamesh, Journey Colab, Lobe
Somewhat surprising is the number of trials here. The duration to develop a psychedelic as Sciences, Lophora, MAPS, MindMed,
already sponsored by governments. This is medicine can vary widely. At this time, we only Mindset, Mydecine, Neonmind, Perception
mostly done by the Veterans Affairs services have Spravato for TRD and SI, and MDMA for Neuroscience, PharmaTher, Psilera,
in America. In the coming years, we expect PTSD as examples. Psybio, Revixia, Sacred Medicines, Seelos
this number to rise as psychedelic research Therapeutics, Small Pharma, Tactogen, Tryp
becomes more mainstream, and more data With the very short development cycle and Therapeutics, Usona, Viridia and Wesana.
because it was a known chemical entity, the
cost of development for Johnson & Johnson
most probably is way below their average of
Number of patients in clinical trials the US$5.8 billion that they’ve spent per newly
developed drug. Presumably, it is also below
MDD TRD BIPOLAR SUICIDAL IDEATION the average of US$800 million that is the esti-
PTSD AUD ANXIETY SUM mated cost to bring a single drug to market.
1997
3000 We do know that MAPS, although with a
longer timeline, is following a far leaner ap-
2915
proach, with their total costs still under
2500 US$100 million; they expect to spend an
additional $100 million in further research
2577
expenses plus around $70 million in com-

2000
1408
mercialisation expenses prior to launch. Al-

though the expected approval has crept up
1034
over the years, 2023 seems to be a reason-

1420
1500
able estimate.
1000 The trials listed on the next two pages are

856
542
633
sorted by either their start date or probable

start date if the trial isn’t ongoing right now.
517
500 As previously mentioned, much research is

367
207
284
289
picking up in the UK, with Beckley Psytech,

194
108
92
225
27
16
Awakn and Small Pharma being three of the

0
companies running trials.
2004
2008
2006
2009
2003
2002
2020
2007
YTD*
2001
2010
2018
2019
2016
2021
2013
2014
2012
2015
2017
2011
*2021 includes all trials registered; more trials are expected to be registered, continuing the upward trend observed.
Source: ClinicalTrails.Gov / Blossom
Notable ongoing and planned clinical trials Notable Scientific Papers patients were smoking-free six months
Research is a cumulative process where later after undergoing two sessions of psilo-
Sponsor Compound Condition Start research papers build on the work that has cybin-assisted therapy. Five years later,
come before. A new process is better under- 60% were still free from smoking. Un-
stood, or a more controlled study is done to fortunately, no other research papers on
PHASE III MAPS MDMA PTSD 2020 confirm the findings from an open-label trial. smoking, which kills eight million people
Some studies, however, are revolutionary per year, have been published.
PHASE II Compass Psilocybin TRD+ 2019 and bring about a change in perspective that
moves a field ahead to a new milestone, from
Usona Psilocybin MDD 2019 which small new steps can be taken again. 4. The safety and efficacy of
±3,4-methylenedioxymetham-
MindMed LSD Cluster Headaches 2019 Based on the database of more than 1,200 phetamine-assisted psycho-
psychedelic research papers, we’ve highlight- therapy in subjects with chronic,
Seelos Therapeutics Ketamine Suicidal Ideation 2020 ed some of the most influential, revolutionary treatment-resistant post-traumat-
papers on psychedelics below. These mark ic stress disorder: the first ran-
Small Pharma DMT MDD 2020 some of the moments that marked the age of domised controlled pilot study
psychedelics as medicines.
GH Research 5-MeO-DMT TRD (and others) 2021 The first RCT that studied MDMA for
1. Antidepressant effects of ket- PTSD was published in 2010. The study
MAPS MDMA Eating Disorders 2021 amine in depressed patients was incredibly successful and showed
that 83% of participants who received
MindMed LSD Anxiety 2021 This paper, published in 2000, is the MDMA did not qualify for PTSD anymore;
most cited paper in our database and one this was only 25% in the control group.
Mydecine Psilocybin PTSD 2021 of the first to investigate ketamine for Many studies, after this one, have been
depression in a double-blind randomised finding similarly spectacular results. A
Awakn MDMA Alcoholism 2022 controlled trial (RCT). The study found follow-up four years later found that, of
improvements in depressive symptoms for those treated with MDMA, only two, out
Cybin Psilocybin MDD 2022 patients three days later. of the 16 contacted, had relapsed.
DemeRx Ibogaine Opioids 2022

2. Pilot study of psilocybin treatment 5. Neural correlates of the psyche-
PHASE I MindMed Ibogaine (18-MC) Opioids 2020 for anxiety in patients with ad- delic state as determined by fMRI
vanced-stage cancer studies with psilocybin
Perception Neuroscience Ketamine TRD 2020
Ten years later, in 2010, this RCT investi- Many hypotheses existed around what
Beckley Psytech 5-MeO-DMT MDD 2021 gated the effect of psilocybin on anxiety happens when psychedelics are adminis-
in those battling life-threatening cancer. It tered; in 2012, we get a first glimpse at what
Eleusis LSD Alzheimers 2021 found reductions in anxiety and depres- lies below the hood. The ICL team finds
sion which later studies found helped up that blood flow decreased in several hub
Algernon DMT Stroke 2021 to five years later. The study was conduct- regions of the brain, something that was
ed only with 12 patients; a 2016 study with quite surprising at that time. Although more
Beckley Psytech Psilocybin Headaches/pain 2021 51 patients found similar results. fMRI studies have been done since that time,
there are still many open questions about
Entheon Biomedical DMT SUD 2021 how psychedelics influence brain processes.
3. Pilot study of the 5-HT2AR agonist
Eleusis Psilocybin MDD 2022 psilocybin in the treatment of
tobacco addiction
Lophora Psilocybin MDD 2022
It is hard to believe that it is already
Journey Colab Mescaline AUD 2022 seven years ago that, in 2014, an
open-label trial showed that 80% of
Source: ClinicalTrails.Gov / Blossom
6. The entropic brain: a theory of identified that may (together) underlie Psychedelics as medicines approval
conscious states informed by the therapeutic effects of psychedelics.
neuroimaging research with psy- 2019 2023 2025 2026 2027
chedelic drugs
9. Human hallucinogen research:
A bridge between the neuroscience and guidelines for safety MDD Psilocybin DMT
the psychology of psychedelics was
built with the publication of ‘the entropic Less exciting than other studies, the TRD Esketamine Psilocybin DMT Ketamine
brain’. The paper proposes two different guidelines for safety that were published
forms or states of cognition where one is in 2008 have served a critical role in the PTSD MDMA Psilocybin
more ‘critical’ and unconstrained; the psy- development of psychedelic research. The
chedelic state. Several revisions since the ‘set’ and ‘setting’, knowledge of dosing, HEADACHES/ LSD Psilocybin
publication in 2014, such as the Relaxed and developing trust with the partici- MIGRAINES
Beliefs Under Psychedelics model, have pants, are key elements to facilitating a
continued refining this framework. good research protocol. SUICIDAL Esketamine Ketamine
IDEATION
7. Psychedelics and Mental Health: 10. Trial of Psilocybin versus Escitalo- EATING MDMA
A Population Study pram for Depression DISORDERS
Psychedelics were studied in patients Contrary to the other papers indexed ANXIETY LSD
with life-threatening diseases not only here, this RCT was only published in
because of their need for help but also April 2021. The study pitted psychedel- SUBSTANCE Ibogaine, MDMA DMT, Mescaline
because regulators were more likely ics directly against an antidepressant USE DISORDERS
to approve the study if patients had a (escitalopram). The study found that the
shorter life to live during which they psilocybin group had better results, but ALZHEIMERS LSD
could be negatively impacted by the use unfortunately, the main measure was not
of psychedelics. Studies like this survey statistically different. Still, this marks a STROKE DMT
of nearly 22,000 people show that these seminal moment where a direct compar-
concerns may not be valid, as it found a ison against one of the most widely used Source: Blossom
slightly lower rate of mental health prob- antidepressants was made.

lems for those who used psychedelics
than the general public. Psychedelics making
it to market
The timeline presented here is our best, argu- faces somewhat better odds and has about a
8. Psilocybin can occasion mysti- ably optimistic estimate, for when the different 25% chance of getting approved.
cal-type experiences having sub- psychedelics or their second-generation equiv-
stantial and sustained personal alents could be approved for medical use. Will this be different for psychedelics? Possi-
meaning and spiritual significance bly. For many, we know the safety profile from
This is based on the current drugs under devel- earlier research and a lot of evidence is point-
Through which mechanisms psyche- opment, such as MDMA for PTSD, and drugs ing towards effectiveness. But enthusiasm
delics have long-term positive effects, that are just now going into clinical trials. There and personal transformation stories may not
when the molecules have long since is good anecdotal evidence for many com- always translate to success in phase III trials.
left the body, is hotly debated. One line pounds and health indicators, and we expect Novel psychedelics will also have to prove
of thought finds that the more intense many to pass through the trials successfully. their efficacy against those already approved;
the mystical experience, the better the something that will turn out to be difficult if
effects on mental health. Since the Based on research from Biotechnology Inno- real-world data supports the effectiveness
publication of this paper in 2006, many vation Organisation, QLS Advisors andInforma found in trials conducted with classical psy-
others have found similar correlations. UK from this year, the chances of developing a chedelics. Off-label use of psychedelics could
Other processes such as long-lasting novel compound as a medicine are below 10%. also be expected in the future, much as it has
neurological changes have also been Repurposing a drug, for a new health indicator, been with ketamine.
The Psychedelics as Medicine Report | The Psychedelics as Medicine Report |
Thank you to everyone who believes in us and

in our mission. Our successful IPO is just one
measure of this ongoing support and has set
us up to continue to do incredible work.
Our deepest gratitude to those who recognized

the therapeutic potential of these compounds
long before we did, often risking their careers
and livelihoods in the pursuit of public health
and good. We also recognize that much of our
work builds on hundreds, if not thousands of
years, of indigenous knowledge. Without the
wisdom, ingenuity of indigenous cultures our
current frameworks—and knowledge of these
medicines—would not be as sophisticated as
they currently are. But we believe that there is
still far more to be revealed.
We also thank those who have become

believers in the potential therapeutic value
of these compounds. Together we can see a
bright future, and we hope we can be part of
the solution, addressing the crises occurring
in the field of mental health.
And lastly, a big thank you to the most

important person in the room – the patient.
While struggling with mental health disorders
for so long, we thank you for bravely
participating in clinical trials, for your open-
mindedness, and for your persistence
in gaining acceptance of these unfairly
maligned compounds.
The Psychedelics as Medicine Report | Glossary The Psychedelics as Medicine Report | Glossary
Glossary
ACT acceptance and commitment therapy
ADHD attention deficit hyperactivity disorder
AUD alcohol use disorder
BTD Breakthrough Therapy designation
CBCT Cognitive behavioural conjoint therapy
CBT Cognitive behavioural therapy
CIIS California Institute of Integral Studies
CSE Canadian Stock Exchange
CNS central nervous system
DALYs disability adjusted life years
DEA Drug Enforcement Administration
DMT Dimethyltryptamine
DSCP Drug software combination products
ECT electroconvulsive therapy
EDs eating disorders
EEG electroencephalogram
EMA European Medicines Agency
FDA Food and Drug Administration
fMRI functional magnetic resonance imaging
GITA Global ibogaine therapy alliance
The Psychedelics as Medicine Report | Glossary The Psychedelics as Medicine Report | Glossary
GMP Good Manufacturing Practice SNRIs serotonin and norepinephrine reuptake inhibitors
ICL Imperial College London SSRIs selective serotonin reuptake inhibitors
IND investigational new drug SUD substance use disorder
IM intramuscular TBI traumatic brain injury
IP intellectual property TGA Therapeutic Goods Administration
IPO initial public offering TRD treatment-resistant depression
IV intravenous UCLA University of California, Los Angeles
LSD lysergic acid diethylamide VR virtual reality
MAOIs monoamine oxidase inhibitors WHO World Health Organisation
MAPS Multidisciplinary Association for Psychedelic Studies
MAPS PBC Multidisciplinary Association for Pyschedelic Studies Public Benefit Corporation
MDD major depressive disorder
MDMA methylenedioxymethamphetamine
MMA Mind Medicine Australia
NGO non-government organisation
NHS National Health Service
OCD obsessive-compulsive disorder
OUD opioid use disorder
PAT psychedelic assisted therapy
PPD postpartum depression
PTSD post-traumatic stress disorder
RCT randomised controlled trial
SI suicidal ideation
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PSYCH:

About Unlocking the commercial

As our collective understanding of and atti-

The use of psychedelics as medicine has

PSYCH tracks key psychedelic players, inno-

PSYCH provides a coercive perspective on the

PSYCH unlocks the commercial potential of

Empowering our partners

ABOUT BLOSSOM SERVICES

As psychedelics leave the lab and shape to

TEAM Our joint team works

William Potts Floris Wolswijk

Russell Cafferty Beriwan Ceren Stephen Murphy

The psychedelic substances profiled in this Serotonin (5-HT)

Psychedelics Mescaline (peyote) LSD

Research is Psychedelics poised

Psychedelics are being investigated and ex- Legislation and

KEY TAKEAWAYS A GROWING MARKET

1. Medical psychedelics companies

2. The market value of medical

3. The pandemic has great potential

Biotech and pharmaceutical companies con-

There are over 100 ketamine clinics in op-

Projected growth of medical psychedelics

Projected growth of aligned to their goals, though it will be en- ECONOMIC

and COMPASS Pathway. Diversity in the offer-

Legal classification of psychedelics

DRUG UN STATUS* US STATUS CANADA STATUS

Ayahuasca Uncontrolled Schedule I/ Schedule III/

Cannabis Schedule I Schedule I Schedule VIII

DMT Schedule I Schedule I Schedule III

Ibogaine Uncontrolled Schedule I Controlled

Ketamine Uncontrolled Schedule III Schedule I

LSD Schedule I Schedule I Schedule III

MDMA Schedule I Schedule I Schedule I

Peyote/ Schedule I/ Schedule I/ Schedule III/

Psilocybin Schedule I Schedule I Schedule III

1. We discovered that approximately

2. Two in three individuals are aware

3. Consumer knowledge about

4. Results show that 38% of

AGREE STRONGLY AGREE

AGREE STRONGLY AGREE

I SUPPORT THE COVERAGE BY HEALTH INSURANCE OF PSYCHEDELICS FOR MEDICINAL USE

0% 25% 50% 75% 100%

I KNOW SOMEONE WHO WOULD BENEFIT FROM PSYCHEDELIC THERAPY

The education opportunity

Which statement best describes your awareness of

UNITED STATES CANADA UNITED KINGDOM FRANCE GERMANY

VERY UNLIKELY/ NEUTRAL/ VERY LIKELY/

50% REASON FOR SEEKING PSYCHEDELIC DRUG USE

1. Healthcare professionals are

2. There is strong agreement about

3. Two-thirds of healthcare providers

STATE OF MENTAL HEALTH:

Do you have a pre-existing mental health condition?

YES, AND CURRENTLY

Healthcare workers’ atti-

I HAVE NEVER COME ACROSS SUCH RESEARCH

THERAPY: THE BENEFITS Healthcare workers'

cases and training initiatives. The most popu-

As more states look to decriminalise and le-