Psychedelics 2021

PSYCHEDELICS 2021
A YEAR IN REVIEW
A five-part review of psychedelics in 2021: from drug policy

reform and research highlights, to pop culture and controversy.
1
INTRODUCTORY
REMARKS
"JUST AS THE NUMBER OF MOLECULES UNDER
INVESTIGATION HAS, WELL, MUSHROOMED; SO TOO HAVE
THE AILMENTS THAT RESEARCHERS AND DRUG DEVELOPERS
SEEK TO TARGET."
Given that Psilocybin Alpha was launched in Spring psychedelics research centres; Bills passed that man-
2020, this past year marked our first full year of date State-level research into psychedelics; amend-
reporting on the psychedelics space. It’s also the first ments to Canada’s Special Access Programme and
year that I was able to meet so many folks in person further Section 56 exemptions allowing access to psi-
for the first time, which was a welcome change from locybin-assisted therapy; and many, many other posi-
Zoom. tive signals.
These days I am increasingly reflecting on just how But, just as we see outsized expectations from par-
inappropriate the name Psilocybin Alpha has become. ticipants in clinical trials (which can lead to outsized
When I started writing about psychedelics nearly two disappointment among patients who fail to respond),
years ago, psilocybin was at the forefront of clinical we certainly saw high expectations of publicly-listed
research into the ‘true’ psychedelics, and the sub- psychedelics stocks, which instead performed terribly
ject of early investor interest. Today, psilocybin is just this year. There is a clear disconnect between funda-
one of a whole host of molecules under investigation, mentals, such as company news and data readouts,
with derivatives and entirely new chemical entities and stock prices, as investors struggle to value these
increasingly the subject of drug development efforts. unusual ventures. But, psychedelics startups conti-
nued to succeed in their fundraising efforts in 2021,
Just as the number of molecules under investiga- with little signs of slowing.
tion has, well, mushroomed; so too have the ailments
that researchers and drug developers seek to tar- As the psychedelics space continues to change
get. While neuropsychiatric diseases such as depres- in both size and composition, some have right-
sion and PTSD represent a beachhead for psychede- fully expressed concerns about new influences,
lic research, we’re increasingly seeing a move toward such as the increasing attention paid to profitabi-
other areas of medicine that are also characterised by lity and defensibility by psychedelics companies.
high unmet needs, such as neurodegenerative disea- Controversies have also emerged from more esta-
ses. We should be cautious, however, with oversta- blished sides of the psychedelic ecosystem, with
ting the ‘promise’ of psychedelics to treat such disea- sexual abuse allegations surfacing long overdue
ses: while psychedelics appear to work in a trans- conversations.
diagnostic manner, much of the research is in early
stages. In this review series, we’ll look at a number of key
areas of activity for psychedelics in 2021, before sha-
2021 brought a great deal of validation to psyche- ring some trends and events to keep an eye on in
delic-assisted therapies, most notably via the stellar 2022. Of course, this is not exhaustive: either in con-
results of MAPS’ Phase 3 MDMA-assisted therapy for tent, or in terms of the voices represented. As always, Written by Josh Hardman
PTSD study. we welcome your comments. with research support from Noah Smith
This psychedelic research is taking place amidst an With thanks to Michael Haichin, Graham Pechenik, and Sean
increasingly warm context, which includes: federal Clancy for their feedback
grants in the U.S. and Australia; increased psychede- J OS H H A R D M A N

lics production quotas in the U.S.; a fast-track desig- Founder and Editor © Psilocybin Alpha 2022
nation for a DMT therapy in the UK; a flurry of new
4 P SYC H ED EL I CS 2 02 1: A YEA R I N R EVI EW 5

8. 20. 46. 66.
CONTENTS 4. 46.
INTRODUCTORY REMARKS PSYCHEDELIC COMPANY HIGHLIGHTS IN
2021
8. 66.
PSYCHEDELIC DRUG POLICY REFORM IN PSYCHEDELIC PERCEPTIONS IN 2021:
2021 POPULAR CULTURE & CONTROVERSY
20. 78.
PSYCHEDELIC RESEARCH & CLINICAL LOOKING AHEAD TO A PSYCHEDELIC 2022
TRIALS IN 2021

SECTION
ONE
PSYCHEDELIC
DRUG POLICY
REFORM IN
2021
1
1.1 - FOREWORD 1.2 - THE UNITED STATES
While this Review focuses on 2021, it’s difficult to the two-year development process that ends This year we have seen an explosion of psychede- Perhaps the best way of conveying the sheer volume
contextualise the levels of psychedelic drug policy December 31, 2022. lic drug policy reform initiatives in the U.S. that follow and diversity of efforts underway is to review our
reform witnessed this year without appreciating the a variety of templates: some call for decriminalisa- Psychedelic Legalization & Decriminalization
gravitas of events in late 2020. 2020 was a groun- Beyond progress updates on these two landmark tion of psychedelics in some manner, others for lega- Tracker, produced in collaboration with Calyx Law
dbreaking year for psychedelics decriminalisation initiatives, 2021 saw a flurry of policy reform efforts lisation. Others, still, call for state-funded research and Emerge Law. A majority of the efforts visualised
and legalisation efforts, with the U.S. leading the pack across the world. As advocates and decision-makers into psychedelic-assisted therapies or other specific in the tracker were initiated in 2021.
with significant activity at both the local and state pressed for changes to antiquated drug policies, actions.
level. The twin successes of Oregon’s Measure 109 ending the prohibition and criminalization of psyche-
and Washington, D.C.’s Initiative 81, to create legal delic drug use appeared in political agendas all over
access to psilocybin-assisted therapy and to decrimi- the world.
nalise psychedelics, respectively, propelled psyche-
delics decriminalisation and legalisation efforts to the Here are some of 2021’s most significant develop-
mainstream. ments from the U.S., Canada, UK, and Australia.
Here at Psilocybin Alpha, our readership increased

in quantity and diversity almost overnight following
these successes at the ballot box. In response to
these initiatives we were now being contacted by—
and seeing subscribers from—journalists of all stripes;
entrepreneurs looking to launch biotechs or retreats;
investment banks looking to keep tabs on the emer-
ging industry; therapists hoping to offer this new
modality as part of their practice; and more.
We also observed psychedelic companies, and their

executives, scramble to find a line and toe it. Many
chose to publicly celebrate Oregon’s Measure 109,
with Field Trip’ Ronan Levy exclaiming, “what an
incredible accomplishment,” when discussing the
results with Psilocybin Alpha. Other executives have
been more hesitant to condone the Measure, while
others still have been accused of drumming up
opposition to the measure.
As individuals and companies try to find their feet in

this rapidly changing legal and public opinion lands-
cape, the pace of drug policy reform efforts has not
slowed in 2021. The aforementioned Initiative 81
came into effect in D.C., with psychedelics de facto
decriminalised, and Oregon Psilocybin Services, hou-
sed within the Oregon Health Authority, is making
progress toward implementing Measure 109 through

TEXAS BILL MANDATES STATE RE- In response to the success of the Bill, the Center for CALIFORNIA MOVES CLOSER TO-
Psychedelic Research and Therapy was launched The Verdict: SB 519, which would decriminalise
SEARCH INTO PSYCHEDELICS WARDS DECRIMINALISATION many psychedelics in California, drew a great deal
at the University of Texas at Austin’s Dell Medical
School. We spoke to the Co-Director, Dr. Greg of attention this year. While the Bill has now been
While liberal states and cities have no doubt led the Fonzo, who explained that the centre will “advance The most populous state in the U.S. captured a great put on pause, the fact that it passed a number
charge, as was the case with marijuana, some initiati- the application of psychedelics for the treatment of deal of attention with the introduction of Senate Bill of key Assembly Committees is a feat in itself,
ves have a surprisingly bipartisan flavour. Take Texas, mental health disorders through impactful clinical 519 (SB 519) which would decriminalise the posses- and many will be closely watching SB 519 as it is
for example. Former GOP Governor Rick Perry joined research.” sion of some psychedelic drugs in the golden state. reintroduced for consideration in 2022.
Democrat Alex Dominguez to back House Bill 1802,
which was enacted into law on June 18th, came into Emphasising the centre’s focus on veterans, Fonzo Notably, and importantly, the bill explicitly exclu-
effect on September 1st and expires in two years. explained that the first of its kind in Texas facility will des peyote, and as such both peyote and mesca-
aim to “improve the health of those suffering from line will remain illegal in the state. The reasoning for A WEALTH OF OTHER INITIATIVES
HB 1802 requires the Department of State Health severe depression, anxiety and PTSD through psy- this exclusion is to ensure that the endangered plant
Services to evaluate the therapeutic efficacy of psychedelic-assisted psychotherapy and research focu- remains available for use in Native American spiritual
Events in Texas and California are but two examples.
chedelics including MDMA and psilocybin for the sed heavily on military veterans and adults affected by practices.
Over the past year, U.S. states and municipalities have
treatment of depression, anxiety, PTSD, migraine and early childhood trauma.”
proposed, introduced, and voted on a range of laws
other conditions. The report, which is to be submit- We followed the early passage of SB 519 closely as
governing psychedelics. Decriminalisation and lega-
ted by December 1, 2022, is to involve a clinical trial Why might people feel the need to mandate this it passed a number of key California State Assembly
lisation initiatives were undertaken across 20 states,
of psilocybin for PTSD in veterans, with $1.4m in fun- research at the State level? Well, Alexandria Ocasio- Committees, including the Committee on Public
many of which prioritised the need to reduce or eli-
ding allocated. Cortez’s attempt to lift barriers on federal research Safety where it passed by a 5-3 vote. Senator Scott
minate criminal penalties for psychedelic possession
into psychedelics via an amendment was defeated Wiener, who authored the Bill, claimed that psyche-
and increase access for therapeutics purposes.
In November, Perry appeared on stage along- for a second time this year in a 285-140 vote. But, delics are “fixing people’s brains,” and was supported
side Tim Ferriss and Rick Doblin at a gala in support it’s important to compare this margin of defeat to by witnesses including veterans group Heroic Hearts
Visit our Psychedelics Legalisation &
of Veterans Exploring Treatment Solutions (VETS), when the amendment was put to vote in 2019, when and MAPS’ Ismail Ali.
Decriminalisation Tracker to stay up-to-date with the
a non-profit dedicated to assisting U.S. veterans it was defeated 331-91. “I am undeterred,” explained
latest developments on this front.
seeking psychedelic-assisted therapies. This appea- Ocasio-Cortez, “I’ll keep bringing it up until the times The Bill didn’t proceed unscathed, however, and was
rance drives home just how important the narrative catch up.” watered-down by a number of amendments conce-
surrounding veterans is to some corners of the psy- ded by Wiener. Perhaps most notably, a clause that
chedelic renaissance, and has certainly been cen- mandated the expungement of historic convictions
tral to building a bipartisan agenda around their The Verdict: Texas House Bill 1802, which related to the possession of psychedelics was remo-
acceptance. requires the State’s health agency to evaluate the ved from the Bill. Ketamine was also removed from
therapeutic efficacy of psychedelics, is remarkable the Bill, at the request of the Committee on Public
We highlight Texas’ HB1802, and Rick Perry’s involve- for a number of reasons, not least its success in Safety.
ment, for two reasons. Firstly, and as aforementioned, a firmly Republican state. It also propelled the PSYCHEDELICS LEGALISATION
because it succeeded in a decidedly Republican state, launch of a new Center for Psychedelic Research Then, in late August Senator Wiener announced that &
and was openly supported by prominent Republicans and Therapy at the University of Texas at Austin, the Bill had been put on pause. The Bill is still “alive DECRIMINALISATION TRACKER
like Rick Perry. It’s also forming a model for other and has provided a cookie cutter template for like- & well,” the Senator explained on Twitter, but it has Powered by Calyx Law & Emerge Law
Republican states, such as Florida, where politicians minded states such as Florida been paused until 2022. The Senator explained that,
have now introduced similar bills (SB348 and HB193). “over the next year [a] coalition of veterans, parents, ACC E SS DATA H E R E
Secondly, it’s not a decriminalisation or legalisa- healthcare professionals and others will continue to
tion initiative, but rather an effort to mandate state work hard to earn the support of Assembly Members.”
governments to support research into psychedelic
therapies.

Beyond state-level efforts, many reform advocates for psilocybin under Section 56. This (admittedly HEALTH CANADA SPECIAL
found success at the local level. According to Emerge modest) batch of exemptions was particularly impor-
ACCESS PROGRAM TO
Law’s Sean Clancy, “targeted local government mea- tant, not just because it signalled the incoming Health
sures with smaller footprints achieved more political Minister’s openness to the process, because they ALLOW CONSIDERATION OF
success” in 2021. were granted to patients who are not palliative, or in
receipt of a terminal diagnosis. PSYCHEDELICS AND OTHER
The Verdict: What a year it’s been for RESTRICTED DRUGS
We spoke to TheraPsil, a Canadian non-profit that
psychedelic drug policy reform in the U.S. On
works closely with physicians and patients to advo-
the whole, we agree with Emerge Law’s Sean
cate for compassionate access to psilocybin. To date, Just days after we spoke with TheraPsil’s CEO, news
Clancy, who told Psilocybin Alpha: “2021 revealed
the organisation has helped 47 individuals access psi- broke that Health Canada will amend its Special
mixed success among a small handful of state
locybin for a number of therapeutic needs via the Access Program to allow for drugs like MDMA and
lawmakers who aimed at psychedelic drug
Section 56 exemption route. psilocybin to be considered.
decriminalization or legalization – in contrast,
targeted local government measures with smaller
Spencer Hawkswell, TheraPsil’s CEO, told us that We covered this news in late 2020, when Health
footprints achieved more political success.”
“2021 was a year for the Canadian history books.” Canada first signalled its intent to make such an
According to Hawkswell, 81 Canadians were gran- amendment. Just as 2021 drew to a close, and just
ted access to legal psilocybin therapy in 2021. 62 of over a year after our first reporting on the matter,
these were patients (47 of which were supported by Numinus broke the news that the amendments will
TheraPsil) and 19 were health care practitioners (all of come into effect on January 5th, 2022.
which were supported by TheraPsil).
In 2013, an amendment to the Food and Drug
Despite these successes, Hawkswell was keen to note Regulations (section C.08.010) saw restricted drugs—
that these cohorts represent a relatively small number including psychedelics like MDMA and Psilocybin—
of those who might benefit from psilocybin therapy. explicitly excluded from the SAP. Under this amend-
“While the successes of the past year are certainly to ment, clinical trials were the only route through
be celebrated, so many Canadians still wait months which patients could access these drugs. The new
for their exemptions and all 81 Canadians who have/ amendment restores potential access to restricted
had exemptions were forced to find their psilocybin drugs. This could afford Canadians access to poten-
mushrooms underground/illicitly,” he explained. tially life-saving medications and therapies prior to
their formal approval and routine provision.
1.3 - CANADA The Verdict: These case-by-case exemptions Once the relevant subsection is repealed on January
are certainly important for the individuals that 5th, restricted drugs will be treated in the same man- The Verdict: This amendment represents
received them, but long wait times and the ner as all other controlled substances when conside-
HEALTH CANADA GRANTS relatively small number of recipients indicate red under the SAP, that is: practitioners can request
the latest in a string of progressive moves by
Health Canada, and will allow psychedelics to
the insufficiency of such a piecemeal process. these drugs for patients with serious or life-threate-
FURHTER SECTION 56 EXEMP- Nonetheless, the willingness of Health Canada to
be considered for access via the Special Access
ning conditions where other therapies have failed, Program (SAP). However, much will remain open
TIONS grant such exemptions, including the country’s aren’t suitable, or aren’t available in Canada. to debate, such as the point at which other
new Minister of Health, demonstrates a pragmatic
therapies are deemed to have ‘failed’ or to not
stance by the regulator, which will hopefully This reversal does not guarantee that restricted drugs be ‘suitable,’ which are prerequisites for an SAP
In 2021, Health Canada continued to affirm its com- be reflected in further reforms in the coming will be approved via a SAP application, but rather that application.
mitment to providing psilocybin access exemptions months and years. they will be treated in the same manner as all other
to patients in need. Most recently, Canada's new controlled substances.
Minister of Health granted his first three exemptions

Alluding to broader strategic initiatives underway in
“It is of course exciting to hear the Prime Minister post-Brexit Britain, McDonald explained that the UK
Boris Johnson saying in the House of Commons that government has embarked on “the fastest increase in
"The ask is simple: Psilocybin he will consider the evidence for the rescheduling R&D spending ever.”
and other similar psychedelics to of psilocybin as to facilitate medical research in
be moved to the same levels of the UK, but in the context of the Home Office’s “The clinical trial system as well as the broader inno-
control as heroin. Rescheduling position regarding psilocybin we know that this vation system is being transformed, as is the regula-
to Schedule 2, for research must be presaged by continued engagement with tor, to become an enabler of innovation,” McDonald
purposes only, would address the realities of the regulations by Ministers to get noted. “These changes create an increasingly fric-
some of the issue and unlock vast this right.” tionless pathway that will allow developers of psy-
potential in new treatments and chedelic drugs to undertake speedier and more cost-
science. The interia to move on - Timmy Davis -effective research processes in the UK.”
this is not based on evidence and
is unacceptable" This is certainly evidenced in recent actions by regu-
lators such as the Medicines and Healthcare pro-
- Crispin Blunt, MP ducts Regulatory Agency’s (MHRA), which issued new
The Verdict: There’s plenty of misplaced hype guidance on the use of real-world data in clinical
here, which isn’t helped by shoddy editorial trials, and the National Institute for Health and Care
standards at the BBC. What is being proposed Excellence (NICE) which issued its first update to gui-
is a rescheduling, not legalisation, of psilocybin delines on the treatment of depression for over a
in the UK, which would reduce barriers to decade this year.
research. Action by the Home Office to enact
1.3 - THE UNITED KINGDOM such a rescheduling is long overdue, according

to insiders who claim the Prime Minister
In concrete terms, we have seen these innovations in
UK drug development regulations manifest in a fas-
approved the action in principle earlier this year. t-track designation for Small Pharma’s DMT therapy
BORIS JOHNSON CONSIDERS “I can say that we will consider the Advisory Council application. candidate, which is discussed later in our Research
on the Misuse of Drugs recent advice on reducing and Clinical Trials section.
RESCHEDULING PSILOCYBIN barriers to research with controlled drugs such as
the one he describes, and we will be getting back
In October 2021 news broke that UK Prime Minister to him as soon as possible.” The Verdict: As the UK seeks to find its edge in
Boris Johnson is set to “consider calls to legalise A POST-BREXIT FOCUS ON R&D a post-Brexit world, nurturing its biotech industry
magic mushroom drug psilocybin” (BBC). The BBC - Boris Johnson has emerged as a clear focus. This bodes well
headline, which featured the word ‘legalise,’ overs- SPENDING AND STREAMLINING for psychedelic researchers and companies, who
tates the proposed change, which is a rescheduling Speaking to the Express in September, Crispin Blunt may benefit from streamlined drug development
rather than legalisation. claimed that the Prime Minister had assured him in
MAY FAVOUR PSYCHEDELICS
routes such as the Innovative Licensing and
May that psilocybin would be rescheduled. However, COMPANIES Access Pathway (ILAP) and pragmatic approaches
During Prime Minister’s Questions (a weekly fixture in no such action has yet occurred. to research and clinical trials such as the
UK Parliament where MPs pitch questions to the PM), employment of real-world data.
conservative MP Crispin Blunt urged Johnson to res- Regardless, the fact that these debates are playing Tom McDonald, CEO of London-based psychede-
chedule psilocybin to enable further research into the out on the floor of the UK Parliament is remarka- lics company Clerkenwell Health, told Psilocybin
drug’s therapeutic potential. ble, and promising. But, the Conservative Drug Policy Alpha that while the aforementioned movement
Reform Group (CDPRG) warns that continued enga- to reschedule psilocybin “is gaining traction within
In response to the question, the Prime Minister said gement with Ministers is necessary in order to secure civil society”, “the real action is within the regulatory
that he would get back to Blunt “as soon as possible.” the rescheduling. Speaking to Psilocybin Alpha, bodies of the state.”
His full response to Blunt was as follows: CDPRG’s Timmy Davis said:

1.4 - AUSTRALIA
AUSTRALIAN REGULATORS FEDERAL GOVERNMENT CARVES
REJECT PSILOCYBIN AND MDMA OUT $15M FOR PSYCHEDELIC
RESCHEDULING RESEARCH
It’s not all bad news for psychedelics advocates in

In late 2020, a proposal was submitted to the
Oz, though. Just weeks after the proposal was ini-
Australian Therapeutic Goods Administration (TGA),
tially rejected in Spring 2021, the federal govern-
the regulatory body in charge of the country’s drug
ment announced a $15m grant program to support
scheduling, to reclassify psilocybin and MDMA from
research into psychedelics, including MDMA-assisted
prohibited substances to controlled medicines.
psychotherapy.
Following two rounds of consideration, the TGA ulti-
mately rejected the rescheduling efforts in mid-De-
cember, citing the emergent nature of evidence and The Verdict: This capital injection into
explaining that “the therapeutic value… has not been psychedelic research was welcomed by
established.” researchers. Beyond its cash value, it sends
a strong message that Australia is open for
psychedelics research.
The Verdict: We would have been surprised if
the TGA had taken the decision to reschedule
psilocybin and MDMA at this stage, which would
be out of kilter with other similar countries.
However, this has put the issue firmly on the
national agenda in the land down under.
18 P SYC H ED EL I CS 2 02 1: A YEA R I N R EVI EW

SECTION
TWO
PSYCHEDELIC
RESEARCH
& CLINICAL
TRIALS IN
2021
2
2.1 – FOREWORD As such, it’s worth looking at studies announced and 2.2 – PSILOCYBIN GOES However, despite these methodological misfortu-
approved in 2021, and considering when we may nes Witowski explained that, “there is still promise for
expect to see data readouts from such work. HEAD-TO-HEAD WITH psilocybin in the treatment of depression but more
The resurgence of research into psychedelics has
continued to thrive over the past year. Dozens of Just as the funding environment for psychedelic
SSRI ANTIDEPRESSANT studies are needed to prove this in the eyes of regu-
lators; the best way to do this and increase access is
trials and hundreds of studies have been published research has heated up significantly in recent years, through top-quality science and clinical research.”
in 2021, expanding the depth and scope of scientific regulators are also demonstrating an increasingly
TRIAL OF PSILOCYBIN VERSUS ESCITALOPRAM
inquiry in this flourishing space. warm attitude to such work. Toward the end of this The trial was also profiled in a BBC documentary,
FOR DEPRESSION
section we review some key regulatory developments somewhat unimaginatively titled, The Psychedelic
Robin Carhart-Harris et al. (2021)
If published findings from this past year are a reliable in 2021, and profile a handful of new psychedelics Drug Trial.
Access Publication Here
indicator of what is to come, these investigations will research centres.
foreseeably expand our fundamental understanding
The Verdict: Despite some prima facie
of psychedelics and point to new, promising avenues As you will see as you leaf through this report, psy- In April 2021 results of a Phase 2 trial evaluating psi-
shortcomings, a closer look at this study shows
of exploration. chedelic research is showing no signs of slowing. locybin-assisted therapy compared with psychothe-
that psilocybin-assisted therapy outperformed
One of the most prolific psychedelics researchers, rapy and escitalopram, a common SSRI antidepres-
the (standard of care) SSRI antidepressant on
However, we must also appreciate the methodolo- Robin Carhart-Harris, predicts “more of the same” sant, in the treatment of major depressive disorder
a number of measures. Its publication in the
gical challenges inherent in psychedelic research, as in 2022, and data confirms that we’re witnessing (MDD) were published in the New England Journal of
prestigious journal NEJM, and its widespread
well as the broader fields within which such research the most productive period of psychedelic research Medicine. This was the first randomised, controlled
reporting in mainstream media, marks a
is nested. (at least that which is conducted in recognised study of psilocybin for the treatment of MDD.
significant moment for psychedelic research in
institutions).
itself.
It’s worth reminding ourselves of the lengthy times- Publication in NEJM—one of the oldest and most
cales involved in drug development, with clinical trials To begin, here are some of 2021s most notable prestigious medical journals—is, in itself, a significant
regularly taking in excess of six years to complete. publications... moment for psychedelic research. The study was also
covered widely in mainstream media outlets, inclu-
ding NBC; Scientific American; BBC; Rolling Stone;
2.3 – MAPS PUBLISHES
and the Guardian. RESULTS FROM PHASE 3
However, the results didn’t—at least on the face of TRIAL OF MDMA-ASSISTED
it—appear to meet the lofty expectations of many.
This is partly due to the study’s design, including the
THERAPY FOR PTSD
measure of depression that was chosen as the pri-
mary outcome in the study’s pre-registration.
MDMA-ASSISTED THERAPY FOR SEVERE PTSD:
Speaking to Psilocybin Alpha, Psilera Bioscience’s
A RANDOMIZED, DOUBLE BLIND, PLACEBO-
Co-Founder and CEO Chris Witowski explained, “by
CONTROLLED PHASE 3 STUDY
primary endpoints [sic] there was no difference in
Jennifer M. Mitchel et al. (2021)
efficacy, however, when you look at other endpoints
Access Publication Here
there seem to be better outcomes trending towards
psilocybin.”
One of the year's most anticipated publications came
We featured exclusive expert commentary from in May, when MAPS released results of its MAPP1
Stanford School of Medicine’s Boris Heifets in an April Phase 3 trial investigating MDMA-assisted therapy
Bulletin, in which he further explained some of these (MDMA-AT) in the treatment of PTSD.
“very unfortunate (and unlucky) design features” that
make this study “difficult to interpret.” The trial, which enrolled 90 participants, found that
88% of individuals who underwent MAPS’ MDMA-AT

protocol experienced clinically meaningful reductions trial,” said Gül Dölen, a neuroscientist at Johns Some important findings in the publication can be Haichin points out that the ability to eliminate the
in PTSD symptoms. Perhaps even more remarkable Hopkins University School of Medicine, who was not found below: overnight stay from the treatment protocol would
was the fact that 67% of participants in the treatment involved in the research. “There is nothing like this in have a significant impact on cost-effectiveness.
arm no longer met the criteria for a PTSD diagnosis clinical trial results for a neuropsychiatric disease.” There is no obvious impact of past SSRI usage. However, he also points out that 10/14 participants
2 months post-treatment, versus 32% of those in the Importantly, the study found that there was “no that requested further integrative visits were in the
placebo group. It’s been no small feat to get this far, Rick Doblin obvious impact of SSRI history on the effectiveness MDMA arm, indicating that the amount of psycho-
reminded Psilocybin Alpha. “MAPS trained over 800 of MDMA.” This is a reassuring finding, especially in therapy in the current model may be insufficient for
In a view shared by many, MAPS’ Founder Rick Doblin therapists [in 2021],” he explained. “We still need to the context of a study published in 2020 that sugges- some.
characterised these results as “outstanding.” So supervise each new therapist as they work with their ted past antidepressant usage reduces the efficacy of
remarkable, in fact, that Science magazine shortlis- first PTSD patient, and we still need to arrange for MDMA-assisted psychotherapy for PTSD. It’s not clear The Blinding Problem.
ted the nonprofit’s work for its 2021 Breakthrough those therapists who want to volunteer to receive why we see a discrepancy between these findings, As with most, if not all, psychedelic studies, the ele-
of the Year, dubbing MDMA-AT “a psychedelic PTSD MDMA themselves in a therapeutic setting as part of but we may expect deeper analysis following MAPS’ phant in the room is the ability of the researchers to
remedy”. their training.” second Phase 3 trial. We discuss studies published in adequately prevent participants from guessing what
2021 that further elaborate the potential interactions treatment they received, and potentially influen-
In terms of safety, there were no serious adverse There’s plenty of work ahead, too. In our Looking between SSRIs and psychedelics below. cing the results (more in this later, where we discuss
events in the MDMA group. Rather, the two serious Ahead to a Psychedelic 2022 section, we discuss a number of methodological stumbling blocks that
adverse events recorded were both in the placebo the next steps in MAPS’ path to approval with Doblin Diversity and Representation. were further highlighted in 2021).
group. Non-serious adverse events, meanwhile, himself. As a field, we still have a significant amount of work
occurred to a greater extent in the placebo group to do in terms of representation in clinical trials of Previous MDMA research used low-dose MDMA ins-
than the MDMA group. psychedelics. Just 2 participants in this trial were tead of an inactive placebo in the comparator group,
The Verdict: Our Pharmaceutical Advisor black or African American, representing just over 2% which improved blinding but made participants’ PTSD
The study received a great deal of mainstream media Michael Haichin summed up these results suc- of the sample size. For context, according to the US worse. Since the use of low-dose MDMA made it
attention, including a major write-up in the New York cinctly: “Both the efficacy and safety results are Census Bureau around 12.4% of the U.S. population is easier to find a treatment difference (and would be
Times: A Psychedelic Drug Passes a Big Test for PTSD pretty astounding. Now, MAPS will hope to repro- black or African American. unethical to give), MAPS decided—in partnership with
Treatment. Other write-ups include those from the duce these results in its second Phase 3, before the FDA—that an inactive placebo group was more
BBC, TIME, Fast Company, and a second piece from presenting data to the FDA for a potential appro- A significant body of literature (e.g., Roberts et al., appropriate for both Phase III trials.
the New York Times. val of MDMA-AT as early as 2023. 2010) shows that lifetime prevalence of PTSD is
higher in minority groups than Whites, but that mino- “However, although blinding was not formally asses-
This is about as excited as I can get about a clinical rity groups are less likely to seek treatment. While, like sed during the study, when participants were contac-
many clinical trials, MAPS’ study falls short of repre- ted to be informed of their treatment assignment at
senting society in an equitable manner, it is hoped the time of study unblinding it became apparent that
that MAPS will be in a position to deliver MDMA- at least 10% had inaccurately guessed their treatment
Assisted Therapy to a diverse range of individuals, arm. Although anecdotal, at least 7 of 44 participants
should it be approved. MAPS is prioritising this in their in the placebo group (15.9%) inaccurately believed
second Phase 3 trial, and in their therapist training that they received MDMA, and at least 2 of 4 partici-
efforts. Comments from MAPS PBC at Horizons 2021 pants in the MDMA group (4.3%) inaccurately believed
reinforced the fact that this is high on their agenda. that they had received placebo.”
Overnight Stay vs. Evening Discharge. In other words, almost 90% of participants gues-
The study also found that whether or not a partici- sed whether they received MDMA-assisted psycho-
pant had an overnight stay following treatment had therapy or not. Because of this, critics will say the
no effect on the success of the protocol. This was trial is essentially open-label, where the given treat-
achieved by allowing participants at two study sites ment is known and treatment effects tend to be
to be discharged in the evening, as opposed to being overestimated.
kept at the site overnight.

2.4 – PSILOCYBIN THER- produces a statistically significant and clinically rele-
For much deeper analysis on these results,
2.5 – MICRODOSING:
vant reduction in depression symptom severity.
APY FOR TREATMENT-RE- including contextualisation of the serious adverse LITTLE DOSES, LITTLE
events and efficacy data, read our Special Issue:
SISTANT DEPRESSION: Summarising the findings, COMPASS CEO George
Goldsmith said, “a high dose of psilocybin works
Deconstructing COMPASS Pathways’ Phase 2b EVIDENCE?
Results (>3,000 words).
COMPASS PATHWAYS' immediately, the day after, for a large number of peo-
ple, and continues to work.” READ OUR SPECIAL ISSUE HERE Anecdotal evidence has suggested that even sub-
PHASE IIB RESULTS -perceptual doses of psychedelics can produce
This appears borne out in the topline data, which Upon publication of the results, COMPASS’ stock a number of therapeutic or wellbeing-enhancing
showed that at least twice the number of patients in price took a tumble and dragged much of the sec- benefits. From general wellness benefits, to impro-
COMP360 PSILOCYBIN THERAPY FOR
the 25 mg group demonstrated response to the the- tor down with it. CMPS had been climbing since ved creativity and attention, microdosing psyche-
TREATMENT-RESISTANT DEPRESSION
rapy and remission from their treatment-resistant October, closing in on $50 for the first time since delics has garnered a substantial amount of public
Phase IIb Topline Data (2021)
depression at weeks 3 and 12 compared with the 1 February. attention.
Access Presentation Here
mg group.
How might we explain this: a rational reaction to the These positive reports have led to high expectations
In June, COMPASS Pathways announced that it However, many expressed concern about the serious publication of topline results, or a buy the rumour, and hopes that clinical evidence might one day legi-
had finished administering psilocybin therapy to all adverse events reported in the study, which invol- sell the news moment? Remember, many psyche- timise the practice in the eyes of regulators and prac-
patients enrolled in its Phase 2b clinical trial. The ved 12 patients and were more common in the 25 mg delics stocks are characterised by an unusually high titioners. To this end, many researchers have been
company had been investigating the safety and effi- COMP360 group than in the 10 mg or 1 mg arms. level of retail investor ownership compared to other evaluating the practice.
cacy of psilocybin therapy for treatment-resistant small-cap biotech companies, which may explain
depression (TRD) since March 2019. The study, which Goldsmith suggested that some of the most concer- some of the apparent irrationality. Here’s what their efforts taught us about microdo-
enrolled over 200 patients, was the largest clinical ning adverse events were among non-responders, sing in 2021…
trial for psilocybin therapy in history. who were perhaps despairing at the therapy’s inability
to help them (especially in the context of such hype The Verdict: This Phase 2b trial is the largest IMPERIAL COLLEGE LONDON
The population targeted by this psychedelic interven- and promise). On this topic, readers may find Tehseen randomised controlled double-blind trial of
tion are those with treatment-resistant depression Noorani’s piece on The Pollan Effect of interest. It’s psilocybin in the world, enrolling 233 patients RESEARCHERS FIND ANECDOTAL
(TRD). These individuals, of which there are thou- also worth remembering that TRD sufferers are a very across North America and Europe. Despite
ght to be at least 100 million worldwide, have fai- vulnerable group of people, with suicidal ideation, for concern surrounding adverse events, some
BENEFITS OF MICRODOSING
of which were serious, COMPASS’ psilocybin-
led to respond to at least two existing antidepressant example, not uncommon. "CAN BE EXPLAINED BY THE
treatments. assisted therapy protocol appears to be effective
In this trial, COMPASS Pathways attempted to stan- in a significant proportion of participants, with at PLACEBO EFFECT"
In anticipation of the results we published a Special dardise their psilocybin-assisted therapy protocol as least twice the number of patients in the high-
Issue, 2b, or not to be? Preparing for COMPASS far as possible across its trial sites and individuals: a dose (25 mg) group entering remission from SELF-BLINDING CITIZEN SCIENCE TO EXPLORE
Pathways’ Data Readout, in which we explored the significant undertaking given the heterogeneity of treatment-resistant depression at weeks 3 and 12 MICRODOSING
significance of the forthcoming results and aimed to psychedelic-assisted therapies. versus the main comparator group (1 mg). When Szigetti, B et al. (2021)
provide a primer on their interpretation. considering these results, it’s worth remembering
Overcoming the incongruities between the idiosyn- that the population targeted in this trial are In March, a group of researchers at Imperial College
Not a week later, while we were attending cratic psychedelic-assisted therapy modality and the treatment-resistant. COMPASS will now meet London published the largest placebo-controlled trial
Microdose’s Wonderland conference in Miami, the objectivity and standardisation demanded by the cli- with the FDA to discuss the design of its Phase 3 on psychedelics to date, which used an innovative
company published topline results from the study on nical trial regime is certainly no small feat. In fact, it trial. citizen science approach to explore microdosing. The
November 9th. was a significant contributor to the downfall of psy- researchers concluded that the “anecdotal benefits of
chedelic research in the first place (see Oram, 2014; microdosing can be explained by the placebo effect.”
The results of the trial were generally positive, finding Bonson, 2017; or, Hall, 2021 for a broader overview).
that a 25 mg dose of the company’s synthetic psilo- The research design was certainly interesting: 191
cybin (COMP360), alongside ‘psychological support’, participants were asked to incorporate placebo

control into their microdosing routine. However, it’s The publication, titled Adults who microdose psy- Perhaps the most important thing to note here is that effects were significantly more intense among micro-
important to note that this was not supervised: ins- chedelics report health related motivations and lower identifying a correlation between microdosing and dosers than those consuming placebo (which, the
tead, the study was self-blinded with participants levels of anxiety and depression compared to non- better mental health does not imply that microdosing researchers note, could be explained by unblinding),
instructed to place placebo and active capsules into -microdosers, was co-authored by a mix of resear- has caused a better mental state. for other measurements the group observed trends
envelopes with QR codes, before drawing the enve- chers at the University of British Columbia and those toward cognitive impairment, reductions in certain
lopes at random. with other affiliations, including mycologist and A co-author of the study reiterated that the purpose brain activity, or null results.
microdosing advocate Paul Stamets. of the study was not to establish causality, noting
While this study is, of course, not comparable in that it would not be possible via an observational The researchers conclude:
rigour to a randomised controlled trial (RCT), the The observational study found that: approach.
authors claim that their novel self-blinding approach
allows them to reach the following conclusion: There were other concerns surrounding this study, “Our findings support the possibility that
“those who [microdose] appear to be slightly less expectation effects underlie at least some of the
including the omission of any discussion around pla-
symptomatic of depression and anxiety than their anecdotal benefits attributed to microdosing with
"…Our study validates the positive anecdotal reports cebo or expectancy effects, which we would expect
peers who report similar mental health concerns psilocybin mushrooms.”
about the psychological benefits of microdosing to see in this type of study.
but do not microdose…”
(significant improvements from baseline in a broad
range of psychological measures); however, our Read our late November Bulletin for a more detailed
The study also sought to understand the motivations exploration of the study. Also note that Paul Stamets,
results also suggest that these improvements
of microdosers, with health and wellness-related
STUDY FINDS MICRODOSING
are not due to the pharmacological action of a co-author of the paper, announced that a second
microdosing, but are rather explained by the motives proving to be the most prominent. microdosing study is due to be published in 2022. PSILOCYBIN DID NOT AFFECT
placebo effect (lack of significant between-groups
differences)." Interestingly, and perhaps frustratingly, the paper was ANXIETY OR DEPRESSION
reported with headlines such as: PREPRINT STUDY SUGGESTS COMPARED WITH PLACEBO
The study was covered broadly in the media: the
“EXPECTATION EFFECTS
Guardian; FT; Science; Wired; Forbes; and others. It
PSILOCYBIN MICRODOSING DOES NOT AFFECT
also encouraged a great deal of conversation and UNDERLIE AT LEAST SOME OF EMOTION-RELATED SYMPTOM AND PROCESSING
debate within the psychedelics community, especially
Marschall, J et al. (2021)
from those who claim to have found, or witnessed, THE ANECDOTAL BENEFITS” OF
benefits from the practice.
MICRODOSING Another double-blind placebo-controlled microdo-
sing study emerged in December, which sought to
investigate whether microdosing psilocybin across
STUDY FINDS CORRELATION But, this reporting implies that causality was identified
MICROEVIDENCE FOR MICRODOSING WITH
the space of three weeks modulated emotion pro-
PSILOCYBIN (PREPRINT)
through the study: i.e., that the practice of micro- cessing, altered interoceptive awareness, and redu-
BETWEEN MICRODOSERS AND Cavanna, F et al. (2021)
dosing causes, or leads to, lower levels of anxiety ced symptoms of anxiety and depression.
LOWER LEVELS OF ANXIETY AND and depression. However, this was neither what the
A preprint of a study by Cavanna et al. published in
observational study sought to, or did, demonstrate. The researchers ultimately found that “psilocybin
December delivered another blow to microdosing.
DEPRESSION microdosing did not affect emotion processing or
Researchers recruited 34 individuals who planned to
symptoms of anxiety and depression compared with
microdose with psilocybin mushrooms and employed
ADULTS WHO MICRODOSE PSYCHEDELICS placebo.” However, the researchers were stymied by
a double-blind placebo-controlled design to investi-
REPORT HEALTH RELATED MOTIVATIONS... the fact that most participants had tried psychede-
gate the effects of microdosing on subjective expe-
Rootman, J et al. (2021)
lics previously, and many easily broke the blinding. As
rience, behaviour, creativity, perception, cognition
has been recommended for many psychedelics stu-
and brain activity.
Later in the year, in November, a microdosing study dies, research in a substance-naive population may
published in Scientific Reports caused a stir among be more fruitful
While the researchers found that reported acute
microdosing advocates and skeptics alike. Source: Big Data Made Simple.

BEYOND THE ‘BENEFITS’: studies thus far are generally healthy individuals. As 2.6 – PSYCHEDELICS IN- Commenting on the group’s approach, co-author Dr.
such, some may argue that the likelihood of seeing Alex Kwan, Associate Professor of Psychiatry at Yale
POTENTIAL RISKS ASSOCIATED
an improvement in wellbeing is lower, due to a relati- DUCE NEUROPLASTICITY School of Medicine, told Psilocybin Alpha:
WITH MICRODOSING vely high baseline.
AND NEUROGENESIS?
“Although there have been hints of psilocybin
So, we shouldn’t write-off the possibility that micro- promoting neural plasticity, we were able to
Speaking to Psilocybin Alpha, Dr. Kelan Thomas dosing may be beneficial to those diagnosed with Recent foundational scientific research has brought visualize and track the plasticity over many days
(Associate Professor of Clinical Sciences at Touro depression or anxiety, for example, just yet. investigators closer to understanding how psychede- in a live brain for the first time. The approach
University California College of Pharmacy and Board It’s also possible that we might see differences in the lics might elicit their purported therapeutic effects. is powerful, and opens up new ways to screen
Certified Psychiatric Pharmacist) noted: efficacy of microdosing across different molecules. compounds, by looking at how they directly affect
Perhaps microdosing LSD will demonstrate a dif- While the full pharmacological profiles of drugs like neural circuits.”
ferent safety and efficacy profile to, say, psilocybin. psilocybin, LSD, and DMT are not yet fully unders-
“While psychedelic macrodoses have consistently Companies like MindMed are certainly hoping this will tood, the past year saw many important break- - Dr. Alex Kwan
demonstrated benefits for mental health in clinical be the case. The company is sponsoring trials of LSD throughs that have helped push that understanding
trials, the current evidence available from double- microdosing, including via its recently announced forward. Recent discoveries appear to add support to Through their innovative efforts, the Yale researchers
blind randomized placebo-controlled microdosing study of low-dose LSD effects on sleep and cognitive the theory that much of the therapeutic potential of found that a single dose of psilocybin can quickly
trials show minimal positive benefit beyond the measures. psychedelics can be attributed to their ability to eli- lead to structural changes in the medial frontal cortex
placebo response, suggesting that anecdotal cit structural and functional changes in the brain via of mice. Shao et al. demonstrated that the adminis-
reports of microdosing efficacy may be due to mechanisms like neuroplasticity and neurogenesis. tration of psilocybin resulted in the increased growth
positive expectation effects. Pharmacology and The Verdict: This year, a number of studies have and formation of dendritic spines. Evidence sugges-
toxicology researchers have also expressed concern called the purported benefits of microdosing into Should psychedelics act as a catalyst for neuroplasti- ted that a number of these new spines lasted long
over the potential risk of long-term chronic LSD question. We shouldn’t write off microdosing city and neurogenesis, these compounds may prove enough to develop into functional synapses, some of
and psilocybin microdosing to cause valvular heart entirely, though. Further research, especially to be viable treatments for disorders beyond those which were found to persist 34 days after adminis-
disease due to 5-HT2B receptor binding affinity.” that with a focus on participants with clinical falling within the realm of mental health, such as tration. Together, their results added to the growing
diagnoses of mental health disorders, may still be neurodegenerative disorders. body of research that points towards neuroplasticity
- Dr. Kelan Thomas fruitful. as an impetus for many of the therapeutic benefits
In 2021’s most popular study on psychedelics psychedelics are believed to produce.
and neuroplasticity (according to Altmetrics; see
more studies ranked by attention later in this sec- The researchers also attempted to shed light on the
Thomas has prominently sounded alarm around the tion), researchers from Yale set out to understand relationship between hallucinatory effects and neu-
potential dangers of microdosing, including in a pre- what effects psilocybin had on structural plasti- roplasticity. To achieve this, they administered ketan-
sentation titled “Safety First: Microdosing’s Possible city in vivo, how quickly these changes might occur, serin, a serotonin 5-HT2A receptor antagonist, before
Benefits and Potential Risks,” and in a pair of articles how enduring the effects may be, and whether the administering psilocybin. The researchers found that
on Chacruna Chronicles. drug’s hallucinatory effects are related to structural psilocybin continued to elicit some of its neuroplas-
remodelling. tic effects, despite a roughly 30% reduction in availa-
It’s also worth noting that several FDA-approved ble 5-HT2A receptors (the primary receptor on which
medications that are agonists of the 5-HT2B recep- psilocybin acts to generate hallucinogenic effects)
tor, such as fenfluramine/phentermine (‘fen-phen’), in the mice treated with ketanserin. While these
have been withdrawn due to the risk of valvular heart
LEARN MORE ABOUT THE results seem to suggest that neuroplasticity might not
disease. However, there is a dearth of longitudinal
RESEARCH AT IMPERIAL depend on psilocybin’s hallucinatory effects, Shao et
research on microdosing, and the doses involved are
COLLEGE LONDON al. maintained that due to the differences between
(unsurprisingly) small, so no firm conclusions can be humans and mice, further studies will be needed to
drawn. evaluate this relationship in humans. Nonetheless,
LE ARN MO RE
their discoveries add to an exciting conversation
It’s also worth noting that participants in microdosing around psilocybin’s therapeutic mechanisms.

Studies being conducted by researchers and com- neuroplasticity: see Szabó et al., 2021, for example). 2.7 – FURTHER CLARITY COMP360 psilocybin therapy. The company found
panies alike continue to contribute to our understan- Should the emerging evidence continue to support that a single 25 mg dose of COMP360 resulted in
ding of the relationship between psychedelics, neu- the theory of psychedelic-induced neuroplasticity ON INTERACTIONS comparable treatment outcomes to patients in the
roplasticity, and derived therapeutic benefits. Recent
results from an in vitro preclinical trial by Algernon
in humans, these compounds may be applied to a
much broader range of psychiatric and neurodege-
BETWEEN SSRIS AND company’s Phase 2b trial (mentioned above), in
which patients were required to taper off their SSRIs.
Pharmaceuticals (which, it should be noted, are nei- nerative treatment indications. PSILOCYBIN These findings will likely inform the company’s Phase
ther published nor peer-reviewed) suggested that 3 trial design, for which it is set to meet with the FDA
even a sub-perceptual (non-hallucinogenic) dose in the new year with an eye to commencing the trial
The Verdict: Researchers are still attempting
of N, N-Dimethyltryptamine (DMT) could result in a Given that many of the populations targeted by psy- in Q3 2022.
to prove out the underlying mechanisms of
rapid growth of neural connections in the brain. The chedelic-assisted therapies are attempting to find
psychedelics’ apparent therapeutic effects, and
company hopes to one day leverage these effects to relief via other pharmacological agents, such as SSRI MindMed, via its collaboration with the Liechti Lab,
have made significant headway in 2021. The
treat patients recovering from the neurodegenerative antidepressants, it’s important that we understand also published results from an SSRI and psilocybin
promotion of neuroplasticity and neurogenesis
impacts of strokes. the interaction between these common drugs and interaction study. The research also appears to refute
continues to be a popular thesis, which gained
psychedelics. received wisdom that chronic administration of sero-
further evidence through a number of impressive
Another 2021 study found that the in vivo adminis- tonergic antidepressants (such as SSRIs) dampen the
studies this year. If true, this could explain the
tration of the non-hallucinogenic (according to ani- Beyond avoiding potential issues with safety or redu- subjective effects of psychedelics (e.g. Bonson and
apparent transdiagnostic efficacy of psychedelics,
mal studies) ibogaine analogue tabernanthalog led to ced efficacy, deepening our understanding of drug Murphy, 1996, in the case of LSD).
and broaden its potential clinical applications.
dendritic spine formation as well. This work is being interactions of this kind may help increase the acces-
commercialised by Delix Therapeutics in partnership sibility of psychedelic-assisted therapies. If it’s found The MindMed sponsored study pretreated partici-
with the National Institute on Drug Abuse (NIDA). that SSRIs and psychedelics do not generate adverse pants with the SSRI escitalopram for 14 days (7 days
Selected psychedelics and neuroplasticity & effects when co-administered, this could allow psy- at a 10 mg dose, followed by 7 days at a 20 mg dose),
So what might some of the implications of these fin- neurogenesis publications from 2021: chedelic-assisted therapies to be provided as an or placebo pretreatment, and then administered 25
dings be? As the researchers iterated, these neural adjunct therapy as opposed to a monotherapy. This mg of psilocybin.
modifying effects may help explain some of psilocy- Psilocybin induces rapid and persistent growth of dendritic wouldn’t require participants in the therapy to taper
bin’s purported antidepressant benefits. Like others in spines in frontal cortex in vivo off SSRIs, which can be a daunting and tumultuous The study found that pretreatment with escitalopram
the field, including Delix Therapeutics’ David Olson, process for those who have been chronically taking had “no relevant effect on positive mood effects of
Kwan sees the promotion of neural plasticity as a key antidepressants. psilocybin but significantly reduced bad drug effects,
DMT Increases Growth of Rat Neurons by 40 Percent, New
mechanism of action behind psychedelics’ apparent anxiety, adverse cardiovascular effects, and other
Data Shows (Algernon)
therapeutic effects. It’s not surprising, then, that for-profit companies are adverse effects of psilocybin compared with placebo
keen to produce such data. pretreatment.”
An analog of psychedelics restores functional neural circuits
“We are now seeing hundreds, if not thousands, of
disrupted by unpredictable stress
novel psychedelic-like compounds. For me, a key In December, COMPASS Pathways shared unpub- But, is a 14 day stepped pretreatment represen-
question is how to screen them and prioritize the lished results of a single-arm open label study of 19 tative of real-world SSRI usage? The Psychedelic
A Single Dose of Psilocybin Increases Synaptic Density and patients taking SSRI antidepressants alongside its Pharmacists Association asked, “Is 14 days of pre-
most promising candidates for human studies? I
Decreases 5-HT2A Receptor Density in the Pig Brain treatment sufficient to draw conclusions about
believe neural plasticity is key, and a step towards
identifying changes in the brain that are unique to the need for antidepressant tapering and cessation
psychedelics and that drive the beneficial actions.” Psychedelics and Neuroplasticity: A Systematic Review before psilocybin administration?”
Unraveling the Biological Underpinnings of Psychedelics
- Dr. Alex Kwan The authors of the study noted this limitation them-
Therapies to Restore Consciousness in Patients with Severe selves, explaining that, “escitalopram pretreatment
Brain Injuries: A Gap Analysis and Future Directions lasted only 14 days, which may have been too short
A number of popular 2021 publications have pro-
to produce more chronic neuroadaptations and
posed that psychedelics could one day be used
changes in receptor expression that can alter the res-
as treatments for Alzheimer’s and brain injuries From Psychiatry to Neurology: Psychedelics as Prospective
ponse to psilocybin.”
(perhaps working via other mechanisms beyond Therapeutics for Neurodegenerative Disorders

The Verdict: If the co-administration of SSRI
2.9 – NEWLY APPROVED &
antidepressants and psychedelics is found to ANNOUNCED STUDIES
be safe and effective, it would be a boon for
psychedelics companies. This would reduce
As interest continued to grow throughout 2021,
the barrier to entry for patients who (along with
investigations into the effects, mechanisms, and
their healthcare providers) may be hesitant
therapeutic potential of psychedelics proliferated.
to wean themselves off SSRIs, and would
Companies at various stages of development annou-
take psychedelic-assisted therapies from
nced the approval and initiation of dozens of new
monotherapies to adjunct therapies, greatly
trials studying psychedelics for an increasingly wide
expanding their markets. It’s not surprising, then,
range of treatment indications, and investigators at
that companies are sponsoring research to try
academic institutions and research centres across the
and demonstrate such safety and efficacy. But,
globe helped push the number of ongoing investiga-
these studies are far from conclusive due to
tions to new heights. Researchers are working dili-
limitations that include their small size and short
gently to bolster and challenge our current unders-
pre-treatment periods. As is often the case:
tanding of psychedelic science.
further research is needed.
Over the next few pages you will find a sample of

sponsor or investigator led trials that were announ-
ced, approved, or initiated in 2021.
2.8 – APPRECIATING
METHODOLOGICAL
ISSUES
Throughout the course of recapping some of these

central studies of 2021, it should have become appa-
rent that psychedelic research is fraught with metho-
dological challenges. Some of these are inherent to
the broader field of psychotherapy and pharmaco-
logy, but others are unique to psychedelics. These
include outsized expectancy effects (due, in part, to
PSYCHEDELICS DRUG
increasing ‘hype’) and, perhaps most obviously, the
DEVELOPMENT TRACKER
difficulty (impossibility?) of designing a genuinely pla-
Developed by Michael Haichin, PharmD
cebo-controlled trial, given that it’s pretty obvious to
most people if they’re having a ‘trip’.
ACCE SS DATA HE RE
Those interested in reading more about these metho-
dological issues will likely enjoy a recent preprint
publication by Aday et al., which provides recom-
mendations for improving the methodological rigor
of psychedelic clinical trials.

COMPANY-SPONSORED TRIALS
THAT WERE APPROVED OR
BEGAN IN 2021
TRYP Initiates a Phase 2 Trial of Psilocybin for Binge Mydecine Announces a Phase 2/3 Trial of MYCO-
Eating Disorder [December 23, 2021] 001 for Smoking Cessation [September 7, 2021]
In October of 2021, TRYP Therapeutics announced On September 7, 2021, Mydecine announced its
that the FDA had placed a clinical hold on its Phase intent to initiate a new Phase 2/3 studying its MYCO-
2 trial of psilocybin in the treatment of binge eating 001 psilocybin drug candidates for nicotine depen-
disorder. The company subsequently amended its dence. The company will collaborate on the trial with
IND application with the FDA. On December 23, TRYP Johns Hopkins researcher Dr. Matthew Johnson.
announced that it had received notice from the FDA Through the study, researchers will assess the effi-
that the clinical hold had been lifted. The study will cacy of using MYCO-001 in conjunction with a
evaluate both the safety and feasibility of treating smoking cessation treatment program to treat nico-
patients diagnosed with binge eating disorder using tine dependent patients.
psilocybin. [NCT05035927]
Cybin and the University of Washington Initiate Small Pharma Initiates Part 2 of a Phase 1/2 Trial of Braxia Initiates a Phase 2 Trial of Psilocybin for TRD
MindMed Initiates a Phase 2a Proof-of-Concept a Phase 2 Trial of Psilocybin for COVID-Related DMT for MDD [September 21, 2021] [August 27, 2021]
Trial of LSD for ADHD [December 17, 2021] Distress [December 1, 2021]
On September 21, 2021, Small Pharma announced In August of 2021, Braxia Scientific announced the
On December 17, 2021, MindMedicine announ- On November 30, 2021, Cybin announced that the that it had completed the first phase of its Phase 1/2a initiation of a Phase 2 trial studying psilocybin for
ced that it had begun enrollment for a Phase 2a trial FDA had authorized advancement of an investigator- clinical trial studying SPL026 (DMT) as a treatment treatment-resistant depression (TRD). Braxia will col-
evaluating repeated low doses of LSD as a treat- -initiated Phase 2 trial studying psilocybin-assisted for major depressive disorder (MDD). The company laborate on the study with the Usona Institute to
ment for ADHD. The company will collaborate with psychotherapy in the treatment of frontline clinicians subsequently initiated the second Phase 2a proof- assess the safety, feasibility, and efficacy of varying
both Maastricht University and the University Hospital suffering from COVID-related distress. The co-fun- -of-concept segment of the trial to assess the effi- doses of psilocybin in patients diagnosed with treat-
at Basel. Through the study, researchers will gather ded trial will occur at the University of Washington cacy, safety, and tolerability of its intravenous DMT ment-resistant depression. [NCT05029466]
information on changes in ADHD symptoms, dosing in Seattle. Investigators will use Cybin’s EMBARK drug candidate in conjunction with psychotherapy.
regime, therapeutic mechanisms, and other effects of model of psychedelic-assisted psychotherapy to [NCT04673383] Beckley Psytech Initiates a Phase 1b of Psilocybin
low doses of LSD. inform its use in future company-sponsored trials. for SUNHA [September 14, 2021]
[NCT05163496] COMPASS Pathways Announces a Phase 2 Trial of
TRYP Receives FDA Approval for a Phase 2a Trial of Psilocybin for PTSD [November 3, 2021] On September 14, 2021, Beckley Psytech announ-
Psilocybin for Fibromyalgia [December 6, 2021] DemeRx (atai) Initiated Part 1 of a Phase 1/2a Trial of ced that it had begun dosing patients in its previou-
DMX-1002 for OUD [September 21, 2021] On November 3, 2021, COMPASS Pathways announ- sly approved Phase 1b trial of low-dose psilocybin
In December of 2021, TRYP Therapeutics announced ced a new Phase 2 trial investigating COMP360 psi- for Short-lasting Unilateral Neuralgiform Headache
that it had received FDA approval to study its TRP- On September 21, 2021, atai life Sciences announced locybin therapy as a potential treatment for PTSD. Attacks (SUNHA). The trial will investigate the safety,
8802 psilocybin candidates as a potential treatment that its platform company DemeRx had dosed its first The company intends to enroll 20 patients to assess tolerability, and efficacy of different ascending doses
for fibromyalgia. The trial, which is slated to begin patients in the first part of a Phase 1/2a trial investi- the safety, tolerability, and efficacy of its psilocybin of psilocybin in patients diagnosed with SUNHA.
in 2022, will evaluate whether or not psilocybin-as- gating DMX-1002 (ibogaine) as a treatment for opioid therapy protocol. This announcement followed the [NCT04905121]
sisted psychotherapy can help treat chronic pain withdrawal syndrome. The company announced that completion of the company’s flagship Phase 2b trial
symptoms in patients diagnosed with fibromyalgia. this Phase 1 part of the trial will evaluate the safety, of psilocybin therapy for treatment-resistant depres-
[NCT05128162] tolerability, pharmacokinetics, and efficacy of its sion (TRD).
DMX-1002 oral ibogaine formulation. [NCT05029401]

2.10 – AN INCREASINGLY increases to the 2021 quotas, the DEA expres-
sed plans to increase psilocybin production to
WARM REGULATORY 1,500 grams (1.5 kg), which represented a fifty-fold
ENVIRONMENT FOR increase from the 30 g federal quota. On Monday

15th November, a notice published in the Federal
PSYCHEDELIC RESEARCH Register revealed that the agency has boosted this
in-year quota increase yet again, with the final adjus-
ted aggregate production quotas allowing for 6,000
Following a near half-century nadir in psychedelic grams (6 kg) of psilocybin and 3,500 grams (3 kg) of
research, the field is booming. This is helped, in part, psilocin to be produced in 2021. In December, that
by an increasingly warm regulatory environment: number was increased even further to 8,000 grams
from federal funding and increases in production (8 kg).
quotas for research purposes, right through to fur-
ther fast-track designations and research partnerships
The Verdict: Supply of scheduled substances
with federal agencies.
has been a bottleneck for researchers in many
Phase I Trial of Psilocybin for Headache Disorders at
INVESTIGATOR-INITIATED TRIALS fields, not least psychedelics. Moves by the
Yale University Below, we highlight some of the key signals of
DEA, which governs the production quotas of
THAT WERE APPROVED OR bureaucratic amenability toward psychedelic
scheduled substances for research in the U.S.,
This Phase I trial will study repeated dosing of psi- research.
BEGAN IN 2021 locybin as a potential treatment for migraines. The
to increase the availability of psychedelics for
research purposes are a positive development
trial will recruit 24 participants who will receive
that should reduce friction.
varying dose combinations of psilocybin and placebo.
DEA INCREASES PSYCHEDELICS
Trial of LSD Microdosing for Creativity and Brain Primary measures in the trial include migraine fre-
Activity at the University of Auckland quency, intensity, and duration. [NCT04218539] PRODUCTION QUOTAS
This randomised controlled trial will study the Phase I/II Trial of Psilocybin for Severe OCD at Beer-
effects of LSD microdosing on healthy adult males. Sheva Mental Health Center The U.S. Drug Enforcement Administration (DEA) sets
The study will assess the effects that LSD micro- annual quotas for the legal production of controlled
dosing has on a number of personality and creati- This open label, Phase I study will evaluate the safety, substances for research purposes, including psyche-
vity measures. Researchers will also measure brain efficacy, and feasibility of psilocybin-assisted psycho- delics like psilocybin, DMT and MDMA. For those looking for a deeper dive, Kyle Jaeger’s
activity before and after the administration of LSD. therapy for the treatment of severe obsessive com- reporting in Marijuana Moment provides a fantastic
[ACTRN12621000436875] pulsive-disorder (OCD). 15 patients suffering from The federal agency has increased these quotas—both overview of the changes.
OCD who had failed at least one prior treatment will intra-year quotas for 2021, and for the current year,
Phase II Trial of Psilocybin for Co-occurring MDD be enrolled. [NCT04882839] 2022—multiple times in the latter half of 2021, with L E A R N M OR E
and AUD at Johns Hopkins University drugs like psilocybin seeing enormous boosts to pro-
Phase II Trial of Psilocybin for AUD at Copenhagen duction levels.
This double blind, placebo controlled study University Hospital Rigshospitalet
will evaluate the therapeutic effects of psilocy- In an early September 2021 bulletin we reported on
bin in patients suffering from both major depres- This trial, sponsored by Anders Fink-Jensen, MD, the DEA’s proposal to significantly increase the pro-
sive disorder (MDD) and alcohol use disorder (AUD). DMSci, will evaluate safety of using psilocybin in duction quota for research psilocybin for 2021. Then,
Primary measures include reductions in depressive patients suffering from alcohol use disorder (AUD). in mid-October, we covered the Administration’s
symptoms and amount of alcohol consumption. Secondary measures will focus on feasibility, phar- proposal to greatly increase psychedelic production
[NCT04620759] macokinetics, several subjective effects, and changes quotas for the present year, 2022.
in alcohol cravings, self-efficacy, and mindfulness.
[NCT04718792] Take psilocybin, for example. In its earlier proposed

BIDEN-HARRIS ADMINISTRATION Beyond the grant itself, which amounts to nearly In the case of CaaMTech, the company has ente-
$4m, this government funding “legitimizes the red into a Cooperative Research and Development
RECOMMENDS REDUCING
research and makes it much more feasible for resear- Agreement (CRADA) with the Designer Drug Research
BARRIERS TO RESEARCH FOR chers to build careers working on psychedelics,” Unit (DDRU) at the National Institute on Drug Abuse
Nayak added, noting that, “it's also a clear sign of how (NIDA) Intramural Research Program (IRP). That’s a
SCHEDULE I SUBSTANCES LEARN MORE ABOUT THE much public opinion has shifted.” lot of jargon, but the company told Psilocybin Alpha
that the purpose of this agreement is to screen
RESEARCH AT JOHNS HOPKINS
The Johns Hopkins researcher, who is working alon- CaaMTech’s library of tryptamine compounds using a
In a press release published in September the White LE ARN MO RE gside Matthew W. Johnson on this research, believes number of in vitro and in vivo assays.
House explained that Regina LaBelle, Acting Director this isn’t the last we will see of government funding
of National Drug Control Policy, presented to for psychedelic research: “This funding is significant According to a CaaMTech spokesperson, “previous
Congress the Biden-Harris Administration’s recom- on its own, but I anticipate it will be the first of many.” work in this area has been frustrated by a lack of
mendations that primarily related to reducing the Finally, he noted that this trend is not limited to the access to pure, well-characterized compounds.” As
supply and availability of illicitly manufactured fen- U.S., “there are now government funded psychedelic such, the aim of the CaaMTech-DDRU collaboration
tanyl-related substances (FRS). FEDERAL GRANT AWARDED TO trials in Germany and Canada, and likely we'll see this is to “supply much-needed data about the funda-
expand greatly in coming years.” As we mentioned in mental biological activity of tryptamine compounds,
However, if one looks beyond recommendations
JOHNS HOPKINS RESEARCHERS our first Year in Review section, the Australian gover- making it possible to develop safer and more effec-
related to FRS, the piece explains the Administration’s nment carved out $15m for psychedelic research, tive next-generation psychedelic drugs.”
TO STUDY PSILOCYBIN FOR
ambition to “establish a simplified process that would which is supporting seven trials.
align research registration for all Schedule I substan- SMOKING CESSATION In December, Boston-based Delix Therapeutics
ces […] more closely with the research registration announced its own partnership with NIDA. Research
process for Schedule II substances.” The Verdict: This is a watershed moment for will be conducted under NIDA’s Addiction Treatment
In September 2021, prominent psychedelic resear- psychedelics research, representing the first grant Discovery Program (ATDP), which works to screen
The press release goes on to explain that, “the Biden- cher Matthew W. Johnson announced (via Twitter) from the U.S. government in over half a century promising therapies that may be more effective than
Harris Administration strongly supports expanding the that he has received a grant from the National to investigate the therapeutic potential of a the standard of care for substance use disorders.
research of Schedule I substances to help advance Institute on Drug Abuse (NIDA) to study psilocybin for classic psychedelic. As Dr. Johnson himself said,
evidence-based public policy.” the treatment of tobacco addiction. this is a “new era in legitimacy” for psychedelic Delix’s non-hallucinogenic (in animal models) drug
science, and we should expect governments candidates, such as DLX-7, appear to reduce alcohol-
Given that psychedelics are Schedule I substan- According to Johnson, this is the first grant from the across the world to follow (or, continue and heroin-seeking behaviour in preclinical studies.
ces in the United States, these recommendations U.S. Government dedicated to investigating the the- following) suit. The company will hope to have these findings vali-
to Congress could make research into psychede- rapeutic effects of a classic psychedelic in over a hal- dated through further study, with initial data from
lics such as psilocybin and DMT more straightforward f-century, marking a “new era in legitimacy” for psy- NIDA’s research on the candidate expected in early
than at present, especially when combined with DEA chedelic science. 2022.
quota increases.
We spoke to Sandeep Nayak, Post-Doctoral Research
NATIONAL INSTITUTE ON
Fellow at Johns Hopkins’ Center for Psychedelic &
The Verdict: This is another positive signal from
DRUG ABUSE PARTNERS WITH
Consciousness Research, about this development.
the highest echelon of the U.S. government for PSYCHEDELICS COMPANIES
researchers and companies looking to explore “It's hard to overstate the importance of fede-
the potential therapeutic applications of Schedule ral funding for psychedelic research,” Nayak noted.
I substances. Commenting on the changing research funding Two psychedelic drug developers, Delix Therapeutics
landscape, he went on to add that, “this is a huge step and CaaMTech, are among a growing crop of com-
towards normalizing this line of work which has been panies to score cooperative R&D agreements with
mostly funded by philanthropy and now nascent drug U.S. federal agencies.
companies.”

The Verdict: Delix has gained a great deal of
designation since they began being issued in Spring 2.11 – NEW PSYCHEDELICS Medeiros was keen to highlight this point, telling us
2021. that, “as we emerge into this psychedelic renaissance,
attention in 2021, and enters 2022 with the RESEARCH CENTRES it is crucial that we promote collaboration and Open
goal of proving out the potential of its ‘non-
Speaking to Psilocybin Alpha, Small Pharma’s Chief Science methods to move this field forward together
hallucinogenic’ compounds in the treatment of
Medical and Scientific Officer Dr. Carol Routledge 2021 saw the number of prestigious institutions with for the greater good of humanity.”
conditions including substance use disorders.
explained that the designation allowed for the com- psychedelic research centres continue to swell.
CaaMTech, meanwhile, has taken a stealthier
pany to receive “specialist advice throughout the Below are just a few of the new centres launched this
approach, and appears to have been filing patents
drug development process,” and that the Innovation past year…
prolifically. The fact that both companies have The Verdict: This centre will likely constitute
Passport “has the potential to enable a speedier, more
struck partnerships with the National Institute a new hub for psychedelics research in
efficient development process for SPL026,” the com-
on Drug Abuse (NIDA) once again demonstrates Toronto, which is already home to a number
pany’s lead candidate.
the increasing openness to, and interest in, NIKEAN FOUNDATION PROVIDES of psychedelics researchers, companies
psychedelic research by national agencies. and investment funds. Nikean Foundation’s
SLP026, the company’s DMT-assisted therapy, ente- $5M TO LAUNCH CENTRE FOR commitment to collaboration, codified in Open
red clinical trials for major depressive disorder (MDD)
at the start of this year, with topline results expected PSYCHEDELIC PSYCHOTHERAPY Science methods, is also of interest.
H1 2022.
IN TORONTO
DMT THERAPY RECEIVES FAST- Investors seemed optimistic, too, with the company’s
TRACK DESIGNATION IN UK share price jumping c.60% on the news after mon- In September, we helped break the news of the lau-
ths of steady decline. This was short-lived, however, nch of the Psychedelic Psychotherapy Research
with the stock price slowly bleeding toward pre-news Centre at Toronto’s University Health Network.
In October, London-based Small Pharma annou- levels.
nced that it had been granted a fast-track desig- A $5m donation from the Nikean Foundation, foun-
nation from a UK regulator for its DMT lead candi- ded in 2019 by Canadian tech entrepreneur Sanjay
date. The UK Medicines and Healthcare products The Verdict: As the UK seeks to make its mark Singhal, provides founding capital for the new centre.
Regulatory Agency (MHRA)–the country’s equivalent in a post-Brexit milieu, becoming a haven for LEARN MORE ABOUT THE
of the FDA–granted Small Pharma’s SPL026 candi- drug development has become a clear priority, Linda Medeiros, Director of Operations at Nikean NIKEAN FOUNDATION
date an Innovation Passport Designation via a rela- with the ILAP program (which approximates the Foundation, told Psilocybin Alpha that the creation of
tively new Innovative Licensing and Access Pathway FDA’s Fast Track Designation) representing a this centre “was a giant leap forward in Canadian his- L E A R N M OR E
(ILAP) program. cornerstone of this new strategy. The fact that tory.” Medeiros went on to say, “the partnership with
Small Pharma’s DMT candidate has been one the University Health Network validated the need
In a similar manner to the FDA’s fast-track designa- of the first recipients of such a designation is a for systemic change in mental healthcare and the
HARVARD LAW SCHOOL’S PETRIE-
tion, the ILAP aims to accelerate time to market and positive signal of UK regulators’ evidence-based urgent need for new tools to meet unmet therapeu-
facilitate patient access to emerging novel treat- approach to catalysing drug development: a tic needs.” FLOM CENTRE LAUNCHES
ments. The ILAP connects other key stakeholders in good sign for all psychedelic research and trials
the drug development and roll-out process, inclu- taking place in the UK, not just Small Pharma’s. Importantly, Nikean supports those organisations RESEARCH INITIATIVE ON
ding the country’s National Health Service (NHS) and conducting research in accordance with an Open
the National Institute for Health and Care Excellence Science approach rooted in principles of coopera-
PSYCHEDELICS AND THE LAW
(NICE). The program was touted as a way to encou- tion and accessibility. This is in contrast to the opera-
rage the development of innovative medicines in the ting principles of many for-profit actors, especially in In June, the Petrie-Flom Center for Health Law
UK post-Brexit. drug discovery and development, who tend to focus Policy, Biotechnology, and Bioethics at Harvard Law
on confidentiality and defensibility (through various School announced a new research initiative that will
Psilocybin Alpha understands that Small Pharma’s forms of IP, for example). promote safety, innovation, equity and access in psy-
DMT candidate is the first psychedelic to receive this chedelics research, commerce, and therapeutics.

The Project on Psychedelics Law and Regulation, or
The Broader Verdict: What started as a small crop of research centres at prestigious universities such as
POPLAR, is the first academic initiative offering a clear
Imperial College London and Johns Hopkins has turned into a global trend, with tens of new institutions
focus on psychedelics law, regulation and ethics.
joining the fray this year. What’s interesting is the increasingly interdisciplinary nature of these centres and
LEARN MORE ABOUT THE
their research programs. While the earlier centres have a core focus on scientific and clinical research,
In our coverage of the launch we spoke to Mason MASTERS PROGRAM AT
the new crop of psychedelics research centres are focusing on other facets of the field: from law to
Marks, Senior Fellow at the Center and Project Lead UW-MADISON
journalism.
of POPLAR.
LE ARN MO RE
Beyond legislative measures, the debate around inte-
llectual property in the psychedelics space is set to
be a “major focus” of POPLAR, which will “analyze the
role of biopiracy in psychedelics commercialization
2.12 – TOP PUBLICATIONS 8. Psychedelic-Inspired Drug Discovery Using An Engineered
Biosensor
and the ethics, validity, and social utility of patents on BY ATTENTION (Altmetric Score: 551) [May 13, 2021]
psychedelics related inventions,” Marks explained. We spoke to the Director of the Center, Dr. Paul
Hutson, who explained that the Center will expand its
current portfolio of translational and Phase I, II, and III Hungry for more? We pulled the top 15 articles of the 9. Ketamine for the Treatment of Mental Health and Substance
clinical research into psychedelics, as well as “embra- year, according to Altmetric. We covered some of Use Disorders: Comprehensive Systematic Review
The Verdict: The launch of the POPLAR (Altmetric Score: 400) [December 23, 2021]
cing members from across the UW Madison campus” these above, but not all...
research initiative marks the first academic
from a variety of disciplines including, “historians,
initiative with a specific focus on the legal,
anthropologists, and ethnobotanists, as well as the 10. Adults Who Microdose Psychedelics Report Health Related
regulatory and ethical contexts of psychedelics,
expected biomedical scientists and clinicians.” 1. Trial of Psilocybin Versus Escitalopram for Depression Motivations and Lower Levels of Anxiety and Depression
and the present renaissance. It also looks set to
Compared to Non-Microdosers
(Altmetric Score: 2,875) [April 15, 2021]
further increase the salience of debates around
According to Hutson, the Master’s program was well (Altmetric Score: 389) [November 18, 2021]
intellectual property in the space.
subscribed in the Fall of 2021, “and anticipates expan-
2. A 'Trip' to the ICU: Intravenous Injection of Psilocybin
sion in the coming years that will include internships 11. Lysergic Acid Diethylamide (LSD) Promotes Social Behaviour
(Altmetric Score: 2,554) [January 1, 2021]
in many of the new global psychedelic pharmaceuti- Through mTORC1 In the Excitatory Neurotransmission
See our Pharmaceutical Advisor Michael Haichin's Viral Tweet
cal companies. (Altmetric Score: 387) [February 2, 2021]
On This Subject
UNIVERSITY OF WISCONSIN
3. MDMA-Assisted Therapy for Severe PTSD: A Phase 3 Study 12. Acute Effects of Psilocybin After Escitalopram or Placebo
MADISON LAUNCHES The Verdict: This new centre hosts what was (Altmetric Score: 2,216) [May 10, 2021] Pretreatments In A Randomized, Double-Blind, Placebo-
Controlled, Crossover Study in Health Subjects
widely touted as ‘the first psychedelic master’s
PSYCHOACTIVE RESEARCH 4. How Ecstasy and Psilocybin Are Shaking Up Psychiatry (Altmetric Score: 384) [November 7, 2021]
program,’ which appears to already have become
CENTRE AND MASTER’S a popular offering. (Altmetric Score: 1,721) [January 27, 2021]
13. Psychedelic Therapy: A Roadmap for Wider Acceptance and
PROGRAM 5. Psilocybin Induces Rapid and Persistent Growth of Dendritic

Utilization
(Altmetric Score: 348) [October 4, 2021]
Spines in Frontal Cortex In Vivo
(Altmetric Score: 964) [April 15, 2021]
This year, the University of Wisconsin Madison appro- 14. First Study of Safety and Tolerability of MDMA-Assisted
ved a new Transdisciplinary Center for Research in Psychotherapy In Patients With Alcohol Use Disorder
6. Self-Blinding Citizen Science to Explore Psychedelic
Psychoactive Substances, and launched the first psy- (Altmetric Score: 342) [February 18, 2021]
Microdosing
chedelic master’s program in psychoactive phar-
(Altmetric Score: 729) [April 15, 2021]
maceutical investigation, which is led by Dr. Cody 15. Psychedelics and Other Psychoplastogens for Treating
Wenthur. 7. Racial Justice Requires Ending the War On Drugs Mental Illness
(Altmetric Score: 666) [January 7, 2021] (Altmetric Score: 340) [October 4, 2021]

SECTION
THREE
PSYCHEDELIC
COMPANY
HIGHLIGHTS
IN 2021
3
3.1 – FOREWORD 3.2 – A BASKET OF 3.3 – OVERVIEW OF 3.4 – CAPITAL
PSYCHEDELICS: NEW CAPITAL FLOWS INTO THE ALLOCATION AND
If public company valuations are anything to go by,
it’s been a difficult year for the psychedelics sector.
PSYCHEDELICS-FOCUSED SECTOR COMPANY TRENDS
Many companies in the space have seen their share ETFS
prices slashed, with ETFs like PSYK down over 50% According to our data, which tracks around 100 of
since inception. the leading public and private psychedelics com- INCREASINGLY CROWDED DRUG
The past year saw the creation of three ETFs focused panies, nearly $2 billion was invested in the psyche-
But, a focus on public companies (of which there are on tracking the performance of companies operating delics sector in 2021 across more than 60 financing DEVELOPMENT PIPELINES:
now around fifty) and their share prices alone obs- in the psychedelics space. events.
cures a great deal of successes that have occurred CERTAIN MOLECULES ATTRACT
in 2021 for psychedelics companies: from promising On January 26, Horizons launched the world's first This remarkable volume of capital continued to dis-
MORE CAPITAL THAN OTHERS
data readouts to significant private financing rounds. psychedelic-focused ETF in Canada under the ticker proportionately accrue to companies engaging
symbol PSYK. Subsequently, Defiance would move in drug discovery and development, with atai Life
Here are some of the year’s most notable financings to establish its US-listed PSY ETF to track companies Sciences’ Series D ($157m) and GH Research’s Series At the molecular level, it’s clear that certain psy-
and public markets moments… operating in the psychedelic, cannabis, and ketamine B ($125m) representing the sheer scale of financings chedelics are attracting more funding than others.
spaces. Finally, in September AdvisorShares estab- in this segment of the value chain. Investment in companies developing 5-MeO-DMT
lished its US-listed actively managed PSIL ETF. was strong in 2021, with the Irish company GH
However, we are seeing investment in other areas Research securing a $125m Series B in April. The
Representative of the psychedelics market in general of the emergent psychedelics value chain begin to round was led by two U.S.-based pharmaceutical
these ETFs have performed poorly this year, under- tick upward, with digital therapeutics and adjunct investment firms: RA Capital and RTW Investments.
performing the broader stock market significantly, technologies of increasing interest to investors (e.g., The company has kept its cards close to its chest,
and seeing greater downside than the biotech sector. MINDCURE’s $23m bought deal; Osmind’s $15m but we know that its three drug candidates are all
Series A). 5-MeO-DMT based.
In August, UK-based Beckley Psytech announced

the closing of its own Series B, bringing in c.$80m to
accelerate its drug development pipeline. 5-MeO-
DMT features again, with the company hoping to har-
ness it in the treatment of undisclosed neuropsychia-
tric indications.
According to our data, which tracks Take a look at our Psychedelics Drug Development
around 100 of the leading public and Tracker to see other molecules and indications
private psychedelics companies, that are receiving outsized attention from drug
nearly $2 billion was invested developers.
in the psychedelics sector in 2021 across
more than 60 financing events. We’re also seeing a clear trend in the move beyond
‘known’ psychedelics, and toward a plethora of ana-
logs, derivatives, and new chemical entities. These
include the so-called ‘non-hallucinogenic psychede-
lics,’ which are discussed in more detail later in this
section.

COLLABORATIONS WITH hesitancy, a number of groups from what may be which has now synthesised and supplied compou- These tools aren’t just on the patient-facing side. In
characterised as the psychedelic ‘underground’ have nds for psychedelics research across the globe. ASRI 2021, companies committed substantial resources
NATIONAL INSTITUTES BOOST
now forayed into the commercial side of today’s psy- was formally incorporated in April 2021 by Shulgin’s to the acquisition and development of technologies
INVESTOR CONFIDENCE chedelics space. widow, Ann, and recently raised a $6.95m Seed to support novel drug discovery efforts, for example.
Round to continue its work in developing the legacy Supported by AI-powered drug discovery platforms,
The Alexander Shulgin Research Institute (ASRI) is a of Sasha’s work. drug developers in the space are creating catalogues
As we mentioned in our Psychedelic Research and fine example of this trend. The Institute was founded, of novel derivatives and analogues based on many
Clinical Trials in 2021 section, the National Institute albeit informally, by legendary chemist and psyche- classical psychedelic compounds and therapeutic
on Drug Abuse (NIDA) has partnered with a number delics enthusiast Alexander (“Sasha”) Shulgin in the
GROWTH OF DIGITAL targets.
of psychedelics companies. NIDA has also hosted vir- 1980s. THERAPEUTICS, DELIVERY
tual events showcasing research into psychedelics, While companies such as Mydecine announced (fur-
further demonstrating its interest and active involve- Shulgin was known for his hands-on research metho- TECHNOLOGIES & DRUG ther explained in a buzzword-heavy press release)
ment in the space. dology, which involved self-experimentation with new technology-driven drug discovery programs in
psychoactives, after which he tested them with small DISCOVERY TECH 2021, others such as Enveric, CaaMTech, and Delix
Two such companies were Delix Therapeutics and groups of friends. Two years after publishing PiHKAL continued to leverage existing discovery technolo-
CaaMTech, both of which closed significant rounds (now canonical, alongside TiHKAL) the DEA raided Innovative technologies have become an increasingly gies to identify the next generation of psychedelic
in 2021. The former closed a $70m Series A, while the Shulgin’s lab and forced him to give up his licence. A interwoven element of drug development and treat- compounds
latter raised $22m via its own Series A. DEA spokesperson characterised the tomes as “pretty ment delivery more broadly. Over the course of 2021,
much cookbooks on how to make illegal drugs.” many companies operating in the psychedelic space Drug Discovery Technology-Related Press Releases
Are such collaborations with National Institutes fue- took steps to incorporate and leverage new techno- from 2021:
ling investor confidence in psychedelics companies? After Shulgin passed in 2014, his research colleagues logical tools with a wide range of scientific and thera-
Paul Daley and Nicholas Cozzi helmed the Institute, peutic applications. • atai Life Sciences Partners With CB
Therapeutics to Launch TryptageniX
(December 9, 2021)
• Mydecine Unveils AI Drug Discovery
Program (June 16, 2021)
• MindMed Partners With MindShift AG
(February 11, 2021)
In 2021, many drug developers began investigating

new drug delivery technologies that might one day
be paired with approved psychedelic drugs. The use
of different drug delivery technologies is expected to
allow companies to overcome many challenges rela-
ted to drug bioavailability, time to onset of effects,
drug metabolism, duration of effects, and more.
EMERGING FROM THE
Companies are looking to leverage, among others,
PSYCHEDELIC ‘UNDERGROUND’
nasal, intravenous, sublingual, subcutaneous, and
oral drug delivery technologies for a variety of psy-
As the ‘psychedelic renaissance’ reaches a fever pitch, chedelic candidates. A 2021 collaboration between
many individuals and organisations who have been MindMedicine and Nextage, for example, will see the
involved in psychedelics for a long time are now con- two companies focusing on delivering ibogaine deri-
sidering whether, or how, to benefit from this recent vatives using a brain targeting liposome technology.
ACCES S TH E I N TERACTI V E V ERS I ON H ERE
influx of interest and investment. Despite some

Drug Delivery Technology-Related Press Releases drug development companies intend to build new to psychedelics (read more in our Psychedelic Drug A FOCUS ON RECIPROCITY AND
from 2021: in-house digital technologies, others have acquired Policy Reform in 2021 section). These efforts are cen-
PHILANTHROPY?
or partnered with technology-focused companies tral for the realization of accessible and impactful
• Mycrodse Therapeutics & Nova Mentis that are already creating digital therapeutics tailored psychedelic therapies.
Sign Collaborate to Advance Drug Delivery for these emerging treatments. Throughout 2021 questions of ethics, reciprocity and
System (October 19, 2021) Here are some notable developments on this front philanthropy continued to be pointed at for-profit
• Bexson Biomedical Launches New Digital Therapeutics-Related Press Releases from from 2021: psychedelics companies, with many arguing that as
Subcutaneous Delivery Technology Program 2021: a sector we should aspire to do better than the con-
for Psychedelics (August 12, 2021) • TheraPsil Helps 47th Patient Access ventional biotech and pharmaceutical playbook.
• atai Life Sciences Launches InnarisBio (July • atai Life Sciences Launches PsyProtix Psilocybin In Canada (December 13, 2021)
28, 2021) (November 11, 2021) • Fluence Raises $1.6m to Meet Demands for A number of psychedelics companies and investors
• MindMed Collaborates With Nextage • MINDCURE Joins Digital Therapeutics Psychedelic Therapy Training (November 4, actioned this call, but whether or not these moves
Therapeutics (May 24, 2021) Alliance (September 16, 2021) 2021) were tokenistic or genuine and substantial is up to
• BetterLife Files Patent for Novel • Cybin Announces Digital Therapeutics • Cybin Launches EMBARK Psychedelic the reader to decide.
Subcutaneous Implant (April 29, 2021) Strategy (July 13, 2021) Facilitator Training Program (October 28,
• Cybin Signs Drug Development Agreement • Mydecine Announces Launch of Mindleap 2021) atai Life Sciences announced the launch of atai
With Catalent (March 22, 2021) 2.0 (July 13, 2021) • Field Trip Expands Clinic Network to Seattle, Impact in October, which is “committed to advan-
• IntelGenx Announces Strategic Partnership • atai Life Sciences Acquires Majority Stake in Vancouver, and Fredericton (October 19, cing education, expanding access and supporting the
With atai Life Sciences (March 15, 2021) Psyber (April 7, 2021) 2021) wider ecosystem of mental health care.” The pro-
• MindMed Acquires HealthMode (February • Beckley Psytech & Fluence Partner to gram announced its first major initiative two months
The unique nature of psychedelic-assisted psycho- 26, 2021) Created Psychedelic Therapy Training later, establishing a Fellowship Fund in Psychedelic
therapy will foreseeably create a demand for assistive • Cybin Partners with Kernel (January 11, Program (April 20, 2021) Neuroscience with Massachusetts General Hospital’s
technologies that can support patient preparation, 2021) • TheraPsil Hosts Health Canada-Approved Center for the Neuroscience of Psychedelics.
monitoring, treatment integration, and more. Experiential Psilocybin-Assisted Therapy
Training Program (March 2, 2021) Other companies have sought to bake recipro-
As the first generation of drugs move closer to • NYU Langone Launches Center for city and equity into their cap tables. Panacea Plant
approvals, many companies have begun to develop EXPANDING NETWORKS OF Psychedelic Medicine Dedicated to Sciences, for example, has reserved 32% of its equity
new digital therapeutics platforms that will be used Research and Professional Medical Training for Indigenous Groups and related 401(c)3 organisa-
to support future psychedelic therapies. While some
TREATMENT CLINICS, THERAPIST (February 24, 2021) tions, with these preferred shares benefitting from a
• ATMA Journey Centers Opens Psychedelic 10x dividend rate over common shares. This affords
TRAINING & PATIENT ACCESS
Therapy Clinic in Calgary (February 16, 2021) the aforementioned cohorts a potential source of
revenue, as well as voting rights.
Over the course of 2021, for-profits and nonprofits
alike were hard at work setting the foundation for the Other companies and funds have made similar com-
delivery of future psychedelic therapies. Many com- mitments, such as Woven Science which is dedi-
panies continued to create or expand networks of cating 10% of its equity to El Puente, “a foundation
specialized clinics that may be used for psychedelic- for access and benefit-sharing,” and Journey Colab
-assisted psychotherapies if and when approved. which dedicates 10% of its founding equity to the
Journey Reciprocity Trust..
To address the growing demand for therapists equi-
pped to deliver these unique treatments, many new
training programs for prospective therapists are pro- Note: the above are just a selection of trends from
liferating across the world. Over the past year, we 2021, it wouldn’t be possible to catalogue them all
have also seen nonprofits such as TheraPsil continue here.
to successfully advocate for greater patient access

3.5 – MORE Clerkenwell Health and Octarine Bio Ink Partnership
COMPANY - COMPANY COMPANY - ACADEMIC
(September 8, 2021)
COLLABORATION In September, Clerkenwell Health, a contract
PARTNERSHIPS PARTNERSHIPS
Here are some other notable 2021 partnerships Here are some other notable 2021 partnerships
BETWEEN COMPANIES research organisation (CRO), and Octarine Bio, a drug
manufacturer, announced a partnership focused on
and collaboration between different psychedelic and collaboration between companies and
companies academic institutions
AND ACADEMIC delivering and supporting psychedelic clinical trials
in Europe. The companies hope that this partnership
INSTITUTIONS will allow contracting investigators to conduct clinical Revive Therapeutics & PharmaTher Sign CaaMTech Partners With the University of
trials with access to both a reliable supply of psilocy- Research Collaboration Wyoming to Study Psychedelics for Addiction
bin (via Octarine’s biosynthesis process) and speciali- November 3, 2021 Press Release November 16, 2021 Press Release
Over the last year, we have seen a number of organi- sed CRO resources.
sations engaging in collaborations, including com- Nova Mentis & Mycrodose Therapeutics Partner Silo Pharma Enters Sponsored Research
pany-company partnerships and academic partner- to Co-Develop Drug Delivery System Agreement With Columbia University
COMPANY - ACADEMIC October 19, 2021 Press Release October 27, 2021 Press Release
ships. Here are some of 2021’s most notable partner-
ships and collaborations. PARTNERSHIPS &
MindMed Joins Clinical Trial Transformation PharmaDrug Collaborates With Johns Hopkins
COLLABORATIONS Initative on DMT Study
COMPANY - COMPANY October 13, 2021 Press Release August 25, 2021 Press Release
PARTNERSHIPS &
Mydecine Signs Five-Year Research Collaboration MINDCURE Joins Digital Therapeutic Alliance TRYP Therapeutics Partners With the
COLLABORATIONS Agreement With Johns Hopkins (August 18, 2021) September 16, 2021 Press Release University of Michigan to Evaluate Psychedelic
In August of 2021, Mydecine announced that it had Formulations
entered into a 5-year collaborative research agree- Wesana Commits $1.5 Million to Exploring July 7, 2021 Press Release
atai Partners With CB Therapeutics to Launch ment with Johns Hopkins. The research will initially Viability of MAPS' MDMA-Assisted Therapy to
TryptageniX (December 9, 2021) focus on using psilocybin as a potential treatment for Treat TBI Wesana Partners With the University of South
In December, atai announced that it had launched a smoking cessation before expanding to other the- September 14, 2021 Press Release Carolina for TBI Research
new platform company focused on discovering and rapeutic areas. Mydecine subsequently announced June 24, 2021 Press Release
synthesising new drug candidates in partnership with a Phase 2/3 trial in partnership with Johns Hopkins Cybin Partners With Greenbrook TMS
CB Therapeutics. The platform, named TryptageniX, researcher Dr. Matthew Johnson evaluating its July 6, 2021 Press Release Silo Pharma Collaborates With UCSF On
hopes to leverage bioprospecting for the discovery MYCO-001 psilocybin candidate as a treatment for Psilocybin Research
of novel compounds and biosynthesis as a means of nicotine addiction. MindMed Joins Digital Medicine Society June 8, 2021 Press Release
production. August 3, 2021 Press Release
COMPASS Pathways Partners With King’s College BetterLife Enters Research Agreement With
COMPASS Pathways Acquires MiHKAL GmbH, London & South London and Maudsley NHS Beckley Psytech Parters With Fluence to Create Carleton University On Depression Studies
a Portfolio of Novel Psychedelic Compounds Foundation Trust (SLaM) (July 5, 2021) Psychedelic Therapy Training Programme March 8, 2021 Press Release
(September 14, 2021) In July of 2021, COMPASS Pathways announced that April 20, 2021 Press Release
In September, COMPASS Pathways announced that it had partnered with King’s College London and Atai Collaborates With Massachusetts General
it had entered into an agreement with Matthias Grill SLaM to advance research on COMPASS’s psyche- Otsuka Collaborates With Perception Hospital to Study Psychedelic Mechanisms of
Ph.D. and MiHKAL GmbH to acquire MiHKAL’s cata- delic therapies for treating indications such as post- Neuroscience (atai) to Develop PCN-101 Action
logue of purportedly novel psychedelic and empa- -traumatic stress disorder (PTSD) and anorexia ner- March 16, 2021 Press Release January 26, 2021 Press Release
thogenic compounds. In addition to the IP acqui- vosa. The partnership will also focus on training the-
sition, COMPASS and Matthias Grill will continue to rapists to deliver psychedelic-assisted psychothera- Cybin Partners With Kernel to Leverage Its
work together in an effort to develop new psychede- pies, integrate digital therapeutics, and developing Neuroimaging Technology
lic drug candidates.. “new models of care for mental health in the UK.” January 11, 2021 Press Release

DISPATCH FROM HORIZONS: “As we have commented before, there is increasing Hall foregrounds a confluence of factors that contri-
competition across molecules, indications, and value buted to the abandonment of psychedelic research in
PERSPECTIVES ON PSYCHEDELICS
chain segments. As such, we should expect to conti- psychiatry, which may be parsed out into three (inter-
nue seeing smaller companies pivot accordingly.” related) strands: a tightening of controls on phar-
Horizons conference in New York City, which also maceutical research; the ascendant primacy of the
featured a Business Forum, was an agora for heal- Pivot or perish will likely be a theme in 2022. Randomised Control Trial; and, Sandoz cutting the
thy debate, discussion, and reflection. Following our supply of psychedelics like LSD.
PSILOCYBIN ALPHA WEEKLY return, we shared a summary of some of the key
BULLETIN topics covered, which included: funding and business We ended by asking whether lessons from the past
Stay up to date on all of the most recent news models for psychedelic ventures; legal and regulatory REMS PATENTS: THE NEXT have been learned and assimilated into the psyche-
matters, including IP; accountability and ethics; the delic renaissance.
and developments in the psychedelic space
scale-up and roll-out of psychedelics; research and
FRONTIER IN THE PSYCHEDELICS
R EA D OU R BU LLET I NS science; and much more. PATENT SKIRMISH?
This deep dive on REMS Patents was one of our Many of the contributing factors to this
NO DATA PROTECTION IN
most technical (and speculative) pieces of the year, ‘first’ demise in psychedelic research are
CANADA FOR KETAMINE’S which presented an overview of Risk Evaluation and still present today, including difficulties
Mitigations Strategies (REMS) programs, the poten- surrounding the blinding of participants or
3.6 – YOUR FAVOURITE CHEMICAL COUSIN, ESKETAMINE tial for elements of them to be patented, and the the availability of effective placebos. We also
implications that both of these facts may have on see much of the same (over-)exuberance
PSILOCYBIN ALPHA (SPRAVATO) psychedelics. among advocates of psychedelic medicine,
BULLETINS In this Bulletin, we covered Canada’s Federal Court In short, we asked: “could the patenting of REMS pro-
which Hall is clearly concerned about.
of Appeals’ decision to uphold a refusal to grant grams be the next frontier in the apparent psychede- He is also keen to warn against psychedelics
We covered many of the above trends via our weekly data protection for Janssen’s Spravato (esketamine) lics IP skirmish?” following the same path as medical
Bulletins throughout 2021. Here’s some of your product. cannabis, arguing that such policies “would
favourite segments from our 2021 catalogue…. enable the medical use of psychedelics to
While this is, on the surface, a very ‘in the weeds’ get well ahead of any evidence on their
topic, we used it as an opportunity to discuss enan- WAS IT ALL LEARY’S FAULT? efficacy and safety for common psychiatric
tiomers, cost-effectiveness, and data exclusivity more indications.” Others might argue that Hall is
DECONSTRUCTING COMPASS THALIDOMIDE, RCTS, SANDOZ
generally, as well as making some broad comments minimising existing evidence from Phase II
PATHWAYS’ PHASE 2B RESULTS regarding implications for psychedelics companies.
AND ‘THE END’ OF PSYCHEDELIC
and III trials, which many advocates believe
should be sufficient for their inclusion in
RESEARCH compassionate access programmes, at the
This deep dive was, by a wide margin, our most least.
MINDMED INITIATES PHASE I
popular Bulletin of the year. Following the publication
of COMPASS Pathways’ Phase 2b topline data, there TRIAL OF IV DMT Here, we covered a journal article by Wayne Hall that Hall’s article might also encourage us to
was a great deal of confusion around their interpreta- complicated a common narrative: one which sug- remember that expectancy effects and
tion (we covered this in the preceding section). gests the passage of the Controlled Substances Act small-study effects tend to dampen the
In late July we reported on MindMed’s Phase I trial (CSA) in 1970, and the resultant scheduling of psy- efficacy of new drugs when they transition
Here, we sought to begin contextualising the pre- of intravenous DMT, using it as an opportunity to chedelics alongside heroin and cocaine, singularly from clinic to the real world.
liminary safety and efficacy data from this influen- explore the other DMT drug development efforts that marked the end of any meaningful clinical research
tial trial, and ended by summarising the next steps for were underway at the time, notably Small Pharma’s into psychedelics.
COMPASS. pipeline.

3.7 – MAJOR IPOS AND FIELD TRIP UPLISTINGS
UPLISTINGS In 2021 Field Trip Health successfully uplisted to
both a major Canadian and American exchange.
We covered many of the above trends via our weekly Field Trip had previously traded on the Canadian
Bulletins throughout 2021. Here’s some of your Securities Exchange (CSE) since going public in
favourite segments from our 2021 catalogue…. October of 2020. In late May, the company announ-
ced that it had gained approval to list on the Toronto
Stock Exchange (TSX). Field Trip would subsequently
MINDMED’S NASDAQ UPLISTING achieve its first uplisting milestone of the year at
market-open on June 7, 2021.
In September 2020, then-CEO JR Rahn disclosed that A little over a month later, the company would
the company had applied to uplist on the NASDAQ announce that it had received conditional approval
stock exchange. On April 23rd, 2021, following many to graduate from the OTC markets onto the NASDAQ
months of anticipation, MindMed announced that its Global Select Market, listing on July 29th.
GH RESEARCH IPO
listing application had been approved.
On April 27th, the company’s shares began trading on

ATAI LIFE SCIENCES’ IPO On April 20th, 2021, the Irish drug development com-
the NASDAQ under the ticker MNMD, with the company GH Research filed a draft registration statement
pany’s share price reaching $6.97 before falling to On April 20th, 2021, after more than 2 years as a pri- confirming its intent to IPO. The company would
$4.92 at close, up over 180% compared to just a few vate company, atai set the stage for its eventual IPO subsequently announce the pricing of its estimated
days prior. with the filing of a preliminary prospectus. $160 million initial public offering, and on June 25th
GH Research would begin trading on the NASDAQ.
MindMed’s successful uplisting made it the second The registration statement outlined the company’s
publicly-traded psychedelic drug developer to goal of raising $100 million through its initial public The company’s share price would climb to a high of
achieve this milestone. offering. The company’s subsequent prospectus $24.19 before settling at $19.25 by market close. GH
amendment would reveal a target valuation of rou- Research announced that it had raised roughly $184
ghly $2.3 billion. million through its IPO.
On June 18th, 2021, the company began trading

under the ticker “ATAI” and became the third psyche-
delic drug developer to list on the NASDAQ. atai’s
share price reached a high of $22.91 and closed out
CYBIN UPLISTING
its first day of trading at $19.45, with the IPO raising
roughly $231.6 million.
Like many other companies in the sector, Cybin
Many investors hoped that this high-profile IPO underwent an exchange uplisting of its own in 2021.
would buoy the broader sector, but this failed to be However, unlike the companies before it, on July 22
the case as most psychedelics traded lower throu- Cybin announced that it had received conditional
ghout the month. approval to uplist onto the New York Stock Exchange
(NYSE) as opposed to the NASDAQ. As of market
Note: We appeared on the Business Trip podcast to open on August 5, 2021, Cybin would become the
discuss atai’s IPO in June 2021. first psychedelic-focused company to list on the
NYSE.

3.8 – PSYCHEDELIC Below you can see a recap of some of 2021’s most benefits, the impact could be enormous. Imagine if a
notable private financings... cheaper, non-hallucinogenic product approximates
COMPANIES INCLUDED IN the benefit of a 'true' psychedelic-assisted therapy:
MAJOR INDICES surely payers would prefer it. And, surely it would be
easier to scale, with a take-home drug representing
atai Life Sciences (now public) - $157m Series D
significantly reduced labour intensity versus classic
• Apeiron Investment Group, Thiel Capital,
As a result of some of the past year’s high-profile psychedelic-assisted therapy?
Woodline Partners, [...]
IPOs and exchange graduations, many companies
• Development of drug candidate pipeline and
became eligible for inclusion in major indices. This potential is captured in the below table, which
enabling technologies
appears in a journal article co-authored by Olson.
NASDAQ and NEO-listed MindMed announced on
GH Research (now public) - $125m Series B
March 19th, 2021, that the company had been inclu-
• RA Capital, RTW Investments, BVF Partners,
ded in both the FTSE Russell Global Micro-Cap CASE STUDY: INVESTORS BACK
[...]
and FTSE Total-Cap indices. On June 25th, 2021,
MindMed would be included in the FTSE Russell
• Clinical development of 5-MeO-DMT candi- DELIX THERAPEUTICS' ATTEMPT
date for TRD, among others
3000 index. At the same time, NASDAQ-listed Seelos TO SKIP THE TRIP
Therapeutics announced that it had been included in
Beckley Psytech - $80m Series B
the Russell 2000, Russell 3000, and Russell Microcap
• Integrated, Prime Movers Lab, Adage Capital
indices. In December 2021, both atai Life Sciences Boston-based Delix Therapeutics closed a $70m
Management, Palo Santo [...]
and COMPASS Pathways were selected to be inclu- Series A financing in September 2021, with the aim of
• Clinical development of low-dose psilocybin
ded in the NASDAQ Biotechnology Index. advancing ‘non-hallucinogenic’ psychedelics. It was certainly promising enough to convince the
(SUNHA) 5-MeO-DMT (TRD & other undis-
investors in Delix’s Series A, which included ARTIS
closed neuropsychiatric indications)
Institutions and investment managers often create The company’s thesis, which is largely borne out of Ventures, RA Capital and OMX Ventures, a founding
index funds and ETFs that track the performance of co-founder David Olson’s research, hinges on the investor. It also earned the company a place in Fierce
Delix Therapeutics - $70m Series A
major indices such as those previously mentioned. idea that many psychedelics promote neuroplasticity. Biotech’s 2021 Fierce 15 list.
• ARTIS Ventures, RA Capital Management,
As a result, many prominent investment manage- Olson believes that these neuroplasticity-promoting
OMX Ventures, [...]
ment corporations such as Blackrock’s iShares and properties (which we discussed in more detail in the But, the non-hallucinatory nature of these molecu-
• Development of non-hallucinogenic psy-
ProFunds Group’s ProShares have since included atai, previous section of this Review) may be isolated from les, and their efficacy in treating a range of diseases,
choplastogens (see case study for more).
COMPASS, MindMed, and Seelos in various related psychedelic properties of a molecule, leaving a non- is yet to be borne out in human trials, and is situated
funds. -hallucinogenic ‘psychoplastogen’. within a much broader debate of whether the subjec-
Gilgamesh Pharmaceuticals - $27m Series A
tive effects of a psychedelic are necessary to derive
• Prime Movers Lab, Noetic Fund, Gron
Delix is not alone in seeking to develop non-hallu- therapeutic benefits. Indeed, not a single clinical trial
Ventures, [...]
3.9 – MAJOR PRIVATE • Development of new chemical entities
cinogenic psychedelics. MindMed has a program
around 18-MC, and appointed Bryan Roth to its
has been conducted with non-hallucinogenic psy-
choplastogens as of today.
FINANCINGS CaaMTech - $22m Series A
Scientific Advisory Board in the same week that Delix
announced their Series A. Roth’s research focuses Yaden and Griffiths, for example, contend that
• Noetic Fund
on engineering drugs that are, “maximally helpful to “underlying neurobiological-based mechanisms are
• Advance compounds from its library into cli-
A considerable amount of the capital that flowed into patients while minimizing discomfort in the treatment undoubtedly necessary but likely not sufficient to
nical trials
psychedelics companies last year did so via private process,” explaining that “not all patients are comfor- confer full beneficial effects.” It also gets at a more
financings. As a result, many of these companies have table with their treatment program requiring halluci- philosophical question as to whether non-hallucino-
Alexander Shulgin Research Institute (ASRI) -
secured the capital needed to support and expand natory trips.” genic psychedelics ignore the broader social or spiri-
$7.2m Seed Round
their drug discovery, development, and delivery tual ‘purpose’ of psychedelics that at least some folks
• Noetic Fund
efforts for the foreseeable future. If these researchers and companies are able to cor- ascribe.
• Seed financing to advance discovery and
roborate preclinical signals of efficacy in using non-
development efforts
-hallucinogenic psychedelics to provide therapeutic

CASE STUDY: PSYMED VENTURES PsyMed launched its fund in November 2021 and has
Details on the SPV
raised over $8m to date, aiming for a final close of
• Target size: $70m.
the $25m fund in Q1 2022.
• The SPV receives 6.1% of North America MDMA
We spoke to Matias Serebrinsky, one of the three fou-
revenue for 7 years following initial drug sales.
nding partners of PsyMed Ventures. PsyMed began The trio have raised and deployed $6.5m
• ‘Reciprocity payment mechanism’: after paying
as a syndicate investing in psychedelics companies, through their syndicate, which has supported the
back the principal, the SPV returns 15% of the reve-
and recently announced the launch of a $25m fund following companies: atai Life Sciences, Beckley
nue share back to MAPS. After hitting a 3x payback,
to support companies operating in psychedelic medi- Psytech, Bexson Biomedical, Delix Therapeutics,
the SPV returns 50% of the revenue share back to
cine, precision psychiatry, and neurotechnology. Journey Clinical, Mindstate Design Labs, Reset
CASE STUDY: VINE VENTURES MAPS.
Pharmaceuticals, Tactogen, Terran Biosciences, and
• Vine will not take any carry or fees on the SPV.
CREATES SPV TO HELP FUND Serebrinsky, along with co-founders Dina TRIPP.
Burkitbayeva and Greg Kubin, will continue to ope-
MAPS' FINAL PUSH TOWARD themselves “Why should I donate? Let me just invest,” rate their syndicate—which has around 750 mem- The fund has made investments in Delix Therapeutics
explained Doblin. bers—alongside the new venture fund. “There are and Freedom Bioscience.
MDMA-AT APPROVAL AND ROLL- valuable synergies between both,” Serebrinsky told
Doblin’s preference for donations over investment is, Psilocybin Alpha. When we asked Serebrinsky about the types of psy-
OUT according to the founder, related to his broader plans chedelics companies the trio are most interested
to focus on “mass mental health.” This might include Explaining the difference between the two vehicles, in, he explained that, “there are venture-backable
In December, Vine Ventures’ Ryan Zurrer announ- providing MDMA-AT to places around the world Serebrinsky noted: opportunities in every part of the ecosystem, it's all
ced The Regenerative Financing Vine, a $70m Special where “there’s a lot of trauma,” and he worries that about the right team working on the right approach
Purpose Vehicle (SPV) that intends to fund patient having to return money to investors might change and business model,” adding that, “the space is still in
access infrastructure and research for MAPS’ MDMA- decision-making around the loftier goals. its very early stages.”
assisted therapy (MDMA-AT) for PTSD. This is somewhat akin to project financing: i.e.,
investments are structured and appraised on the “We first started the syndicate because it allowed In line with the broader trend identified earlier in this
According to details released by MAPS and Vine basis of projected future cash flows, as opposed to therapists, psychiatrists, practitioners, men- section, PsyMed’s focus on drug development com-
Ventures (who have pledged a minimum of $13m the current balance sheet of the project’s sponsors. tal health entrepreneurs, and anyone else that panies is set to continue. But, Serebrinsky noted that,
to the SPV), this model “fully maintains both MAPS’ Investors do not gain equity in MAPS PBC, but rather is an accredited investor who wanted to invest “as new psychedelic therapeutics are getting closer
nonprofit mission and governance and MAPS Public a share of future revenues, as explained above. See in expanding access to psychedelic medi- to market authorization, we're excited to meet more
Benefit Corporation’s (MAPS PBC) public benefit drug McKinsey’s New frontiers in pharma R&D investment cine. We have 750 members, and the syndi- entrepreneurs working on solutions to reduce friction
development and post-approval activities.” (PDF) for more on these types of models. cate has allowed them to invest starting with and improve outcomes.”
$1,000 check sizes. It makes investing way more
Thus far, MAPS’ research has been funded via $130m This $70m represents a portion of MAPS’ $150m fun- accessible.
in philanthropic donations over its 35-year history. draising target for the next three years. MAPS will 3.9 – OVERVIEW OF
This SPV represents a shift away from this donation- hope to raise the remainder through non-investment From the fund, we invest in earlier-stage com-
-only approach, funding the next stretch of MAPS means, such as via philanthropy but also partnerships panies (pre-seed to Series A) since it can be diffi- ANALYST RATINGS
MDMA-AT for PTSD work via an investment vehicle. and joint ventures. cult to raise large amounts ($250k+) for early-s-
tage businesses through the syndicate. The fund Despite a terrible year in terms of stock price per-
Speaking to Lucid News, Doblin expressed fee- Recommended Reading allows for more nimble, faster decisions. formance across the psychedelics sector, analysts
ling, “in some ways a sense of massive failure in that remain bullish on many of the largest psychedelics
I hoped we would have this bridge to sustainability Lucid News spoke with Doblin shortly after the Going forward, we will also invest from the syn- stocks.
come through philanthropy.” But, as more for-profit announcement. Read the interview here, where dicate in follow ons (Series B to pre-IPO) from
entities have entered the space – no doubt benefit- Doblin shares his thoughts on the new funding both the syndicate and our fund.” On the next page we present data on 2021 analyst
ting from and to some extent relying on the clinical, model, some further specifics on the mechanisms ratings for a number of psychedelics companies and
political and cultural work that MAPS has trailblazed baked-in to the SPV, the uses of the funds, and more. - Matias Serebrinsky compare them with their stock prices.
in the field – many former -donors are now asking

SECTION
FOUR
PSYCHEDELIC
4
PERCEPTIONS IN
2021: POPULAR
CULTURE &
CONTROVERSY
4.1 – FOREWORD 4.2 – PSYCHEDELICS IN
POPULAR CULTURE
In 2021, the psychedelic space was flush with nota-
ble, and sometimes controversial events. Burgeoning Public interest in psychedelics seemed to continue
interest led to the creation and support of research increasing throughout 2021, with every week brin-
centres, institutes, and conferences all centred ging a new mainstream media mention or celebrity
around psychedelics. More mainstream media outlets 'endorsement'.
covered psychedelics, TV shows and documenta-
ries featured them, and a great number of celebrities Using Google search trends as a proxy for public
came out of the psychedelics closet. interest, the graph below shows that the last two
years have seen significant levels of interest in
However, amidst all of the excitement emerged psychedelics.
many important, and challenging, ethical considera-
tions that will demand more attention as the space The map displayed on the next page, meanwhile,
matures. suggests that state-level drug policy reform efforts
are driving a significant amount of interest in psyche-
Here, we review a number of pop culture moments delics like psilocybin. It's clear that Oregonians are
that foregrounded psychedelics in 2021, before tou- Googling the psychedelic most frequently, no doubt
ching on just a couple of the controversies that deve- due to the increased attention it's received since
loped throughout the year. Measure 109 passed in November 2020.
TV, FILM AND CULTURE Writing in the LA Times, Qualey (who also authored
the Mic piece) is keen to point out that the show’s
Psychedelics also appeared in a number of mains- director, Jonathan Levine, is an ardent psychedelic
tream TV shows, films, documentaries and cultural therapy proponent. Levine told Qualey psychedelic
arenas in 2021. Below are just a handful of examples.. therapy “is one of my top five options for the salva-
tion of humanity.”
Nine Perfect Strangers Drives Interest in Psychedelic
Therapies What did you think of Nine Perfect Strangers? Is any
publicity [for psychedelic therapy] good publicity?
Hulu’s Nine Perfect Strangers series, which first aired
in August 2021, stoked a great deal of interest in psy-
chedelic therapies, but also contributed to the further
development of common misconceptions around
these practices.
Two articles sought to clarify the portrayals, with

Business Insider tackling 12 elements of psychede-
lics retreats that the show got right and wrong, and
Mic publishing a more critical piece in which the title
describes the show’s portrait of psychedelic wellness
retreats as “deranged.”

LSD-Themed Broadway Show Launches: Flying Over CTV News W5 Investigation ‘Harnessing the Power Jeff Novitzky, the senior president of health and per-
Sunset of Psychedelic Drug Therapy’ formance of the UFC, described how the company
may look to involve both current and retired figh-
A new Broadway musical dramatizes a fictional An October 2021 W5 investigation shared the stories ters in psychedelic research. Should these emerging
account of a meeting between Aldous Huxley, Cary of Canadians using ketamine and psilocybin as treat- treatments prove to be effective for brain and psy-
Grant and Clare Boothe Luce, all of whom used LSD ments for post-traumatic stress disorder and cancer- chiatric health, UFC president Dana White has said
over the years. The show’s website sets the scene: -related anxiety. that “we want to be on board and we want to be
first.”
1950s Hollywood. You are at a beautiful beach house The episode also briefly discusses the status of
overlooking the Pacific with Cary Grant, Clare Boothe drug policy in Canada and the need for more well-
Luce and Aldous Huxley… and they are on an acid -regulated and accessible psychedelic-assisted
trip. Together. psychotherapies.
Hamilton’s Pharmacopeia Returns with Season 3
Flying Over Sunset premiered in November, officially CityNews (Canada) ‘The Psychedelic Frontier’
The third season of Hamilton Morris’ VICE series, opening just over a month later on December 13th.
Hamilton’s Pharmacopeia, aired in January 2021. In January 2021, Canadian media outlet CityNews
Psychedelic City’ TV Series and Metaverse Platform aired The Psychedelic Frontier. The special shared
The first episode, Synthetic Toad Venom Machine, Under Development the stories of many Canadians working to deliver or
saw Morris reflect on his earlier reporting regarding access psychedelic therapies. The episode follows a
an “international toad venom smoking phenome- A Los Angeles Magazine cover story titled, ‘Shrooms! Canadian war veteran as he searches for relief from
non” by clarifying the history of 5-MeO-DMT, before Shamans! Kosher LSD! Why Los Angeles Is Suddenly post-traumatic stress disorder (PTSD) and addiction
urging viewers that wish to experience “The God Tripping Out, is set to be developed as a TV series through psychedelic therapy.
Molecule'' to do so via a synthetic option. Shortly and metaverse platform, according to The Hollywood
after the episode aired, psychedelics company Reporter. CityNews also featured a number of Canadian com-
CaaMTech published research investigating the che- panies operating in the psychedelic space including
mical differences between pure 5-MeO-DMT, its deri- The author of the original story, Peter Kiefer, explai- Numinus, Braxia, and Red Light Holland.
vatives, and natural Bufo alvarius toad secretions. ned: “It’s such wonderful fodder for a series and
what’s more, I think it’s an extremely important topic Retired NHL Player Daniel Carcillo Heads Up
ATHLETES IN PSYCHEDELIA
The six-part series went on to explore other psyche- that is only going to become more so in the coming Wesana Health
delics including ibogaine and LSD, with the final epi- years.”
sode profiling “a new era of psychedelic research.” In 2021, a number of prominent athletes expressed Ex-NHL player Daniel Carcillo has emerged as a pro-
Is this a sign of things to come re: the confluence of their interest in psychedelic therapies. Below are just minent figure in the psychedelic space. In 2015,
BBC Airs Documentary: The Psychedelic Drug Trial) psychedelics and other ‘edgy’ investment and tech a few examples…. Carcillo retired from professional hockey after wit-
categories such as the metaverse, crypto, and VR? nessing and experiencing the enduring health
A special hour-long documentary aired on the BBC UFC Looking at Johns Hopkins Study on damage caused by concussions. Since then, Carcillo
in May 2021, the culmination of 16 months of filming Psychedelics As Potential Therapy for Fighters has worked to create a new company, Wesana, focu-
Imperial College London’s escitalopram vs. psilocy- sed on healing brain injuries using psychedelics. The
bin study. ESPN published an article in January of 2021 covering inspiration for Wesana came from the now-CEO’s
the UFC’s growing interest in psychedelics as possible personal healing experience using psychedelics.
In the film we hear from the likes of Professor David therapies for its athletes. According to the article, the
Nutt, Dr Robin Carhart-Harris and Dr Rosalind Watts, UFC had been in contact with researchers at Johns In 2021, Wesana, under the leadership of Carcillo,
as well as participants in the groundbreaking trial. Hopkins University to discuss the potential psychede- began trading on the Canadian Securities Exchange
lic might have in treating brain injury, addiction, pos- and has since engaged a number of partners in an
We discussed the trial itself in our earlier section on t-traumatic stress disorder (PTSD), and other mental- effort to develop new treatment options for traumatic
Psychedelic Research and Clinical Trials in 2021. -health challenges. brain injuries (TBI).

Documentary ‘Lamar Odom Reborn’ Released SIGNIFICANT NEWS
Joe Rogan Hosts Rick Kristen Bell Tried PUBLICATIONS

In May 2021, a documentary titled Lamar Odom
Reborn was released. The film follows the story of Doblin Psilocybin
ex-NBA player, Lamar Odom, as he works to over- Episode #1661 of The Joe Rogan After struggling with depression News outlets from the BBC through to Good
come his struggles with addiction and depression Experience featured MAPS' and anxiety for 22 years, Bell says Housekeeping covered psychedelics in 2021, with the
through “medically-guided alternative treatments.” Rick Doblin for over 3 hours of she tried psilocybin. montage below highlighting just a handful of these
Following a nearly fatal overdose in 2015, Odom’s discussion... headlines.
struggles with mental health were propelled into the
public spotlight. As the documentary depicts, Odom
has since been able to recover and heal with the help
of ketamine and ibogaine treatments.
You can also watch a follow-up Q&A on psychedelic

Chelsea Handler Says She Mike Tyson Continues to
medicines with Lamar Odom and others here.
Microdoses Discuss 'The Toad'
On The Tonight Show, Handler Tyson received a great deal of
CELEBRITIES IN PSYCHEDELICS said "I take mushrooms almost attention for his comments on
every day... microdosing 'doing the toad' throughout the
mushrooms is a gamechanger." year.
In 2021, even more celebrities came out of the psy-
chedelic closet, sharing their experiences with a
variety of psychedelics via interviews and news
pieces.
But, some may argue that the evangelism displayed

Elon Musk Endorses Christina Haack Smoked
by at least some of the below celebrities is irresponsi-
Psychedelics at Code Toad Venom
ble from a harm reduction or environmental point of
Conference In mid-2021, Haack explained in
view.
Musk said, "I think generally a lengthy Instagram post that she
people should be open to smoked toad venom which 'reset'
Take Tyson's comments, for example, in which he
psychedelics..." her brain.
sings the praises of 'toad venom': might that encou-
rage folks who hear his comments to seek out toad-
-derived 5-MeO-DMT, and what might that do for the
already-struggling population of Bufo alvarius? We
discussed this in a November Bulletin.
Handler's claim that "psilocybin is good for Megan Fox Discusses Will Smith Discusses
everybody, it puts you in a good mood, keeps you Ayahuasca on Jimmy Ayahuasca Rituals with GQ
upbeat..." could also be seen as a concerning blanket Kimmel Live In a Cover Story for GQ, Smith
statement that smoothes out the complexities of the Fox explained that she 'went explained that 'more than a dozen
psychedelic experience. to hell for enternity' during her ayahusaca rituals' in Peru changed
ayahuasca trip. his life.
See the spread on this page and the next for more
information.

article from November. of work and cost close to a million dollars. The rest to watch, and one that COMPASS is no doubt gea-
“I want to be clear that having sex with the client
came from donors like Bill Linton, Bronner’s Soaps, ring up to fight. Around the time the news of the
or patient in a psychedelic therapy relationship is
The discussion was also a recurrent theme at The Steve and Alexandra Cohen Foundation and challenge broke, COMPASS announced the forth-
always sexual abuse, and that is because of the
December’s Horizons conference in New York. Laura Evolve Foundation, according to Carey Turnbull. coming appointment of a new Chief Legal Officer
power dynamic.”
Mae Northrup gave a powerful talk on sexual abuse (and, the departure of co-founder Lars Wilde as Chief
in psychedelic-assisted therapy, saying what many That expense begins to make sense when you read Business Officer), Matthew Owens. Owens was for-
- Laura Mae Northrup
might hope is obvious: “I want to be clear that having that researchers involved in the challenge had to merly responsible for legal and IP strategy at Novartis,
sex with the client or patient in a psychedelic the- scour the world for “high-quality synthetic psilocy- in his role as Global Head Legal, Digital.
rapy relationship is always sexual abuse, and that is bin stored in safe conditions,” with one such sample
4.3 – CONTROVERSIES because of the power dynamic.” being a 1963 bottle of Sandoz psilocybin, obtained via Some of the researchers hired by the non-profit sub-
NIDA’s Drug Supply Program. Turnbull told Psilocybin mitted additional findings to an academic crystallo-
2021 also foregrounded a number of debates and This healthy and long overdue debate will surely con- Alpha that the sample most extensively used in the graphy journal, in an article that was accepted later in
controversies in the psychedelics space, not least the tinue into the new year. research was obtained via Rolan Griffiths’ lab at December.
long overdue discussion around sexual abuse in the Johns Hopkins University, and was made by Heffter
context of psychedelic therpay and the salient debate Research Institute founder Dave Nichols.
THE PSYCHEDELIC PATENT WARS
surrounding the role of patents in the space. Some Recommended Reading
COMPASS Pathways has 3 months to respond to the
Below we touch on these two controversies and The role of intellectual property, and particularly post-grant review that this research has informed. This debate has been charted by Shayla Love’s repor-
debates, but readers should be sure that there are patents, in the psychedelics space continued to be Then, the Patent Trial and Appeal Board (PTAB) deci- ting over at Vice, which is recommended reading for those
many more. heavily debated in 2021, with some using the phrase des whether a case should proceed to trial. If it does, looking to dive deeper into this topic.
‘patent wars’ to describe the situation. a lengthy process ensues.
SEXUAL ABUSE IN PSYCHEDELIC • Can a Company Patent the Basic Components of

Case Study: Non-Profit Group Challenges COMPASS The company responded to the story by stating that Psychedelic Therapy? (February ‘21)
THERAPY Pathways Patent they “remain highly confident in the strength of our
patents and our polymorph A is the subject of nume- • Investors Are Debating Who Should Own the Future of
Much of the criticism has been levied at COMPASS rous granted patents from several different Patent Psychedelics (March ‘21)
A collaboration between New York Magazine and Pathways, which has been awarded patents cove- Offices, confirming that it is novel and inventive.”
Psymposia brings the discussion around (sexual) ring synthetic forms of psilocybin, as well as common • The Race to Patent Psychedelics Is Just Getting Started
abuse in the psychedelics space to the foreground elements of a psychedelic-assisted therapy protocol. This isn’t the first time the company’s patents have (May ‘21)
via the first season of the Cover Story podcast, titled been questioned, however. In July 2021, a patent
Power Trip. Across 8 episodes, host iO Tillet Wright In December, COMPASS’ “infamous” patent on syn- examiner at the UK IP Office issued an opinion • Is it Possible to Create an Ethical Psychedelics
and collaborator Lily Kay Ross “uncover the secrets thetic psilocybin was challenged by a non-profit on Compass Pathways’ UK Polymorph A patent Company? (June ‘21)
and expose the darkest corners of the psychede- group, which argued that COMPASS’ Polymorph A is (GB2572023), having received a request for opinion
lic revolution through a twisted, deeply personal tale no different to the crystalline forms made over and from Kohn & Associates acting on behalf of Freedom • Psychedelics Patent Claim Raises Questions From
at the intersection of mind, body, and control.” Learn over again since psilocybin was first synthesized. to Operate. The examiner found a number of claims Researchers Who Say They Did It First (June ‘21)
more, and listen to the series, here. to be lacking an “inventive step,” a foundational tenet
The group challenging the patent is Freedom to of the patent regime • Can LSD Treat Food Allergies? We Don’t Know, But It’s
The podcast series builds on a spate of allegations Operate, a non-profit group dedicated to “protec- Already Been Patented (July ‘21)
and testimonies that have emerged in recent mon- ting psychedelic science and medical development However, an earlier petition for post-grant review
ths, including that of Will Hall who shared a power- for public benefit,” of which Carey Turnbull is at the levied at COMPASS was denied in 2020, with the • Psychedelics Are a Billion-Dollar Business, and No One
ful account of his experience with a number of (for- helm. You can download the post-grant review peti- PTAB concluding that the petitioner failed to show Can Agree Who Should Control It (September ‘21)
merly-)respected psychedelic therapists and tea- tion here. that “it is more likely than not” that claims were unpa-
chers. Hall’s account was originally shared in a sel- tentable as obvious. • New Filing Challenges Compass Pathways’ Infamous
f-authored article published on Mad in America in Turnbull footed around half of the bill for the research Patent on Synthetic Psilocybin (December ‘21)
September, and is explored in detail in an Inverse that underpins the challenge, which took months This will certainly be an interesting development

OUR PATENT TRACKERS
We are pleased to have contributed to greater

transparency around psychedelic patents through
the provision of our freely-available psychedelic
patent trackers which you can access by clicking the
embedded boxes below.
Patent trackers are powered by Calyx Law
DMT PATENT TRACKER MDMA PATENT TRACKER

A catalogue of U.S. DMT-related patent A catalogue of U.S. MDMA-related patent
publications publications
ACC ES S DATA ACCE SS DATA
PSILOCYBIN PATENT FILINGS PSILOCYBIN PATENT TRACKER

TRACKER A catalogue of U.S. psilocybin-related patent
A catalogue of psilocybin-related patent filings
publications
in the U.S.
ACCE SS DATA
ACC ES S DATA
76 P SYC H ED EL I CS 2 02 1: A YEA R I N R EVI EW

SECTION
FIVE
LOOKING
AHEAD TO A
PSYCHEDELIC
2022
5
5.1 – FOREWORD afford individuals access to psychedelic-assisted
2021 Prediction #1 2021 Prediction #2 therapies.
2022 looks set to be another busy year for the psy- There are plenty of catalysts on the horizon as We also expect to see access to psychedelics, And, amid all of these psychedelic drug policy reform
chedelics space, with a number of late-stage clini- we enter a new year, including clinical trial rea- notably psilocybin, continue to expand via pro- developments, many psychedelics companies have
cal trials commencing or wrapping; important deci- douts from COMPASS Pathways’ Phase 2b psi- gressive moves from local governments (urged attempted to capitalise on the newfound attention
sions on the table for Oregon’s legal supervised psilocybin-for-depression study and ATAI Life by grassroots campaigns) and national regula- and regulatory loosening by press releasing their
locybin therapy rollout in 2023; further (psychedelic) Sciences’ expected IPO. We should also see tory bodies such as Health Canada. The combi- support for amendments, motions, and movements.
drug policy reform efforts set to progress; and much, MAPS continue to make progress in their Phase nation of bottom-up grassroots advocacy and
much more. 3 investigations into MDMA-for-PTSD, which top-down regulatory amendments may generate Read our Psychedelic Drug Policy Reform in 2021
appear promising thus far. Should the clinical a reinforcing cycle that gradually expands access section for more on the above topics.
Rather than making cold, hard predictions about data from these trials continue to indicate the to psychedelics in both a geographical sense,
what’s sure to be a very psychedelic 2022, we’re safety and efficacy of psychedelics such as psilo- but also in terms of access criteria. We may even
going to share some key trends that we’ll be keeping cybin and MDMA, it is likely to continue to propel see a national legal framework for psilocybin 2021 Prediction #3
an eye on, and covering, in this new year. interest and activity in the broader space. emerge in Canada next year. It is likely that local
decriminalisation and legalisation measures in We expect that mainstream media will increa-
But first, let’s take a look back at our 2021 the United States will follow a similar timeline as singly cover developments from the psyche-
‘predictions’... marijuana, with states such as California next in delic space. This coverage of psychedelics will
Well, that was an easy prediction, and one that line for such measures. We anticipate a conti- increasingly contribute to conversations regar-
came true (at least to some extent). As mentioned nuation of the current trend whereby some psy- ding the mental health crisis, which we expect to
in our earlier section on Psychedelic Research and chedelics companies publicly state their ambi- remain a salient issue given the ongoing impact
Clinical Trials in 2021, data readouts from COMPASS tions to enter these regionally-legalised markets of COVID-19. Societies across the world have
THE PSYCHEDELIC Pathways’ Phase 2b and MAPS’ Phase 3 study did (e.g., Field Trip in the case of Oregon), while been forced to confront shortcomings in mental
RENAISSANCE IN 2020 attract a great deal of mainstream attention. So too others intend to steer clear of entering state health provision, which should catalyse efforts to
Click the button bellow to read our full year in did atai Life Sciences’ Nasdaq IPO. markets so long as psychedelics remain federally discover and deliver alternative treatments.
review from 2020 illegal (e.g., MindMed in the case of Oregon).
However, on the investor side of the equation
C LI C K HERE COMPASS’ readout and atai’s IPO did little to bolster
confidence in the companies’ valuations. As afore-
Another easy one, which unsurprisingly came true.
mentioned in this series, both companies’ stocks have You could argue that this was another easy predic- As aforementioned, media coverage was stoked by
performed poorly in 2021, reflecting (and perhaps tion for us to have made back in December 2020. MAPS’ Phase 3 results and psychedelic drug policy
even leading) the broader psychedelics market Nonetheless, we are taking this one as a win.
5.2 – OUR 2021 downtrend: it seems that capital letters are not the
reform efforts, among other catalysts. See our sec-
tion on Psychedelic Perceptions in 2021 for more on
only type of capitalisation atai reduced during 2021
PREDICTIONS: HOW DID (the company name was formerly styled ATAI Life
As you can see in our Psychedelics Legalization and
Decriminalization Tracker, psychedelic drug policy
this topic.
WE DO? Sciences). reform is now prolific in the United States, with a

great number of bills emerging in 2021. A prime
example being California’s SB 519 which, though put
Last year we published a much shorter Year in Review on hold, aims to decriminalize a range of psychede-
for 2020, which included a Looking Ahead section lics in the Golden State.
where we made some broad suggestions of what we
might expect to see in 2021. So, how did we do? We didn’t see the type of national legal framework for
psilocybin emerge in Canada that we may have allu-
Let’s take a look at each broad ‘prediction’... ded to, but we have seen important reforms to the
nationwide Special Access Programme which could
80 P SYC H ED EL I CS 2 02 1: A YEA R I N R EVI EW 81 81

M&A activity didn’t materialise in any substantial way. The figure at the bottom of this page (reproduced A small portion of this work will enter clinical trials in
2021 Prediction #4 We will be shamelessly rolling over this prediction from our earlier section on Psychedelic Research and 2022.
into our 2022 batch: more on that below. Clinical Trials in 2021) visualises a number of these
Technology and digital therapeutics should play target indications. As mentioned earlier in this report: we must be cau-
an increasing role in the work of psychedelics tious not to overstate the ‘promise’ of psychede-
companies, from augmenting drug discovery by Should psychedelics’ effects on structural and func- lics to treat such diseases. While psychedelics appear
employing AI, right through to empowering end- 2021 Prediction #6 tional neuroplasticity and inflammation continue to to work in a transdiagnostic manner, much of the
-users of psychedelic therapies and medicines be validated through research, we might expect them research is in early stages, particularly around this
by providing actionable insights through the use We anticipate the pace of press releases and to prove efficacious (with or without the ‘trip’) in the broader list of conditions.
of wearables. announcements from psychedelics companies treatment of at least some of the conditions outlined
to continue increasing, particularly in relation above. This broadening of the research and drug develo-
to intellectual property (e.g., patent filings) and pment pipeline to include a whole swathe of new
research and development (including clinical A number of review articles published in 2021 expan- conditions certainly makes it more difficult for inves-
This one certainly rang true. Check out the segment trials). As with any nascent sector, there will also ded on this potential, including Albert Garcia-Romeu tors, analysts, and other observers to make an infor-
Growth of Digital Therapeutics, Delivery Technologies be a great deal of noise that threatens to obs- et al.'s exploration of psychedelics as potential novel med appraisal of any particular drug development
& Drug Discovery Tech in our earlier section for more cure the underlying value in any given company therapeutics for Alzheimer’s disease, and Saeger and programme. Now, not only must interested parties
on this. or project. Olson’s survey of psychedelic-inspired approaches have a grasp of the broader context of neuropsychia-
for the treatment of neurodegenerative disorders tric research and drug development, but also that of
more broadly. fields such as Alzheimer’s research, which brings with
it a whole new field of debates, varying degrees of
2021 Prediction #5 Tell us about it! It’s been quite the year in terms of the We’re already seeing a number of research labs and (un)certainty in terms of drug targets, and more.
pace of company news and research publications. companies seek to develop psychedelic drugs for
From a financial point of view, we expect money the treatment of many of these conditions, and we One thing’s for certain: it’s going to get a lot more
will continue entering the space in large sums, Now let’s look ahead to 2022… should expect more of this work to emerge in 2022. difficult to keep tabs on the breadth and variety of the
with ATAI’s expected IPO representing an psychedelic drug development pipeline in 2022.
important date in the psychedelics financial
calendar for 2021. We may also see greater M&A 5.3 – TRENDS TO FOLLOW
activity in the space next year, and interest from
the more conventional pharma industry is likely IN 2022
to increase. We also expect some companies
in the space to continue seeking out shorter- As aforementioned, we’re sharing some of the key
-term revenue streams. Clinics and wellness trends we will be following, and writing about, in
centres offering ketamine treatment programs 2022. As always, this is by no means exhaustive…
are likely to continue to be a dominant trend,
along with consumer packaged goods such as
PSYCHEDELICS R&D MOVES
nutraceuticals.
BEYOND MENTAL HEALTH
A mixed bag, here. While large sums of money have While mental health conditions like depression and
continued to flow into the space, the story on the PTSD have represented the beachhead for clinical
public markets has been much less rosy: atai’s IPO, research into psychedelics, we’re now seeing more
for example, proved to be a damp squib that failed to investigations geared toward treating a broader set of
lift the psychedelics market. conditions such as neurodegenerative disorders and
pain-related indications.
82 P SYC H ED EL I CS 2 02 1: A YEA R I N R EVI EW 83 83

THE ‘PSYCHEDELIC PATENT WARS’ companies with relatively large sums of cash on Elliot Marseille, lead author of a 2020 paper
hand. As of September 2021, atai had just over that sought to demonstrate the cost-effective-
RAGE ON
$430m cash on hand, while COMPASS and MindMed ness of MDMA-AT for the treatment of PTSD, ser-
had around $294m and $146m, respectively. ves as Director of a dedicated initiative housed at
The ‘patent wars’ will be stoked by an acceleration UC Berkeley and UCSF. The Global Initiative for
of patent application publications, with potential Indeed, atai was busy in 2021 when it came to lau- Psychedelic Science Economics (GIPSE) is a network
grants, rejections, and litigation. nching new programs and making strategic invest- of health economists with the shared goal of increa-
ments, with 6 such deals made. Though, it remains to sing access to psychedelic therapies by demonstra-
The Intellectual Property (IP) landscape of the psy- be seen how substantive each of these are. ting (and improving) their cost-effectiveness. The
chedelics space is becoming clearer week-by-week group is working with MAPS as well as the Usona
as companies announce filings, patent applications We might also expect companies outside the psy- Institute and others.
publish, and IP offices hand down their verdicts. chedelics space to make acquisitions of psychedelics
companies or programs in 2022. Some smaller psy- Insurance coverage will be key to ensuring a scalable
IS CONSOLIDATION ON THE
As mentioned in the preceding section, the patenting chedelics companies may be acquired by larger ones and accessible roll-out of psychedelic-assisted the-
of psychedelics and their related technologies and CARDS? operating in ‘adjacent’ industries, such as canna- rapies. We will be keeping a close eye on this trend,
uses has not been without controversy. At the close bis, as was the case with MagicMed Industries which and groups like GIPSE and companies like Enthea, in
of 2021, the non-profit Freedom to Operate filed was acquired by Nasdaq-listed CBD biotech Enveric 2022.
two petitions for post-grant reviews of COMPASS As aforementioned, we expected some level of con- Biosciences in 2021.
Pathways’ patents, supported by research conducted solidation in 2021, but this didn’t play out in any subs-
by a group of crystallographers. This case alone will tantial way. At risk of a double fault, we’re rolling this Though perhaps more of a stretch, we might even
be one to watch as we enter 2022, with COMPASS prediction over into 2022. see companies in the broader biotech and pharma-
expected to respond in the coming months, and a ceutical industry acquiring psychedelics companies
potential trial thereafter. If the broader economy, biotech sector and public and programs. After all, Otsuka Pharmaceutical has
markets continue to flag in 2022, we could see an already invested in and partnered with a handful of
It’s unlikely this will be an isolated case, though. Many untenable environment for a number of publicly-tra- companies and drug candidates in the space.
patent applications will be published in 2022, with the ded psychedelics companies. We’re not alone in pre-
18 months of secrecy attached to many such filings dicting that there will be a number of companies that
expiring this year. This means that by the end of 2022, fold in 2022: MINDCURE CEO Kelsey Ramsden goes
A CLOSER EYE ON INSURANCE
we should have a much clearer picture of the psy- as far to suggest that half of the psychedelics com- COVERAGE
chedelic intellectual property topography, which may panies with a sub-$300m market cap (a category in
have impacts on drug development pipelines and which her company sits) will “die” in the coming year.
research activity. As MAPS’ MDMA-AT for PTSD nears potential appro-
MAPS’ Rick Doblin, meanwhile, told us that he vals, and COMPASS Pathways enters Phase 3 trials, ALL EYES ON OREGON
expects a “major” consolidation of the for-pro- we will see a greater focus on the cost-effectiveness
fit psychedelic companies, “with many running out of psychedelic-assisted therapies and the willingness
of money or seeing their ideas not borne out once of insurance companies to cover these novel treat- The two-year development period for the Oregon
actual research is started.” ments in 2022. Psilocybin Services section ends December 31, 2022.
That means that by the end of this year the Oregon
But, going bust isn’t the only way that the sector This is a key priority for MAPS, with Founder Rick Psilocybin Advisory Board must be in a position to
might be reorganised. A less pessimistic prediction is Doblin telling Psilocybin Alpha that “a key challenge implement the regulation of the manufacture, trans-
that we will see a greater level of mergers and acqui- in 2022 will be the early negotiations with insurance portation, delivery, sale and purchase of psilocybin
sitions (M&A) in 2022, both from companies outside companies for possible coverage of psychedelic-as- products and the provision of psilocybin services in
the psychedelics space, and from within. sisted therapies post-approval for prescription use.” the state. Applications for licences begin January 2,
2023: there’s no wiggle room.
Intra-industry acquisitions may be driven by public

That’s a hefty task, and it won’t be without debate. in psychedelic harm reduction and peer support will
Key fault lines include whether microdosing should launch for the general public in 2022, just one such
be included in the provision, to what extent adverti- initiative.
sing should be permitted, and more. As a recent arti-
cle on the matter pointed out, the clock is ticking: the
Board has until the end of June to send their recom-
mendations to the Oregon Health Authority.
OTHER TRENDS TO FOLLOW IN
2022
Interested parties should follow these debates clo-
sely; we certainly will be.
While we couldn’t possibly cover every trend that’s
worth following in 2022, here are several others to
keep in mind:
OTHER (PSYCHEDELIC) DRUG
POLICY REFORM EFFORTS • Psychedelics companies and researchers conti-
nue to explore digital therapeutics and innovative
CONTINUE tech across the drug development pipeline and
patient journey.
• Might we see conventional drug developers
When we said ‘all eyes on Oregon,’ we didn’t mean to expand their pipelines to include psychedelics?
take your attention away from the slew of other (psy- • We’ll see plenty of failures in 2022, with a num-
chedelic) drug policy reform efforts that will develop ber of preclinical and clinical studies wrapping.
throughout 2022. Research has shown that Phase II trials have the
highest attrition rates out of all clinical stages,
Perhaps most notably is California’s SB 519, which and there are plenty of Phase II trials underway in
would decriminalize a number of psychedelics in the psychedelics.
Golden State. The Bill was put on pause in 2021, but • The debate around the rigour of trials will
is set to be re-introduced this year. continue.
Emerge Law’s Sean Clancy is, unsurprisingly, Taken together, many of these trends point toward a
following this trend closely (not least to keep the changing regulatory, scientific, and financial lands-
Psychedelics Legalization and Decriminalization cape for psychedelic researchers, practitioners, and
Tracker up-to-date along with the team at Calyx (in particular) companies. Pivot or perish will likely be
Law). He told us that in 2022 he expects “more local a scenario that a number of these companies face in
measures and perhaps more ambitious state-wide 2022.
measures, especially from newer, creative politi-
cians seeking to set themselves apart by following
Oregon’s bold lead to decriminalize personal posses-
sion while regulating specific compounds, such as
psilocybin.”
As we expect to see decrim. and legalization initia-

tives continue apace in 2022, we might also expect
to see a greater need for harm reduction efforts.
Rick Doblin told us that MAPS’ Psychonaut training

5.4 – PSYCHEDELIC
CLINICAL TRIAL RESULTS
TO WATCH FOR IN 2022
PSILOCYBIN FOR MDD R-KETAMINE FOR TRD PSILOCYBIN FOR SUNHA
In our Psychedelic Research and Clinical Trials in Phase 2 Clinical Trial Phase 2 Clinical Trial Phase 1 Clinical Trial
2021 section we discussed a handful of publications N CT0 386 6 174 2 0 2 0 - 0 0 5 45 7 - 2 5 N C T 0 49051 2 1
and readouts that occured over the course of last
year. While some of these results, such as MAPS first
Phase 3 results, drew a great deal of positive attention
to the space, others served to temper expectations
somewhat.
Next you will find a sample of clinical trials that, bar-

ring any delays, we might expect to see results from
over the course of this year.
LSD FOR ANXIETY DISORDERS 18-MC PK & SAFETY DMT FOR DEPRESSIVE
Phase 2a Clinical Trial Phase 1 Clinical Trial
DISORDERS
Phase 1 Clinical Trial
N CT0 315 35 79 N C T 0 42 9 2 1 97
N C T 0 2 98 1 1 7 3
MDMA-AT FOR PTSD

Phase 3 Clinical Trial (#2)
NCT0407 7437
• Rick Doblin tells Psilocybin Alpha that MAPS has already PSILOCYBIN FOR COCAINE USE 5-MEO-DMT PK & SAFETY PSILOCYBIN FOR CLUSTER
enrolled 71 of the 100 participants needed for the Phase 2 Clinical Trial Phase 1 Clinical Trial HEADACHES
second Phase 3, and that interim analysis will provide
N CT0 2 0 3712 6 NCT05032833
results in May 2022. NCT02981173
• Doblin told us that the study is expected to conclude
in November 2022. Should these results be statistically
significant, and no novel safety issues emerge, MAPS will
finalise its New Drug Application (NDA) with the FDA.
• MAPS will also seek to broaden its footprint
geographically, buoyed by a recent fast-track
designation from UK regulators. “MAPS will complete
the training of about 40 therapists in 6 countries and
9 sites in England and Europe who will be conducting
DMT FOR MDD ORAL IBOGAINE PK & SAFETY PSILOCYBIN FOR OCD
Phase 2a Clinical Trial Phase 1 Clinical Trial Phase 1 Clinical Trial
Phase 3 research into MDMA-assisted therapy for PTSD,”
Doblin explained. He added, “we’ll train another 800 or N C T 0 5 0 2 940 1
N CT0 4 6 73383 N C T 0 3 3 009 4 7
more therapists in MDMA-assisted therapy for PTSD.”

5.5 – PSYCHEDELIC
CLINICAL TRIALS
EXPECTED TO BEGIN IN PSILOCYBIN FOR SMOKING
2022 CESSATION 4-HO-DIPT SAFETY & PK
Phase 2/3 Clinical Trial Phase 1 Clinical Trial
AN N OU N CE D OR E XPECTE D A N N O UN C E D O R E X P EC T E D
In 2021, many companies and academic institutions
announced their intent to initiate several new psy-
chedelic clinical trials in the near future. Next, you
will find a sample of clinical trials that are expected to
begin in 2022.
Visit our Psychedelic Drug Development Tracker for

more information.
PSILOCYBIN FOR BINGE PSILOCYBIN FOR CLINICIAN
EATING DISORDER DEPRESSION AND BURNOUT
Phase 2 Clinical Trial Phase 1/2 Clinical Trial
N CT0 5 0 35 9 2 7 N C T 0 5 1 6 3 49 6
PSYCHEDELICS DRUG
DEVELOPMENT TRACKER
Developed by Michael Haichin, PharmD
COMP360 PSILOCYBIN FOR
TRD
ACC E SS DATA H E R E
AN NOUNCED OR EXPECTED
18-MC FOR OPIOID PSILOCYBIN FOR DISTRESS IN
WITHDRAWAL PALLIATIVE CARE
• COMPASS will be the first for-profit company to take
Phase 2 Clinical Trial Phase 1/2 Clinical Trial
a classic psychedelic into a Phase 3 trial this year,
following the conclusion of its 2b trial in 2021. AN N OU N CE D OR E XPECTE D N C T 0 47 5 40 61
PSILOCYBIN FOR EFFECTS OF LSD ON

LSD FOR GAD FIBROMYALGIA NEUROPLASTICITY
Phase 2b Clinical Trial Open-Label Phase 2 Clinical Trial Phase 1 Clinical Trial
A PPR OVED N CT0 5 12 816 2 N C T 0 5 1 7 741 9

CLOSING
REMARKS We hope that this report has offered an overview of
some of the most salient events and trends in psy-
chedelics last year, from fundamental research
and clinical trials through to policy reform and pop
culture.
Today, the publication of research, filing of patents
and penning of popular media stories covering psy-
chedelics is growing exponentially. So much so, just
keeping tabs on this space and identifying reliable
sources—or, ‘cutting through the noise’—is an endea-
vour in itself.
Throughout 2022 we will continue providing news
and analysis as well as trackers and resources that That’s why we appreciate you, our readers, for your
allow you to keep tabs on psychedelic patents, policy ongoing trust, support and engagement.
reform, and more. We are proud that in 2021 these
resources were cited in a range of mainstream outlets Here’s to a very psychedelic 2022!
including Vox, Newsweek, Business Insider, VICE,
Wired, Rolling Stone and Mother Jones.
J OSH H AR DM AN
Founder and Editor
93
MEMORABLE QUOTES “This space could become dominated by companies whose primary obli-
FROM 2021 gation is to shareholders. Let’s not do that. That’s why we’re all here.”
- Amy Emerson, CEO of MAPS Public Benefit Corporation, Speaking at Horizons NYC
Business Forum
“I want to be clear that having sex with the client or patient in a psychedelic
therapy relationship is always sexual abuse, and that is because of the power
“In 2021, we may even have reached a tipping point
dynamic.”
of acceptability.”
- Laura Mae Northrup Speaking at Horizons NYC Business Forum
- BBC Science Focus Magazine Commenting on 'Psychedelic Therapies'
“I guess people just didn't want to go out and hunt these toads on a large scale, but that
“I was coming to these ideas right around the same time that the moon landing took
changed in the 21st century. Suddenly, there was an enormous explosion in interest
place. Then you get some of these astronauts talking about how when they saw the
in 5-MeO-DMT partially due to various celebrities trying it and talking about their
Earth from space, they changed their views. So it's a lot easier and a lot less expensive
transformative experiences. I think it sort of became what Ayahuasca was, like, maybe 10
to give somebody LSD than to shoot them up in space.”
or 15 years ago. Where, you know, if you want to show that you're a serious psychedelic
- Rick Doblin Speaking to GQ
person who really cares about this stuff: you need to do Ayahuasca. You have to go to
South America and go to a retreat and then you're a real psychedelic person. Well the
same thing happened with 5-MeO-DMT: it became a kind of psychedelic status symbol. “Your retreat centre is not a religion.”
This is how you show people that you're really into this stuff. That's all fine and good, - Ismail Ali, MAPS Policy Director, speaking on the difference between sanctioned
religious uses of psychedelics and those retreat centres and other providers that may
except it involves the molestation of toads. That also may be okay if one or two people simply try to invoke such settings.
are doing it, but if everybody is doing it the results will absolutely be catastrophic.”
- Hamilton Morris Speaking at Horizons NYC

“The idea behind EmpathBio is that Doblin’s
approach, while promising, will only represent “I am very concerned by the patent land grab warming up in the for-profit
MDMA 1.0.” psychedelic world. Is anyone working on a IP Defense Fund -- or coalition of
- Srini Rao, CSO at atai Life Sciences pro-bono lawyers -- of some type to file USPTO objections/comments, etc.
when companies attempt to secure broad patents that could hinder scientific
research, reasonable competition (i.e., for "scale" and wide accessibility,

“If MAPS is ‘MDMA 1.0,’ I would say that what we need competition to help drive costs down), and so on? Who are the
atai [and EmpathBio] is working on is ‘MDMA smartest people thinking about this?”
0.5.” - Tim Ferriss' Tweet on Patent Concerns
- Rick Doblin Responding to Rao's Comments
“Hence, to your question if I think a monopoly/duopoly is good for
innovation/the ecosystem: IF a monopoly/duopoly emerged, it suggests
that all the other would-be competitors had failed with their own creative
and entrepreneurial endeavours. Then it would be a sign of quality and
constitutional reward. In that case, you should not blame them, but
blame the rest, who then clearly would have not done a good job. And
once more, don’t forget the arbiter is neither me, nor you nor Twitter, but
the US legal system and the market - systems that I do have a great deal
of trust in.”
- Christian Angermayer, Founder and Chairman at atai Life Sciences, Excerpt From
An Open Letter Reply to Tim Ferriss

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A five-part review of psychedelics in 2021: from drug policy

grants in the U.S. and Australia; increased psychede- J OS H H A R D M A N

nation for a DMT therapy in the UK; a flurry of new

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6 P SYC H ED EL I CS 2 02 1: A YEA R I N R EVI EW 7

Here at Psilocybin Alpha, our readership increased

We also observed psychedelic companies, and their

As individuals and companies try to find their feet in

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1.3 - THE UNITED KINGDOM such a rescheduling is long overdue, according

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It’s not all bad news for psychedelics advocates in

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Over the next few pages you will find a sample of

Throughout the course of recapping some of these

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ENVIRONMENT FOR increase from the 30 g federal quota. On Monday

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PROGRAM 5. Psilocybin Induces Rapid and Persistent Growth of Dendritic

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In August, UK-based Beckley Psytech announced

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In 2021, many drug developers began investigating

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On April 27th, the company’s shares began trading on

On June 18th, 2021, the company began trading

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Two articles sought to clarify the portrayals, with

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Joe Rogan Hosts Rick Kristen Bell Tried PUBLICATIONS

You can also watch a follow-up Q&A on psychedelic

But, some may argue that the evangelism displayed

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SEXUAL ABUSE IN PSYCHEDELIC • Can a Company Patent the Basic Components of

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We are pleased to have contributed to greater

Patent trackers are powered by Calyx Law

DMT PATENT TRACKER MDMA PATENT TRACKER

ACC ES S DATA ACCE SS DATA

PSILOCYBIN PATENT FILINGS PSILOCYBIN PATENT TRACKER

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