atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage
biopharmaceutical company aiming to transform the treatment of
mental health disorders, today reported financial results for the
fourth quarter and full year ended December 31, 2021 and
provided business updates.
“2021 was a transformative year for atai. We expanded our
pipeline with the launch of seven new programs, bringing our total
number of development programs to 12 by end of 2021. Meanwhile, our
approach to value creation and capture was validated through a
significant licensing deal with Otsuka Pharmaceuticals for PCN-101.
We raised over $410 million in our June 2021 IPO, Series D and
other financings, and closed out 2021 well-capitalized with a cash
position of $362 million,” said Greg Weaver, Chief Financial
Officer of atai Life Sciences.
“From an R&D perspective, in addition to hitting many
discovery and pre-clinical milestones, we initiated Phase 1 studies
with GRX-917 and DMX-1002 and a Phase 2a proof-of-concept study
with PCN-101 in TRD. Additionally, we announced pro-cognitive
effects of RL-007 in our Phase 2a proof-of-mechanism study in CIAS,
an indication where patients have currently no approved treatment
options. We also increased our strategic investment in COMPASS
Pathways following their positive Phase 2b data with COMP360 in
TRD,” said Srinivas Rao, Chief Scientific Officer & Co-founder
of atai Life Sciences.
“This exciting momentum continues in 2022 and our cash runway of
approximately 2 years enables us to work towards our goal of
achieving clinically meaningful and sustained behavioral change in
mental health patients. We will focus on three strategic pillars:
namely, rapid acting intervention, ongoing digital support and a
biomarker-driven precision mental health,” said Florian Brand,
Chief Executive Officer & Co-founder of atai Life Sciences.
The Company anticipates at least 14 drug development and
enabling technology catalysts over the next two years, including
the Phase 2a proof-of-concept topline data readout with PCN-101 for
TRD and results from the Phase 1 relative bioavailability study
with PCN-101 designed to bridge between the current intravenous
formulation to a subcutaneous formulation to support at-home
use.
atai also expects data from the Phase 1 element of a combined
Phase 1/2 trial of DMX-1002 by the end of 2022 as well as topline
data from a Phase 1 trial with GRX-917 by mid of this year. Just
this month, the first subject in a Phase 1 with KUR-101 was dosed,
and atai anticipates topline results for this study later this
year. The initiation of Phase 2a proof-of-concept trials with
RL-007 and GRX-917 and Phase 1 trials with EMP-01 and RLS-01 are
anticipated in the second half of this year. The initiation of a
Phase 1 trial with VLS-01 is expected by mid of this year.
atai also expects further advancement in its ongoing patient
support technologies and precision mental health approaches. With
this ongoing positive traction across the Company’s platform, atai
will continue delivering on its vision to heal mental health
disorders and tackle the escalating global mental health crisis
head on.
In parallel to its R&D activities, in October 2021, atai
launched its philanthropic arm, atai Impact. atai Impact’s first
initiative, in December 2021, was the establishment of the atai
Fellowship Fund in Psychedelic Neuroscience at Massachusetts
General Hospital’s Center for the Neuroscience of Psychedelics.
This year, atai Impact has already made sizeable donations to the
Multidisciplinary Association for Psychedelics Studies (MAPS) and
to leading non-profit organizations supporting humanitarian efforts
in the Ukraine, with a special focus on mental health.
Conference Call and Webcast
A live webcast for today’s corporate update and fourth quarter
2021 financial results will take place today at 8:30 a.m. EST. To
access the webcast, please log in at
https://wsw.com/webcast/cc/atai/1358298. The conference call will
also be accessible live and for replay in the “Events” section of
the Company’s website www.atai.life. The archived copy of the
webcast will be available on the Company’s website for at least 30
days following the conclusion of the conference call.
Pipeline Highlights
Leveraging atai’s platform for innovation and accelerating
mental healthcare solutions, the Company continues to execute on
its pipeline of pharmacologically diverse candidates with the
potential for rapid-acting interventions that address the unmet
needs of mental health patients.
Treatment Resistant Depression (TRD)
COMPASS Pathways - COMP360: In November, atai’s strategic
investment COMPASS Pathways announced Phase 2b data for COMP360 in
TRD. The 233-patient trial met its primary endpoint, showing a
6.6-point reduction on the Montgomery-Åsberg Depression Rating
Scale (MADRS) total score from baseline to 3 weeks when comparing
the 25mg dose to the 1mg dose. COMP360 also showed both rapid
response and durability of efficacy and was generally well
tolerated. In Q4-2021, atai increased its holdings in COMPASS
Pathways to 22.8%. COMPASS plans to hold an end-of-Phase 2 meeting
with the FDA in April 2022 to discuss their Phase 3 program, which
is anticipated to commence in the second half of this year.
Perception Neuroscience – PCN-101: In December 2021, the FDA
gave Investigational New Drug (IND) clearance for the development
of PCN-101 for the treatment of TRD. In September 2021, the Phase
2a proof-of-concept trial of PCN-101 for TRD was initiated. This
randomized, double-blind, placebo-controlled Phase 2a
proof-of-concept trial is designed to assess the efficacy, safety,
dose response, and duration of response in patients with TRD. A
topline data readout of this trial is expected by the end of 2022.
The initiation of a Phase 1 relative bioavailability study, which
is designed to bridge the intravenous formulation to a subcutaneous
formulation of PCN-101, is anticipated for late 2022.
Viridia Life Sciences – VLS-01: VLS-01 is in preclinical
development for TRD with a Phase 1 trial expected to be initiated
in the middle of 2022.
Revixia Life Sciences – RLS-01: RLS-01 is in preclinical
development for TRD with a Phase 1 trial expected to be initiated
in the second half of 2022.
Cognitive Impairment Associated with Schizophrenia (CIAS)
Recognify Life Sciences - RL-007: In December of last year, atai
announced positive biomarker data from the Phase 2a
proof-of-mechanism study of RL-007 in CIAS patients. RL-007 was
well tolerated and demonstrated a clinically meaningful behavioral
pro-cognitive profile consistent with previous Phase 1 and 2 trials
of this compound. Changes in quantitative electroencephalogram
(qEEG) consistent with a previous Phase 1 trial involving a
scopolamine challenge were noted. These results support the
progression of RL-007 to a double-blind, placebo-controlled Phase
2a proof-of-concept trial in CIAS, which is anticipated to be
initiated in the second half of 2022.
Generalized Anxiety Disorder (GAD)
GABA Therapeutics – GRX-917: In June 2021, GABA initiated a
Phase 1 single and multiple ascending dose trial of GRX-917.
Topline data for this trial is expected by mid of this year and the
initiation of a Phase 2a proof-of-concept trial is anticipated to
follow in the second half of this year.
Opioid Use Disorder (OUD)
DemeRx IB – DMX-1002: DMX-1002 is being tested in an ongoing
Phase 1/2 trial to evaluate its safety, tolerability,
pharmacokinetics, and efficacy. Safety data from the phase 1
element of this trial are expected in the second half of 2022.
Kures – KUR-101: A Phase 1 single ascending dose trial to
evaluate the maximum tolerable dosage was initiated, with first
patient dosed in March and topline results expected in the second
half of 2022.
Post-Traumatic Stress Disorder (PTSD)
EmpathBio – EMP-01: EMP-01 is in preclinical development for
PTSD with a Phase 1 trial expected to be initiated in the second
half of 2022
Drug Discovery
atai is conducting robust drug discovery through four subsidiary
companies, including two newly added companies – TryptageniX
(December 2021) and Invyxis (January 2022). TryptageniX will
develop new chemical entities through a unique bioprospecting and
synthetic biology approach, while Invyxis brings proven medicinal
chemistry and comprehensive biological evaluation capabilities to
our discovery efforts. These new approaches complement atai’s
existing drug discovery efforts at EntheogeniX, which uses an
AI-based computational chemistry platform to create structurally
differentiated molecules. Finally, PsyProtix is a discovery stage
company that is developing compounds to treat specific subsets of
TRD patients that are characterized by mitochondrial dysfunction,
thus representing an important first step towards our goal of
delivering biomarker-driven precision mental health.
Ongoing digital patient support and precision mental health
atai’s digital efforts include digital therapeutics that are
focused on improving the safety, efficacy and scalability of our
compounds by providing continuous digital care to patients before,
during and after treatment. In addition, our efforts include a
multimodal data analytics platform designed to better characterize
mental health indications and that may facilitate more personalized
treatments. Psyber is developing interventions that use brain
computer interface-based technology to induce rapid behavioral
change through biofeedback. Introspect Digital
Therapeutics is focused on providing personalized, digitally
delivered, evidence-based psychotherapy to patients receiving our
compounds. As announced in September 2021, Introspect launched
a user acceptability trial in TRD patients undergoing ketamine
therapy to validate the combination of a digital app and drug in
improving treatment outcomes.
Consolidated Financial Results
atai ended the year with a strong cash position of $362 million
which it anticipates will be sufficient to provide a cash runway of
approximately two years, including funding of additional
anticipated business development activity.
Cash and Cash Equivalents
Cash and cash equivalents totaled $362.3 million as of December
31, 2021, compared to $97.2 million as of December 31, 2020. The
twelve-month increase of $265.1 million is attributed to net
proceeds of $409.9 million from the June IPO, Series C and Series D
equity raises and other financing activities, and $20.0 million of
license revenue proceeds. Offsetting were cash payments of $52.5
million of additional investment in Compass Pathways, $14.9 million
investment in and loan to IntelGenx, $10.6 million additional
investment in GABA, $3.5 million for investments in other platform
companies and assets, and $83.3 million in net operating expenses
and effect of foreign exchange rate changes.
Operating Costs and Expenses
Research and development (R&D) expenses were $13.0 million
and $48.0 million for the three and twelve months ended December
31, 2021, respectively, as compared to $3.4 million and $11.4
million for the same prior year periods. The year-over-year
full-year increase of $36.6 million was attributable to an increase
of $23.4 million in R&D personnel costs, including a $19.1
million increase in stock-based compensation expense, and $13.2
million of increased contract research organization expenses
related to advancements of R&D programs.
Acquisition of in-process R&D expense was $6.5 million and
$15.5 million for the three and twelve months ended December 31,
2021, respectively, relating to investments in TryptageniX,
InnarisBio, and Neuronasal. Acquisition of in-process R&D
expense was $11.9 million and $12.0 million for the three and
twelve months ended December 31, 2020, respectively, relating to
its investments in Recognify and Kures.
General and administrative (G&A) expenses for the three and
twelve months ended December 31, 2021 were $25.9 million and $92.7
million, respectively, as compared to $72.0 million and $80.7
million in the same prior year periods. The year-over-year full
year increase of $12.0 million was attributable to an increase of
$25.3 million in G&A personnel cost and professional consulting
fees, and $9.7 million of other G&A costs related to supporting
platform growth and public company requirements. These increases
were partially offset by a decrease of $22.9 million in stock-based
compensation expense.
Total stock-based compensation expense for the three and twelve
months ended December 31, 2021 was $13.4 million and $63.4 million,
respectively, as compared to $67.2 million for the fourth quarter
and prior year periods, reflecting the recognition of expense in
2021 related to the achievement of IPO performance-based partial
vesting conditions and the issuance of convertible notes in
2020.
Net loss attributable to shareholders for the three and twelve
months ended December 31, 2021 was $88.9 million and $167.8
million, respectively, as compared to $86.6 million and $169.8
million for the comparable prior year periods.
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical company
aiming to transform the treatment of mental health disorders.
Founded in 2018 as a response to the significant unmet need and
lack of innovation in the mental health treatment landscape, atai
is dedicated to acquiring, incubating, and efficiently developing
innovative therapeutics to treat depression, anxiety, addiction,
and other mental health disorders.
atai's business model combines funding, technology, scientific,
and regulatory expertise with a focus on innovative compounds,
including psychedelic therapy and other drugs with differentiated
safety profiles and therapeutic potential. By pooling resources and
best practices, atai aims to responsibly accelerate the development
of new medicines across its companies to achieve clinically
meaningful and sustained behavioral change in mental health
patients.
atai's vision is to heal mental health disorders so that
everyone, everywhere can live a more fulfilled life. atai has
offices in New York, San Diego, Boston, London and Berlin. For more
information, please visit www.atai.life.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended. We intend such forward-looking
statements to be covered by the safe harbor provisions for
forward-looking statements contained in Section 27A of the
Securities Act of 1933, as amended (the “Securities Act”), and
Section 21E of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”). The words “believe,” “may,” “will,” “estimate,”
“continue,” “anticipate,” “intend,” “expect,” “anticipate,”
“initiate,” “could,” “would,” “project,” “plan,” “potentially,”
“preliminary,” “likely,” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these words. All statements
contained in this press release other than statements of historical
fact, including statements regarding our future operating results
and financial position, the success, cost and timing of development
of our product candidates, including the progress of preclinical
studies and clinical trials and related milestones, the
commercialization of our current product candidates and any other
product candidates we may identify and pursue, if approved,
including our ability to successfully build a specialty sales force
and commercial infrastructure to market our current product
candidates and any other product candidates we may identify and
pursue, the timing of and our ability to obtain and maintain
regulatory approvals, our business strategy and plans, potential
acquisitions, and the plans and objectives of management for future
operations and capital expenditures, are forward-looking
statements. The forward-looking statements in this press release
are neither promises nor guarantees, and you should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties, and other factors, many of
which are beyond our control and which could cause actual results,
levels of activity, performance or achievements to differ
materially from those expressed or implied by these forward-looking
statements.
We have based these forward-looking statements
largely on our current expectations and projections about future
events and trends that we believe may affect our financial
condition, results of operations, business strategy, short-term and
long-term business operations and objectives, and financial needs.
These forward-looking statements are subject to a number of risks,
uncertainties, and assumptions, including without limitation:
statements regarding our future operating results and financial
position, the success, cost and timing of development of our
product candidates, including the progress of preclinical studies
and clinical trials and related milestones, the commercialization
of our current product candidates and any other product candidates
we may identify and pursue, if approved, including our ability to
successfully build a specialty sales force and commercial
infrastructure to market our current product candidates and any
other product candidates we may identify and pursue, the timing of
and our ability to obtain and maintain regulatory approvals, our
business strategy and plans, potential acquisitions, and the plans
and objectives of management for future operations and capital
expenditures. Other risk factors include the important factors
described in the section titled “Risk Factors” in our most recent
Annual Report on Form 10-K filed with the Securities and Exchange
Commission (“SEC”), as updated by our subsequent filings with the
SEC, that may cause our actual results, performance or achievements
to differ materially and adversely from those expressed or implied
by the forward-looking statements.
Any forward-looking statements made herein speak only as of the
date of this press release, and you should not rely on
forward-looking statements as predictions of future events.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee that
the future results, performance, or achievements reflected in the
forward-looking statements will be achieved or will occur. Except
as required by applicable law, we undertake no obligation to update
any of these forward-looking statements for any reason after the
date of this press release or to conform these statements to actual
results or revised expectations.
Contact Information
Media Contact:Camilla DormerVP,
Communicationscamilla@atai.life
Investor Contact:Greg WeaverChief Financial
Officergreg.weaver@atai.life
|
ATAI LIFE
SCIENCES N.V. |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(Amounts in
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
Year
Ended |
|
|
December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
License revenue |
|
$ |
20,376 |
|
|
$ |
- |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
47,956 |
|
|
|
11,408 |
|
Acquisition of in-process research and development |
|
|
15,480 |
|
|
|
12,020 |
|
General and administrative |
|
|
92,745 |
|
|
|
80,734 |
|
Total operating expenses |
|
|
156,181 |
|
|
|
104,162 |
|
Loss from operations |
|
|
(135,805 |
) |
|
|
(104,162 |
) |
Other income (expense), net |
|
|
(796 |
) |
|
|
2,349 |
|
Net loss before income taxes |
|
|
(136,601 |
) |
|
|
(101,813 |
) |
Benefit from (provision for) income taxes |
|
|
3,989 |
|
|
|
(305 |
) |
Gain on investment dilution |
|
|
16,923 |
|
|
|
- |
|
Losses from investments in equity method investees, net of tax |
|
|
(58,555 |
) |
|
|
(76,507 |
) |
Net loss |
|
|
(174,244 |
) |
|
|
(178,625 |
) |
Net income loss) attributable to redeemable noncontrolling
interests and noncontrolling interests |
|
|
(6,436 |
) |
|
|
(8,782 |
) |
Net loss attributable to ATAI Life Sciences N.V. stockholders |
|
$ |
(167,808 |
) |
|
$ |
(169,843 |
) |
Net loss per share attributable to ATAI Life Sciences N.V.
stockholders-- basic and diluted |
|
$ |
(1.21 |
) |
|
$ |
(1.83 |
) |
Weighted average common shares outstanding attributable to ATAI
Life Sciences N.V. stockholders — basic and diluted |
|
|
138,265,859 |
|
|
|
93,019,072 |
|
|
|
|
|
|
|
|
ATAI LIFE
SCIENCES N.V. |
CONDENSED
CONSOLIDATED BALANCE SHEET |
(Amounts in
thousands) |
|
|
|
|
|
|
|
December
31, |
|
December
31, |
|
|
2021 |
|
2020 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
362,266 |
|
$ |
97,246 |
Prepaid expenses and other current assets |
|
|
11,903 |
|
|
2,076 |
Short term notes receivable |
|
|
913 |
|
|
- |
Short term notes receivable - related party |
|
|
- |
|
|
226 |
Property and equipment, net |
|
|
149 |
|
|
71 |
Deferred offering costs |
|
|
- |
|
|
1,575 |
Equity method investments |
|
|
16,131 |
|
|
- |
Other investments |
|
|
11,628 |
|
|
8,044 |
Long term notes receivable |
|
|
- |
|
|
911 |
Long term notes receivable - related parties |
|
|
3,835 |
|
|
1,060 |
Other assets |
|
|
7,341 |
|
|
339 |
Total assets |
|
$ |
414,166 |
|
$ |
111,548 |
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
Accounts payable |
|
$ |
6,004 |
|
$ |
3,083 |
Accrued liabilities |
|
|
14,829 |
|
|
9,215 |
Current portion of contingent consideration liability - related
parties |
|
|
51 |
|
|
- |
Other current liabilities |
|
|
51 |
|
|
- |
Non-current portion of Contingent consideration liability - related
parties |
|
|
2,432 |
|
|
1,705 |
Convertible promissory notes - related parties, net of discounts
and deferred issuance costs |
|
|
743 |
|
|
1,199 |
Convertible promissory notes and derivative liability |
|
|
- |
|
|
978 |
Other liabilities |
|
|
4,097 |
|
|
- |
Total stockholders' equity attributable to ATAI Life Sciences N.V.
stockholders |
|
|
376,908 |
|
|
90,822 |
Noncontrolling interests |
|
|
9,051 |
|
|
4,546 |
Total liabilities and stockholders' equity |
|
$ |
414,166 |
|
$ |
111,548 |
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