atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage
biopharmaceutical company aiming to transform the treatment of
mental health disorders, today reported its financial results for
the third quarter ended September 30, 2021, and provided its
corporate update.
“Following our IPO in June, we continue to see positive
momentum. We have 11 therapeutic programs underway and each
clinical development milestone marks progress towards achieving our
vision to heal mental health disorders so that everyone, everywhere
can live a more fulfilled life,” said Florian Brand, CEO and
Co-Founder.
“In response to the heterogeneity of the mental health patient
population, we are developing a pharmacologically diverse array of
treatments. We intend to support these treatments with innovative
digital therapeutics and robust insights from our multi-modal data
approach. Our ultimate goal is to tailor our treatments to
individual patient needs by using a diverse set of biomarkers. We
anticipate further growth of our drug development pipeline and our
enabling technologies through our ‘buy and build’ approach and will
remain highly active in business development.
“We recently initiated two new clinical trials: a Phase 2a trial
with PCN-101 (R-ketamine) for treatment-resistant depression and a
Phase 1/2 trial with DMX-1002 (ibogaine) in opioid use disorder. In
terms of clinical readouts, just last week we saw positive Phase 2b
data from COMPASS Pathways, the first company we funded to
rigorously research the potential of psychedelics. This clinical
trial demonstrated the rapid onset of effect, large effect size,
and durability of COMP360 (a proprietary synthetic formulation of
psilocybin) in treatment-resistant depression. We expect another
important clinical readout before the end of the year for RL-007 in
cognitive impairment associated with schizophrenia.
“The narrow focus on mental health treatments means that every
single trial result offers important insights not only for the
program in question but for all our programs, allowing us to
accelerate the development of novel treatments for patients in
need.”
Program Updates
COMP360 (psilocybin): Program Details: COMP360
is a proprietary formulation of synthetic psilocybin, a 5-HT2A-R
agonist being developed as an oral, potentially rapid-acting
antidepressant.Recent Advancements:
- In November, COMPASS announced positive topline results from
its Phase 2b randomized, controlled, double-blind, dose-controlled
trial of COMP360 psilocybin therapy for treatment-resistant
depression.
- The 233-patient study 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. Rapid onset of action with statistically significant
treatment differences between the 25mg vs 1mg groups were apparent
the day after COMP360 psilocybin administration. Responder rates at
week 12 based upon a ≥50% decrease in MADRS total score from
baseline were 32.9% and 16.4% for psilocybin doses of 25mg and 1mg
respectively. Remitter rates at week 12 based upon a MADRS total
score ≤10 were 26.6% and 11.4% for psilocybin doses of 25mg and 1mg
respectively.
- COMP360 was generally well tolerated.
Upcoming Milestones:
- A pivotal Phase 3 study is anticipated to launch in 2022.
Affiliate: COMPASS Pathways
PCN-101 (R-ketamine): Program
Details: PCN-101 is a parenteral formulation of R-ketamine, a
glutamatergic modulator being developed as a potentially
rapid-acting antidepressant, with the potential for at-home
treatment.Recent Advancements:
- In September 2021, Perception Neuroscience initiated the Phase
2 trial of PCN-101 (R-ketamine) for TRD. This randomized, double
blind, placebo-controlled trial is designed to assess the efficacy,
safety, dose response and duration of action in patients with
TRD.
Upcoming Milestones:
- Topline data are expected at the end of 2022.
Affiliate: Perception Neuroscience
RL-007: Program Details: RL-007, a cholinergic,
glutamatergic and GABA-B receptor modulator, is an orally available
compound that is being developed for the treatment of cognitive
impairments associated with schizophrenia (CIAS). The currently
active open-label, multi-dose, biomarker-focused Phase 2a trial of
RL-007 in patients with CIAS is designed to evaluate the compound’s
safety, tolerability and its impact on electroencephalogram-based
biomarkers.Recent Advancements:
- Following the encouraging results of a recently completed
interim analysis of Quantitative Electroencephalogram
(qEEG) data from the eight patients in the first cohort, atai
advanced a portion of a future milestone payment aiming to
accelerate initiation of the subsequent trial, which, broadly, will
be a double-blind, placebo controlled, proof-of-concept study
focused on more traditional cognitive endpoints, including subsets
of the MATRICS battery.
Upcoming Milestones:
- Topline data are expected by the end of 2021.
Affiliate: Recognify Life Sciences
GRX-917 (deuterated etifoxine): Program
Details: GRX-917 is an oral formulation of a deuterated version of
etifoxine, a mitochondrial translocator protein agonist, designed
to provide potentially rapid anxiolytic activity with improved
tolerability compared to current treatments for anxiety in the
United States.Recent Advancements:
- The Phase 1 randomized, double blind, placebo-controlled trial
of GRX-917 is designed to evaluate the compound’s safety,
tolerability, pharmacokinetics, as well as pharmacodynamics using
qEEG. We have recently completed the single ascending dose (SAD)
component of the trial, and dosing in the multiple ascending dose
(MAD) component is ongoing.
Upcoming Milestones:
- Topline data are expected in mid-2022.
Affiliate: GABA Therapeutics
DMX-1002 (ibogaine):Program
Details: DMX-1002 is an oral formulation of ibogaine, a
cholinergic, glutamatergic and monoaminergic receptor modulator
being developed for the treatment of opioid use disorder
(OUD).Recent Advancements:
- In September 2021, DemeRx IB dosed the first subject in a Phase
1/2a trial of DMX-1002. This trial is designed to assess the
safety, tolerability, pharmacokinetics, and efficacy of DMX-1002
and will inform future studies in patients with OUD.
Upcoming Milestones
- Topline safety data are expected in early 2022.
Affiliate: DemeRx IB
Q3 and Recent Corporate UpdatesDiscovery
Programs
- Launched PsyProtix, a precision psychiatry company creating new
chemical entities targeting mitochondrial dysfunction related to
TRD and other mental health conditions. PsyProtix is currently
engaged in discovery and preclinical development and expects to
launch clinical trials in 2023.
- Created and pharmacologically tested over 250 novel compounds
at EntheogeniX based upon structures generated using computational
chemistry approach. Lead candidate selection is currently
ongoing.
Formulation Technologies
- Entered into an expanded agreement with strategic partner
IntelGenx, building on positive early feasibility data, to support
IntelGenx’s graduation from the TSX Venture Exchange to the Toronto
Stock Exchange. As part of the strategic partnership, IntelGenx has
exclusively partnered with atai to develop formulations of
compounds for the prevention or treatment of mental health
disorders.
- Completed a proof-of-principle study demonstrating that
InnarisBio’s sol-gel based excipient technology can effectively
transport compounds from the nose directly to the brain in an
animal model. InnarisBio is developing its nose-to-brain excipient
technology to facilitate potentially rapid, non-invasive entry into
the brain for use across various drug candidates in atai’s
pipeline, including Revixia, Neuronasal, and DemeRx.
Digital Therapeutics
- Initiated a user acceptability testing of our digital
therapeutics (DTx) app, one of our key enabling technologies, in
patients with TRD receiving ketamine treatment.
- In addition, we have assembled a proof-of-concept, EEG- and
VR-based digital therapeutic device to support patients undergoing
psychedelic therapy, and we have kicked off user feedback testing
to optimize across product parameters.
- Both technologies are expected to be implemented in Viridia and
Revixia Phase 1 trials and DemeRx IB Phase 2 trial starting next
year.
New Initiatives
- Launched atai Impact, atai’s philanthropic program, established
to support and collaborate with nonprofits and institutions that
share atai Life Sciences' vision, with the key pillars of:
advancing education, expanding access, and supporting the wider
ecosystem of mental health care. atai Impact has an initial focus
on the psychedelics sector, given its emerging potential in
tackling the growing mental health crisis. Its formation is
underpinned by atai’s belief that harmonization across commercial
and non-profit entities represents the best path forward to harness
the power of innovative mental health approaches for positive
social change. The atai Impact program will be initially funded by
1% of the gross proceeds from our June 2021 IPO and founders’ and
shareholders’ contributions.
Third Quarter 2021 Financial Results
Cash and Cash EquivalentsCash and cash
equivalents totaled $430.3 million as of September 30, 2021,
compared to $97.2 million as of December 31, 2020. The nine month
increase of $333.1 million is attributed to net proceeds of $231.6
million from atai’s IPO, net proceeds of $166.4 million from Series
C and Series D and common stock issuances, $20.0 million of license
revenue proceeds, and $10.1 million proceeds from the sale of
investments and issuance and conversion of convertible notes.
Offsetting were cash payments of $32.6 million for investments in
platform companies and other assets, and $62.4 million in net
operating expenses and effect of foreign exchange rate changes.
Operating Costs and ExpensesResearch and
development (R&D) expenses were $13.4 million and $35.0 million
for the three and nine months ended September 30, 2021,
respectively, as compared to $3.1 million and $8.1 million for the
same prior year periods. The increase of $10.3 million and $26.9
million, respectively, were attributable to personnel costs,
including stock-based compensation expense, and increased contract
research organization expenses related to advancements in atai’s
R&D programs.
atai recorded acquisition of in-process R&D expense of $9.0
million for the nine months ended September 30, 2021, relating to
its investments in Neuronasal and InnarisBio.
General and administrative expenses for the three and nine
months ended September 30, 2021 were $20.3 million and $66.9
million, respectively, as compared to $4.3 million and $8.7 million
in the same prior year periods. The increases of $16.0 million and
$58.2 million, respectively, were attributable to personnel costs,
including stock-based compensation expense, professional fees, and
other costs related to support of atai’s platform growth and public
company requirements.
Total stock-based compensation expense for the three and nine
months ended September 30, 2021 was $12.2 million and $50.0
million, respectively, as compared to $2.1 and $2.2 for the
comparable prior year periods, reflecting the recognition of
expense related to the achievement of IPO performance-based partial
vesting conditions.
Net loss attributable to atai shareholders for the three and
nine months ended September 30, 2021 was $31.2 million and $78.9
million, respectively, as compared to $83.2 million and $83.2
million for the comparable prior year periods.
Conference Call Informationatai will host a
conference call and live audio webcast today at 08:30am EST to
discuss its financial results and provide a corporate update. To
access the live conference call, please dial 877-407-3982 from the
United States, or +1 (201) 493-6780 internationally, using the
conference ID: 13724750. The live and archived webcast of
this call will be available in the “Events” section of the atai
Life Sciences website at ir.atai.life. An archived copy of the
webcast will be available on the atai website for at least 30 days
after the conference call.
About atai Life Sciences atai is a
clinical-stage biopharmaceutical company aiming to transform the
treatment of mental health disorders. atai was 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 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, seeking to effectively treat and ultimately heal mental
health disorders.
atai's mission is to bridge the gap between what the mental
healthcare system currently provides and what patients need. atai
is headquartered in Berlin, with offices in New York and London.
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. 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. Forward-looking statements include
express or implied statements relating to, among other things, our
future operating results and financial position; the success, cost
and timing of development of our product candidates, including the
progress of preclinical 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. 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: we
are a clinical-stage biopharmaceutical company and have incurred
significant losses since our inception, and we anticipate that we
will continue to incur significant losses for the foreseeable
future; we will require substantial additional funding to achieve
our business goals, and if we are unable to obtain this funding
when needed and on acceptable terms, we could be forced to delay,
limit or terminate our product development efforts; our limited
operating history may make it difficult to evaluate the success of
our business and to assess our future viability; we have never
generated revenue and may never be profitable; our product
candidates contain controlled substances, the use of which may
generate public controversy; clinical and preclinical development
is uncertain, and our preclinical programs may experience delays or
may never advance to clinical trials; we rely on third parties to
assist in conducting our clinical trials and some aspects of our
research and preclinical testing, and those clinical trials,
including progress and related milestones, may be impacted by
several factors including the failure by such third parties to meet
deadlines for the completion of such trials, research, or testing,
changes to trial sites and other circumstances; we currently rely
on qualified therapists working at third-party clinical trial sites
to administer certain of our product candidates in our clinical
trials and we expect this to continue upon approval, if any, of our
current or future product candidates; if third-party sites fail to
recruit and retain a sufficient number of therapists or effectively
manage their therapists, our business, financial condition and
results of operations would be materially harmed; we cannot give
any assurance that any of our product candidates will receive
regulatory approval, which is necessary before they can be
commercialized; research and development of drugs targeting the
central nervous system, or CNS, is particularly difficult, and it
can be difficult to predict and understand why a drug has a
positive effect on some patients but not others; we face
significant competition in an environment of rapid technological
and scientific change; third parties may claim that we are
infringing, misappropriating or otherwise violating their
intellectual property rights, the outcome of which would be
uncertain and may prevent or delay our development and
commercialization efforts; a change in our effective place of
management may increase our aggregate tax burden; we identified
material weaknesses in connection with our internal control over
financial reporting; and a pandemic, epidemic, or outbreak of an
infectious disease, such as the COVID-19 pandemic, may materially
and adversely affect our business, including our preclinical
studies, clinical trials, third parties on whom we rely, our supply
chain, our ability to raise capital, our ability to conduct regular
business and our financial results. Other risk factors include the
important factors described in the section titled “Risk Factors” in
our final prospectus, dated June 17, 2021, filed with the
Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b)
under the Securities Act, and in our other 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, Communications, atai Life
Sciences Email: camilla@atai.life
Investor Contact:Chad MesserVP, Investor Relations, atai Life
Sciences Email: chad@atai.life
ATAI LIFE SCIENCES N.V. |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(Amounts in thousands, except share and per share
amounts) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
License revenue |
|
$ |
266 |
|
|
$ |
- |
|
|
$ |
20,146 |
|
|
$ |
- |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
13,363 |
|
|
|
3,058 |
|
|
|
34,974 |
|
|
|
8,056 |
|
|
Acquisition of in-process research and development |
|
|
- |
|
|
|
- |
|
|
|
8,934 |
|
|
|
120 |
|
|
General and administrative |
|
|
20,264 |
|
|
|
4,328 |
|
|
|
66,868 |
|
|
|
8,749 |
|
|
Total operating expenses |
|
|
33,627 |
|
|
|
7,386 |
|
|
|
110,776 |
|
|
|
16,925 |
|
|
Loss from operations |
|
|
(33,361 |
) |
|
|
(7,386 |
) |
|
|
(90,630 |
) |
|
|
(16,925 |
) |
|
Other income (expense), net |
|
|
6,887 |
|
|
|
(13,942 |
) |
|
|
2,608 |
|
|
|
6,352 |
|
|
Net loss before income taxes |
|
|
(26,474 |
) |
|
|
(21,328 |
) |
|
|
(88,022 |
) |
|
|
(10,573 |
) |
|
Provision for income taxes |
|
|
(368 |
) |
|
|
(4 |
) |
|
|
(432 |
) |
|
|
(4 |
) |
|
Gain on investment dilution |
|
|
- |
|
|
|
- |
|
|
|
16,923 |
|
|
|
- |
|
|
Losses from investments in equity method investees, net of tax |
|
|
(4,800 |
) |
|
|
(61,862 |
) |
|
|
(9,440 |
) |
|
|
(73,693 |
) |
|
Net loss |
|
|
(31,642 |
) |
|
|
(83,194 |
) |
|
|
(80,971 |
) |
|
|
(84,270 |
) |
|
Net income (loss) attributable to redeemable noncontrolling |
|
|
|
|
|
|
|
|
|
interests and noncontrolling interests |
|
|
(484 |
) |
|
|
1 |
|
|
|
(2,040 |
) |
|
|
(1,021 |
) |
|
Net loss attributable to ATAI Life Sciences N.V. stockholders |
|
$ |
(31,158 |
) |
|
$ |
(83,195 |
) |
|
$ |
(78,931 |
) |
|
$ |
(83,249 |
) |
|
Net loss per share attributable to ATAI Life Sciences N.V.
stockholders-- basic and diluted |
|
$ |
(0.21 |
) |
|
$ |
(0.92 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.92 |
) |
|
Weighted average common shares outstanding attributable to ATAI
Life Sciences N.V. stockholders — basic and
diluted |
|
|
151,130,212 |
|
|
|
90,709,312 |
|
|
|
134,334,685 |
|
|
|
90,709,312 |
|
|
|
|
|
|
|
|
|
|
|
|
ATAI LIFE SCIENCES N.V. |
CONDENSED CONSOLIDATED BALANCE SHEET |
(Amounts in thousands) |
|
|
|
|
|
September 30, |
December 31, |
|
|
2021 |
|
|
2020 |
|
|
(unaudited) |
|
|
(1) |
|
Assets |
|
|
|
Cash and cash equivalents |
$ |
430,308 |
|
$ |
97,246 |
|
Prepaid expenses and other current assets |
|
11,551 |
|
|
2,076 |
|
Short term notes receivable - related party |
|
- |
|
|
226 |
|
Property and equipment, net |
|
138 |
|
|
71 |
|
Deferred offering costs |
|
- |
|
|
1,575 |
|
Equity method investments |
|
15,086 |
|
|
- |
|
Other investments held at fair value |
|
6,816 |
|
|
- |
|
Other investments |
|
14,256 |
|
|
8,044 |
|
Long term notes receivable |
|
908 |
|
|
911 |
|
Long term notes receivable - related parties |
|
3,784 |
|
|
1,060 |
|
Other assets |
|
1,262 |
|
|
339 |
|
Total assets |
$ |
484,109 |
|
$ |
111,548 |
|
Liabilities and Stockholders' Equity |
|
|
|
Accounts payable |
$ |
1,974 |
|
$ |
3,083 |
|
Accrued liabilities |
|
13,075 |
|
|
9,215 |
|
Current portion of contingent consideration liability - related
parties |
|
50 |
|
|
- |
|
Deferred revenue |
|
180 |
|
|
- |
|
Short-term notes payable |
|
38 |
|
|
- |
|
Non-current portion of contingent consideration liability - related
parties |
|
1,947 |
|
|
1,705 |
|
Convertible promissory notes - related parties, net of discounts
and deferred issuance costs |
|
800 |
|
|
1,199 |
|
Convertible promissory notes and derivative liability |
|
- |
|
|
978 |
|
Other liabilities |
|
3,285 |
|
|
- |
|
Total stockholders' equity attributable to ATAI Life Sciences N.V.
stockholders |
|
453,186 |
|
|
90,822 |
|
Noncontrolling interests |
|
9,574 |
|
|
4,546 |
|
Total liabilities and stockholders' equity |
$ |
484,109 |
|
$ |
111,548 |
|
|
|
|
|
(1) The condensed consolidated financial statements as of and
for the year ended December 31, 2020 are derived from the
audited consolidated financial statements as of that
date. |
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