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 second quarter ended June 30, 2021 and provided a
corporate update.
“In the second quarter of 2021, we made significant advancements
to build our business and successfully completed an initial public
offering on Nasdaq, raising approximately US$258.8 million in gross
proceeds,” said Florian Brand, CEO and co-founder of atai. “We have
the financial resources to maximize the value of our decentralized
drug development platform for improved probability of clinical
success and leverage the value of our transformative pipeline. 2021
continues to be a pivotal year for atai with multiple upcoming
catalysts across our expanding pipeline.”
Q2 Corporate Updates
- Received $20 million as part of Perception’s collaboration with
Otsuka for the development of R-ketamine, the first major
collaboration between a biopharmaceutical company developing
psychedelics and large pharma.
- Entered a strategic partnership with IntelGenx, a leader in
pharmaceutical films. As part of the strategic partnership,
IntelGenx will exclusively partner with atai to develop compounds
for the prevention or treatment of mental health diseases or
disorders.
- Announced InnarisBio in partnership with UniQuest, Australia’s
leading university technology transfer company commercializing the
research of The University of Queensland (UQ), to develop a novel
sol-gel-based intranasal drug delivery technology to improve
treatments for mental health disorders.
Recent Advancements and Upcoming Milestones for atai’s
Core Value Drivers
Perception Neuroscience: Program Details:
PCN-101 is a parenteral formulation of R-ketamine, a glutamatergic
modulator being developed as a rapid-acting antidepressant, with
the potential to be an at-home non-dissociative alternative to
S-ketamine (marketed as SPRAVATO).
Upcoming Milestones
- Phase 2 randomized, double blind, placebo-controlled trial in
patients with treatment-resistant depression (TRD) to be initiated
in the third quarter and expected to run through late 2022.
- The trial will assess efficacy and safety, dose response and
duration of action in patients with TRD.
Recognify Life Sciences: Program Details:
- RL-007, a cholinergic, glutamatergic and GABA-B receptor
modulator, is an orally available compound that is thought to alter
the excitatory/inhibitory balance in the brain to produce
pro-cognitive effects.
- atai is developing this compound for the treatment of cognitive
impairments associated with schizophrenia.
Q2 Advancements
- In April 2021, Recognify initiated a Phase 2a study for RL-007,
after receiving IND clearance from the U.S. Food and Drug
Administration to commence clinical trials for the treatment of
Cognitive Impairment Associated with Schizophrenia (CIAS).
- The study is designed to evaluate the effects of RL-007 on
safety, tolerability, electroencephalogram-based biomarkers, and
cognition.
Upcoming Milestones: Topline results from the Phase 2a
single-arm, multiple dose trial in patients with CIAS expected in
late 2021.
GABA: Program Details
- GRX-917 is an oral formulation of a deuterated version of
etifoxine, a compound that has a long history of prescription use
in France for treating anxiety disorders.
- GRX-917 is designed to provide rapid anxiolytic activity with
improved tolerability compared to current treatments for anxiety in
the United States.
Q2 Advancements
- In June 2021, GABA initiated a randomized, double blind,
placebo-controlled Phase 1 trial.
- The study will evaluate safety, tolerability, pharmacokinetics,
as well as pharmacodynamics using qEEG.
Upcoming Milestones: Topline results from the Phase 1 single
ascending dose/multiple ascending dose program expected early in
2022.
DemeRx: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.
Q2 Advancements: DemeRx received approval from the UK Medicines
and Healthcare products Regulatory Agency to commence subject
enrollment in our proposed Phase 1/2 clinical trial.
Upcoming Milestones
- Phase 1 component of Phase 1/2 trial of DMX-1002 in
recreational drug users and healthy volunteers to be initiated in
Q3 2021 and is expected to read out safety data in early 2022.
- The trial is designed to assess safety, tolerability,
pharmacokinetics, and efficacy, and the results will inform future
studies in patients with opioid use disorder.
COMPASS Pathways: Program Details: COMP360 is a
proprietary formulation of synthetic psilocybin, a 5-HT2A-R agonist
being developed as an oral, rapid-acting antidepressant.
Q2 Advancements
- In June 2021, COMPASS completed dosing in the Phase 2b clinical
trial of COMP360 psilocybin therapy for treatment-resistant
depression.
- The randomized, double-blind, dose-ranging study investigated
the safety and efficacy of psilocybin therapy in 233 patients,
making it the largest clinical trial with psilocybin to date.
Upcoming Milestones: Phase 2b trial results are expected in late
2021.
Second Quarter 2021 Financial Results
Cash and Cash EquivalentsCash and cash
equivalents totaled $453.6 million as of June 30, 2021, compared to
$97.2 million as of December 31, 2020. The six month increase of
$356.4 million is attributed to net proceeds of $231.6 million from
our Initial Public Offering, net proceeds of $168.6 million from
Series C and Series D common stock issuances, $20.0 million of
license revenue proceeds, and $4.0 million proceeds from the sale
of investments and conversion of convertible notes. Offsetting were
cash payments of $32.0 million for investments in platform
companies, and $35.8 million in net operating expenses.
RevenuesLicense revenue in the first half 2021
of $19.9 million was related to proceeds received from Perception’s
License and Collaboration Agreement with Otsuka.
Operating Costs and ExpensesResearch and
development expenses were $16.0 million and $21.6 million for the
three and six months ended June 30, 2021, as compared to $2.9
million and $5.0 million for the same prior year periods. The
increase of $13.1 million and $16.6 million, respectively, were
attributable to personnel costs, including stock-based compensation
expense, and increased CRO expenses related to advancements in our
R&D programs.
We recorded acquisition of in-process research and development
expense of $8.0 million and $9.0 million for the three and six
months ended June 30, 2021, relating to our investments in
Neuronasal and InnarisBio.
General and administrative expenses for the three and six months
ended June 30, 2021 were $37.3 million and $46.6 million, as
compared to $2.9 million and $4.4 million in the same prior year
periods. The increases of $34.4 million and $42.2 million,
respectively, were attributable to personnel costs, including
stock-based compensation expense, professional fees, and other
costs related to support of our platform growth and public company
requirements.
Total stock-based compensation expense for the three and six
months ended June 30, 2021 was $37.5 million and $37.7 million,
respectively, as compared to $41,000 and $82,000 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 stockholders for the three and six
months ended June 30, 2021 was $48.5 million and $47.8 million,
respectively, as compared to $16.4 million and $0.1 million for the
comparable prior year periods.
Conference Call Information
atai will host a conference call and live audio webcast today at
08:30am ET 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: 13721888. 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; 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 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, filed with the Securities and Exchange
Commission (“SEC”) on June 21, 2021 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.
Investor Contact:Greg Weaveratai – Chief
Financial OfficerEmail: greg.weaver@atai.life
Media Contact:Anne DonohoeKCSA Strategic
CommunicationsPhone: +1 (212) 896-1265Email: atai@kcsa.com
ATAI LIFE
SCIENCES N.V. |
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
(Amounts in
thousands, except share and per share amounts) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Six Months
Ended |
|
|
|
|
|
|
|
|
|
June 30, |
|
June 30, |
|
|
|
|
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
License revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
19,880 |
|
|
$ |
- |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
16,026 |
|
|
|
2,854 |
|
|
|
21,611 |
|
|
|
4,998 |
|
|
Acquisition of in-process research and development |
|
|
7,962 |
|
|
|
120 |
|
|
|
8,934 |
|
|
|
120 |
|
|
General and administrative |
|
|
37,331 |
|
|
|
2,851 |
|
|
|
46,604 |
|
|
|
4,421 |
|
|
Total operating expenses |
|
|
61,319 |
|
|
|
5,825 |
|
|
|
77,149 |
|
|
|
9,539 |
|
|
Loss from operations |
|
|
(61,319 |
) |
|
|
(5,825 |
) |
|
|
(57,269 |
) |
|
|
(9,539 |
) |
|
Other income (expense), net |
|
|
(5,982 |
) |
|
|
(1,321 |
) |
|
|
(4,279 |
) |
|
|
20,294 |
|
|
Net loss before income taxes |
|
|
(67,301 |
) |
|
|
(7,146 |
) |
|
|
(61,548 |
) |
|
|
10,755 |
|
|
Provision for income taxes |
|
|
(58 |
) |
|
|
- |
|
|
|
(64 |
) |
|
|
- |
|
|
Gain on investment dilution |
|
|
16,923 |
|
|
|
- |
|
|
|
16,923 |
|
|
|
- |
|
|
Losses from investments in equity method investees, net of tax |
|
|
(2,937 |
) |
|
|
(9,811 |
) |
|
|
(4,640 |
) |
|
|
(11,831 |
) |
|
Net loss |
|
|
|
|
(53,373 |
) |
|
|
(16,957 |
) |
|
|
(49,329 |
) |
|
|
(1,076 |
) |
|
Net loss attributable to redeemable noncontrolling |
|
|
|
|
|
|
|
|
|
interests and noncontrolling interests |
|
|
(4,912 |
) |
|
|
(600 |
) |
|
|
(1,556 |
) |
|
|
(1,022 |
) |
|
Net loss attributable to ATAI Life Sciences N.V. stockholders |
|
$ |
(48,461 |
) |
|
$ |
(16,357 |
) |
|
$ |
(47,773 |
) |
|
$ |
(54 |
) |
|
Net loss per
share attributable to ATAI Life Sciences N.V. stockholders-- basic
and diluted |
|
|
|
|
|
|
|
$ |
(0.37 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.00 |
) |
|
Weighted average
common shares outstanding attributable to ATAI Life Sciences N.V.
stockholders — basic and diluted |
|
|
|
|
|
|
|
|
|
132,265,075 |
|
|
|
90,709,312 |
|
|
|
125,797,732 |
|
|
|
90,709,312 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ATAI LIFE
SCIENCES N.V. |
CONDENSED
CONSOLIDATED BALANCE SHEET |
(Amounts in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
(unaudited) |
|
|
(1) |
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
453,622 |
|
$ |
97,246 |
|
Prepaid expenses and other current assets |
|
|
3,964 |
|
|
2,076 |
|
Short term notes receivable - related party |
|
|
- |
|
|
226 |
|
Property and equipment, net |
|
|
331 |
|
|
71 |
|
Deferred offering costs |
|
|
- |
|
|
1,575 |
|
Equity method investments |
|
|
19,780 |
|
|
- |
|
Other investments held at fair value |
|
|
6,886 |
|
|
- |
|
Other investments |
|
|
16,107 |
|
|
8,044 |
|
Long term notes receivable |
|
|
1,388 |
|
|
911 |
|
Long term notes receivable - related parties |
|
|
3,194 |
|
|
1,060 |
|
Other assets |
|
|
689 |
|
|
339 |
|
Total assets |
|
$ |
505,961 |
|
$ |
111,548 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
Accounts payable |
|
$ |
6,202 |
|
$ |
3,083 |
|
Accrued liabilities |
|
|
7,824 |
|
|
9,215 |
|
Deferred revenue |
|
|
120 |
|
|
- |
|
Short-term notes payable |
|
|
39 |
|
|
- |
|
Contingent consideration liability - related parties |
|
|
2,466 |
|
|
1,705 |
|
Convertible promissory notes - related parties, net of discounts
and deferred issuance costs |
|
|
|
|
1,176 |
|
|
1,199 |
|
Convertible promissory notes and derivative liability |
|
|
- |
|
|
978 |
|
Other liabilities |
|
|
3,239 |
|
|
- |
|
Total stockholders' equity attributable to ATAI Life Sciences N.V.
stockholders |
|
|
474,850 |
|
|
90,822 |
|
Noncontrolling interests |
|
|
10,045 |
|
|
4,546 |
|
Total liabilities and stockholders' equity |
|
$ |
505,961 |
|
$ |
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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