atai Life Sciences N.V. (Nasdaq: ATAI) (“atai” or “the Company”), a
clinical-stage biopharmaceutical company aiming to transform the
treatment of mental health disorders, today reported financial
results for the quarter ended September 30, 2022 and provided a
business update.
“In addition to multiple study initiations this quarter, we have
announced two positive clinical trial results, with more on the
way,” said Florian Brand, Co-Founder and Chief Executive Officer of
atai. “We’re excited about the upcoming Phase 2a topline results of
PCN-101 that could represent a meaningful shift in the current
treatment paradigm for patients.”
“The third quarter of 2022 demonstrated our strong capability to
execute. Not only did we have first patient dosed of a Phase 1
trial of VLS-01 and initiation of a Phase 1 trial of EMP-01, we
also began collecting data on our digital therapeutic app
supporting ‘(mind)set-and-setting’ prior to dosing,” said Srinivas
Rao, Co-Founder and Chief Scientific Officer. “Moreover, positive
safety, tolerability, and pharmacodynamic results from both KUR-101
and GRX-917 Phase 1 trials reinforce our belief in our unique
approach to drug selection, which emphasizes prior evidence in
humans. Finally, we continue to strengthen our enabling technology
capabilities through initiation of a proof-of-concept Phase 1
clinical trial of a sol-gel based technology which could enable
direct-to-brain delivery of various compounds in development across
atai’s pipeline.”
Video Interview with Management
A video interview with atai Life Sciences CEO & Co-Founder
Florian Brand, CSO & Co-Founder Srinivas Rao, and CFO Stephen
Bardin will be available today at 8:30 a.m. Eastern Time at
https://vimeo.com/atailifesciences.
The interview will also be available for replay in the “Events”
section of the Company’s website at www.atai.life. The archived
copy of the interview will be available on the Company’s website
for at least 30 days.
Pipeline Update and Highlights
In the third quarter, the Company continued to advance its
programs and is looking forward to additional clinical milestones
for the remainder of 2022 and beyond. Most significantly, eight
compounds are now in clinical development, paving the way for
significant additional value inflection points over the next 6 to
12 months. Foremost among these milestones was the dosing of the
final patient in the Phase 2a Proof-of-Concept (PoC) trial of
PCN-101 for TRD, positioning the company on track for topline
results around the end of the year.
Recent Developments
Perception Neuroscience – PCN-101 (R-ketamine) for TRD
- Last patient dosed the in Phase 2a trial of PCN-101 PoC study
in TRD with topline data expected around year-end 2022
- Patients were assessed for change in depressive symptomology
using the Montgomery-Asberg Depression Rate Scale (MADRS) with the
primary endpoint being at 24 hours and secondary assessments at 7
and 14 days post dosing
- In addition to monitoring vital signs and adverse events, the
objective is to assess sedation and dissociation via the Modified
Observer’s Assessment of Alertness (MOAA/S) scale and the
Clinician-Administered Dissociative States Scale (CADSS),
respectively
- A Phase 1 relative bioavailability bridging study of the
current intravenous formulation to the subcutaneous formulation to
support at-home use is expected to initiate H1 2023, with topline
results available mid 2023
COMPASS Pathways – COMP360 (Psilocybin assisted therapy) to
treat TRD
- Announced Phase 3 program composed of two pivotal trials and
one long-term outcomes study, the first of which is expected to
commence by the end of 2022
- Phase 3 study design informs the development of atai’s
psychedelic compounds, including VLS-01
- Phase 2b trial results published in The New England Journal of
Medicine
- Ongoing Phase 2 trials in anorexia nervosa and PTSD across
world-leading research institutes in the UK and US
Recognify Life Sciences – RL-007 for Cognitive Impairment
Associated with Schizophrenia (CIAS)
- RL-007 Phase 2b dose finding trial to be initiated by the end
of this year, with results expected in the first half of 2024
GABA Therapeutics – GRX-917 (deuterated etifoxine) for GAD
- Completed Phase 1 SAD and multiple-ascending dose (MAD) study
and found GRX-917 was well-tolerated with no dose-limiting
toxicities, and both SAD & MAD showed only mild adverse events
comparable to placebo
- Phase 1 data confirmed an improved pharmacokinetic profile of
deuterated etifoxine compared to etifoxine, including longer
half-life and greater bioavailability
- Dose-dependent increase in frontal beta power was demonstrated
through quantitative electroencephalograph (qEEG), providing
evidence of target engagement and mechanism of action
- Initiation of GRX-917 efficacy study in healthy volunteers is
anticipated in H2 2022 with results expected H2 2023
Kures – KUR-101 (deuterated mitragynine) for OUD
- Announced positive initial results for the SAD component of the
Phase 1 trial
- Results showed that oral dosing of KUR-101 produces
dose-dependent pain relief, a measure of central opioid receptor
function, with effects on respiration comparable to that of
placebo
- Safety and analgesia data from Part 2 of the Phase 1 study,
designed to be a head-to-head comparator trial versus the standard
of care, are expected by the end of 2022
DemeRx – DMX-1002 (ibogaine) for OUD
- Last patient dosed for Cohorts 1 and 2 in Phase 1 SAD
clinical trial with Cohort 3 expected to begin in the first half of
2023
- Safety data from the Phase 1 portion of the trial are expected
in the first half of 2023
Viridia Life Sciences - VLS-01 (dimethyltryptamine) for TRD
- First patient dosed in Phase 1 open-label SAD trial of VLS-01
and topline results expected in the first half of 2023
- The objectives of this Phase 1 trial are to compare the safety
and tolerability of VLS-01 and PK of intravenous versus buccal
administration of DMT
- The Phase 1 trial is the first application of atai’s app-based
digital therapeutics technology (DTx) to a pipeline product, and
this technology will be used to prepare subjects prior to
dosing
- Initiation of a Phase 2a proof-of-concept study is expected in
the first half of 2023, with results expected to follow in the
first half of 2024
EmpathBio - EMP-01 (MDMA derivative) for PTSD
- Received Medsafe central regulatory approval and Health and
Disability Ethics Committees (HDEC) approval to initiate a Phase 1
trial to assess the safety and tolerability of orally administered
EMP-01 in up to 32 healthy volunteers
- This trial will incorporate atai’s DTx to prepare subjects
prior to dosing
- Topline results for this Phase 1 study anticipated in mid
2023
InnarisBio – Nasal spray drug-delivery technology to deliver
drugs directly to the brain for use in various mental health
indications
- Initiated a Phase 1 proof-of-concept clinical trial to
demonstrate the safety, tolerability, and direct-to-brain delivery
of intranasal INB-01, a sol-gel based drug-delivery
technology.
- INB-01 may enable direct-to-brain delivery of various compounds
in development across atai’s pipeline
- Potential advantages may include increased patient compliance,
lower dose requirements, rapid onset of action, and minimized
systemic exposure
- Phase 1 proof-of-concept trial results expected in the first
half of 2023
atai Life Sciences Virtual R&D Day
- Held a virtual R&D Day on October 25, 2022. Presentation
and recording can be found on atai’s investor website here:
https://ir.atai.life/events/event-details/rd-investor-day.
Consolidated Financial Results
- On August 9th, atai entered into a non-dilutive term loan
facility agreement for up to $175 million with Hercules Capital,
Inc.
- atai ended the third quarter of 2022 with a cash position of
$304.1 million, which combined with committed funding from the
Hercules loan facility, is anticipated to provide cash runway into
2025.
Cash, Cash Equivalents, and Short-term investments
Cash, cash equivalents and short-term investments totaled $304.1
million as of September 30, 2022, compared to $362.3 million as of
December 31, 2021. The nine-month net decrease of cash of $58.2
million was primarily attributable to net cash used in operating
activities of $73.9 million and $3.6 million additional investments
in platform companies, net of $15 million draw on the Hercules
debt, $4.6 million from conversion of notes, and $2.8 million from
stock option exercises and equity issuance.
Operating Costs & Expenses
Research and development expenses were $19.0 million and $52.4
million for the three and nine months ended September 30, 2022,
respectively, as compared to $13.4 million and $35.0 million for
the same prior year periods.
Acquisition of in-process R&D expense for the nine months
ended September 30, 2022 of $0.4 million related to additional
investment in Kures. Acquisition of in-process R&D expense for
the nine months ended September 30, 2021 of $9.0 million related to
the InnarisBio acquisition and consolidation of Neuronasal.
General and administrative expenses for the three and nine
months ended September 30, 2022, were $19.4 million and $54.6
million, respectively, as compared to $20.3 million and $66.9
million in the same prior year periods.
Net loss attributable to shareholders for the three months ended
September 30, 2022 was $33.9 million (including non-cash
share-based compensation expense of $10.5 million), as compared to
$31.2 million (including non-cash share-based compensation expense
of $12.2 million) for the comparable prior year period.
Net loss attributable to shareholders for the nine months ended
September 30, 2022, was $107.4 million (including non-cash
share-based compensation expense of $30.2 million), as compared to
$78.9 million (including non-cash share-based compensation expense
of $50 million) for the comparable prior year period.
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.
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. 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,” “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 should be considered
forward-looking statements, 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, the sufficiency of our
cash and cash equivalents to fund our operations; available funding
under the Hercules Capital, Inc. loan facility; the plans and
objectives of management for future operations and capital
expenditures; and our participation in upcoming events and
conferences.
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. 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
that could cause actual results to differ materially from those
expressed or implied by the forward-looking statements, 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; 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 cannot give any assurance
that any of our product candidates will receive regulatory
approval, which is necessary before they can be commercialized;
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; 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. These and other important factors described in the section
titled “Risk Factors” in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2021 filed with the Securities and
Exchange Commission (“SEC”) as further updated in our Quarterly
Reports on Form 10-Q, and subsequent filings with the SEC, from
time to time, may cause our actual results, performance, or
achievements to differ materially and adversely from those
expressed or implied by the forward-looking statements. Any such
forward-looking statements represent management’s estimates as of
the date of this press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change.
Contact Information
Investor Contact: Stephen Bardin Chief Financial
OfficerIR@atai.life
Media Contact: Allan MalievskySenior Director, External Affairs
PR@atai.life
ATAI LIFE
SCIENCES N.V. |
CONDENSED
CONSOLIDATED BALANCE SHEET |
(Amounts in
thousands) |
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
2022 |
|
|
2021 |
|
|
|
(unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
142,539 |
|
$ |
362,266 |
|
Securities
carried at fair value |
|
|
161,518 |
|
|
— |
|
Prepaid
expenses and other current assets |
|
|
13,425 |
|
|
11,903 |
|
Short term
notes receivable |
|
|
— |
|
|
913 |
|
Property and
equipment, net |
|
|
728 |
|
|
149 |
|
Equity
method investments |
|
|
— |
|
|
16,131 |
|
Other
investments |
|
|
8,498 |
|
|
11,628 |
|
Long term
notes receivable - related parties |
|
|
7,151 |
|
|
3,835 |
|
Other
assets |
|
|
8,738 |
|
|
7,341 |
|
Total assets |
|
$ |
342,597 |
|
$ |
414,166 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
Accounts
payable |
|
|
3,511 |
|
|
6,004 |
|
Accrued
liabilities |
|
|
22,142 |
|
|
14,829 |
|
Current
portion of contingent consideration liability - related
parties |
|
|
— |
|
|
51 |
|
Other
current liabilities |
|
|
260 |
|
|
51 |
|
Non-current
portion of contingent consideration liability - related
parties |
|
|
1,908 |
|
|
2,432 |
|
Convertible
promissory notes - related parties, net of discounts and deferred
issuance costs |
|
|
380 |
|
|
743 |
|
Other
liabilities |
|
|
3,695 |
|
|
4,097 |
|
Long-term
debt, net |
|
|
14,621 |
|
|
- |
|
Total
stockholders' equity attributable to ATAI Life Sciences N.V.
stockholders |
|
|
289,399 |
|
|
376,908 |
|
Noncontrolling interests |
|
|
6,681 |
|
|
9,051 |
|
Total
liabilities and stockholders' equity |
|
$ |
342,597 |
|
$ |
414,166 |
|
|
|
|
|
|
(1) The condensed
consolidated financial statements as of and for the year ended
December 31, 2021 are derived from the audited consolidated
financial statements as of that date. |
|
|
|
|
|
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, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
License
revenue |
|
$ |
24 |
|
|
$ |
266 |
|
|
$ |
195 |
|
|
$ |
20,146 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
19,028 |
|
|
|
13,363 |
|
|
|
52,437 |
|
|
|
34,974 |
|
Acquisition of in-process research and development |
|
|
— |
|
|
|
— |
|
|
|
357 |
|
|
|
8,934 |
|
General and administrative |
|
|
19,419 |
|
|
|
20,264 |
|
|
|
54,623 |
|
|
|
66,868 |
|
Total operating expenses |
|
|
38,447 |
|
|
|
33,627 |
|
|
|
107,417 |
|
|
|
110,776 |
|
Loss from
operations |
|
|
(38,423 |
) |
|
|
(33,361 |
) |
|
|
(107,222 |
) |
|
|
(90,630 |
) |
Other income
(expense), net |
|
|
5,289 |
|
|
|
6,887 |
|
|
|
11,361 |
|
|
|
2,608 |
|
Loss before
income taxes |
|
|
(33,134 |
) |
|
|
(26,474 |
) |
|
|
(95,861 |
) |
|
|
(88,022 |
) |
Provision
for income taxes |
|
|
(135 |
) |
|
|
(368 |
) |
|
|
(227 |
) |
|
|
(432 |
) |
Gain on
dilution of equity method investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
16,923 |
|
Losses from
investments in equity method investees, net of tax |
|
|
(2,432 |
) |
|
|
(4,800 |
) |
|
|
(14,680 |
) |
|
|
(9,440 |
) |
Net
loss |
|
|
(35,701 |
) |
|
|
(31,642 |
) |
|
|
(110,768 |
) |
|
|
(80,971 |
) |
Net loss
attributable to redeemable noncontrolling interests and
noncontrolling interests |
|
|
(1,814 |
) |
|
|
(484 |
) |
|
|
(3,394 |
) |
|
|
(2,040 |
) |
Net loss
attributable to ATAI Life Sciences N.V. stockholders |
|
$ |
(33,887 |
) |
|
$ |
(31,158 |
) |
|
$ |
(107,374 |
) |
|
$ |
(78,931 |
) |
Net loss per
share attributable to ATAI Life Sciences N.V. stockholders — basic
and diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.59 |
) |
Weighted
average common shares outstanding attributable to ATAI Life
Sciences N.V. stockholders — basic and diluted |
|
|
156,607,468 |
|
|
|
151,130,212 |
|
|
|
154,713,922 |
|
|
|
134,334,685 |
|
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