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 June 30, 2022, and provided a
business update.
“We have taken strong actions to extend our anticipated runway
by one year into 2025. We further strengthened our already strong
cash position of $312M at end of Q2 by securing a non-dilutive term
loan facility of up to $175M, and we anticipate realizing
significant cost savings from a company-wide cost optimization,”
said Florian Brand, Chief Executive Officer & Co-Founder of
atai. “This additional runway provides us with the ability to
achieve numerous proof-of-concept data readouts without additional
dilutive financing.”
“We continue to execute on our pipeline – having achieved
multiple Phase 1 milestones over the last months. These include the
completion of the clinical phase of the PCN-101 drug-drug
interaction (DDI) study, database lock of the GRX-917 Phase 1
SAD/MAD trial, completion of the SAD portion of the KUR-101 Phase 1
trial, and the initiation of the VLS-01 Phase 1 trial. Going
forward, we are focusing on R&D programs that we anticipate
generating meaningful clinical data readouts over the next two
years,” said Srinivas Rao, Chief Scientific Officer &
Co-Founder of atai. “We are excited about our refocused pipeline
with 8 potential value generation events over the next 6-12 months
starting with the PCN-101 Phase 2a read out in treatment-resistant
depression (TRD) by end of year.”
Video Interview with ManagementA video
interview with atai Life Sciences CEO & Co-Founder Florian
Brand, CSO & Co-Founder Srinivas Rao, CFO Greg Weaver and
Deputy CFO Stephen Bardin will be available today at 8:30 a.m.
Eastern Time at https://vimeo.com/atailifesciences.
The interview will also be accessible 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
atai has completed a company-wide cost optimization initiative
and an extensive pipeline review to both reduce its expected
operating expenses and prioritize its capital resources on
R&D programs anticipated to be potentially the most valuable
and meaningful opportunities for patients in its pipeline.
This portfolio review process is consistent with the Company's
three-pillar strategic approach as it looks to achieve
clinically meaningful and durable behavioral change in mental
health patients.
As a result, the Company has streamlined its pipeline by
decelerating programs and discontinuing funding beyond our
obligations to several programs, including Revixia, Neuronasal,
DemeRx NB, and certain discovery efforts. atai will
opportunistically explore business development and partnering
opportunities for these deprioritized programs.
atai’s remaining refocused pipeline and enabling technologies
are the following:
- Drug development programs:
- COMP360
- PCN-101
- RL-007
- GRX-917
- KUR-101
- DMX-1002
- VLS-01
- EMP-01
- Enabling technologies:
- Introspect
- InnarisBio
- IntelGenx
- EntheogeniX
In Q2, the Company continued to advance its programs and is
looking forward to additional clinical milestones for the remainder
of 2022 and beyond. The Company anticipates all 8 compounds listed
above to be in clinical development by the end of this year. atai’s
development pipeline of pharmaceuticals, digital therapeutics, and
precision mental health approaches are supported by a total of 293
issued patents and 125 pending non-provisional patents.
Recent Developments
COMPASS Pathways – COMP360 (Psilocybin assisted therapy) to
treat Treatment-Resistant Depression (TRD)
- Launched Phase 2 clinical trial of COMP360 in Anorexia Nervosa
in July 2022.
- COMP360 Phase 3 program for TRD submitted to FDA and expected
to commence by end of FY 2022.
- Kabir Nath, former Senior Managing Director of Global
Pharmaceuticals at Otsuka, appointed as new CEO on August 1st,
2022.
- Investor Day scheduled for October 12th, 2022, during which
details on Phase 3 will be presented.
Perception Neuroscience – PCN-101 (R-ketamine) to treat
Treatment-Resistant Depression (TRD)
- Completion of the clinical phase of the Phase 1 DDI study.
- Data from PCN-101 Phase 2 Proof-of-Concept (PoC) study in TRD
expected by end of FY 2022.
- PCN-101 Phase 1 SQ to IV bioavailability bridging study is
expected to initiate within the next few quarters.
Recognify Life Sciences – RL-007 to treat Cognitive Impairment
Associated with Schizophrenia (CIAS)
- RL-007 Phase 2b PoC study for CIAS expected to commence in H2
2022.
GABA Therapeutics – GRX-917 (deuterated etifoxine) to treat
Generalized Anxiety Disorder (GAD)
- Database lock of phase 1 SAD/MAD for GRX-917 achieved, and
readout of results anticipated in H2 2022.
- GRX-917 PoC trial in healthy volunteers expected to initiate in
H2 2022.
Kures – KUR-101 (deuterated mitragynine) to treat Opioid Use
Disorder (OUD)
- KUR-101 Phase 1 results expected in H2 2022.
- Enrollment completed in the SAD portion of the Phase 1 trial,
and dosing in the second double-blind, placebo- and
active-controlled relative efficacy and tolerability portion of the
trial has commenced.
DemeRx – DMX-1002 (ibogaine) to treat Opioid Use Disorder
(OUD)
- DMX-1002 Phase 1 results expected in H2 2022.
Viridia Life Sciences - VLS-01 (dimethyltryptamine) to treat
Treatment-Resistant Depression (TRD)
- VLS-01 Phase 1 SAD trial initiation occurred in May of this
year.
- The Phase 1 trial is the first application of Introspect’s DTx
to an atai pipeline product, and this technology will be used to
support subjects before and after dosing.
- The objectives of this phase 1 trial will be to compare the
safety, tolerability, and PK of intravenous versus oral
transmucosal administration of DMT. The oral transmucosal film
product being tested was developed in conjunction with
IntelGenX.
EmpathBio - EMP-01 (MDMA derivative) to treat Post-Traumatic
Stress Disorder (PTSD)
- EMP-01 Phase 1 SAD trial recently received ethics committee
approval, and central regulatory approval is anticipated in H2
2022.
- This trial will incorporate Introspect’s DTx to support
subjects before and after dosing.
InnarisBio – Nasal spray drug-delivery technology to effect
direct-to-brain drug delivery for use in various mental health
indications
- InnarisBio proof of mechanism trial results expected in H2
2022.
atai will host an R&D Day for investors on October 25th,
2022 to provide further updates and details on its innovative
pipeline.
Team Expansion
- Stephen Bardin joined atai as CFO Designate in June 2022 and
will succeed Greg Weaver as CFO on August 16th, 2022. Mr. Weaver
has agreed to stay on board as strategic advisor until the end of
Q1 2023.
- Kures Therapeutics appointed Chad Beyer, PhD, MBA, as CEO in
July 2022.
- GABA Therapeutics appointed Mario Saltarelli, MD, PhD, as CEO
and CMO in April 2022.
Consolidated Financial Results
- On August 9th, atai entered into a term loan facility agreement
for up to $175 million with Hercules Capital, Inc. (NYSE:HTGC).
More details are available in a separate press release filed by
atai on August 15th.
- atai ended the second quarter of 2022 with a cash position of
$312 million, which combined with committed funding from Hercules
loan facility is anticipated to provide cash runway into 2025.
Cash, Cash Equivalents, and Short-term investmentsCash, cash
equivalents and short-term investments totaled $312.5 million as of
June 30, 2022, compared to $362.3 million as of December 31, 2021.
The six-month net decrease of cash of $49.8 million was primarily
attributable to net cash used in operating activities of $45.9
million, $3.0 million of additional investments in the platform
companies, offset by $1.9 million received from the conversion of
promissory notes and equity issuances.
Operating Costs & ExpensesResearch and development expenses
were $17.9 million and $33.4 million for the three and six months
ended June 30, 2022, respectively, as compared to $16.0 million and
$21.6 million for the same prior year periods. The increase of $1.9
million and $11.8 million, respectively, was primarily attributable
to an increase in personnel costs, which included a decrease in
stock-based compensation expense and increased contract research
organization expenses related to the advancement of R&D
programs.
Acquisition of in-process R&D expense for the six months
ended June 30, 2022 of $0.4 million was related to IPR&D
acquired from Kures. Acquisition of in-process R&D expense for
the six months ended June 30, 2021 was $8.9 million, which was
related to IPR&D acquired from InnarisBio and Neuronasal.
General and administrative expenses for the three and six months
ended June 30, 2022, were $17.2 million and $35.2 million,
respectively, as compared to $37.3 million and $46.6 million in the
same prior year periods. The decrease of $20.1 million and $11.4
million, respectively, was primarily attributable to a decrease in
stock-based compensation expense and professional fees, partially
offset by an increase in insurance costs, and personnel and
facilities costs.
Net loss attributable to shareholders for the three months ended
June 30, 2022, was $36.6 million (including non-cash share-based
compensation expense of $9.5 million) as compared to $48.5 million
(including non-cash share-based compensation expense of $37.5
million) for the comparable prior year period.
Net loss attributable to shareholders for the six-months ended
June 30, 2022, was $73.5 million (including non-cash share-based
compensation expense of $19.7 million) as compared to $47.8 million
(including non-cash share-based compensation expense of $37.7
million) for the comparable prior year period.
About atai Life Sciencesatai 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 StatementsThis 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 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, the plans and objectives of management for
future operations and capital expenditures, and our participating
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”) and our Quarterly Report on Form 10-Q
for the quarter ended June 30, 2022, as updated by our subsequent
filings with the SEC, 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 InformationInvestor Contact: Stephen
Bardin Deputy Chief Financial Officerstephen@atai.life
Media Contact: Allan MalievskySenior Director, External Affairs
allan@atai.life
ATAI LIFE SCIENCES
N.V.CONDENSED CONSOLIDATED BALANCE
SHEET(Amounts in thousands, except share and per
share amounts)
|
|
June 30, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
84,132 |
|
|
$ |
362,266 |
|
Debt Securities carried at
fair value |
|
|
228,354 |
|
|
|
— |
|
Prepaid expenses and other
current assets |
|
|
11,122 |
|
|
|
11,903 |
|
Short term notes
receivable |
|
|
— |
|
|
|
913 |
|
Property and equipment,
net |
|
|
303 |
|
|
|
149 |
|
Equity method investments |
|
|
1,162 |
|
|
|
16,131 |
|
Other investments |
|
|
9,233 |
|
|
|
11,628 |
|
Long term notes receivable -
related parties |
|
|
7,040 |
|
|
|
3,835 |
|
Other assets |
|
|
7,590 |
|
|
|
7,341 |
|
Total assets |
|
$ |
348,936 |
|
|
$ |
414,166 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Accounts payable |
|
|
2,738 |
|
|
|
6,004 |
|
Accrued liabilities |
|
|
18,913 |
|
|
|
14,829 |
|
Current portion of contingent
consideration liability - related parties |
|
|
— |
|
|
|
51 |
|
Other current liabilities |
|
|
306 |
|
|
|
51 |
|
Non-current portion of
contingent consideration liability - related parties |
|
|
2,338 |
|
|
|
2,432 |
|
Convertible promissory notes -
related parties, net of discounts and deferred issuance costs |
|
|
619 |
|
|
|
743 |
|
Other liabilities |
|
|
3,900 |
|
|
|
4,097 |
|
Total stockholders’ equity
attributable to ATAI Life Sciences N.V. stockholders |
|
|
311,675 |
|
|
|
376,908 |
|
Noncontrolling interests |
|
|
8,447 |
|
|
|
9,051 |
|
Total liabilities and stockholders’ equity |
|
$ |
348,936 |
|
|
$ |
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 EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
License revenue |
|
$ |
170 |
|
|
$ |
— |
|
|
$ |
170 |
|
|
$ |
19,880 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
17,949 |
|
|
|
16,026 |
|
|
|
33,409 |
|
|
|
21,611 |
|
Acquisition of in-process research and development |
|
|
357 |
|
|
|
7,962 |
|
|
|
357 |
|
|
|
8,934 |
|
General and administrative |
|
|
17,221 |
|
|
|
37,331 |
|
|
|
35,203 |
|
|
|
46,604 |
|
Total operating expenses |
|
|
35,527 |
|
|
|
61,319 |
|
|
|
68,969 |
|
|
|
77,149 |
|
Loss from operations |
|
|
(35,357 |
) |
|
|
(61,319 |
) |
|
|
(68,799 |
) |
|
|
(57,269 |
) |
Other income (expense),
net: |
|
4,551 |
|
|
(5,982 |
) |
|
6,072 |
|
|
(4,279 |
) |
Loss before income taxes |
|
|
(30,806 |
) |
|
|
(67,301 |
) |
|
|
(62,727 |
) |
|
|
(61,548 |
) |
Provision for income
taxes |
|
|
(51 |
) |
|
|
(58 |
) |
|
|
(92 |
) |
|
|
(64 |
) |
Gain on dilution of equity
method investment |
|
|
— |
|
|
|
16,923 |
|
|
|
— |
|
|
|
16,923 |
|
Losses from investments in
equity method investees, net of tax |
|
|
(6,652 |
) |
|
|
(2,937 |
) |
|
|
(12,248 |
) |
|
|
(4,640 |
) |
Net loss |
|
|
(37,509 |
) |
|
|
(53,373 |
) |
|
|
(75,067 |
) |
|
|
(49,329 |
) |
Net loss attributable to
redeemable noncontrolling interests and noncontrolling
interests |
|
|
(891 |
) |
|
|
(4,912 |
) |
|
|
(1,580 |
) |
|
|
(1,556 |
) |
Net loss attributable to ATAI
Life Sciences N.V. stockholders |
|
$ |
(36,618 |
) |
|
$ |
(48,461 |
) |
|
$ |
(73,487 |
) |
|
$ |
(47,773 |
) |
Net loss per share
attributable to ATAI Life Sciences N.V. stockholders — basic
and diluted |
|
$ |
(0.24 |
) |
|
$ |
(0.37 |
) |
|
$ |
(0.48 |
) |
|
$ |
(0.38 |
) |
Weighted average common shares
outstanding attributable to ATAI Life Sciences N.V.
stockholders — basic and diluted |
|
|
153,971,202 |
|
|
|
132,265,075 |
|
|
|
153,751,456 |
|
|
|
125,797,732 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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