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OFFON

ATAI LIFE SCIENCES N.V.

(ATAI)
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ATAI LIFE SCIENCES N.V. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q)

11/15/2021 | 01:52pm EST
You should read the following discussion and analysis of our financial condition
and results of operations together with our condensed financial statements and
related notes included in this Quarterly Report and our audited consolidated
financial statements and related notes thereto for the year ended December 31,
2020, included in our final prospectus dated June 17, 2021 (the "Prospectus"),
as filed with the Securities and Exchange Commission (the "SEC"), pursuant to
Rule 424(b)(4) under the Securities Act of 1933, as amended, (the "Securities
Act"), relating to our Registration Statements on Form S-1 (File No.
333-255383).



This discussion contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. 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, and Section 21E of
the Securities Exchange Act of 1934, as amended (the "Exchange Act"). In some
cases, you can identify these statements by forward-looking words such as "may,"
"will," "expect," "believe," "anticipate," "intend," "could," "should,"
"estimate," or "continue," and similar expressions or variations. Such
forward-looking statements are subject to risks, uncertainties and other factors
that could cause actual results and the timing of certain events to differ
materially from future results expressed or implied by such forward-looking
statements. Factors that could cause or contribute to such differences include,
but are not limited to, those identified below, and those discussed in the
section titled "Risk Factors" included in the Prospectus. The forward-looking
statements in this Quarterly Report represent our views as of the date of this
Quarterly Report. Except as may be required by law, we assume no obligation to
update these forward-looking statements or the reasons that results could differ
from these forward-looking statements. You should, therefore, not rely on these
forward-looking statements as representing our views as of any date subsequent
to the date of this Quarterly Report. Additionally, our historical results are
not necessarily indicative of the results that may be expected for any period in
the future. All references to years, unless otherwise noted, refer to our fiscal
years, which end on December 31. Unless the context otherwise requires, all
references in this subsection to "we," "us," "our," "ATAI" or the "Company"
refer to ATAI and its consolidated subsidiaries.





Business Overview



We are a clinical-stage biopharmaceutical company aiming to transform the
treatment of mental health disorders. We founded atai Life Sciences in 2018 as a
response to the significant unmet need and lack of innovation in the mental
health treatment landscape, as well as the emergence of therapies that
previously may have been overlooked or underused, including psychedelic
compounds and digital therapeutics. We have built a pipeline of 11 development
programs and six enabling technologies, each led by focused teams with deep
expertise in their respective fields and supported by our internal development
and operational infrastructure. We believe that several of our therapeutic
programs' target indications have potential market opportunities of at least $1
billion in annual sales, if approved. One of our ATAI companies, Recognify Life
Sciences, has initiated a Phase 2a trial in the United States. In addition, we
initiated Perception's Phase 2 trial for TRD and DemeRx's Phase 1/2 OUD trial in
the third quarter of 2021. Further, we plan to initiate three Phase 2 trials and
also expect to initiate four Phase 1 trials in 2022.

Our Emerging Clinical and Preclinical Programs




The table below summarizes the status of our product candidate portfolio as of
the filing date of this Quarterly Report. Our pipeline currently consists of
therapeutic candidates across multiple neuropsychiatric indications including
depression, cognitive impairment associated with schizophrenia, or CIAS, OUD,
anxiety, mTBI and PTSD. We rely on third parties to conduct our preclinical and
clinical trials and, as such, progress and timing of these preclinical and
clinical trials and related milestone events, including those discussed in
greater detail below, may be impacted by several factors including, but not
limited to, changes in existing or future contractual obligations or
arrangements with these third parties, geographic developments, such as site
locations or regulatory requirements, and other changing circumstances
associated with these third parties and the clinical trial sites. See the
section titled "Risk Factors-Risks Related to Reliance on Third Parties" in our
Prospectus. We currently hold at least a majority interest, or have options to
obtain a majority interest, in each of these Atai companies.





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                     [[Image Removed: img104097429_0.jpg]]





Majority Owned Companies



Note: TRD = Treatment-resistant depression; CIAS = Cognitive impairment associated with schizophrenia; OUD = Opioid use disorder; GAD = Generalized anxiety disorder; mTBI = Mild traumatic brain injury; DMT = N,N-dimethyltryptamine;

MDMA = 3,4-Methylenedioxymethamphetamine; PTSD = Post-traumatic stress disorder, VIE = Variable interest entity.

(1)

Unless otherwise indicated herein, ownership percentage based on ownership of
securities with voting rights as of September 30, 2021.
(2)
Perception does not give effect to the shares of common stock issuable after
giving full effect to the anti-dilution feature of the Stock Purchase Agreement,
which would not impact our majority position in Perception.
(3)
RL-007 compound is (2R,
3S)-2-amino-3-hydroxy-3-pyridin-4-yl-1-pyrrolidin-1-yl-propan-1-one(L)-(+)
tartrate salt.
(4)
Neuronasal ownership does not give effect to the obligation to acquire further
shares upon the achievement of specified development milestones which may
increase the ownership to up to 64.5%.
(5)
Kures ownership does not give effect to the obligation to acquire further shares
upon the achievement of specified development milestones which may increase the
ownership to up to 67.9%.
(6)
Operational involvement through MSA model, including Srinivas Rao serving as
GABA CMO; GABA ownership does not give effect to the obligation to acquire
further shares upon the achievement of specified development milestones which
may increase the ownership to up to 54.2%.
(7)
As of September 30, 2021, we held a 19.4% ownership interest in COMPASS.
(8)
DemeRx NB ownership does not give effect to the option to acquire further shares
upon the achievement of specified development milestones which may increase the
ownership to up to 57.1%.


Perception Neuroscience: PCN-101 for TRD




?
Product concept: PCN-101 is a parenteral formulation of R-ketamine, a
glutamatergic modulator that is a component of ketamine and being developed as a
rapid-acting antidepressant, with the potential to be an at-home
non-dissociative alternative to S-ketamine (marketed as SPRAVATO).
?
Prior evidence in humans: In a third-party clinical trial, another formulation
of R-ketamine was observed to produce a rapid and durable response with limited
dissociative side effects in patients with TRD. In September 2020, Perception
Neuroscience completed a Phase 1 trial of PCN-101 supporting the advancement of
PCN-101 into a Phase 2 trial.
?
Upcoming milestones: We initiated a Phase 2 randomized, double blind,
placebo-controlled trial in patients with treatment- resistant depression in the
third quarter and anticipate the trial to run through late 2022. The trial will
assess the efficacy and safety, dose response and duration of action in patients
with TRD.











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Recognify Life Sciences: RL-007 for CIAS




?
Product concept: 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. We
are developing this compound for the treatment of cognitive impairments
associated with schizophrenia.
?
Prior evidence in humans: In third-party studies, other formulations of this
compound have been shown to effect a significant improvement in aspects of
cognitive function in both experimental paradigms involving healthy subjects as
well as in a Phase 2 trial in patients suffering from diabetic peripheral
neuropathic pain.
?
Recent 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.
Following the encouraging results of a recently completed interim analysis of
Quantitative Electroencephalogram (qEEG) data from the 8 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 proof-of-concept study focused on more traditional cognitive
endpoints including subsets of the MATRICS battery.
?
Upcoming milestones: We expect topline results from the Phase 2a single-arm,
multiple dose trial in patients with CIAS in late 2021.





GABA: GRX-917 for GAD

?
Product concept: 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 to current treatments for anxiety in the
United States.
?
Prior evidence in humans: Etifoxine has been observed to have the rapid onset of
anxiolytic activity of benzodiazepines without their sedating or addicting
properties. Furthermore, etifoxine is not associated with abuse, dependence or
respiratory depression and has been observed to have no significant impact on
motor skills or cognition.
?
Recent 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: We expect topline results from the Phase 1 single ascending
dose/multiple ascending dose program in mid-2022.





DemeRx IB: DMX-1002 for OUD

?
Product concept: DMX-1002 is an oral formulation of ibogaine, a cholinergic,
glutamatergic and monoaminergic receptor modulator that is a naturally occurring
psychedelic product isolated from a West African shrub, that we are developing
for the treatment of OUD.
?
Prior evidence in humans: In third-party studies evaluating other formulations
of ibogaine, significant reductions in opioid cravings were observed, both at
discharge and at one month post treatment, and were associated with improved
mood in patients with OUD.
?
Upcoming milestones: We initiated the Phase 1 component of Phase 1/2 trial of
DMX-1002 in recreational drug users and healthy volunteers to be initiated in Q3
and expect 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.



Neuronasal: NN-101 for mTBI


?
Product concept: NN-101 is a novel intranasal formulation of NAC. NAC is
believed to stimulate the synthesis of GSH, an endogenous antioxidant that plays
a protective role in the pathogenesis of mTBI.
?
Prior evidence in humans: An orally administered formulation of NAC was shown to
increase the probability of mTBI symptom resolution at seven days in a
third-party study conducted by the U.S. Army. Neuronasal has also completed a
pilot study of NN-101 in nine healthy volunteers. In this pilot study, NN-101
was observed to be approximately 20 times and 100 times more brain-penetrant
compared to IV and oral NAC, respectively, and was well tolerated.





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Viridia Life Sciences: VLS-01 for TRD


?
Product concept: VLS-01 is a formulation of DMT, the active moiety of the
traditional, hallucinogenic drink ayahuasca. DMT is characterized by an
intrinsically short duration of psychedelic effect with a serum half-life
estimated at less than 10 minutes. VLS-01 is formulated to provide a psychedelic
experience lasting 30 to 45 minutes, thus potentially allowing for a shorter
clinic visit compared to many other psychedelic compounds that may require a
patient to be monitored for four or more hours.
?
Prior evidence in humans: Ayahuasca has shown significant antidepressant effects
compared with placebo at one, two and seven days after dosing in a double-blind,
randomized, placebo-controlled third-party clinical trial in patients with TRD.



EmpathBio: EMP-01 for PTSD

?
Product concept: EMP-01 is an oral formulation of an MDMA derivative being
developed for the treatment of PTSD. We are developing EMP-01 for the potential
to have an improved therapeutic index compared to MDMA.
?
Prior evidence in humans: In a meta-analysis of 21 third-party trials of other
formulations of MDMA-combined with psychotherapy for the treatment of PTSD, the
benefits of such treatment were statistically significant versus placebo or
active placebo-assisted therapy alone. In addition, a recent third-party
randomized, double-blind, placebo-controlled phase 3 study with 90 patients with
severe PTSD, showed statistically significant reduction in PTSD symptoms in the
MDMA-assisted psychotherapy group versus placebo.





Revixia Life Sciences: RLS-01 for TRD




?
Product concept: RLS-01 is a formulation of SalA, a naturally occurring
psychedelic compound with pharmacology differentiated from that of psilocybin or
DMT, being developed for the treatment of TRD and other indications.
?
Prior evidence in humans: In a third-party study of another formulation of SalA,
the effects of the compound were observed to be similar to those of psilocybin
based upon functional brain imaging. We believe these data combined with
anecdotal usage reports suggest that SalA may possess rapid-acting
antidepressant properties.





Kures: KUR-101 for OUD

?
Product concept: KUR-101 is an oral formulation of deuterated mitragynine being
developed for the treatment of OUD. Mitragynine is a component of the leaves of
kratom (Mitragnyna speciosa).
?
Prior evidence in humans: Kratom has a long history of traditional medicine use
as an analgesic in parts of Southeast Asia, and its use in the United States has
increased in recent years, particularly amongst individuals seeking to reduce
prescription opioid consumption or manage opioid withdrawal symptoms. Published
third-party human data involving isolated mitragynine are limited, but recent
mechanistic insights suggest that this compound may be well-suited for the
medically assisted therapy of OUD.





DemeRx NB: DMX-1001 for OUD


?
Product concept: DMX-1001 is an oral formulation of noribogaine being developed
for the treatment of OUD. Noribogaine is an active metabolite of ibogaine
designed to have a longer plasma half-life and potentially reduced
hallucinogenic effects compared with ibogaine.
?
Prior evidence in humans: Three third-party clinical trials have been conducted,
testing various doses of another formulation of noribogaine in both healthy
subjects and opioid dependent subjects undergoing detoxification. We believe the
results from these trials support further development.





Our Ownership Position in COMPASS




In addition to our emerging clinical and preclinical programs and enabling
technologies, we led the Series A financing round in 2018 for COMPASS, co-led
their Series B financing round in 2020 and continue to hold a significant equity
ownership position in COMPASS. COMPASS is developing its investigational COMP360
psilocybin therapy, which comprises administration of COMP360 with psychological
support from specially trained therapists, with an initial focus on TRD. The
therapeutic potential of psilocybin administered in conjunction with
psychological support has been shown in multiple academic-sponsored studies,
which did not involve COMP360, specifically exhibiting rapid reductions in
depression symptoms after a single high dose with no SAEs. COMPASS evaluated
COMP360 in



                                       55
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conjunction with psychological support in a Phase 2b trial that concluded in
July 2021 and reported its topline data in November 2021. The randomized,
double-blind, dose-ranging study investigated the safety and efficacy of
psilocybin therapy in 233 patients, the largest clinical trial with psilocybin
to date. As of September 30, 2021, we beneficially owned 8,075,663 shares
representing 19.4 % equity interest in COMPASS. Certain of our founding
investors were also seed investors and founders of COMPASS. Our interest in the
product candidates of COMPASS is limited to the potential appreciation of our
equity interest.





Recent Developments



Purchase of Psyber Shares



In July 2021, pursuant to the Psyber Purchase Agreement, we purchased additional
shares of Series A preferred stock from Psyber, Inc. ("Psyber") for an aggregate
cost of $0.7 million based on the achievement of certain development milestones.
Psyber released the shares from the escrow account and therefore our voting
interest remained unchanged.



Purchase of EntheogeniX Shares




In September 2021, we executed an amendment to the Stockholders Agreement and
Contribution and Subscription Agreement between ATAI, EntheogeniX Biosciences,
Inc. ("EntheogeniX") and Cyclica Inc. ("Cyclica"), in which ATAI agreed to
purchase 500,000 shares of Class A EntheogeniX common stock for an aggregate
purchase price of $0.5 million. As a result of anti-dilution protection
available to Cyclica, our ownership percentage in EntheogeniX did not change due
to the Class A common stock purchase.



Loan to IntelGenx



In September 2021, we executed an amendment to the loan agreement between
IntelGenx Corp. ("IntelGenx") and ATAI, in which we increased the principal
amounts of loans available to IntelGenx by $6.0 million to $8.5 million based on
the achievement of certain corporate milestone. The additional loan amount of
$6.0 million will be funded via two separate tranches of $3.0 million each in
the beginning of 2022 and 2023 respectively, subject to certain conditions. In
connection with the amendment, the maturity date under which the principal, any
accrued interest and other amounts payable by IntelGenx will become due and
payable is January 5, 2024.



Financial Overview



Since our inception in 2018, we have focused substantially all of our efforts
and financial resources on acquiring and developing product and technology
rights, establishing our platform, building our intellectual property portfolio
and conducting research and development activities for our product candidates
within our ATAI companies that we consolidate based on our controlling financial
interest of such entities. We operate a decentralized model to enable scalable
drug or technological development at our ATAI companies. Our ATAI companies
drive development of our programs and enabling technologies that we have either
acquired a controlling or significant interest in or created de novo. We believe
that this model provides our development teams the support and incentives to
rapidly advance their therapeutic candidates or technologies in a cost-efficient
manner. We look to optimize deployment of our capital in order to maximize value
for our stakeholders.



Wholly owned subsidiaries and variable interest entities ("VIE") with greater
than 50% ownership and deemed control are consolidated in our financial
statements, and our net income (loss) is reduced for the non-controlling
interest of the VIE's share, resulting in net income (loss) attributable to ATAI
stockholders.



Investments, where we have ownership in the underlying company's equity greater
than 20% and less than 50%, or where we have significant influence, are recorded
under the equity method. We then record income (loss) in equity method
investments for our proportionate share of the underlying company's net results
until the investment balance is adjusted to zero. If we make subsequent
additional investments in that same company, we may record additional
gains(losses) based on changes to our investment basis and also may record
additional income(loss) in equity method investments.



We do not have any products approved for sale and have not generated any revenue
from product sales. We have funded our operations to date primarily with
proceeds from the sale of our common stock and from issuances of convertible
notes.



We were incorporated pursuant to the laws of the Netherlands on September 10,
2020. As more fully described in the Prospectus in the section titled "Corporate
Reorganization," and in the Notes to Condensed Consolidated Financial Statements
appearing elsewhere in this Quarterly Report, we undertook a corporate
reorganization, or the Corporate Reorganization on April 23, 2021. In April
2021, all of the outstanding shares in ATAI Life Sciences AG were contributed
and transferred to ATAI Life Sciences N.V. in a capital increase in exchange for
newly issued common shares of ATAI Life Sciences N.V. on a 1 to 10 basis, and,
as a result, ATAI Life Sciences AG became a wholly owned subsidiary of ATAI Life
Sciences N.V. Furthermore, on June 7, 2021, shares of ATAI Life Sciences N.V.
were split applying a ratio of 1.6 to one. The Corporate Reorganization is
considered a continuation of ATAI Life Sciences AG resulting in no change in the
carrying values of assets or liabilities. As a result, the financial statements
for periods prior to the Corporate Reorganization are the financial statements
of ATAI Life Sciences AG as the predecessor to ATAI Life Sciences N.V. for
accounting and reporting purposes. All



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share, per-share and financial information presented and corresponding
disclosures have been retrospectively adjusted, where applicable, to reflect the
impact of the share exchange and share split resulting from the Corporate
Reorganization. In connection with the Corporate Reorganization, outstanding
share awards and option grants of ATAI Life Sciences AG were exchanged for share
awards and option grants of ATAI Life Sciences N.V. with identical restrictions.



On June 22, 2021, we completed an IPO on Nasdaq, in which we issued and sold
17,250,000 shares of our common stock at a public offering price of $15.00 per
share, including 2,500,000 shares of common stock sold pursuant to the
underwriters' exercise of their option to purchase additional shares of common
stock, for aggregate net proceeds of $231.6 million, after deducting
underwriting discounts and commissions of $18.1 million and offering costs of
$9.0 million. Prior to the IPO, we received gross cash proceeds of $361.5
million from sales of our common stock and convertible notes.



We have incurred significant operating losses since our inception. Our net loss
attributable to ATAI Life Sciences N.V. stockholders was $31.2 million and $83.2
million for the three months ended September 30, 2021 and 2020, respectively,
and $78.9 million and $83.2 million for the nine months ended September 30, 2021
and 2020, respectively. As of September 30, 2021 and December 31, 2020, our
accumulated deficit was $268.9 million and $190.0 million, respectively. Our
ability to generate product revenue sufficient to achieve profitability will
depend substantially on the successful development and eventual
commercialization of product candidates at our ATAI companies that we
consolidate based on our controlling financial interest of such entities as
determined under the variable interest entity model, or VIEs. We expect to
continue to incur significant expenses and increasing operating losses for at
least the next several years.



Our historical losses resulted principally from costs incurred in connection
with research and development activities and general and administrative costs
associated with our operations. In the future, we intend to continue to conduct
research and development, preclinical testing, clinical trials, regulatory
compliance, market access, commercialization and business development activities
that, together with anticipated general and administrative expenses, will result
in incurring further significant losses for at least the next several years. Our
operating losses stem primarily from development of our mental health research
programs. Furthermore, we expect to incur additional costs associated with
operating as a public company, including audit, legal, regulatory, and
tax-related services associated with maintaining compliance with exchange
listing and SEC requirements, director and officer insurance premiums, and
investor relations costs. As a result, we will need substantial additional
funding to support our continuing operations and pursue our growth strategy.
Until such time as we can generate significant revenue from sales of our product
candidates, if ever, we expect to finance our operations through a combination
of equity offerings, debt financings, strategic collaborations and alliances or
licensing arrangements. Our inability to raise capital as and when needed could
have a negative impact on our financial condition and ability to pursue our
business strategies. There can be no assurances, however, that our current
operating plan will be achieved or that additional funding will be available on
terms acceptable to us, or at all.



As of September 30, 2021, we had cash and cash equivalents of $430.3 million. We
believe that our existing cash will be sufficient for us to fund our operating
expenses and capital expenditure requirements for at least the next 12 months.
We have based this estimate on assumptions that may prove to be wrong, and we
could exhaust our available capital resources sooner than we expect. See
"Liquidity and Capital Resources-Liquidity Risk" below.





Factors Affecting our Results


We believe that the most significant factors affecting our results of operations include:






Acquisitions/Investments



To continue to grow our business and to aid in the development of our various
product candidates, we are continually acquiring and investing in companies that
share our common goal towards advancing transformative treatments, including
psychedelic compounds and digital therapeutics, for patients that suffer from
mental health disorders. During the three and nine months ended September 30,
2021, we spent $0 and $28.8 million, respectively, on investments in GABA,
COMPASS, IntelGenx and Neuronasal.





Research and Development Expenses




Our ability to successfully develop innovative product candidates through our
programs will be the primary factor affecting our future growth. Our approach to
the discovery and development of our product candidates is still being
demonstrated. As such, we do not know whether we will be able to successfully
develop any products. Developing novel product candidates requires a significant
investment of resources over a prolonged period of time, and a core part of our
strategy is to continue making sustained investments in this area. We have
chosen to leverage our platform to initially focus on advancing our product
candidates in the area of mental health.



All of our product candidates are still in development stages, and we have
incurred and will continue to incur significant research and development costs
for their preclinical studies and clinical trials. We expect that our research
and development expenses will constitute the



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most substantial part of our expenses in future periods in line with the advancement and expansion of the development of our product candidates.

Acquisition of In-Process Research and Development Expenses




In an asset acquisition, including the initial consolidation of a VIE that is
not a business, acquired in-process research and development, or IPR&D, with no
alternative future is charged to the condensed consolidated statements of
operations as a component of operating expenses at the acquisition date.



Since inception, we have grown primarily by continually acquiring and investing
in other companies. Our IPR&D expenses were $0 and $9.0 million, representing 0%
and 8.1% of our total operating expenses for the three and nine months ended
September 30, 2021, respectively. Our IPR&D expenses for the three and nine
months ended September 30, 2020 were $0 and $0.1 million. As we continue to
acquire and invest in companies, we expect our IPR&D expenses to increase in
absolute amounts.





Stock-Based Compensation



In August 2020, we adopted the 2020 Equity Incentive Plan and the Hurdle Share
Option Plan, which allowed us to grant stock-based awards to executive officers,
directors, employees and consultants. Prior to our IPO, we issued stock options
that vest over a two to four-year service period, only if and when a "Liquidity
Event" (as defined in the plans) occurs, with accelerated vesting if a Liquidity
Event occurred by specified dates. Upon the closing of our IPO, the stock-based
award vesting contingent upon a Liquidity Event was no longer deferred. For the
three and nine months ended September 30, 2021, stock-based compensation of
$12.2 million and $50.0 million, respectively.





Impact of COVID-19



The COVID-19 pandemic has continued to present global public health and economic
challenges during the nine months ended September 30, 2021. Although some
research and development timelines have been impacted by delays related to the
COVID-19 pandemic, we have not experienced material financial impacts on our
business and operations as a result of the COVID-19 pandemic. We continue to
monitor the impact of the COVID-19 pandemic on our employees and business and
have undertaken a number of business continuity measures to mitigate potential
disruption to our operations.



The future impact of COVID-19 on our business and operations, including our
research and development programs and related clinical trials, will largely
depend on future developments, which are highly uncertain, such as the duration
of the pandemic, the spread of the disease and variants thereof, the
availability and effectiveness of vaccines and related roll-out efforts,
breakthrough infections among the vaccinated, vaccine hesitancy, the
implementation of vaccine mandates, travel restrictions, social distancing and
related government actions around the world, business closures or business
disruptions and the ultimate impact of COVID-19 on financial markets and the
global economy. For a discussion of the risks to our business from COVID-19,
refer to the section titled "Risk Factors" in our Prospectus.

Basis of Presentation and Consolidation




Since our inception, we have created wholly-owned subsidiaries or made
investments in certain controlled entities, including partially-owned
subsidiaries for which we have majority voting interest under the VOE model or
for which we are the primary beneficiary under the VIE model, which we refer to
collectively as our consolidated entities. Ownership interests in entities over
which we have significant influence, but not a controlling financial interest,
are accounted for as cost and equity method investments. Ownership interests in
consolidated entities that are held by entities other than us are reported as
redeemable convertible noncontrolling interests and noncontrolling interests in
our condensed consolidated balance sheets. Losses attributed to redeemable
convertible noncontrolling interests and noncontrolling interests are reported
separately in our condensed consolidated statements of operations.

Components of Our Results of Operations



Revenue



On March 11, 2021, we entered into a license and collaboration agreement, or the
Otsuka Agreement, with Otsuka Pharmaceutical Co., LTD, or Otsuka, under which we
granted exclusive rights to Otsuka to develop and commercialize certain products
containing arketamine in Japan for the treatment of depression and other select
indications. We received an upfront, non-refundable payment of $20.0 million in
June 2021 and we are also eligible to receive up to $35.0 million if certain
development and regulatory milestones are achieved



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and up to $66.0 million in commercial milestones upon the achievement of certain
commercial sales thresholds. We are eligible to receive a tiered, double-digit
royalties on net sales of licensed products subject to reduction in certain
circumstances.



In March 2021, we satisfied the performance obligation related to the license
upon delivery of the license and recognized the amount of $19.7 million
allocated to the license as license revenue. Additionally, we recognized
revenues of $0.4 million related to certain research and development services.
As of September 30, 2021, we had current deferred revenue of $0.2 million due to
certain research and development services under the Otsuka Agreement which will
be recognized over time as the respective study results are delivered. To date,
there have been no milestones achieved under the Otsuka Agreement. License
revenue of $0.3 million and $20.1 million was recorded for the three and nine
months ended September 30, 2021, respectively.



For the foreseeable future, we may generate revenue from reimbursements of
services under the Otsuka Agreement, as well as milestone payments under our
current and/or future collaboration agreements. We do not expect to generate any
revenue from the sale of products unless and until such time that our product
candidates have advanced through clinical development and regulatory approval,
if ever. We expect that any revenue we generate, if at all, will fluctuate from
quarter-to-quarter as a result of the timing and amount of payments relating to
such services and milestones and the extent to which any of our products are
approved and successfully commercialized. If we fail to complete preclinical and
clinical development of product candidates or obtain regulatory approval for
them, our ability to generate future revenues and our results of operations and
financial position would be adversely affected.





Operating Expenses


Research and Development Expenses




Research and development expenses consist primarily of costs incurred for our
research activities, including our discovery efforts and the development of our
product candidates, which include:



?
employee-related expenses, including salaries, related benefits and stock-based
compensation, for employees engaged in research and development functions;
?
expenses incurred in connection with the preclinical and clinical development of
our product candidates, including our agreements with third parties, such as
consultants and CROs;
?
expenses incurred under agreements with consultants who supplement our internal
capabilities;
?
the cost of lab supplies and acquiring, developing and manufacturing preclinical
study materials and clinical trial materials;
?
costs related to compliance with regulatory requirements;
?
facilities, depreciation and other expenses, which include direct and allocated
expenses for rent and maintenance of facilities, insurance and other operating
costs; and
?
payments made in connection with third-party licensing agreements.



Research and development costs, including costs reimbursed under the Otsuka
Agreement, are expensed as incurred, with reimbursements of such amounts being
recognized as revenue. We account for nonrefundable advance payments for goods
and services that will be used in future research and development activities as
expenses when the service has been performed or when the goods have been
received.



Our direct research and development expenses are tracked on a program-by-program
basis for our product candidates and consist primarily of external costs, such
as fees paid to outside consultants, CROs, CMOs and research laboratories in
connection with our preclinical development, process development, manufacturing
and clinical development activities. Our direct research and development
expenses by program also include fees incurred under third-party license
agreements.



We do not allocate internal research and development expenses consisting of employee and contractor-related costs, to specific product candidate programs because these costs are deployed across multiple product candidate programs under research and development and, as such, are separately classified.




Research and development activities are central to our business model. Product
candidates in later stages of clinical development generally have higher
development costs than those in earlier stages of clinical development,
primarily due to the increased size and duration of later-stage clinical trials.
We expect that our research and development expenses will continue to increase
for the foreseeable future in connection with our planned preclinical and
clinical development activities in the near term and in the future.





                                       59
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The successful development of our product candidates is highly uncertain. As
such, at this time, we cannot reasonably estimate or know the nature, timing and
estimated costs of the efforts that will be necessary to complete the remainder
of the development of these product candidates. We are also unable to predict
when, if ever, material net cash inflows will commence from our product
candidates. This is due to the numerous risks and uncertainties associated with
developing products, including the uncertainty of whether (i) any clinical
trials will be conducted or progress as planned or completed on schedule, if at
all, (ii) we obtain regulatory approval for our product candidates and (iii) we
successfully commercialize product candidates.





Acquisition of In-Process Research and Development Expenses




Acquisition of in-process research and development expenses consist of acquired
in-process research and development with no future alternative use based on the
probability of clinical success. We expect our acquisition of IPR&D expenses to
increase as we continue to grow and expand.





General and Administrative Expenses




General and administrative expenses consist primarily of salaries and other
related costs, including stock-based compensation, for personnel in our
executive, finance, corporate and business development and administrative
functions, professional fees for legal, patent, accounting, auditing, tax and
consulting services, travel expenses and facility-related expenses, which
include allocated expenses for rent and maintenance of facilities, advertising,
and information technology-related expenses.



We expect that our general and administrative expenses will increase in the
future as we increase our general and administrative headcount to support our
continued research and development and potential commercialization of our
product candidates. We also expect to incur increased expenses associated with
being a public company, including increased costs of accounting, audit, legal,
regulatory and tax-related services associated with maintaining compliance with
exchange listing and SEC requirements, director and officer insurance costs, and
investor and public relations costs.





Other Income (Expense), Net



Interest Income



Interest income consists of interest earned on cash balances held in
interest-bearing accounts and interest earned on notes receivable. We expect
that our interest income will fluctuate based on the timing and ability to raise
additional funds as well as the amount of expenditures for our research and
development of our product candidates and ongoing business operations.





Change in Fair Value of Contingent Consideration Liability-Related Parties

Changes in fair value of contingent consideration liability-related parties, consists of subsequent remeasurement of our contingent consideration liability-related parties with Perception and InnarisBio for which we have elected the fair value option. See "-Liquidity and Capital Resources-Indebtedness" below for further discussion of our contingent consideration liability-related parties.

Change in Fair Value of Short Term Notes Receivable-Related Party




Changes in fair value of short term notes receivable-related party, including
interest, consists of subsequent remeasurement of our short term notes
receivable-related party with COMPASS for which we have elected the fair value
option. The COMPASS notes were converted during 2020. See "-Liquidity and
Capital Resources-Indebtedness" below for further discussion of our short term
notes receivable - related party.





Change in Fair Value of Warrant Liability

Changes in fair value of consists of subsequent remeasurement of our warrant liability relating to issued and outstanding warrants to purchase shares of Neuronasal's common stock acquired in connection with the acquisition of Neuronasal in May 2021.

Change in Fair Value of Convertible Promissory Notes




Changes in fair value of convertible promissory notes consists of subsequent
remeasurement of our convertible promissory notes for which we have elected the
fair value option. See "-Liquidity and Capital Resources-Indebtedness" below for
further discussion of our convertible promissory notes.











                                       60
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Change in Fair Value of Derivative Liability




Changes in fair value of derivative liability consists of subsequent
remeasurement of our derivative liability relating to certain embedded features
contained in the Perception convertible promissory notes for which we have
elected the fair value option. The Perception convertible promissory notes were
converted during June 2021. See "-Liquidity and Capital Resources-Indebtedness"
below for further discussion the Perception convertible promissory notes.





Unrealized Loss on Other Investments Held at Fair Value




In May 2021, we received IntelGenx common stock, warrants and additional unit
warrants for a price of approximately $12.3 million. We determined that the
initial aggregate fair value is equal to the transaction price and recorded the
common shares at $3.0 million, the warrants at $1.2 million and the additional
unit warrants at $8.2 million on a relative fair value basis resulting in no
initial gain or loss recognized in the condensed consolidated statements of
operations. Subsequently, changes in fair value of the common shares, the
warrants and additional unit warrants are recorded as a component of other
income (expense), net in the condensed consolidated statement of operations.




Unrealized Gain on Other Investments




In March 2020, we entered into a series of transactions including the purchase
of additional shares of COMPASS Series A and Series B preferred stock under the
secondary Series A preferred stock purchase agreement and the Series B preferred
stock subscription agreement, respectively. In April 2020, COMPASS entered into
a Series B preferred stock subscription agreement with other investors for
issuance of its Series B preferred stock, which resulted in the automatic
conversion of our COMPASS convertible notes receivable into shares of COMPASS
Series B preferred stock. We remeasured our investment in COMPASS' Series A
preferred shares to fair value due to the observable price change in connection
with COMPASS' secondary Series A preferred stock purchase in March 2020 and
recognized unrealized gains on other investments in the condensed consolidated
statements of operations in association with the transaction.



Loss on Conversion of Convertible Promissory Notes




In June 2021, upon the funding of the Otsuka Agreement, the Perception
convertible promissory notes were converted into Perception Series A preferred
stock. The loss represents the difference between (i) carrying value including
derivative liability of the Perception December 2020 Notes of $2.2 million and
(ii) the fair value of Perception Series A preferred stock into which the notes
converted of $2.7 million.


Gain on Consolidation of a Variable Interest Entity




Gain on consolidation of a variable interest entity resulted from the purchase
of additional shares of Neuronasal in May 2021. The gain was calculated as the
sum of the consideration paid of $1.0 million, the fair value of the
noncontrolling interest issued of $3.0 million, the carrying value of our
investments in Neuronasal's common stock and preferred stock prior to May 2021
of $0.8 million, less the fair value of identifiable net assets acquired of $8.3
million.


Foreign exchange gain (loss), net




Foreign exchange gain (loss), net consists of the impact of changes in foreign
currency exchange rates on our foreign exchange denominated liabilities,
relative to the U.S. dollar. The impact of foreign currency exchange rates on
our results of operations fluctuates period over period based on our foreign
currency exposures resulting from changes in applicable exchange rates
associated with our foreign denominated liabilities.



Other Income (Expense), net



Other income (expense), net consists principally of interest expense, impairment
related to our other investments and credits related to our research and
development tax credits which are claimed from the Australian tax authority, in
respect to qualifying research and development costs incurred.





Income Tax



For our consolidated entities, deferred income taxes are provided for the
effects of temporary differences between the amounts of assets and liabilities
recognized for financial reporting purposes and the amounts recognized for
income tax purposes. Deferred income taxes reflect the net tax effects of
temporary differences between the carrying amounts of assets and liabilities for
financial reporting purposes and the amounts used for income tax purposes.



We regularly assess the need to record a valuation allowance against net deferred tax assets if, based upon the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. Accordingly we continue to maintain a full valuation

                                       61

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allowance against our deferred tax assets as of September 30, 2021, consistent
with prior periods, which primarily relate to our German and international tax
loss carryforwards. In assessing the realizability of deferred tax assets, we
consider whether it is more likely than not that some or all of the deferred tax
assets will not be realized. The future realization of deferred tax assets is
subject to the existence of sufficient taxable income of the appropriate
character (e.g., ordinary income or capital gain) as provided under the
carryforward provisions of local tax law. We consider the scheduled reversal of
deferred tax liabilities (including the effect in available carryback and
carryforward periods), future projected taxable income, including the character
and jurisdiction of such income, and tax-planning strategies in making this
assessment.



Unrecognized tax benefits arise when the estimated benefit recorded in the
financial statements differs from the amounts taken or expected to be taken in a
tax return because of the considerations described above. As of September 30,
2021 and December 31, 2020, we had no unrecognized tax benefits.





Losses from Investments in Equity Method Investees, Net of Tax




Losses from investments in equity method investees, net of tax consists of our
share of equity method investees losses on the basis of our equity ownership
percentage, IPR&D charges resulting from basis differences and impairment
related to our equity method investments.





Net Loss Attributable to Redeemable Noncontrolling Interests and Noncontrolling Interests




Net loss attributable to redeemable noncontrolling interests and noncontrolling
interests in our condensed consolidated statements of operations is a result of
our investments in certain of our consolidated VIEs, and consists of the portion
of the net loss of these consolidated entities that is not allocated to us. Net
losses in consolidated VIEs are attributed to redeemable noncontrolling
interests and noncontrolling interests considering the liquidation preferences
of the different classes of equity held by the shareholders in the VIE and their
respective interests in the net assets of the consolidated VIE in the event of
liquidation, and their pro rata ownership. Changes in the amount of net loss
attributable to redeemable noncontrolling interests and noncontrolling interests
are directly impacted by changes in the net loss of our VIEs and our ownership
percentage changes.







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Results of Operations



Comparison of the Three Months Ended September 30, 2021 and 2020 (unaudited)



                                            Three months ended
                                               September 30,
                                            2021          2020        $ Change       % Change
                                                   (in thousands, except percentages)
License revenue                           $     266     $       -           266       100.0%
Operating expenses:
Research and development                     13,363         3,058        10,305       337.0%
General and administrative                   20,264         4,328        15,936       368.2%
Total operating expenses                     33,627         7,386        26,241       355.3%
Loss from operations                        (33,361 )      (7,386 )     (25,975 )     351.7%
Other income (expense), net:
Interest income                                   8            19           (11 )    (57.9%)
Change in fair value of contingent
consideration liability -
  related parties                               469            86           383       445.3%
Change in fair value of convertible
promissory notes                                  -       (13,867 )      13,867      (100.0%)
Change in fair value of derivative
liability                                         -           (10 )          10      (100.0%)
Change in fair value of warrant
liability                                        47             -            47       100.0%
Unrealized loss on other investments
held at fair value                              (70 )           -           (70 )     100.0%
Foreign exchange gain (loss), net             6,462          (159 )       6,621     (4164.2%)
Other income (expense), net                     (29 )         (11 )         (18 )     163.6%
Total other income (expense), net             6,887       (13,942 )      20,829      (149.4%)
Net loss before income taxes                (26,474 )     (21,328 )      (5,146 )     24.1%
Provision for income taxes                     (368 )          (4 )        (364 )    9100.0%
Losses from investments in equity
method investees, net of tax                 (4,800 )     (61,862 )      57,062      (92.2%)
Net loss                                    (31,642 )     (83,194 )      51,552      (62.0%)
Net income (loss) attributable to
redeemable noncontrolling interests and
  noncontrolling interests                     (484 )           1          (485 )   (48500.0%)
Net loss attributable to ATAI Life
Sciences N.V. stockholders                $ (31,158 )$ (83,195 )$  52,037      (62.5%)




License Revenue



License revenue was $0.3 million for the three months ended September 30, 2021,
compared to $0 for the three months ended September 30, 2020. The increase of
$0.3 million was attributable to certain research and development services
provided to Otsuka in connection with the Otsuka license and collaboration
agreement.









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Research and Development Expenses

The table and discussion below present research and development expenses for the three months ended September 30, 2021 and 2020:



                                           Three months ended September 30,
                                             2021                  2020            Change       % Change
                                                        (in thousands, except percentages)
Direct research and development
expenses by program:
PCN-101 (Perception)                      $     1,340         $         1,493     $    (153 )     (10.2%)
KUR-101 (Kures)                                   992                     321           671         209.0 %
DMX-1002 (DemeRx IB)                              841                     515           326          63.3 %
RL-007 (Recognify)                                786                       -           786         100.0 %
VLS-01 (Viridia)                                  526                      37           489        1321.6 %
EMP-01 (EmpathBio Inc)                            337                      
2           335       16750.0 %
RLS-01 (Revixia)                                  275                       -           275         100.0 %
NN-01 (Neuronasal)                                275                       -           275         100.0 %
Novel drug delivery (InnarisBio)                  271                       -           271         100.0 %
Novel compounds (EntheogeniX)                     195                     109            86          78.9 %
Other (Introspect, Psyber, Psyprotix)             102                      14            88         628.6 %
Unallocated research and development
expenses:
Personnel expenses                              7,159                     486         6,673        1373.0 %
Professional and consulting services               75                      74             1           1.4 %
Other                                             189                       7           182        2600.0 %

Total research and development expenses $ 13,363 $ 3,058 $ 10,305 337.0 %





Research and development expenses were $13.4 million for the three months ended
September 30, 2021, compared to $3.1 million for the three months ended
September 30, 2020. The increase of $10.3 million was primarily attributable to
$6.7 million of personnel costs, which included $5.3 million of stock- based
compensation and an increase of $3.4 million of direct costs at the platform
companies as discussed below.



The $0.1 million decrease in direct costs for PCN-101 was primarily due to an
decrease of $0.3 million in preclinical development costs, partially offset by
an increase of $0.1 million in personnel related costs and an increase of $0.1
million in clinical development and manufacturing costs.



The $0.7 million increase in direct costs for KUR-101 program was primarily due
to an increase of $0.6 million preclinical activities, $40,000 in manufacturing
and $50,000 in personnel costs.



The $0.3 million increase in direct costs for DMX-1002 program was primarily due to an increase of $0.4 million clinical development costs and $70,000 preclinical activities, partially offset by a decrease of $0.2 million in manufacturing.

The direct costs of $0.8 million for RL-007 program were $0.6 million in clinical development costs and $0.2 million of personnel related costs, which included $0.1 million of stock-based compensation expense.

The $0.5 million increase in direct costs for VLS-01 program was due to an increase of $0.5 million of preclinical activities and manufacturing.

The direct costs for EMP-001 were $0.3 million of manufacturing and control processes costs and other preclinical activities.

The direct costs for RLS-01 were $0.3 million of manufacturing and control processes costs and other preclinical activities.




The direct costs for NN-01, which are from the date of acquisition in May 2021
were $0.3 million in clinical development costs, manufacturing and personnel
costs.


The direct costs for InnarisBio were $0.3 million of preclinical activities.

The $0.1 million increase in direct costs for EntheogeniX was primarily due to an increase in preclinical activities.





                                       64
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During the three months ended September 30, 2021, we did not incur any significant direct costs in association with IntroSpect, Psyber, or Psyprotix; direct costs associated with these programs were related to the ramp up of preclinical development and initial clinical-stage activities.

General and Administrative Expenses




General and administrative expenses were $20.3 million for the three months
ended September 30, 2021 compared to $4.3 million for the three months ended
September 30, 2020. The increase of $15.9 million, was attributable to $9.5
million of personnel costs, which included $4.7 million of stock-based
compensation, $3.5 million of professional fees, $1.6 million of insurance
costs, and $1.3 million other costs related to support of our platform growth
and public company requirements.





Interest Income



Interest income for the three months ended September 30, 2021 and 2020 primarily
consisted of interest earned on our cash balances and notes receivable during
these periods. We had interest income for the three months ended September 30,
2021 and 2020 of $8,000 and $19,000, respectively.





Change in Fair Value of Contingent Consideration Liability-Related Parties




The milestone and royalty payments in relation to the acquisition of Perception
Neuroscience were recorded at the acquisition date or at the exercise date
related to the call option, and is subsequently remeasured to fair value as of
September 30, 2021, resulting in an expense of $0.5 million and $90,000 being
recognized for the three months ended September 30, 2021 and 2020, respectively.
The increase of $0.4 million was primarily attributable to Perception's
completion of its Phase 1 clinical trial in September 2020, which increased the
probability of the milestone event occurring, and a potential license agreement
with a third-party pharmaceutical company, which would include an upfront
payment and additional milestone payments. As the license agreement had not been
executed as of December 31, 2020, we used a probability weighted approach for
the royalty payments, where 80% was applied to the license scenario and 20% was
applied to the no-license scenario. At March 31, 2021, the license transaction
had closed and the scenario-based method with 80%/20% probability was no longer
used.



The milestone and royalty payments in relation to the acquisition of InnarisBio
were recorded at the acquisition date and is subsequently remeasured to fair
value as of September 30, 2021, resulting in an immaterial expense being
recognized for the three months ended September 30, 2021 because there were no
material changes to any of the significant assumptions used that impacts the
fair value of the contingent liability.





Change in Fair Value of Convertible Promissory Notes




Change in fair value of convertible promissory notes for the three months ended
September 30, 2020 was $13.9 million, which was primarily associated with the
change in fair value of our 2020 convertible notes, or the 2020 Notes. The
change in fair value of the 2020 Notes was primarily attributable to an increase
in the fair value of the underlying common stock in 2020 leading up to the
conversion of the convertible promissory notes into our common shares in
November 2020. We did not recognize a change in fair value of convertible
promissory notes for the three months ended September 30, 2021.



Change in Fair Value of Derivative Liability




Change in fair value of derivative liability was $10,000 for the three months
ended September 30, 2020. The derivative liability was recorded in connection
with certain embedded features contained in the Perception convertible
promissory notes for which we have elected the fair value option. The Perception
convertible promissory notes were converted during June 2021.



Change in Warrant Liability



Change in fair value of warrant liability was $47,000 for the three months ended
September 30, 2021. The warrant liability was recorded in connection with issued
and outstanding warrants to purchase shares of Neuronasal's common stock
acquired in connection with the acquisition of Neuronasal. The warrant liability
was recorded in connection with the May 2021 acquisition of Neuronasal.



Unrealized Loss on Other Investments Held at Fair Value




Unrealized loss on other investments held at fair value for the three months
ended September 30, 2021 was $70,000. In May 2021, we received IntelGenx common
stock, warrants and additional unit warrants for a price of approximately $12.3
million. The immaterial change in fair value of the IntelGenx common stock,
warrants and additional unit warrants was recorded in unrealized loss on other
investments held at fair value for the three months ended September 30, 2021.





                                       65
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Foreign Exchange Gain (Loss), Net




Foreign exchange gain (loss), net was $6.5 million for the three months ended
September 30, 2021 compared to $(0.2 million) for the three months ended
September 30, 2020. The increase of $6.6 million was a result of the impact of
fluctuations in the foreign currency exchange rate between the Euro and the U.S.
dollar on our foreign exchange denominated balances.





Other Income (Expense), Net

We incurred an immaterial amount of other income (expense), net for the three months ended September 30, 2021 and 2020.





Income Tax



We incurred income tax expense of $0.4 million for the three months ended
September 30, 2021. The income tax expense relates to book profits and thus
taxable profits generated in one of our United States subsidiaries. Given our
early stage development and lack of prior earnings history, we have a full
valuation allowance primarily related to German and overseas tax loss
carryforwards that we do not consider more likely than not to be realized. We
incurred an immaterial amount of income tax expense for the three months ended
September 30, 2020.




Losses from Investments in Equity Method Investees




Losses from investment in equity method investees for the three months ended
September 30, 2021 and 2020 were $4.8 million and $61.9 million, respectively.
Loss from investment in equity method investees represents our share of equity
method investee losses on the basis of our equity ownership percentages or based
on our proportionate share of the respective class of securities in our other
investments in the event that the carrying amount of our equity method
investments was zero.

















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Comparison of the Nine Months Ended September 30, 2021 and 2020 (unaudited)



                                          Nine months ended September
                                                      30,
                                             2021             2020        $ Change      % Change
                                                    (in thousands, except percentages)
License revenue                           $   20,146       $        -        20,146      100.0%
Operating expenses:
Research and development                      34,974            8,056        26,918      334.1%
Acquisition of in-process research and
development                                    8,934              120         8,814      7345.0%
General and administrative                    66,868            8,749        58,119      664.3%
Total operating expenses                     110,776           16,925        93,851      554.5%
Loss from operations                         (90,630 )        (16,925 )     (73,705 )    435.5%
Other income (expense), net:
Interest income                                   80               57            23       40.4%
Change in fair value of contingent
consideration liability -
  related parties                               (191 )             20          (211 )   (1055.0%)
Change in fair value of short term
notes receivable - related party                   -              718          (718 )   (100.0%)
Change in fair value of convertible
promissory notes                                   -          (14,000 )      14,000     (100.0%)
Change in fair value of derivative
liability                                         41              (23 )          64     (278.3%)
Change in fair value of warrant
liability                                         87                -            87      100.0%
Unrealized loss on other investments
held at fair value                            (5,530 )              -        (5,530 )    100.0%
Unrealized gain on other investments               -           19,856       (19,856 )   (100.0%)
Loss on conversion of convertible
promissory notes                                (513 )              -          (513 )    100.0%
Gain on consolidation of a variable
interest entity                                3,543                -         3,543      100.0%
Foreign exchange gain (loss), net              5,446             (191 )       5,637     (2951.3%)
Other income (expense), net                     (355 )            (85 )        (270 )    317.6%
Total other income (expense), net              2,608            6,352        (3,744 )    (58.9%)
Net loss before income taxes                 (88,022 )        (10,573 )     (77,449 )    732.5%
Provision for income taxes                      (432 )             (4 )        (428 )   10700.0%
Gain on dilution of equity method
investment                                    16,923                -        16,923      100.0%
Losses from investments in equity
method investees, net of tax                  (9,440 )        (73,693 )      64,253      (87.2%)
Net loss                                     (80,971 )        (84,270 )       3,299      (3.9%)
Net income (loss) attributable to
redeemable noncontrolling interests and
  noncontrolling interests                    (2,040 )         (1,021 )      (1,019 )     99.8%
Net loss attributable to ATAI Life
Sciences N.V. stockholders                $  (78,931 )$  (83,249 )$   4,318      (5.2%)




License Revenue



License revenue was $20.1 million for the nine months ended September 30, 2021,
which related to the Otsuka Agreement. The license revenue recognized during the
nine months primarily relates to the delivery of the license to Otsuka, which
occurred in March 2021. No license revenue was recognized during the nine months
ended September 30, 2020.











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Research and Development Expenses

The table and discussion below present research and development expenses for the nine months ended September 30, 2021 and 2020:



                                             Nine months ended
                                               September 30,
                                             2021          2020         Change       % Change
                                                   (in thousands, except percentages)
Direct research and development
expenses by program:
PCN-101 (Perception Neuroscience)         $    5,412$   3,280$   2,132          65.0 %
DMX-1002 (DemeRx IB)                           2,676           876         1,800         205.5 %
RL-007 (Recognify)                             1,862             -         1,862         100.0 %
KUR-101 (Kures)                                1,680         1,915          (235 )     (12.3%)
VLS-01 (Viridia)                               1,593            39         1,554        3984.6 %
EMP-01 (EmpathBio)                               668             2           666       33300.0 %
RLS-01 (Revixia)                                 555             -           555         100.0 %
Novel compounds (InnarisBio)                     495             -           495         100.0 %
Novel compounds (EntheogeniX)                    440           473           (33 )      (7.0%)
NN-01 (Neuronasal)                               398             -           398         100.0 %
Other (Introspect, Psyber, Psyprotix)            168            16           152         950.0 %
Unallocated research and development
expenses:
Personnel expenses                            18,278         1,165        17,113        1468.9 %
Professional and consulting services             378           178           200         112.4 %
Other                                            371           112          

259 231.3 % Total research and development expenses $ 34,974$ 8,056$ 26,918 334.1 %





Research and development expenses were $35.0 million for the nine months ended
September 30, 2021, compared to $8.1 million for the nine months ended September
30, 2020. The increase of $26.9 million was primarily attributable to $17.1
million of personnel costs, which included $14.0 million in stock-based
compensation and an increase of $9.3 million of direct costs at the platform
companies as discussed below.



The $2.1 million increase in direct costs for PCN-101 was primarily due to an
increase of $1.2 million in clinical development costs, $0.6 million in drug
manufacturing costs, and $0.3 million in consulting and personnel related costs.



The $1.8 million increase in direct costs for DMX-1002 program was primarily due
to an increase of $1.0 million in clinical development cost, $0.5 million in
preclinical activities, $0.2 million in manufacturing, and $0.2 million increase
in personnel related costs.


The direct costs of $1.9 million for RL-007 program were $1.1 million in clinical development costs, $0.6 million of personnel related costs, which included $0.3 million of stock-based compensation expense and $0.2 million in manufacturing costs.

The $0.2 million decrease in direct costs for KUR-101 was primarily due to a decrease in manufacturing and control processes costs.

The direct costs for VLS-01 program were $1.6 million of manufacturing and control processes and other preclinical activities.

The direct costs for EMP-001 were $0.7 million of manufacturing and control processes costs and other preclinical activities.

The direct costs for RLS-01 were $0.6 million of manufacturing and control processes costs and other preclinical activities.

The direct costs for InnarisBio were $0.5 million of preclinical activities.

The decrease of $0.03 million in direct costs for EntheogeniX was primarily due to a $0.3 million decrease in data and analytical support costs, partially offset by a $0.27 million increase in manufacturing and control processes costs.

The direct costs for NN-01, which are from the date of acquisition in May 2021, were $0.4 million of clinical development and manufacturing costs.

During the nine months ended September 30, 2021, we did not incur any significant direct costs in association with IntroSpect, Psyber, or Psyprotix; direct costs associated with these programs were related to the ramp up of preclinical development and initial clinical-stage activities.









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Acquisition of In-Process Research and Development Expense



                                           Nine Months Ended September 30,
                                              2021                 2020          Change       % Change
                                                       (in thousands, except percentages)
Acquisition of in-process research and
development expense by
  program:
Neuronasal                                 $     7,962         $          -     $   7,962      100.0%
InnarisBio                                         972                    -           972      100.0%
Total acquisition of in-process research
and development
  expense                                  $     8,934$        120$   8,814     7345.0%




Acquisition of in-process research and development expenses was $9.0 million for
the nine months ended September 30, 2021, which was IPR&D acquired from
Neuronasal in May 2021 and InnarisBio in March 2021. Acquisition of in-process
research and development expenses was $0.1 million for the nine months ended
September 30, 2020, which was IPR&D acquired from Kures. The acquired IPR&D were
all considered to have no future alternative use.





General and Administrative Expenses




General and administrative expenses were $66.9 million for the nine months ended
September 30, 2021 compared to $8.7 million for the nine months ended September
30, 2020. The increase of $58.1 million, was attributable to $42.1 million of
personnel costs, which included $33.4 million of stock-based compensation, $11.8
million of professional fees, $1.9 million of insurance costs, and $2.3 million
other costs related to support of our platform growth and public company
requirements.





Interest Income



Interest income for the nine months ended September 30, 2021 and 2020 primarily
consisted of interest earned on our cash balances and notes receivable during
these periods. We had interest income for the nine months ended September 30,
2021 and 2020 of $80,000 and $57,000, respectively.





Change in Fair Value of Contingent Consideration Liability-Related Parties




The milestone and royalty payments in relation to the acquisition of Perception
Neuroscience were recorded at the acquisition date or at the exercise date
related to the call option, and is subsequently remeasured to fair value as of
September 30, 2021, resulting in an expense of $0.2 million and income of
$20,000 being recognized for the nine months ended September 30, 2021 and 2020,
respectively. The increase of $0.2 million was primarily attributable to
Perception's completion of its Phase 1 clinical trial in September 2020, which
increased the probability of the milestone event occurring, and a potential
license agreement with a third-party pharmaceutical company, which would include
an upfront payment and additional milestone payments. As the license agreement
had not been executed as of December 31, 2020, we used a probability weighted
approach for the royalty payments, where 80% was applied to the license scenario
and 20% was applied to the no-license scenario. At March 31, 2021, the license
transaction had closed and the scenario- based method with 80%/20% probability
was no longer used.



The milestone and royalty payments in relation to the acquisition of InnarisBio
were recorded at the acquisition date and is subsequently remeasured to fair
value as of September 30, 2021, resulting in an immaterial expense being
recognized for the nine months ended September 30, 2021 because there were no
material changes to any of the significant assumptions used that impacts the
fair value of the contingent liability.



Change in Fair Value of Short Term Notes Receivable-Related Party




Change in fair value of short term notes receivable with COMPASS for the nine
months ended September 30, 2020 was $0.7 million. The COMPASS notes were
converted during 2020. No change in fair value of short term notes receivable of
related parties was recognized for the nine months ended September 30, 2021.




Change in Fair Value of Convertible Promissory Notes




Change in fair value of convertible promissory notes for the nine months ended
September 30, 2020 was $14.0 million, which was primarily associated with the
change in fair value of our 2020 convertible notes, or the 2020 Notes. The
change in fair value of the 2020 Notes was primarily attributable to an increase
in the fair value of the underlying common stock in 2020 leading up to the
conversion of the



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convertible promissory notes into our common shares in November 2020. No changes
in fair value of convertible promissory notes were recognized for the nine
months ended September 30, 2021 as the 2020 Notes were converted in November
2020.




Change in Fair Value of Derivative Liability




Change in fair value of derivative liability was $41,000 for the nine months
ended September 30, 2021, compared to $(23,000) for the nine months ended
September 30, 2020. The $64,000 increase was primarily due to the additional
issuance of convertible promissory notes in January 2021 and the increased
probability of a potential licensing transaction with a third-party
pharmaceutical company and a decrease in the probability of a potential
preferred equity financing round.



Change in Warrant Liability



Change in fair value of warrant liability was $87,000 for the nine months ended
September 30, 2021. The warrant liability was recorded in connection with issued
and outstanding warrants to purchase shares of Neuronasal's common stock
acquired in connection with the acquisition of Neuronasal. The warrant liability
was recorded in connection with the May 2021 acquisition of Neuronasal.



Unrealized Loss on Other Investments Held at Fair Value




In May 2021, we received IntelGenx common stock, warrants and additional unit
warrants for a price of approximately $12.3 million. We determined that the
initial aggregate fair value is equal to the transaction price and recorded the
common shares at $3.0 million, the warrants at $1.2 million and the additional
unit warrants at $8.2 million on a relative fair value basis resulting in no
initial gain or loss recognized in the condensed consolidated statements of
operations. Subsequently, changes in fair value of the common shares, the
warrants and additional unit warrants are recorded as a component of other
income (expense), net in the condensed consolidated statement of operations.
During the nine months ended September 30, 2021, we recognized $5.5 million of
unrealized loss on other investments held at fair value.





Unrealized Gain on Other Investments




Unrealized gain on other investments for the nine months ended September 30,
2021 was zero compared to $19.9 million for the nine months ended September 30,
2020. The $19.9 million gain in 2020 mainly related to our remeasurement of our
investment in COMPASS' Series A preferred shares to fair value due to the
observable price change in connection with COMPASS' secondary Series A preferred
stock purchase in March 2020.




Loss on Conversion of Convertible Promissory Notes




Loss on conversion of convertible promissory notes for the nine months ended
September 30, 2021 was $0.5 million. In June 2021, upon the funding of the
Otsuka license and collaborative agreement, the Perception convertible
promissory notes were converted into Perception Series A preferred stock. The
loss represents the difference between (i) carrying value including derivative
liability of the Perception December 2020 Notes of $2.2 million and (ii) the
fair value of Perception Series A preferred stock into which the notes converted
of $2.7 million. There was no loss on conversion of convertible promissory notes
recorded in the nine months ended September 30, 2020.





Gain on Consolidation of a Variable Interest Entity




Gain on consolidation of a variable interest entity was $3.5 million for the
nine months ended September 30, 2021. We purchased additional shares of
Neuronasal in May 2021 and recognized a gain of $3.5 million. The gain was
calculated as the sum of the consideration paid of $1.0 million, the fair value
of the noncontrolling interest issued of $3.0 million, the carrying value of our
investments in Neuronasal's common stock and preferred stock prior to May 2021
of $0.8 million, less the fair value of identifiable net assets acquired of $8.3
million. The fair value of the IPR&D acquired of $8.3 million was charged to
research and development expense as it had no alternative future use at the time
of the acquisition. There was no gain on consolidation of a variable interest
entity recorded in the nine months ended September 30, 2020.





Foreign Exchange Gain (Loss), Net




Foreign exchange gain (loss), net was $5.4 million for the nine months ended
September 30, 2021 compared to $(0.2 million) for the nine months ended
September 30, 2020. The increase of $5.6 million was a result of the impact of
fluctuations in the foreign currency exchange rate between the Euro and the U.S.
dollar on our foreign exchange denominated balances.



Other Income (Expense), Net


Other expense, net for the nine months ended September 30, 2021 was $0.4 million, compared to $85,000 for the nine months ended September 30, 2020. The increase of $0.3 million was primarily related to interest expense.

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Income Tax



We incurred income tax expense of $0.4 million for the nine months ended
September 30, 2021. The income tax expense relates to book profits and thus
taxable profits generated in one of our United States subsidiaries. Given our
early stage development and lack of prior earnings history, we have a full
valuation allowance primarily related to German and overseas tax loss
carryforwards that we do not consider more likely than not to be realized. We
incurred an immaterial amount of income tax expense for the nine months ended
September 30, 2020.




Losses from Investments in Equity Method Investees




Losses from investment in equity method investees for the nine months ended
September 30, 2021 and 2020 were $9.4 million and $73.7 million, respectively.
Loss from investment in equity method investees represents our share of equity
method investee losses on the basis of our equity ownership percentages or based
on our proportionate share of the respective class of securities in our other
investments in the event that the carrying amount of our equity method
investments was zero.



Liquidity and Capital Resources

Sources of Liquidity




In June 2021, we completed our IPO and issued and sold 17,250,000 of our common
shares at a price to the public of $15.00 per share, including the exercise in
full by the underwriters of their option to purchase 2,250,000 additional common
shares. We received aggregate net proceeds of $231.6 million, after underwriting
discounts and commissions of $18.1 million and offering costs of $9.0 million.
Since our inception through September 30, 2021, sources of capital raised to
fund our operations were comprised of aggregate gross proceeds of $630.0 million
from sales of our common stock and convertible notes. As of September 30, 2021,
we had cash and cash equivalents of $430.3 million.





Convertible Promissory Notes



In November 2018, we issued an aggregate principal amount of $0.2 million of
convertible notes, or the 2018 Convertible Notes. The 2018 Convertible Notes are
non-interest-bearing and have a maturity date of September 30, 2025, unless
previously redeemed, converted, purchased or cancelled. In October 2020, we
issued an additional principal amount of $1.0 million of 2018 Convertible Notes.
Each note has a face value of €1 and is convertible into one ordinary share of
ATAI Life Sciences AG upon the payment of €17.00. In September 2021, several
investors agreed to convert their 2018 Convertible Notes into shares of ATAI
Life Sciences N.V. and paid an aggregate amount of €5.1 million or $6.0 million.
Concurrently, with the conversion of the 2018 Convertible Notes into ATAI Life
Sciences AG shares, the shares of ATAI Life Sciences AG that were issued to the
noteholders were exchanged for shares of ATAI Life Sciences N.V. through a
transfer and sale arrangement such that ATAI Life Sciences AG continued to
remain a wholly owned subsidiary of ATAI Life Sciences N.V and the transaction
was accounted for as an equity transaction that resulted in no gain or loss
recognition. The remaining convertible promissory notes balance as of September
30, 2021 was $0.8 million.





Investments



While a significant potential source of liquidity resides in our investment in
COMPASS ordinary shares, we do not expect that our investment in COMPASS will be
a material source of liquidity in the near term. Based on quoted market prices,
the market value of our ownership in COMPASS was $241.2 million as of September
30, 2021. As of September 30, 2021, the carrying value of our investment in
COMPASS was $15.1 million under the equity method. As a result of additional
ordinary shares issued by COMPASS in May 2021, including additional shares
purchased by us for an aggregate cost of $5.0 million, our ownership interest in
COMPASS was reduced to 19.4%.





Liquidity Risks



As of September 30, 2021, we had cash and cash equivalents of $430.3 million. We
believe that our cash and cash equivalents will be sufficient to fund our
projected operating expenses and capital expenditures through at least the next
12 months.



We expect to incur substantial additional expenditures in the near term to
support our ongoing activities. Additionally, we expect to incur additional
costs as a result of operating as a public company. We expect to continue to
incur net losses for the foreseeable future. Our ability to fund our product
development and clinical operations as well as commercialization of our product
candidates, will depend on the amount and timing of cash received from planned
financings.





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Our future capital requirements will depend on many factors, including:




?
the time and cost necessary to complete ongoing and planned clinical trials;
?
the outcome, timing and cost of meeting regulatory requirements established by
the FDA, the EMA and other comparable foreign regulatory authorities;
?
the progress, timing, scope and costs of our preclinical studies, clinical
trials and other related activities for our ongoing and planned clinical trials,
and potential future clinical trials;
?
the costs of commercialization activities for any of our product candidates that
receive marketing approval, including the costs and timing of establishing
product sales, marketing, distribution and manufacturing capabilities, or
entering into strategic collaborations with third parties to leverage or access
these capabilities;
?
the amount and timing of sales and other revenues from our product candidates,
if approved, including the sales price and the availability of coverage and
adequate third party reimbursement;
?
the cash requirements in purchasing additional equity from certain of our ATAI
companies upon the achievement of specified development milestone events;
?
the cash requirements of developing our programs and our ability and willingness
to finance their continued development;
?
the cash requirements of any future acquisitions or discovery of product
candidates; and
?
the time and cost necessary to respond to technological and market developments,
including other products that may compete with one or more of our product
candidates.



A change in the outcome of any of these or other variables with respect to the
development of any of our product candidates could significantly change the
costs and timing associated with the development of that product candidate.
Further, our operating plans may change in the future, and we may need
additional funds to meet operational needs and capital requirements associated
with such operating plans. 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."



Until such time, if ever, as we can generate substantial product revenue, we
expect to finance our operations through a combination of equity financings,
debt financings, collaborations with other companies or other strategic
transactions. We do not currently have any committed external source of funds.
Debt financing and preferred equity financing, if available, may involve
agreements that include covenants limiting or restricting our ability to take
specific actions, such as incurring additional debt, making acquisitions or
capital expenditures or declaring dividends. If we are unable to raise
additional funds through equity or debt financings or other arrangements when
needed, we may be required to delay, limit, reduce or terminate our product
development or future commercialization efforts or grant rights to develop and
market product candidates that we would otherwise prefer to develop and market
ourselves.



Further, our operating plans may change, and we may need additional funds to
meet operational needs and capital requirements for clinical trials and other
research and development activities. Because of the numerous risks and
uncertainties associated with the development and commercialization of our
product candidates, we are unable to estimate the amounts of increased capital
outlays and operating expenditures associated with our current and anticipated
product development programs.





Cash Flows



The following table summarizes our cash flows for nine months ended September
30, 2021 and 2020:



                                                       September 30,
                                                    2021          2020
                                                      (in thousands)
Net cash used in operating activities             $ (42,737 )$ (14,552 )
Net cash used in investing activities               (32,643 )     (24,405 )
Net cash provided by financing activities           408,139        31,072
Effect of foreign exchange rate changes on cash         303           533
Net increase (decrease) in cash                   $ 333,062$  (7,352 )










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Net Cash Used in Operating Activities




Net cash used in operating activities was $42.7 million for the nine months
ended September 30, 2021, which consisted of a net loss of $81.0 million,
adjusted by non-cash charges of $46.1 million and net cash outflows from the
change in operating assets and liabilities of $7.9 million. The non-cash charges
primarily consisted of $50.0 million of stock-based compensation, $8.9 million
of IPR&D considered to have no future alternative use, $9.4 million of losses
from our equity method investments, $8.3 million of unrealized foreign exchange
gains and $5.5 million of unrealized loss on other investments held at fair
value and partially offset by $16.9 million of gain on investment dilution. The
net cash outflows from the change in operating assets and liabilities were
primarily due to a $9.4 million increase in prepaid expenses and a $1.7 million
decrease in accounts payable, partially offset by a $3.3 million increase in
accrued liabilities and $0.1 million increase in deferred revenue.



Net cash used in operating activities was $14.6 million in the nine months ended
September 30, 2020, which consisted of a net loss of $84.3 million, adjusted by
non-cash adjustments of $69.3 million and net cash inflows from the change in
operating assets and liabilities of $0.4 million. The non-cash charges primarily
consisted of $19.9 million of unrealized gains on other investments associated
with COMPASS, $0.7 million related to the change in the fair value of short term
note receivable with a related party, offset by $73.7 million of losses from
investments in equity method investees, $14.0 million related to the change in
the fair value of convertible promissory notes, $2.2 million of stock-based
compensation expense, and $0.1 million of IPR&D considered to have no future
alternative use. The net cash inflows from the change in operating assets and
liabilities were primarily due to a $1.5 million increase in accounts payable
and accrued liabilities, offset by a $1.1 million increase in prepaid expenses.




Net Cash Used in Investing Activities




Net cash used in investing activities was $32.6 million for the nine months
ended September 30, 2021, primarily driven by additional investments of $23.7
million in our other investments, $5.4 million additional investments into
equity-method investees, $2.6 million of loans to related parties, $0.7 million
of capitalized internal-use software development costs, $0.1 million of
purchases of property and equipment, and $0.3 million of purchase of other
assets.



Net cash used in investing activities was $24.4 million in the nine months ended
September 30, 2020, primarily driven by additional investments of $23.2 million
in our other investments and $1.2 million of long term notes receivable
additional investments.




Net Cash Provided by Financing Activities




Net cash provided by financing activities was $408.1 million for the nine months
ended September 30, 2021, primarily due to $409.9 million of net proceeds from
the issuance of our common stock, $6.1 million of proceeds from conversion of
convertible notes to common stock, $2.4 million of proceeds from our sale of
Innoplexus AG investments treated as a secured financing, and $1.6 million of
proceeds from the issuance of convertible promissory notes. The net cash influx
was offset by $12.4 million paid for common stock issuance costs.



Net cash provided by financing activities was $31.1 million in the nine months
ended September 30, 2020, primarily due to $31.1 million from the issuance of
convertible promissory notes.





Indebtedness



Convertible Notes


Between November 2018 and September 2021, we issued an aggregate of $34.3 million of convertible notes.




In November 2018, we issued an aggregate principal amount of $0.2 million of
convertible notes, or the 2018 Convertible Notes. The 2018 Convertible Notes are
non-interest-bearing and have a maturity date of September 30, 2025, unless
previously redeemed, converted, purchased or cancelled. In October 2020, we
issued an additional principal amount of $1.0 million of 2018 Convertible Notes.
Each note has a face value of €1 and is convertible into one ordinary share of
ATAI Life Sciences AG upon the payment of €17.00. Conversion rights may be
exercised by a noteholder at any time prior to maturity, except during certain
periods subsequent to the consummation of the IPO. In September 2021, several
noteholders elected to convert their convertible promissory notes into shares of
ATAI Life Sciences N.V. These investors paid €17.00 per share for the aggregate
amount of €5.1 million or $6.0 million in order to convert their convertible
promissory notes into ATAI Life Sciences AG common shares, which was in
accordance with the original terms of the 2018 Convertible Note Agreements.
Concurrent, with the conversion of the 2018 Convertible Notes into ATAI Life
Sciences AG shares, the shares of ATAI Life Sciences AG that were issued to the
noteholders were exchanged for 4,838,176 shares of ATAI Life Sciences N.V.
through a transfer and sale arrangement such that ATAI Life Sciences AG
continued to remain a wholly owned subsidiary of ATAI Life Sciences N.V and the
transaction was accounted for as an equity transaction that resulted in no gain
or loss recognition. As of September 30, 2021 an aggregate principal amount of
$0.8 million remaining outstanding under the 2018 Convertible Notes.





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During the year ended December 31, 2020, we issued an aggregate of $30.4 million
of the 2020 Notes. The 2020 Notes accrue interest at a rate of 5% per annum and
have a maturity date of January 31, 2022, unless previously redeemed, converted,
purchased or cancelled. The 2020 Notes are convertible upon mandatory conversion
events into shares of ATAI Life Sciences N.V., subject to certain dilution
adjustments. In November 2020, all of the outstanding principal and accrued
interest under the 2020 Notes was automatically converted into shares of common
stock.



In March 2020, we received proceeds of $0.6 million from the issuance of
Perception Notes, as defined below, to third party investors. In December 2020,
January 2021, and May 2021 we received $0.4 million, $0.8 million, and $0.8
million respectively, in proceeds from the issuance of additional Perception
Notes. The Perception Notes are convertible upon mandatory conversion events
into shares of Perception. As of June 30, 2021 and December 31, 2020, $0 million
and $1.0 million, respectively, of the Perception Notes remained outstanding.





Promissory Note



In December 2019, we executed a promissory note payable to DemeRx IB whereby we
agreed, under a contribution agreement and a Series A Preferred Stock Purchase
Agreement, or the DemeRx IB SPA, to make aggregate payments to DemeRx IB of up
to $17.0 million upon the achievement of specified clinical and regulatory
milestones. As of September 30, 2021, we had made aggregate payments of $10.0
million pursuant to the DemeRx IB SPA.





Investment in Convertible Promissory Notes-Related Party




On May 15, 2019, we purchased convertible promissory notes from Kures, or the
Kures Notes, in an aggregate principal amount of $0.1 million that earned
interest at an annual rate of 5% and matured on December 31, 2019. We qualified
for and elected the fair value option. All principal and interest accrued under
the Kures Notes was converted into shares of Series A-1 preferred stock in
connection with Kures' sale of Series A-1 preferred stock in August 2019.



On September 27, 2019, we purchased convertible promissory notes from COMPASS
for a total principal amount of $4.0 million, and on November 6, 2019, we
purchased an additional convertible promissory note for $4.2 million, together,
the COMPASS Notes. The COMPASS Notes bear interest at an annual rate of 3%,
which was considered contingent in nature and therefore no earned interest was
recorded. We qualified for and elected the fair value option. All principal
amounts under the COMPASS Notes were converted into shares of Series B preferred
stock in connection with COMPASS' sale of Series B preferred stock in April
2020.



On March 16, 2020, Perception Neuroscience entered into a convertible promissory
note agreement with us and certain other unrelated investors, or the Perception
Note Purchase Agreement, pursuant to which Perception Neuroscience issued $3.9
million in principal amount of convertible notes in aggregate. Under the
Perception Note Purchase Agreement, Perception Neuroscience issued convertible
notes, or the Perception Notes, in the aggregate principal amount of $3.3
million to us and $0.6 million to other investors, including related parties.
The Perception Notes bear interest at an annual rate of 5% and are due and
payable on June 30, 2022 unless earlier converted. In December 2020, Perception
Neuroscience issued additional convertible notes to us, certain related parties
and third party investors in the aggregate principal amount of $7.0 million, of
which $5.8 million was issued to us and $1.2 million was issued to other
investors, including related parties. In May 2021, Perception Neuroscience
issued additional convertible notes to us, certain related parties and third
party investors in the aggregate principal amount of $5.0 million, of which $4.2
million was issued to us and $0.8 million was issued to other investors,
including related parties, as part of its second tranche funding. The notes bear
interest at an annual rate of 5% and are due and payable on February 28, 2022,
unless earlier converted. Perception Neuroscience may not prepay in whole or in
part without our consent. In June 2021, the convertible promissory notes were
converted.



In January 2021, pursuant to the Perception Note Purchase Agreement, Perception
issued an aggregate principal amount of $0.8 million to other investors,
including related parties, as part of its first tranche funding. Pursuant to the
Perception Note Purchase Agreement, an additional $5.0 million under the second
tranche funding was issued in May 2021. In June 2021, Perception received
proceeds of $20.0 million pursuant to the licensing and collaboration
arrangement between Perception and Otsuka Pharmaceutical Co., LTD. Upon receipt
of the proceeds, the convertible promissory notes automatically converted into
6,456,595 shares of Series A preferred stock of Perception pursuant to their
original terms.




Contractual Obligations and Commitments




We have entered into other contracts in the normal course of business with
certain CROs, CMOs and other third parties for preclinical research studies and
testing, clinical trials and manufacturing services. These contracts do not
contain any minimum purchase commitments and are cancelable by us upon written
notice. Payments due upon cancellation consist only of payments for services
provided and expenses incurred, including noncancelable obligations of our
service providers, up to the date of cancellation. The amounts and timing of
such payments are not known.



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In addition, under various licensing and related agreements to which we are a
party, we are obligated to pay annual license maintenance fees and may be
required to make milestone payments and to pay royalties and other amounts to
third parties. The payment obligations under these agreements are contingent
upon future events, such as our achievement of specified milestones or
generating product sales, and the amount, timing and likelihood of such payments
are not known. Such contingent payment obligations are described below. For
additional information regarding our license agreements described below, see
Note 15 to our condensed consolidated financial statements included elsewhere in
this Quarterly Report.




Columbia Stock Purchase Agreement




In June 2020, Kures and Columbia entered into a stock purchase agreement, or the
Kures SPA. Pursuant to the Kures SPA, Kures can, from time to time, issue to
Columbia additional shares of Kures' common stock, at a per share price equal to
the then fair market value of each such share, and shall be deemed to have been
paid in partial consideration for the execution, delivery and performance by
Columbia of the Kures License Agreement. If Kures proposes to sell any equity
securities or securities convertible into equity securities, Columbia will have
the right to purchase up to 5% of such securities. These rights shall terminate
upon the occurrence of an IPO, if Kures becomes subject to periodic reporting
requirements under Section 12(g) or 15(d) of the Exchange Act or certain
liquidation events. Columbia also has certain co-sale rights. At the acquisition
date, we recorded the fair value of the shares of Kures common stock issued to
Columbia of $0.1 million to our additional-paid-in-capital and a debit to
research and development expense.





GABA Preferred Stock Purchase Agreement




We entered into the Preferred Stock Purchase Agreement, or the GABA PSPA, in
August 2019 with GABA Therapeutics LLC, and purchased shares of Series A
preferred stock of GABA at a price of approximately $5.5 million. In addition,
pursuant to the GABA PSPA, we are obligated to purchase additional shares of
Series A preferred stock, at the same price as the original transaction, for up
to $10.0 million, upon the achievement of specified contingent development
milestones.



In October 2020, we entered into an Omnibus Amendment Agreement, or the GABA
Omnibus Amendment Agreement, with GABA and GABA Therapeutics LLC under which the
Right of First Refusal and Co-Sale Agreement was amended. Pursuant to the GABA
Omnibus Amendment, GABA Therapeutics LLC granted us the right to purchase
additional shares of common stock of GABA held by GABA Therapeutics LLC at the
call option purchase price of $1.8 million. In November 2020, we exercised the
call option and made a cash contribution of $1.8 million in exchange for
additional shares of common stock of GABA.



In April 2021, pursuant to the GABA PSPA, we purchased additional shares of Series A preferred stock of GABA for an aggregate cost of $5.0 million based on the achievement of certain development milestones.




In May 2021, we purchased additional shares of Series A preferred stock prior to
the achievement of certain development milestones for an aggregate cost of $5.0
million. The GABA PSPA terminates upon the occurrence of certain liquidation
events.



In May 2021, we, GABA and GABA Therapeutics LLC entered into an Amendment
Agreement under which the GABA PSPA was amended. Pursuant to the Amendment
Agreement, we purchased additional shares of GABA Series A preferred stock at a
price of approximately $0.6 million. We are obligated to purchase additional
shares of GABA Series A preferred stock for up to $1.5 million with the same
price per share as our initial investment and additional shares of GABA common
stock for up to $1.0 million upon the achievement of specified contingent
development milestones.



Further in accordance with the GABA PSPA, we have the option but not the
obligation to purchase the aforementioned additional shares of Series A
preferred stock at any time prior to the achievement of any of the specified
milestones. Additionally, we have the Right of First Refusal and Co-Sale
Agreement with GABA Therapeutics LLC, under which we have the option but not the
obligation to purchase shares of common stock for up to $2.0 million from the
existing common shareholders.



As of September 30, 2021, we had made aggregate payments of $15.5 million pursuant to the GABA PSPA, $1.8 million pursuant to the GABA Omnibus Amendment Agreement and $0.6 million pursuant to the Amendment Agreement.

Neuronasal Preferred Stock Purchase Agreement




Under our Preferred Stock Purchase Agreement, or the Neuronasal PSPA, and the
Secondary Sale and Put Right Agreement, or the Neuronasal Secondary Sale
Agreement, entered with Neuronasal in December 2019, we are obligated to
purchase additional shares of Series A preferred stock from Neuronasal, and
shares of common stock from the existing common shareholders, at the same price
as the original transaction, at a purchase price of approximately $3.8 million,
upon the achievement of specified contingent clinical development milestones.



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In October 2020, pursuant to the Neuronasal PSPA, we purchased additional Series
A preferred shares at a price of approximately $0.8 million upon the achievement
of a specified contingent clinical development milestone.



In March 2021, pursuant to the Neuronasal PSPA and the Neuronasal Secondary Sale Agreement, we purchased additional Series A preferred shares and additional common shares for an aggregate of approximately $1.1 million based on the achievement of certain development milestones.




In May 2021, pursuant to the Neuronasal PSPA and the Neuronasal Secondary Sale
Agreement, we exercised our option to purchase additional Series A preferred
shares for an aggregate of approximately $1.0 million.



Under the Neuronasal PSPA, we have the option but not the obligation to purchase
additional shares of Series A preferred stock, at the same price as the original
transaction, at a purchase price of up to approximately $1.0 million upon
achievement of certain contingent clinical development milestones by a specified
date. Additionally, pursuant to the Neuronasal Secondary Sale Agreement, upon
the achievement of certain development milestones, existing common shareholders
have the right to sell and we have the option but not the obligation to purchase
additional shares of common stock at a price determined based on the fair market
value per share. These options are contingent only upon the exercise of the
options of the common shareholders.



Additionally, under the Neuronasal PSPA, we have a right of first offer, which
requires Neuronasal to first offer us new securities it proposes to sell. The
Neuronasal PSPA terminates upon the occurrence of certain liquidation events.
The Neuronasal Secondary Sale Agreement terminates when shares of Neuronasal are
no longer held by us or our affiliates, Neuronasal consummates a sale of its
securities pursuant to a registration statement or the consummation of certain
mergers or consolidations.


As of September 30, 2021, we had made aggregate payments of $3.7 million pursuant to this agreement.

Kures Preferred Stock Purchase Agreement




We entered into the Preferred Stock Purchase Agreement, or the Kures PSPA, in
August 2019 with Kures, where we purchased shares of Series A-1 preferred stock
of Kures for an aggregate purchase price of $3.5 million. The Kures PSPA
provided us with control of Kures' board of directors, resulting in us having
unilateral rights to control all decisions related to the significant activities
of Kures. In connection with the Kures PSPA, we are required to purchase up to
approximately $5.5 million of Series A-2 preferred stock upon the achievement of
specified clinical milestones. The Kures PSPA also contains a call option, such
that we have the right, but not the obligation, to purchase up to a certain
number of shares of Series B preferred stock upon the achievement of specified
clinical milestones. As of September 30, 2021, we have not exercised our option
to purchase any shares of Series B preferred stock of Kures.



As of September 30, 2021, we had made aggregate payments of $3.5 million pursuant to the Kures PSPA.

Perception Preferred Stock Purchase Agreement




We formed ATAI US 2, Inc., or ATAI US 2, an entity formed for the sole purpose
of effecting the acquisition and a wholly owned subsidiary of Perception,
entered into a series of transactions to acquire 100% of the equity of
Perception Neuroscience, a pre-clinical stage biotech company. In connection
with the Perception SPA and the Rollover Agreement between us, Perception and
Perception Neuroscience, Perception acquired the outstanding common shares of
Perception Neuroscience, or the Rollover Shares, in exchange for aggregate
consideration which consisted of (i) a $4.0 million cash payment by Perception
at closing ($4.6 million purchase price, less transaction costs of Perception
Neuroscience assumed by Perception of $0.6 million), (ii) contingent
consideration payable to a founder of Perception Neuroscience of $2.4 million
based on the achievement of certain development milestones and royalties on
future revenues and (iii) issuance of Class B common shares of Perception to the
founders of Perception Neuroscience, representing a 100% interest in the common
equity of Perception. In connection with the Perception SPA, we are required to
make milestone payments and sub-single-digit royalty payments to a founder of
Perception Neuroscience upon the achievement of certain development milestones
and royalties on future revenues. Also, in connection with the Perception SPA,
Perception entered into a call option agreement with one of the founders of
Perception Neuroscience, whereby Perception was granted an option to repurchase
2,350,000 shares of its Class B common stock from the founder. Upon the exercise
of the call option, the other founder was entitled to receive a contingent
consideration payment.



In connection with the acquisition of Perception Neuroscience by Perception and,
ultimately, ATAI US 2, and pursuant to the Perception Preferred Stock Purchase
Agreement or Perception PSPA, we purchased shares of Perception's Series A
preferred stock for approximately $9.5 million. The Perception PSPA provided us
with control of Perception's board of directors, resulting in us having
unilateral rights to control all decisions related to the significant activities
of Perception. Pursuant to a Secondary Perception Preferred Stock Purchase
Agreement, we sold shares of Series A preferred stock to secondary investors for
approximately $1.6 million in November and December of 2018 under the same terms
and conditions of the original purchase. In addition, under the Perception PSPA,
Perception



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was granted the option to sell, and we had the obligation to purchase additional
shares of Perception Series A preferred stock at a price equal to Perception
PSPA purchase price upon the exercise of the call option. In April 2019,
Perception exercised the call option with the founder resulting in the
redemption and cancellation of Perception Class B common shares. The exercise of
the call option and the related purchase of the noncontrolling interest resulted
in a cash payment of $1.0 million.



As of September 30, 2021, we had made aggregate payments of $4.0 million pursuant to the Perception SPA and $10.5 million pursuant to the Perception PSPA.






DemeRx NB Options



We entered into a Series A Preferred Stock Purchase Agreement, or the DemeRx NB
PSPA, pursuant to which we purchased shares of Series A Preferred Stock of
DemeRx NB at a purchase price of $1.0 million. In accordance with the DemeRx NB
PSPA, we also have the option but not the obligation to purchase additional
shares of Series A preferred stock at a purchase price of up to $19.0 million.
As of June 30, 2021, we have not exercised our option to purchase any shares of
Series A preferred stock of DemeRx NB. The DemeRx NB PSPA can be terminated with
the written consent of all parties.



As of September 30, 2021, we had made aggregate payments of $1.0 million pursuant to the DemeRx NB PSPA.

DemeRx IB Preferred Stock Purchase Agreement




In December 2019, we entered into the DemeRx IB SPA, pursuant to which we
purchased shares of Series A Preferred Stock of DemeRx IB in exchange for an
initial payment of $5.0 million in cash and a promissory note issued by us
payable to DemeRx IB. Under the promissory note, we agreed to make aggregate
payments to DemeRx IB of up to $17.0 million upon the achievement of specified
clinical and regulatory milestones. As of September 30, 2021, we had made
aggregate payments of $0 million pursuant to the DemeRx IB SPA.



Further, in connection with the promissory note issued, we pledged and assigned
to DemeRx IB a portion of shares of our Series A preferred stock of DemeRx IB,
or the Pledged Shares, as security under the promissory note. The Pledged Shares
have voting and all other rights until an event of default occurs where we fail
to make a payment when due. In the event of default, a pro rata portion of the
Pledged Shares will automatically be surrendered and be deemed forfeited and
canceled.




Recognify Preferred Stock Purchase Agreement




We entered into the Preferred Stock Purchase Agreement, or the Recognify PSPA,
in November 2020 with Recognify, where we purchased shares of Series A preferred
stock of Recognify at a purchase price of $2.0 million. In addition, pursuant to
the Recognify PSPA, we agreed to make aggregate payments to Recognify of up to
$18.0 million upon the achievement of specified clinical and regulatory
milestones to complete the purchase of the shares and provide additional funding
to Recognify. In connection with the Recognify PSPA for additional funding,
Recognify issued the corresponding Series A preferred shares to the us provided
that the shares, or the Escrow Shares, were held in an escrow account. The
Escrow Shares will be released, from time to time, to us upon Recognify
achieving certain milestones as defined in the Recognify PSPA with cash payments
to be made by us.



In addition, we have the right, but not the obligation, to make payment for the
certain Escrow Shares at any time, regardless of the achievement of any
milestones. The Escrow Shares have voting and all other rights until an event of
default occurs where we fail to make a payment within 10 days following the
written notice of the achievement of the relevant milestone. In the event of
default, a pro rata portion of the Escrow Shares will automatically be
surrendered and be deemed forfeited and canceled, and could result in us losing
control of Recognify's board of directors and our controlling financial interest
in Recognify.


In May 2021, pursuant to the Recognify PSPA, we purchased additional shares of Series A preferred stock prior to the achievement of certain development milestone for an aggregate cost of $0.5 million.

In September 2021, pursuant to the Recognify PSPA, we purchased additional shares of Series A preferred stock prior to the achievement of certain development milestone for an aggregate cost of $0.3 million.

As of September 30, 2021, we had made aggregate payments of $2.8 million pursuant to the Recognify PSPA.

EntheogeniX License Agreement




In November 2019, EntheogeniX entered into a license agreement with Cyclica
relating to EntheogeniX's drug discovery and development initiatives. Pursuant
to the agreement, EntheogeniX obtained a limited, non-transferable, and
non-exclusive right, solely for the term of the agreement, to access and use
Cyclica's hosted and cloud-based software platforms, solely for the purposes of
screening



                                       77
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certain compounds generated by Cyclica pursuant to the license agreement. Upon
execution of the agreement, EntheogeniX paid Cyclica an upfront service fee of
$0.1 million. In addition, EntheogeniX is obligated to make aggregate milestone
payments to Cyclica of up to $0.3 million upon the achievement of specified
development milestones. The term of the license agreement will continue for the
life of EntheogeniX and may only be terminated by either party following a
non-curable material breach of the shareholders agreement between Cyclica and
EntheogeniX.



In September 2021, we executed an amendment to the license agreement between
ATAI and EntheogeniX, in which we agreed to purchase 500,000 shares of Class A
common stock for an aggregate purchase price of $0.5 million. As a result of
anti-dilution protection available to Cyclica, our ownership in EntheogeniX did
not change due to the Class A common stock purchase





PsyProtix Purchase Agreement




In February 2021, we jointly formed PsyProtix with Chymia, LLC, or Chymia.
PsyProtix was created for the purpose of exploring and developing a
metabolomics-based precision psychiatry approach, initially targeting the
stratification and treatment of TRD patients. In February 2021, pursuant to a
Series A Preferred Stock Purchase Agreement, or the PsyProtix Purchase
Agreement, we acquired shares of PsyProtix's Series A preferred stock in
exchange for an initial payment of $0.1 million in cash. In addition, pursuant
to the PsyProtix Purchase Agreement, we agreed to make aggregate payments to
PsyProtix of up to $4.9 million upon the achievement of specified clinical
milestones to complete the purchase of the shares and provide additional funding
to PsyProtix.





Psyber Purchase Agreement



In February 2021, pursuant to a Series A Preferred Stock Purchase Agreement, or
the Psyber Purchase Agreement, we acquired shares of Psyber's Series A preferred
stock in exchange for an initial payment of $0.2 million in cash. In addition,
pursuant to the Psyber Purchase Agreement, we agreed to make aggregate payments
to Psyber of up to $1.8 million upon the achievement of specified clinical
milestones to complete the purchase of the shares and provide additional funding
to Psyber. In July 2021, we purchased additional Series A preferred shares from
Psyber for an aggregate cost of $0.7 million upon the achievement of specified
clinical milestones.




InnarisBio Preferred Stock Purchase Agreement




In February 2021, we jointly formed InnarisBio with UniQuest Pty Ltd, or
UniQuest, for the purpose of adding a solgel-based direct-to-brain intranasal
drug delivery technology to our platform. In March 2021, pursuant to a Series A
Preferred Stock Purchase Agreement, or the InnarisBio Purchase Agreement, we
acquired shares of InnarisBio's Series A preferred stock in exchange for an
initial payment of $1.1 million in cash. In addition, pursuant to the InnarisBio
Purchase Agreement, we agreed to make aggregate payments to InnarisBio of up to
$3.9 million upon the achievement of specified clinical milestones to complete
the purchase of the shares and provide additional funding to InnarisBio.



For additional information regarding our contingent commitments and future put rights or options associated with our investments, see Note 5 to our consolidated financial statements included elsewhere in this Quarterly Report.

Off-Balance Sheet Arrangements

As of September 30, 2021, we did not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of Regulation S-K. While we have investments classified as VIEs, their purpose is not to provide off-balance sheet financing.

Recent Accounting Pronouncements

See Note 2, "Summary of Significant Accounting Policies-Recently Adopted Accounting Pronouncements" to our unaudited condensed consolidated financial statements appearing under Part 1, Item 1 for more information.

Critical Accounting Policies and Estimates




There have been no significant changes to our critical accounting policies from
our disclosure reported in "Critical Accounting Policies and Estimates" in the
section titled "Management's Discussion and Analysis of Financial Condition and
Results of Operations" in our Prospectus.





JOBS Act



We are an emerging growth company, as defined in the JOBS Act. We intend to rely
on certain of the exemptions and reduced reporting requirements provided by the
JOBS Act. As an emerging growth company, we are not required to, among other
things, (i) provide an auditor's attestation report on our system of internal
controls over financial reporting pursuant to Section 404(b) of the



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Sarbanes-Oxley Act, and (ii) comply with any requirement that may be adopted by
the Public Company Accounting Oversight Board regarding mandatory audit firm
rotation or a supplement to the auditor's report providing additional
information about the audit and the financial statements (auditor discussion and
analysis). We have elected to use the extended transition period for complying
with new or revised accounting standards that have different effective dates for
public and private companies until the earlier of the date that (i) we are no
longer an emerging growth company or (ii) we affirmatively and irrevocably opt
out of the extended transition period provided in the JOBS Act. As a result, our
consolidated financial statements may not be comparable to companies that comply
with the new or revised accounting pronouncements as of public company effective
dates.



As described in Note 2 to our condensed consolidated financial statements
included elsewhere in this Quarterly Report, we have early adopted accounting
standards, as the JOBS Act does not preclude an emerging growth company from
adopting a new or revised accounting standard earlier than the time that such
standard applies to private companies. We expect to use the extended transition
period for any other new or revised accounting standards during the period in
which we remain an emerging growth company.



We will remain an emerging growth company until the earliest to occur of: (1)
the last day of the fiscal year (a) following the fifth anniversary of the
completion of our initial public offering, or December 31, 2026, (b) in which we
have total annual gross revenues of $1.07 billion or more, or (c) in which we
are deemed to be a large accelerated filer under the rules of the SEC, which
means the market value of our outstanding common stock held by non-affiliates
exceeds $700 million as of last business day of our most recently completed
second fiscal quarter, and (2) the date on which we have issued more than $1.0
billion in nonconvertible debt during the previous three years.



Further, even after we no longer qualify as an emerging growth company, we may
still qualify as a "smaller reporting company," which would allow us to take
advantage of many of the same exemptions from disclosure requirements, including
reduced disclosure obligations regarding executive compensation in our periodic
reports and proxy statements. We cannot predict if investors will find our
common shares less attractive because we may rely on these exemptions. If some
investors find our common shares less attractive as a result, there may be a
less active trading market for our common shares and our share price may be more
volatile.





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