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M
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2021 or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from __________ to __________
Commission File Number: 001-40493
ATAI Life Sciences N.V.
(Exact name of registrant as specified in its charter)
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The Netherlands |
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Not Applicable |
(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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ATAI Life Sciences N.V. c/o Mindspace Krausenstraße 9-10 Berlin, Germany |
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Not Applicable |
(Address of principal executive offices) |
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(Zip Code) |
+49 89 2153 9035
(Registrant’s telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common shares, par value €0.10 per share |
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ATAI |
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The Nasdaq Stock Market LLC (Nasdaq Global Market) |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of November 1, 2021, the registrant had 160,297,952 common shares, par value €0.10 per share, outstanding.
ATAI Life Sciences N.V.
FORM 10-Q
Table of Contents
i
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
The Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021 (this “Quarterly Report”) 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 of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this Quarterly Report other than statements of historical fact, including statements regarding our future operating results and financial position, the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones, the commercialization of our current product candidates and any other product candidates we may identify and pursue, if approved, including our ability to successfully build a specialty sales force and commercial infrastructure to market our current product candidates and any other product candidates we may identify and pursue, the timing of and our ability to obtain and maintain regulatory approvals, our business strategy and plans, potential acquisitions, and the plans and objectives of management for future operations and capital expenditures, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidate, and if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus dated June 17, 2021 (the "Prospectus"), filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.
Any forward-looking statements made herein speak only as of the date of this Quarterly Report, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this Quarterly Report on Form 10-Q or to conform these statements to actual results or revised expectations.
GENERAL
Unless the context otherwise requires, all references in this Quarterly Report to “we,” “us,” “our,” “ATAI” or the “Company” refer to ATAI Life Sciences N.V. and its consolidated subsidiaries.
1
All reports we file with the SEC are available for download free of charge via the Electronic Data Gathering Analysis and Retrieval (EDGAR) System on the SEC’s website at www.sec.gov. We also make electronic copies of our reports available for download, free of charge, through our investor relations website at ir.atai.life as soon as reasonably practicable after filing such material with the SEC.
We may announce material business and financial information to our investors using our investor relations website at ir.atai.life. We therefore encourage investors and others interested in ATAI to review the information that we make available on our website, in addition to following our filings with the SEC, webcasts, press releases and conference calls. Information contained on our website is not part of this Quarterly Report.
2
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
430,308 |
|
|
$ |
97,246 |
|
Prepaid expenses and other current assets |
|
|
11,551 |
|
|
|
2,076 |
|
Short term notes receivable - related party |
|
|
— |
|
|
|
226 |
|
Total current assets |
|
|
441,859 |
|
|
|
99,548 |
|
Property and equipment, net |
|
|
138 |
|
|
|
71 |
|
Deferred offering costs |
|
|
— |
|
|
|
1,575 |
|
Equity method investments |
|
|
15,086 |
|
|
|
— |
|
Other investments held at fair value |
|
|
6,816 |
|
|
|
— |
|
Other investments |
|
|
14,256 |
|
|
|
8,044 |
|
Long term notes receivable |
|
|
908 |
|
|
|
911 |
|
Long term notes receivable - related parties |
|
|
3,784 |
|
|
|
1,060 |
|
Other assets |
|
|
1,262 |
|
|
|
339 |
|
Total assets |
|
$ |
484,109 |
|
|
$ |
111,548 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,974 |
|
|
$ |
3,083 |
|
Accrued liabilities |
|
|
13,075 |
|
|
|
9,215 |
|
Current portion of contingent consideration liability - related parties |
|
|
50 |
|
|
|
— |
|
Deferred revenue |
|
|
180 |
|
|
|
— |
|
Short-term notes payable |
|
|
38 |
|
|
|
— |
|
Total current liabilities |
|
|
15,317 |
|
|
|
12,298 |
|
Non-current portion of contingent consideration liability - related parties |
|
|
1,947 |
|
|
|
1,705 |
|
Convertible promissory notes - related parties, net of discounts and deferred issuance costs |
|
|
800 |
|
|
|
1,199 |
|
Convertible promissory notes and derivative liability (including a related party convertible promissory note and derivative liability of $0 million and $0.3 million at September 30, 2021 and December 31, 2020, respectively) |
|
|
— |
|
|
|
978 |
|
Other liabilities |
|
|
3,285 |
|
|
|
— |
|
Total liabilities |
|
|
21,349 |
|
|
|
16,180 |
|
Commitments and contingencies (Note 15) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, €0.10 par value ($0.12 par value at September 30, 2021 and December 31, 2020, respectively); 750,000,000 and 173,116,704 shares authorized at September 30, 2021 and December 31, 2020, respectively; 159,657,952 and 114,735,712 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively |
|
|
17,870 |
|
|
|
13,372 |
|
Additional paid-in capital |
|
|
709,475 |
|
|
|
261,626 |
|
Accumulated other comprehensive income (loss) |
|
|
(5,233 |
) |
|
|
5,819 |
|
Accumulated deficit |
|
|
(268,926 |
) |
|
|
(189,995 |
) |
Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders |
|
|
453,186 |
|
|
|
90,822 |
|
Noncontrolling interests |
|
|
9,574 |
|
|
|
4,546 |
|
Total stockholders’ equity |
|
|
462,760 |
|
|
|
95,368 |
|
Total liabilities and stockholders’ equity |
|
$ |
484,109 |
|
|
$ |
111,548 |
|
See accompanying notes to the unaudited condensed consolidated financial statements
3
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
|
September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
License revenue |
|
$ |
266 |
|
|
$ |
— |
|
|
|
$ |
20,146 |
|
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
13,363 |
|
|
|
3,058 |
|
|
|
|
34,974 |
|
|
|
|
8,056 |
|
Acquisition of in-process research and development |
|
|
— |
|
|
|
— |
|
|
|
|
8,934 |
|
|
|
|
120 |
|
General and administrative |
|
|
20,264 |
|
|
|
4,328 |
|
|
|
|
66,868 |
|
|
|
|
8,749 |
|
Total operating expenses |
|
|
33,627 |
|
|
|
7,386 |
|
|
|
|
110,776 |
|
|
|
|
16,925 |
|
Loss from operations |
|
|
(33,361 |
) |
|
|
(7,386 |
) |
|
|
|
(90,630 |
) |
|
|
|
(16,925 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
8 |
|
|
|
19 |
|
|
|
|
80 |
|
|
|
|
57 |
|
Change in fair value of contingent consideration liability - related parties |
|
|
469 |
|
|
|
86 |
|
|
|
|
(191 |
) |
|
|
|
20 |
|
Change in fair value of short term notes receivable - related party |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
718 |
|
Change in fair value of convertible promissory notes |
|
|
— |
|
|
|
(13,867 |
) |
|
|
|
— |
|
|
|
|
(14,000 |
) |
Change in fair value of derivative liability |
|
|
— |
|
|
|
(10 |
) |
|
|
|
41 |
|
|
|
|
(23 |
) |
Change in fair value of warrant liability |
|
|
47 |
|
|
|
— |
|
|
|
|
87 |
|
|
|
|
— |
|
Unrealized loss on other investments held at fair value |
|
|
(70 |
) |
|
|
— |
|
|
|
|
(5,530 |
) |
|
|
|
— |
|
Unrealized gain on other investments |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
19,856 |
|
Loss on conversion of convertible promissory notes |
|
|
— |
|
|
|
— |
|
|
|
|
(513 |
) |
|
|
|
— |
|
Gain on consolidation of a variable interest entity |
|
|
— |
|
|
|
— |
|
|
|
|
3,543 |
|
|
|
|
— |
|
Foreign exchange gain (loss), net |
|
|
6,462 |
|
|
|
(159 |
) |
|
|
|
5,446 |
|
|
|
|
(191 |
) |
Other income (expense), net |
|
|
(29 |
) |
|
|
(11 |
) |
|
|
|
(355 |
) |
|
|
|
(85 |
) |
Total other income (expense), net |
|
|
6,887 |
|
|
|
(13,942 |
) |
|
|
|
2,608 |
|
|
|
|
6,352 |
|
Net income (loss) before income taxes |
|
|
(26,474 |
) |
|
|
(21,328 |
) |
|
|
|
(88,022 |
) |
|
|
|
(10,573 |
) |
Provision for income taxes |
|
|
(368 |
) |
|
|
(4 |
) |
|
|
|
(432 |
) |
|
|
|
(4 |
) |
Gain on dilution of equity method investment |
|
|
— |
|
|
|
— |
|
|
|
|
16,923 |
|
|
|
|
— |
|
Losses from investments in equity method investees, net of tax |
|
|
(4,800 |
) |
|
|
(61,862 |
) |
|
|
|
(9,440 |
) |
|
|
|
(73,693 |
) |
Net loss |
|
|
(31,642 |
) |
|
|
(83,194 |
) |
|
|
|
(80,971 |
) |
|
|
|
(84,270 |
) |
Net income (loss) attributable to redeemable noncontrolling interests and noncontrolling interests |
|
|
(484 |
) |
|
|
1 |
|
|
|
|
(2,040 |
) |
|
|
|
(1,021 |
) |
Net loss attributable to ATAI Life Sciences N.V. stockholders |
|
$ |
(31,158 |
) |
|
$ |
(83,195 |
) |
|
|
$ |
(78,931 |
) |
|
|
$ |
(83,249 |
) |
Net loss per share attributable to ATAI Life Sciences N.V. stockholders — basic and diluted |
|
$ |
(0.21 |
) |
|
$ |
(0.92 |
) |
|
|
$ |
(0.59 |
) |
|
|
$ |
(0.92 |
) |
Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted |
|
|
151,130,212 |
|
|
|
90,709,312 |
|
|
- |
|
|
134,334,685 |
|
|
- |
|
|
90,709,312 |
|
See accompanying notes to the unaudited condensed consolidated financial statements
4
ATAI LIFE SCIENCES N.V.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Amounts in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Net loss |
|
$ |
(31,642 |
) |
|
$ |
(83,194 |
) |
|
$ |
(80,971 |
) |
|
$ |
(84,270 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments, net of tax |
|
|
(9,158 |
) |
|
|
6,329 |
|
|
|
(11,074 |
) |
|
|
6,216 |
|
Comprehensive income (loss) |
|
$ |
(40,800 |
) |
|
$ |
(76,865 |
) |
|
$ |
(92,045 |
) |
|
$ |
(78,054 |
) |
Comprehensive income (loss) attributable to redeemable noncontrolling interests and noncontrolling interests |
|
|
(484 |
) |
|
|
1 |
|
|
|
(2,040 |
) |
|
|
(1,021 |
) |
Foreign currency translation adjustments, net of tax attributable to noncontrolling interests |
|
|
12 |
|
|
|
(1 |
) |
|
|
(22 |
) |
|
|
(8 |
) |
Comprehensive loss attributable to redeemable noncontrolling interests and noncontrolling interests |
|
|