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M

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 10-Q

 

 

(Mark One)

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

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)

 

The Netherlands

 

Not Applicable

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer
Identification No.)

 

 

ATAI Life Sciences N.V. c/o Mindspace

Krausenstraße 9-10

Berlin, Germany

 

Not Applicable

(Address of principal executive offices)

 

(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:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common shares, par value €0.10 per share

 

ATAI

 

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.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

 

 

Emerging growth company

 

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

 

 

 

 

Page

Forward-Looking Statements

1

PART I. FINANCIAL INFORMATION

3

Item 1.

 

Financial Statements (Unaudited)

3

 

 

Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020

3

 

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2021 and 2020

4

 

 

Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2021 and 2020

5

 

 

Condensed Consolidated Statements of Redeemable Convertible Noncontrolling Interests and Changes in Stockholders’ Equity (Deficit) for the Three and Nine Months Ended September 30, 2021 and 2020

6

 

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020

8

 

 

Notes to Condensed Consolidated Financial Statements

9

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

52

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

80

Item 4.

 

Controls and Procedures

81

PART II. OTHER INFORMATION

83

Item 1.

 

Legal Proceedings

83

Item 1A.

 

Risk Factors

84

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

85

Item 3.

 

Defaults Upon Senior Securities

85

Item 4.

 

Mine Safety Disclosures

85

Item 5.

 

Other Information

85

Item 6.

 

Exhibits

86

 

 

Signatures

87

 

 

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

)

 

 

(