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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 10-Q

 

n

(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, 2022 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.

Wallstraße 16, 10179

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 4, 2022, the registrant had 165,875,307 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, 2022 and December 31, 2021

3

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2022 and 2021

4

 

Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2022 and 2021

5

 

Condensed Consolidated Statements of Redeemable Convertible Noncontrolling Interests and Changes in Stockholders' Equity for the Three and Nine Months Ended September 30, 2022 and 2021

6

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2022 and 2021

8

 

Notes to Condensed Consolidated Financial Statements

9

Item 2.

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

45

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

68

Item 4.

Controls and Procedures

68

PART II. OTHER INFORMATION

70

Item 1.

Legal Proceedings

70

Item 1A.

Risk Factors

70

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

70

Item 3.

Defaults Upon Senior Securities

70

Item 4.

Mine Safety Disclosures

70

Item 5.

Other Information

71

Item 6.

Exhibits

72

 

Signatures

74

 

 


 

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022 (the “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, macroeconomic, geopolitical, health and industry trends, 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, though not all forward-looking statements use these words or expressions.

 

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 neither promises nor guarantees, but involve known and unknown risks, uncertainties and are subject to a number of important factors that could cause actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; 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; as a result of covenants to our loan agreement with Hercules Capital, Inc., our operating activities may be restricted and we may be required to repay the outstanding indebtedness in the event of a breach by us, or an event of default thereunder, which could have a materially adverse effect on our business; 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 important factors include the risks, uncertainties, and assumptions described under “Risk Factors" in our Form 10-K for the year ended December 31, 2021 (the "Form 10-K") as further updated in this Quarterly Report, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 2 of this Quarterly Report, and elsewhere in our filings with the Securities and Exchange Commission (“SEC”).

 

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 or to conform these statements to actual results or revised expectations.

 

1


 

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. References to "Quarterly Report" herein refer to this Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022 and references to “Form 10-K” and “Annual Report” herein refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2021.

 

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.

As of June 30, 2022, we determined that we qualified as a smaller reporting company, as defined in Rule 12b-2 of the Exchange Act. Consistent with Section 5120.1(d) of the Financial Reporting Manual, we have elected to reflect this status immediately. As a result, for the year ending December 31, 2023 and the remainder of the year ending December 31, 2022, we expect that we will be exempt from certain disclosure requirements and permitted to rely on certain reduced disclosure requirements.

2


 

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

 

ATAI LIFE SCIENCES N.V.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Amounts in thousands, except share and per share amounts)

 

 

 

September 30,

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

142,539

 

 

$

362,266

 

Securities carried at fair value

 

 

161,518

 

 

 

 

Prepaid expenses and other current assets

 

 

13,425

 

 

 

11,903

 

Short term notes receivable

 

 

 

 

 

913

 

Total current assets

 

 

317,482

 

 

 

375,082

 

Property and equipment, net

 

 

728

 

 

 

149

 

Equity method investments

 

 

 

 

 

16,131

 

Other investments

 

 

8,498

 

 

 

11,628

 

Long term notes receivable - related parties

 

 

7,151

 

 

 

3,835

 

Other assets

 

 

8,738

 

 

 

7,341

 

Total assets

 

$

342,597

 

 

$

414,166

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

 

3,511

 

 

 

6,004

 

Accrued liabilities

 

 

22,142

 

 

 

14,829

 

Current portion of contingent consideration liability - related parties

 

 

 

 

 

51

 

Other current liabilities

 

 

260

 

 

 

51

 

Total current liabilities

 

 

25,913

 

 

 

20,935

 

Non-current portion of contingent consideration liability - related parties

 

 

1,908

 

 

 

2,432

 

Convertible promissory notes - related parties, net of discounts and deferred issuance costs

 

 

380

 

 

 

743

 

Other liabilities

 

 

3,695

 

 

 

4,097

 

Long-term debt, net

 

 

14,621

 

 

 

 

Total liabilities

 

$

46,517

 

 

$

28,207

 

Commitments and contingencies (Note 15)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock, €0.10 par value ($0.12 par value at September 30, 2022 and December 31, 2021, respectively); 750,000,000 shares authorized at September 30, 2022 and December 31, 2021, respectively; 165,875,307 and 160,677,001 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

 

18,554

 

 

 

18,002

 

Additional paid-in capital

 

 

761,811

 

 

 

725,045

 

Accumulated other comprehensive loss

 

 

(25,788

)

 

 

(8,336

)

Accumulated deficit

 

 

(465,178

)

 

 

(357,803

)

Total stockholders’ equity attributable to ATAI Life Sciences N.V. stockholders

 

 

289,399

 

 

 

376,908

 

Noncontrolling interests

 

 

6,681

 

 

 

9,051

 

Total stockholders’ equity

 

 

296,080

 

 

 

385,959

 

Total liabilities and stockholders’ equity

 

$

342,597

 

 

$

414,166

 

 

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 September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

License revenue

 

$

24

 

 

$

266

 

 

$

195

 

 

$

20,146

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

19,028

 

 

 

13,363

 

 

 

52,437

 

 

 

34,974

 

Acquisition of in-process research and development

 

 

 

 

 

 

 

 

357

 

 

 

8,934

 

General and administrative

 

 

19,419

 

 

 

20,264

 

 

 

54,623

 

 

 

66,868

 

Total operating expenses

 

 

38,447

 

 

 

33,627

 

 

 

107,417

 

 

 

110,776

 

Loss from operations

 

 

(38,423

)

 

 

(33,361

)

 

 

(107,222

)

 

 

(90,630

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

145

 

 

 

8

 

 

 

361

 

 

 

80

 

Change in fair value of contingent consideration liability - related parties

 

 

430

 

 

 

469

 

 

 

525

 

 

 

(191

)

Change in fair value of derivative liability

 

 

 

 

 

 

 

 

 

 

 

41

 

Change in fair value of warrant liability

 

 

 

 

 

47

 

 

 

53

 

 

 

87

 

Change in fair value of securities carried at fair value

 

 

344

 

 

 

 

 

 

(981

)

 

 

 

Unrealized loss on other investments held at fair value

 

 

 

 

 

(70

)

 

 

 

 

 

(5,530

)

Loss on conversion of convertible promissory notes

 

 

 

 

 

 

 

 

 

 

 

(513

)

Gain on consolidation of a variable interest entity

 

 

 

 

 

 

 

 

 

 

 

3,543

 

Foreign exchange gain (loss), net

 

 

4,470

 

 

 

6,462

 

 

 

11,515

 

 

 

5,446

 

Other income (expense), net

 

 

(100

)

 

 

(29

)

 

 

(112

)

 

 

(355

)

Total other income (expense), net

 

 

5,289

 

 

 

6,887

 

 

 

11,361

 

 

 

2,608

 

Loss before income taxes

 

 

(33,134

)

 

 

(26,474

)

 

 

(95,861

)

 

 

(88,022

)

Provision for income taxes

 

 

(135

)

 

 

(368

)

 

 

(227

)

 

 

(432

)

Gain on dilution of equity method investment

 

 

 

 

 

 

 

 

 

 

 

16,923

 

Losses from investments in equity method investees, net of tax

 

 

(2,432

)

 

 

(4,800

)

 

 

(14,680

)

 

 

(9,440

)

Net loss

 

 

(35,701

)

 

 

(31,642

)

 

 

(110,768

)

 

 

(80,971

)

Net loss attributable to redeemable noncontrolling interests and noncontrolling interests

 

 

(1,814

)

 

 

(484

)

 

 

(3,394

)

 

 

(2,040

)

Net loss attributable to ATAI Life Sciences N.V. stockholders

 

$

(33,887

)

 

$

(31,158

)

 

$

(107,374

)

 

$

(78,931

)

Net loss per share attributable to ATAI Life Sciences N.V. stockholders — basic and diluted

 

$

(0.22

)

 

$

(0.21

)

 

$

(0.69

)

 

$

(0.59

)

Weighted average common shares outstanding attributable to ATAI Life Sciences N.V. stockholders — basic and diluted

 

 

156,607,468

 

 

 

151,130,212

 

 

 

154,713,922

 

 

 

134,334,685

 

 

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,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

Net loss

 

$

(35,701

)

 

$

(31,642

)

 

$

(110,768

)

 

$

(80,971

)

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments, net of tax

 

 

(4,597

)

 

 

(9,158

)

 

 

(17,452

)

 

 

(11,074

)

 

Comprehensive loss:

 

$

(40,298

)

 

$

(40,800

)

 

$

(128,220

)

 

$

(92,045

)

 

Comprehensive loss attributable to redeemable noncontrolling interests and noncontrolling interests

 

 

(1,814

)

 

 

(484

)

 

 

(3,394

)

 

 

(2,040

)

 

Foreign currency translation adjustments, net of tax attributable to noncontrolling interests

 

 

48

 

 

 

12

 

 

 

67

 

 

 

(22

)

 

Comprehensive loss attributable to redeemable noncontrolling
   interests and noncontrolling interests

 

 

(1,766

)

 

 

(472

)

 

 

(3,327

)

 

 

(2,062

)

 

Comprehensive loss attributable to ATAI Life Sciences
   N.V. stockholders

 

$

(38,532

)

 

$

(40,328

)

 

$

(124,893

)

 

$

(89,983

)

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

5


 

ATAI LIFE SCIENCES N.V.

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE NONCONTROLLING

INTERESTS AND STOCKHOLDERS’ EQUITY