February 28, 2026--12-31August 01, 2012falseseven yearsMay 31, 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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 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 001-36548

 

ATARA BIOTHERAPEUTICS, INC.

(Exact name of Registrant as specified in its Charter)

 

 

Delaware

 

46-0920988

(State or other jurisdiction of incorporation or organization)

 

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

 

 

 

611 Gateway Blvd., Suite 900

South San Francisco, CA

 

94080

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (650) 278-8930

 

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 Stock, par value $0.0001 per share

 

ATRA

 

The Nasdaq Stock Market LLC

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 ☒

The number of outstanding shares of the Registrant’s Common Stock as of July 29, 2022 was 94,362,320 shares.

 

 


 

ATARA BIOTHERAPEUTICS, INC.

INDEX

 

 

 

 

 

Page

PART I.

 

FINANCIAL INFORMATION

 

 

 

 

 

Item 1.

 

Financial Statements (Unaudited)

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets

 

6

 

 

 

 

 

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

 

7

 

 

 

 

 

Condensed Consolidated Statements of Changes in Stockholders’ Equity

 

8

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows

 

9

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements

 

10

 

 

 

Item 2.

 

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

 

24

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

33

 

 

 

Item 4.

 

Controls and Procedures

 

34

 

 

 

PART II.

 

OTHER INFORMATION

 

35

 

 

 

Item 1.

 

Legal Proceedings

 

35

 

 

 

Item 1A.

 

Risk Factors

 

35

 

Item 6.

 

Exhibits

 

76

 

 

 

 

Signatures

 

77

 

 

 

 

2


 

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements, which represent our intent, belief or current expectations, involve risks and 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. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “predict,” “plan,” “expect” or the negative or plural of these words or similar expressions. The forward-looking statements include, but are not limited to, statements about:

our expectations regarding the timing of initiating clinical studies, opening client sites, enrolling clinical studies and reporting results of clinical studies for our programs, including in light of the COVID-19 pandemic;
the likelihood and timing of regulatory submissions or related approvals for our product candidates, including the initiation, completion and expectations about the timing of approvals for a biologics license application (BLA) and our marketing authorization application (MAA) for tab-cel® for patients with Epstein-Barr virus with post-transplant lymphoproliferative disease (EBV+ PTLD);
the potential indications for our product candidates, if approved for commercial use;
the potential commercial market opportunities for our product candidates;
the termination of our Research, Development and License Agreement and related ancillary agreements with Bayer AG;
our Commercialization Agreement with Pierre Fabre Medicament, including potential milestone and royalty payments under the agreement;
our Asset Purchase Agreement and related transactions with FUJIFILM Diosynth Biotechnologies California, Inc., including the Master Services and Supply Agreement;
our expectations regarding the potential market size and the size of the patient populations for our product candidates, if approved for commercial use;
estimates of our expenses, capital requirements and need for additional financing;
our expectation regarding the length of time that our existing capital resources will be sufficient to enable us to fund our planned operations;
our ability to enter into favorable commercialization arrangements with third parties to commercialize our product candidates, if approved for commercial use;
our ability to develop, acquire and advance product candidates into, and successfully complete, clinical studies;
the initiation, timing, costs, progress and results of future preclinical studies and clinical studies and our research and development programs;
our ability to enter into and maintain contracts with clinical research organizations, manufacturing organizations and other vendors for clinical and pre-clinical studies, supplies and other services;
the scope of protection we are able to obtain and maintain for the intellectual property rights covering our product candidates;
our financial performance;
developments and projections relating to our competitors and our industry;
our ability to have our product candidates manufactured for our clinical studies, or if approved, for commercial sale;
the impact of COVID-19 to our business and operations, as well as the businesses and operations of third parties on which we rely;
the impact of our planned reduction in workforce on our ability to attract and retain qualified personnel and to our business, operations and financial condition;
our ability to have manufactured approved products at commercially reasonable values; and
timing and costs related to qualification of our contract manufacturing organizations’ (CMO) manufacturing facilities for commercial production.

3


 

These statements are only current predictions and are subject to known and unknown risks, uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the COVID-19 pandemic, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in South San Francisco and Southern California and at our clinical trial sites, as well as the business or operations of our third-party manufacturers, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of our cash resources and need for additional capital, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in this report in greater detail under the heading “1A. Risk Factors” and elsewhere in this report. You should not rely upon forward-looking statements as predictions of future events. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties.

In this Quarterly Report on Form 10-Q, unless the context requires otherwise, “Atara,” “Atara Biotherapeutics,” “Company,” “we,” “our,” and “us” means Atara Biotherapeutics, Inc. and, where appropriate, its subsidiaries.

Summary Risk Factors

Our business is subject to numerous risks and uncertainties that may have a material adverse effect on our business, financial condition or results of operations. These risks are more fully described below. These risks include, among others:

we have incurred substantial cumulative losses since our inception and anticipate that we will continue to incur substantial losses for the foreseeable future;
we currently have no approved products and thus have no revenues from commercialization of any products and may never generate revenues from the commercial sale of products or achieve profitability;
we are generally early in our development efforts, have only a small number of product candidates in clinical development, and we will need to successfully complete preclinical and clinical testing of our product candidates before we can seek regulatory approval and potentially generate commercial sales;
we will require substantial additional financing to achieve our goals, which may not be available to us on acceptable terms, or at all;
our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel;
the results of preclinical studies or earlier clinical studies are not necessarily predictive of future results, and our existing product candidates in clinical studies, and any other product candidates we advance into clinical studies may not have favorable results in later clinical studies or receive regulatory approval;
clinical drug development, both in the U.S. and international jurisdictions, involves a lengthy and expensive process with an uncertain outcome and even if our product candidates receive regulatory approval, they may still face future development and regulatory difficulties;
our T-cell immunotherapy product candidates and our next-generation CAR T programs represent new therapeutic approaches that could result in heightened regulatory scrutiny or our inability to achieve regulatory approval, commercialization or payor coverage of our product candidates;
there can be no assurance that we will achieve all of the anticipated benefits of the Fujifilm Transaction and we could face unanticipated challenges;
the market opportunities for our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and may be small;
we may not be able to obtain or maintain orphan drug exclusivity for our product candidates;
the COVID-19 pandemic continues to impact our business and operations and could materially and adversely affect our business and operations in the future, as well as the businesses and operations of third parties on which we rely;
our success depends upon our ability to obtain and maintain sufficient intellectual property protection for our product candidates, and we may not be able to protect our intellectual property rights throughout the world;
our principal stockholders own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval;
our planned workforce reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business; and

4


 

we may not be able to obtain and maintain the relationships with third parties that are necessary to develop, commercialize and manufacture some or all of our product candidates.

5


 

Atara Biotherapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except per share amounts)

 

 

 

 

 

June 30,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

70,688

 

 

$

106,084

 

Short-term investments

 

 

260,623

 

 

 

264,984

 

Restricted cash

 

 

1,346

 

 

 

194

 

Accounts receivable

 

 

637

 

 

 

986

 

Prepaid expenses and other current assets

 

 

13,690

 

 

 

12,373

 

Total current assets

 

 

346,984

 

 

 

384,621

 

Property and equipment, net

 

 

8,328

 

 

 

53,780

 

Operating lease assets

 

 

73,582

 

 

 

26,159

 

Restricted cash - long-term

 

 

 

 

 

1,200

 

Other assets

 

 

7,227

 

 

 

2,367

 

Total assets

 

$

436,121

 

 

$

468,127

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

12,799

 

 

$

17,368

 

Accrued compensation

 

 

16,317

 

 

 

25,150

 

Accrued research and development expenses

 

 

15,125

 

 

 

13,451

 

Deferred revenue

 

 

1,671

 

 

 

40,760

 

Other current liabilities

 

 

19,776

 

 

 

9,057

 

Total current liabilities

 

 

65,688

 

 

 

105,786

 

Deferred revenue - long-term

 

 

43,329

 

 

 

55,708

 

Operating lease liabilities - long-term

 

 

63,999

 

 

 

25,518

 

Other long-term liabilities

 

 

5,626

 

 

 

1,501

 

Total liabilities

 

 

178,642

 

 

 

188,513

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock—$0.0001 par value, 500,000 shares authorized as of June 30,
   2022 and December 31, 2021;
94,356 and 91,671 shares issued and outstanding
   as of June 30, 2022 and December 31, 2021, respectively

 

 

9

 

 

 

9

 

Additional paid-in capital

 

 

1,794,449

 

 

 

1,744,695

 

Accumulated other comprehensive (loss) income

 

 

(2,618

)

 

 

(368

)

Accumulated deficit

 

 

(1,534,361

)

 

 

(1,464,722

)

Total stockholders’ equity

 

 

257,479

 

 

 

279,614

 

Total liabilities and stockholders’ equity

 

$

436,121

 

 

$

468,127

 

See accompanying notes.

6


 

Atara Biotherapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(Unaudited)

(In thousands, except per share amounts)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

License and collaboration revenue

 

$

51,579

 

 

$

3,870

 

 

$

58,893

 

 

$

7,422

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

64,898

 

 

 

68,475

 

 

 

139,861

 

 

 

132,534

 

General and administrative

 

 

18,813

 

 

 

19,397

 

 

 

39,384

 

 

 

37,135

 

Total operating expenses

 

 

83,711

 

 

 

87,872

 

 

 

179,245

 

 

 

169,669

 

Loss from operations

 

 

(32,132

)

 

 

(84,002

)

 

 

(120,352

)

 

 

(162,247

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Gain on sale of ATOM Facility (See Note 7)

 

 

50,237

 

 

 

 

 

 

50,237

 

 

 

 

Interest and other income (expense), net

 

 

361

 

 

 

225

 

 

 

476

 

 

 

135

 

Total other income (expense), net

 

 

50,598

 

 

 

225

 

 

 

50,713

 

 

 

135

 

Income (loss) before provision for income taxes

 

 

18,466

 

 

 

(83,777

)

 

 

(69,639

)

 

 

(162,112

)

Provision for income taxes

 

 

 

 

 

16

 

 

 

 

 

 

16

 

Net income (loss)

 

$

18,466

 

 

$

(83,793

)

 

$

(69,639

)

 

$

(162,128

)

Other comprehensive gain (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale securities

 

 

(726

)

 

 

(99

)

 

 

(2,250

)

 

 

(234

)

Comprehensive income (loss)

 

$

17,740

 

 

$

(83,892

)

 

$

(71,889

)

 

$

(162,362

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic earnings (loss) per common share

 

$

0.18

 

 

$

(0.91

)

 

$

(0.69

)

 

$

(1.77

)

Diluted earnings (loss) per common share

 

$

0.18

 

 

$

(0.91

)

 

$

(0.69

)

 

$

(1.77

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic weighted-average shares outstanding

 

 

101,601

 

 

 

92,152

 

 

 

101,166

 

 

 

91,806

 

Diluted weighted-average shares outstanding

 

 

101,866

 

 

 

92,152

 

 

 

101,166

 

 

 

91,806

 

 

See accompanying notes.

7


 

Atara Biotherapeutics, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(Unaudited)

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

Common

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

For the Six Months Ended June 30, 2022

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance as of January 1, 2022

 

 

91,671

 

 

$

9

 

 

$

1,744,695

 

 

$

(368

)

 

$

(1,464,722

)

 

$

279,614

 

Issuance of common stock through ATM facilities, net of commissions and offering costs of $419

 

 

1,320

 

 

 

 

 

 

20,516

 

 

 

 

 

 

 

 

 

20,516

 

RSU settlements, net of shares withheld

 

 

405

 

 

 

 

 

 

(616

)

 

 

 

 

 

 

 

 

(616

)

Issuance of common stock pursuant to employee stock awards

 

 

10

 

 

 

 

 

 

96

 

 

 

 

 

 

 

 

 

96

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

14,335

 

 

 

 

 

 

 

 

 

14,335

 

Net income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(88,105

)

 

 

(88,105

)

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(1,524

)

 

 

 

 

 

(1,524

)

Balance as of March 31, 2022

 

 

93,406

 

 

$

9

 

 

$

1,779,026

 

 

$

(1,892

)

 

$

(1,552,827

)

 

$

224,316

 

RSU settlements, net of shares withheld

 

 

647

 

 

 

 

 

 

(3

)

 

 

 

 

 

 

 

 

(3

)

Issuance of common stock pursuant to employee stock awards

 

 

303

 

 

 

 

 

 

1,309

 

 

 

 

 

 

 

 

 

1,309

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

14,117

 

 

 

 

 

 

 

 

 

14,117

 

Net income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

18,466

 

 

 

18,466

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(726

)

 

 

 

 

 

(726

)

Balance as of June 30, 2022

 

 

94,356

 

 

$

9

 

 

$

1,794,449

 

 

$

(2,618

)

 

$

(1,534,361

)

 

$

257,479

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

Common

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

For the Six Months Ended June 30, 2021

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance as of January 1, 2021

 

 

83,372

 

 

$

8

 

 

$

1,586,616

 

 

$

296

 

 

$

(1,124,581

)

 

$

462,339

 

Issuance of common stock through ATM facilities, net of commissions and offering costs of $139

 

 

146

 

 

 

 

 

 

2,382

 

 

 

 

 

 

 

 

 

2,382

 

RSU settlements, net of shares withheld

 

 

449

 

 

 

 

 

 

(1,231

)

 

 

 

 

 

 

 

 

(1,231

)

Issuance of common stock pursuant to employee stock awards

 

 

108

 

 

 

 

 

 

1,749

 

 

 

 

 

 

 

 

 

1,749

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

12,268

 

 

 

 

 

 

 

 

 

12,268

 

Net income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(78,335

)

 

 

(78,335

)

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(135

)

 

 

 

 

 

(135

)

Balance as of March 31, 2021

 

 

84,075

 

 

$

8

 

 

$

1,601,784

 

 

$

161

 

 

$

(1,202,916

)

 

$

399,037

 

RSU settlements, net of shares withheld

 

 

423

 

 

 

 

 

 

(13

)

 

 

 

 

 

 

 

 

(13

)

Issuance of common stock pursuant to employee stock awards

 

 

256

 

 

 

 

 

 

2,599

 

 

 

 

 

 

 

 

 

2,599

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

13,807

 

 

 

 

 

 

 

 

 

13,807

 

Net income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(83,793

)

 

 

(83,793

)

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(99

)

 

 

 

 

 

(99

)

Balance as of June 30, 2021

 

 

84,754

 

 

$

8

 

 

$

1,618,177

 

 

$

62

 

 

$

(1,286,709

)

 

$

331,538

 

 

See accompanying notes.

8


 

Atara Biotherapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(69,639

)

 

$

(162,128

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Gain on sale of ATOM Facility

 

 

(50,237

)

 

 

 

Stock-based compensation expense

 

 

28,452

 

 

 

26,075

 

Depreciation and amortization expense

 

 

3,029

 

 

 

4,540

 

Amortization of investment premiums

 

 

811

 

 

 

851

 

Non-cash operating lease expense

 

 

3,355

 

 

 

755

 

Asset retirement obligation accretion expense

 

 

46

 

 

 

43

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

349

 

 

 

1,250

 

Prepaid expenses and other current assets

 

 

(1,546

)

 

 

2,419

 

Other assets

 

 

76

 

 

 

18

 

Accounts payable

 

 

(3,384

)

 

 

4,356

 

Accrued compensation

 

 

(8,833

)

 

 

(5,135