Atara Biotherapeutics
Atara Biotherapeutics, Inc. (Form: 10-Q, Received: 05/04/2017 16:49:24)

 

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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 March 31, 2017

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

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).    Yes       No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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

 

  (Do not check if a small reporting company)

  

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 April 30, 2017 was 29,109,123 shares.

 

 

 

 

 

 


 

ATARA BIOTHERAPEUTICS, INC.

INDEX

 

 

  

 

  

Page

PART I.

  

FINANCIAL INFORMATION

  

 

 

 

 

Item 1.

  

Financial Statements (Unaudited)

  

3

 

 

 

 

  

Condensed Consolidated Balance Sheets

  

3

 

 

 

 

  

Condensed Consolidated Statements of Operations and Comprehensive Loss

  

4

 

 

 

 

  

Condensed Consolidated Statements of Cash Flows

  

5

 

 

 

 

  

Notes to Condensed Consolidated Financial Statements

  

6

 

 

 

Item 2.

  

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

  

15

 

 

 

Item 3.

  

Quantitative and Qualitative Disclosures about Market Risk

  

24

 

 

 

Item 4.

  

Controls and Procedures

  

24

 

 

 

PART II.

  

OTHER INFORMATION

  

 

 

 

 

Item 1.

  

Legal Proceedings

  

25

 

 

 

Item 1A.

  

Risk Factors

  

25

 

 

 

Item 2.

  

Unregistered Sales of Equity Securities and Use of Proceeds

  

54

 

Item 3.

  

Defaults Upon Senior Securities

  

54

 

Item 4.

  

Mine Safety Disclosures

  

54

 

Item 5.

  

Other Information

  

54

 

Item 6.

  

Exhibits

  

55

 

 

 

  

Signatures

  

56

 

 

 

 

  

Index to Exhibits

  

57

 

 

2


 

Atara Biotherapeutics, Inc.

Condensed Conso lidated Balance Sheets

(Unaudited)

(In thousands, except per share amounts)

 

 

 

March 31,

 

 

December 31,

 

 

 

2017

 

 

2016

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

62,430

 

 

$

47,968

 

Short-term investments

 

 

168,216

 

 

 

207,714

 

Restricted cash - short-term

 

 

194

 

 

 

194

 

Prepaid expenses and other current assets

 

 

4,478

 

 

 

4,677

 

Total current assets

 

 

235,318

 

 

 

260,553

 

Property and equipment, net

 

 

4,400

 

 

 

3,259

 

Restricted cash - long-term

 

 

1,200

 

 

 

-

 

Other assets

 

 

820

 

 

 

102

 

Total assets

 

$

241,738

 

 

$

263,914

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,204

 

 

$

2,778

 

Accrued compensation

 

 

2,609

 

 

 

3,745

 

Accrued research and development expenses

 

 

2,106

 

 

 

2,408

 

Other accrued liabilities

 

 

886

 

 

 

744

 

Total current liabilities

 

 

7,805

 

 

 

9,675

 

Long-term liabilities

 

 

799

 

 

 

503

 

Total liabilities

 

 

8,604

 

 

 

10,178

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Common stock—$0.0001 par value, 500,000 shares authorized as of

   March 31, 2017 and December 31, 2016; 29,109 and 28,933 shares

   issued and outstanding as of March 31, 2017 and December 31, 2016,

   respectively

 

 

3

 

 

 

3

 

Additional paid-in capital

 

 

436,096

 

 

 

431,075

 

Accumulated other comprehensive loss

 

 

(152

)

 

 

(183

)

Accumulated deficit

 

 

(202,813

)

 

 

(177,159

)

Total stockholders’ equity

 

 

233,134

 

 

 

253,736

 

Total liabilities and stockholders’ equity

 

$

241,738

 

 

$

263,914

 

 

 

See accompanying notes.

 

 

3


 

Atara Biotherapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except per share amounts)

 

 

 

 

 

 

 

Three   Months Ended March 31,

 

 

 

2017

 

 

2016

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

$

17,541

 

 

$

11,247

 

General and administrative

 

 

8,620

 

 

 

5,814

 

Total operating expenses

 

 

26,161

 

 

 

17,061

 

Loss from operations

 

 

(26,161

)

 

 

(17,061

)

Interest and other income, net

 

 

509

 

 

 

503

 

Loss before provision for income taxes

 

 

(25,652

)

 

 

(16,558

)

Less: Provision for income taxes

 

 

2

 

 

 

3

 

Net loss

 

$

(25,654

)

 

$

(16,561

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

 

31

 

 

 

569

 

Comprehensive loss

 

$

(25,623

)

 

$

(15,992

)

Net loss per common share:

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.88

)

 

$

(0.58

)

 

 

 

 

 

 

 

 

 

Weighted-average shares outstanding used

   to calculate basic and diluted net loss per common share

 

 

29,056

 

 

 

28,542

 

 

 

 

 

See accompanying notes.

4


 

Atara Biotherapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended March 31,

 

 

 

2017

 

 

2016

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(25,654

)

 

$

(16,561

)

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

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

5,347

 

 

 

4,724

 

Amortization of investment premiums and discounts

 

 

301

 

 

 

1,286

 

Depreciation expense

 

 

206

 

 

 

15

 

Loss on foreign exchange

 

 

 

 

 

42

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

199

 

 

 

(1,304

)

Other assets

 

 

(718

)

 

 

18

 

Accounts payable

 

 

(466

)

 

 

451

 

Accrued compensation

 

 

(1,136

)

 

 

(1,287

)

Accrued research and development expenses

 

 

(302

)

 

 

(682

)

Other accrued liabilities

 

 

179

 

 

 

669

 

Long-term liabilities

 

 

10

 

 

 

138

 

Net cash used in operating activities

 

 

(22,034

)

 

 

(12,491

)

Investing activities

 

 

 

 

 

 

 

 

Purchases of short-term investments

 

 

(51,988

)

 

 

(130,963

)

Maturities of short-term investments

 

 

63,760

 

 

 

66,849

 

Sales of short-term investments

 

 

27,456

 

 

 

75,866

 

Purchases of property and equipment

 

 

(1,206

)

 

 

(891

)

Restricted cash

 

 

(1,200

)

 

 

 

Net cash provided by investing activities

 

 

36,822

 

 

 

10,861

 

Financing activities

 

 

 

 

 

 

 

 

Taxes paid related to net share settlement of restricted stock units

 

 

(326

)

 

 

(32

)

Proceeds from employee stock awards

 

 

 

 

 

14

 

Net cash used in financing activities

 

 

(326

)

 

 

(18

)

Effect of exchange rates on cash

 

 

 

 

 

(42

)

Increase (decrease) in cash and cash equivalents

 

 

14,462

 

 

 

(1,690

)

Cash and cash equivalents at beginning of period

 

 

47,968

 

 

 

23,746

 

Cash and cash equivalents at end of period

 

$

62,430

 

 

$

22,056

 

Non-cash investing and financing activities

 

 

 

 

 

 

 

 

Issuance of common stock upon vesting of stock awards

 

$

 

 

$

20

 

Change in long-term liabilities related to non-vested stock awards

 

$

 

 

$

(20

)

Capitalized lease obligations

 

$

286

 

 

$

 

Property and equipment purchases included in liabilities

 

$

207

 

 

$

 

Supplemental cash flow disclosure

 

 

 

 

 

 

 

 

Cash paid for taxes

 

$

2

 

 

$

3

 

 

See accompanying notes.

 

 

5


 

Atara Biotherapeutics, Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

1.

Description of Business

Atara Biotherapeutics, Inc. (“Atara”, “we”, “our” or “the Company”) was incorporated in August 2012 in Delaware. Atara is a clinical-stage biopharmaceutical company focused on developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation. We are focused on developing allogeneic or third-party derived antigen-specific T-cells. T-cells are a type of white blood cell. Cytotoxic T-cells, otherwise known as cytotoxic T lymphocytes, or CTLs, which can mount an immune response against an antigen or antigens in order to combat viral infection or disease.  

Our cellular therapy platform is designed to provide a healthy immune capability to a patient whose immune system is compromised or is unable to identify the disease targets. We licensed rights to T-cell product candidates from Memorial Sloan Kettering Cancer Center (“MSK”) in June 2015 and to know-how and technology from QIMR Berghofer Medical Research Institute (“QIMR Berghofer”) in October 2015 and September 2016. See Note 6 for further information.

 

2.

Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and following the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair statement of the Company’s consolidated financial information. The results of operations for the three month period ended March 31, 2017 are not necessarily indicative of the results to be expected for the full year or any other future period. The condensed consolidated balance sheet as of December 31, 2016 has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete consolidated financial statements.

Significant Risks and Uncertainties

We have incurred significant operating losses since inception and have relied on public and private equity financings to fund our operations. As of March 31, 2017 we had an accumulated deficit of $202.8 million. As we continue to incur losses, our transition to profitability will depend on the successful development, approval and commercialization of product candidates and on the achievement of sufficient revenues to support our cost structure. We may never achieve profitability, and unless and until we do, we will need to continue to raise additional capital. Management expects that our cash, cash equivalents and short-term investments as of March 31, 2017 will be sufficient to fund our planned operations into the first quarter of 2019.

Concentration of Credit Risk and Other Uncertainties

We place cash and cash equivalents in the custody of financial institutions that management believes are of high credit quality, the amount of which at times, may be in excess of the amount insured by the Federal Deposit Insurance Corporation. We also have short-term investments in money market funds, U.S. Treasury, government agency and corporate debt obligations, commercial paper and asset-backed securities, which can be subject to certain credit risk. However, we mitigate the risks by investing in high-grade instruments, limiting our exposure to any one issuer, and monitoring the ongoing creditworthiness of the financial institutions and issuers.

We are subject to certain risks and uncertainties and believe that changes in any of the following areas could have a material adverse effect on future financial position or results of operations: our ability to obtain future financing; regulatory approval and market acceptance of, and reimbursement for, our product candidates, if approved; performance of third-party clinical research organizations and manufacturers upon which we rely; development of sales channels; protection of our intellectual property; litigation or claims against us based on intellectual property, patent, product, regulatory or other factors; and our ability to attract and retain employees necessary to support our growth.

6


 

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions, and judgments that affect the amounts reported in the financial statements and accompanying notes. Significant estimates relied upon in preparing these financial statements include estimates related to clinical trial and other accruals, stock-based compensation expense, construction costs and income taxes. Actual results could differ materially from those estimates.

Leases

We lease office space in multiple locations. In addition, we are constructing a manufacturing facility in Thousand Oaks, California under a non-cancelable lease agreement. The leases are reviewed for classification as operating or capital leases. For operating leases, rent is recognized on a straight-line basis over the lease period. For capital leases, we record the leased asset with a corresponding liability for principal and interest. Payments are recorded as reductions to these liabilities with interest being charged to interest expense in our statements of operations and comprehensive loss.

We analyzed the nature of the renovations and our involvement during the construction period of a newly-leased manufacturing facility and determined that we are the deemed “owner” of the construction project during the construction period. As a result, we are required to capitalize the fair value of the building as well as the construction costs incurred on our condensed consolidated balance sheet along with a corresponding financing liability for landlord paid construction costs (i.e. “build-to-suit” accounting). Upon occupancy for build-to-suit leases, we are also required to assess whether the circumstances qualify for sale recognition under “sale-leaseback” accounting guidance.

Recent Accounting Pronouncements

 

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) , which is intended to increase the transparency and comparability in the reporting of leasing arrangements by generally requiring leased assets and liabilities to be recorded on the balance sheet. The new standard is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2018, with early adoption permitted. The Company has not yet determined the method of adoption and the potential effect the new standard will have on the Company’s consolidated financial statements.

In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting (Topic 718) , which simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification in the statement of cash flows. The new standard is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2016, with early adoption permitted. The Company prospectively adopted the new standard on January 1, 2017 and that adoption did not have a material effect on the Company’s consolidated financial statements due to the full valuation allowance of its deferred tax assets.

 

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments . ASU 2016-13 requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. ASU 2016-13 limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. The new standard will be effective for us on January 1, 2020. Early adoption will be available on January 1, 2019. We are currently evaluating the effect that the updated standard will have on our consolidated financial statements and related disclosures.

In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments , which clarifies how certain cash receipts and cash payments should be presented and classified in the statement of cash flows. The new standard is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2017, with early adoption permitted. The Company has not yet determined the method of adoption and the potential effect the new standard will have on the Company’s consolidated financial statements.

 

In November 2016, the FASB issued ASU No. 2016-18 Statement of Cash Flows (Topic 230): Restricted Cash , which clarifies the statement of cash flow treatment of restricted cash or restricted cash equivalents. The new standard is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2017, with early adoption permitted. The standard should be applied using a retrospective transition method to each period presented. The Company has not yet determined the potential effect the new standard will have on the Company’s consolidated financial statements.

 

 

7


 

 

3.

Net Loss per Common Share

Basic net loss per common share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration of common share equivalents. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of shares of common stock and common share equivalents outstanding for the period. Common share equivalents are only included in the calculation of diluted net loss per common share when their effect is dilutive.

Potential dilutive securities, which include unvested restricted stock awards (“RSAs”), unvested restricted stock units (“RSUs”), vested and unvested options to purchase common stock and shares to be issued under our employee stock purchase plan (“ESPP”) have been excluded from the computation of diluted net loss per share as the effect is antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in all periods presented.

The following table represents the potential common shares issuable pursuant to outstanding securities as of the related period end dates that were excluded from the computation of diluted net loss per common share as their inclusion would have an antidilutive effect:

 

 

As of March 31,

 

 

2017

 

 

2016

 

Unvested RSAs

 

 

 

 

161,779

 

Unvested RSUs

 

1,818,315

 

 

 

1,007,542

 

Vested and unvested options

 

3,775,661

 

 

 

3,430,482

 

ESPP share purchase rights

 

27,765

 

 

 

 

Total

 

5,621,741

 

 

 

4,599,803

 

 

 

4.

Financial Instruments

Our financial assets are measured at fair value on a recurring basis using the following hierarchy to prioritize valuation inputs, in accordance with applicable GAAP:

 

Level 1:

  

Quoted prices in active markets for identical assets or liabilities that we have the ability to access

 

Level 2:

  

 

Observable market based inputs or unobservable inputs that are corroborated by market data such as quoted prices, interest rates and yield curves

 

Level 3:

  

 

Inputs that are unobservable data points that are not corroborated by market data

We review the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels of certain securities within the fair value hierarchy. We recognize transfers into and out of levels within the fair value hierarchy in the period in which the actual event or change in circumstances that caused the transfer occurs. There have been no transfers between Level 1, Level 2, and Level 3 in any periods presented.

Financial assets and liabilities are considered Level 2 when their fair values are determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. U.S. Treasury, government agency and corporate debt obligations, and commercial paper and asset-backed securities are valued primarily using market prices of comparable securities, bid/ask quotes, interest rate yields and prepayment spreads and are included in Level 2.

Financial assets and liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies, or similar techniques, and at least one significant model assumption or input is unobservable. We have no Level 3 financial assets or liabilities.

8


 

The following tables summarize the estimated fair value and related valuation input hierarchy of our available-for-sale securiti es as of each period end:

 

 

 

 

 

Total

 

 

Total

 

 

Total

 

 

Total

 

 

 

 

 

Amortized

 

 

Unrealized

 

 

Unrealized

 

 

Estimated

 

As of March 31, 2017:

 

Input Level

 

Cost

 

 

Gain

 

 

Loss

 

 

Fair Value

 

 

 

 

 

(in thousands)

 

Money market funds

 

Level 1

 

$

46,617

 

 

$

 

 

$

 

 

$

46,617

 

U.S. Treasury obligations

 

Level 2

 

 

54,363

 

 

 

1

 

 

 

(37

)

 

 

54,327

 

Government agency obligations

 

Level 2

 

 

12,343

 

 

 

2

 

 

 

(4

)

 

 

12,341

 

Corporate debt obligations

 

Level 2

 

 

104,168

 

 

 

9

 

 

 

(106

)

 

 

104,071

 

Commercial paper

 

Level 2

 

 

798

 

 

 

 

 

 

 

 

 

798

 

Asset-backed securities

 

Level 2

 

 

12,390

 

 

 

 

 

 

(17

)

 

 

12,373

 

Total available-for-sale securities

 

 

 

 

230,679

 

 

 

12

 

 

 

(164

)

 

 

230,527

 

Less amounts classified as cash equivalents

 

 

 

 

(62,315

)

 

 

 

 

 

4

 

 

 

(62,311

)

Amounts classified as short-term securities

 

 

 

$

168,364

 

 

$

12

 

 

$

(160

)

 

$

168,216

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

Total

 

 

Total

 

 

Total

 

 

 

 

 

Amortized

 

 

Unrealized

 

 

Unrealized

 

 

Estimated

 

As of December 31, 2016:

 

Input Level

 

Cost

 

 

Gain

 

 

Loss

 

 

Fair Value

 

 

 

 

 

(in thousands)

 

Money market funds

 

Level 1

 

$

28,816

 

 

$

 

 

$

 

 

$

28,816

 

U.S. Treasury obligations

 

Level 2

 

 

65,403

 

 

 

3

 

 

 

(21

)

 

 

65,385

 

Government agency obligations

 

Level 2

 

 

23,860

 

 

 

5

 

 

 

(5

)

 

 

23,860

 

Corporate debt obligations

 

Level 2

 

 

113,649

 

 

 

8

 

 

 

(172

)

 

 

113,485

 

Commercial paper

 

Level 2

 

 

699

 

 

 

 

 

 

 

 

 

699

 

Asset-backed securities

 

Level 2

 

 

13,414

 

 

 

4

 

 

 

(6

)

 

 

13,412

 

Total available-for-sale securities

 

 

 

 

245,841

 

 

 

20

 

 

 

(204

)

 

 

245,657

 

Less amounts classified as cash equivalents

 

 

 

 

(37,944

)

 

 

 

 

 

1

 

 

 

(37,943

)

Amounts classified as short-term securities

 

 

 

$

207,897

 

 

$

20

 

 

$

(203

)

 

$

207,714

 

 

The amortized cost and fair value of our available-for-sale securities by contractual maturity were as follows:

 

 

As of March 31, 2017

 

 

As of December 31, 2016

 

 

Amortized

 

 

Estimated

 

 

Amortized

 

 

Estimated

 

 

Cost

 

 

Fair Value

 

 

Cost

 

 

Fair Value

 

 

(in thousands)

 

 

(in thousands)

 

Maturing within one year

$

194,903

 

 

$

194,823

 

 

$

198,022

 

 

$

197,956

 

Maturing in one to five years

 

35,776

 

 

 

35,704

 

 

 

47,819

 

 

 

47,701

 

Total available-for-sale securities

$

230,679

 

 

$

230,527

 

 

$

245,841

 

 

$

245,657

 

 

As of March 31, 2017, certain available-for-sale securities had been in a continuous unrealized loss position, each for less than twelve months. As of this date, no significant facts or circumstances were present to indicate a deterioration in the creditworthiness of the respective issuers, and the Company has no requirement or intention to sell these securities before maturity or recovery of their amortized cost basis. During the three months ended March 31, 2017 and 2016 , we did not recognize any other-than-temporary impairment loss.

In addition, restricted cash collateralized by money market funds is a financial asset measured at fair value and is a Level 1 financial instrument under the fair value hierarchy. As of March 31, 2017 and December 31, 2016, restricted cash was $1.4 million and $0.2 million, respectively.

 

 

9


 

5.

Property and Equipment

Property and equipment consisted of the following as of each period end :

 

 

March 31,

 

 

December 31,

 

 

 

2017

 

 

2016

 

 

 

(in thousands)

 

Construction in progress

 

$

2,192

 

 

$

970

 

Lab equipment

 

 

1,631

 

 

 

1,506

 

Leasehold improvements

 

 

580

 

 

 

580

 

Furniture and fixtures

 

 

526

 

 

 

526

 

Computer equipment and software

 

 

66

 

 

 

66

 

 

 

 

4,995

 

 

 

3,648

 

Less accumulated depreciation and amortization

 

 

(595

)

 

 

(389

)

Property and equipment, net

 

$

4,400

 

 

$

3,259

 

 

Property and equipment includes lab equipment, furniture and fixtures, computer equipment and software, which are depreciated over the estimated useful lives of the assets, ranging from three to five years. Leasehold improvements are amortized over the lesser of the life of the leasehold improvements or the lease term. Costs for construction in progress relate to expenses capitalized for our planned manufacturing facility in Thousand Oaks, California. Depreciation and amortization expense was $0.2 million and $15,000 for the three months ended March 31, 2017 and 2016, respectively.

 

 

6.

License and Collaboration Agreements

MSK Agreements – In September 2014, we entered into an exclusive option agreement with MSK under which we had the right to acquire the exclusive worldwide license rights to three clinical stage T-cell therapies from MSK. In exchange for the option, we paid $1.25 million in cash and issued 59,761 shares of our common stock to MSK. At the time of issuance, we estimated the fair value of the stock issued to MSK to be $0.75 million. The total of $2.0 million was recorded as research and development expense in our statements of operations and comprehensive loss. In June 2015, we exercised an option to enter into an exclusive license agreement with MSK for three clinical stage T-cell therapies.  In connection with the execution of the license agreement, we paid $4.5 million in cash to MSK, which was recorded as research and development expense in our condensed consolidated statement of operations and comprehensive loss.

We are required to make additional payments of up to $33.0 million to MSK based on achievement of specified regulatory and sales-related milestones, as well as mid-single-digit percentage tiered royalty payments based on future sales of products resulting from the development of the licensed product candidates, if any. In addition, under certain circumstances, we are required to make certain minimum annual royalty payments to MSK, which are creditable against earned royalties owed for the same annual period. We are also required to pay a low double-digit percentage of any consideration we receive for sublicensing the licensed rights. The license agreement expires on a product-by-product and country-by-country basis on the later of: (i) expiration of the last licensed patent rights related to each licensed product, (ii) expiration of any market exclusivity period granted by law with respect to each licensed product, and (iii) a specified number of years after the first commercial sale of the licensed product in each country. Upon expiration of the license agreement, Atara will retain non-exclusive rights to the licensed products.  

QIMR Berghofer Agreements – In October 2015, we entered into an exclusive license agreement and a research and development collaboration agreement with QIMR Berghofer. 

Under the terms of the license agreement, we obtained an exclusive, worldwide license to develop and commercialize allogeneic cytotoxic T-lymphocyte (“CTL”) therapy programs utilizing technology and know-how developed by QIMR Berghofer.  In consideration for the exclusive license, we paid $3.0 million in cash to QIMR Berghofer, which was recorded as research and development expense in our statement of operations and comprehensive loss in the fourth quarter of 2015. In September 2016, the exclusive license agreement and research and development collaboration agreement were amended and restated. Under the amended and restated agreements, we obtained an exclusive, worldwide license to develop and commercialize additional CTL programs as well as the option to license additional technology in exchange for $3.3 million in cash, which was recorded as research and development expense in our statement of operations and comprehensive loss in the third quarter of 2016 and paid in October 2016. The amended and restated license agreement also provides for various milestone and royalty payments to QIMR Berghofer based on future product sales, if any.

10


 

Under the terms of the amended and restated research and devel opment collaboration agreement, we are also required to reimburse the cost of agreed-upon development activities related to programs developed under the collaboration. These payments are expensed on a straight-line basis over the related development period s and recorded in research and development expense in our condensed consolidated statements of operations and comprehensive loss. The agreement also provides for various milestone payments to QIMR Berghofer based on achievement of certain developmental and regulatory milestones.

Amgen License Agreements – In September 2012, we entered into license agreements with Amgen, Inc., for several molecular programs, including PINTA745, ATA842 and STM434. In December 2015, we announced the suspension of further development of PINTA745 and, in June 2016, we returned the rights related to this and the ATA842 program to Amgen.

Milestones and royalties under each of the above agreements are contingent upon future events and will be recorded as expense when it is probable that the milestones will be achieved or royalties are due. As of March 31, 2017 and December 31, 2016, there were no outstanding obligations for milestones and royalties.  

 

7.

Commitments and Contingencies

License and Collaboration Agreements

Certain potential payments related to our license and collaboration agreements, including milestone and royalty payments, are detailed in Note 6. As the achievement of these milestones and royalties are currently not fixed and determinable, such commitments have not been included in our condensed consolidated balance sheets.  

Other Research and Development Agreements

We may enter into contracts in the normal course of business with clinical research organizations for clinical trials, with contract manufacturing organizations for clinical supplies, and with other vendors for pre-clinical studies, supplies and other services for our operating purposes. These contracts generally provide for termination on notice, with the exception of potential termination charges related to one of our contract manufacturing agreements in the event certain minimum purchase volumes are not met. As of March 31, 2017 and December 31, 2016, there were no amounts accrued related to termination charges for minimum purchase volumes not being met.

Operating Leases

 

We lease our corporate headquarters in South San Francisco, California under a non-cancellable lease agreement that expires in April 2021. In connection with the lease, we were required to issue a letter of credit in the amount of $0.2 million to the landlord, which expires in December 2017 and is classified as restricted cash in our condensed consolidated balance sheet. We also lease office space in Westlake Village, California that expires in April 2019. 

 

Rent expense for the three months ended March 31, 2017 and 2016 was $0.3 million and $0.3 million, respectively.  

 

Financing Obligation—Build-to-Suit Lease

 

In February 2017, we entered into a lease agreement for approximately 90,580 square feet of office, lab and cellular therapy manufacturing space in Thousand Oaks, California.  The initial 15-year term of the lease commences after the end of the construction project when the landlord delivers possession of the property to us. The contractual obligations during the initial term are $16.4 million in aggregate.   We have the option to extend the lease for two additional periods of ten and nine years, respectively, after the initial term. In connection with the lease, we were required to issue a letter of credit in the amount of $1.2 million to the landlord, which is recorded as long-term restricted cash in our condensed consolidated balance sheet.

 

Based on the terms of the lease agreement and due to our involvement in certain aspects of the construction, we were deemed the owner of the building (for accounting purposes only) during the construction period in accordance with U.S. GAAP.  Under this build-to-suit lease arrangement, we recognize construction in progress based on all construction costs incurred by both us and the landlord. We also recognize a financing obligation equal to all costs funded by the landlord.

 

As the accounting owner of these buildings during the construction period, we have recorded approximately $2.2 million as construction in progress through March 31, 2017, representing the costs of the building and improvements incurred and a corresponding long-term financing obligation of $0.3 million. We have also recorded a long-term prepaid asset of $0.8 million for costs of construction paid

11


 

to our landlord.  In addition, we recorded ground lease expense of $37,000 for the three months ended March 31, 2017 in our condensed consolidated statement of operations and comprehensive loss.

 

Indemnification Agreements

In the normal course of business, we enter into contracts and agreements that contain a variety of representations and warranties and provide for indemnification for certain liabilities. The exposure under these agreements is unknown because it involves claims that may be made against us in the future but have not yet been made. To date, we have not paid any claims or been required to defend any action related to our indemnification obligations. However, we may record charges in the future as a result of these indemnification obligations. We also have indemnification obligations to our directors and executive officers for specified events or occurrences, subject to some limits, while they are serving at our request in such capacities. There have been no claims to date and we believe the fair value of these indemnification agreements is minimal. Accordingly, we did not record liabilities for these agreements as of March 31, 2017 and December 31, 2016.

Contingencies

From time to time, we may be involved in legal proceedings, as well as demands, claims and threatened litigation, which arise in the normal course of our business or otherwise. The ultimate outcome of any litigation is uncertain and unfavorable outcomes could have a negative impact on our results of operations and financial condition. Regardless of outcome, litigation can have an adverse impact on us because of the defense costs, diversion of management resources and other factors. We are not currently involved in any material legal proceedings.

 

 

8.

Stockholders’ Equity

The following shares of common stock were reserved for future issuance as of March 31, 2017:

 

 

Total Shares Reserved

 

2014 Equity Incentive Plan

 

10,403,584

 

2014 Employee Stock Purchase Plan

 

871,592

 

Total reserved shares of common stock

 

11,275,176

 

 

Equity Incentive Plan

Under the terms of the 2014 Equity Incentive Plan, (“2014 EIP”), we may grant options, RSAs and RSUs to employees, directors, consultants and other service providers. As of March 31, 2017, a total of 10,403,584 shares of common stock were reserved for issuance under the 2014 Plan, of which 4,784,205 shares were available for future grant and 5,619,379 shares were subject to outstanding options and RSUs.

Restricted Stock Units

The RSUs granted prior to our October 2014 IPO had a time-based service condition and a liquidity-based performance condition, and vest when both conditions are met. The liquidity-based performance condition was satisfied upon the closing of our IPO. The fair value of RSUs is determined as the closing stock price on the date of grant. The weighted average grant date fair value of RSUs granted during the three months ended March 31, 2017 and 2016 was $15.09 and $15.78, respectively. As of March 31, 2017, there was $27.1 million of unrecognized stock-based compensation expense related to RSUs that is expected to be recognized over a weighted average period of 3.2 years. The aggregate intrinsic value of the RSUs outstanding as of March 31, 2017 was $37.9 million.  

12


 

The following is a summary of RSU activity under our 2014 EIP:

 

 

 

RSUs

 

 

 

Shares

 

 

Weighted

Average Grant Date Fair Value

 

Unvested as of December 31, 2016

 

 

1,286,262

 

 

 

$16.61

 

Granted

 

 

744,913

 

 

 

$15.09

 

Forfeited

 

 

(16,905

)

 

 

$15.49

 

Vested

 

 

(195,955

)

 

 

$13.34

 

Unvested as of March 31, 2017

 

 

1,818,315

 

 

 

$16.35

 

Vested and unreleased

 

 

25,403

 

 

 

 

 

Outstanding as of March 31, 2017

 

 

1,843,718

 

 

 

 

 

 

Under our RSU net settlement procedures, we withhold shares at settlement to cover the minimum payroll withholding tax obligations. During the three months ended March 31, 2017, we settled 195,957 RSUs, of which 175,723 RSUs were net settled by withholding 20,234 shares.  The value of the RSUs withheld was $0.3 million, based on the closing price of our common stock on the settlement date. During the three months ended March 31, 2016, we settled 52,933 RSUs, of which 50,912 RSUs were net settled by withholding 2,021 shares.  The value of the RSUs withheld was $32,000, based on the closing price of our common stock on the settlement date. The value of RSUs withheld in each period was remitted to the appropriate taxing authorities and has been reflected as a financing activity in our condensed consolidated statements of cash flows.

 

Stock Options

The following is a summary of stock option activity under our 2014 EIP:

 

 

 

Shares

 

 

Weighted   Average Exercise Price

 

 

Weighted Average Remaining Contractual Term (Years)

 

 

Aggregate Intrinsic Value

(in thousands)

 

Outstanding as of December 31, 2016

 

 

3,733,847

 

 

 

$24.14

 

 

 

 

 

 

 

 

 

Granted

 

 

155,100

 

 

 

$14.89

 

 

 

 

 

 

 

 

 

Exercised

 

 

 

 

$

 

 

 

 

 

 

 

 

 

Forfeited or expired

 

 

(113,286

)

 

 

$30.79

 

 

 

 

 

 

 

 

 

Outstanding as of March 31, 2017

 

 

3,775,661

 

 

 

$23.56

 

 

 

5.5

 

 

 

$6,519

 

Vested and expected to vest as of

   March 31, 2017

 

 

3,775,661

 

 

 

$23.56

 

 

 

5.5

 

 

 

$6,519

 

Exercisable as of March 31, 2017

 

 

1,392,218

 

 

 

$24.24

 

 

 

5.0

 

 

 

$2,821

 

 

Aggregate intrinsic value represents the difference between the closing stock price of our common stock on March 31, 2017 and the exercise price of outstanding, in-the-money options. As of March 31, 2017, there was $29.8 million of unrecognized stock-based compensation expense related to stock options that is expected to be recognized over a weighted average period of 2.6 years.

No options were exercised during the three months ended March 31, 2017.  Options for 1,244 shares of our common stock were exercised during the three months ended March 31, 2016, with an intrinsic value of $10,000. As we believe it is more likely than not that no stock option related tax benefits will be realized, we do not record any net tax benefits related to exercised options.

 

13


 

The fair value of each option issued was estimated at the date of grant using the Black-Scholes valuation model. The following table summarizes the weighted-average assumptions used as inputs to the Black-Scholes model, and resulting weighted-average grant date fair values of stock options granted to employees during the periods indicated :

 

 

Three months ended

March 31, 2017

 

 

Three months ended

March 31, 2016

 

 

 

 

 

 

 

 

 

Assumptions:

 

 

 

 

 

 

 

Expected term (years)

 

4.4

 

 

 

4.5

 

Expected volatility

 

69.2

%

 

 

68.8

%

Risk-free interest rate

 

1.9

%

 

 

1.5

%

Expected dividend yield

 

0.0

%

 

 

0.0

%

Fair Value:

 

 

 

 

 

 

 

Weighted-average estimated

   grant date fair value per share

$

8.21

 

 

$

11.42

 

Options granted

 

155,100

 

 

 

325,900

 

Total estimated grant date fair

   value

$

1,273,000

 

 

$

3,722,000

 

 

There were no options granted to consultants in the three months ended March 31, 2017 and 2016.

 

The estimated fair value of stock options that vested in the three months ended March 31, 2017 and 2016 was $4.2 million and $2.7 million, respectively.

Employee Stock Purchase Plan

 

As of March 31, 2017, there were 871,592 shares available for purchase under the 2014 Employee Stock Purchase Plan (“2014 ESPP”). The Company recorded $0.1 million and no expense related to the 2014 ESPP in the three months ended March 31, 2017 and 2016, respectively. No shares were purchased during the three months ended March 31, 2017 and 2016, respectively.

 

Stock-based Compensation Expense

Total stock-based compensation expense related to all employee and non-employee stock awards was as follows:

 

 

Three   months ended March 31,

 

 

2017

 

 

2016

 

 

(in thousands)

 

Research and development

$

2,141

 

 

$

2,246

 

General and administrative

 

3,206

 

 

 

2,478

 

Total stock-based compensation expense

$

5,347

 

 

$

4,724

 

 

 

14


 

Item 2. Management’s Discussion and Analy sis of Financial Condition and Results of Operations

 

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and related notes included elsewhere in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. This discussion and other parts of this Quarterly Report contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations and intentions. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a clinical-stage biopharmaceutical company focused on developing meaningful therapies for patients with severe and life-threatening dise ases that have been underserved by scientific innovation. We are focused on developing allogeneic or third-party derived antigen-specific T-cells.  T-cells are a type of white blood cell. Cytotoxic T-cells, otherwise known as cytotoxic T lymphocytes, or CTLs, can mount an immune response against an antigen or antigens in order to combat viral infection or disease.

Our cellular therapy platform is designed to provide a healthy immune capability to a patient whose immune system is compromised or is unable to identify the disease targets. Our product candidates are derived from cells donated by healthy individuals. These cells are trained to recognize an antigen, expanded, characterized, banked and held as inventory. These cells are ready to infuse in a partially human leukocyte antigen, or HLA, matched patient in approximately 3-5 days. Once administered, the cells home to their target, expand in-vivo to eliminate diseased cells, and eventually recede. This versatile platform can be directed towards a broad array of disease causing targets and has demonstrated clinical proof of concept across both viral and non-viral targets in conditions ranging from liquid and solid tumors to infectious and autoimmune diseases. We licensed rights to T-cell product candidates from Memorial Sloan Kettering Cancer Center, or MSK, in June 2015 and to know-how and technology from QIMR Berghofer Medical Research Institute, or QIMR Berghofer, in October 2015, and September 2016. In connection with the license from QIMR Berghofer, we a lso received an option to exclusively license the autologous, or patient-derived, version of product candidates intended for the potential treatment of Epstein-Barr virus, or EBV, related diseases, including ATA188.

Our relationship with QIMR Berghofer provides rights to know-how and a technology that is complementary to that which we licensed from MSK. This know-how and technology is enabling the development of EBV, and other virally targeted CTLs for other indications such as multiple sclerosis, or MS. We are working with QIMR Berghofer on the development of product candidates for these new indications.

ATA129 for EBV-PTLD after HCT or SOT

Our most advanced T-cell product candidate, ATA129 (previously referred to as EBV-CTL) is currently being investigated for the treatment of EBV associated post-transplant lymphoproliferative disorder, or EBV-PTLD. In immunocompromised patients, EBV causes lymphomas and other lymphoproliferative disorders, collectively called EBV-PTLD. EBV-PTLD most commonly affects patients after hematopoietic cell transplant, or HCT, or after solid organ transplant, or SOT. In December 2016, we announced that we had reached agreement with the U.S. Food and Drug Administration, or FDA, on the designs of two Phase 3 trials for ATA129 intended to support approval in two separate indications: the treatment of rituximab-refractory EBV-PTLD, after HCT and after SOT.

The MATCH trial (EBV-PTLD after HCT) is designed to be a multicenter, open label, single arm trial designed to enroll approximately 35 patents with rituximab-refractory EBV-PTLD after HCT. The ALLELE trial (EBV-PTLD after SOT) is designed to be a multicenter, open label trial with two non-comparative cohorts. Each cohort is designed to enroll approximately 35 patients. The first cohort will include patients who previously received rituximab monotherapy, and the second cohort will include patients who previously received rituximab plus chemotherapy. Both cohorts are planned to enroll concurrently.

The primary endpoint of both the MATCH and ALLELE trials is objective response rate, defined as the percent of patients achieving either a complete or partial response to treatment with ATA129. Secondary endpoints for both trials include duration of response, overall survival, safety, quality of life metrics, and other data in support of potential health economic benefits. The trials are expected to open initially in the United States and later expand to include ex-U.S. sites.

In addition, in June 2016, we opened a multicenter expanded access protocol, or EAP, trial to provide access to ATA129 treatment and collect additional safety data while the medication is not commercially available or available to patients through another

15


 

protocol. The trial is open to patients with EBV-associated viremia or certain malignancies for whom there are no appropriate alternative treatment options.

We are continuing to determine the comparability of ATA129 produced by our contract manufacturing organization, or CMO.  We generated and evaluated data from new material manufactured by our CMO and initiated discussions with the FDA. We have been successful in producing ATA129 drug product and identified certain assays that need refinement prior to initiating the Phase 3 trials. We are refining these assays within our laboratories, manufacturing lots to further support comparability evaluations and the Phase 3 trials, and expect to review these data in ongoing discussions with the FDA and European Medicines Agency, or EMA. We expect to initiate the Phase 3 trials in the second half of this year.

In clinical trials that enrolled patients with EBV-PTLD following HCT or SOT, efficacy following treatment with ATA129 compared favorably with historical data in these patient populations. In rituximab-refractory patients with EBV-PTLD after HCT, treatment with ATA129 resulted in one-year overall survival of approximately 60% in two separate clinical trials in comparison with historical data where median survival, or the time by which 50% of patients had died, was 16-56 days. In the setting of rituximab-refractory EBV-PTLD after SOT, similar results were observed, with one-year overall survival of approximately 60% in ATA129-treated patients in comparison with an expected historical one-year survival of 36% in patients with high risk disease similar to the patients treated in the trials. In February 2015, the FDA granted breakthrough therapy designation for ATA129 in the treatment of rituximab-refractory EBV-PTLD after HCT. Breakthrough therapy designation is an FDA process designed to accelerate the development and review of drugs intended to treat a serious condition when early trials show that the drug may be substantially better than current treatment. In February 2016, the FDA granted orphan drug designation for ATA129 for the treatment of patients with EBV-PTLD after HCT or SOT.

We are also pursuing marketing approval of ATA129 in the European Union, or EU. In March 2016, the EMA issued a positive opinion for orphan drug designation for ATA129 for the treatment of patients with EBV-PTLD. In October 2016, the EMA Committee for Medicinal Products for Human Use, or CHMP, and Committee for Advanced Therapies, or CAT, granted access to the EMA’s newly established Priority Medicines, or PRIME, regulatory initiative for ATA129 for the treatment of patients with rituximab-refractory EBV-PTLD following HCT. PRIME provides early enhanced regulatory support to facilitate regulatory applications and accelerate the review of medicines that address a high unmet need. In January 2017, we announced that pursuant to parallel scientific advice from the EMA’s Scientific Advice Working Group and several national Health Technology Assessment, or HTA, agencies in the EU, in 2018 we plan to submit an application for Conditional Marketing Authorization, or CMA, of ATA129 in the treatment of patients with rituximab-refractory EBV-PTLD following HCT. The CMA will be based on clinical data from Phase 1 and 2 trials conducted at MSK and supported by available data from our Phase 3 trials in rituximab-refractory EBV-PTLD after HCT and SOT, which will be ongoing at the time of filing.

ATA129 for Nasopharyngeal Carcinoma

In April 2017, we entered into an agreement where Merck (known as Merck Sharp & Dohme or MSD outside the United States and Canada) provides drug supply for a trial sponsored and conducted by Atara to evaluate ATA129 in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in patients with platinum resistant or recurrent EBV-associated nasopharyngeal carcinoma. The Phase 1/2 trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination and is planned for initiation in 2018.

Other T-Cell Programs

ATA188 for Multiple Sclerosis

Our second T-cell product candidate, ATA188 is in development for the treatment of multiple sclerosis, or MS. Allogeneic ATA188 is a third party derived EBV-CTL that selectively targets specific antigens of EBV that we believe are important for the treatment of MS. Studies suggest that EBV positive B-cells and plasma cells in the central nervous system, or CNS, have the potential to catalyze an autoimmune response and MS pathophysiology.  Atara Bio believes that selectively targeting and eliminating EBV positive B-cells and plasma cells has the potential to benefit patients with MS. Based on FDA discussions, we are on track to initiate a Phase 1 trial utilizing allogeneic ATA188 in patients with MS in the second half of 2017.

In addition, QIMR Berghofer, is currently conducting a Phase 1 trial utilizing the autologous version of ATA188, or autologous ATA188, for the treatment of patients with either primary or secondary MS. We have an exclusive option to license this program from QIMR Berghofer. The Phase I trial is designed to enroll ten patients, including five with primary progressive MS, or PPMS, and five with secondary progressive MS, or SPMS. In this trial, patients receive four escalating doses of autologous ATA188 over six weeks and are followed for an additional twenty weeks after the last dose.  The objectives of the trial are first, to assess the

16


 

safety and tolerability of autologous ATA188 in patients with progressive MS; second, to document preliminary evidence of ef ficacy through the evaluation of both clinically measured and patient reported changes in MS symptoms during and following treatment; and third, to generate autologous ATA188 at clinical scale from the blood of patients with progressive MS. Our collaborati ng investigators at QIMR Berghofer and the University of Queensland reported interim results from this trial at the 69th AAN Annual Meeting in Boston, Massachusetts in April 2017.

Dr. Michael Pender, M.D., an honorary senior principal research fellow at QIMR Berghofer, and his colleagues reported the following interim clinical results from the trial:   

 

Six patients were treated to date – four with SPMS, two with PPMS.

 

Three of six patients, including two with SPMS and one with PPMS, experienced improvements in MS symptoms as measured by patient reported and objective clinical evaluations.  

 

All three patients with observed clinical improvement showed demonstrated improvement two to eight weeks after initiation of T-cell therapy, including reductions in fatigue and gains in quality of life, ability to perform activities of daily living, and manual dexterity.

We look forward to additional development with both the autologous and allogeneic versions of ATA188 to further evaluate the potential therapeutic utility of targeting EBV in the treatment of MS.  

ATA520 for Hematologic Malignancies

Our third T-cell product candidate, ATA520, targets cancers expressing the antigen Wilms Tumor 1, or WT1, and is currently in Phase 1 clinical trials. WT1 is an intracellular protein that is overexpressed in a number of cancers, including multiple myeloma, or MM.  MSK has two ongoing Phase 1 clinical trials evaluating ATA520. The first trial is a dose escalation trial of ATA520 for residual or relapsed leukemia after HCT. The second trial is a dose escalation trial of ATA520 following T-cell depleted HCT for patients with relapsed or refractory MM, including plasma cell leukemia, or PCL.  Based on data from these trials, we intend to develop ATA520 in hematologic malignancies, including PCL. We expect to initiate a Phase 1/2 clinical trial in patients with hematologic malignancies in 2018.

ATA230 for CMV Viremia

Our fourth T-cell product candidate, ATA230, which is a third-party derived cytomegalovirus, or CMV, CTL, is in Phase 2 clinical trials for refractory CMV an infection that occurs in some patients who have received an HCT or SOT or are otherwise immunocompromised. We met with the FDA for an end of Phase 2 meeting to discuss late stage development of ATA230 for the treatment of anti-viral refractory or resistant CMV infection following either HCT or SOT.  Given the opportunity to pursue a conditional marketing authorization in the EU for ATA129, we have decided to prioritize at this time our EBV related programs ahead of ATA230.  Therefore, we intend to further evaluate ATA230 Phase 3 trial designs following the initiation of our ATA129 Phase 3 trials.

17


 

Financial Overview

 

We have a limited operating history. Since our inception in 2012, we have devoted substantially all of our resources to identify, acquire and develop our product candidates, including conducting preclinical studies and clinical trials and providing general and administrative support for these operations.

We have never generated revenues and have incurred losses since inception. We do not expect to receive any revenues from any product candidates that we develop until we obtain regulatory approval and commercialize our products or enter into collaborative agreements with third parties.

Our net loss was $25.7 million for the three months ended March 31, 2017, and as of March 31, 2017, we had an accumulated deficit of $202.8 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative expenses associated with our operations. As of March 31, 2017, our cash, cash equivalents and short-term investments totaled $230.6 million, which we intend to use to fund our operations.

Research and Development Expenses

The largest component of our total operating expenses since inception has been our investment in research and development activities, including the preclinical and clinical development of our product candidates. Research and development expenses consist primarily of compensation and benefits for research and development employees, including stock-based compensation; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical trials and preclinical studies; the costs of acquiring and manufacturing clinical trial materials and other supplies; payments under licensing and research and development agreements; other outside services and consulting costs; and an allocation of facilities, information technology and overhead expenses. Research and development costs are expensed as incurred.

We plan to increase our research and development expenses as we continue the development of our product candidates. Our current planned research and development activities include the following:

 

initiating and enrolling patients in ATA129 Phase 3 clinical trials for the treatment of EBV-PTLD after HCT and SOT;

 

process development, testing and manufacturing of drug supply to support clinical trials and IND-enabling studies;

 

continuing development of autologous ATA188 and initiation of the Phase 1 trial of allogeneic ATA188 in MS;

 

continuing development of ATA520 for the treatment of hematologic malignancies, including PCL;

 

continuing to develop other product candidates; and

 

leveraging our relationships and experience to in-license or acquire additional product candidates or technologies.

In addition, we believe it is important to invest in the development of new product candidates to continue to build the value of our product candidate pipeline and our business. We plan to continue to advance our most promising early product candidates into preclinical development with the objective to advance these early-stage programs to human clinical trials over the next several years.

Our expenditures on current and future preclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. The duration, costs, and timing of clinical trials and development of our product candidates will depend on a variety of factors, including:

 

the availability of qualified drug supply for use in our planned Phase 3 or other clinical trials;

 

the scope, rate of progress, and expenses of our ongoing as well as any additional clinical trials and other research and development activities;

 

future clinical trial results;

 

uncertainties in clinical trial enrollment rates or discontinuation rates of patients;

 

potential additional safety monitoring or other studies requested by regulatory agencies;

 

significant and changing government regulation; and

 

the timing and receipt of any regulatory approvals.

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The process of conducting the necessary clinical research to obtain FDA approval is costly and time consuming and the successful development of our product candidates is highly uncertain. The risks and u ncertainties associated with our research and development projects are discussed more fully in the section of this report titled “1A.  Risk Factors.” As a result of these risks and uncertainties, we are unable to determine with any degree of certainty the duration and completion costs of our research and development projects, or if, when, or to what extent we will generate revenues from the commercialization and sale of any of our product candidates that obtain regulatory approval. We may never succeed in a chieving regulatory approval for any of our product candidates.

General and Administrative Expenses

General and administrative expenses consist primarily of compensation and benefits for general and administrative employees, including stock-based compensation; outside professional service costs, including legal, patent, human resources, audit and accounting services; and allocated information technology and facilities costs. We anticipate that our general and administrative expenses will continue to increase in the future as we increase our headcount to support our continued research and development and potential commercialization of one or more of our product candidates.

Interest and Other Income, net

Interest and other income, net consists primarily of interest earned on our cash, cash equivalents and short-term investments.

Critical Accounting Policies and Significant Judgments and Estimates

There have been no significant changes during the three months ended March 31, 2017 to our critical accounting policies and significant judgments and estimates as disclosed in our management’s discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2016.

Emerging Growth Company Status

We are an “emerging growth company” as defined in the JOBS Act, and therefore we may take advantage of certain exemptions from various public company reporting requirements. As an “emerging growth company”,

 

we will avail ourselves of the exemption from the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act;

 

we will provide less extensive disclosure about our executive compensation arrangements; and

 

we will not require stockholder non-binding advisory votes on executive compensation or golden parachute arrangements.

However, we are choosing to irrevocably opt out of the extended transition periods available under the JOBS Act for complying with new or revised accounting standards. We will remain an “emerging growth company” for up to five years from the date of our initial public offering, although we will cease to be an “emerging growth company” upon the earliest of: (1) December 31, 2019; (2) the last day of the first fiscal year in which our annual gross revenues are $1 billion or more; (3) the date on which we have, during the previous rolling three-year period, issued more than $1 billion in non-convertible debt securities; and (4) the date on which we are deemed to be a “large accelerated filer” as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

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Results of Operations

Comparison of the Three Months Ended March 31, 2017 and 2016

Research and development expenses

Research and development expenses consisted of the following costs, by program:

 

 

 

Three   months ended March 31,

 

 

Increase

 

 

 

2017

 

 

2016

 

 

(Decrease)

 

 

 

(in thousands)

 

 

 

 

 

ATA129 (formerly EBV-CTL)

 

$

3,794

 

 

$

1,990

 

 

$

1,804

 

ATA230 (formerly CMV-CTL)

 

 

908

 

 

 

15

 

 

 

893

 

T-cell manufacturing and other program-related

 

 

4,547

 

 

 

3,180

 

 

 

1,367

 

STM 434 and other molecular programs

 

 

103

 

 

 

370

 

 

 

(267

)

Employee and overhead costs

 

 

8,189

 

 

 

5,692

 

 

 

2,497

 

Total research and development

 

$

17,541

 

 

$

11,247

 

 

$

6,294

 

 

ATA129 costs were $3.8 million in the 2017 period as compared to $2.0 million in the 2016 period. The increase was primarily due to manufacturing and outside service costs related to the preparation for the two Phase 3 clinical trials of ATA129 in EBV-PTLD and ongoing costs for our Expanded Access Protocol (“EAP”) clinical trial, which was initiated in mid-2016. We anticipate that ATA129 costs will increase in 2017 due to the initiation of the two Phase 3 clinical trials for this product candidate.

ATA230 costs were $0.9 million in the 2017 period as compared to $15,000 in the 2016 period. The increase was primarily related to manufacturing and outside services costs associated with the anticipated EAP clinical trial for this product candidate.

T-cell manufacturing and other program-related expenses were $4.5 million in the 2017 period as compared to $3.2 million in the 2016 period. The increase was primarily due to increased general manufacturing activity for our product candidate and costs associated with our collaboration with QIMR Berghofer. We anticipate that T-cell manufacturing and other program-related expenses will increase in 2017 due to an increase in manufacturing activity, the continued development of our manufacturing processes, and the development of products obtained from our collaboration with QIMR Berghofer.

STM434 and other molecular program costs were $0.1 million in the 2017 period as compared to $0.4 million in the 2016 period. The decrease was primarily due to a de-prioritization of the STM434 program following completion of the dose escalation portion of the Phase 1 clinical trial in 2016. We anticipate that STM434 and other molecular program costs will decrease further in 2017 as we prioritize the development of our T-cell product candidates.

Employee and overhead costs were $8.2 million in the 2017 period as compared to $5.7 million in the 2016 period. The increase was primarily a result of higher payroll and related costs of $1.3 million from increased headcount and an increase in allocated facilities, information technology and overhead expenses of $0.5 million in support of our continuing expansion of research and development activities. We anticipate that employee and overhead costs will continue to increase in future periods as we continue to expand our research and development activities.

General and administrative expenses

 

 

 

Three   months ended March 31,

 

 

Increase

 

 

 

2017

 

 

2016

 

 

(Decrease)

 

 

 

(in thousands)

 

General and administrative

 

$

8,620

 

 

$

5,814

 

 

$

2,806

 

 

General and administrative expenses increased to $8.6 million in the 2017 period as compared to $5.8 million in the 2016 period. The increase between the three-month periods was primarily due to a $0.9 million increase in payroll and related costs driven by increased headcount, a $0.7 million increase in stock-based compensation expense driven by new award grants, and to a lesser extent, higher consulting, outside services and legal costs. We expect that general and administrative costs will continue to increase in 2017 as we continue to expand our operations.

 

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Liquidity and Capital Resources

Sources of Liquidity

Since our inception in 2012, we have funded our operations primarily through the issuance of common and preferred stock. In October 2014, we completed our initial public offering and received net proceeds of $56.5 million. In February 2015, we completed a follow-on offering and received net proceeds of $69.5 million and in July 2015, we completed a follow-on offering and received net proceeds of $193.9 million.

We have incurred losses and negative cash flows from operations in each year since inception. As of March 31, 2017, we had an accumulated deficit of $202.8 million. It will be several years, if ever, before we have a product candidate ready for commercialization, and we anticipate that we will continue to incur losses for at least the next several years. We expect that our research and development and general and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements.

Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash, cash equivalents and short-term investments are held in bank and custodial accounts and consist of money market funds, U.S. Treasury, government agency and corporate debt obligations, commercial paper and asset-backed securities .   For the remainder of 2017 and early 2018, w e expect to spend approximately $50 million of cash to build-out our office, lab and cellular therapy manufacturing space in Thousand Oaks, California. Management expects that existing cash, cash equivalents and short-term investments as of March 31, 2017 will be sufficient to fund our planned operations into the first quarter of 2019 .  

Our cash, cash equivalents and short-term investments balances as of the dates indicated were as follows:

 

 

 

March 31,

 

 

December 31,

 

 

 

2017

 

 

2016

 

 

 

(in thousands)

 

Cash and cash equivalents

 

$

62,430

 

 

$

47,968

 

Short-term investments

 

 

168,216

 

 

 

207,714

 

Total cash, cash equivalents and short-term investments

 

$

230,646

 

 

$

255,682