atra-10q_20160331.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x

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

For the quarterly period ended March 31, 2016

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  x    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  x    No  ¨

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definition of “large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer

¨

Accelerated filer

x

Non-accelerated filer

¨

Smaller reporting company

¨

(Do not check if a smaller reporting company)

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No   x

The number of outstanding shares of the Registrant’s Common Stock as of April 29, 2016 was 28,744,466 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

  

3

 

 

 

 

  

Notes to Condensed Consolidated Financial Statements

  

6

 

 

 

Item 2.

  

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

  

14

 

 

 

Item 3.

  

Quantitative and Qualitative Disclosures about Market Risk

  

21

 

 

 

Item 4.

  

Controls and Procedures

  

21

 

 

 

PART II.

  

OTHER INFORMATION

  

 

 

 

 

Item 1.

  

Legal Proceedings

  

22

 

 

 

Item 1A.

  

Risk Factors

  

22

 

 

 

Item 2.

  

Unregistered Sales of Equity Securities and Use of Proceeds

  

53

 

Item 3.

  

Defaults Upon Senior Securities

  

53

 

Item 4.

  

Mine Safety Disclosures

  

53

 

Item 5.

  

Other Information

  

53

 

Item 6.

  

Exhibits

  

54

 

 

 

  

Signatures

  

55

 

 

 

 

  

Index to Exhibits

  

56

 

 

 

 

 

2

 


 

Atara Biotherapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share and per share amounts)

 

 

 

March 31,

 

 

December 31,

 

 

 

2016

 

 

2015

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

22,056

 

 

$

23,746

 

Short-term investments

 

 

284,347

 

 

 

296,736

 

Restricted cash

 

 

194

 

 

 

194

 

Prepaid expenses and other current assets

 

 

5,144

 

 

 

3,921

 

Total current assets

 

 

311,741

 

 

 

324,597

 

Property and equipment, net

 

 

1,148

 

 

 

270

 

Other assets

 

 

89

 

 

 

108

 

Total assets

 

$

312,978

 

 

$

324,975

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,896

 

 

$

1,445

 

Accrued compensation

 

 

1,337

 

 

 

2,624

 

Accrued research and development expenses

 

 

4,430

 

 

 

5,112

 

Other accrued liabilities

 

 

1,197

 

 

 

528

 

Total current liabilities

 

 

8,860

 

 

 

9,709

 

Long-term liabilities

 

 

284

 

 

 

166

 

Total liabilities

 

 

9,144

 

 

 

9,875

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

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

   March 31, 2016 and December 31, 2015; 28,582,597 and 28,458,807 shares issued

   and outstanding as of March 31, 2016 and December 31, 2015, respectively

 

 

3

 

 

 

3

 

Additional paid-in capital

 

 

418,451

 

 

 

413,725

 

Accumulated other comprehensive income (loss)

 

 

51

 

 

 

(518

)

Accumulated deficit

 

 

(114,671

)

 

 

(98,110

)

Total stockholders’ equity

 

 

303,834

 

 

 

315,100

 

Total liabilities and stockholders’ equity

 

$

312,978

 

 

$

324,975

 

 

 

See accompanying notes.

 

3

 


 

Atara Biotherapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except share and per share amounts)

 

 

 

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

 

2015

 

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

$

11,247

 

 

$

5,767

 

 

General and administrative

 

5,814

 

 

 

3,544

 

 

Total operating expenses

 

17,061

 

 

 

9,311

 

 

Loss from operations

 

(17,061

)

 

 

(9,311

)

 

Interest and other income, net

 

503

 

 

 

153

 

 

Loss before provision for income taxes

 

(16,558

)

 

 

(9,158

)

 

Provision for income taxes

 

3

 

 

 

2

 

 

Net loss

$

(16,561

)

 

$

(9,160

)

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

569

 

 

 

82

 

 

Comprehensive loss

$

(15,992

)

 

$

(9,078

)

 

Net loss per common share:

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

$

(0.58

)

 

$

(0.42

)

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share

 

28,541,896

 

 

 

21,918,467

 

 

See accompanying notes.

4

 


 

Atara Biotherapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

 

 

 

 

Three months ended March 31,

 

 

 

2016

 

 

2015

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(16,561

)

 

$

(9,160

)

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

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

4,724

 

 

 

2,483

 

Amortization of investment premiums and discounts

 

 

1,286

 

 

 

358

 

Depreciation expense

 

 

15

 

 

 

6

 

Loss on foreign exchange

 

 

42

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(1,304

)

 

 

(1,081

)

Other assets

 

 

18

 

 

 

(31

)

Accounts payable

 

 

451

 

 

 

354

 

Accrued compensation

 

 

(1,287

)

 

 

(703

)

Accrued research and development expenses

 

 

(682

)

 

 

910

 

Other accrued liabilities

 

 

669

 

 

 

229

 

Long-term liabilities

 

 

138

 

 

 

13

 

Net cash used in operating activities

 

 

(12,491

)

 

 

(6,622

)

Investing activities

 

 

 

 

 

 

 

 

Purchases of short-term investments

 

 

(130,963

)

 

 

(54,796

)

Sales and maturities of short-term investments

 

 

142,715

 

 

 

41,368

 

Purchases of property and equipment

 

 

(891

)

 

 

(5

)

Net cash provided by (used in) investing activities

 

 

10,861

 

 

 

(13,433

)

Financing activities

 

 

 

 

 

 

 

 

Proceeds from sale of common stock, net of offering costs

 

 

 

 

 

69,487

 

Taxes paid related to net share settlement of restricted stock units

 

 

(32

)

 

 

 

Proceeds from exercise of stock options

 

 

14

 

 

 

 

Net cash provided by (used in) financing activities

 

 

(18

)

 

 

69,487

 

Effect of exchange rates on cash

 

 

(42

)

 

 

 

Increase (decrease) in cash and cash equivalents

 

 

(1,690

)

 

 

49,432

 

Cash and cash equivalents at beginning of period

 

 

23,746

 

 

 

21,897

 

Cash and cash equivalents at end of period

 

$

22,056

 

 

$

71,329

 

Non-cash financing activities

 

 

 

 

 

 

 

 

Issuance of common stock upon vesting of stock awards

 

$

20

 

 

$

20

 

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

 

$

(20

)

 

$

(20

)

Supplemental cash flow disclosure

 

 

 

 

 

 

 

 

Cash paid for taxes

 

$

3

 

 

$

2

 

 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 have two groups of product candidates: (a) allogeneic, or third-party derived, antigen-specific T-cells, and (b) molecularly targeted biologics.

Our T-cell programs were acquired through licensing arrangements with Memorial Sloan Kettering Cancer Center (“MSK”). Our molecularly targeted biologics programs were acquired through licensing arrangements with Amgen Inc. (“Amgen”). See Note 5 for further information.

 

2.

Summary of Significant Accounting Policies

Basis of Presentation

The accompanying interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and the rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”). The accounting policies followed in the preparation of these financial statements are consistent in all material respects with those presented in Note 2 to the consolidated and combined financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015.  

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, 2016, we had an accumulated deficit of $114.7 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, 2016 will be sufficient to fund our planned operations through 2018.

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, 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: ability to obtain future financing; regulatory approval and market acceptance of, and reimbursement for, our product candidates; 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.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant estimates relied upon in preparing these financial statements include the fair value of common stock and the fair value of preferred stock prior to our IPO and estimates related to clinical trial accruals and stock-based compensation expense. Actual results could differ materially from those estimates.

6

 


 

Recent Accounting Pronouncements

In January 2016, the FASB issued ASU No. 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities, which amends the guidance in U.S. GAAP on the classification and measurement of financial instruments. Although the ASU retains many current requirements, it significantly revises an entity’s accounting related to the classification and measurement of investments in equity securities and the presentation of certain fair value changes for financial liabilities measured at fair value. The ASU also amends certain disclosure requirements associated with the fair value of financial instruments. The new standard is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2017, with early adoption permitted for certain changes. The Company is in the process of determining the effects the adoption will have on its consolidated financial statements as well as whether to adopt certain provisions early.

In February 2016, the FASB issued 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 is in the process of determining the effects the adoption will have on its consolidated financial statements as well as whether to adopt certain provisions early.   

In March 2016, the FASB issued ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting, 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. We do not expect that the adoption of the new standard will have a significant impact on our consolidated financial statements.

 

3.

Net Loss per Common Share

Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing the 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 RSAs, unvested RSUs and vested and unvested options 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,

 

 

2016

 

 

2015

 

Unvested restricted common stock awards

 

161,779

 

 

 

487,836

 

Unvested restricted stock units

 

1,007,542

 

 

 

632,838

 

Vested and unvested options

 

3,430,482

 

 

 

340,444

 

 

    

 

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

7

 


 

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.

The following tables summarize the estimated fair value and related valuation input hierarchy of our financial assets measured on a recurring basis, which were comprised solely of available-for-sale securities as of each period end:

 

 

 

 

 

Total

 

 

Total

 

 

Total

 

 

Total

 

 

 

 

 

Amortized

 

 

Unrealized

 

 

Unrealized

 

 

Estimated

 

As of March 31, 2016:

 

Input Level

 

Cost

 

 

Gain

 

 

Loss

 

 

Fair Value

 

 

 

 

 

(in thousands)

 

Money market funds

 

Level 1

 

$

12,104

 

 

$

 

 

$

 

 

$

12,104

 

U.S. Treasury obligations

 

Level 2

 

 

599

 

 

 

 

 

 

 

 

 

599

 

Government agency obligations

 

Level 2

 

 

115,627

 

 

 

45

 

 

 

(20

)

 

 

115,652

 

Corporate debt obligations

 

Level 2

 

 

166,731

 

 

 

99

 

 

 

(68

)

 

 

166,762

 

Commercial paper

 

Level 2

 

 

1,000

 

 

 

 

 

 

 

 

 

1,000

 

Asset-backed securities

 

Level 2

 

 

7,773

 

 

 

2

 

 

 

(7

)

 

 

7,768

 

Total available-for-sale securities

 

 

 

 

303,834

 

 

 

146

 

 

 

(95

)

 

 

303,885

 

Less amounts classified as cash equivalents

 

 

 

 

(19,538

)

 

 

 

 

 

 

 

 

(19,538

)

Amounts classified as short-term investments

 

 

 

$

284,296

 

 

$

146

 

 

$

(95

)

 

$

284,347

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

Total

 

 

Total

 

 

Total

 

 

 

 

 

Amortized

 

 

Unrealized

 

 

Unrealized

 

 

Estimated

 

As of December 31, 2015:

 

Input Level

 

Cost

 

 

Gain

 

 

Loss

 

 

Fair Value

 

 

 

 

 

(in thousands)

 

Money market funds

 

Level 1

 

$

16,364

 

 

$

 

 

$

 

 

$

16,364

 

U.S. Treasury obligations

 

Level 2

 

 

599

 

 

 

 

 

 

(1

)

 

 

598

 

Government agency obligations

 

Level 2

 

 

36,480

 

 

 

1

 

 

 

(88

)

 

 

36,393

 

Corporate debt obligations

 

Level 2

 

 

203,767

 

 

 

8

 

 

 

(339

)

 

 

203,436

 

Commercial paper

 

Level 2

 

 

999

 

 

 

 

 

 

 

 

 

999

 

Asset-backed securities

 

Level 2

 

 

61,304

 

 

 

2

 

 

 

(102

)

 

 

61,204

 

Total available-for-sale securities

 

 

 

 

319,513

 

 

 

11

 

 

 

(530

)

 

 

318,994

 

Less amounts classified as cash equivalents

 

 

 

 

(22,259

)

 

 

 

 

 

1

 

 

 

(22,258

)

Amounts classified as short-term investments

 

 

 

$

297,254

 

 

$

11

 

 

$

(529

)

 

$

296,736

 

 

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

 

 

As of March 31, 2016

 

 

As of December 31, 2015

 

 

Amortized

 

 

Estimated

 

 

Amortized

 

 

Estimated

 

 

Cost

 

 

Fair Value

 

 

Cost

 

 

Fair Value

 

 

(in thousands)

 

 

(in thousands)

 

Maturing within one year

$

209,513

 

 

$

209,508

 

 

$

211,311

 

 

$

211,059

 

Maturing in one to five years

 

94,321

 

 

 

94,377

 

 

 

108,202

 

 

 

107,935

 

Total available-for-sale securities

$

303,834

 

 

$

303,885

 

 

$

319,513

 

 

$

318,994

 

 

 

As of March 31, 2016, 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 had no requirement or intention to sell these securities before maturity or recovery of their amortized cost basis. During the three months ended March 31, 2016 and 2015, we did not recognize any other-than-temporary impairment loss.

 

 

8

 


 

5.

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, which at the time of issuance had an estimated fair value of $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 our option and entered into an exclusive license agreement with MSK. 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 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.

Amgen License Agreements - In September 2012, we entered into three license agreements with Amgen. In accordance with terms of the agreements with Amgen, we use commercially reasonable efforts to prepare, file, prosecute, defend and maintain the patents covered by the license agreements. During the three months ended March 31, 2016 and 2015, we incurred expenses of $0.2 million and $0.5 million, respectively, related to these activities.

In December 2015, we announced that we would be suspending further development of PINTA 745 and in March 2016, we gave notice to Amgen that we were returning the rights to this and the ATA 842 program. Under the remaining license agreements, potential payments of up to $58.0 million are due to Amgen upon the achievement of development and regulatory approval milestones and payments of up to $104.0 million are due upon the achievement of sales-based milestones.

We are also required to pay mid-single-digit percentage tiered royalties on future net sales of products which are developed and approved as defined by the agreements, if any. Our royalty obligations as to a particular licensed product will be payable, on a country-by-country and product-by-product basis, until the later of (a) the date of expiration of the last to expire valid claim within the licensed patents that covers the manufacture, use or sale, offer to sell, or import of such licensed product by us or a sublicense in such country, (b) loss of regulatory exclusivity, or (c) 10 years after the first commercial sale of the applicable licensed product in the applicable country. These agreements expire at the end of all royalty obligations to Amgen and, upon expiration, the licenses will be fully paid, royalty-free, irrevocable and non-exclusive.

QIMR Berghofer Agreements – In October 2015, we entered into an exclusive license agreement and a research and development collaboration agreement with QIMR Berghofer Medical Research Institute (“QIMR Berghofer”). Under the terms of the license agreement, we obtained an exclusive, worldwide license to develop and commercialize allogeneic cytotoxic T-lymphocytes (“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. Under the research and development collaboration agreement, we are required to reimburse the cost of agreed upon development activities. These payments are expensed on a straight-line basis over the term of the agreement and resulted in research and development expense of $0.3 million for the three months ended March 31, 2016. The agreement also provides for various milestone and royalty payments to QIMR Berghofer based on achievement of certain developmental milestones and future product sales, if any.

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, 2016 and December 31, 2015, there were no outstanding obligations for milestones and royalties to MSK, Amgen and QIMR Berghofer.

9

 


 

 

6.

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 5. As the achievement of these milestones and royalties are currently not fixed and determinable, such commitments have not been included in our 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.

Operating Leases

In December 2015, we entered into a lease agreement for our new corporate headquarters in South San Francisco, California, which is expected to expire in April 2021. In connection with the lease, we issued a letter of credit for $0.2 million to the landlord, which expires in December 2016 and is classified as restricted cash in our balance sheet. The sublease agreement for our previous corporate headquarters in South San Francisco, which was vacated in April 2016, expires in January 2017. We also lease a facility in Westlake Village, California under a lease agreement that expires in April 2019, and office space in New York, under a lease agreement that expires in April 2016. As of March 31, 2016, future minimum commitments for these operating leases were as follows:

 

 

 

Operating Leases

 

Periods Ending December 31,

 

(in thousands)

 

2016

 

$

802

 

2017

 

 

969

 

2018

 

 

981

 

2019

 

 

734

 

2020

 

 

614

 

Thereafter

 

 

208

 

Total operating lease commitments

 

$

4,308

 

 

Rent expense for the three months ended March 31, 2016 and 2015 was $0.3 million and $0.1 million, respectively.

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, 2016 and December 31, 2015.

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.

 

10

 


 

7.

Stockholders’ Equity  

The following shares of common stock were reserved for future issuance as of March 31, 2016:

 

Total Shares Reserved

 

2014 Equity Incentive Plan

 

5,971,408

 

2014 Employee Stock Purchase Plan

 

663,667

 

Total reserved shares of common stock

 

6,635,075

 

Restricted Stock Awards

  In August 2012 and March 2013, our CEO and one Atara employee purchased restricted stock awards (“RSAs”) with certain vesting conditions. As of March 31, 2016, 1,173,606 of these shares had vested and are reported as shares outstanding in the financial statements. The remaining 161,779 shares are expected to fully vest in 2016. Stock-based compensation expense related to the RSAs is recorded using accelerated graded vesting model and was $0.1 million and $0.3 million for the three months ended March 31, 2016 and 2015, respectively. The unrecognized stock-based compensation expense related to unvested RSAs was $0.1 million as of March 31, 2016 and this expense is expected to be recognized in 2016. The aggregate intrinsic value of unvested RSAs was $3.0 million as of March 31, 2016.

2014 Equity Incentive Plan (2014 EIP)

Our 2014 EIP permits the issuance of stock options (“options”), restricted stock units (“RSUs”) and other types of awards to employees, directors and consultants.  

 As of March 31, 2016, a total of 5,971,408 shares of common stock were reserved for issuance under the 2014 Plan, of which 836,815 shares were available for future grant and 4,462,003 were subject to outstanding options and RSUs.  

Restricted Stock Units and Awards

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

 

 

 

RSAs

 

 

RSUs

 

 

 

Shares

 

 

Weighted Average Grant Date Fair Value

 

 

Shares

 

 

Weighted Average Grant Date Fair Value

 

Unvested as of December 31, 2015

 

 

48,317

 

 

$

0.40

 

 

 

427,605

 

 

$

7.86

 

Granted

 

 

 

 

 

 

 

 

 

642,697

 

 

$

15.78

 

Forfeited

 

 

 

 

 

 

 

 

 

(10,683)

 

 

$

6.28

 

Vested

 

 

(16,106)

 

 

$

0.40

 

 

 

(52,077)

 

 

$

8.59

 

Unvested as of March 31, 2016

 

 

32,211

 

 

$

0.40

 

 

 

1,007,542

 

 

$

12.99

 

Vested and unreleased

 

 

 

 

 

 

 

 

 

 

23,979

 

 

 

 

 

Outstanding as of March 31, 2016

 

 

 

 

 

 

 

 

 

 

1,031,521

 

 

 

 

 

 

As of March 31, 2016, there was $10.9 million of unrecognized stock-based compensation expense related to RSUs that is expected to be recognized over a weighted average period of 1.9 years. The aggregate intrinsic value of the RSUs outstanding as of March 31, 2016 was $19.6 million. 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, 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 approximately $32,000 based on the closing price of our common stock on the settlement date. This amount was remitted to the appropriate taxing authorities and has been reflected as a financing activity in our condensed consolidated statements of cash flows.

11

 


 

Stock Options

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

 

 

 

Number of shares

 

 

Weighted Average Exercise Price

 

 

Weighted Average Remaining Contractual Term (Years)

 

 

Aggregate Intrinsic Value

(in thousands)

 

Outstanding as of December 31, 2015

 

 

3,137,529

 

 

$

25.81

 

 

 

 

 

 

 

 

 

Granted

 

 

325,900

 

 

$

20.73

 

 

 

 

 

 

 

 

 

Exercised

 

 

(1,244)

 

 

$

11.19

 

 

 

 

 

 

 

 

 

Forfeited or expired

 

 

(31,703)

 

 

$

18.79

 

 

 

 

 

 

 

 

 

Outstanding as of March 31, 2016

 

 

3,430,482

 

 

$

25.46

 

 

 

6.26

 

 

$

3,901

 

Vested and expected to vest as of March 31, 2016

 

 

3,430,482

 

 

$

25.46

 

 

 

6.26

 

 

$

3,901

 

Exercisable as of March 31, 2016

 

 

490,828

 

 

$

20.66

 

 

 

5.77

 

 

$

1,393

 

 

Aggregate intrinsic value represents the difference between the closing stock price of our common stock on March 31, 2016 and the exercise price of outstanding, in-the-money options. As of March 31, 2016, there was $40.6 million of unrecognized stock-based compensation expense related to stock options that is expected to be recognized over a weighted average period of 3.2 years.  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. No options were exercised during the three months ended March 31, 2015.  

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 during the period indicated:

 

 

Three months ended

March 31, 2016

 

 

Three months ended March 31, 2015

 

 

Employees

 

 

Employees

 

Consultants

 

Assumptions:

 

 

 

 

 

 

 

 

 

 

Expected term (years)

 

4.5

 

 

 

4.5

 

 

6.9

 

Expected volatility

 

68.8

%

 

 

71.1

%

 

70.1

%

Risk-free interest rate

 

1.5

%

 

 

1.3

%

 

1.6

%

Expected dividend yield

 

-

 

 

 

-

 

 

-

 

Weighted-average estimated grant date fair value per share

$

11.42

 

 

$

14.07

 

$

16.66

 

 

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

 

The estimated fair value of stock options that vested during the three months ended March 31, 2016 and 2015 was $2.7 million and $0.4 million, respectively.

12

 


 

2014 Employee Stock Purchase Plan (2014 ESPP)

As of March 31, 2016, there were 663,667 shares authorized for issuance under the 2014 ESPP. No offerings commenced and there were no purchases of shares under the 2014 ESPP in the three months ended March 31, 2016 and 2015.

Stock-based Compensation Expense

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

 

 

 

Three months ended March 31,

 

 

 

2016

 

 

2015

 

 

 

(in thousands)

 

Research and development

 

$

2,246

 

 

$

1,288

 

General and administrative

 

 

2,478

 

 

 

1,195

 

Total stock-based compensation

 

$

4,724

 

 

$

2,483

 

 

 

13

 


 

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

 

Management’s Discussion and Analysis 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, 2016. 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 diseases that have been underserved by scientific innovation. We have two groups of product candidates: (a) allogeneic, or third-party derived, antigen-specific T-cells, and (b) molecularly targeted biologics.

T-cells are a type of white blood cell, and cytotoxic T-cells, otherwise known as cytotoxic T lymphocytes, or CTLs, have the ability to kill cancer cells. Our T-cell product candidates arise from a platform technology designed to produce off-the-shelf, partially human leukocyte antigen, or HLA, matched cellular therapeutics. We licensed rights to these product candidates from Memorial Sloan Kettering Cancer Center, or MSK, in June 2015. Our initial T-cell product candidates target viral- or cancer-specific antigens and are designed to harness the body’s immune system to counteract specific viral infections and cancers. Our most advanced T-cell product candidate, EBV-CTL, is in Phase 2 clinical trials for malignancies associated with Epstein Barr Virus, or EBV, including EBV-associated post-transplant lymphoproliferative disorders, or EBV-PTLD. EBV-PTLD is a cancer affecting some patients who have received an allogeneic hematopoietic cell transplant, or HCT, a solid organ transplant, or SOT, or are otherwise immunocompromised. Our second T-cell product candidate, CMV-CTL, is in Phase 2 clinical trials for cytomegalovirus, or CMV, an infection that occurs in some patients who have received an HCT or SOT or are otherwise immunocompromised. Our third T-cell product candidate, WT1-CTL, targets cancers expressing the antigen Wilms Tumor 1, or WT1, and is currently in Phase 1 clinical trials. In addition, we entered into a sponsored research collaboration with MSK to discover and develop additional T-cell product candidates. In October 2015, we entered into exclusive license and research agreements with another academic institution. These agreements enable us to access a technology complementary to that which was licensed from MSK and to pursue development of EBV and CMV-CTLs for other indications such as nasopharyngeal carcinoma, or NPC, gastric cancer, and multiple sclerosis, or MS. We are working with this academic institution to initiate clinical trials utilizing allogeneic CTLs in these new indications.

Our molecularly targeted product candidates are biologics that inhibit myostatin and activin, members of the Transforming Growth Factor-Beta, or TGF-ß, protein superfamily, which play roles in the growth and maintenance of muscle and many other body tissues. Our lead molecularly targeted product candidate is STM 434. We commenced a Phase 1 clinical trial of STM 434 for ovarian cancer and other solid tumors in 2014.

In February 2015, the U.S. Food and Drug Administration, or FDA, granted breakthrough therapy designation for EBV-CTL 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 June 2015, we met with the FDA to discuss late-stage development to support a potential approval in this indication. Based on guidance from the FDA, we submitted a special protocol assessment, or SPA, for a single arm pivotal trial in rituximab-refractory EBV-PTLD after HCT. We received feedback from the FDA regarding this SPA in which the FDA indicated that a single arm trial with response rate as the primary endpoint may provide an adequate basis for approval but it would be unlikely to grant an SPA for our proposed trial. We intend to continue the dialogue with the FDA regarding this trial design under breakthrough therapy designation and expect to initiate this pivotal trial towards the end of 2016.  Additionally, we also intend to initiate a randomized pivotal trail in patients with EBV-PTLD after SOT towards the end of 2016.  In February 2016, the FDA granted orphan drug designation for EBV-CTL for the treatment of patients with EBV-PTLD after HCT or SOT, and in March 2016, the European Medicines Agency, or EMA, granted orphan drug designation for EBV-CTL for the treatment of patients with EBV-PTLD. We anticipate commencing a multi-center expanded access clinical trial of EBV-CTL in the middle of 2016 and two pivotal trials of EBV-CTL in patients with EBV-PTLD towards the end of 2016. We expect to meet with the FDA in the middle of 2016 to discuss late phase development with CMV-CTL to support approval. We have been accepted into the EMA’s Adaptive Pathways project, and we now intend to seek scientific advice from the EMA later this year.

14

 


 

While we evaluate the path to registration for both EBV-CTL and CMV-CTL in these initial indications, we intend to concurrently explore the clinical utility of these T-cell product candidates or other cellular therapies in other relevant disease states to expand their potential applicability. In addition, we believe that T-cells can be directed at a broad range of other targets to create future product candidates. We believe that viral antigens are well suited to adoptive immunotherapy given that people with normal immune systems are able to mount robust responses to these viral targets, but immunocompromised patients and some cancer patients are not.

Our lead molecularly targeted product candidate, STM 434, is in a Phase 1 clinical trial that is enrolling patients with ovarian cancer and other solid tumors. In October 2015, we received orphan drug designation from the FDA for ovarian cancer. STM 434 is a soluble ActR2B receptor that binds Activin A. We are testing the potential use of Activin A as a biomarker in our Phase 1 clinical trial. We believe that novel therapies for clear cell and granulosa cell tumors could qualify for breakthrough therapy designation. Based on its mechanism of action, we also believe that STM 434 has the potential to be the first product to target tumor growth and proliferation through the inhibition of Activin A.

STM 434 is a novel molecule with a well-characterized mechanism of action. It was developed initially, along with our other in-licensed molecularly targeted biologic product candidates, at Amgen. Taken together, we believe these product candidates constitute a pipeline of biologics that have benefited from years of investment, resulting in a large patent portfolio, with broad preclinical testing. We are evaluating the remaining pre-clinical molecularly targeted product candidates to determine the best path forward. Where appropriate, we intend to conduct preclinical studies and file INDs with the FDA for these candidates.

In December 2015, we announced results from our Phase 2 proof-of-concept clinical trial of PINTA 745 for the treatment of protein energy wasting in patients with end stage renal disease.  The trial did not meet its primary endpoint and in March 2016, we gave notice to Amgen that we were returning the rights to this program.

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. Our net loss was $16.6 million for the three months ended March 31, 2016, and as of March 31, 2016, we had an accumulated deficit of $114.7 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, 2016, our cash, cash equivalents and short-term investments totaled $306.4 million, which we intend to use to fund our operations.

Financial Overview

Revenues

To date, we have not generated any revenues. 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.

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 agreements; other outside services and consulting costs; and an allocation of facilities 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:

 

·

advancing EBV-CTL into Phase 3 clinical trials for the treatment of EBV-PTLD after HCT and SOT;

 

·

developing CMV-CTL in refractory CMV infection after HCT;

 

·

continuing development of WT1-CTL in relapsed refractory multiple myeloma, including plasma cell leukemia;

 

·

collaborating with MSK and another academic institution in the discovery and development of additional T-cell programs;

15

 


 

 

·

expanding our licensed T-cell platforms into other indications or viral targets;  

 

·

completing our Phase 1 clinical trial of STM 434;

 

·

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

 

·

evaluating our other molecularly targeted product candidates and advancing them into the clinic as appropriate; 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 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.

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 uncertainties 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 costs to complete 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 achieving 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 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 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.

16

 


 

Critical Accounting Policies and Significant Judgments and Estimates

There have been no significant changes during the three months ended March 31, 2016 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, 2015.

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, 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”).

Results of Operations

Comparison of the Three Months Ended March 31, 2016 and 2015

Research and development expenses

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

 

 

 

Three months March 31,

Increase

 

 

 

2016

 

 

2015

 

 

(Decrease)

 

 

 

(in thousands)

 

 

 

 

 

EBV-CTL

 

$

1,990

 

 

$

59

 

 

$

1,931

 

CMV-CTL

 

 

15

 

 

 

 

 

 

15

 

Other T-cell program expenses

 

 

3,180

 

 

 

63

 

 

 

3,117

 

STM 434 and other molecular programs

 

 

370

 

 

 

3,123

 

 

 

(2,753

)

Employee and overhead costs

 

 

5,692

 

 

 

2,522

 

 

 

3,170

 

Total research and development

 

$

11,247

 

 

$

5,767

 

 

$

5,480

 

 

EBV-CTL costs were $2.0 million in the 2016 period as compared to $0.1 million in the 2015 period, primarily due to development work undertaken following our exercise of the option to license this program from MSK in June 2015. We anticipate that EBV-CTL costs will increase significantly in 2016 due to the initiation of additional clinical trials for this product candidate.

Other T-cell program expenses increased to $3.2 million in the 2016 period as compared to $0.1 million in the 2015 period, primarily due to manufacturing costs for product that can be used across all of our T-cell programs. We anticipate that these costs will continue to increase in 2016.

STM 434 and other molecular program expenses, which include costs related to PINTA 745 and ATA 842, which are in the process of being returned to Amgen, decreased to $0.4 million in the 2016 period as compared to $3.1 million in the 2015 period. We anticipate that costs related to STM 434 and other molecular program expenses will decrease in 2016 following the return of the PINTA 745 and ATA 842 programs to Amgen.

17

 


 

Employee and overhead costs increased to $5.7 million in the 2016 period as compared to $2.5 million in the 2015 period, primarily as a result of higher compensation-related costs resulting from increased headcount in support our continuing expansion of research and development activities. In particular, payroll and employee stock-based compensation increased by $1.8 million and $1.0 million, respectively, in the 2016 period as compared to the 2015 period. 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

 

 

 

2016

 

 

2015

 

 

(Decrease)

 

 

 

(in thousands)

 

General and administrative

 

$

5,814

 

 

$

3,544

 

 

$

2,270

 

 

General and administrative expenses increased to $5.8 million in the 2016 period as compared to $3.5 million in the 2015 period, primarily due to a $1.3 million increase in stock-based compensation expense driven by new award grants and a $1.0 million increase in payroll and related costs driven by increased headcount. We expect that general and administrative costs will continue to increase in 2016 as we continue to expand our operations.

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.

We have incurred losses and negative cash flows from operations in each year since inception. As of March 31, 2016, we had an accumulated deficit of $114.7 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 written 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.  Management expects that existing cash and cash equivalents as of March 31, 2016 will be sufficient to fund our planned operations through 2018.  

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

 

 

 

 

 

 

 

 

 

 

 

March 31,

 

 

December 31,

 

 

 

2016

 

 

2015

 

 

 

(in thousands)

 

Cash and cash equivalents

 

$

22,056

 

 

$

23,746

 

Short-term investments

 

 

284,347

 

 

 

296,736

 

Total cash, cash equivalents and short-term investments

 

$

306,403

 

 

$

320,482

 

18

 


 

Cash Flows

Comparison of the Three months Ended March 31, 2016 and 2015

The following table details the primary sources and uses of cash for each of the periods set forth below:

 

 

 

Three months ended March 31,

 

 

 

2016

 

 

2015

 

 

 

(in thousands)

 

Net cash provided by (used in):

 

 

 

 

 

 

 

 

Operating activities

 

$

(12,491

)

 

$

(6,622

)

Investing activities

 

 

10,861

 

 

 

(13,433

)

Financing activities

 

 

(18

)

 

 

69,487

 

Effect of exchange rates on cash

 

 

(42

)

 

 

 

Net increase (decrease) in cash and cash equivalents

 

$

(1,690

)

 

$

49,432

 

Operating activities

Net cash used in operating activities was $12.5 million in the 2016 period as compared to $6.6 million in the 2015 period. The increase of $5.9 million was primarily due to a $7.4 million increase in net loss and a $2.0 million decrease in operating assets and liabilities, partially offset by a $2.2 million increase in stock-based compensation and a $0.9 million increase in the amortization of investment premiums and discounts.

Investing activities

Net cash provided by investing activities in the 2016 period consisted primarily of $142.7 million from maturities and sales of available-for-sale securities partially offset by $131.0 million used to purchase available-for-sale securities. Net cash used in investing activities in the 2015 period consisted primarily of $54.8 million invested in short-term available-for-sale securities, offset by maturities of $41.4 million of such securities.  

Financing activities

Net cash used in financing activities in the 2016 period was negligible.  Net cash provided by financing activities in the 2015 period was $69.5 million, consisting of proceeds from the sale of common stock, net of offering costs.  

Operating Capital Requirements and Plan of Operations

To date, we have not generated any revenue from product sales. We do not know when, or if, we will generate any revenue from product sales. We do not expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and commercialize one of our current or future product candidates. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of and seek regulatory approvals for our product candidates, and begin to commercialize any approved products. We are subject to all of the risks inherent in the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need to raise substantial additional funding in connection with our continuing operations.

We expect that our existing cash, cash equivalents and short-term investments will be sufficient to fund our planned operations through 2018. In order to complete the process of obtaining regulatory approval for our lead product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our lead product candidates, if approved, we will require substantial additional funding.

We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:

 

·

the timing and costs of our planned clinical trials and preclinical studies for our product candidates;

 

·

our success in establishing and scaling commercial manufacturing capabilities;

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·

the number and characteristics of product candidates that we pursue;  

 

·

the outcome, timing and costs of seeking regulatory approvals;

 

·

subject to receipt of regulatory approval, revenues received from commercial sales of our product candidates;

 

·

the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may establish;

 

·

the amount and timing of any payments we may be required to make in connection with the licensing, filing, prosecution, maintenance, defense and enforcement of any patents or patent applications or other intellectual property rights; and

 

·

the extent to which we in-license or acquire other products and technologies.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

 

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Item 3. Quantitative and Qualitative Disclosures about Market Risk

During the three months ended March 31, 2016, there were no material changes to our interest rate risk disclosures, market risk disclosures and foreign currency exchange rate risk disclosures reported in our Annual Report on Form 10-K for the year ended December 31, 2015.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Under the supervision of our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) of the Exchange Act as of March 31, 2016.  Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of March 31, 2016 to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely discussion regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Inherent Limitations on Controls and Procedures

Our management, including our Chief Executive Officer and our Chief Financial Officer and Principal Accounting Officer, does not expect that our disclosure controls and procedures and our internal controls will prevent all error and all fraud. A control system, no matter how well designed and operated, can only provide reasonable assurances that the objectives of the control system are met. The design of a control system reflects resource constraints; the benefits of controls must be considered relative to their costs. Because there are inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been or will be detected. As these inherent limitations are known features of the financial reporting process, it is possible to design into the process safeguards to reduce, though not eliminate, these risks. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns occur because of simple error or mistake. Controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls is based in part upon certain assumptions about the likelihood of future events. While our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives, there can be no assurance that any design will succeed in achieving its stated goals under all future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

We intend to review and evaluate the design and effectiveness of our disclosure controls and procedures on an ongoing basis and to improve our controls and procedures over time and to correct any deficiencies that we may discover in the future. While our Chief Executive and Financial Officer and Principal Accounting Officer have concluded that, as of March 31, 2016, the design of our disclosure controls and procedures, as defined in Rule 13a-15(e) under the Exchange Act, was effective, future events affecting our business may cause us to significantly modify our disclosure controls and procedures.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended March 31, 2016 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

None.

 

Item 1A. Risk Factors

 

Investing in our common stock involves a high degree of risk. You should carefully consider all of the risk factors and uncertainties described below, in addition to the other information contained in this Quarterly Report on Form 10-Q, including the section of this report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our unaudited condensed consolidated financial statements and related notes, before investing in our common stock.  If any of the following risks materialize, our business, financial condition and results of operations could be seriously harmed.  In these circumstances, the market price of our common stock could decline, and you may lose all or a part of your investment. We have marked with an asterisk (*) those risk factors that reflect substantive changes from the risk factors included in our previously filed Annual Report on Form 10-K for the year ended December 31, 2015.

Risks Related to Our Financial Results and Capital Needs

We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the foreseeable future.*

We are a clinical-stage biopharmaceutical company. Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to prove effective, gain regulatory approval or become commercially viable. We do not have any products approved by regulatory authorities and have not generated any revenues from product sales to date, and have incurred significant research, development and other expenses related to our ongoing operations and expect to continue to incur such expenses. As a result, we have not been profitable and have incurred significant operating losses in every reporting period since our inception. For the three months ended March 31, 2016, we reported a net loss of $16.6 million and we had an accumulated deficit of $114.7 million as of March 31, 2016.

We do not expect to generate revenues for many years, if at all. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate these losses to increase as we continue to research, develop and seek regulatory approvals for our product candidates and any additional product candidates we may acquire, and potentially begin to commercialize product candidates that may achieve regulatory approval. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. If any of our product candidates fails in clinical trials or does not gain regulatory approval, or if approved, fails to achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. We anticipate that our expenses will increase in the future as we continue to invest in research and development of our existing product candidates, investigate and potentially acquire new product candidates and expand our manufacturing and commercialization activities.

We have a limited operating history, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

Our company was formed in August 2012. Our operations to date have been limited to organizing and staffing our company, acquiring product and technology rights and conducting product development activities for our product candidates. We have not yet demonstrated our ability to successfully complete any Phase 2 or Phase 3 clinical trials, obtain regulatory approval, manufacture a commercial scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization for any of our product candidates. In addition, the adoptive immunotherapy technology underlying our T-cell product candidates, EBV-CTL, CMV-CTL and WT1-CTL, is new and largely unproven. Any predictions about our future success, performance or viability, particularly in view of the rapidly evolving cancer immunotherapy field, may not be as accurate as they could be if we had a longer operating history or approved products on the market.

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In addition, as a young business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition. We expect our financial condition and operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of future operating performance.

We currently have no source of revenues. We may never generate revenues or achieve profitability.

To date, we have not generated any revenues from product sales or otherwise. Even if we are able to successfully achieve regulatory approval for our product candidates, we do not know when we will generate revenues or become profitable, if at all. Our ability to generate revenues from product sales and achieve profitability will depend on our ability to successfully commercialize products, including any of our current product candidates, and other product candidates that we may develop, in-license or acquire in the future. Our ability to generate revenues and achieve profitability also depends on a number of additional factors, including our ability to:

 

·

successfully complete development activities, including the necessary clinical trials;

 

·

complete and submit BLAs to the FDA and obtain US regulatory approval for indications for which there is a commercial market;

 

·

complete and submit applications to, and obtain regulatory approval from, foreign regulatory authorities in Europe, Asia and other jurisdictions;

 

·

obtain coverage and adequate reimbursement from third parties, including government and private payors;

 

·

set commercially viable prices for our products, if any;

 

·

establish and maintain supply and manufacturing relationships with reliable third parties and ensure adequate, legally compliant manufacturing of bulk drug substances and drug products to maintain that supply;

 

·

develop manufacturing and distribution processes for our novel T-cell product candidates;

 

·

obtain commercial quantities of our products at acceptable cost levels;

 

·

achieve market acceptance of our products, if any;

 

·

attract, hire and retain qualified personnel;

 

·

protect our rights in our intellectual property portfolio;

 

·

develop a commercial organization capable of sales, marketing and distribution for any products we intend to sell ourselves in the markets in which we choose to commercialize on our own; and

 

·

find suitable distribution partners to help us market, sell and distribute our approved products in other markets.

Our revenues for any product candidate for which regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for the product, the ability to get reimbursement at any price, and whether we own the commercial rights for that territory. If the number of our addressable disease patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenues from sales of such products, even if approved. In addition, we anticipate incurring significant costs associated with commercializing any approved product candidate. As a result, even if we generate revenues, we may not become profitable and may need to obtain additional funding to continue operations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations.

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We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.*

We expect to expend substantial resources for the foreseeable future to continue the clinical development and manufacturing of EBV-CTL, CMV-CTL, WT1-CTL, STM 434 and the advancement and expansion of our preclinical research pipeline. We also expect to expend resources for the development and manufacturing of product candidates and the technology we recently licensed from another academic institution. These expenditures will include costs associated with research and development, potentially acquiring new product candidates or technologies, conducting preclinical studies and clinical trials and potentially obtaining regulatory approvals and manufacturing products, as well as marketing and selling products approved for sale, if any. Under the terms of our license agreements with Amgen and MSK, taking into account the expectation that the licenses for PINTA 745 and ATA 842 will terminate in June 2016, we are obligated to make payments of up to $58.0 million to Amgen and up to $9.0 million to MSK with respect to the three licensed clinical stage T-cell programs upon the achievement of certain development and regulatory approval milestones. We are also obligated to make payments for certain commercial milestones. In addition, other unanticipated costs may arise. Because the design and outcome of our planned and anticipated clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our product candidates.

Our future capital requirements depend on many factors, including:

 

·

the scope, progress, results and costs of researching and developing our product candidates, and conducting preclinical studies and clinical trials;

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