Business description of ATARA-BIOTHERAPEUTICS-INC from last 10-k form

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

x

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

For the fiscal year ended December 31, 2014

¨

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.)

701 Gateway Blvd., Suite 200

South San Francisco, CA

 

94080

(Address of principal executive offices)

 

(Zip Code)

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

Securities registered pursuant to Section 12(b) of the Act: Common Stock, Par Value $0.001 Per Share; Common stock traded on the NASDAQ stock market

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ¨ NO x

Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES ¨ NO x

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 if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405) is not contained herein, and will not be contained, to the best of Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. x

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

 

¨

 

 

 

 

Non-accelerated filer

 

x  (Do not check if a small reporting company)

  

Small 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 x

The Registrant did not have a public float on the last business day of its most recently completed second fiscal quarter because there was no public market for the registrant’s common equity as of such date.

The number of shares of Registrant’s Common Stock outstanding as of February 18, 2015 was 24,360,247.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Registrant’s definitive proxy statement relating to its 2015 Annual Meeting of Stockholders are incorporated by reference into Part III of this Report where indicated.  Such proxy statement will be filed with the US Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates.

ATARA BIOTHERAPEUTICS, INC.

INDEX

 

 

Page

 

 

Item 1.

4

Item 1A.

38

Item 1B.

69

Item 2.

69

Item 3.

69

Item 4.

69

 

 

 

 

 

Item 5.

70

Item 6.

72

Item 7.

73

Item 7A.

83

Item 8.

84

Item 9.

103

Item 9A.

104

Item 9B.

104

 

 

 

 

 

Item 10.

105

Item 11.

105

Item 12.

105

Item 13.

105

Item 14.

105

 

 

 

 

 

Item 15.

106

FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements, which represent our intent, belief or current expectations, involve risks and uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions. Forward-looking statements in this Annual Report on Form 10-K include, but are not limited to, statements about:

·

our expectations regarding the timing of reporting results from our Phase 2 clinical trial of PINTA 745;

·

our expectations regarding the timing of reporting results from our Phase 1 clinical study of STM 434;

·

our expectations regarding the timing of reporting results from clinical studies and trial being conducted by Memorial Sloan Kettering Cancer Center (“MSK”) of the T-cell programs we have an option to license;

·

the likelihood and timing of regulatory approvals for our product candidates and any product candidates resulting from the T-cell programs we have an option to license;

·

the potential market opportunities for commercializing our product candidates and any product candidates resulting from the T-cell programs we have an option to license;

·

our expectations regarding the potential market size and the size of the patient populations for our product candidates and any product candidates resulting from the T-cell programs we have an option to license, if approved for commercial use;

·

estimates of our expenses, capital requirements and need for additional financing;

·

our expectation that our existing capital resources and net proceeds from our public offerings of common stock will be sufficient to enable us to complete our planned confirmatory Phase 2 clinical trial of PINTA 745 and our initial Phase 1 clinical study of STM 434 and fund our operations and capital expenditure requirements into the second half of 2017;

·

our ability to develop, acquire and advance product candidates into, and successfully complete, clinical studies and trials;

·

the initiation, timing, progress and results of future preclinical studies and clinical trials and our research and development programs;

·

the scope of protection we are able to obtain and maintain for our intellectual property rights covering our product candidates;

·

our use of proceeds from our recently completed public offerings of common stock;

·

our financial performance;

·

developments and projections relating to our competitors and our industry; and

·

our ability to sell or manufacture products at commercially reasonable values.

These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in this report in greater detail under the heading “1A.  Risk Factors” and elsewhere in this report. You should not rely upon forward-looking statements as predictions of future events. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties.

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

PART I  

Item 1. Business

Overview

We are a clinical-stage biopharmaceutical company focused on developing novel therapeutics for serious unmet medical needs, with an initial focus on muscle wasting conditions and oncology. Our product candidates are biologics targeting myostatin and activin, members of the Transforming Growth Factor-Beta (“TGF-ß”), protein superfamily, which play roles in the growth and maintenance of muscle and many other body tissues. Our lead product candidate, PINTA 745, is in a Phase 2 clinical trial for protein energy wasting (“PEW”), a condition affecting many end-stage renal disease (“ESRD”) patients. Our second product candidate is STM 434. We commenced a Phase 1 clinical study of STM 434 for ovarian cancer and other solid tumors in 2014. We have five additional product candidates targeting the TGF-ß pathway in preclinical development. In addition, we have an exclusive option to license several T-cell programs targeting oncology and infectious diseases through an agreement with Memorial Sloan Kettering Cancer Center (“MSK”). We intend to license or acquire additional product candidates to develop and commercialize.