Atara Biotherapeutics
Nov 4, 2016

Atara Bio Announces Third Quarter 2016 Financial Results and Recent Highlights

SOUTH SAN FRANCISCO, Calif., Nov. 04, 2016 (GLOBE NEWSWIRE) -- Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, today reported financial results for the third quarter ended September 30, 2016 and recent operational highlights.

"We are pleased to report that for our lead product candidate, EBV-CTL, we have received feedback from FDA on our approach to comparing material manufactured by our CMO with material previously produced at MSK and have commenced manufacturing to support our Phase 3 trials," said Isaac Ciechanover, Chief Executive Officer and President of Atara Bio. "We have also submitted our Phase 3 trial protocols to FDA, and we look forward to the initiation of these trials by year end."

Recent Highlights and Anticipated Upcoming Milestones   



CTL Platform Expansion

Third Quarter 2016 Financial Results

About Atara Biotherapeutics' Allogeneic Cellular Therapy Platform

Atara Bio's cellular therapy platform provides healthy immune capability to a patient and arms the immune system to precisely target and combat disease. Cells derived from healthy donors are manufactured in advance and stored as inventory so that a customized unit of cells can be chosen for each patient. The cells are ready to infuse in patients in approximately 3 to 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. The Company's lead product candidate derived from this platform is expected to enter Phase 3 trials in 2016. The Company has pursued prospective feedback from health authorities on both manufacturing and clinical trial design. Its lead product candidate has the potential to be the first commercial allogeneic T-cell therapy for a viral target implicated in cancer.

About Atara Biotherapeutics, Inc.

Atara Biotherapeutics, Inc. is a biopharmaceutical company developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, with an initial focus on immunotherapy and oncology. Atara Bio's programs include T-cell product candidates and molecularly targeted product candidates. The T-cell product candidates include EBV-CTL, CMV-CTL, and Wilms Tumor 1 targeted Cytotoxic T-cells (WT1-CTL) and harness the power of the immune system to recognize and attack cancer cells and cells infected with certain viruses. The molecularly targeted product candidates include STM 434. These product candidates target activin and myostatin, members of the TGF-beta family of proteins, and have demonstrated the potential to have therapeutic benefit in a number of clinical indications.

Forward-Looking Statements

This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding the initiation of the Phase 3 trials for EBV-CTLs for EBV-PTLD by year end, the Scientific Advice meeting with EMA and health technology assessment groups scheduled in the 4th quarter of 2016, expectation to broaden our EAP trial to include enrollment of patients with other EBV-associated hematologic malignancies and solid tumors, expectation to initiate a pivotal trial with CMV-CTL in 2017, and the belief that cash and investments, as of September 30, 2016, will be sufficient to fund the Company's planned operations through 2018. Because such statements deal with future events and are based on Atara Bio's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara Bio could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those discussed under the heading "Risk Factors" in Atara Bio's quarterly report in Form 10-Q filed with the SEC on August 8, 2016, including the documents incorporated by reference therein, and subsequent filings with the Securities and Exchange Commission (SEC). Except as otherwise required by law, Atara Bio disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
  September 30,  December 31, 
  2016  2015 
Current assets:        
Cash and cash equivalents $46,013  $23,746 
Short-term investments  232,134   296,736 
Restricted cash  194   194 
Prepaid expenses and other current assets  3,889   3,921 
Total current assets  282,230   324,597 
Property and equipment, net  2,085   270 
Other assets  102   108 
Total assets $284,417  $324,975 
Liabilities and stockholders' equity        
Current liabilities:        
Accounts payable $4,463  $1,445 
Accrued compensation  3,156   2,624 
Accrued research and development expenses  5,109   5,112 
Other accrued liabilities  960   528 
Total current liabilities  13,688   9,709 
Long-term liabilities  527   166 
Total liabilities  14,215   9,875 
Commitments and contingencies        
Stockholders' equity:        
Common stock  3   3 
Additional paid-in capital  429,088   413,725 
Accumulated other comprehensive income (loss)  35   (518)
Accumulated deficit  (158,924)  (98,110)
Total stockholders' equity  270,202   315,100 
Total liabilities and stockholders' equity $284,417  $324,975 

Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)

  Three Months Ended
September 30,
  Nine Months Ended September 30, 
  2016  2015  2016  2015 
Operating expenses:                
Research and development $18,802  $8,113  $43,040  $25,387 
General and administrative  7,140   4,146   19,448   11,291 
Total operating expenses  25,942   12,259   62,488   36,678 
Loss from operations  (25,942)  (12,259)  (62,488)  (36,678)
Interest and other income, net  576   380   1,684   696 
Loss before provision (benefit) for income taxes  (25,366)  (11,879)  (60,804)  (35,982)
Provision (benefit) for income taxes  7   (11)  10   (9)
Net loss $(25,373) $(11,868) $(60,814) $(35,973)
Other comprehensive gain (loss):                
Unrealized gain (loss) on available-for-sale securities  (158)  117   553   151 
Comprehensive loss $(25,531) $(11,751) $(60,261) $(35,822)
Net loss per common share:                
Basic and diluted net loss per common share $(0.88) $(0.43) $(2.12) $(1.46)
Weighted-average common shares outstanding used
  to calculate basic and diluted net loss per common
  28,801   27,675   28,670   24,628 

Steve Klass
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Justin Jackson
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