Full Press Release Details
Atara Biotherapeutics Announces First Quarter 2017 Financial Results and Recent Highlights
SOUTH SAN FRANCISCO, Calif., May 4, 2017 (GLOBE NEWSWIRE) -- Atara Biotherapeutics, Inc. (Nasdaq: ATRA) today reported financial results for the first quarter of 2017 and recent operational highlights.
"We continued to make important progress advancing our robust pipeline of T-cell therapies in the first quarter," said Isaac Ciechanover, Chief Executive Officer and President of Atara Biotherapeutics. "With the expected initiation of two Phase 3 trials this year and a conditional marketing authorization submission in the EU next year for our lead oncology product candidate, ATA129, we are on our way to becoming a commercial immunotherapy company. The recent data reported at AAN with autologous ATA188 in progressive multiple sclerosis also highlights the potential to expand our platform beyond oncology to include autoimmune disease."
Recent Highlights and Anticipated Upcoming Milestones
First Quarter 2017 Financial Results
Research and development expenses include $2.1 million and $2.2 million of non-cash stock-based compensation expenses in the first quarters of 2017 and 2016, respectively.
About Atara's "Off-the-Shelf" Allogeneic Immunotherapy Platform
Atara's immunotherapy platform provides healthy immune capability to a patient and arms the immune system to precisely target and combat disease. T-cells derived from healthy donors are manufactured in advance and stored as inventory so that a customized unit of T-cells can be chosen for each patient. The T-cells are ready to infuse in approximately 3 to 5 days. Once administered, the T-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 autoimmune and infectious diseases. The Company has pursued prospective feedback from health authorities on both manufacturing and clinical trial design. Atara's lead product candidate, ATA129, 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 who have been underserved by scientific innovation, with an initial focus on allogeneic T-cell therapies for cancer, autoimmune, and infectious disease. Atara's T-cell product candidates harness the power of the immune system to recognize and attack cancer cells and cells infected with certain viruses. The Company's initial clinical stage T-cell product candidates include Epstein-Barr virus targeted Cytotoxic T-cells (EBV-CTL), or ATA129, Cytomegalovirus targeted Cytotoxic T-cells (CMV-CTL), or ATA230, and Wilms Tumor 1 targeted Cytotoxic T-cells (WT1-CTL), or ATA520. These product candidates have demonstrated the potential to have therapeutic benefit in a number of clinical indications including hematologic malignancies, solid tumors, and refractory viral infections. The Company is also developing a next generation of T-cell product candidates utilizing a technology to selectively enhance a T-cell's ability to target specific viral proteins implicated in a disease. The Company's ATA188 product candidate leverages this
technology. Initial clinical investigations employing this approach will focus on multiple sclerosis and other virally mediated cancers.
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 Company's expected initiation of two Phase 3 clinical trials in the second half of 2017 with leading bone marrow and solid organ transplant centers in the U.S. and Europe and its plan to submit a conditional marketing authorization application in the EU for ATA129; the Company's continued growth and development as a commercial immunotherapy company and its belief that it is advancing its product pipeline and moving towards the potential commercialization of ATA129; the Company's belief that it has been successful in producing ATA129 drug product; the Company's refinement of certain assays, manufacture of lots to further support comparability evaluations and the Phase 3 trials, and expectations to review these data with FDA prior to starting these trials; the Company's potential to expand its platform beyond oncology to include autoimmune disease; the Company's expected commencement of a Phase 1/2 trial with ATA129 and Merck's KEYTRUDA in 2018; the Company's belief that its collaborating investigators' autologous ATA188 Phase 1 trial will be completed in 2017; the Company's expectation of pursuing clinical development of both autologous and allogeneic versions of ATA188 and the initiation of a Phase 1 allogeneic ATA188 trial in MS in the second half of 2017; and the Company's belief that its cash and investments as of March 31, 2017 will be sufficient to fund its planned operations into the first quarter of 2019. Because such statements deal with future events and are based on Atara Biotherapeutics' current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara Biotherapeutics 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 Biotherapeutics' annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 9, 2017, including the documents incorporated by reference therein, and subsequent filings with the SEC. Except as otherwise required by law, Atara Biotherapeutics 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.
Atara Biotherapeutics, Inc.
Condensed Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2017 | 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 62,430 | $ | 47,968 | ||||
| Short-term investments | 168,216 | 207,714 | ||||||
| Restricted cash - short-term | 194 | 194 | ||||||
| Prepaid expenses and other current assets | 4,478 | 4,677 | ||||||
| Total current assets | 235,318 | 260,553 | ||||||
| Property and equipment, net | 4,400 | 3,259 | ||||||
| Restricted cash - long-term | 1,200 | - | ||||||
| Other assets | 820 | 102 | ||||||
| Total assets | $ | 241,738 | $ | 263,914 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,204 | $ | 2,778 | ||||
| Accrued compensation | 2,609 | 3,745 | ||||||
| Accrued research and development expenses | 2,106 | 2,408 | ||||||
| Other accrued liabilities | 886 | 744 | ||||||
| Total current liabilities | 7,805 | 9,675 | ||||||
| Long-term liabilities | 799 | 503 | ||||||
| Total liabilities | 8,604 | 10,178 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock | 3 | 3 | ||||||
| Additional paid-in capital | 436,096 | 431,075 | ||||||
| Accumulated other comprehensive loss | (152 | ) | (183 | ) | ||||
| Accumulated deficit | (202,813 | ) | (177,159 | ) | ||||
| Total stockholders' equity | 233,134 | 253,736 | ||||||
| Total liabilities and stockholders' equity | $ | 241,738 | $ | 263,914 |
Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
| Three Months Ended March 31, | ||||||||
| 2017 | 2016 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 17,541 | $ | 11,247 | ||||
| General and administrative | 8,620 | 5,814 | ||||||
| Total operating expenses | 26,161 | 17,061 | ||||||
| Loss from operations | (26,161 | ) | (17,061 | ) | ||||
| Interest and other income, net | 509 | 503 | ||||||
| Loss before provision for income taxes | (25,652 | ) | (16,558 | ) | ||||
| Less: Provision for income taxes | 2 | 3 | ||||||
| Net loss | $ | (25,654 | ) | $ | (16,561 | ) | ||
| Other comprehensive loss: | ||||||||
| Unrealized gain on available-for-sale securities | 31 | 569 | ||||||
| Comprehensive loss | $ | (25,623 | ) | $ | (15,992 | ) | ||
| Net loss per common share: | ||||||||
| Basic and diluted net loss per common share | $ | (0.88 | ) | $ | (0.58 | ) | ||
| Weighted-average shares outstanding used to calculate basic and diluted net loss per common share | 29,056 | 28,542 |
INVESTOR & MEDIA CONTACTS:
John Craighead, Atara Biotherapeutics
Steve Klass, Burns McClellan
Justin Jackson, Burns McClellan