Full Press Release Details
Atara Biotherapeutics Announces Second Quarter 2019 Financial Results and Recent Operational Progress
SOUTH SAN FRANCISCO, Calif., August 8, 2019 - Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, today reported financial results for the second quarter of 2019 and recent operational highlights.
"I am confident we are now in a strong position to execute and create value across our tab-cel , multiple sclerosis and next-generation CAR T programs," said Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics. "We believe our updated tab-cel development strategy, focusing on initiating an EBV+ PTLD regulatory submission first in the United States, prioritizes the most attractive market for such an ultra-rare disease and advances our mission to bring transformative T-cell immunotherapies to patients in critical need. In addition, we are encouraged by the initial safety results from our ongoing ATA188 Phase 1 study for patients with progressive MS and look forward to presenting the initial efficacy results from this study in September. We also strengthened our financial position, funding planned operations into 2021 and through key milestones next year including initiating the tab-cel BLA submission and next-generation mesothelin CAR T IND."
Recent Highlights and Anticipated Upcoming Milestones
Tab-cel (tabelecleucel)
ATA188 & ATA190 for Multiple Sclerosis (MS)
Next-Generation CAR T
Second Quarter 2019 Financial Results
Conference Call and Webcast Information
Atara will host a live conference call and webcast today at 8:00 a.m. EDT to discuss the Company's financial results and recent operational highlights. Analysts and investors can participate in the
conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 4179789. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company's website for approximately 14 days following the live webcast.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. (@Atarabio) is a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases. Atara's technology platform leverages research collaborations with leading academic institutions with the Company's scientific, clinical, regulatory and manufacturing expertise. Atara's pipeline includes tab-cel (tabelecleucel), which is in Phase 3 development for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disorder (EBV+ PTLD) as well as in earlier stage development for other EBV-associated hematologic malignancies and solid tumors, including nasopharyngeal carcinoma (NPC); T-cell immunotherapies targeting EBV antigens believed to be important for the potential treatment of multiple sclerosis; and next-generation chimeric antigen receptor T-cell (CAR T) immunotherapies. The company was founded in 2012 and is co-located in South San Francisco and Southern California. Our Southern California hub is anchored by the state-of-the-art Atara T-cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California. For additional information about the company, please visit atarabio.com.
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 timing of and the Company's ability to achieve clinical and regulatory milestones in 2019 and 2020, including submission of a tab-cel BLA for patients with EBV+ PTLD, initiation of a Phase 2 study including patients with EBV+ cancers, expansion of the Company's ATA188 study using the RP2D, initiation of an ATA190 study and submission of an IND for ATA2271; discussions with regulators, including with the EMA regarding its tab-cel CMA application; enrollment and results of the Company's clinical studies, including its ability to open additional clinical sites; the Company's planned presentation of clinical results; and commercial production qualification activities; and the sufficiency of the Company's cash, cash equivalents and short-term investments to fund operations into 2021. 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 in Atara Biotherapeutics' filings with the Securities and Exchange Commission (SEC), including in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. 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.
Consolidated Balance Sheets
| June 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 59,159 | $ | 60,698 | ||||
| Short-term investments | 130,976 | 248,933 | ||||||
| Restricted cash - short-term | 194 | 194 | ||||||
| Prepaid expenses and other current assets | 10,810 | 11,664 | ||||||
| Total current assets | 201,139 | 321,489 | ||||||
| Property and equipment, net | 57,090 | 68,576 | ||||||
| Operating lease assets | 14,396 | - | ||||||
| Restricted cash - long-term | 1,200 | 1,200 | ||||||
| Other assets | 319 | 574 | ||||||
| Total assets | $ | 274,144 | $ | 391,839 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,420 | $ | 3,719 | ||||
| Accrued compensation | 7,822 | 10,636 | ||||||
| Accrued research and development expenses | 5,139 | 19,210 | ||||||
| Other current liabilities | 6,422 | 6,414 | ||||||
| Total current liabilities | 25,803 | 39,979 | ||||||
| Operating lease liabilities - long-term | 14,919 | - | ||||||
| Other long-term liabilities | 1,143 | 13,003 | ||||||
| Total liabilities | 41,865 | 52,982 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock | 5 | 5 | ||||||
| Additional paid-in capital | 899,671 | 866,541 | ||||||
| Accumulated other comprehensive income (loss) | 173 | (340 | ) | |||||
| Accumulated deficit | (667,570 | ) | (527,349 | ) | ||||
| Total stockholders' equity | 232,279 | 338,857 | ||||||
| Total liabilities and stockholders' equity | $ | 274,144 | $ | 391,839 |
Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 52,251 | $ | 33,387 | $ | 100,919 | $ | 61,847 | ||||||||
| General and administrative | 23,284 | 19,236 | 42,507 | 33,228 | ||||||||||||
| Total operating expenses | 75,535 | 52,623 | 143,426 | 95,075 | ||||||||||||
| Loss from operations | (75,535 | ) | (52,623 | ) | (143,426 | ) | (95,075 | ) | ||||||||
| Interest and other income, net | 1,207 | 1,743 | 2,841 | 2,752 | ||||||||||||
| Loss before provision for income taxes | (74,328 | ) | (50,880 | ) | (140,585 | ) | (92,323 | ) | ||||||||
| Provision for income taxes | - | 3 | - | 3 | ||||||||||||
| Net loss | $ | (74,328 | ) | $ | (50,883 | ) | $ | (140,585 | ) | $ | (92,326 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale securities | 135 | 19 | 513 | (354 | ) | |||||||||||
| Comprehensive loss | $ | (74,193 | ) | $ | (50,864 | ) | $ | (140,072 | ) | $ | (92,680 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic and diluted net loss per common share | $ | (1.60 | ) | $ | (1.15 | ) | $ | (3.04 | ) | $ | (2.20 | ) | ||||
| Weighted-average shares outstanding used to calculate basic and diluted net loss per common share | 46,426 | 44,379 | 46,276 | 42,001 |
INVESTOR & MEDIA CONTACTS:
John Craighead, Atara Biotherapeutics
John Grimaldi, Burns McClellan
Robert Flamm, Burns McClellan