Conference Call and Webcast Today at 4:30 p.m. EDT
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, today reported financial results for the first quarter 2021, recent business highlights and key catalysts over the next 18 months.
“Atara is off to a strong start in 2021, advancing all three strategic priorities to deliver on key value drivers,” said Pascal Touchon, President and Chief Executive Officer of Atara. “We look forward to several milestones in 2021, including the expected tab-cel® BLA and MAA filings, progress on the ATA188 program – especially the presentation of clinical and translational data from the Phase 1 OLE study, and the first clinical data on our mesothelin CAR T franchise.”
Tabelecleucel (tab-cel®) for Post-Transplant Lymphoproliferative Disease (PTLD)
Tab-cel® for Potential Additional Indications
ATA188 for Progressive Forms of Multiple Sclerosis (MS)
CAR T Programs
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)
ATA3219 (B-cell Malignancies)
First Quarter 2021 Financial Results
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc.(@Atarabio) is a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform to create a robust pipeline including: tab-cel® in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients’ lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California. For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn.
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 potential benefits, safety and efficacy of tab-cel®; the timing and progress of tab-cel®, including (i) tab-cel® clinical trials, the timing and outcome of Atara’s discussions with the FDA regarding the BLA submission for tab-cel®, including the content of CMC Module 3, (ii) the timing of the initiation or submission of the BLA and MAA for tab-cel®, (iii) Atara’s ability to successfully advance the development of tab-cel®, and (iv) Atara’s activities in anticipation of potential tab-cel® approval and launch; and (v) Atara’s efforts to seek a commercialization partner for tab-cel® in Europe; the potential benefits, safety and efficacy of ATA188; the timing and progress of ATA188, including (i) ATA188 clinical trials and (ii) Atara’s ability to successfully advance the development of ATA188; the timing and progress of ATA2271 and ATA3271; progress of the strategic collaboration with Bayer; the timing and progress of ATA3219; and Atara’s ability to successfully advance the development of its CAR T programs, and Atara’s ability to advance development of its programs. 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, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the ongoing COVID-19 pandemic, which may significantly impact (i) our business, research, clinical development plans and operations, including our operations in South San Francisco and Southern California and at our clinical trial sites, as well as the business or operations of our third-party manufacturer, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital, and (iii) the value of our common stock; the sufficiency of Atara’s cash resources and need for additional capital; and other risks and uncertainties affecting Atara and its development programs, 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.
Conference Call and Webcast Information
Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13717803. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of atarabio.com. An archived webcast replay will be available on the Company's website for 30 days.
Financials
ATARA BIOTHERAPEUTICS, INC. Consolidated Balance Sheets (Unaudited) (In thousands) | ||||||||
March 31, | December 31, | |||||||
| 2021 |
|
| 2020 |
| |||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 151,097 |
| $ | 200,404 |
| ||
Short-term investments |
| 284,064 |
|
| 300,255 |
| ||
Restricted cash - short-term |
| 194 |
|
| 194 |
| ||
Accounts receivable |
| 9,610 |
|
| 1,250 |
| ||
Prepaid expenses and other current assets |
| 19,342 |
|
| 21,170 |
| ||
Total current assets |
| 464,307 |
|
| 523,273 |
| ||
Property and equipment, net |
| 51,471 |
|
| 50,517 |
| ||
Operating lease assets |
| 11,930 |
|
| 12,303 |
| ||
Restricted cash - long-term |
| 1,200 |
|
| 1,200 |
| ||
Other assets |
| 729 |
|
| 827 |
| ||
Total assets | $ | 529,637 |
| $ | 588,120 |
| ||
| ||||||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 17,355 |
| $ | 7,118 |
| ||
Accrued compensation |
| 12,786 |
|
| 20,458 |
| ||
Accrued research and development expenses |
| 10,655 |
|
| 15,813 |
| ||
Deferred revenue |
| 35,497 |
|
| 33,455 |
| ||
Other current liabilities |
| 7,901 |
|
| 6,057 |
| ||
Total current liabilities |
| 84,194 |
|
| 82,901 |
| ||
Deferred revenue - long-term |
| 31,811 |
|
| 27,795 |
| ||
Operating lease liabilities - long-term |
| 12,569 |
|
| 13,041 |
| ||
Other long-term liabilities |
| 2,026 |
|
| 2,044 |
| ||
Total liabilities |
| 130,600 |
|
| 125,781 |
| ||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Common stock |
| 8 |
|
| 8 |
| ||
Additional paid-in capital |
| 1,601,784 |
|
| 1,586,616 |
| ||
Accumulated other comprehensive income |
| 161 |
|
| 296 |
| ||
Accumulated deficit |
| (1,202,916 | ) |
| (1,124,581 | ) | ||
Total stockholders’ equity |
| 399,037 |
|
| 462,339 |
| ||
Total liabilities and stockholders’ equity | $ | 529,637 |
| $ | 588,120 |
|
ATARA BIOTHERAPEUTICS, INC. Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except per share amounts) | ||||||||
Three Months Ended March 31, | ||||||||
| 2021 |
|
| 2020 |
| |||
License and collaboration revenue | $ | 3,552 |
| $ | — |
| ||
Operating expenses: | ||||||||
Research and development |
| 64,059 |
|
| 57,659 |
| ||
General and administrative |
| 17,738 |
|
| 17,038 |
| ||
Total operating expenses |
| 81,797 |
|
| 74,697 |
| ||
Loss from operations |
| (78,245 | ) |
| (74,697 | ) | ||
Interest and other (expense) income, net |
| (90 | ) |
| 1,188 |
| ||
Loss before provision for income taxes |
| (78,335 | ) |
| (73,509 | ) | ||
Provision for income taxes |
| — |
|
| — |
| ||
Net loss | $ | (78,335 | ) | $ | (73,509 | ) | ||
Other comprehensive loss: | ||||||||
Unrealized loss on available-for-sale securities |
| (135 | ) |
| (16 | ) | ||
Comprehensive loss | $ | (78,470 | ) | $ | (73,525 | ) | ||
Net loss per common share: | ||||||||
Basic and diluted net loss per common share | $ | (0.86 | ) | $ | (1.20 | ) | ||
Weighted-average shares outstanding used to calculate basic and diluted net loss per common share |
| 91,456 |
|
| 61,208 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210504006256/en/
INVESTORS & MEDIA: Investors Eric Hyllengren Vice President, Investor Relations & Finance Atara Biotherapeutics 805-395-9669 ehyllengren@atarabio.com Media Kerry Beth Daly Head, Corporate Communications Atara Biotherapeutics 516-982-9328 kdaly@atarabio.com
Source: Atara Biotherapeutics