Full Press Release Details
Atara Biotherapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Operational Progress
On track to complete the rolling tab-cel BLA submission in Q3 2021 for patients with EBV+ PTLD through active and productive discussions with FDA
On track with ATA188 Phase 2 RCT (randomized clinical trial) enrollment in patients with progressive forms of MS, enabling an interim analysis in H1 2022
Continued progress on advancing CAR T portfolio, enabling clinical data presentation for mesothelin-targeted ATA2271 in Q4 2021 and IND submission for novel allogeneic CD19 CART ATA3219 in Q4 2021/Q1 2022
Conference Call and Webcast Today at 4:30 p.m. EST
SOUTH SAN FRANCISCO, Calif., March 1, 2021 - 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 fourth quarter and full year 2020, recent business highlights and key catalysts over the next 18 months.
"Atara had a very strong year in 2020, delivering on key milestones across the Company's three strategic priorities," said Pascal Touchon, President and Chief Executive Officer of Atara. "We anticipate several additional key catalysts over the next 18 months, especially the completion of the tab-cel BLA filing in Q3 2021, significant advancement on the ATA188 program - including long-term clinical data update from the Phase 1 study as well as enrollment progress in the Phase 2 RCT enabling an interim analysis, and preclinical and clinical progress on both the mesothelin and CD19 CAR T programs."
Tabelecleucel (tab-cel ) for Post-transplant Lymphoproliferative Disease (PTLD)
Tabelecleucel (tab-cel ) for Potential Additional Indications
ATA188 for Progressive Forms of Multiple Sclerosis (MS)
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)
ATA3219 (B-cell Malignancies)
Fourth Quarter and Full Year 2020 Financial Results
About Atara Biotherapeutics, Inc.
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 and progress of ATA2271, the timing and progress of ATA3219, Atara's ability to successfully advance the development of its CAR T programs, the potential benefits, safety and efficacy of tab-cel ; the timing and progress of tab-cel , including tab-cel clinical trials, the outcome of the Company's discussions with the FDA regarding the BLA submission for tab-cel , the timing of the initiation or submission of the BLA and MAA for tab-cel ; Atara's ability to successfully advance the development of tab-cel ; the potential benefits, safety and efficacy of ATA-188; the timing and progress of ATA-188, including ATA-188 clinical trials, Atara's ability to successfully advance the development of ATA-188; data on an innovative testing solution, 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's 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 888-540-6216 for domestic callers and 734-385-2715 for international callers, using the conference ID 7893151. A live audio webcast can be accessed by visiting the Investors & Media - News & Events section of atarabio.com. An archived replay will be available on the Company's website for 30 days following the live webcast.
Vice President, Investor Relations & Finance
Atara Biotherapeutics
Head, Corporate Communications
Atara Biotherapeutics
Atara Biotherapeutics, Inc.
Consolidated Balance Sheets
| December 31, | December 31, | |||||
| 2020 | 2019 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 200,404 | $ | 74,317 | ||
| Short-term investments | 300,255 | 184,792 | ||||
| Restricted cash - short-term | 194 | 194 | ||||
| Accounts receivable | 1,250 | - | ||||
| Prepaid expenses and other current assets | 21,170 | 13,689 | ||||
| Total current assets | 523,273 | 272,992 | ||||
| Property and equipment, net | 50,517 | 54,176 | ||||
| Operating lease assets | 12,303 | 14,007 | ||||
| Restricted cash - long-term | 1,200 | 1,200 | ||||
| Other assets | 827 | 567 | ||||
| Total assets | $ | 588,120 | $ | 342,942 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 7,118 | $ | 7,963 | ||
| Accrued compensation | 20,458 | 14,706 | ||||
| Accrued research and development expenses | 15,813 | 8,341 | ||||
| Deferred revenue | 33,455 | - | ||||
| Other current liabilities | 6,057 | 5,733 | ||||
| Total current liabilities | 82,901 | 36,743 | ||||
| Deferred revenue - long-term | 27,795 | - | ||||
| Operating lease liabilities - long-term | 13,041 | 14,136 | ||||
| Other long-term liabilities | 2,044 | 1,282 | ||||
| Total liabilities | 125,781 | 52,161 | ||||
| Commitments and contingencies (Note 9) | ||||||
| Stockholders' equity: | ||||||
| Common stock | 8 | 6 | ||||
| Additional paid-in capital | 1,586,616 | 1,108,516 | ||||
| Accumulated other comprehensive income | 296 | 220 | ||||
| Accumulated deficit | (1,124,581) | (817,961) | ||||
| Total stockholders' equity | 462,339 | 290,781 | ||||
| Total liabilities and stockholders' equity | $ | 588,120 | $ | 342,942 |
Atara Biotherapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 65,554 | $ | 61,640 | $ | 244,650 | $ | 216,097 | ||||||||
| General and administrative | 16,143 | 18,059 | 64,402 | 79,584 | ||||||||||||
| Total operating expenses | 81,697 | 79,699 | 309,052 | 295,681 | ||||||||||||
| Loss from operations | (81,697 | ) | (79,699 | ) | (309,052 | ) | (295,681 | ) | ||||||||
| Interest and other income, net | 398 | 1,215 | 2,447 | 4,717 | ||||||||||||
| Loss before income taxes | (81,299 | ) | (78,484 | ) | (306,605 | ) | (290,964 | ) | ||||||||
| Provision for income taxes | 8 | 12 | 15 | 12 | ||||||||||||
| Net loss | (81,307 | ) | (78,496 | ) | $ | (306,620 | ) | $ | (290,976 | ) | ||||||
| Other comprehensive gain (loss): | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale securities | (231 | ) | (13 | ) | 76 | 560 | ||||||||||
| Comprehensive loss | $ | (81,538 | ) | $ | (78,509 | ) | $ | (306,544 | ) | $ | (290,416 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic and diluted net loss per common share | $ | (0.95 | ) | $ | (1.36 | ) | $ | (4.15 | ) | $ | (5.67 | ) | ||||
| Weighted-average shares outstanding used to calculate basic and diluted net loss per common share | 85,301 | 57,662 | 73,973 | 51,308 |