Full Press Release Details
Atara Biotherapeutics Announces Third Quarter 2020 Financial Results and Operational Progress
Interim Analysis of the pivotal 302 study (ALLELE) showed tab-cel in EBV+ PTLD achieved a 50 percent objective response rate and safety consistent with historical data
Discussions with FDA confirmed Atara can complete BLA filing with the ALLELE study's currently enrolled patients with at least six-months follow-up for duration of response
Atara plans to initiate the rolling BLA submission of tab-cel for EBV+ PTLD by the end of 2020 and finalize BLA the submission in Q3 2021
Initiated the tab-cel Phase 2 multi-cohort study in Q3 2020
Conference call to discuss results and operational highlights today at 4:30 p.m. EST
SOUTH SAN FRANCISCO, Calif.-- 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 disease, today reported financial results for the third quarter ended September 30, 2020 and recent business highlights.
"Atara is on track to finish the year strong, meeting each milestone set to date," said Pascal Touchon, President and Chief Executive Officer of Atara. "Following an encouraging interim analysis of the pivotal Phase 3 data for tab-cel in relapsed-refractory EBV+ PTLD and very productive interactions with regulatory authorities, we are preparing for tab-cel submissions, and then approval and launch. We are committed to bringing this potentially life-saving therapy to the patients who acutely need it as they have no other therapeutic solution and face a very limited median life expectancy of only two to three months."
Tab-cel for Post-transplant Lymphoproliferative Disease (PTLD)
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)
Third Quarter 2020 Financial Results
About Atara Biotherapeutics, Inc.
Conference Call and Webcast Information
Atara will host a live conference call and webcast today at 4:30 p.m. EST 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 2053259. 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 14 days following the live webcast.
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: Atara's ability to deliver on key milestones relating to tab-cel , including (i) discussions with the FDA, including regarding the totality of tab-cel data, prior to initiating the BLA submission for patients with EBV+ PTLD, (ii) discussions with the EMA regarding a PIP under the PRIME mechanism for the EMA,, (iii) the timing and plans for submitting an EU MAA, (iv) initiating enrollment in a Phase 2 multi-cohort study and potentially expanding tab-cel into other indications, (v) the timing and results of additional clinical data, and (vi) the timing and plans for initiating and completing the BLA for tab-cel ; investment into the ATA188 program and the amendment and expansion of the RCT; the potential benefits and efficacy of Atara's drug candidates; the timing, enrollment and results of additional data from Atara's clinical trials; and the sufficiency of our cash, cash equivalents and short-term investments for our operations into 2022. 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 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 manufacturers, 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 the sections titled "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 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
| September 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 62,620 | $ | 74,317 | ||||
| Short-term investments | 264,565 | 184,792 | ||||||
| Restricted cash - short-term | 194 | 194 | ||||||
| Prepaid expenses and other current assets | 12,053 | 13,689 | ||||||
| Total current assets | 339,432 | 272,992 | ||||||
| Property and equipment, net | 51,954 | 54,176 | ||||||
| Operating lease assets | 12,069 | 14,007 | ||||||
| Restricted cash - long-term | 1,200 | 1,200 | ||||||
| Other assets | 877 | 567 | ||||||
| Total assets | $ | 405,532 | $ | 342,942 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,190 | $ | 7,963 | ||||
| Accrued compensation | 16,710 | 14,706 | ||||||
| Accrued research and development expenses | 8,883 | 8,341 | ||||||
| Other current liabilities | 5,272 | 5,733 | ||||||
| Total current liabilities | 36,055 | 36,743 | ||||||
| Operating lease liabilities - long-term | 13,129 | 14,136 | ||||||
| Other long-term liabilities | 2,413 | 1,282 | ||||||
| Total liabilities | 51,597 | 52,161 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock | 8 | 6 | ||||||
| Additional paid-in capital | 1,396,674 | 1,108,516 | ||||||
| Accumulated other comprehensive income | 527 | 220 | ||||||
| Accumulated deficit | (1,043,274 | ) | (817,961 | ) | ||||
| Total stockholders' equity | 353,935 | 290,781 | ||||||
| Total liabilities and stockholders' equity | $ | 405,532 | $ | 342,942 |
Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 59,877 | $ | 53,538 | $ | 179,096 | $ | 154,457 | ||||||||
| General and administrative | 14,829 | 19,018 | 48,259 | 61,525 | ||||||||||||
| Total operating expenses | 74,706 | 72,556 | 227,355 | 215,982 | ||||||||||||
| Loss from operations | (74,706 | ) | (72,556 | ) | (227,355 | ) | (215,982 | ) | ||||||||
| Interest and other income, net | 364 | 661 | 2,049 | 3,502 | ||||||||||||
| Loss before provision for income taxes | (74,342 | ) | (71,895 | ) | (225,306 | ) | (212,480 | ) | ||||||||
| Provision for income taxes | 6 | - | 7 | - | ||||||||||||
| Net loss | $ | (74,348 | ) | $ | (71,895 | ) | $ | (225,313 | ) | $ | (212,480 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized (loss) gain on available-for-sale securities | (283 | ) | 60 | 307 | 573 | |||||||||||
| Comprehensive loss | $ | (74,631 | ) | $ | (71,835 | ) | $ | (225,006 | ) | $ | (211,907 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic and diluted net loss per common share | $ | (0.92 | ) | $ | (1.31 | ) | $ | (3.21 | ) | $ | (4.32 | ) | ||||
| Weighted-average shares outstanding used to calculate basic and diluted net loss per common share | 81,176 | 54,920 | 70,170 | 49,176 |
Vice President, Investor Relations & Finance
Atara Biotherapeutics
Head, Corporate Communications
Atara Biotherapeutics