Full Press Release Details
Atara Biotherapeutics Announces Third Quarter 2021 Financial Results and Operational Progress
Positive Pivotal Phase 3 ALLELE Data Reinforcing the Transformative Potential of Tab-cel
to be Highlighted as Oral Presentation at Upcoming American Society of Hematology Meeting
Significant Tab-cel Regulatory Progress with Imminent EU MAA Submission and Additional Clarity on FDA Requirements for BLA Submission Planned for Q2 2022
ATA188 Data Demonstrates Durable, Clinically Meaningful Disability Improvement and Possible Remyelination in Patients with Progressive Multiple Sclerosis
Company to Host Live Conference Call and Webcast Today at 8:30 a.m. EDT
SOUTH SAN FRANCISCO, Calif., November 4 -- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the third quarter 2021, recent business highlights and key catalysts over the next several months.
"Atara continues to make meaningful progress across our strategic priorities and with positive data from our pivotal Phase 3 ALLELE study and imminent EU regulatory submission, we are now at an inflection point as we work to deliver tab-cel , a potentially transformative first-in-kind therapy, to patients in need," said Pascal Touchon, President and Chief Executive Officer of Atara. "We are equally encouraged by new data confirming our conviction for ATA188 as the first investigational therapy to reverse disability in progressive multiple sclerosis, and upcoming milestones related to our potentially best-in-class CAR T portfolio that does not require TCR or HLA gene editing."
Tabelecleucel (tab-cel ) for Post-Transplant Lymphoproliferative Disease (PTLD)
Tab-cel for Potential Additional Indications
ATA188 for Progressive Multiple Sclerosis
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)
ATA3219 (B-cell Malignancies)
Allogeneic T Cell Platform Development
Third Quarter 2021 Financial Results
Conference Call and Webcast Details
Atara will host a live conference call and webcast today, Thursday, November 4, 2021, at 8:30 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 888-437-3179 for domestic callers and 862-298-0702 for international callers, using the conference ID 13723551. 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.
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: (1) the potential benefits, safety and efficacy of tab-cel ; the timing and progress of tab-cel , including (i) data and analyses from ALLELE study; (ii) tab-cel clinical trials, and the timing and outcome of Atara's discussions with the FDA regarding a BLA submission for tab-cel , (iii) the timing and outcome of Atara's discussions with EMA regarding an MAA for tab-cel , (iv) the timing of the initiation or submission of the BLA and MAA for tab-cel , (v) Atara's ability to successfully advance the development of tab-cel , (vi) Atara's activities in anticipation of potential tab-cel approval and commercial launch in the U.S., and (vii) Atara's collaboration with Pierre Fabre for commercializing tab-cel in Europe, Middle East, Africa and other emerging markets; (2) the
potential benefits, safety and efficacy of ATA188; the timing and progress of ATA188, including (i) translational and biomarker data for ATA188, including magnetization transfer ratio (MTR) data and MTR's potential link with remyelination; (ii) data from ATA188 OLE study; (iii) ATA188 clinical trials, (iv) Atara's ability to successfully advance the development of ATA188, and (v) partnering options for ATA188; (3) the timing and progress of its CAR T programs, including (i) ATA2271 clinical trial, (ii) ATA3271 and ATA3219 preclinical development, (iii) progress of the strategic collaboration with Bayer for ATA2271 and 3271, and (iv) Atara's ability to successfully advance the development of its CAR T programs; and (4) Atara's research and development activities at ARC; (5) Atara's ability to advance development of its programs. Because such statements deal with future events and are based on Atara's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara 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's 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 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, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 113,209 | $ | 200,404 | ||||
| Short-term investments | 244,036 | 300,255 | ||||||
| Restricted cash - short-term | 194 | 194 | ||||||
| Accounts receivable | - | 1,250 | ||||||
| Prepaid expenses and other current assets | 12,058 | 21,170 | ||||||
| Total current assets | 369,497 | 523,273 | ||||||
| Property and equipment, net | 53,485 | 50,517 | ||||||
| Operating lease assets, net | 25,071 | 12,303 | ||||||
| Restricted cash - long-term | 1,200 | 1,200 | ||||||
| Other assets | 670 | 827 | ||||||
| Total assets | $ | 449,923 | $ | 588,120 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 16,543 | $ | 7,118 | ||||
| Accrued compensation | 19,140 | 20,458 | ||||||
| Accrued research and development expenses | 9,974 | 15,813 | ||||||
| Deferred revenue | 31,226 | 33,455 | ||||||
| Other current liabilities | 9,267 | 6,057 | ||||||
| Total current liabilities | 86,150 | 82,901 | ||||||
| Deferred revenue - long-term | 26,843 | 27,795 | ||||||
| Operating lease liabilities - long-term | 24,574 | 13,041 | ||||||
| Other long-term liabilities | 2,215 | 2,044 | ||||||
| Total liabilities | 139,782 | 125,781 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock | 9 | 8 | ||||||
| Additional paid-in capital | 1,681,481 | 1,586,616 | ||||||
| Accumulated other comprehensive income | 24 | 296 | ||||||
| Accumulated deficit | (1,371,373) | (1,124,581) | ||||||
| Total stockholders' equity | 310,141 | 462,339 | ||||||
| Total liabilities and stockholders' equity | $ | 449,923 | $ | 588,120 |
Atara Biotherapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| License and collaboration revenue | $ | 5,370 | $ | - | $ | 12,792 | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 70,333 | 59,877 | 202,867 | 179,096 | ||||||||||||
| General and administrative | 19,849 | 14,829 | 56,984 | 48,259 | ||||||||||||
| Total operating expenses | 90,182 | 74,706 | 259,851 | 227,355 | ||||||||||||
| Loss from operations | (84,812) | (74,706 | ) | (247,059 | ) | (227,355 | ) | |||||||||
| Interest and other income, net | 148 | 364 | 283 | 2,049 | ||||||||||||
| Loss before provision for income taxes | $ | (84,664 | ) | $ | (74,342 | ) | $ | (246,776 | ) | $ | (225,306 | ) | ||||
| Provision for income taxes | - | 6 | 16 | 7 | ||||||||||||
| Net loss | $ | (84,664 | ) | $ | (74,348 | ) | $ | (246,792 | ) | $ | (225,313 | ) | ||||
| Other comprehensive gain (loss): | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale securities | (38) | (283 | ) | (272 | ) | 307 | ||||||||||
| Comprehensive loss | $ | (84,702 | ) | $ | (74,631 | ) | $ | (247,064 | ) | $ | (225,006 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic and diluted net loss per common share | $ | (0.90 | ) | $ | (0.92 | ) | $ | (2.67 | ) | $ | (3.21 | ) | ||||
| Weighted-average shares outstanding used to calculate basic and diluted net loss per common share | 93,602 | 81,176 | 92,411 | 70,170 |