Full Press Release Details
Atara Biotherapeutics Announces First Quarter 2022 Financial Results and Operational Progress
FDA Fast-Track Designated ATA188 Interim Analysis On-Track for June 2022
Tab-cel Anticipated European Commission Approval On-Track for Q4 2022; Dialogue with FDA Ongoing
Cash Expected to Fund Planned Operations into Q4 2023 with Sale of Cell Therapy Manufacturing Facility to FUJIFILM for $100M
Conference Call and Webcast Today at 1:30 p.m. PDT/4:30 p.m. EDT
SOUTH SAN FRANCISCO, Calif.--May 5, 2022--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the first quarter 2022, recent business highlights and key upcoming catalysts.
"Atara is off to a strong start in 2022, and we look forward to the upcoming interim analysis of our ATA188 Phase 2 study. With compelling Phase 1 data, two Fast Track designations, and validated groundbreaking science, ATA188 has the potential to transform treatment in progressive forms of MS with high unmet need and limited options," said Pascal Touchon, President and Chief Executive Officer of Atara. "We have also commenced our strategic manufacturing partnership with FUJIFILM Diosynth Biotechnologies, continue to progress tab-cel with EMA's review in Europe and further engagement with FDA, and anticipate IND filings for our innovative CAR T programs later this year."
ATA188 for Progressive Multiple Sclerosis (MS)
where updated Phase 1 and open-label extension (OLE) data demonstrated that 20 out of 24 patients have had either EDSS improvement or EDSS stability throughout their observation in the study with up to 42 months follow-up. Overall, 33% of patients in the high-dose cohorts achieved confirmed EDSS improvement at the 12-month timepoint
Tabelecleucel (tab-cel ) for Post-Transplant Lymphoproliferative Disease (PTLD)
Tab-cel for Potential Additional Indications
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)
ATA3219 (B-cell Malignancies)
Allogeneic T-Cell Platform Manufacturing and Operations
First Quarter 2022 Financial Results
Conference Call and Webcast Details
Atara will host a live conference call and webcast today, Thursday, May 5, 2022, at 4:30 p.m. EDT to discuss the Company's financial results and recent operational highlights. 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 13728000. 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 occurrence, timing and outcome of Atara's interactions and discussions with the FDA regarding a BLA submission for tab-cel , (iii) the timing and outcome of the MAA for tab-cel , (iv) the timing of the initiation or submission of the BLA for tab-cel , and (iv) the timing of the EMA's review of the MAA for tab-cel ,; (2) the potential benefits, safety and efficacy of ATA188; the timing and progress of ATA188, including (i) regulatory designations for ATA188 granted by FDA and the impact thereof; (ii) the mechanistic link between EBV and multiple sclerosis and the ability of ATA188 to specifically target such link; (iii) data from ATA188 OLE study; (iv) ATA188 clinical trials, (v) the planned interim analysis for the EMBOLD study, potential next steps for the program and planned discussions with FDA; (vi) Atara's ability to successfully advance the development of ATA188, and (vii) partnering options for ATA188; (3) the timing and progress of its CAR T programs, and the safety and efficacy of product candidates emerging from such 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; (4) Atara's research and development activities at ARC; (5) Atara's sale of its ATOM manufacturing facility to FUJIFILM Diosynth Biotechnologies (FDB), including (i) the potential benefits of such transaction to Atara, including the potential financial benefits to Atara, (ii) the supply agreement between the parties and the duration and benefits thereof, (iii) FDB's ability to perform under the supply agreement and meet Atara's requirements, (v) FDB's plans for ATOM, and (iv) Atara's ability to retain its staff and capabilities, and (6) Atara's ability to advance development of its other 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 and the current events involving Russia and Ukraine, 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
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 101,669 | $ | 106,084 | ||||
| Short-term investments | 200,142 | 264,984 | ||||||
| Restricted cash | 146 | 194 | ||||||
| Accounts receivable | 668 | 986 | ||||||
| Prepaid expenses and other current assets | 11,574 | 12,373 | ||||||
| Assets held for sale | 190 | - | ||||||
| Total current assets | 314,389 | 384,621 | ||||||
| Property and equipment, net | 9,109 | 53,780 | ||||||
| Operating lease assets | 18,933 | 26,159 | ||||||
| Restricted cash - long-term | 1,200 | 1,200 | ||||||
| Other assets | 2,220 | 2,367 | ||||||
| Long-term assets held for sale | 51,429 | - | ||||||
| Total assets | $ | 397,280 | $ | 468,127 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 11,945 | $ | 17,368 | ||||
| Accrued compensation | 16,381 | 25,150 | ||||||
| Accrued research and development expenses | 13,990 | 13,451 | ||||||
| Deferred revenue | 50,943 | 40,760 | ||||||
| Other current liabilities | 8,051 | 9,057 | ||||||
| Liabilities held for sale | 252 | - | ||||||
| Total current liabilities | 101,562 | 105,786 | ||||||
| Deferred revenue - long-term | 45,000 | 55,708 | ||||||
| Operating lease liabilities - long-term | 17,453 | 25,518 | ||||||
| Other long-term liabilities | 616 | 1,501 | ||||||
| Long-term liabilities held for sale | 8,333 | - | ||||||
| Total liabilities | $ | 172,964 | $ | 188,513 | ||||
| Stockholders' equity: | ||||||||
| Common stock-$0.0001 par value, 500,000 shares authorized as of March 31, 2022 and December 31, 2021; 93,406 and 91,671 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively | 9 | 9 | ||||||
| Additional paid-in capital | 1,779,026 | 1,744,695 | ||||||
| Accumulated other comprehensive (loss) income | (1,892 | ) | (368 | ) | ||||
| Accumulated deficit | (1,552,827 | ) | (1,464,722 | ) | ||||
| Total stockholders' equity | 224,316 | 279,614 | ||||||
| Total liabilities and stockholders' equity | $ | 397,280 | $ | 468,127 |
Atara Biotherapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| License and collaboration revenue | $ | 7,314 | $ | 3,552 | ||||
| Operating expenses: | ||||||||
| Research and development | 74,963 | 64,059 | ||||||
| General and administrative | 20,571 | 17,738 | ||||||
| Total operating expenses | 95,534 | 81,797 | ||||||
| Loss from operations | (88,220 | ) | (78,245 | ) | ||||
| Interest and other income (expense), net | 115 | (90 | ) | |||||
| Loss before provision for income taxes | (88,105 | ) | (78,335 | ) | ||||
| Provision for income taxes | - | - | ||||||
| Net loss | $ | (88,105 | ) | $ | (78,335 | ) | ||
| Other comprehensive gain (loss): | ||||||||
| Unrealized gain (loss) on available-for-sale securities | (1,524 | ) | (135 | ) | ||||
| Comprehensive loss | $ | (89,629 | ) | $ | (78,470 | ) | ||
| Net loss per common share: | ||||||||
| Basic and diluted net loss per common share | $ | (0.87 | ) | $ | (0.86 | ) | ||
| Weighted-average shares outstanding used to calculate basic and diluted net loss per common share | 100,726 | 91,456 |