Full Press Release Details
Atara Biotherapeutics Announces First Quarter 2018 Financial Results and Recent Operational Progress
SOUTH SAN FRANCISCO, Calif., May 8, 2018 (GLOBE NEWSWIRE) -- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, today reported financial results for the first quarter of 2018 and recent operational highlights.
"During the first quarter of 2018, we continued to advance our T-cell immunotherapy pipeline and platform," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Our two Phase 3 pivotal studies of tab-cel are progressing, and we remain focused on building Atara's global commercial and operational capabilities in anticipation of the first tab-cel Phase 3 results and submission of an EU conditional marketing authorization application in the first half of 2019. We are also excited to have recently expanded our collaboration with Memorial Sloan Kettering Cancer Center to develop next generation chimeric antigen receptor T cell (CAR T) technologies, marking our entry into genetically engineered T-cells and furthering our leadership position in off-the-shelf, allogeneic T-cell immunotherapy. I am pleased with our strong operational and strategic execution in the first quarter and look forward to both continuing this momentum and updating you on our progress throughout the rest of the year."
Recent Highlights and Anticipated Upcoming Milestones
First Quarter 2018 Financial Results
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. (@Atarabio) is a leading T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases. The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells. Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who
have failed rituximab, as well as other EBV associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study). Atara is also developing off-the-shelf, allogenic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara also initiated a multinational Phase 1 ATA188 clinical study in patients with progressive or relapsing-remitting MS in Australia in the fourth quarter of 2017 and in the U.S. in March 2018. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).
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 of the Company's license and collaboration with MSK; the Company's enrollment, later expansion of additional sites in the U.S. and other geographies; expected results and completion of its Phase 3 studies of tab-cel ; the timing of the Company's submission of a CMA for tab-celTM in the EU; the potential benefits of Atara MatchMeTM; the expected start of a Phase 1/2 study of tab-cel in combination with Merck's anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV associated NPC in 2018; the sufficiency of the Company's cash, cash equivalents and short-term investments to fund operations to mid-2020; the Company's ability to leverage its platform in other indications and initiate development of additional immunotherapies; and the potential advantages of its product candidates. 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 those discussed under the heading "Risk Factors" in Atara Biotherapeutics' annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 27, 2018, including the documents incorporated by reference therein, and subsequent filings with the SEC. 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.
INVESTOR & MEDIA CONTACTS:
John Craighead, Atara Biotherapeutics
Steve Klass, Burns McClellan
Justin Jackson, Burns McClellan
Atara Biotherapeutics, Inc.
Consolidated Balance Sheets
| March 31, | December 31, | |||
| 2018 | 2017 | |||
| Assets | ||||
| Current assets: | ||||
| Cash and cash equivalents | $ 90,495 | $ 79,223 | ||
| Short-term investments | 316,826 | 86,873 | ||
| Restricted cash - short-term | 194 | 194 | ||
| Prepaid expenses and other current assets | 6,099 | 5,900 | ||
| Total current assets | 413,614 | 172,190 | ||
| Property and equipment, net | 58,194 | 44,129 | ||
| Restricted cash - long-term | 1,200 | 1,200 | ||
| Other assets | 100 | 260 | ||
| Total assets | $ 473,108 | $ 217,779 | ||
| Liabilities and stockholders' equity | ||||
| Current liabilities: | ||||
| Accounts payable | $ 6,098 | $ 14,711 | ||
| Accrued compensation | 4,312 | 5,644 | ||
| Accrued research and development expenses | 6,336 | 4,006 | ||
| Other current liabilities | 4,303 | 3,265 | ||
| Total current liabilities | 21,049 | 27,646 | ||
| Long-term liabilities | 12,875 | 12,269 | ||
| Total liabilities | 33,924 | 39,915 | ||
| Commitments and contingencies | ||||
| Stockholders' equity: | ||||
| Common stock | 4 | 3 | ||
| Additional paid-in capital | 777,797 | 474,662 | ||
| Accumulated other comprehensive loss | (524) | (151) | ||
| Accumulated deficit | (338,093) | (296,650) | ||
| Total stockholders' equity | 439,184 | 177,864 | ||
| Total liabilities and stockholders' equity | $ 473,108 | $ 217,779 |
Atara Biotherapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
| Three Months Ended March 31, | ||||
| 2018 | 2017 | |||
| Operating expenses: | ||||
| Research and development | $ 28,460 | $ 17,541 | ||
| General and administrative | 13,992 | 8,620 | ||
| Total operating expenses | 42,452 | 26,161 | ||
| Loss from operations | (42,452) | (26,161) | ||
| Interest and other income, net | 1,009 | 509 | ||
| Loss before provision for income taxes | (41,443) | (25,652) | ||
| Provision for income taxes | - | 2 | ||
| Net loss | $ (41,443) | $ (25,654) | ||
| Other comprehensive loss: | ||||
| Unrealized gain (loss) on available-for-sale securities | (373) | 31 | ||
| Comprehensive loss | $ (41,816) | $ (25,623) | ||
| Net loss per common share: | ||||
| Basic and diluted net loss per common share | $ (1.05) | $ (0.88) | ||
| Weighted-average shares outstanding used to calculate basic and diluted net loss per common share | 39,596 | 29,056 |