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SOUTH SAN FRANCISCO, Calif., Aug. 01, 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 second quarter of 2018 and recent operational highlights.
“The future of T-cell immunotherapy is both off-the-shelf and across multiple therapeutic areas,” said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. “During the second quarter, we continued to advance our robust T-cell immunotherapy pipeline, highlighted by our ongoing Phase 3 studies of tab-cel™ in patients with EBV+ PTLD and Phase 1 study of ATA188 in patients with progressive multiple sclerosis. In parallel, we continue to build 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 preparing to expand our pipeline with the development of the next generation of chimeric antigen receptor T cell (CAR T) technologies. This is an exciting time for Atara as we enter the next phase of the Company’s growth as a leader in off-the-shelf, allogeneic T-cell immunotherapy.”
Recent Highlights and Anticipated Upcoming Milestones
ATA188 & ATA190 for Multiple Sclerosis (MS)
Second Quarter 2018 Financial Results
Atara Biotherapeutics, Inc.
Condensed Consolidated Balance Sheets
|June 30,||December 31,|
|Cash and cash equivalents||$||103,203||$||79,223|
|Restricted cash - short-term||194||194|
|Prepaid expenses and other current assets||7,861||5,900|
|Total current assets||425,070||172,190|
|Property and equipment, net||66,075||44,129|
|Restricted cash - long-term||1,200||1,200|
|Liabilities and stockholders’ equity|
|Accrued research and development expenses||6,661||4,006|
|Other current liabilities||8,752||3,265|
|Total current liabilities||27,234||27,646|
|Commitments and contingencies|
|Additional paid-in capital||841,975||474,662|
|Accumulated other comprehensive loss||(505||)||(151||)|
|Total stockholders’ equity||452,499||177,864|
|Total liabilities and stockholders’ equity||$||492,707||$||217,779|
Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||$||33,387||$||18,296||$||61,847||$||35,837|
|General and administrative||19,236||9,613||33,228||18,233|
|Total operating expenses||52,623||27,909||95,075||54,070|
|Loss from operations||(52,623||)||(27,909||)||(95,075||)||(54,070||)|
|Interest and other income, net||1,743||481||2,752||990|
|Loss before provision for income taxes||(50,880||)||(27,428||)||(92,323||)||(53,080||)|
|Provision for income taxes||3||—||3||2|
|Other comprehensive loss:|
|Unrealized gain (loss) on available-for-sale securities||19||38||(354||)||69|
|Net loss per common share:|
|Basic and diluted net loss per common share||$||(1.15||)||$||(0.94||)||$||(2.20||)||$||(1.82||)|
|Weighted-average shares outstanding used
to calculate basic and diluted net loss per common share
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, allogeneic 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 is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).
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: enrollment of patients in the Company’s clinical trials; opening additional clinical sites in the United States and other geographies; expected results and completion of its Phase 3 studies of tab-cel™; the timing of the Company’s submission of a conditional market authorization for tab-celTM in the EU; 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 timing and results of the Company’s Phase 1 studies of ATA 188 and autologous ATA190 in patients with progressive MS; the Company’s ability to rapidly advance its CAR T development programs; 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' quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 1, 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
Robert Flamm, Burns McClellan