SOUTH SAN FRANCISCO, Calif., Nov. 07, 2019 (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 third quarter of 2019 and recent business highlights.
“I am pleased with our recent clinical, operational and strategic progress,” said Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics. “Following a comprehensive strategic portfolio review, we will focus our resources going forward on innovative off-the-shelf, allogeneic T-cell immunotherapy programs, specifically tab-cel®, ATA188, ATA2271/ATA3271 and ATA3219. In parallel, we will continue to leverage the capabilities and expertise of external partners for development of autologous CAR T immunotherapies.”
Following a six-month assessment of patients with progressive Multiple Sclerosis (MS) enrolled in cohort 3 of an ATA188 Phase 1a study, Atara selected this cohort 3 dose to initiate the randomized, double-blind, placebo-controlled Phase 1b part of this study.
“We are encouraged by the safety profile and early findings of potential efficacy for people living with progressive MS, as shown in our Phase 1a study data presented at ECTRIMS in September,” said AJ Joshi, MD, Senior Vice President and Chief Medical Officer of Atara Biotherapeutics. “The decision to initiate the Phase 1b was based on achieving in cohort 3 our pre-determined criteria of a continued well-tolerated safety profile and at least 50 percent of patients achieving clinical improvement from more than one clinical study site using the criteria we defined at ECTRIMS. Recognizing these are early data, and incorporating input from external experts, we believe these results merit the acceleration of ATA188 development for progressive MS patients who have limited treatment options and in whom continual clinical decline is expected.”
Recent Highlights and Anticipated Upcoming Milestones
61st American Society of Hematology (ASH) Annual MeetingAnnounced four abstracts highlighting robust off-the-shelf, allogeneic T-cell immunotherapy pipeline and next-generation CAR T technologies to be presented at the 61st ASH Annual Meeting, December 7-10, 2019 in Orlando, Florida Among these data are tab-cel® long-term clinical outcomes from a multicenter expanded access protocol (EAP) study for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD)
Tab-cel® (tabelecleucel)Atara continues to progress tab-cel® Phase 3 development for patients with EBV+ PTLD
ATA2271/ATA3271 and ATA3219 CAR T ProgramsAtara is developing a mesothelin-targeted autologous CAR T (ATA2271) for patients with advanced mesothelioma with an IND planned in 2020
OperationalFacility commissioning and qualification activities to support clinical development at ATOM (Atara T-cell Operations and Manufacturing) are complete
Third Quarter 2019 Financial ResultsCash, cash equivalents and short-term investments as of September 30, 2019 totaled $282.9 million, which includes $140.7 million in net proceeds from an underwritten public offering completed in July 2019 The Company believes that its current cash, cash equivalents and short-term investments are sufficient to fund planned operations into 2021 The Company reported a net loss of $71.9 million, or $1.31 per share, for the third quarter of 2019 as compared to $58.4 million, or $1.29 per share, for the same period in 2018 Total operating expenses include non-cash stock-based compensation and depreciation and amortization expenses of $13.9 million for the third quarter of 2019 as compared to $10.4 million for the same period in 2018 Research and development expenses were $53.5 million for the third quarter of 2019 as compared to $43.4 million for the same period in 2018. The increase in the third quarter of 2019 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
Conference Call and Webcast Information
Atara will host a live conference call and webcast today at 8:00 a.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 6069034. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company's website for approximately 14 days following the live webcast.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. (@Atarabio) is a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases. Atara’s technology platform leverages research collaborations with leading academic institutions with the Company’s scientific, clinical, regulatory and manufacturing expertise. Atara’s pipeline includes tab-cel® (tabelecleucel), which is in Phase 3 development for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) as well as in earlier stage development for other EBV-associated hematologic malignancies and solid tumors, including nasopharyngeal carcinoma (NPC); T-cell immunotherapies targeting EBV antigens believed to be important for the potential treatment of Multiple Sclerosis; and next-generation chimeric antigen receptor T-cell (CAR T) immunotherapies. The company was founded in 2012 and is co-located in South San Francisco and Southern California. Our Southern California hub is anchored by the state-of-the-art Atara T-cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California. For additional information about the company, please visit atarabio.com.
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 and efficacy of Atara Biotherapeutics’ drug candidates; the outcome of discussions with regulators, including the EMA; the timing of and the Company’s ability to achieve clinical and regulatory milestones, including the timing of CTA and BLA submissions for tab-cel® for patients with EBV+ PTLD, the results from Atara’s ongoing tab-cel® EAP study and the timing and results of additional data from Atara Biotherapeutics’ clinical trials; Atara Biotherapeutics’ ability to accelerate the Phase 1b study of ATA188; the outcome of strategic options with respect to ATA190; commercial production qualification activities at ATOM; and the sufficiency of the Company’s cash, cash equivalents and short-term investments. These forward-looking statements are subject to risks and uncertainties, including those discussed in Atara Biotherapeutics' 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 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.
ATARA BIOTHERAPEUTICS, INC.
Consolidated Balance Sheets
|September 30,||December 31,|
|Cash and cash equivalents||$||94,431||$||60,698|
|Restricted cash - short-term||194||194|
|Prepaid expenses and other current assets||10,302||11,664|
|Total current assets||293,418||321,489|
|Property and equipment, net||55,697||68,576|
|Operating lease assets||14,204||—|
|Restricted cash - long-term||1,200||1,200|
|Liabilities and stockholders’ equity|
|Accrued research and development expenses||6,172||19,210|
|Other current liabilities||6,482||6,414|
|Total current liabilities||30,706||39,979|
|Operating lease liabilities - long-term||14,532||—|
|Other long-term liabilities||1,105||13,003|
|Additional paid-in capital||1,057,669||866,541|
|Accumulated other comprehensive income (loss)||233||(340||)|
|Total stockholders’ equity||318,442||338,857|
ATARA BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||$||53,538||$||43,355||$||154,457||$||105,202|
|General and administrative||19,018||16,865||61,525||50,093|
|Total operating expenses||72,556||60,220||215,982||155,295|
|Loss from operations||(72,556||)||(60,220||)||(215,982||)||(155,295||)|
|Interest and other income, net||661||1,859||3,502||4,611|
|Loss before provision for income taxes||(71,895||)||(58,361||)||(212,480||)||(150,684||)|
|Provision for income taxes||—||—||—||3|
|Other comprehensive (gain) loss:|
|Unrealized gain (loss) on available-for-sale securities||60||56||573||(298||)|
|Net loss per common share:|
|Basic and diluted net loss per common share||$||(1.31||)||$||(1.29||)||$||(4.32||)||$||(3.49||)|
|Weighted-average shares outstanding used to calculate basic and diluted net loss per common share||54,920||45,406||49,176||43,148|
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