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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Atara Biotherapeutics Inc | NASDAQ:ATRA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0341 | -4.98% | 0.6504 | 0.6503 | 0.659 | 0.7062 | 0.61 | 0.70 | 2,207,294 | 22:02:10 |
Tab-cel U.S. BLA Submission Not Currently Expected for Q2 2022 as Further FDA Engagement and Alignment Required; Anticipated EU Approval On-Track for Q4 2022 Under Accelerated Assessment
ATA188 Granted FDA Fast Track Designation in Both Non-Active PPMS and Non-Active SPMS with Phase 2 EMBOLD Study Interim Analysis Planned for Q2 2022
Entered Long-Term Strategic Manufacturing Partnership with Fujifilm with Upfront Cash Payment of USD 100 Million
Conference Call and Webcast Today at 1:30 p.m. PST/ 4:30 p.m. EST
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 fourth quarter and full year 2021, recent business highlights and key upcoming catalysts for 2022.
“With our EMA filing for tab-cel® and a strategic commercial collaboration with Pierre Fabre, ATA188’s FDA Fast Track designations and new data reinforcing its potential to reverse or halt disability in progressive multiple sclerosis, 2021 provided strong validation for Atara and our industry-leading allogeneic T-cell pipeline,” said Pascal Touchon, President and Chief Executive Officer of Atara. “2022, which has already delivered two landmark publications confirming EBV as the leading cause of MS in advance of our interim analysis from our ATA188 Phase 2 study, and a long-term strategic manufacturing partnership with Fujifilm, will be a critical year as we progress our strategic priorities. Although further engagement and alignment is required with FDA to determine the path forward for a BLA submission in the U.S., we anticipate a groundbreaking EU approval this year that will position tab-cel as the first ever allogeneic off-the-shelf T-cell therapy available for patients.”
Tabelecleucel (tab-cel®) for Post-Transplant Lymphoproliferative Disease (PTLD)
Tab-cel for Potential Additional Indications
ATA188 for Progressive Multiple Sclerosis (MS)
CAR T Programs
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)
ATA3219 (B-cell Malignancies)
Allogeneic T-Cell Platform Development and Operations
Fourth Quarter and Full Year 2021 Financial Results
Conference Call and Webcast Details
Atara will host a live conference call and webcast today, Monday, February 28, 2022, at 4:30 p.m. EST 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 13725930. 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.
Atara Biotherapeutics, Inc. (@Atarabio) is a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program in Phase 3 clinical development and currently under review to support registration in Europe, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-associated diseases, or other serious diseases through incorporation of engineered CARs (chimeric antigen receptors) or TCRs (T-cell receptors). Atara is applying this one platform, which does not require TCR or HLA gene editing, to create a robust pipeline including: tab-cel® (tabelecleucel) in Phase 3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD); ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Improving patients’ lives is our mission and we will never stop working to bring transformative therapies to those in need. Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California. For additional information about the company, please visit atarabio.com and follow us on Twitter and LinkedIn.
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®, (iv) the timing of the EMA’s review of the MAA for tab-cel®, (v) Atara’s ability to successfully advance the development of tab-cel®, and (vi) 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) 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, (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, 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 proposed sale of its ATOM manufacturing facility to FUJIFILM Diosynth Biotechnologies (FDB), including (i) the parties ability to consummate such transaction, including the timing thereof, (ii) the potential benefits of such transaction to Atara, including the potential financial benefits to Atara, (iii) the proposed supply agreement between the parties and the duration and benefits thereof, (iv) FDB’s ability to perform under the proposed supply agreement and meet Atara’s requirements, (v) FDB’s potential plans for ATOM, and (vi) 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, 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.
Financials
ATARA BIOTHERAPEUTICS, INC.
Consolidated Balance Sheets
(Unaudited)
(In thousands)
December 31,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
106,084
$
200,404
Short-term investments
264,984
300,255
Restricted cash - short-term
194
194
Accounts receivable
986
1,250
Prepaid expenses and other current assets
12,373
21,170
Total current assets
384,621
523,273
Property and equipment, net
53,780
50,517
Operating lease assets
26,159
12,303
Restricted cash - long-term
1,200
1,200
Other assets
2,367
827
Total assets
$
468,127
$
588,120
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
17,368
$
7,118
Accrued compensation
25,150
20,458
Accrued research and development expenses
13,451
15,813
Deferred revenue
40,760
33,455
Other current liabilities
9,057
6,057
Total current liabilities
105,786
82,901
Deferred revenue - long-term
55,708
27,795
Operating lease liabilities - long-term
25,518
13,041
Other long-term liabilities
1,501
2,044
Total liabilities
188,513
125,781
Commitments and contingencies
Stockholders’ equity:
Common stock
9
8
Additional paid-in capital
1,744,695
1,586,616
Accumulated other comprehensive (loss) income
(368
)
296
Accumulated deficit
(1,464,722
)
(1,124,581
)
Total stockholders’ equity
279,614
462,339
Total liabilities and stockholders’ equity
$
468,127
$
588,120
ATARA BIOTHERAPEUTICS, INC.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per share amounts)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2021
2020
2021
2020
License and collaboration revenue
$
7,548
$
—
$
20,340
$
—
Operating expenses:
Research and development
79,134
65,554
282,001
244,650
General and administrative
21,817
16,143
78,801
64,402
Total operating expenses
100,951
81,697
360,802
309,052
Loss from operations
(93,403
)
(81,697
)
(340,462
)
(309,052
)
Interest and other income, net
84
398
367
2,447
Loss before provision for income taxes
$
(93,319
)
$
(81,299
)
$
(340,095
)
$
(306,605
)
Provision for income taxes
30
8
46
15
Net loss
$
(93,349
)
$
(81,307
)
$
(340,141
)
$
(306,620
)
Other comprehensive gain (loss):
Unrealized gain (loss) on available-for-sale securities
(392
)
(231
)
(664
)
76
Comprehensive loss
$
(93,741
)
$
(81,538
)
$
(340,805
)
$
(306,544
)
Net loss per common share:
Basic and diluted net loss per common share
$
(0.96
)
$
(0.95
)
$
(3.63
)
$
(4.15
)
Weighted-average shares outstanding used to calculate basic and diluted net loss per common share
97,407
85,301
93,670
73,973
_____________________________
1 The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
View source version on businesswire.com: https://www.businesswire.com/news/home/20220228005915/en/
Investors Eric Hyllengren 805-395-9669 ehyllengren@atarabio.com
Media Alex Chapman 805-456-4772 achapman@atarabio.com
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