Conference Call and Webcast Today at 4:30 p.m.
EDT
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), 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
diseases, today reported financial results for the first quarter
2021, recent business highlights and key catalysts over the next 18
months.
“Atara is off to a strong start in 2021, advancing all three
strategic priorities to deliver on key value drivers,” said Pascal
Touchon, President and Chief Executive Officer of Atara. “We look
forward to several milestones in 2021, including the expected
tab-cel® BLA and MAA filings, progress on the ATA188 program –
especially the presentation of clinical and translational data from
the Phase 1 OLE study, and the first clinical data on our
mesothelin CAR T franchise.”
Tabelecleucel (tab-cel®) for Post-Transplant
Lymphoproliferative Disease (PTLD)
- Atara is in active discussions with the FDA and progressing
toward alignment on the content of CMC Module 3, including
methodologies to assess comparability between the product used in
the pivotal ALLELE study and the intended commercial product
- A recent analysis shows that duration of response (DoR) in its
ALLELE study is maturing as anticipated with a larger number of
responders followed for at least six months and a safety profile
consistent with previously published data with no new safety
signals
- Atara is working toward completing a BLA submission in Q3 2021
pending alignment with the FDA
- The Company has submitted a letter of intent to the European
Medicines Agency (EMA), starting the process for a submission of an
EU Marketing Authorization Application (MAA) for tab-cel® in
patients with EBV+ PTLD expected in Q4 2021
- Atara has data at two medical congresses from a combined
long-term overall survival (OS) analysis from three clinical
studies of tab-cel® demonstrating that patients with EBV+ PTLD,
following both HCT (hematopoietic cell transplantation) and SOT
(solid organ transplant), that is relapsed or refractory (R/R) to
initial treatment, derived similar OS benefit greater than 80
percent at two years whether they achieved complete or partial
response (CR or PR) with tab-cel®
- Data from the Phase 3 ALLELE study will be presented at an
appropriate congress in Q4 2021
- The Company is continuing to invest in U.S. commercial
readiness activities in anticipation of tab-cel® approval and
planned launch in H1 2022. In addition, Atara is in discussions
with potential partners for the commercialization of tab-cel® in
Europe
Tab-cel® for Potential Additional Indications
- Atara is actively opening sites in the Phase 2 multi-cohort
study for patients with other EBV-driven cancers
ATA188 for Progressive Forms of Multiple Sclerosis
(MS)
- Atara continues to make progress enrolling the ATA188 Phase 2
randomized, double-blind, placebo-controlled trial (RCT) evaluating
the efficacy and safety of ATA188 in patients with progressive
forms of MS (PMS)
- Atara plans to conduct an interim analysis (IA) in H1 2022
including efficacy and safety from the Phase 2 RCT in patients with
PMS, and following the IA, expects to complete enrollment of the
study in H1 2022
- The Company plans to present long-term, two-year clinical data
from the Phase 1 open-label extension (OLE) and translational data
from the Phase 1 study in H2 2021
- In the first quarter of 2021, Atara filed and received approval
of a Clinical Trial Application (CTA) for the Phase 2 RCT in
Canada
CAR T Programs
ATA2271/ATA3271 (Solid Tumors Over-Expressing
Mesothelin)
- The global strategic collaboration with Bayer including ATA2271
and ATA3271 is progressing well with successful launch of joint
governance and activities
- Enrollment of the first cohort in the Phase 1 clinical study of
ATA2271 for patients with advanced mesothelioma has completed and
the Company anticipates presentation of first clinical data in an
appropriate forum in Q4 2021
- Atara is continuing to make progress on IND-enabling studies
for ATA3271, an off-the-shelf, allogeneic CAR T therapy targeting
mesothelin using a PD-1 DNR and 1XX CAR co-stimulatory signaling
domain through its EBV T-cell platform, and expects an IND filing
in Q2/Q3 of 2022
ATA3219 (B-cell Malignancies)
- Atara expects to submit an IND for ATA3219, its next-generation
off-the-shelf, allogeneic CAR T using a 1XX CAR co-stimulatory
signaling domain through its EBV T-cell platform for patients with
B-cell malignancies, in Q4 2021 / Q1 2022
First Quarter 2021 Financial Results
- Cash, cash equivalents and short-term investments as of March
31, 2021 totaled $435.2 million, as compared to $500.7 million as
of December 31, 2020
- Atara believes that its cash as of March 31, 2021 together with
projected revenue from U.S. tab-cel® sales is sufficient to fund
its operations into 2023, including expenses related to the BLA
filing and commercial launch of tab-cel® in the U.S.
- License and collaboration revenue was $3.6 million for the
first quarter 2021 and consisted of revenue from activities
performed under the Bayer Collaboration Agreements. Atara did not
recognize any license and collaboration revenue for the same period
in 2020
- Net cash used in operating activities was $65.7 million for the
first quarter 2021, as compared to $67.0 million for the same
period in 2020
- Atara reported net losses of $78.3 million, or $0.86 per share,
for the first quarter 2021, as compared to $73.5 million, or $1.20
per share, for the same period in 2020
- Total operating expenses include non-cash expenses of $14.4
million for the first quarter 2021, as compared to $14.5 million
for the same period in 2020
- Research and development expenses were $64.1 million for the
first quarter 2021, as compared to $57.7 million for the same
period in 2020
- The increase in the first quarter 2021 was primarily due to
higher employee-related costs from increased headcount, increased
spending on the Company’s ATA188 and CAR T programs and increased
facilities and information technology expenses allocated to
research and development
- Research and development expenses include $7.5 million of
non-cash stock-based compensation expenses for the first quarter
2021, as compared to $7.7 million for the same period in 2020
- General and administrative expenses were $17.7 million for the
first quarter 2021, as compared to $17.0 million for the same
period in 2020
- General and administrative expenses include $4.7 million of
non-cash stock-based compensation expenses for the first quarter
2021, as compared to $5.0 million for the same period in 2020
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,
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 to
create a robust pipeline including: tab-cel® in Phase 3 development
for Epstein-Barr virus-driven post-transplant lymphoproliferative
disease (EBV+ PTLD) and other EBV-driven diseases; 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:
the potential benefits, safety and efficacy of tab-cel®; the timing
and progress of tab-cel®, including (i) tab-cel® clinical trials,
the timing and outcome of Atara’s discussions with the FDA
regarding the BLA submission for tab-cel®, including the content of
CMC Module 3, (ii) the timing of the initiation or submission of
the BLA and MAA for tab-cel®, (iii) Atara’s ability to successfully
advance the development of tab-cel®, and (iv) Atara’s activities in
anticipation of potential tab-cel® approval and launch; and (v)
Atara’s efforts to seek a commercialization partner for tab-cel® in
Europe; the potential benefits, safety and efficacy of ATA188; the
timing and progress of ATA188, including (i) ATA188 clinical trials
and (ii) Atara’s ability to successfully advance the development of
ATA188; the timing and progress of ATA2271 and ATA3271; progress of
the strategic collaboration with Bayer; the timing and progress of
ATA3219; and Atara’s ability to successfully advance the
development of its CAR T programs, and Atara’s ability to advance
development of its programs. 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, 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 and its development programs, 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.
Conference Call and Webcast Information
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 13717803. A live
audio webcast can be accessed by visiting the Investors & Media
– News & Events section of atarabio.com. An archived webcast
replay will be available on the Company's website for 30 days.
Financials
ATARA BIOTHERAPEUTICS,
INC.
Consolidated Balance
Sheets
(Unaudited)
(In thousands)
March 31,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
151,097
$
200,404
Short-term investments
284,064
300,255
Restricted cash - short-term
194
194
Accounts receivable
9,610
1,250
Prepaid expenses and other current
assets
19,342
21,170
Total current assets
464,307
523,273
Property and equipment, net
51,471
50,517
Operating lease assets
11,930
12,303
Restricted cash - long-term
1,200
1,200
Other assets
729
827
Total assets
$
529,637
$
588,120
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
17,355
$
7,118
Accrued compensation
12,786
20,458
Accrued research and development
expenses
10,655
15,813
Deferred revenue
35,497
33,455
Other current liabilities
7,901
6,057
Total current liabilities
84,194
82,901
Deferred revenue - long-term
31,811
27,795
Operating lease liabilities -
long-term
12,569
13,041
Other long-term liabilities
2,026
2,044
Total liabilities
130,600
125,781
Commitments and contingencies
Stockholders’ equity:
Common stock
8
8
Additional paid-in capital
1,601,784
1,586,616
Accumulated other comprehensive income
161
296
Accumulated deficit
(1,202,916
)
(1,124,581
)
Total stockholders’ equity
399,037
462,339
Total liabilities and stockholders’
equity
$
529,637
$
588,120
ATARA BIOTHERAPEUTICS,
INC.
Consolidated Statements of
Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per
share amounts)
Three Months Ended March
31,
2021
2020
License and collaboration revenue
$
3,552
$
—
Operating expenses:
Research and development
64,059
57,659
General and administrative
17,738
17,038
Total operating expenses
81,797
74,697
Loss from operations
(78,245
)
(74,697
)
Interest and other (expense) income,
net
(90
)
1,188
Loss before provision for income taxes
(78,335
)
(73,509
)
Provision for income taxes
—
—
Net loss
$
(78,335
)
$
(73,509
)
Other comprehensive loss:
Unrealized loss on available-for-sale
securities
(135
)
(16
)
Comprehensive loss
$
(78,470
)
$
(73,525
)
Net loss per common share:
Basic and diluted net loss per common
share
$
(0.86
)
$
(1.20
)
Weighted-average shares outstanding used
to calculate basic and diluted net loss per common share
91,456
61,208
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210504006256/en/
INVESTORS & MEDIA: Investors Eric Hyllengren
Vice President, Investor Relations & Finance Atara
Biotherapeutics 805-395-9669 ehyllengren@atarabio.com Media
Kerry Beth Daly Head, Corporate Communications Atara
Biotherapeutics 516-982-9328 kdaly@atarabio.com
Atara Biotherapeutics (NASDAQ:ATRA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Atara Biotherapeutics (NASDAQ:ATRA)
Historical Stock Chart
From Apr 2023 to Apr 2024