Atara Bio Announces Fourth Quarter and Full Year 2016 Financial Results and Recent Highlights
10 March 2017 - 12:00AM
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical
company developing meaningful therapies for patients with severe
and life-threatening diseases that have been underserved by
scientific innovation, today reported financial results for the
fourth quarter and full year ended December 31, 2016 and recent
operational highlights.
"We believe 2017 will be a transformative year for Atara Bio as
we continue to advance our robust pipeline of allogeneic T-cell
therapies to address multiple diseases with high unmet medical
need,” said Isaac Ciechanover, Chief Executive Officer and
President of Atara Bio. “In December of last year, we reached
agreement with the FDA on the designs of two separate Phase 3
trials of ATA129 in the treatment of EBV-PTLD, and more recently we
announced EMA support for our plan to submit a conditional
marketing authorization application for potential approval of
ATA129 in the EU.”
Recent Highlights and Anticipated Upcoming
Milestones
- Reached agreement with the U.S. Food and Drug Administration
(FDA) on the design of two Phase 3 trials for ATA129 intended to
support approval in the treatment of rituximab-refractory
Epstein-Barr Virus (EBV)-Associated Post Transplant
Lymphoproliferative Disorder (EBV-PTLD) after hematopoietic cell
transplant (HCT) or solid organ transplant (SOT).
- The MATCH trial (EBV-PTLD after HCT) is a multicenter, open
label, single arm trial designed to enroll approximately 35
patients previously treated with rituximab.
- The ALLELE trial (EBV-PTLD after SOT) is a multicenter, open
label trial designed to enroll patients concurrently in two
non-comparative cohorts. The first cohort will include
approximately 35 patients who previously received rituximab
monotherapy; the second cohort will include approximately 35
patients who previously received rituximab plus chemotherapy.
- The primary endpoint of both the MATCH and ALLELE trials is
objective response rate, defined as the percent of patients
achieving either a complete or partial response to treatment with
ATA129.
- Generated and evaluated data from lots of ATA129 manufactured
by the Company’s contract manufacturing organization and initiated
discussions with FDA. The Company has been successful in producing
ATA129 drug product and identified certain assays that need
refinement prior to initiating the Phase 3 trials. Atara is
refining these assays within its laboratories, manufacturing lots
to further support comparability evaluations and the Phase 3
trials, and expects to review these data in ongoing discussions
with the FDA.
- Announced plans to submit in 2018 an application for
Conditional Marketing Authorization (CMA) to the European Medicines
Agency (EMA) for ATA129 in the treatment of patients with rituximab
refractory EBV-PTLD following HCT.
- The CMA will be based on clinical data from Phase 1 and 2
trials conducted at MSK and supported by available data from the
Company's Phase 3 MATCH and ALLELE trials, which will be ongoing at
the time of filing.
- Announced that access was granted by the EMA's recently
established Priority Medicines (PRIME) regulatory initiative for
ATA129 in the treatment of patients with rituximab refractory
EBV-PTLD following HCT.
- Broadened ongoing expanded access protocol (EAP) trial for
ATA129 to include other EBV-positive malignancies such as Diffuse
large B-cell lymphoma, Hodgkin lymphoma, Burkitt lymphoma, and
nasopharyngeal carcinoma.
- Expect collaborating investigators to present at a medical
conference in 2017 initial data from a Phase 1 trial of the
autologous version of ATA188 in patients with primary and secondary
progressive multiple sclerosis (MS). ATA188 is an EBV
specific cytotoxic T lymphocyte that is targeted to specific
antigens that we believe are important for the treatment of MS.
- Plan to initiate a Phase 1 trial of ATA188 in MS in the second
half of 2017.
- Signed a lease for an approximately 90,000 square foot facility
in Thousand Oaks, CA and plan to build-out a multi-product cellular
therapy manufacturing facility with manufacturing operations
expected to commence in 2018.
- Reported additional efficacy and safety data from the Company's
ongoing Phase 2 trial of ATA230, cytomegalovirus (CMV)-targeted
cytotoxic T lymphocytes (CMV-CTLs), in the treatment of patients
with refractory CMV infections that occur following HCT during the
American Society of Hematology (ASH) Annual Meeting in December
2016.
Fourth Quarter and Full Year 2016 Financial
Results
- Cash and investments as of December 31, 2016 totaled $255.7
million, which the Company believes will be sufficient to fund its
planned operations into the first quarter of 2019.
- The Company reported net losses of $18.2 million, or $0.63 per
share, and $79.0 million, or $2.75 per share, for the fourth
quarter and fiscal year 2016, as compared to $21.2 million, or
$0.75 per share, and $57.2 million, or $2.24 per share, for the
same periods in 2015. Substantially all of the Company's net losses
resulted from research and development expenses related to clinical
and preclinical programs and from general and administrative
expenses associated with operations.
- Total research and development expenses were $13.5 million and
$56.5 million for the fourth quarter and fiscal year 2016, as
compared to $16.2 million and $41.6 million for the same periods in
2015. The decrease in fourth quarter expenses from the prior period
was primarily due to license fees of $3.0 million included in the
fourth quarter of 2015. The increase in fiscal 2016 expense was in
large part due to preparations for the two Phase 3 clinical trials
in EBV-PTLD and the initiation of our EAP clinical trial, as well
as an increase in manufacturing activities related to the technical
transfer of ATA129 manufacturing to a third party CMO. Research and
development expenses include $7.6 million and $4.8 million of
non-cash stock-based compensation expenses in fiscal 2016 and 2015,
respectively.
- General and administrative expenses were $5.3 million and $24.7
million for the fourth quarter and fiscal year 2016, as compared to
$5.5 million and $16.8 million for the same periods in 2015. The
increase in fiscal year expense in 2016 was primarily due to an
increase in compensation-related costs for the additional headcount
to support our expanding operations. General and administrative
expenses include $9.2 million and $5.4 million of non-cash
stock-based compensation expenses in fiscal 2016 and 2015,
respectively.
About Atara Biotherapeutics’ Allogeneic Cellular Therapy
Platform
Atara Bio's cellular therapy platform provides healthy immune
capability to a patient and arms the immune system to precisely
target and combat disease. Cells derived from healthy donors are
manufactured in advance and stored as inventory so that a
customized unit of cells can be chosen for each patient. The cells
are ready to infuse in approximately 3 to 5 days. Once
administered, the cells home to their target, expand in-vivo to
eliminate diseased cells, and eventually recede. This versatile
platform can be directed towards a broad array of disease causing
targets and has demonstrated clinical proof of concept across both
viral and non-viral targets in conditions ranging from liquid and
solid tumors to infectious and autoimmune diseases. The Company has
pursued prospective feedback from health authorities on both
manufacturing and clinical trial design. Atara Bio’s lead product
candidate has the potential to be the first commercial allogeneic
T-cell therapy for a viral target implicated in cancer.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. is a biopharmaceutical company
developing meaningful therapies for patients with severe and
life-threatening diseases that have been underserved by scientific
innovation, with an initial focus on allogeneic T-cell therapies
for cancer, autoimmune, and infectious disease. Atara Bio's T-cell
product candidates harness the power of the immune system to
recognize and attack cancer cells and cells infected with certain
viruses. The Company's initial clinical stage T-cell product
candidates include Epstein-Barr virus targeted Cytotoxic T-cells
(EBV-CTL), or ATA129, Cytomegalovirus targeted Cytotoxic T-cells
(CMV-CTL), or ATA230, and Wilms Tumor 1 targeted Cytotoxic T-cells
(WT1-CTL), or ATA520. These product candidates have demonstrated
the potential to have therapeutic benefit in a number of clinical
indications including hematologic malignancies, solid tumors, and
refractory viral infections. The Company is also developing a next
generation of allogeneic T-cell product candidates utilizing a
technology to selectively enhance a T-cell's ability to target
specific viral proteins implicated in disease. Initial clinical
investigations employing this approach will focus on multiple
sclerosis and other virally mediated cancers and infections.
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 Company’s belief that 2017 will be a transformative year for
Atara Bio; the Company’s plan to submit a conditional marketing
authorization application for potential approval of ATA129 in the
EU; the Company’s belief that it has been successful in producing
ATA129 drug product; the Company’s refinement of certain assays,
manufacture of lots to further support comparability evaluations
and the Phase 3 trials, and expectations to review these data with
FDA prior to starting these trials; plans for the CMA to be based
on clinical data from Phase 1 and 2 trials conducted at MSK and
supported by available data from the Company's Phase 3 MATCH and
ALLELE trials, which will be ongoing at the time of filing; the
Company’s expectation that its collaborating investigators will
present at a medical conference in 2017 initial data from a Phase 1
trial of the autologous version of ATA188 in patients with primary
and secondary progressive MS; the Company’s plan to initiate a
Phase 1 trial of ATA188 in MS in the second half of 2017; the
Company’s plan to build-out a multi-product cellular therapy
manufacturing facility with manufacturing operations expected to
commence in 2018; and the Company’s belief that its cash and
investments as of December 31, 2016 will be sufficient to fund its
planned operations into the first quarter of 2019. Because such
statements deal with future events and are based on Atara Bio's
current expectations, they are subject to various risks and
uncertainties and actual results, performance or achievements of
Atara Bio 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
Bio's quarterly report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 4, 2016, including the
documents incorporated by reference therein, and subsequent filings
with the SEC. Except as otherwise required by law, Atara Bio
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 |
(Unaudited) |
(In thousands) |
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
47,968 |
|
|
$ |
23,746 |
|
Short-term investments |
|
|
207,714 |
|
|
|
296,736 |
|
Restricted cash |
|
|
194 |
|
|
|
194 |
|
Prepaid
expenses and other current assets |
|
|
4,677 |
|
|
|
3,921 |
|
Total current
assets |
|
|
260,553 |
|
|
|
324,597 |
|
Property and equipment,
net |
|
|
3,259 |
|
|
|
270 |
|
Other assets |
|
|
102 |
|
|
|
108 |
|
Total assets |
|
$ |
263,914 |
|
|
$ |
324,975 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,778 |
|
|
$ |
1,445 |
|
Accrued
compensation |
|
|
3,745 |
|
|
|
2,624 |
|
Accrued
research and development expenses |
|
|
2,408 |
|
|
|
5,112 |
|
Other
accrued liabilities |
|
|
744 |
|
|
|
528 |
|
Total current
liabilities |
|
|
9,675 |
|
|
|
9,709 |
|
Long-term
liabilities |
|
|
503 |
|
|
|
166 |
|
Total liabilities |
|
|
10,178 |
|
|
|
9,875 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Common
stock |
|
|
3 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
431,075 |
|
|
|
413,725 |
|
Accumulated other comprehensive loss |
|
|
(183 |
) |
|
|
(518 |
) |
Accumulated deficit |
|
|
(177,159 |
) |
|
|
(98,110 |
) |
Total stockholders’
equity |
|
|
253,736 |
|
|
|
315,100 |
|
Total liabilities and
stockholders’ equity |
|
$ |
263,914 |
|
|
$ |
324,975 |
|
ATARA BIOTHERAPEUTICS, INC. |
Consolidated Statements of Operations and
Comprehensive Loss |
(Unaudited) |
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
$ |
13,474 |
|
|
$ |
16,231 |
|
|
$ |
56,514 |
|
|
$ |
41,618 |
|
General and
administrative |
|
5,280 |
|
|
|
5,539 |
|
|
|
24,728 |
|
|
|
16,830 |
|
Total operating
expenses |
|
18,754 |
|
|
|
21,770 |
|
|
|
81,242 |
|
|
|
58,448 |
|
Loss from
operations |
|
(18,754 |
) |
|
|
(21,770 |
) |
|
|
(81,242 |
) |
|
|
(58,448 |
) |
Interest and other
income, net |
|
519 |
|
|
|
522 |
|
|
|
2,203 |
|
|
|
1,218 |
|
Loss before provision
for income taxes |
|
(18,235 |
) |
|
|
(21,248 |
) |
|
|
(79,039 |
) |
|
|
(57,230 |
) |
Provision (benefit) for
income taxes |
|
- |
|
|
|
- |
|
|
|
10 |
|
|
|
(9 |
) |
Net loss |
$ |
(18,235 |
) |
|
$ |
(21,248 |
) |
|
$ |
(79,049 |
) |
|
$ |
(57,221 |
) |
Other comprehensive
loss: |
|
|
|
|
|
|
|
Unrealized gain (loss)
on available-for-sale securities |
|
(218 |
) |
|
|
(569 |
) |
|
|
335 |
|
|
|
(418 |
) |
Comprehensive loss |
$ |
(18,453 |
) |
|
$ |
(21,817 |
) |
|
$ |
(78,714 |
) |
|
$ |
(57,639 |
) |
Net loss per common
share: |
|
|
|
|
|
|
|
Basic and diluted net
loss per common share: |
$ |
(0.63 |
) |
|
$ |
(0.75 |
) |
|
$ |
(2.75 |
) |
|
$ |
(2.24 |
) |
Weighted-average common
shares outstanding used to calculate basic and diluted net
loss per common share |
|
28,915 |
|
|
|
28,413 |
|
|
|
28,732 |
|
|
|
25,583 |
|
|
|
|
|
|
|
|
|
INVESTOR & MEDIA CONTACTS:
Investors:
Steve Klass, Burns McClellan on behalf of Atara Bio
212-213-0006 x331
sklass@burnsmc.com
Media:
Justin Jackson, Burns McClellan
212-213-0006 x327
jjackson@burnsmc.com
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