Positive Pivotal Phase 3 ALLELE Data
Reinforcing the Transformative Potential of Tab-cel® to be
Highlighted as Oral Presentation at Upcoming American Society of
Hematology Meeting
Significant Tab-cel® Regulatory Progress with
Imminent EU MAA Submission and Additional Clarity on FDA
Requirements for BLA Submission Planned for Q2 2022
ATA188 Data Demonstrates Durable, Clinically
Meaningful Disability Improvement and Possible Remyelination in
Patients with Progressive Multiple Sclerosis
Company to Host Live Conference Call and
Webcast Today at 8:30 a.m. EDT
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell
immunotherapy, leveraging its novel allogeneic Epstein-Barr virus
(EBV) T-cell platform to develop transformative therapies for
patients with cancer and autoimmune diseases, today reported
financial results for the third quarter 2021, recent business
highlights and key catalysts over the next several months.
“Atara continues to make meaningful progress across our
strategic priorities and with positive data from our pivotal Phase
3 ALLELE study and imminent EU regulatory submission, we are now at
an inflection point as we work to deliver tab-cel®, a potentially
transformative first-in-kind therapy, to patients in need,” said
Pascal Touchon, President and Chief Executive Officer of Atara. “We
are equally encouraged by new data confirming our conviction for
ATA188 as the first investigational therapy to reverse disability
in progressive multiple sclerosis, and upcoming milestones related
to our potentially best-in-class CAR T portfolio that does not
require TCR or HLA gene editing.”
Tabelecleucel (tab-cel®) for Post-Transplant
Lymphoproliferative Disease (PTLD)
- First presentation of new positive data from the pivotal Phase
3 ALLELE study, reinforcing the transformative potential of
tab-cel, has been accepted as an oral session at the 63rd American
Society of Hematology (ASH) Annual Meeting in December 2021
- Top-line data with additional patients and extended follow up
confirm a strong objective response rate (ORR) and a safety profile
in line with prior results, demonstrate durability of response, and
will support the imminent EU Marketing Authorization Application
(MAA) submission
- An ORR, as measured by independent oncologic response
adjudication (IORA) assessment, of 50% (19/38, 95% CI: 33.4, 66.6)
was observed, with an ORR of 50% (12/24, 95% CI: 29.1, 70.9) in
PTLD following SOT and 50% (7/14, CI: 23.0, 77.0) in PTLD following
HCT, with a best overall response of Complete Response (CR; n=5,
SOT; n=5, HCT) or Partial Response (PR; n=7, SOT; n=2, HCT)
- Overall, the median time to response (TTR) was 1.1 months
(0.7-4.7). Of 19 responders, 11 had a duration of response (DOR)
lasting more than six months and median DOR has not been reached
yet
- The one-year survival rate was 61.1% overall (57.4% for SOT,
and 66.8% for HCT). Those who responded had a longer survival
compared to the non-responders, with a median overall survival (OS)
not evaluable (NE) (95% CI: 16.4, NE) and 1-year survival rate of
89.2% (95% CI: 63.1, 97.2)
- Safety findings were consistent with previously published data,
with no new signals. There were no reports of tumor flare reaction,
and no confirmed evidence of graft versus host disease (GvHD),
organ rejection, infusion reactions, or cytokine release syndrome
(CRS) related to tab-cel
- At ASH, Atara will present additional data on tab-cel through
several abstracts, including a second oral presentation on long
term OS from Phase 2 and multi-center Expanded Access Protocol
(EAP) studies in relapsed/refractory EBV+ PTLD showing median OS of
54.6 months in all patients and OS at two years reaching over 86%
in responders whether patients experienced CR or PR
- Following successful interactions with the European Medicines
Agency (EMA), and their recent granting of accelerated assessment
to tab-cel, Atara will imminently submit a MAA for tab-cel, with an
EU approval decision anticipated in H2 2022
- The previously announced exclusive agreement with Pierre Fabre
for the commercialization of tab-cel in Europe, the Middle East,
Africa, and other select emerging markets for EBV-positive cancers
has started strongly. Atara will retain full rights to tab-cel in
other major markets, including North America, Asia Pacific, and
Latin America
- Atara has continued to make good progress through Type B
meetings with the U.S. Food and Drug Administration (FDA)
- After gaining clarity, alignment on key comparability
methodology has been reached
- Based on the requests from FDA following recent interactions,
Atara will provide the Agency with additional analyses of CMC data
already generated
- FDA has not requested additional studies or manufacturing
lots
- Atara subsequently plans to have further interactions with the
FDA in Q1 2022 and complete the Biologics License Application (BLA)
submission for tab-cel in Q2 2022
Tab-cel for Potential Additional Indications
- Atara is committed to pursuing the development of tab-cel in
additional EBV-positive patient populations, with a primary focus
on immunodeficiency-associated lymphoproliferative diseases
(IA-LPDs)
- Enrollment is continuing at sites in the Phase 2 multi-cohort
study, which is evaluating six patient populations, including four
within IA-LPDs and two in other EBV-driven diseases, in the U.S.
and EU. Phase 2 study data is expected in 2023
ATA188 for Progressive Multiple Sclerosis
- Positive momentum around the ATA188 program continues to build,
with increasing awareness of and excitement for the transformative
potential of ATA188 in multiple sclerosis (MS) among the medical
community and industry
- At the 37th Congress of the European Committee for Treatment
and Research in Multiple Sclerosis (ECTRIMS) meeting in October,
Atara presented translational data based on magnetization transfer
ratio (MTR), an imaging biomarker of myelin density, and updated
Phase 1 open-label extension (OLE) clinical data in patients with
progressive MS treated with ATA188 for up to 39 months
- Findings continue to demonstrate that patients may achieve
sustained disability improvement (SDI) at a higher rate and longer
duration than would be expected based on the natural history of
progressive MS; the majority of SDI is driven by improvement in the
expanded disability status scale (EDSS)
- In seven of eight patients, SDI was maintained at all
subsequent timepoints up to 33 months, with multiple patients
regaining enough function that they no longer needed a walking aid
and were able to walk a few hundred meters unassisted. Most
patients in the OLE were progression free, which could be another
significant measure of clinical benefit in people with progressive
MS
- Magnetic Resonance Imaging (MRI) results showed increases in
MTR suggestive of remyelination. In patients treated with ATA188
who achieved sustained EDSS improvement versus those who did not,
MTR for non-enhancing T2 chronic brain lesions increased at six
months and this increase achieved statistical significance at 12
months; A similar trend of MTR increase was also seen in
normal-appearing brain tissue
- These MTR data, where the time course for increase in MTR
parallels the EDSS improvements observed, provides evidence that
remyelination may be the driver for clinical improvement, and
supports a potential biological basis for clinical EDSS
improvements observed with ATA188
- Updated results from the ongoing OLE demonstrate continued
safety and tolerability of ATA188 with up to three annual
treatments. As of August 2021, no fatal adverse events, grade >3
events, dose-limiting toxicities, CRS, or GvHD were observed
- Atara is continuing to make good progress with enrollment of
the Phase 2 randomized, double-blind, placebo-controlled
dose-expansion EMBOLD study evaluating the efficacy and safety of
ATA188 in patients with progressive MS, across clinical sites in
North America and Australia
- An interim analysis to assess efficacy and safety is planned
for H1 2022. The Company plans to communicate its decision on next
steps for the program, including rationale, while still maintaining
the integrity of the study
- Atara expects to complete enrollment for EMBOLD in H1 2022
- Atara will present encore data at the 29th Annual Meeting of
the European Charcot Foundation in November 2021. The Company will
present an overview of the methodology planned to determine the
potential pharmacodynamic effect of ATA188, by quantifying a
decrease of EBV infected cells following treatment with ATA188
CAR T Programs
ATA2271/ATA3271 (Solid Tumors Over-Expressing
Mesothelin)
- The global strategic collaboration for ATA2271 and ATA3271 with
Bayer continues to progress, with work advancing across both
mesothelin-partnered CAR-T immunotherapy programs
- The first presentation of preclinical, clinical, and
translational data from the lowest dose cohorts of the open-label,
single-arm Phase 1 clinical study of ATA2271, an autologous CAR-T
therapy targeting mesothelin, designed to improve efficacy,
persistence, and durability of response for patients with advanced
mesothelioma, will take place during a Mini Oral session at the
ESMO Immuno-Oncology Congress on December 9, 2021 (presentation
#46MO)
- Atara is continuing to make progress on IND-enabling studies
for ATA3271, an off-the-shelf, allogeneic CAR-T therapy targeting
mesothelin using next-generation PD-1 dominant negative receptor
(DNR) and 1XX CAR co-stimulatory signaling domain technologies and
expects an IND filing in H2 2022
- Preclinical data for ATA3271 will be presented at the Society
for Immunotherapy of Cancer (SITC) 36th Annual Meeting, taking
place November 10-14, 2021 (poster #136)
ATA3219 (B-cell Malignancies)
- Atara is making good progress and expects to submit an IND for
ATA3219, an off-the-shelf, allogeneic CD19 CAR T immunotherapy
targeting B-cell malignancies, in Q1 2022
- Leveraging our next-generation 1XX CAR co-stimulatory signaling
domain and allogeneic EBV T-cell platform, ATA3219 is a potential
best-in-class therapy that does not require T-cell receptor (TCR)
or human leukocyte antigen (HLA) gene editing
Allogeneic T Cell Platform Development
- To date, the safety and tolerability of Atara’s allogeneic EBV
T-cell therapies and platform has been validated by clinical
studies and experience in approximately 400 patients in various
disease areas
- We have established a new Atara Research Center (ARC) to house
the Company’s Translational and Pre-Clinical Sciences, Process
Sciences, and Analytical Development teams. New capabilities will
support our product pipeline and further drive innovation by
leveraging our unique and differentiated allogeneic cell therapy
platform
Third Quarter 2021 Financial Results
- Cash, cash equivalents and short-term investments as of
September 30, 2021 totaled $357.2 million, as compared to $373.4
million as of June 30, 2021
- The September 30, 2021 cash balance includes $46.4 million from
the sale of 3,123,570 shares of common stock through the Company’s
at-the-market (ATM) facility
- Atara believes that its cash as of September 30, 2021, together
with the $45.0 million upfront payment received as a result of our
entry into the Pierre Fabre Commercialization Agreement, is
sufficient to fund planned operations into the second quarter of
2023
- License and collaboration revenue was $5.4 million for the
third 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 $59.0 million for the
third quarter 2021, as compared to $53.0 million for the same
period in 2020
- Atara reported net losses of $84.7 million, or $0.90 per share,
for the third quarter 2021, as compared to $74.3 million, or $0.92
per share, for the same period in 2020
- Total operating expenses include non-cash expenses of $16.0
million for the third quarter 2021, as compared to $15.4 million
for the same period in 2020
- Research and development expenses were $70.3 million for the
third quarter 2021, as compared to $59.9 million for the same
period in 2020
- The increase in the third quarter 2021 was primarily due
increased research and clinical trial costs related to the
Company’s ATA188 and CAR T programs, and higher employee-related
costs from increased headcount
- Research and development expenses include $7.8 million of
non-cash stock-based compensation expenses for the third quarter
2021, as compared to $8.2 million for the same period in 2020
- General and administrative expenses were $19.8 million for the
third quarter 2021, as compared to $14.8 million for the same
period in 2020
- The increase was primarily driven by higher
compensation-related costs from increased headcount and activities
to support our anticipated tab-cel launch
- General and administrative expenses include $5.9 million of
non-cash stock-based compensation expenses for the second quarter
2021, as compared to $5.1 million for the same period in 2020
Conference Call and Webcast Details
Atara will host a live conference call and webcast today,
Thursday, November 4, 2021, at 8:30 a.m. EDT to discuss the
Company’s financial results and recent operational highlights.
Analysts and investors can participate in the conference call by
dialing 888-437-3179 for domestic callers and 862-298-0702 for
international callers, using the conference ID 13723551. 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,
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® 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:
(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 timing
and outcome of Atara’s discussions with the FDA regarding a BLA
submission for tab-cel®, (iii) the timing and outcome of Atara’s
discussions with EMA regarding an MAA for tab-cel®, (iv) the timing
of the initiation or submission of the BLA and MAA for tab-cel®,
(v) Atara’s ability to successfully advance the development of
tab-cel®, (vi) Atara’s activities in anticipation of potential
tab-cel® approval and commercial launch in the U.S., and (vii)
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) translational and
biomarker data for ATA188, including magnetization transfer ratio
(MTR) data and MTR’s potential link with remyelination; (ii) data
from ATA188 OLE study; (iii) 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, 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; and (4) Atara’s research and development activities at
ARC; (5) Atara’s ability to advance development of its 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)
September 30,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
113,209
$
200,404
Short-term investments
244,036
300,255
Restricted cash - short-term
194
194
Accounts receivable
—
1,250
Prepaid expenses and other current
assets
12,058
21,170
Total current assets
369,497
523,273
Property and equipment, net
53,485
50,517
Operating lease assets, net
25,071
12,303
Restricted cash - long-term
1,200
1,200
Other assets
670
827
Total assets
$
449,923
$
588,120
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
16,543
$
7,118
Accrued compensation
19,140
20,458
Accrued research and development
expenses
9,974
15,813
Deferred revenue
31,226
33,455
Other current liabilities
9,267
6,057
Total current liabilities
86,150
82,901
Deferred revenue - long-term
26,843
27,795
Operating lease liabilities -
long-term
24,574
13,041
Other long-term liabilities
2,215
2,044
Total liabilities
139,782
125,781
Commitments and contingencies
Stockholders’ equity:
Common stock
9
8
Additional paid-in capital
1,681,481
1,586,616
Accumulated other comprehensive income
24
296
Accumulated deficit
(1,371,373
)
(1,124,581
)
Total stockholders’ equity
310,141
462,339
Total liabilities and stockholders’
equity
$
449,923
$
588,120
ATARA BIOTHERAPEUTICS,
INC.
Consolidated Statements of
Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per
share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2021
2020
2021
2020
License and collaboration revenue
$
5,370
$
—
$
12,792
$
—
Operating expenses:
Research and development
70,333
59,877
202,867
179,096
General and administrative
19,849
14,829
56,984
48,259
Total operating expenses
90,182
74,706
259,851
227,355
Loss from operations
(84,812
)
(74,706
)
(247,059
)
(227,355
)
Interest and other income, net
148
364
283
2,049
Loss before provision for income taxes
(84,664
)
(74,342
)
(246,776
)
(225,306
)
Provision for income taxes
—
6
16
7
Net loss
$
(84,664
)
$
(74,348
)
$
(246,792
)
$
(225,313
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
(38
)
(283)
(272
)
307
Comprehensive loss
$
(84,702
)
$
(74,631
)
$
(247,064
)
$
(225,006
)
Net loss per common share:
Basic and diluted net loss per common
share
$
(0.90
)
$
(0.92
)
$
(2.67
)
$
(3.21
)
Weighted-average shares outstanding used
to calculate basic and diluted net loss per common share
93,602
81,176
92,411
70,170
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211104005358/en/
Investors Eric Hyllengren 805-395-9669
ehyllengren@atarabio.com
Media Alex Chapman 805-456-4772 achapman@atarabio.com
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