Atara to Focus on R&D Activities
Prioritizing Upcoming Milestones for Key Pipeline Assets
ATA188 Phase 2 EMBOLD Study Interim Analysis
Completed with Target Enrollment Achieved; Primary Endpoint Data
Read Out Planned for October 2023
FDA Recommended Pathway to Potential Tab-cel
BLA Filing Without Need for New Clinical Trial; European Commission
Approval on Track for Q4 2022
ATA3219 on Track for Q4 2022 IND Submission
Conference Call and Webcast Today at 1:30 p.m.
PDT / 4:30 p.m. EDT
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
second quarter 2022, an update to its corporate strategy, recent
business highlights, and key upcoming catalysts.
“We are excited about the transformative potential of ATA188 in
MS and are pleased that as a result of our significant and
constructive engagement, the FDA has recommended a possible path
towards a tab-cel BLA filing without the need for a new clinical
study,” said Pascal Touchon, President and Chief Executive Officer
of Atara. “Atara’s R&D-centered strategy, clear portfolio
prioritization, and purposeful partnerships are positioning us for
success in reaching critical value-generating milestones for our
key pipeline assets. I would like to extend my sincere gratitude
and thanks to Atara’s staff for their significant contributions and
unwavering commitment to advancing truly innovative medicines for
patients in need."
Corporate Strategy Update
- Atara announced plans to focus its activities as a leaner
organization centered on R&D to further advance the Company’s
innovative pipeline, while reducing cash burn
- Staff will be reduced by approximately 20% across the
organization
- Future annual cash burn is anticipated to be reduced by over
20%, extending Atara’s cash runway into Q1 2024
- Leveraging its differentiated allogeneic T-cell therapy
platform and unique clinical experience in over 500 patients
treated, Atara will prioritize R&D activities over the next 18
months on three core priorities:
- Clinical development of ATA188, our potentially transformative
Phase 2 asset for progressive multiple sclerosis
- EU and potential U.S. regulatory filings and approvals for
tab-cel while seeking a commercial partner for tab-cel in the U.S.,
including all related activities and costs, which is expected to
further extend the Company’s cash runway
- Anticipated Q4 2022 IND filing for ATA3219, a potential
best-in-class allogeneic CD19 CAR T, with the potential to address
the significant opportunity in the field for improving durable
clinical response in hard-to-treat B-cell malignancies
- These actions are part of a broader ongoing strategy to focus
the organization on R&D, building on the previously announced
manufacturing and commercialization collaborations with FUJIFILM
Diosynth Biotechnologies (FDB) and Pierre Fabre, respectively, and
continuing with the R&D-focused prioritization announced
today
ATA188 for Progressive Multiple Sclerosis (MS)
- Atara completed the Phase 2 EMBOLD study Interim Analysis (IA)
in patients with progressive MS in June 2022 and the Company
determined no sample size adjustment or modification would be made
to the study
- Based on enrollment at the end of July, approximately 90
patients are planned to be included in the read out of the study
primary endpoint of confirmed disability improvement by EDSS at 12
months. Communication of these data is planned to occur at an
appropriate forum in October 2023
- Atara continues to plan for Phase 3 readiness, including
interacting with the U.S. Food & Drug Administration (FDA)
based on two Fast Track designations, and further developing its
proprietary large-scale bioreactor manufacturing process
- New Phase 1 MRI data providing further evidence of the
potential clinical impact of ATA188 in progressive MS patients, as
well as updated OLE data, are planned for presentation at an
appropriate forum in Q4 2022
Tabelecleucel (tab-cel®) for Post-Transplant
Lymphoproliferative Disease (PTLD)
- Based on constructive discussions with Atara, the FDA
recommended a possible path to a Biologics License Application
(BLA) submission that does not require a new clinical trial
- Following planned interactions with FDA, Atara intends to
provide further guidance on progress to a BLA submission at our
next quarterly call
- The European Medicines Agency (EMA) review of tab-cel is
on-track and Atara anticipates European Commission (EC) approval in
Q4 2022
- Atara has successfully completed all six pre-approval
inspections required to support the Marketing Authorization
Application (MAA) for tab-cel in Europe
CAR T Programs
ATA2271/ATA3271 (Solid Tumors Over-Expressing
Mesothelin)
- Following Bayer’s strategic review and asset-level
prioritization of its pipeline, the exclusive worldwide licensing
agreement for next-generation mesothelin-directed CAR T-cell
therapies ATA2271, an autologous version, and ATA3271, an armored
allogeneic T-cell immunotherapy has been terminated
- Accordingly, the IND for ATA3271 is paused pending funding for
clinical development
- Following the findings of the Memorial Sloan Kettering
(MSK)-generated autopsy report and correlative data analyses, Atara
intends to continue supporting the clinical development of ATA2271
through our collaboration with MSK and a protocol amendment to be
discussed shortly with the FDA
ATA3219 (B-cell Malignancies)
- Atara continues to make progress toward the anticipated IND
filing for ATA3219 in Q4 2022. This allogeneic EBV CD19 CAR T
program, using an optimized manufacturing process, is enriched for
a memory T-cell phenotype and continues to show robust activity in
preclinical studies
Second Quarter 2022 Financial Results
- Cash, cash equivalents and short-term investments as of June
30, 2022 totaled $331.3 million, as compared to $301.8 million as
of March 31, 2022. The increase includes the impact of net proceeds
of $94.8 million from the sale of the ATOM facility during the
second quarter
- Atara believes that its cash and investments as of June 30,
2022, together with the expected reductions in operating cash burn,
will be sufficient to fund the Company’s planned operations into
the first quarter of 2024
- Net cash used in operating activities was $64.0 million for the
second quarter 2022, as compared to $61.6 million for the same
period in 2021
- Atara reported net income of $18.5 million, or $0.18 per share,
for the second quarter 2022, as compared to a net loss of $83.8
million, or $0.91 per share, for the same period in 2021. Second
quarter 2022 net income included a gain on the sale of the ATOM
facility of $50.2 million.
- License and collaboration revenue was $51.6 million for the
second quarter 2022, primarily consisting of deferred revenue
recognized due to the termination of the Bayer Collaboration
Agreements, as compared to $3.9 million for the same period in
2021. We anticipate that license and collaboration revenues will
decrease substantially in future quarters due to the termination of
the Bayer Agreements.
- Total operating expenses include non-cash expenses of $15.6
million for the second quarter 2022, as compared to $16.1 million
for the same period in 2021
- Research and development expenses were $64.9 million for the
second quarter 2022, as compared to $68.5 million for the same
period in 2021
- The decrease in the second quarter 2022 was primarily due to
lower employee-related and overhead costs as a result of the FDB
transaction, partially offset by increased spending on the
Company’s ATA188 and CAR T programs
- Research and development expenses include $7.9 million of
non-cash stock-based compensation expenses for the second quarter
2022 as compared to $8.3 million for the same period in 2021
- General and administrative expenses were $18.8 million for the
second quarter 2022, as compared to $19.4 million for the same
period in 2021
- General and administrative expenses include $6.2 million of
non-cash stock-based compensation expenses for the second quarter
2022, as compared to $5.5 million for the same period in 2021
Conference Call and Webcast Details
Atara will host a live conference call and webcast today,
Monday, August 8, 2022, at 4:30 p.m. EDT 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 13730293. 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, 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 Company’s updated corporate strategy to focus as a leaner,
R&D-centered organization, including (i) the staff reduction;
and (ii) seeking a commercial partner for tab-cel in the U.S; (2)
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 potential timing of the
initiation or submission of the BLA for tab-cel®, and (iv) the
timing of the EMA’s review of the MAA for tab-cel®; (3) 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) data and
analyses from ATA188 OLE study; (iii) ATA188 clinical trials, (iv)
data and analyses from the planned interim analysis for the EMBOLD
study, potential next steps for the program and planned discussions
with FDA; and (v) Atara’s ability to successfully advance the
development of ATA188; (4) 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) termination
of the strategic collaboration with Bayer for ATA2271 and ATA3271,
and (iv) Atara’s ability to successfully advance the development of
its CAR T programs; (5) Atara’s research and development
activities; (6) Atara’s ability to reach critical value-generating
milestones for its key pipeline assets or to generate value from
such assets; and (7) 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 and the war in Ukraine, 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.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
June 30,
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
70,688
$
106,084
Short-term investments
260,623
264,984
Restricted cash
1,346
194
Accounts receivable
637
986
Prepaid expenses and other current
assets
13,690
12,373
Total current assets
346,984
384,621
Property and equipment, net
8,328
53,780
Operating lease assets
73,582
26,159
Restricted cash - long-term
—
1,200
Other assets
7,227
2,367
Total assets
$
436,121
$
468,127
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
12,799
$
17,368
Accrued compensation
16,317
25,150
Accrued research and development
expenses
15,125
13,451
Deferred revenue
1,671
40,760
Other current liabilities
19,776
9,057
Total current liabilities
65,688
105,786
Deferred revenue - long-term
43,329
55,708
Operating lease liabilities -
long-term
63,999
25,518
Other long-term liabilities
5,626
1,501
Total liabilities
$
178,642
$
188,513
Stockholders’ equity:
Common stock—$0.0001 par value, 500,000
shares authorized as of June 30,2022 and December 31, 2021; 94,356
and 91,671 shares issued and outstanding as of June 30, 2022 and
December 31, 2021, respectively
9
9
Additional paid-in capital
1,794,449
1,744,695
Accumulated other comprehensive (loss)
income
(2,618
)
(368
)
Accumulated deficit
(1,534,361
)
(1,464,722
)
Total stockholders’ equity
257,479
279,614
Total liabilities and stockholders’
equity
$
436,121
$
468,127
ATARA BIOTHERAPEUTICS,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Income (Loss)
(Unaudited)
(In thousands, except per
share amounts)
Three Months Ended
June 30,
Six Months Ended
June 30,
2022
2021
2022
2021
License and collaboration revenue
$
51,579
$
3,870
$
58,893
$
7,422
Operating expenses:
Research and development
64,898
68,475
139,861
132,534
General and administrative
18,813
19,397
39,384
37,135
Total operating expenses
83,711
87,872
179,245
169,669
Loss from operations
(32,132
)
(84,002
)
(120,352
)
(162,247
)
Other income (expense), net:
Gain on sale of ATOM Facility
50,237
—
50,237
—
Interest and other income, net
361
225
476
135
Total other (expense), net
50,598
225
50,713
135
Income (loss) before provision for income
taxes
18,466
(83,777
)
(69,639
)
(162,112
)
Provision for income taxes
—
16
—
16
Net income (loss)
$
18,466
$
(83,793
)
$
(69,639
)
$
(162,128
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
(726
)
(99
)
(2,250
)
(234
)
Comprehensive income (loss)
$
17,740
$
(83,892
)
$
(71,889
)
$
(162,362
)
Basic net earnings (loss) per common
share
$
0.18
$
(0.91
)
$
(0.69
)
$
(1.77
)
Diluted net earnings (loss) per common
share
$
0.18
$
(0.91
)
$
(0.69
)
$
(1.77
)
Weighted-average basic shares
outstanding
101,601
92,152
101,166
91,806
Weighted-average diluted shares
outstanding
101,866
92,152
101,166
91,806
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220808005646/en/
INVESTORS & MEDIA: Investors Eric Hyllengren
805-395-9669 ehyllengren@atarabio.com Media Alex Chapman
805-456-4772 achapman@atarabio.com
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