Ebvallo™ EU Launch Activities Led by Pierre
Fabre to Commence in Q1 2023
Discussions with FDA Progressing on Potential
U.S. BLA for Tab-cel®
ATA188 Phase 2 EMBOLD Study Primary Data
Readout On-Track for October 2023
Cash Runway Extended into Q2 2024
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 fourth quarter and full year 2022, recent
business highlights and key upcoming catalysts for 2023.
“Following the landmark approval of EbvalloTM in Europe, we had
productive discussions with the FDA about their requirements for a
tab-cel BLA. We welcome the opportunity to further discuss the
topic of comparability that may advance our progress towards a BLA
submission,” said Pascal Touchon, President and Chief Executive
Officer of Atara. "Meanwhile, we are on track for the results of
our Phase 2 EMBOLD study this October, a key catalyst that could
progress ATA188 towards becoming the first ever targeted and
transformative therapy in multiple sclerosis (MS) following the
landmark scientific discovery of EBV as the leading trigger of
MS.”
Tabelecleucel (tab-cel® or EbvalloTM) for Post-Transplant
Lymphoproliferative Disease (PTLD)
- Atara recently held a productive meeting with FDA on clinical
aspects for a potential biologics license application (BLA)
submission for tab-cel
- Atara and the FDA are expected to hold another meeting to
further discuss chemistry, manufacturing, and controls (CMC)
matters relating to a potential BLA for tab-cel, including aspects
related to comparability that may support pooling clinical data
from different process versions
- Atara expects to provide a further update in Q2 2023
- In December 2022, Atara announced that the European Commission
(EC) granted marketing authorization for the first-of-its-kind,
off-the-shelf, allogeneic T-cell therapy, Ebvallo™ (tabelecleucel)
as a monotherapy for the treatment of adult and pediatric patients
two years of age and older with relapsed or refractory Epstein‑Barr
virus positive post‑transplant lymphoproliferative disease (EBV+
PTLD) who have received at least one prior therapy
- In February 2023, Atara completed the transfer of the EC
marketing authorization to Pierre Fabre, who is now leading all
commercialization, distribution, medical, and regulatory activities
in Europe, Middle East, Africa and other selected markets
- Pierre Fabre is planning to launch Ebvallo™ in the first
European countries during Q1 2023
- Atara anticipates investigating label expansion opportunities
with its ongoing Phase 2 multi-cohort study with initial data
expected in 2023
- Atara is engaged in discussions with potential U.S.
commercialization partners
ATA188 for Progressive Multiple Sclerosis (MS)
- Following target enrollment in the Phase 2 EMBOLD study, the
primary analysis data read out is on track for October 2023
ATA3219: CD19 Program for B-Cell Malignancies
- IND for ATA3219 is anticipated for Q2 2023
- ATA3219 is an allogeneic CD19-1XX CAR+ EBV T cell that
incorporates multiple clinically-validated technologies designed
for T-cell memory, robust expansion, and potent anti-tumor
efficacy
- Currently, the majority of eligible patients are not receiving
approved autologous CD19 CAR-T treatment due to technical,
operational and access challenges. Within the minority of diffuse
large B-cell lymphoma (DLBCL) patients who do receive CAR T
treatment, only 30-40% have durable response at 6 months,
representing a significant opportunity for ATA3219 to potentially
expand patient access and deliver durable, safe responses
Chief Financial Officer Transition
- Utpal Koppikar, who has served as the Company’s Chief Financial
Officer since 2018, will depart Atara to pursue an external career
opportunity effective March 31, 2023
- Effective April 1, 2023, Eric Hyllengren will assume the role
of Senior Vice President, Chief Financial Officer. Mr. Hyllengren
will also serve as the Company’s Principal Financial Officer and
Principal Accounting Officer
- Mr. Hyllengren joined Atara in 2018 as Vice President,
Financial Planning and Analysis and added the role of Head of
Investor Relations in April 2020. Previously, Mr. Hyllengren spent
15 years at Amgen Inc. in several finance roles with increasing
responsibilities, including corporate finance and investor
relations
Fourth Quarter and Full Year 2022 Financial Results
- Atara sold a portion of its right to receive royalties and
certain milestones in Ebvallo under the Pierre Fabre
Commercialization Agreement to HCR Molag Fund L.P (HCRx) for $31.0
million, which was received in December 2022. Total royalties and
milestones payable to HCRx are capped between 185% and 250% of the
$31.0 million, depending upon the timing of such payments to
HCRx
- Cash, cash equivalents and short-term investments as of
December 31, 2022 totaled $242.8 million, as compared to $371.1
million as of December 31, 2021
- Atara believes that its cash and investments as of December 31,
2022, together with the $40.0 million received in January 2023 for
achievement of certain milestones under the Pierre Fabre
Commercialization Agreement, will be sufficient to fund the
Company’s planned operations into Q2 2024
- Atara reported net losses of $74.6 million, or $0.72 per share,
and $228.3 million, or $2.24 per share, for the fourth quarter and
fiscal year 2022, respectively, as compared to $93.3 million, or
$0.96 per share, and $340.1 million, or $3.63 per share, for the
same periods in 2021
- Total operating expenses include non-cash stock-based
compensation, depreciation and amortization expenses of $12.6
million and $59.5 million for the fourth quarter and fiscal year
2022, respectively, as compared to $16.5 million and $63.0 million
for the same periods in 2021
- Research and development expenses were $62.5 million and $272.5
million for the fourth quarter and fiscal year 2022, respectively,
as compared to $79.1 million and $282.0 million for the same
periods in 2021
- Research and development expenses include $7.0 million and
$31.4 million of non-cash stock-based compensation expenses for the
fourth quarter and fiscal year 2022, respectively, as compared to
$8.4 million and $32.1 million for the same periods in 2021
- General and administrative expenses were $13.2 million and
$71.6 million for the fourth quarter and fiscal year 2022,
respectively, as compared to $21.8 million and $78.8 million for
the same periods in 2021
- General and administrative expenses include $4.4 million and
$22.5 million of non-cash stock-based compensation expenses for the
fourth quarter and fiscal year 2022, respectively, as compared to
$5.6 million and $21.8 million for the same periods in 2021
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 receiving marketing authorization 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 for Epstein-Barr virus
positive 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 Southern 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) dialogue with the FDA regarding a potential BLA submission for
tab-cel; (2) 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 ®; (3) the potential
submission of a BLA for tab-cel®; (4) the potential benefits,
safety and efficacy of ATA188; (5) the timing and progress of
ATA188, including (i) data and analyses from ATA188 OLE study; (ii)
ATA188 clinical trials, (iii) data and analyses from the EMBOLD
study and the timing of when such data will be received and
communicated; and (iv) Atara’s ability to successfully advance the
development of ATA188; (6) the timing and progress of Atara’s CAR T
programs, and the safety and efficacy of product candidates
emerging from such programs, including ATA3219, a potential IND for
ATA3219 and the timing thereof; (7) Atara’s cash runway; and (8)
Pierre Fabre’s activities relating to the commercialization of
Ebvallo™ in Europe and the timing thereof. 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 Southern California and Denver 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 , 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,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
92,942
$
106,084
Short-term investments
149,877
264,984
Restricted cash
146
194
Accounts receivable
40,221
986
Inventories
1,586
—
Other current assets
10,308
12,373
Total current assets
295,080
384,621
Property and equipment, net
6,300
53,780
Operating lease assets
68,022
26,159
Restricted cash - long-term
—
1,200
Other assets
7,018
2,367
Total assets
$
376,420
$
468,127
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
6,871
$
17,368
Accrued compensation
17,659
25,150
Accrued research and development
expenses
24,992
13,451
Deferred revenue
8,000
40,760
Other current liabilities
21,394
9,057
Total current liabilities
78,916
105,786
Deferred revenue - long-term
77,000
55,708
Operating lease liabilities -
long-term
58,064
25,518
Liability related to the sale of future
revenues - long-term
30,236
—
Other long-term liabilities
5,564
1,501
Total liabilities
249,780
188,513
Stockholders’ equity:
Common stock
10
9
Additional paid-in capital
1,821,721
1,744,695
Accumulated other comprehensive (loss)
income
(2,067
)
(368
)
Accumulated deficit
(1,693,024
)
(1,464,722
)
Total stockholders’ equity
126,640
279,614
Total liabilities and stockholders’
equity
$
376,420
$
468,127
ATARA BIOTHERAPEUTICS,
INC.
Consolidated Statements of
Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per
share amounts)
Three Months Ended December
31,
Twelve Months Ended December
31,
2022
2021
2022
2021
License and collaboration revenue
$
221
$
7,548
$
63,573
$
20,340
Operating expenses:
Research and development
62,515
79,134
272,533
282,001
General and administrative
13,245
21,817
71,553
78,801
Total operating expenses
75,760
100,951
344,086
360,802
Loss from operations
(75,539
)
(93,403
)
(280,513
)
(340,462
)
Other income (expense), net:
Gain on sale of ATOM Facility
—
—
50,237
—
Interest and other income, net
969
84
1,986
367
Total other income (expense), net
969
84
52,223
367
Loss before provision for income taxes
(74,570
)
(93,319
)
(228,290
)
(340,095
)
Provision for income taxes
2
30
12
46
Net loss
$
(74,572
)
$
(93,349
)
$
(228,302
)
$
(340,141
)
Other comprehensive (loss) gain:
Unrealized (loss) gain on
available-for-sale securities
892
(392
)
(1,699
)
(664
)
Comprehensive loss
$
(73,680
)
$
(93,741
)
$
(230,001
)
$
(340,805
)
Net loss per common share:
Basic and diluted net loss per common
share
$
(0.72
)
$
(0.96
)
$
(2.24
)
(3.63
)
Basic and diluted weighted-average shares
outstanding
103,178
97,407
101,990
93,670
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230208005851/en/
Investors Eric Hyllengren 805-395-9669
ehyllengren@atarabio.com Media Alex Chapman 805-456-4772
achapman@atarabio.com
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