First Patients Treated in Europe with EBVALLOTM
Following Transfer of EC Marketing Authorization to Pierre Fabre;
Discussions with FDA Progressing
ATA188 Phase 2 EMBOLD Study Primary Data
Readout On-Track for October 2023
ATA3219 IND Filing Anticipated End of Q2
2023
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 first quarter 2023, recent business
highlights and key upcoming catalysts.
“We are entering an important period of potential
value-generating milestones for our prioritized pipeline assets and
continue to have productive dialogue and senior level engagement
with FDA regarding tab-cel,” said Pascal Touchon, President and
Chief Executive Officer of Atara. “In parallel, we continue to
identify operational efficiencies and reduce cash burn with the
goal of further extending our cash runway to best position Atara
for future success.”
Tabelecleucel (tab-cel® or EBVALLOTM) for Post-Transplant
Lymphoproliferative Disease (PTLD)
- Following a recent meeting with FDA on chemistry,
manufacturing, and controls (CMC) matters, Atara and the FDA agreed
to hold a subsequent meeting, anticipated in Q2, to discuss
additional details requested by the FDA on CMC aspects related to a
potential biologics license application (BLA) submission for
tab-cel. We expect to provide an update on our plans for a BLA
submission for tab-cel at our next earnings release
- Following the successful transfer of the European Commission
(EC) Marketing Authorization of EBVALLO to Pierre Fabre, the first
patients have received treatment. Pierre Fabre is progressively
launching EBVALLO on a country-by-country basis
- Atara is investigating label expansion opportunities with its
ongoing Phase 2 multi-cohort study with initial data expected in Q4
2023
- Atara is engaged in discussions with potential U.S.
commercialization partners
ATA188 for Progressive Multiple Sclerosis (MS)
- The primary analysis data read out for the Phase 2 EMBOLD study
is on track for October 2023
ATA3219: CD19 Program for B-Cell Malignancies
- Atara is advancing an Investigational New Drug Application
(IND) for ATA3219, an allogeneic CD19-1XX CAR+ EBV T cell
immunotherapy that incorporates multiple clinically validated
technologies designed for T-cell memory, robust expansion, and
potent anti-tumor efficacy, that is anticipated for filing in Q2
2023
Leadership Changes
- Jakob Dupont M.D., who has served as the Company’s Head of
Global Research & Development since 2020, will depart Atara to
pursue an opportunity in venture capital effective May 12, 2023.
Following this date, Dr. Dupont will consult for Atara until the
end of the year in support of progressing a potential BLA for
tab-cel, the Phase 2 EMBOLD primary analysis data readout for
ATA188, and advancing an IND for ATA3219. AJ Joshi, M.D., Chief
Medical Officer, Jill Henrich, Head of Global Regulatory Affairs,
and Cokey Nguyen, Ph.D., Chief Scientific Officer, will assume Dr.
Dupont’s responsibilities
- Separately, Charlene Banard, who has served as Atara’s Chief
Technical Officer since 2022, will be departing the Company
effective June 9, 2023. Dr. Nguyen and Ms. Henrich will assume Ms.
Banard’s responsibilities
First Quarter 2023 Financial Results
- Cash, cash equivalents and short-term investments as of March
31, 2023, totaled $205.4 million, as compared to $242.8 million as
of December 31, 2022
- Atara believes that its cash and investments as of March 31,
2023, will be sufficient to fund the Company’s planned operations
into Q2 2024
- Atara reported net losses of $74.8 million, or $0.72 per share
for the first quarter 2023, as compared to $88.1 million, or $0.87
per share for the same period in 2022
- Total costs and operating expenses include non-cash stock-based
compensation, depreciation and amortization expenses of $13.0
million for the first quarter 2023, as compared to $15.9 million
for the same period in 2022
- Research and development expenses were $62.2 million for the
first quarter 2023, as compared to $75.0 million for the same
period in 2022
- Research and development expenses include $6.8 million of
non-cash stock-based compensation expenses for the first quarter
2023 as compared to $8.5 million for the same period in 2022
- General and administrative expenses were $13.9 million for the
first quarter 2023, as compared to $20.6 million for the same
period in 2022
- General and administrative expenses include $5.0 million of
non-cash stock-based compensation expenses for the first quarter
2023, as compared to $5.8 million for the same period in 2022
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) timing and progress of
Atara’s marketing authorization application filed with the
Medicines and Healthcare Products Regulatory Authority for
tab-cel®; (5) the timing and progress of ATA188, including data and
analyses from the EMBOLD study and the timing of when such data
will be received and communicated (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.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
March 31,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
48,741
$
92,942
Short-term investments
156,666
149,877
Restricted cash
146
146
Accounts receivable
397
40,221
Inventories
5,340
1,586
Other current assets
12,892
10,308
Total current assets
224,182
295,080
Property and equipment, net
5,852
6,300
Operating lease assets
65,143
68,022
Other assets
6,906
7,018
Total assets
$
302,083
$
376,420
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
5,068
$
6,871
Accrued compensation
8,913
17,659
Accrued research and development
expenses
23,766
24,992
Deferred revenue
9,924
8,000
Other current liabilities
20,205
21,394
Total current liabilities
67,876
78,916
Deferred revenue - long-term
78,041
77,000
Operating lease liabilities -
long-term
54,918
58,064
Liability related to the sale of future
revenues - long-term
31,111
30,236
Other long-term liabilities
5,177
5,564
Total liabilities
$
237,123
$
249,780
Stockholders’ equity:
Common stock
10
10
Additional paid-in capital
1,833,982
1,821,721
Accumulated other comprehensive (loss)
income
(1,237
)
(2,067
)
Accumulated deficit
(1,767,795
)
(1,693,024
)
Total stockholders’ equity
64,960
126,640
Total liabilities and stockholders’
equity
$
302,083
$
376,420
ATARA BIOTHERAPEUTICS,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per
share amounts)
Three Months Ended March
31,
2023
2022
Commercialization revenue
$
884
$
—
License and collaboration revenue
342
7,314
Total revenue
1,226
7,314
Costs and operating expenses:
Cost of commercialization revenue
216
—
Research and development expenses
62,156
74,963
General and administrative expenses
13,872
20,571
Total costs and operating expenses
76,244
95,534
Loss from operations
(75,018
)
(88,220
)
Interest and other income (expense),
net
269
115
Loss before provision for income taxes
(74,749
)
(88,105
)
Provision for income taxes
22
—
Net loss
$
(74,771
)
$
(88,105
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
830
(1,524
)
Comprehensive loss
$
(73,941
)
$
(89,629
)
Net loss per common share:
Basic and diluted loss per common
share
$
(0.72
)
$
(0.87
)
Basic and diluted weighted-average shares
outstanding
103,969
100,726
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230508005577/en/
Investors Eric Hyllengren 805-395-9669
ehyllengren@atarabio.com
Media Alex Chapman 805-456-4772 achapman@atarabio.com
Atara Biotherapeutics (NASDAQ:ATRA)
Historical Stock Chart
From May 2024 to Jun 2024
Atara Biotherapeutics (NASDAQ:ATRA)
Historical Stock Chart
From Jun 2023 to Jun 2024