FDA Fast-Track Designated ATA188 Interim
Analysis On-Track for June 2022
Tab-cel Anticipated European Commission
Approval On-Track for Q4 2022; Dialogue with FDA Ongoing
Cash Expected to Fund Planned Operations into
Q4 2023 with Sale of Cell Therapy Manufacturing Facility to
FUJIFILM for USD 100 Million
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 first
quarter 2022, recent business highlights and key upcoming
catalysts.
“Atara is off to a strong start in 2022, and we look forward to
the upcoming interim analysis of our ATA188 Phase 2 study. With
compelling Phase 1 data, two Fast Track designations, and validated
groundbreaking science, ATA188 has the potential to transform
treatment in progressive forms of MS with high unmet need and
limited options,” said Pascal Touchon, President and Chief
Executive Officer of Atara. “We have also commenced our strategic
manufacturing partnership with FUJIFILM Diosynth Biotechnologies,
continue to progress tab-cel® with EMA’s review in Europe and
further engagement with FDA, and anticipate IND filings for our
innovative CAR T programs later this year.”
ATA188 for Progressive Multiple Sclerosis (MS)
- Atara is on track to conduct a formal interim analysis (IA) of
the Phase 2 EMBOLD study, planned for June 2022, to include
efficacy, safety, and biomarker data to further inform our
development strategy
- A key data point at the time of IA will be expanded disability
status scale (EDSS) improvement at six months, for applicable
patients which, based on Phase 1 data, is >85% predictive of
achieving confirmed EDSS improvement at 12 months, the
FDA-validated primary endpoint of EMBOLD
- This IA will also include EDSS improvement beyond six months
for patients with longer treatment duration, other clinical
endpoints, imaging biomarkers like magnetization transfer ratio
(MTR) and biologic biomarkers
- Results of the IA will determine whether any sample size
adjustments are needed to optimize the likelihood of success in
Phase 2 and best inform Phase 3 design and planning
- After the IA is conducted, Atara plans to communicate next
steps for the program in July 2022, including rationale, while
still maintaining the integrity of the study
- With the recent granting of Fast Track designation to ATA188
for non-active primary progressive multiple sclerosis (PPMS) and
non-active secondary progressive multiple sclerosis (SPMS) by the
FDA, we also then plan to meet with the FDA following the IA to
share the data and to discuss next steps for the development
pathway
- Atara continues to advance enrollment in the Phase 2 EMBOLD
study, with target enrollment of 80 patients expected soon after
conducting the IA
- Landmark studies in Nature and Science continue to drive
significant interest and awareness of EBV as the trigger of MS
- Momentum around ATA188 continues to build, marked by Atara’s
successful EBV and MS Day where updated Phase 1 and open-label
extension (OLE) data demonstrated that 20 out of 24 patients have
had either EDSS improvement or EDSS stability throughout their
observation in the study with up to 42 months follow-up. Overall,
33% of patients in the high-dose cohorts achieved confirmed EDSS
improvement at the 12-month timepoint
Tabelecleucel (tab-cel®) for Post-Transplant
Lymphoproliferative Disease (PTLD)
- The European Medicines Agency (EMA) review of tab-cel is
progressing well and Atara anticipates European Commission (EC)
approval in Q4 2022
- The EMA has transitioned tab-cel to a standard assessment as
Atara was informed that additional time was needed to adequately
review the Company’s responses to EMA questions. Atara does not
expect an impact to the anticipated EC approval timeframe
- Atara remains in active dialogue with the FDA and has made
further progress on discussing proposals to enable potential filing
of the BLA that do not require a new Phase 3 clinical study
- Proposals reflect tab-cel clinical and commercial product data
generated to date, its status as a Breakthrough Therapy Designation
product that addresses an urgent medical need, and its potential to
save the lives of patients with an ultra-rare, often fatal disease
with no approved therapeutic options
Tab-cel for Potential Additional Indications
- The multi-cohort Phase 2 study evaluating tab-cel in six
additional patient populations for EBV+ immunodeficiency-associated
lymphoproliferative diseases (IA-LPDs) and other EBV-driven
diseases continues to enroll in the U.S. and EU
- First data from the multi-cohort study is on track for
presentation in 2023
CAR T Programs
ATA2271/ATA3271 (Solid Tumors Over-Expressing
Mesothelin)
- The global strategic collaboration for autologous ATA2271 and
allogeneic ATA3271 with Bayer continues to progress
- In February 2022, Memorial Sloan Kettering Cancer Center (MSK)
notified the FDA of a fatal serious adverse event (SAE) in a
patient treated in the third, higher dose cohort in the ongoing
Phase 1, MSK-conducted and investigator led dose-escalation
clinical study of autologous mesothelin CAR T, ATA2271
- Per protocol, MSK voluntarily paused enrollment of new patients
in the study on a temporary basis while additional information
regarding the case is gathered and reviewed
- Autopsy and additional data are still being analyzed by
MSK
- As is typical, we expect MSK will share autopsy and other
results with FDA when ready, in addition to any intended informed
consent and/or study protocol amendments
- Atara and MSK expect to provide a Phase 1 data update for
ATA2271 in H2 2022
- IND-enabling work for ATA3271, our off-the-shelf, allogeneic
CAR-T therapy targeting mesothelin using next-generation PD-1 DNR
and 1XX CAR technologies for patients with advanced mesothelioma,
is advancing, with the IND filing anticipated in Q4 2022
ATA3219 (B-cell Malignancies)
- Atara continues to progress ATA3219, a potential best-in-class,
allogeneic CAR T for B cell malignancies expressing CD19
- Atara is on track to submit an IND in Q4 2022
- ATA3219 is an optimized approach to address high unmet medical
need, leveraging our next-generation 1XX CAR co-stimulatory
signaling domain and allogeneic EBV T-cell platform and does not
require TCR or human leukocyte antigen (HLA) gene editing
Allogeneic T-Cell Platform Manufacturing and
Operations
- In April 2022, Atara announced the appointment of Charlene
Banard as Chief Technical Officer, who will oversee process science
and development, quality, manufacturing and supply, further
validating Atara’s advanced technology and its potential to
transform the lives of patients with serious diseases
- In April 2022, Atara announced the completion of the sale of
its cell therapy manufacturing facility for USD 100 million upfront
and the commencement of a long-term strategic manufacturing
partnership with FUJIFILM Diosynth Biotechnologies (FDB)
- With the closing of the transaction, FDB provides Atara with
access to the flexible capacity and specific capability needed to
manufacture clinical and commercial-stage allogeneic cell therapies
for its maturing and promising pipeline, including tab-cel, ATA188
for multiple sclerosis, and allogeneic CAR T therapies, ATA3271 and
ATA3219
- The agreement is expected to reduce Atara’s planned operating
expenses over the multi-year partnership period
- Atara has retained a talented Technical Operations team who
will continue to manage external manufacturing partnerships,
manufacturing process science & development, quality assurance,
supply chain, and logistics. Atara’s Thousand Oaks-based Atara
Research Center (ARC) now houses Atara’s pre-clinical,
translational sciences, manufacturing process sciences, and
analytical development teams to further drive innovation by
leveraging our unique and differentiated allogeneic cell therapy
platform
First Quarter 2022 Financial Results
- Cash, cash equivalents and short-term investments as of March
31, 2022, totaled $301.8 million, as compared to $371.1 million as
of December 31, 2021; the amount as of March 31, 2022, excludes the
$100.0 million upfront received from FDB in April
- The March 31, 2022, cash balance includes $20.5 million of net
proceeds from the sale of 1,319,878 shares of common stock through
the Company’s ATM facilities in the first quarter
- Atara believes that its cash as of March 31, 2022, together
with the $100.0 million received from FDB on April 4, 2022, will be
sufficient to fund the Company’s planned operations into the fourth
quarter of 2023
- Net cash used in operating activities was $84.5 million for the
first quarter 2022, as compared to $65.7 million for the same
period in 2021
- Atara reported net losses of $88.1 million, or $0.87 per share
for the first quarter 2022, as compared to $78.3 million, or $0.86
per share for the same period in 2021
- Total operating expenses include non-cash expenses of $15.9
million for the first quarter 2022, as compared to $14.5 million
for the same period in 2021
- Research and development expenses were $75.0 million for the
first quarter 2022, as compared to $64.1 million for the same
period in 2021
- The increases in the first quarter 2022 were primarily due to
higher employee-related and overhead costs from increased headcount
in support of continuing expansion of research and development
activities and increased spending on research, development, and
clinical trial costs related to the ATA188 program
- Research and development expenses include $8.5 million of
non-cash stock-based compensation expenses for the first quarter
2022 as compared to $7.5 million for the same period in 2021
- General and administrative expenses were $20.6 million for the
first quarter 2022, as compared to $17.7 million for the same
period in 2021
- The increases in the first quarter 2022 were primarily due to
higher compensation-related costs from increased headcount
- General and administrative expenses include $5.8 million of
non-cash stock-based compensation expenses for the first quarter
2022, as compared to $4.7 million for the same period in 2021
Conference Call and Webcast Details Atara will host a
live conference call and webcast today, Thursday, May 5, 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
13728000. 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 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 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 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®,; (2) 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) the mechanistic link between EBV and
multiple sclerosis and the ability of ATA188 to specifically target
such link; (iii) data from ATA188 OLE study; (iv) ATA188 clinical
trials, (v) the planned interim analysis for the EMBOLD study,
potential next steps for the program and planned discussions with
FDA; (vi) Atara’s ability to successfully advance the development
of ATA188, and (vii) partnering options for ATA188; (3) 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) 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; (4)
Atara’s research and development activities at ARC; (5) Atara’s
sale of its ATOM manufacturing facility to FUJIFILM Diosynth
Biotechnologies (FDB), including (i) the potential benefits of such
transaction to Atara, including the potential financial benefits to
Atara, (ii) the supply agreement between the parties and the
duration and benefits thereof, (iii) FDB’s ability to perform under
the supply agreement and meet Atara’s requirements, (v) FDB’s plans
for ATOM, and (iv) Atara’s ability to retain its staff and
capabilities, and (6) 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 current events involving Russia
and 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.
Consolidated Balance Sheets (Unaudited) (In thousands)
March 31,
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
101,669
$
106,084
Short-term investments
200,142
264,984
Restricted cash
146
194
Accounts receivable
668
986
Prepaid expenses and other
current assets
11,574
12,373
Assets held for sale
190
—
Total current assets
314,389
384,621
Property and equipment, net
9,109
53,780
Operating lease assets
18,933
26,159
Restricted cash - long-term
1,200
1,200
Other assets
2,220
2,367
Long-term assets held for sale
51,429
—
Total assets
$
397,280
$
468,127
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
11,945
$
17,368
Accrued compensation
16,381
25,150
Accrued research and
development expenses
13,990
13,451
Deferred revenue
50,943
40,760
Other current liabilities
8,051
9,057
Liabilities held for sale
252
—
Total current liabilities
101,562
105,786
Deferred revenue - long-term
45,000
55,708
Operating lease liabilities -
long-term
17,453
25,518
Other long-term liabilities
616
1,501
Long-term liabilities held for sale
8,333
—
Total liabilities
$
172,964
$
188,513
Stockholders’ equity:
Common stock—$0.0001 par value,
500,000 shares authorized as of March 31,2022 and December 31,
2021; 93,406 and 91,671 shares issued and outstanding as of March
31, 2022 and December 31, 2021, respectively
9
9
Additional paid-in capital
1,779,026
1,744,695
Accumulated other comprehensive
(loss) income
(1,892
)
(368
)
Accumulated deficit
(1,552,827
)
(1,464,722
)
Total stockholders’ equity
224,316
279,614
Total liabilities and stockholders’
equity
$
397,280
$
468,127
ATARA BIOTHERAPEUTICS,
INC.
Consolidated Statements of
Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per
share amounts)
Three Months Ended March
31,
2022
2021
License and collaboration revenue
$
7,314
$
3,552
Operating expenses:
Research and development
74,963
64,059
General and administrative
20,571
17,738
Total operating expenses
95,534
81,797
Loss from operations
(88,220
)
(78,245
)
Interest and other income (expense),
net
115
(90
)
Loss before provision for income taxes
(88,105
)
(78,335
)
Provision for income taxes
—
—
Net loss
$
(88,105
)
$
(78,335
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
(1,524
)
(135
)
Comprehensive loss
$
(89,629
)
$
(78,470
)
Net loss per common share:
Basic and diluted net loss per common
share
$
(0.87
)
$
(0.86
)
Weighted-average shares outstanding used
to calculate basic and diluted net loss per common share
100,726
91,456
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220505006060/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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