EbvalloTM Positioned to be the First Allogeneic
T-Cell Therapy Ever Approved Following CHMP Positive Opinion
New ATA188 Biomarker Imaging Data Show Less
Brain Atrophy and Possible Remyelination in Patients Achieving
Confirmed Disability Improvement in Progressive MS
Phase 1 Study of ATA2271 Enrollment Resumed
Conference Call and Webcast Today at 1:30 p.m.
PST / 4:30 p.m. EST
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 third
quarter 2022, recent business highlights, and key upcoming
catalysts.
“Receiving the positive CHMP opinion for EbvalloTM
(tabelecleucel) positions our product to be the first-ever approved
allogeneic off-the-shelf T-cell therapy and provides important
validation for our EBV T-cell platform and portfolio,” said Pascal
Touchon, President and Chief Executive Officer of Atara. “We
continue to generate positive forward momentum across our programs,
punctuated by compelling new biomarker imaging and long-term
clinical data that further reinforce our belief in the
transformative potential of ATA188.”
Tabelecleucel (tab-cel® or EbvalloTM) for EBV-Associated
Ultra-Rare Cancers
- Atara received a positive opinion from the European Medicines
Agency’s (EMA) Committee for Medicinal Products for Human Use
(CHMP) for EbvalloTM as a monotherapy for 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)
- With CHMP positive opinion, the European Commission’s (EC)
potential approval of the EbvalloTM Marketing Authorization
Application (MAA) is expected by the end of 2022
- Atara recently held a meeting with the U.S. Food and Drug
Administration (FDA) that culminated in clear guidance and
agreement on specific chemistry, manufacturing, and controls (CMC)
Module 3 requirements for potential biologics license application
(BLA) submission
- A new meeting is planned with the FDA to discuss and
potentially align on clinical data package requirements to prepare
for a pre-BLA meeting
- Atara will present updated interim analysis and safety results
of the Phase 3 ALLELE study in relapsed/refractory (r/r) EBV+ PTLD
with additional patients and longer follow up at the 64th American
Society of Hematology (ASH) Annual Meeting in December 2022
- Consistent with the transformative potential of tab-cel in EBV+
PTLD, overall ORR was 51.2% (22/43, 95% CI: 35.5, 66.7), 50% (7/14,
95% CI: 23.0, 77.0) in HCT, and 51.7% (15/29, 95% CI: 32.5, 70.6)
in SOT with median TTR of 1.0 month and median duration of response
(DOR) of 23 months
- Overall median OS was 18.4 months (95% CI: 6.9, NE), with
patients who responded having longer survival versus
non-responders
- Additionally, Atara will present updated efficacy and safety
data from two single-center, open-label studies and a multicenter
expanded access program in patients with EBV+ leiomyosarcomas (EBV+
LMS), who have received at least one therapy at the ASH Annual
Meeting
- Clinical benefit rate (CR, PR, SD) was 77.8% (95% CI: 56.6,
96.2), with objective response rate of 22.2% (95% CI: 6.4, 47.6);
the estimated median OS (95% CI) was 77.4 months (18.0, NE)
- The safety profile of tab-cel remains consistent with
previously reported data with no reports of tumor flare reaction,
cytokine release syndrome, transmission of infectious diseases,
graft-versus-host disease, or infusion reaction related to
treatment
- Atara continues to seek a partner for potential U.S.
commercialization
ATA188 for Progressive Multiple Sclerosis (MS)
- MS is a debilitating disease affecting millions, with limited
treatment options and high unmet medical need in progressive
forms
- Atara presented new magnetic resonance imaging (MRI) biomarker
imaging and open-label extension (OLE) clinical data from the Phase
1 study of ATA188 in progressive MS at the 2022 European Committee
for Treatment and Research in Multiple Sclerosis (ECTRIMS)
conference
- New MRI biomarker imaging data suggest patients who achieved
confirmed disability improvement (CDI) demonstrated significantly
less brain atrophy over time and increased nMTR in unenhancing
lesions. These data support that brain structural changes,
including potential remyelination, may underlie durable CDI
associated with ATA188
- Updated results from the ongoing OLE with up to 46 months total
follow up in patients achieving CDI demonstrate durability of
improvement once achieved. Patients with stable disease, meaning no
decline in EDSS, have maintained stability for up to four
years
- Based on enrollment in the Phase 2 EMBOLD study 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 of EDSS at 12 months. Communication of these data is
planned to occur in October 2023
CAR T Programs
ATA2271 (Solid Tumors Over-Expressing Mesothelin)
- The ongoing Phase 1, Memorial Sloan Kettering Cancer Center
(MSK)-conducted, and investigator led clinical study of autologous
mesothelin chimeric antigen receptor (CAR) T-cell therapy, ATA2271,
has resumed after a voluntary pause in enrollment earlier this
year
- Details on the latest findings, including clinical and safety
observations, will be presented at a session titled, “Building on
CAR-T Experience in Mesothelioma,” at ESMO Immuno-Oncology on
December 7, 2022
ATA3219 (B-cell Malignancies)
- ATA3219 is a potential best in class off-the-shelf allogeneic
CD19 program using 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, ATA3219 does
not require TCR or human leukocyte antigen (HLA) gene editing
- The ATA3219 manufacturing process optimization is progressing
to ensure appropriate scale-up. Atara anticipates filing an IND in
Q2 2023 following completion of process optimization and
manufacturing runs in the GMP manufacturing suites of our strategic
manufacturing partner, FUJIFILM Diosynth Biotechnologies
Third Quarter 2022 Financial Results
- Cash, cash equivalents and short-term investments as of
September 30, 2022 totaled $265.4 million, as compared to $331.3
million as of June 30, 2022
- In September 2022, Atara announced an additional near-term
milestone payment under an updated tabelecleucel commercialization
agreement with Pierre Fabre. Under this agreement, Atara will
receive an additional $30 million upon EC approval and subsequent
filing of the MAA transfer to Pierre Fabre
- Atara believes that its cash and investments as of September
30, 2022, together with potential cash inflows from Pierre Fabre
and the expected reductions in operating cash burn, will be
sufficient to fund the Company’s planned operations into Q1
2024
- Net cash used in operating activities was $65.1 million for the
third quarter 2022, as compared to $59.0 million for the same
period in 2021
- Atara reported a net loss of $84.1 million, or $0.82 per share,
for the third quarter 2022, as compared to a net loss of $84.7
million, or $0.90 per share, for the same period in 2021
- License and collaboration revenue was $4.5 million for the
third quarter 2022, primarily consisting of revenue recognized due
to the termination of the Bayer agreements, as compared to $5.4
million for the same period in 2021.
- Total operating expenses include non-cash expenses of $15.4
million for the third quarter 2022, as compared to $16.0 million
for the same period in 2021
- Research and development expenses were $70.2 million for the
third quarter 2022, as compared to $70.3 million for the same
period in 2021
- Research and development expenses include $8.0 million of
non-cash stock-based compensation expenses for the third quarter
2022 as compared to $7.8 million for the same period in 2021
- General and administrative expenses were $18.9 million for the
third quarter 2022, as compared to $19.8 million for the same
period in 2021
- General and administrative expenses include $6.0 million of
non-cash stock-based compensation expenses for the third quarter
2022, as compared to $5.9 million for the same period in 2021
Conference Call and Webcast Details
Atara will host a live conference call and webcast today,
Tuesday, November 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 13733805. 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 receiving a CHMP positive opinion
for a 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 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 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) the Company’s corporate strategy, including 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 relating to tab-cel®,
including from the 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 potential submission of the BLA for tab-cel®, and (iv)
the potential approval of the MAA for EbvalloTM (tabelecleucel) by
the EC and the timing thereof; (3) the potential benefits, safety
and efficacy of ATA188; (4) 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 communicated; and (iv) Atara’s
ability to successfully advance the development of ATA188; (5) the
timing and progress of Atara’s CAR T programs, and the safety and
efficacy of product candidates emerging from such programs,
including ATA3219 and the ATA2271 clinical trial being conducted by
MSK; and (6) Atara’s cash runway. 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 (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, except per
share amounts)
September 30,
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
65,114
$
106,084
Short-term investments
200,290
264,984
Restricted cash
1,346
194
Accounts receivable
249
986
Prepaid expenses and other current
assets
16,047
12,373
Total current assets
283,046
384,621
Property and equipment, net
7,270
53,780
Operating lease assets
70,834
26,159
Restricted cash - long-term
—
1,200
Other assets
7,166
2,367
Total assets
$
368,316
$
468,127
Liabilities and stockholders’
equity
Current liabilities:
Accounts payable
$
11,296
$
17,368
Accrued compensation
17,605
25,150
Accrued research and development
expenses
17,868
13,451
Deferred revenue
2,662
40,760
Other current liabilities
22,813
9,057
Total current liabilities
72,244
105,786
Deferred revenue - long-term
42,338
55,708
Operating lease liabilities -
long-term
61,072
25,518
Other long-term liabilities
5,549
1,501
Total liabilities
181,203
188,513
Stockholders’ equity:
Common stock—$0.0001 par value, 500,000
shares authorized as of September 30, 2022 and December 31, 2021;
94,879 and 91,671 shares issued and outstanding as of September 30,
2022 and December 31, 2021, respectively
9
9
Additional paid-in capital
1,808,515
1,744,695
Accumulated other comprehensive (loss)
income
(2,959
)
(368
)
Accumulated deficit
(1,618,452
)
(1,464,722
)
Total stockholders’ equity
187,113
279,614
Total liabilities and stockholders’
equity
$
368,316
$
468,127
ATARA BIOTHERAPEUTICS,
INC.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per
share amounts)
Three Months Endeds
September 30,
Nine Months Ended September
30,
2022
2021
2022
2021
License and collaboration revenue
$
4,459
$
5,370
$
63,352
$
12,792
Operating expenses:
Research and development
70,157
70,333
210,018
202,867
General and administrative
18,924
19,849
58,308
56,984
Total operating expenses
89,081
90,182
268,326
259,851
Loss from operations
(84,622
)
(84,812
)
(204,974
)
(247,059
)
Other income (expense), net:
Gain on sale of ATOM Facility
—
—
50,237
—
Interest and other income (expense),
net
541
148
1,017
283
Total other income (expense), net
541
148
51,254
283
Loss before provision for income taxes
(84,081
)
(84,664
)
(153,720
)
(246,776
)
Provision for income taxes
10
—
10
16
Net loss
$
(84,091
)
$
(84,664
)
$
(153,730
)
$
(246,792
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
(341
)
(38
)
(2,591
)
(272
)
Comprehensive loss
$
(84,432
)
$
(84,702
)
$
(156,321
)
$
(247,064
)
Basic and diluted loss per common
share
$
(0.82
)
$
(0.90
)
$
(1.51
)
$
(2.67
)
Basic and diluted weighted-average shares
outstanding
102,423
93,602
101,590
92,411
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221108006038/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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