Pierre Fabre Laboratories to License
Commercialization Rights to Tab-cel®, including Regulatory,
Manufacturing and Development Activities, in the United States and
All Remaining Markets
Atara to Receive Additional Payments of up to
USD 640 Million, Significant Double-digit Tiered Royalties as a
Percentage of Net Sales, and Funding of Tab-cel Global Development
Costs
Tab-cel Global Partnership and Associated
Strategic Restructuring Extends Atara Cash Runway into Q3 2025
ATA188 Phase 2 EMBOLD Study Primary Analysis
and Communication on Track for Early November
Atara to Host Conference Call and Webcast today
at 6:00 a.m. PDT / 9:00 a.m. EDT
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 recent
business highlights including an expanded global partnership with
Pierre Fabre Laboratories for tabelecleucel (tab-cel®), financial
results for the third quarter 2023, and key upcoming catalysts.
“We are proud to expand our global tab-cel partnership with
Pierre Fabre Laboratories, who is committed to delivering this
first-of-its-kind treatment to patients in need across the globe,”
said Pascal Touchon, President and Chief Executive Officer of
Atara. “In light of our expanded tab-cel partnership and to
strategically position the company going forward, we are also
restructuring our operations to significantly reduce expenses,
meaningfully extend our cash runway to nearly two years, and enable
organizational focus on generating the greatest value from our
transformative pipeline: ATA188 and our differentiated allogeneic
CAR-T assets. I wish to personally thank the talented colleagues
who will be departing Atara for their essential contributions in
getting us to this critical point in our journey.”
Expanded Global Partnership for Tabelecleucel (tab-cel® or
EBVALLO™)
- Atara has entered into an expanded partnership with Pierre
Fabre Laboratories for the U.S. and remaining global commercial
markets for tab-cel for up to USD 640 million and significant
double-digit tiered royalties on net sales. In addition, Pierre
Fabre Laboratories has agreed to reimburse Atara for expected
tab-cel global development costs through Biologics License
Application (BLA) transfer, and purchase current and future tab-cel
inventory through the BLA transfer date. Near-term payments to
Atara include:
- Approximately USD 30 million in cash upfront and initial
inventory purchase at closing
- USD 100 million in potential regulatory milestones through BLA
approval
- Substantially all tab-cel manufacturing, clinical, and
regulatory activities are planned to transition from Atara to
Pierre Fabre Laboratories at the time of BLA transfer
- Atara expects to submit the tab-cel post-transplant
lymphoproliferative disease (PTLD) BLA in Q2 2024
“We are eager to progress tabelecleucel toward approval in the
U.S. so that American patients can access this innovative treatment
already approved and commercialized in Europe,” said Eric
Ducournau, CEO of Pierre Fabre Laboratories.
The closing of the transaction, subject to expiration of the
waiting period under the Hart-Scott-Rodino Antitrust Improvements
Act and other customary closing conditions, is expected to occur in
December 2023. PJT Partners served as the exclusive financial
advisor to Atara and Fenwick & West LLP served as legal counsel
to Atara.
Strategic Restructure and Financial Impacts
- Concurrent with the execution of the global tab-cel
partnership, Atara is undertaking a strategic restructuring and is
reducing its current workforce by approximately 30 percent. This
will enable Atara to execute its remaining responsibilities under
the tab-cel collaboration with Pierre Fabre Laboratories, while
focusing on the advancement of ATA188 and its differentiated
allogeneic CAR T (AlloCAR-T) programs
- The strategic restructuring, combined with certain anticipated
payments from the expanded global partnership and the Company’s
existing cash, cash equivalents and short-term investments as of
September 30, 2023, is expected to fund the Company’s planned
operations into Q3 2025
Pipeline Focus Moving Forward
- The ATA188 Phase 2 EMBOLD study primary analysis and
communication remains on track for early November with more than 90
patients to be included
- To create the greatest value from its potentially
transformative pipeline, Atara will focus capital resources on
ATA188 development and to unlock the full promise of its growing
and potential best-in-class oncology and autoimmune targeted
AlloCAR-T portfolio
- Atara will leverage its EBV T-cell biology expertise and novel
CAR-T technologies for areas of significant unmet medical need by
overcoming limitations of current or investigational autologous or
allogeneic CAR-T approaches:
- Initiation of Phase 1 study in relapsed/refractory B-cell
non-Hodgkin’s lymphoma (NHL) for ATA3219—an allogeneic CD19-1XX
CAR+ EBV T cell immunotherapy—expected in the coming months with
preliminary clinical data anticipated H2 2024
- Progressing efforts toward a potential clinical study
evaluating ATA3219 in autoimmune disease in parallel with NHL
development
- Continued advancement of promising early AlloCAR-T development
programs including ATA3431, an allogeneic, bispecific tandem CAR
directed against both CD19 and CD20 built on the EBV T-cell
platform with a 1XX costimulatory signaling domain. ATA3431
preclinical data has been accepted for poster presentation at the
upcoming American Society of Hematology (ASH) meeting in December
2023
Third Quarter 2023 Financial Results (prior to Pierre
Fabre Laboratories partnership expansion in October 2023)
- Cash, cash equivalents and short-term investments as of
September 30, 2023, totaled $102.4 million, as compared to $153.6
million as of June 30, 2023
- Net cash used in operating activities was $51.3 million for the
third quarter 2023, as compared to $65.1 million in the same period
in 2022
- Atara reported a net loss of $69.8 million, or $0.66 per share
for the third quarter 2023, as compared to a net loss of $84.1
million, or $0.82 per share for the same period in 2022.
- Total costs and operating expenses include non-cash stock-based
compensation, depreciation and amortization expenses of $12.4
million for the third quarter 2023, as compared to $15.4 million
for the same period in 2022
- Research and development expenses were $56.9 million for the
third quarter 2023, as compared to $70.2 million for the same
period in 2022
- Research and development expenses include $6.8 million of
non-cash stock-based compensation expenses for the third quarter
2023 as compared to $8.0 million for the same period in 2022
- General and administrative expenses were $12.2 million for the
third quarter 2023, as compared to $18.9 million for the same
period in 2022
- General and administrative expenses include $4.4 million of
non-cash stock-based compensation expenses for the third quarter
2023, as compared to $6.0 million for the same period in 2022
Conference Call and Webcast Details
Atara will host a live conference call and webcast today,
Wednesday, November 1, 2023, at 9:00 a.m. EDT. Analysts and
investors can participate in the conference call by dialing
877-407-8291 for domestic callers and 201-689-8345 for
international callers. 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 is harnessing the natural power of the immune system to
develop off-the-shelf cell therapies for difficult-to-treat cancers
and autoimmune conditions, including multiple sclerosis, that can
be rapidly delivered to patients within days. With cutting-edge
science and differentiated approach, Atara is the first company in
the world to receive regulatory approval of an allogeneic T-cell
immunotherapy. Our advanced and versatile Epstein-Barr virus (EBV)
T-cell platform does not require T-cell receptor or HLA gene
editing and forms the basis of a diverse portfolio of
investigational therapies that target EBV, the root cause of
certain diseases, in addition to next-generation AlloCAR-Ts
designed for best-in-class opportunities across a broad range of
non-EBV-associated liquid and solid tumors. Atara is headquartered
in Southern California. For more information, visit atarabio.com
and follow @Atarabio on X (formerly known as 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 development, timing and progress of tab-cel®, including a
potential BLA, the potential characteristics and benefits of
tab-cel®, and the progress and results of, and prospects for, the
expanded global partnership with Pierre Fabre Laboratories
involving tab-cel®, and the potential financial benefits to Atara
as a result of the expanded global partnership with Pierre Fabre
Laboratories; (2) the Company’s strategic restructure, including
the staff reduction; (3) the development, 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; (4) the
development, timing and progress of Atara’s AlloCAR-T programs,
including the timing of the start of any clinical trials, and the
safety and efficacy of product candidates emerging from such
programs, including ATA3219 and ATA3431; (5) Atara’s cash runway;
and (6) Pierre Fabre Laboratories’ activities relating to tab-cel
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 COVID-19 pandemic and the wars in Ukraine and
the Middle East, 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)
September 30,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
64,791
$
92,942
Short-term investments
37,617
149,877
Restricted cash
146
146
Accounts receivable
163
40,221
Inventories
6,591
1,586
Other current assets
9,388
10,308
Total current assets
118,696
295,080
Property and equipment, net
4,628
6,300
Operating lease assets
59,175
68,022
Other assets
6,289
7,018
Total assets
$
188,788
$
376,420
Liabilities and stockholders’ equity
(deficit)
Current liabilities:
Accounts payable
$
6,511
$
6,871
Accrued compensation
14,430
17,659
Accrued research and development
expenses
23,968
24,992
Deferred revenue
11,611
8,000
Other current liabilities
22,569
21,394
Total current liabilities
79,089
78,916
Deferred revenue - long-term
73,929
77,000
Operating lease liabilities -
long-term
48,508
58,064
Liability related to the sale of future
revenues - long-term
33,252
30,236
Other long-term liabilities
4,848
5,564
Total liabilities
$
239,626
$
249,780
Stockholders’ equity (deficit):
Common stock
10
10
Additional paid-in capital
1,858,423
1,821,721
Accumulated other comprehensive (loss)
income
(571
)
(2,067
)
Accumulated deficit
(1,908,700
)
(1,693,024
)
Total stockholders’ equity (deficit)
(50,838
)
126,640
Total liabilities and stockholders’ equity
(deficit)
$
188,788
$
376,420
ATARA BIOTHERAPEUTICS,
INC. Condensed Consolidated Statements of Operations and
Comprehensive Income (Loss) (Unaudited) (In
thousands, except per share amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2023
2022
2023
2022
Commercialization revenue
$
2,020
$
—
$
3,697
$
—
License and collaboration revenue
118
4,459
624
63,352
Total revenue
2,138
4,459
4,321
63,352
Costs and operating expenses:
Cost of commercialization revenue
2,615
—
5,726
—
Research and development expenses
56,888
70,157
175,185
210,018
General and administrative expenses
12,247
18,924
39,454
58,308
Total costs and operating expenses
71,750
89,081
220,365
268,326
Loss from operations
(69,612
)
(84,622
)
(216,044
)
(204,974
)
Gain on sale of ATOM Facility
—
—
—
50,237
Interest and other income (expense),
net
(204
)
541
372
1,017
Total other income (expense), net
(204
)
541
372
51,254
Loss before provision for (benefit from)
income taxes
(69,816
)
(84,081
)
(215,672
)
(153,720
)
Provision for (benefit from) income
taxes
(19
)
10
4
10
Net loss
$
(69,797
)
$
(84,091
)
$
(215,676
)
$
(153,730
)
Other comprehensive gain (loss):
Unrealized gain (loss) on
available-for-sale securities
362
(341
)
1,496
(2,591
)
Comprehensive loss
$
(69,435
)
$
(84,432
)
$
(214,180
)
$
(156,321
)
Basic and diluted loss per common
share
$
(0.66
)
$
(0.82
)
$
(2.05
)
$
(1.51
)
Basic and diluted weighted-average shares
outstanding
106,401
102,423
105,163
101,590
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231031702630/en/
Investor and Media Relations
Alex Chapman Vice President, Corporate Communications &
Investor Relations (805) 456-4772 achapman@atarabio.com
Jason Awe, Ph.D. Senior Director, Corporate Communications &
Investor Relations (805) 217-2287 jawe@atarabio.com
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