Atara Biotherapeutics Announces Second Quarter Financial Results and Operational Progress
Tab-cel Prescription Drug User Fee Act (PDUFA) Target Action Date of
Atara has transferred substantially all operational activities and associated costs related to tab-cel to
Atara has resumed its evaluation of strategic options
Approval of BLA would unlock a
Tabelecleucel (tab-cel® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD)
The
The BLA has been granted Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of
In July, the Company completed transferring substantially all operational activities and associated costs related to tab-cel to
Corporate Updates
Strategic Options Evaluation: In
Financial Update:
Second Quarter 2025 Financial Results:
-
Cash, cash equivalents and short-term investments as of
June 30, 2025 , totaled$22.3 million , as compared to$13.8 million as ofMarch 31, 2025 -
Net cash used in operating activities was
$7.4 million for the second quarter 2025, as compared to$10.6 million in the same period in 2024 -
Total revenues were
$17.6 million for the second quarter 2025, as compared to$28.6 million for the same period in 2024. Total revenues decreased by$11.0 million year-over-year, primarily due to the accelerated recognition of deferred revenue in the first quarter 2025 following the transition of manufacturing responsibilities toPierre Fabre Laboratories . As a result, less deferred revenue remained available for recognition in the comparative period. -
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of
$3.0 million for the second quarter 2025, as compared to$7.7 million for the same period in 2024 -
Research and development expenses were
$7.3 million for the second quarter 2025, as compared to$33.3 million for the same period in 2024 -
Research and development expenses include
$0.7 million of non-cash stock-based compensation expenses for the second quarter 2025, as compared to$3.3 million for the same period in 2024 -
General and administrative expenses were
$6.5 million for the second quarter 2025, as compared to$8.9 million for the same period in 2024 -
General and administrative expenses include
$2.1 million of non-cash stock-based compensation expenses for the second quarter 2025, as compared to$3.0 million for the same period in 2024 -
Atara reported net income of
$2.4 million , or$0.20 basic earnings per share and$0.19 diluted earnings per share for the second quarter 2025. The net income position is due to the acceleration of revenue recognized following the transition of tab-cel development and safety responsibilities toPierre Fabre Laboratories inJuly 2025
2025 Outlook and Cash Runway:
-
Under its commercialization agreement with
Pierre Fabre Medicament , Atara is eligible to receive a$40 million milestone payment upon FDA approval of the tab-cel BLA. In addition, Atara will be eligible to receive double-digit tiered royalties as a percentage of net sales and milestones related to commercial sales of EBVALLO. -
We anticipate the full-year 2025 operating expenses will decrease by at least 60% compared to 2024, driven by the transition of substantially all tab-cel activities and associated costs to
Pierre Fabre Laboratories as well as the implementation of operational efficiencies in the first half of the year. -
Atara projects that cash, cash equivalents and short-term investments as of
June 30, 2025 , combined with the proceeds of the milestone payment upon tab-cel BLA approval under its commercialization agreement withPierre Fabre Medicament , will provide significant cash runway and flexibility for the company to execute on its strategic priorities.
About
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 that can be rapidly delivered to patients from inventory. 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 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. Atara is headquartered in
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 the timing for FDA review of the resubmission of the BLA, the potential characteristics and benefits of tab-cel, and the results of, and prospects for, the global partnership with
Financials
|
||||||||
Condensed Consolidated Balance Sheets |
||||||||
(Unaudited) |
||||||||
(In thousands) |
||||||||
|
|
|
|
|
|
|
||
|
|
2025 |
|
|
2024 |
|
||
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
16,903 |
|
|
$ |
25,030 |
|
Short-term investments |
|
|
5,420 |
|
|
|
17,466 |
|
Restricted cash |
|
|
— |
|
|
|
146 |
|
Accounts receivable |
|
|
— |
|
|
|
1,482 |
|
Inventories |
|
|
— |
|
|
|
10,655 |
|
Other current assets |
|
|
2,449 |
|
|
|
10,115 |
|
Total current assets |
|
|
24,772 |
|
|
|
64,894 |
|
Property and equipment, net |
|
|
176 |
|
|
|
1,294 |
|
Operating lease assets |
|
|
11,027 |
|
|
|
39,807 |
|
Other assets |
|
|
927 |
|
|
|
3,103 |
|
Total assets |
|
$ |
36,902 |
|
|
$ |
109,098 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity (deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,762 |
|
|
$ |
4,367 |
|
Accrued compensation |
|
|
2,552 |
|
|
|
6,589 |
|
Accrued research and development expenses |
|
|
971 |
|
|
|
7,984 |
|
Deferred revenue |
|
|
1,607 |
|
|
|
95,092 |
|
Other current liabilities |
|
|
7,671 |
|
|
|
20,542 |
|
Total current liabilities |
|
|
14,563 |
|
|
|
134,574 |
|
Deferred revenue - long-term |
|
|
— |
|
|
|
— |
|
Operating lease liabilities - long-term |
|
|
15,426 |
|
|
|
29,914 |
|
Liability related to the sale of future revenues - long-term |
|
|
40,222 |
|
|
|
38,624 |
|
Other long-term liabilities |
|
|
1,732 |
|
|
|
3,269 |
|
Total liabilities |
|
$ |
71,943 |
|
|
$ |
206,381 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ (deficit) equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
1,979,114 |
|
|
|
1,957,261 |
|
Accumulated other comprehensive loss |
|
|
— |
|
|
|
8 |
|
Accumulated deficit |
|
|
(2,014,156 |
) |
|
|
(2,054,553 |
) |
Total stockholders’ (deficit) equity |
|
|
(35,041 |
) |
|
|
(97,283 |
) |
Total liabilities and stockholders’ (deficit) equity |
$ |
36,902 |
|
$ |
109,098 |
|||
|
||||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss |
||||||||||||||||
(Unaudited) |
||||||||||||||||
(In thousands, except per share amounts) |
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
||||||||||
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Commercialization revenue |
|
$ |
17,575 |
|
|
$ |
28,640 |
|
|
$ |
115,724 |
|
|
$ |
55,997 |
|
Costs and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of commercialization revenue |
|
|
554 |
|
|
|
4,627 |
|
|
|
20,993 |
|
|
|
6,612 |
|
Research and development expenses |
|
|
7,310 |
|
|
|
33,332 |
|
|
|
34,743 |
|
|
|
78,838 |
|
General and administrative expenses |
|
|
6,514 |
|
|
|
8,912 |
|
|
|
17,989 |
|
|
|
20,025 |
|
Total costs and operating expenses |
|
|
14,378 |
|
|
|
46,871 |
|
|
|
73,725 |
|
|
|
105,475 |
|
Income (loss) from operations |
|
|
3,197 |
|
|
|
(18,231 |
) |
|
|
41,999 |
|
|
|
(49,478 |
) |
Interest and other income (expense), net |
|
|
(807 |
) |
|
|
(818 |
) |
|
|
(1,599 |
) |
|
|
(1,299 |
) |
Loss before provision for income taxes |
|
|
2,390 |
|
|
|
(19,049 |
) |
|
|
40,400 |
|
|
|
(50,777 |
) |
Provision for income taxes |
|
|
3 |
|
|
|
— |
|
|
|
3 |
|
|
|
24 |
|
Net income (loss) |
|
$ |
2,387 |
|
|
$ |
(19,049 |
) |
|
$ |
40,397 |
|
|
$ |
(50,801 |
) |
Other comprehensive gain (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on available-for-sale securities |
|
|
— |
|
|
|
41 |
|
|
|
(8 |
) |
|
|
190 |
|
Comprehensive income (loss) |
|
$ |
2,387 |
|
|
$ |
(19,008 |
) |
|
$ |
40,389 |
|
|
$ |
(50,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic net income (loss) per common share |
|
$ |
0.20 |
|
|
$ |
(3.10 |
) |
|
$ |
3.52 |
|
|
$ |
(8.64 |
) |
Diluted net income (loss) per common share |
|
$ |
0.19 |
|
|
$ |
(3.10 |
) |
|
$ |
3.49 |
|
|
$ |
(8.64 |
) |
Basic weighted-average shares outstanding |
|
|
12,197 |
|
|
|
6,143 |
|
|
|
11,484 |
|
|
|
5,883 |
|
Diluted weighted-average shares outstanding |
|
|
12,310 |
|
|
|
6,143 |
|
|
|
11,576 |
|
|
|
5,883 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20250811258417/en/
Investor and Media Relations
Sr. Director, Strategy and Operations
adaugherty@atarabio.com
Source: