Productive Type A Meeting with FDA for tabelecleucel
FDA guidance provided on resubmission of tabelecleucel BLA
Year over Year costs and operating expenses reduction of 87%
“This was an important quarter for Atara. We and our partners,
Tabelecleucel (tab-cel® or EBVALLO™) for Post-Transplant Lymphoproliferative Disease (PTLD)
As previously communicated, PFP has indicated they intend to submit an updated dataset with additional patients and longer follow-up from the pivotal Phase 3 single arm ALLELE study as well as supportive data. Atara anticipates providing a further regulatory update later this quarter.
Under its commercialization agreement with
Second Quarter 2026 Financial Results:
- Cash, cash equivalents and short-term investments as of
June 30, 2026 , totaled$9.9 million , as compared to$8.4 million as ofMarch 31, 2026 . - Net cash used in operating activities was
$3.3 million for the second quarter 2026, as compared to$7.4 million in the same period in 2025. - Total revenues were
$0.6 million for the second quarter 2026, as compared to$17.6 million for the same period in 2025. Total revenues decreased by$17.0 million year-over-year, primarily due to the accelerated recognition of deferred revenue in 2025 following the transition of development activities 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
$0.4 million for the second quarter 2026, as compared to$3.0 million for the same period in 2025. - Research and development expenses were
$1.3 million for the second quarter 2026, as compared to$7.3 million for the same period in 2025. - Research and development expenses include
$0.1 million of non-cash stock-based compensation expenses for the second quarter 2026, as compared to$0.7 million for the same period in 2025. - General and administrative expenses were
$3.8 million for the second quarter 2026, as compared to$6.5 million for the same period in 2025. - General and administrative expenses include
$0.3 million of non-cash stock-based compensation expenses for the second quarter 2026, as compared to$2.1 million for the same period in 2025. - Atara reported a net loss of
$4.8 million , or ($0.32 ) basic and diluted loss per share, for the second quarter 2026, as compared to net income of$2.4 million , or$0.20 basic earnings per share and$0.19 diluted earnings per share, for the same period in 2025.
2026 Outlook and Cash Runway:
- Operating expenses are expected to decline significantly year-over-year, reflecting the full-year benefit of cost-reduction initiatives implemented in 2025 and first half of 2026.
- Atara expects its cash, cash equivalents, and short-term investments as of
June 30, 2026 , combined with operating efficiencies achieved in 2025 and first half of 2026, will be sufficient to fund planned operations into mid-2027.
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 of PFP’s resubmission, the potential characteristics and benefits of tab-cel, and the results of, and prospects for bringing tab-cel to
Condensed Consolidated Balance Sheets (Unaudited) (In thousands, except per share amounts) | ||||||||
|
|
| ||||||
|
| 2026 |
| 2025 | ||||
Assets |
|
|
|
| ||||
Current assets: |
|
|
|
| ||||
Cash and cash equivalents |
| $ | 3,221 |
|
| $ | 8,482 |
|
Short-term investments |
|
| 6,652 |
|
|
| - |
|
Accounts receivable |
|
| 318 |
|
|
| 1,253 |
|
Other current assets |
|
| 3,339 |
|
|
| 2,477 |
|
Total current assets |
|
| 13,530 |
|
|
| 12,212 |
|
Property and equipment, net |
|
| 41 |
|
|
| 73 |
|
Operating lease assets |
|
| 6,688 |
|
|
| 7,064 |
|
Other assets |
|
| 765 |
|
|
| 886 |
|
Total assets |
| $ | 21,024 |
|
| $ | 20,235 |
|
|
|
|
|
| ||||
Liabilities and stockholders’ equity (deficit) |
|
|
|
| ||||
Current liabilities: |
|
|
|
| ||||
Accounts payable |
| $ | 824 |
|
| $ | 127 |
|
Accrued compensation |
|
| 699 |
|
|
| 1,271 |
|
Accrued research and development expenses |
|
| 57 |
|
|
| 82 |
|
Deferred revenue |
|
| 775 |
|
|
| 716 |
|
Liability related to the sale of future revenues – current portion |
|
| 1,032 |
|
|
| 9,750 |
|
Other current liabilities |
|
| 3,460 |
|
|
| 2,976 |
|
Total current liabilities |
|
| 6,847 |
|
|
| 14,922 |
|
Operating lease liabilities – long-term |
|
| 8,782 |
|
|
| 9,347 |
|
Liability related to the sale of future revenues – long-term |
|
| 40,506 |
|
|
| 32,673 |
|
Other long-term liabilities |
|
| 1,885 |
|
|
| 1,795 |
|
Total liabilities |
|
| 58,020 |
|
|
| 58,737 |
|
|
|
|
|
| ||||
Commitments and contingencies |
|
|
|
| ||||
|
|
|
|
| ||||
Stockholders’ equity (deficit): |
|
|
|
| ||||
Common stock—$0.0001 par value, 500,000 shares authorized as of |
|
| 1 |
|
|
| 1 |
|
Additional paid-in capital |
|
| 1,993,849 |
|
|
| 1,983,361 |
|
Accumulated other comprehensive income (loss) |
|
| (2 | ) |
|
| 1 |
|
Accumulated deficit |
|
| (2,030,844 | ) |
|
| (2,021,865 | ) |
Total stockholders’ equity (deficit) |
|
| (36,996 | ) |
|
| (38,502 | ) |
Total liabilities and stockholders’ equity (deficit) |
| $ | 21,024 |
|
| $ | 20,235 |
|
Condensed Consolidated Statements of Operations and Comprehensive (Loss) (Unaudited) (In thousands, except per share amounts) | ||||||||||||||||
|
| Three Months Ended |
| Six Months Ended | ||||||||||||
|
| 2026 |
| 2025 |
| 2026 |
| 2025 | ||||||||
Commercialization revenue |
| $ | 630 |
|
| $ | 17,575 |
|
| $ | 1,146 |
|
| $ | 115,724 |
|
Costs and operating expenses: |
|
|
|
|
|
|
|
| ||||||||
Cost of commercialization revenue |
|
| 191 |
|
|
| 554 |
|
|
| 315 |
|
|
| 20,993 |
|
Research and development expenses |
|
| 1,345 |
|
|
| 7,310 |
|
|
| 1,509 |
|
|
| 34,743 |
|
General and administrative expenses |
|
| 3,814 |
|
|
| 6,514 |
|
|
| 7,411 |
|
|
| 17,989 |
|
Total costs and operating expenses |
|
| 5,350 |
|
|
| 14,378 |
|
|
| 9,235 |
|
|
| 73,725 |
|
Income (loss) from operations |
|
| (4,720 | ) |
|
| 3,197 |
|
|
| (8,089 | ) |
|
| 41,999 |
|
Other income (expense), net: |
|
|
|
|
|
|
|
| ||||||||
Interest income |
|
| 78 |
|
|
| 143 |
|
|
| 132 |
|
|
| 379 |
|
Interest expense |
|
| (191 | ) |
|
| (972 | ) |
|
| (1,021 | ) |
|
| (1,989 | ) |
Other income (expense), net |
|
| — |
|
|
| 22 |
|
|
| — |
|
|
| 11 |
|
Total other income (expense), net |
|
| (113 | ) |
|
| (807 | ) |
|
| (889 | ) |
|
| (1,599 | ) |
Income (loss) before provision for (benefit from) income taxes |
|
| (4,833 | ) |
|
| 2,390 |
|
|
| (8,978 | ) |
|
| 40,400 |
|
Provision for (benefit from) income taxes |
|
| 1 |
|
|
| 3 |
|
|
| 1 |
|
|
| 3 |
|
Net income (loss) |
| $ | (4,834 | ) |
| $ | 2,387 |
|
| $ | (8,979 | ) |
| $ | 40,397 |
|
Other comprehensive gain (loss): |
|
|
|
|
|
|
|
| ||||||||
Unrealized gain (loss) on available-for-sale securities |
|
| (2 | ) |
|
| — |
|
|
| (3 | ) |
|
| (8 | ) |
Comprehensive income (loss) |
| $ | (4,836 | ) |
| $ | 2,387 |
|
| $ | (8,982 | ) |
| $ | 40,389 |
|
|
|
|
|
|
|
|
|
| ||||||||
Basic (loss) earnings per common share |
| $ | (0.32 | ) |
| $ | 0.20 |
|
| $ | (0.62 | ) |
| $ | 3.52 |
|
Diluted (loss) earnings per common share |
| $ | (0.32 | ) |
| $ | 0.19 |
|
| $ | (0.62 | ) |
| $ | 3.49 |
|
|
|
|
|
|
|
|
|
| ||||||||
Basic and diluted weighted-average shares outstanding |
|
| 15,033 |
|
|
| 12,197 |
|
|
| 14,560 |
|
|
| 11,484 |
|
Diluted weighted-average shares outstanding |
|
| 15,033 |
|
|
| 12,310 |
|
|
| 14,560 |
|
|
| 11,576 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20260812726239/en/
Investor and Media Relations
Sr. Director, Strategy and Operations
adaugherty@atarabio.com
Source: