Full Press Release Details
Atara Biotherapeutics Announces Third Quarter Financial Results and Operational Progress
Tab-cel Prescription Drug User Fee Act (PDUFA) Target Action Date of January 10, 2026
Atara has completed the transfer of substantially all tab-cel activities, including BLA sponsorship, and associated costs to Pierre Fabre
Approval of BLA would unlock a $40 Million milestone payment from Pierre Fabre Laboratories
THOUSAND OAKS, Calif.-(BUSINESS WIRE)- 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 financial results for the third quarter 2025 and business updates.
Tabelecleucel (tab-cel or Ebvallo ) for Post-Transplant Lymphoproliferative Disease (PTLD)
The U.S. Food and Drug Administration (FDA) has accepted the filing of Atara's Biologics License Application (BLA) for tabelecleucel (tab-cel ) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who
have received at least one prior therapy. There are no FDA approved therapies in this treatment setting.
The BLA has been granted Priority Review with a
Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026.
Atara expects to receive an additional
$40 million milestone payment from Pierre Fabre Laboratories contingent upon FDA approval of the tab-cel BLA.
In October, Atara completed the
transfer of regulatory activities, including BLA sponsorship, to Pierre Fabre Laboratories. Atara will continue to support Pierre Fabre Laboratories, at Pierre Fabre Laboratories expense, with certain regulatory activities related to the BLA.
Substantially all operational activities and associated costs related to tab-cel have been transitioned to Pierre Fabre Laboratories.
Strategic Alternatives Evaluation: As previously communicated, Atara continues to actively explore and assess potential strategic
alternatives with the goal of maximizing shareholder value.
Organizational Restructuring: In October 2025, Atara announced a reduction in its
workforce that impacted approximately 29% of its current employees, retaining approximately 15 employees essential to executing on the Company's strategic priorities.
Third Quarter 2025 Financial Results:
2025 Outlook and Cash Runway:
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
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 Southern California. For more information, visit atarabio.com and
follow @Atarabio on X 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 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 Pierre Fabre Medicament involving tab-cel, and the potential financial benefits to Atara as a result of the global
partnership with Pierre Fabre Medicament, including the receipt, timing and amount of any payments to be received by Atara thereunder; (2) Atara's cash runway, receipt of potential milestone payments, and estimated reduction in operating
expenses; and (3) Atara's evaluation of strategic alternatives and ability to consummate one or more strategic transactions. 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; risks related to FDA's review of
the resubmitted BLA for tab-cel; our ability to access capital, and the sufficiency of Atara's cash resources and access to additional capital on favorable terms or at all; the timing of the strategic review process; whether Atara will pursue
any strategic alternatives; in the event Atara pursues a strategic alternative, that the strategic alternative may not be attractive or ultimately consummated; whether any strategic alternative will result in additional value for Atara and its
stockholders; whether the process will have an adverse impact on Atara and other risks and uncertainties affecting Atara, 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.
ATARA BIOTHERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
| September 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,742 | $ | 25,030 | ||||
| Short-term investments | 7,970 | 17,466 | ||||||
| Restricted cash | - | 146 | ||||||
| Accounts receivable | 1,913 | 1,482 | ||||||
| Inventories | - | 10,655 | ||||||
| Other current assets | 2,807 | 10,115 | ||||||
| Total current assets | 18,432 | 64,894 | ||||||
| Property and equipment, net | 147 | 1,294 | ||||||
| Operating lease assets | 10,707 | 39,807 | ||||||
| Other assets | 881 | 3,103 | ||||||
| Total assets | $ | 30,167 | $ | 109,098 | ||||
| Liabilities and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 318 | $ | 4,367 | ||||
| Accrued compensation | 2,067 | 6,589 | ||||||
| Accrued research and development expenses | 342 | 7,984 | ||||||
| Deferred revenue | 1,011 | 95,092 | ||||||
| Liability related to the sale of future revenues - current portion | 9,670 | 382 | ||||||
| Other current liabilities | 4,649 | 20,160 | ||||||
| Total current liabilities | 18,057 | 134,574 | ||||||
| Operating lease liabilities - long-term | 15,005 | 29,914 | ||||||
| Liability related to the sale of future revenues - long-term | 31,976 | 38,624 | ||||||
| Other long-term liabilities | 1,763 | 3,269 | ||||||
| Total liabilities | 66,801 | 206,381 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock-$0.0001 par value, 500,000 shares authorized as of September 30, 2025 and December 31, 2024; 7,210 and 5,859 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | 1 | 1 | ||||||
| Additional paid-in capital | 1,981,822 | 1,957,261 | ||||||
| Accumulated other comprehensive income (loss) | 2 | 8 | ||||||
| Accumulated deficit | (2,018,459 | ) | (2,054,553 | ) | ||||
| Total stockholders' equity (deficit) | (36,634 | ) | (97,283 | ) | ||||
| Total liabilities and stockholders' equity (deficit) | $ | 30,167 | $ | 109,098 |
ATARA BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
thousands, except per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Commercialization revenue | $ | 3,453 | $ | 40,190 | $ | 119,177 | $ | 96,187 | ||||||||
| Costs and operating expenses: | ||||||||||||||||
| Cost of commercialization revenue | 115 | 7,602 | 21,108 | 14,214 | ||||||||||||
| Research and development expenses | 2,925 | 43,924 | 37,668 | 122,762 | ||||||||||||
| General and administrative expenses | 3,987 | 10,421 | 21,976 | 30,446 | ||||||||||||
| Total costs and operating expenses | 7,027 | 61,947 | 80,752 | 167,422 | ||||||||||||
| Income (loss) from operations | (3,574 | ) | (21,757 | ) | 38,425 | (71,235 | ) | |||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 204 | 459 | 583 | 1,513 | ||||||||||||
| Interest expense | (909 | ) | (1,183 | ) | (2,898 | ) | (3,598 | ) | ||||||||
| Other income (expense), net | 4 | 555 | 15 | 617 | ||||||||||||
| Total other income (expense), net | (701 | ) | (169 | ) | (2,300 | ) | (1,468 | ) | ||||||||
| Income (loss) before provision for (benefit from) income taxes | (4,275 | ) | (21,926 | ) | 36,125 | (72,703 | ) | |||||||||
| Provision for (benefit from) income taxes | 28 | (17 | ) | 31 | 7 | |||||||||||
| Net income (loss) | $ | (4,303 | ) | $ | (21,909 | ) | $ | 36,094 | $ | (72,710 | ) | |||||
| Other comprehensive gain (loss): | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale securities | 2 | 36 | (6 | ) | 226 | |||||||||||
| Comprehensive income (loss) | $ | (4,301 | ) | $ | (21,873 | ) | $ | 36,088 | $ | (72,484 | ) | |||||
| Basic earnings (loss) per common share | $ | (0.32 | ) | $ | (2.93 | ) | $ | 2.96 | $ | (11.34 | ) | |||||
| Diluted earnings (loss) per common share | $ | (0.32 | ) | $ | (2.93 | ) | $ | 2.93 | $ | (11.34 | ) | |||||
| Basic and diluted weighted-average shares outstanding | 13,564 | 7,466 | 12,185 | 6,414 | ||||||||||||
| Diluted weighted-average shares outstanding | 13,564 | 7,466 | 12,319 | 6,414 |
Investor and Media Relations
Sr. Director, Strategy and Operations