On November 12, 2025 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, reported financial results for the third quarter 2025 and business updates.

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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.

Corporate Updates

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.

Financial Update:

Third Quarter 2025 Financial Results:

Cash, cash equivalents and short-term investments as of September 30, 2025, totaled $13.7 million, as compared to $22.3 million as of June 30, 2025.
Net cash used in operating activities was $9.8 million for the third quarter 2025, as compared to $4.0 million in the same period in 2024. Net cash used in operating activities increased by $5.8 million year-over-year, primarily driven by a decrease in cash receipts from Pierre Fabre in the third quarter 2025 after the BLA acceptance milestone and a sale of tab-cel intermediates inventory were completed in the same period in 2024, this was partially offset by a decrease in operating expenses in the third quarter 2025.
Atara reported net loss of $4.3 million, or $0.32 per share for the third quarter 2025 as compared to $21.9 million or $2.93 per share for the same period in 2024.
Total revenues were $3.5 million for the third quarter 2025, as compared to $40.2 million for the same period in 2024. Total revenues decreased by $36.7 million year-over-year, primarily due to the accelerated recognition of deferred revenue and additional upfront and milestone payments received in the same period 2024 as a result of the A&R Commercialization Agreement, effective December 2023. In addition, the decrease is due to the accelerated recognition of deferred revenue in the first and second quarters 2025 following the transition of manufacturing, development and safety responsibilities to Pierre Fabre Laboratories.
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $1.3 million for the third quarter 2025, as compared to $7.6 million for the same period in 2024.
Research and development expenses were $2.9 million for the third quarter 2025, as compared to $43.9 million for the same period in 2024.
Research and development expenses include $0.3 million of non-cash stock-based compensation expenses for the third quarter 2025, as compared to $2.9 million for the same period in 2024.
General and administrative expenses were $4.0 million for the third quarter 2025, as compared to $10.4 million for the same period in 2024.
General and administrative expenses include $0.9 million of non-cash stock-based compensation expenses for the third quarter 2025, as compared to $3.5 million for the same period in 2024.
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 September 30, 2025, combined with the net proceeds of the milestone payment upon tab-cel BLA approval under its commercialization agreement with Pierre Fabre Medicament, will provide significant cash runway and flexibility for the company to execute on its strategic priorities.

(Press release, Atara Biotherapeutics, NOV 12, 2025, View Source [SID1234659805])