On August 11, 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 second quarter 2025 and business updates (Press release, Atara Biotherapeutics, AUG 11, 2025, View Source [SID1234655064]).
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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.
In July, the Company completed transferring substantially all operational activities and associated costs related to tab-cel to Pierre Fabre Laboratories. The sponsorship of the BLA continues to be maintained by the Company.
Corporate Updates
Strategic Options Evaluation: In April 2025, the Company temporarily paused its review of strategic alternatives pending resubmission of the tab-cel BLA. The Company has resumed its evaluation of strategic options following the resubmission of the tab-cel BLA. These options may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, licensing, sale of assets, or other strategic transactions. It is possible that Atara may not pursue a strategic alternative or transaction or that any strategic alternative or transaction, if pursued, will not be completed on attractive terms, or that a strategic alternative or transaction may not ultimately be consummated.
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 of March 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 to Pierre 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 to Pierre Fabre Laboratories in July 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 with Pierre Fabre Medicament, will provide significant cash runway and flexibility for the company to execute on its strategic priorities.