Atara Biotherapeutics(ATRA) - 2025 Q3 - Quarterly Report

Regulatory Approvals and Commercialization - Atara Biotherapeutics received marketing authorization approval for its lead program, Tab-cel (Ebvallo), for commercial sale in the European Economic Area, the UK, and Switzerland[148]. - Tab-cel, under the name Ebvallo, is approved for commercial sale in the EEA, UK, and Switzerland, with ongoing Phase 3 trials in the U.S. for EBV+ PTLD patients[165]. - The Prescription Drug User Fee Act target action date for the tab-cel BLA is set for January 10, 2026[169]. Financial Performance - Commercialization revenue for the nine months ended September 30, 2025, was $119.2 million, a decrease of $36.7 million compared to $96.2 million in the same period of 2024[185]. - The cost of commercialization revenue for the nine months ended September 30, 2025, was $21.1 million, a decrease of $7.5 million from $14.2 million in the same period of 2024[186]. - Research and development expenses for the nine months ended September 30, 2025, totaled $37.7 million, a decrease of $85.1 million compared to $122.8 million in the same period of 2024[187]. - The accumulated deficit as of September 30, 2025, was $2.0 billion, with net losses of $72.7 million for the nine months ended September 30, 2024[173]. - General and administrative expenses decreased to $4.0 million in Q3 2025 from $10.4 million in Q3 2024, a reduction of 61%[190]. - Interest income fell to $0.2 million in Q3 2025 from $0.5 million in Q3 2024, a decrease of 60%[191]. - Total cash, cash equivalents, and short-term investments decreased to $13.7 million as of September 30, 2025, down from $42.5 million as of December 31, 2024, a decline of 68.6%[199]. - Cash and cash equivalents as of September 30, 2025, were $5.7 million, down from $25.0 million as of December 31, 2024, a decrease of 77.2%[199]. - Net cash used in operating activities was $45.2 million for the nine months ended September 30, 2025, compared to $44.2 million in the same period of 2024, an increase of 2.3%[201]. - Net cash provided by financing activities was $16.1 million in the nine months ended September 30, 2025, down from $59.6 million in the same period of 2024, a decrease of 73%[200]. - As of September 30, 2025, the company had $87.2 million of common stock remaining to be sold under the 2023 ATM Facility[195]. - The company expects a $40 million milestone payment from Pierre Fabre upon approval of the tab-cel BLA, which will provide significant cash runway[204]. - The company incurred losses and negative cash flows from operations since inception and anticipates needing additional capital to fund operations[197]. - The company may need substantial additional funding to complete the regulatory approval process for tab-cel in the US[207]. Workforce and Restructuring - The company executed workforce reductions of approximately 30% in November 2023, resulting in restructuring charges of $6.7 million[156]. - A further workforce reduction of approximately 50% was announced in January 2025, with total severance and related benefits recognized at approximately $7.1 million[158]. Strategic Alternatives and Collaborations - The company has engaged a financial advisor to assess strategic alternatives, including potential acquisitions or mergers, following the pause in CAR-T asset development[164]. - The company has entered into research collaborations with leading academic institutions to acquire rights to novel technologies and programs[152]. Program Developments and Changes - The company announced a pause in the development of its allogeneic CAR T cell programs, including ATA3219 and ATA3431, and has completed nearly all wind-down activities for these programs[148]. - The FDA lifted the clinical hold on the ATA3219 program in May 2025 after compliance issues were addressed[166]. - The company returned rights to the ATA188 and EBV Vaccine programs to QIMR in May 2025, and discontinued other programs[168]. - Manufacturing responsibilities for tab-cel were transferred to Pierre Fabre as of March 31, 2025, following an amendment to the A&R Commercialization Agreement[170]. - The Fujifilm Master Services and Supply Agreement was assigned to Pierre Fabre as part of the transition of manufacturing responsibility for Tab-cel[153]. Risks and Future Considerations - The company anticipates no material impact from the recent U.S. corporate tax legislation changes on its business operations[162]. - No material changes to interest rate risk, market risk, and foreign currency exchange rate risk disclosures during the nine months ended September 30, 2025[212]. - The company is subject to the timing of proceeds from the A&R Commercialization Agreement and the HCRx Agreement[212]. - Future commercialization, collaboration, licensing, and partnering arrangements may impact financial performance[212]. - The company may incur costs related to licensing, filing, prosecution, maintenance, defense, and enforcement of patents[212]. - The extent of in-licensing or acquisition of other products and technologies will influence growth strategies[212]. - Timing of qualification for partner's CMOs' manufacturing facilities is critical for operational success[212].