Atara Biotherapeutics(ATRA) - 2023 Q1 - Quarterly Report

Financial Performance - Total revenue for Q1 2023 was $1.226 million, a decrease of 83.2% compared to $7.314 million in Q1 2022[20] - Net loss for Q1 2023 was $74.771 million, compared to a net loss of $88.105 million in Q1 2022, indicating an improvement of 15.1%[20] - For the three months ended March 31, 2023, the net loss was $74.77 million, an improvement from a net loss of $88.10 million for the same period in 2022, representing a 15.0% decrease in losses[26] - Cash, cash equivalents, and restricted cash at the end of the period were $48.89 million, down from $103.02 million at the end of March 31, 2022, indicating a decrease of 52.6% year-over-year[26] - The company reported commercialization revenue of $884,000 in Q1 2023, compared to no revenue in Q1 2022[20] - License and collaboration revenue decreased to $0.3 million for the three months ended March 31, 2023, from $7.3 million in the same period in 2022, primarily due to the termination of agreements with Bayer AG[143] - The company has a significant accumulated deficit of $1.768 billion as of March 31, 2023[17] Cash and Liquidity - Cash and cash equivalents decreased to $48.741 million as of March 31, 2023, from $92.942 million at the end of 2022[15] - The company expects that existing cash and short-term investments as of March 31, 2023, will not be sufficient to fund planned operations for at least the next twelve months, raising substantial doubt about its ability to continue as a going concern[34] - The company expects existing cash and short-term investments to fund operations into Q2 2024 but anticipates needing additional capital for the next twelve months[164] - The company plans to secure additional capital through public or private security offerings, utilizing the remaining $55.2 million from its 2021 ATM Facility, and seeking a commercialization partner for tab-cel in the U.S. to alleviate substantial doubt about its ability to continue as a going concern for at least 12 months[35] Research and Development - Research and development expenses for Q1 2023 were $62.156 million, down from $74.963 million in Q1 2022, reflecting a reduction of 17.2%[20] - Total research and development expenses were $62.2 million in Q1 2023, down from $75.0 million in Q1 2022, reflecting a decrease of $12.8 million[149] - The company plans to continue investment in the development of product candidates, including ongoing Phase 3 clinical studies and next-generation CAR T programs[134] - The company is focused on advancing its product candidates and expects to require substantial additional financing to achieve its goals[13] Commercialization Efforts - The company has entered into a commercialization agreement with Pierre Fabre for the distribution of tab-cel in Europe and select emerging markets[29] - The company received a $30 million milestone payment from Pierre Fabre following the European Commission's approval of Ebvallo for EBV+ PTLD, with an additional $40 million milestone payment received in January 2023[50][52] - The marketing authorization for Ebvallo was transferred to Pierre Fabre in February 2023, with progressive launches planned[120] - The company is engaged in discussions with potential partners for the commercialization of tab-cel in the U.S.[120] Workforce and Restructuring - The company recorded restructuring charges of $6.0 million due to a workforce reduction of approximately 20% to focus on research and development[72] - The company reduced its workforce by approximately 20% in August 2022 to prioritize key research and development programs[189] Regulatory and Clinical Development - Tab-cel (tabelecleucel) has received marketing authorization approval in the EU and is currently in Phase 3 clinical development in the U.S. for EBV+ PTLD[112] - ATA188, targeting EBV antigens for multiple sclerosis treatment, is in Phase 2 development with approximately 90 patients planned for the study[122] - The company may face challenges in obtaining regulatory approval for its product candidates due to the novel nature of T-cell immunotherapies and changing regulatory requirements[200] - The FDA may require additional clinical data or trials for the approval of tab-cel, potentially delaying commercialization plans[203] Risks and Uncertainties - The company acknowledges that raising additional capital may cause dilution to existing stockholders and restrict operations[187] - The company has incurred substantial losses since inception and anticipates continuing to incur significant operating losses for the foreseeable future[175] - The company may experience delays in clinical trials due to health epidemics, including the COVID-19 pandemic, affecting patient enrollment and site operations[197] - Regulatory approvals may contain significant limitations, such as use restrictions or post-approval study requirements, affecting market potential[205]