Atara Biotherapeutics(ATRA) - 2023 Q2 - Quarterly Report

Financial Performance - Total current assets decreased from $295,080,000 in December 2022 to $172,320,000 in June 2023, a decline of approximately 41.5%[17] - Cash and cash equivalents dropped from $92,942,000 in December 2022 to $45,898,000 in June 2023, representing a decrease of about 50.7%[17] - The company reported a total accumulated deficit of $1,838,903,000 as of June 30, 2023, up from $1,693,024,000 in December 2022, indicating an increase in losses[19] - Total revenue for the three months ended June 30, 2023, was $957,000, compared to $51,579 for the same period in 2022, representing a significant increase[22] - The company reported a net loss of $71,108,000 for the six months ended June 30, 2023, compared to a net loss of $69,639,000 for the same period in 2022[22] - Net loss for the six months ended June 30, 2023, was $145.9 million, compared to a net loss of $69.6 million for the same period in 2022[26] - The company reported a gain on the sale of the ATOM Facility of $50,237,000 in the previous year, which significantly impacted the income before provision for income taxes[22] - The total accumulated deficit as of June 30, 2023, was $(1,838,903,000), indicating the ongoing financial challenges faced by the company[24] Research and Development - The company is early in its development efforts, with only a small number of product candidates in clinical development, while others remain in preclinical stages[15] - The company is focused on the commercialization of Ebvallo™ in the UK and EU, with potential milestone and royalty payments under its agreement with Pierre Fabre Medicament[11] - The company is advancing the development of ATA3219, an allogeneic CAR T therapy targeting B-cell malignancies, with plans to start a Phase 1 study in the coming months[124] - The Phase 2 study of ATA188 is expected to include over 90 patients, with data on confirmed disability improvement planned for early November 2023[123] - The company is conducting an open-label, single-arm Phase 1 clinical study of ATA2271 for patients with advanced mesothelioma[126] - The company is developing ATA3431, a multi-targeted allogeneic CAR T immunotherapy targeting B-cell malignancies, and collaborating on a next-generation EBV vaccine[127] - Atara's most advanced T-cell immunotherapy, tab-cel (tabelecleucel), has received marketing authorization in the EU and UK and is in Phase 3 development in the US[30] - Tab-cel has received Breakthrough Therapy Designation in the U.S. for the treatment of EBV+ PTLD after hematopoietic cell transplants[121] Commercialization and Revenue - The company has limited commercialization revenues to date and may never achieve profitability[15] - Commercialization revenue was $0.8 million and $1.7 million for the three and six months ended June 30, 2023, respectively, due to the EC marketing authorization for Ebvallo being transferred to Pierre Fabre in February 2023[146] - License and collaboration revenues decreased to $0.2 million and $0.5 million for the three and six months ended June 30, 2023, compared to $51.6 million and $58.9 million for the same periods in 2022, primarily due to the termination of the Bayer Agreements[147] - The company is entitled to receive up to $308 million in remaining milestone payments and double-digit tiered royalties from Ebvallo sales, subject to specific conditions[53] - The company received a $30 million milestone payment in September 2022 related to the Pierre Fabre Commercialization Agreement, following European Commission approval of Ebvallo[51] - An additional $40 million in milestone payments was received in January 2023 upon meeting certain regulatory milestones[53] Operating Expenses - Research and development expenses for the six months ended June 30, 2023, were $118,297,000, down from $139,861,000 in the same period of 2022, indicating a reduction of approximately 15.5%[22] - The company had total costs and operating expenses of $148,615,000 for the six months ended June 30, 2023, compared to $179,245,000 for the same period in 2022, reflecting a decrease of about 17.1%[22] - General and administrative expenses were $13.3 million and $27.2 million for the three and six months ended June 30, 2023, down from $18.8 million and $39.4 million in 2022, mainly due to lower payroll costs following a reduction in force[156] - Stock-based compensation expense for the six months ended June 30, 2023, was $24,316,000, compared to $14,335,000 for the same period in 2022, showing an increase of approximately 69.5%[24] Cash Flow and Financing - The company expects to require substantial additional financing to achieve its goals, with a failure to obtain necessary capital potentially delaying or terminating product development efforts[15] - The company plans to secure additional capital through public or private offerings and has $55.2 million remaining under its 2021 ATM Facility[35] - Net cash used in operating activities decreased to $91.2 million for the six months ended June 30, 2023, from $148.5 million in the prior year[26] - The company has raised capital in the past but faces uncertainty in obtaining sufficient funding on acceptable terms for ongoing operations[192] - Existing cash and short-term investments are expected to fund operations only into the second quarter of 2024, raising doubts about the company's ability to continue as a going concern[171] - The company anticipates needing to raise substantial additional funding to finance planned operations and product development[172] Risks and Challenges - The company faces risks related to the lengthy and expensive clinical drug development process, which has uncertain outcomes[15] - The approval process for product candidates is unpredictable and may take many years, with the company facing challenges due to the novel nature of its therapies[206] - The company may face significant delays in clinical trials due to health epidemics and pandemics, impacting patient enrollment and site operations[203] - The company may need to relinquish rights to product candidates or grant licenses on unfavorable terms if additional funding is required[193] - The ability to generate revenues and achieve profitability is contingent on successful commercialization efforts by partners and market acceptance of products[188]