Atara Biotherapeutics(ATRA) - 2021 Q1 - Quarterly Report

Financial Performance - Total current assets decreased from $523,273,000 as of December 31, 2020, to $464,307,000 as of March 31, 2021, representing a decline of approximately 11.3%[20] - The net loss for the three months ended March 31, 2021, was $78,335,000, compared to a net loss of $73,509,000 for the same period in 2020, indicating an increase in loss of approximately 6.1%[22] - The company reported a basic and diluted net loss per common share of $0.86 for the three months ended March 31, 2021, compared to $1.20 for the same period in 2020[22] - Total stockholders' equity decreased from $462,339,000 as of December 31, 2020, to $399,037,000 as of March 31, 2021, a decline of approximately 13.7%[20] - The company reported a net loss of $78.3 million for the three months ended March 31, 2021, continuing a trend of significant operating losses since inception[162] - The company does not expect to generate any product revenues in the near future and anticipates continued substantial losses as it develops and seeks regulatory approvals for its product candidates[163] Cash and Liquidity - Cash and cash equivalents decreased from $200,404,000 as of December 31, 2020, to $151,097,000 as of March 31, 2021, a reduction of about 24.6%[20] - The company expects existing cash and short-term investments will be sufficient to fund operations for at least the next twelve months, highlighting a focus on maintaining liquidity[36] - As of March 31, 2021, the company had cash, cash equivalents, and short-term investments totaling $435.2 million, which are intended to fund ongoing operations[113] - Existing cash and short-term investments are projected to fund operations into 2023, contingent on the approval and commercialization of the U.S. tab-cel® product[144] - The company plans to raise substantial additional funding to support ongoing operations and product development, which may involve public or private equity offerings or debt financings[144] Research and Development - Research and development expenses increased to $64,059,000 for the three months ended March 31, 2021, compared to $57,659,000 for the same period in 2020, reflecting a rise of about 11.5%[22] - The company has incurred significant research and development expenses, with expectations for these expenses to increase as it continues to invest in its product candidates[163] - Atara Biotherapeutics is advancing its lead program, tab-cel®, in a Phase 3 clinical trial for EBV+ PTLD, with a BLA submission expected in Q3 2021[99] - The Phase 2 randomized controlled trial for ATA188 in patients with progressive multiple sclerosis is ongoing, with an interim analysis planned for the first half of 2022[102] - Atara Biotherapeutics has several T-cell immunotherapies in clinical development, including next-generation allogeneic CAR T programs, indicating ongoing investment in innovative therapies[33] Partnerships and Collaborations - Atara has entered into a research and development agreement with Bayer AG, granting an exclusive license for certain T-cell product candidates, which may enhance its product pipeline[33] - The company received an upfront cash payment of $45,000,000 from Bayer for an exclusive license grant, along with an additional $15,000,000 reimbursement for research activities[56] - The total potential milestone payments from Bayer could reach up to $610,000,000 upon achieving specific development and regulatory milestones[56] - The company has entered into a collaboration with Bayer for its CAR T programs, including ATA2271 and ATA3271, with multiple agreements signed in March 2021 to advance this partnership[96] Impact of COVID-19 - The impact of the COVID-19 pandemic continues to affect the company's business and operations, posing ongoing risks[17] - The ongoing COVID-19 pandemic has adversely affected business operations, including clinical trial timelines and patient enrollment[177] - The company has experienced delays in clinical site initiation and patient enrollment due to the COVID-19 pandemic[178] - The evolving impact of the COVID-19 pandemic has caused transient delays in clinical trial site initiation and patient enrollment[204] Clinical Development Challenges - The company has not yet demonstrated the ability to complete Phase 2 or Phase 3 clinical studies or obtain regulatory approval for any product candidates[165] - Clinical drug development is lengthy and expensive, with inherent uncertainties that can lead to failure at any stage of the process[199] - The time required to obtain FDA approval is unpredictable and typically takes many years, influenced by various factors including the novelty of product candidates[183] - The company may face significant limitations related to use restrictions or post-approval study requirements even if regulatory approval is obtained[187] - The company must ensure adequate funding to continue studies, as unforeseen costs from delays could hinder progress[206]