Atara Biotherapeutics(US:ATRA)2023-10-31 16:00Financial Performance - Total current assets decreased from $295,080,000 as of December 31, 2022, to $118,696,000 as of September 30, 2023, representing a decline of approximately 60%[18] - Cash and cash equivalents decreased from $92,942,000 to $64,791,000, a reduction of about 30%[18] - The accumulated deficit increased from $1,693,024,000 to $1,908,700,000, indicating a loss of approximately $215,676,000[19] - Total revenue for the three months ended September 30, 2023, was $2,138,000, compared to $4,459,000 for the same period in 2022, representing a decrease of 52.0%[22] - Net loss for the three months ended September 30, 2023, was $(69,797,000), compared to $(84,091,000) for the same period in 2022, showing an improvement of 16.0%[22] - The company reported a comprehensive loss of $(69,435,000) for the three months ended September 30, 2023, compared to $(84,432,000) for the same period in 2022, indicating a reduction of 17.7%[22] - Net loss for the nine months ended September 30, 2023, was $215.676 million, compared to a net loss of $153.730 million for the same period in 2022, representing an increase of 40.3%[26] - Total revenue for the three and nine months ended September 30, 2023, was $2.1 million and $4.3 million, respectively, down from $4.5 million and $63.4 million in the same periods of 2022[148] Expenses and Liabilities - Total liabilities decreased from $249,780,000 to $239,626,000, a decline of about 4.6%[17] - The company reported a total stockholders' equity deficit of $50,838,000 as of September 30, 2023, compared to a positive equity of $126,640,000 at the end of 2022[19] - Research and development expenses for the nine months ended September 30, 2023, totaled $175,185,000, down from $210,018,000 in the same period of 2022, a decrease of 16.6%[22] - Total costs and operating expenses for the three months ended September 30, 2023, were $71,750,000, down from $89,081,000 in the same period of 2022, a decrease of 19.4%[22] - General and administrative expenses were $12.2 million and $39.5 million for the three and nine months ended September 30, 2023, compared to $18.9 million and $58.3 million in the same periods of 2022, reflecting lower payroll and related costs[159] Cash Flow and Financing - The company has incurred significant operating losses since inception and expects that existing cash and short-term investments will not be sufficient to fund operations for at least the next twelve months[34] - The company plans to secure additional capital through public or private security offerings and strategic transactions to alleviate concerns about its ability to continue as a going concern[35] - Net cash used in operating activities decreased to $142.571 million for the nine months ended September 30, 2023, from $213.550 million in the same period of 2022, a reduction of 33.2%[26] - The company expects its existing cash and anticipated payments will fund operations into the third quarter of 2025, but uncertainties could materially impact this cash runway[175] - The company plans to raise additional capital through equity offerings, debt financings, and strategic collaborations, which may lead to substantial dilution for existing shareholders[179] Product Development and Commercialization - The commercialization of tab-cel (Ebvallo™) is expected to expand in the UK and EU, with potential milestone and royalty payments under the amended agreement with Pierre Fabre Medicament[11] - The company is focused on advancing its clinical studies for product candidates ATA188 and ATA3219, with expectations for regulatory submissions in the near future[11] - The most advanced T-cell immunotherapy program, tab-cel® (tabelecleucel), has received marketing authorization approval in the EU and UK, and is currently in Phase 3 development in the US[30] - The company has a robust pipeline including ATA188 in Phase 2 development for multiple sclerosis and ATA3219 in preclinical development targeting B-cell malignancies[115] - The company plans to submit the tab-cel BLA in Q2 2024, following a pre-BLA meeting with the FDA in Q1 2024, to incorporate pivotal data from the Phase 3 ALLELE study[125] Revenue Generation and Collaborations - The company has out-licensed commercialization rights for Ebvallo to Pierre Fabre and sold royalty and milestone interests to HCRx, impacting revenue generation[192] - License and collaboration revenue from the early access program for the nine months ended September 30, 2023, was $0.6 million, down from $1.6 million in the same period of 2022[61] - The company received a total investment of $31.0 million from HCR Molag Fund, L.P. in exchange for tiered sales-based royalties for Ebvallo, capped between 185% and 250% of the investment amount[124] Risks and Future Outlook - The company anticipates continued losses as it develops and seeks regulatory approvals for its product candidates[175] - The company faces risks related to the successful completion of clinical studies and obtaining regulatory approvals, which are critical for future profitability[204] - The company may require substantial additional financing to achieve its goals, with uncertainties surrounding the timing and amount of future capital needs[194] - The company’s ability to generate revenues will depend on successful commercialization efforts by its partners and the market acceptance of its products[193] Workforce and Organizational Changes - A reduction in force was announced on November 1, 2023, expected to reduce the workforce by approximately 30%, with anticipated severance and related benefits costs of about $7.0 million[109] - The company plans to implement a further reduction of its workforce by approximately 30% to prioritize key research and development programs[202]