Atara Biotherapeutics(ATRA) - 2024 Q1 - Quarterly Report

Product Development and Approvals - Tab-cel (Ebvallo) has received marketing authorization approval in the EU and UK and is currently in Phase 3 development in the U.S. for EBV+ PTLD patients who have failed prior therapies[81] - The company expects to submit the Biologics License Application (BLA) for tab-cel in Q2 2024, with pivotal data covering over 430 patients treated across multiple diseases[84] - ATA3219, an allogeneic CAR T therapy targeting CD19, received a Safe to Proceed letter from the FDA, with a Phase 1 study planned for Q4 2024[85] - The company plans to expand the Phase 1 LN Study and add a new cohort in severe SLE without lymphodepletion in Q4 2024, with initial clinical data anticipated in the second half of 2025[86] - The company expects to file an IND submission for ATA3431 in the second half of 2025, following promising preclinical data[88] - The company initiated enrollment of a multi-center, Phase 1 open-label, dose escalation clinical trial for ATA3219 in NHL, with initial clinical data anticipated in Q4 2024[86] - The company has paused development on ATA188 while exploring strategic options for this asset[81] - The company has paused development on ATA188 while exploring strategic options for this asset[88] Financial Performance - Commercialization revenues were $27.4 million for the three months ended March 31, 2024, compared to $0.9 million in the same period in 2023, reflecting an increase of $26.5 million[101] - The cost of commercialization revenue was $2.0 million for the three months ended March 31, 2024, compared to $0.2 million in the same period in 2023, an increase of $1.8 million[103] - The company had net losses of $31.8 million for the three months ended March 31, 2024, compared to $74.8 million for the same period in 2023[92] - As of March 31, 2024, the company had an accumulated deficit of $2.0 billion[92] - Total research and development expenses were $45.5 million in Q1 2024, down from $62.2 million in Q1 2023, reflecting a decrease of $16.7 million[105] - General and administrative expenses decreased to $11.1 million in Q1 2024 from $13.9 million in Q1 2023, primarily due to lower payroll costs[107] - Net cash used in operating activities was $29.6 million in Q1 2024, a decrease of $8.8 million compared to $38.4 million in Q1 2023[113] - Cash and cash equivalents increased to $35.1 million as of March 31, 2024, compared to $25.8 million as of December 31, 2023[111] - The company raised $9.5 million in gross proceeds from the sale of 12,321,365 shares under the 2023 ATM Facility at an average price of $0.77 per share[110] - Total other income (expense), net was $(481,000) in Q1 2024, compared to $269,000 in Q1 2023, reflecting a decrease of $750,000[108] Strategic Partnerships and Agreements - The company has entered into an amended and restated commercialization agreement with Pierre Fabre, expanding exclusive rights to include all countries globally, with potential milestone payments of up to $600 million[82] - The company has partnered with Pierre Fabre for commercialization in Europe and potential worldwide distribution, with an additional $30 million milestone payment received following EC approval of Ebvallo[82] Workforce and Restructuring - The company announced a workforce reduction of approximately 30% in November 2023, resulting in restructuring charges of $6.7 million[83] - A subsequent strategic workforce reduction of approximately 25% in January 2024 incurred additional restructuring charges of $4.8 million[83] Future Funding and Financial Outlook - The company expects to fund operations into 2027 based on existing cash and anticipated payments from the A&R Commercialization Agreement[116] - As of March 31, 2024, the existing cash, cash equivalents, and short-term investments are insufficient to fund planned operations for at least the next 12 months, raising substantial doubt about the company's ability to continue as a going concern[117] - The company expects to seek substantial additional funding through public or private equity offerings, debt financings, or strategic arrangements to support ongoing and planned clinical studies[117] - Future funding requirements will depend on various factors, including the timing and costs of clinical studies, regulatory approvals, and commercialization efforts[117] - The company may face substantial dilution of stockholder equity if additional capital is raised through equity securities[117] Research and Development Initiatives - The company has established research collaborations with leading academic institutions to acquire novel technologies and programs[82] - The company continues to evaluate additional product candidates and opportunities to license or acquire technologies to enhance its existing platform[88] Risk Factors - There have been no material changes to the company's contractual obligations and commitments since the last Annual Report filed on March 28, 2024[118] - During the three months ended March 31, 2024, there were no material changes to the company's interest rate risk, market risk, and foreign currency exchange rate risk disclosures[119]