Financial Performance - The net loss for the three months ended March 31, 2025, was $59.7 million, with an accumulated deficit of $1.9 billion as of the same date[126]. - The net loss for the three months ended March 31, 2025, was $59.7 million, an improvement of 8% compared to a net loss of $65.0 million in 2024[158]. - For the three months ended March 31, 2025, collaboration revenue from related parties was $0, a decrease of 100% compared to $22,000 in 2024[158]. - The company expects to continue incurring net losses and increasing research and development expenses in the foreseeable future[126]. - The company expects future revenue generation to fluctuate based on the timing and amount of license fees, milestones, and product sales[145]. Cash and Investments - The company has $335.5 million in cash and cash equivalents, expecting its cash runway to fund operations into the second half of 2027[126]. - As of March 31, 2025, the company had $335.5 million in cash, cash equivalents, and investments, sufficient to fund operations for at least the next 12 months[166]. - Cash provided by financing activities was $14.0 million for the three months ended March 31, 2025, significantly higher than $1.7 million in 2024[174]. - Cash provided by investing activities was $6.2 million for the three months ended March 31, 2025, down from $22.1 million in 2024[172]. - Net cash used in operating activities was $52.9 million for the three months ended March 31, 2025, compared to $55.9 million in 2024, indicating a reduction of $3.0 million[169]. Research and Development - Research and development expenses for the three months ended March 31, 2025, were $50.2 million, a decrease of 4% from $52.3 million in 2024[158]. - The company anticipates increased research and development expenses as clinical programs progress and additional product candidates are developed[148]. - The company plans to initiate a Phase 1 trial for ALLO-329 in mid-2025, targeting multiple autoimmune diseases, with proof-of-concept expected by the first half of 2026[120]. - A pivotal Phase 2 clinical trial (ALPHA3) for cemacabtagene ansegedleucel (cema-cel) has nearly 50 activated trial sites, with over 250 patients consented for MRD screening[112][113]. - The ALPHA3 trial's primary endpoint is event-free survival (EFS), with a planned interim analysis for futility and lymphodepletion regimen selection anticipated in the first half of 2026[114][121]. Operating Expenses - General and administrative expenses for the three months ended March 31, 2025, were $15.0 million, down 13% from $17.3 million in 2024[158]. - Total operating expenses for the three months ended March 31, 2025, were $65.2 million, a decrease of 6% from $69.5 million in 2024[158]. - Research and development expenses decreased to $50.2 million for the three months ended March 31, 2025, down from $52.3 million in 2024, a reduction of $2.1 million[161]. - General and administrative expenses were $15.0 million for the three months ended March 31, 2025, compared to $17.3 million in 2024, reflecting a decrease of $2.3 million[162]. Strategic Collaborations - The company has entered into multiple strategic collaborations, including a five-year agreement with The University of Texas MD Anderson Cancer Center[135]. - The company has committed approximately $37.3 million in funding for the development of Foresight Diagnostics' MRD assay[143]. - The company has committed up to $15.0 million for a strategic collaboration agreement with MD Anderson for the investigation of allogeneic CAR T cell product candidates[181]. - The company expanded its CD19 license territory to include the European Union and the United Kingdom, with options for further expansion to China and Japan[123][124]. Workforce and Cost Management - A workforce reduction of approximately 28% was initiated to focus on ongoing clinical programs, with an estimated $3.3 million in related cash-based expenses[125].
Allogene Therapeutics(ALLO) - 2025 Q1 - Quarterly Report