Lyell(US:LYEL)2025-11-12 21:12Financial Performance - Lyell reported a net loss of $38.8 million for Q3 2025, a decrease from a net loss of $44.6 million in Q3 2024, primarily due to reduced personnel expenses[13]. - Revenue for Q3 2025 was $15,000, compared to $34,000 in Q3 2024, representing a decrease of 56%[21]. - Total operating expenses for Q3 2025 were $37,268,000, down from $50,539,000 in Q3 2024, a reduction of 26%[21]. - Net loss for Q3 2025 was $38,846,000, compared to a net loss of $44,583,000 in Q3 2024, showing an improvement of 13%[25]. - Non-GAAP net loss for Q3 2025 was $29,124,000, compared to $37,064,000 in Q3 2024, reflecting a 21% improvement[25]. - Cash, cash equivalents, and marketable securities were approximately $320 million as of September 30, 2025, expected to support operations into 2027[17]. - Cash, cash equivalents, and marketable securities as of September 30, 2025, totaled $319,624,000, down from $383,541,000 as of December 31, 2024[22]. Research and Development - Research and development (R&D) expenses were $28.2 million for Q3 2025, down from $39.5 million in Q3 2024, reflecting a $11.3 million decrease attributed to lower research activities and personnel-related expenses[14]. - Research and development expenses for Q3 2025 were $28,172,000, a decrease of 29% from $39,500,000 in Q3 2024[27]. - Lyell plans to submit an IND in 2026 for a CAR T-cell product candidate targeting solid tumors[20]. - The company expects to present new clinical and translational data at the upcoming ASH meeting[20]. Product Development - Lyell's lead product candidate, ronde-cel, is in pivotal development for relapsed/refractory large B-cell lymphoma (LBCL) with a Phase 3 trial (PiNACLE – H2H) expected to begin enrollment by early 2026[3][11]. - The FDA granted RMAT designation for ronde-cel for the treatment of patients with relapsed or refractory LBCL in the second-line setting, enhancing communication frequency with the FDA[9][11]. - The company acquired exclusive global rights to LYL273, a CAR T-cell product candidate for refractory metastatic colorectal cancer (mCRC), which achieved a 67% overall response rate in a Phase 1 trial[4][6]. - The overall response rate for patients treated with LYL273 at the highest dose level was 67%, with an 83% disease control rate observed in the ongoing Phase 1 trial[4][15]. - Two abstracts from the Phase 1/2 trial of ronde-cel have been accepted for oral presentation at the ASH 67th Annual Meeting in December 2025[6][11]. Operational Efficiency - General and administrative (G&A) expenses decreased to $10.7 million in Q3 2025 from $11.8 million in Q3 2024, primarily due to lower stock-based compensation and outside services[16]. - General and administrative expenses for Q3 2025 were $10,687,000, compared to $11,769,000 in Q3 2024, a decrease of 9%[30]. - Lyell's manufacturing facility can produce over 1,200 CAR T-cell doses at full capacity, supporting commercial launch capabilities[18].