Lyell(US:LYEL) Globenewswireยท2025-08-12 20:05Core Viewpoint - Lyell Immunopharma is advancing its lead CAR T-cell therapy, LYL314, which targets relapsed and/or refractory large B-cell lymphoma, showing promising clinical results and securing funding to support its development through mid-2027 [2][5][11]. Financial Results - For Q2 2025, Lyell reported a net loss of $42.7 million, a decrease from a net loss of $45.8 million in Q2 2024, primarily due to reduced stock-based compensation expenses [11][15]. - Cash, cash equivalents, and marketable securities as of June 30, 2025, were approximately $297 million, down from $384 million at the end of 2024, but expected to be sufficient to support operations into mid-2027 [13][19]. Clinical Development - LYL314 is currently in the pivotal PiNACLE trial for patients with relapsed and/or refractory large B-cell lymphoma in the third-line or later setting, with plans to initiate a second pivotal trial for the second-line setting by early 2026 [2][4][9]. - The Phase 1/2 trial data presented showed an overall response rate of 88% in the 3L+ cohort and 91% in the 2L cohort, with complete response rates of 72% and 64%, respectively [9]. Business Highlights - The company completed a private placement for gross proceeds of up to approximately $100 million, which will extend its cash runway and support the advancement of its clinical programs [5][8]. - LYL314 has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, facilitating more frequent communication regarding its development [4][9]. Pipeline and Future Plans - Lyell is advancing a pipeline of next-generation CAR T-cell therapies, with plans to submit an Investigational New Drug (IND) application for a solid tumor candidate in 2026 [7][14]. - An update on the progress of the PiNACLE trial is expected in late 2025, with data anticipated to support a Biologics License Application submission to the FDA in 2027 [9].