Lyell Immunopharma, Inc.

Lyell Immunopharma Reports Business Highlights and Financial Results for the Second Quarter 2026

Lyell reported a Q2 net loss of $44.8 million, ending the quarter with $228.0 million in cash and marketable securities, which management expects to fund operations into Q3 2027. The PiNACLE pivotal trial of ronde-cel remains on track for pivotal data in mid-2027 and a BLA submission in the second half of 2027, with updated safety data showing no Grade ≥ 3 CRS and a 97% manufacturing success rate. For the LYL273 program in colorectal cancer, the implementation of gastrointestinal prophylaxis reduced Grade ≥ 2 diarrhea or colitis from 55% to 10%, and the trial has been amended to a Phase 1/2 design with an FDA meeting expected in the second half of 2026.

•2mo ago

Lyell Immunopharma Presents Updated Safety Data and Translational Insights for Rondecabtagene Autoleucel (Ronde-Cel) in Patients with Large B-Cell Lymphoma at European Hematology Association 2026 Congress

Lyell Immunopharma presented updated safety data for ronde-cel in 108 patients with relapsed or refractory large B-cell lymphoma at the EHA 2026 Congress. The data showed no Grade 3 or higher Cytokine Release Syndrome (CRS) events and low rates of Grade 3 or higher Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), supporting the potential for outpatient administration. Translational insights highlighted the biological basis for durable responses, including enhanced memory potential of cytotoxic effector cells via CD62L+ enrichment and dual-targeting of CD19/CD20. The company expects updated data from the pivotal PiNACLE trial in the second half of 2026, with a BLA submission targeted for the second half of 2027.

•4mo ago

Lyell Immunopharma Provides Update on Safety Profile of LYL273 in Relapsed or Refractory Metastatic Colorectal Cancer and Amends Phase 1 Trial to Phase 1/2 Expansion 

Lyell Immunopharma reported that gastrointestinal prophylaxis reduced Grade ≥ 2 diarrhea or colitis in LYL273 patients from 55% to 10%, with no Grade 3+ CRS or ICANS observed in the prophylaxis group. The company amended its U.S. Phase 1 trial to a Phase 1/2 design (CARABINER), enabling seamless expansion into a potential pivotal single-arm Phase 2 trial pending FDA alignment. New cohorts, including a second-line setting and a radiotherapy combination, will be added, with an End-of-Phase 1 FDA meeting expected in the second half of 2026.

•4mo ago

Lyell Immunopharma to Present Phase 1/2 Safety and Translational Data for Ronde-Cel in Large B-Cell Lymphoma at the European Hematology Association 2026 Congress

Lyell Immunopharma announced it will present updated Phase 1/2 safety and translational data for its lead candidate ronde-cel in large B-cell lymphoma at the EHA 2026 Congress in Stockholm. The two poster presentations will focus on low-grade cytokine release syndrome and neurotoxicity rates, as well as translational insights linking durable responses to cytotoxic T cells with memory potential. The company remains on track to report updated data from the pivotal PiNACLE trial in the second half of 2026, with a Biologics License Application expected in 2027.

•4mo ago

Lyell Immunopharma Reports Business Highlights and Financial Results for the First Quarter 2026

Lyell Immunopharma reported Q1 net loss of $24.2 million, a significant improvement from the prior year, driven by lower R&D and G&A expenses and a gain on its securities purchase agreement. The company closed the second $50 million tranche of its private placement at $25.61 per share, ending the quarter with $261 million in cash to fund operations into Q3 2027. Clinically, Lyell initiated patient dosing in the Phase 3 PiNACLE-H2H trial for ronde-cel and commenced Dose Level 3 dosing for LYL273 in metastatic colorectal cancer.

•5mo ago