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Lyell Immunopharma reports developments tied to its next-generation chimeric antigen receptor, or CAR T-cell, therapy pipeline for patients with cancer. The company’s recurring updates center on ronde-cel, an autologous dual-targeting CD19/CD20 CAR T-cell product candidate for large B-cell lymphoma, and LYL273, a GCC-targeted CAR T-cell product candidate for metastatic colorectal cancer and other GCC-expressing cancers.
Company news also covers clinical-trial activity, FDA designation updates, manufacturing capabilities at the LyFE Manufacturing Center, quarterly financial results, equity financing activity, licensing transactions, investor-conference participation and executive or governance changes.
Lyell Immunopharma (NASDAQ: LYEL) reported Q4 and full-year 2025 results and business updates on March 12, 2026. Key developments include commencement of patient dosing in the Phase 3 PiNACLE-H2H trial (ronde-cel vs axi-cel/liso-cel) and ongoing PiNACLE pivotal and Phase 1 LYL273 programs.
Financials: net loss of $274.4M for 2025, cash of approx. $247.2M at year-end (excluding a subsequent $50M tranche), and a closed $50M equity tranche in March 2026 after a clinical milestone.
Lyell Immunopharma (Nasdaq: LYEL) closed an additional $50 million tranche of a July 2025 equity private placement after achieving a clinical milestone for rondecabtagene autoleucel in the PiNACLE pivotal trial for relapsed/refractory LBCL.
The tranche was sold at $25.61 per share, bringing total placement proceeds to ~$100 million; Lyell expects cash to fund operations into Q2 2027. Smital Shah was appointed Chief Financial and Business Officer effective March 9, 2026.
Lyell Immunopharma (Nasdaq: LYEL) said senior management will present at three investor conferences in early March 2026: TD Cowen (Mar 2, Boston), Leerink Annual Global Healthcare (Mar 9, Miami) and Citizens Life Science (Mar 10, Miami).
Live webcasts and on-demand replays will be available on the company website at www.lyell.com following each presentation.
Lyell Immunopharma (Nasdaq: LYEL) dosed the first patient in PiNACLE – H2H, a Phase 3 randomized head-to-head trial of rondecabtagene autoleucel (ronde-cel) versus liso-cel or axi-cel in second-line relapsed/refractory large B-cell lymphoma. The trial plans ~400 patients (200 per arm) and uses event-free survival as the primary endpoint.
Ronde-cel showed a 93% best overall response rate and 76% complete response rate in 29 efficacy-evaluable 3L+ patients; median progression-free survival was 18 months (data cutoff Sept 5, 2025). A BLA submission for the pivotal 3L+ trial is expected in 2027.
Lyell Immunopharma (NASDAQ: LYEL) presented new clinical and translational data for rondecabtagene autoleucel (ronde-cel) at ASH on Dec 7, 2025 showing high responses in large B-cell lymphoma (LBCL). In 3L+ patients (n=29 efficacy-evaluable) ronde-cel achieved a 93% ORR, 76% CR rate and median progression-free survival of 18 months. In 2L patients (n=18 efficacy-evaluable; 94% primary refractory) it showed an 83% ORR and 61% CR rate with durable CRs.
Safety was manageable for outpatient use: no Grade ≥3 CRS and ≤5% Grade ≥3 ICANS after dexamethasone prophylaxis. Two pivotal trials (PiNACLE – H2H and PiNACLE) are underway.
Lyell Immunopharma (NASDAQ: LYEL) on Nov 12, 2025 reported Q3 2025 results and program updates. Key clinical highlights include acquisition of global rights to LYL273 (GCC-targeted CAR T) with 67% ORR and 83% disease control at the highest dose in a U.S. Phase 1 mCRC trial, and FDA RMAT designation for ronde-cel in the 2L setting (complementing 3L+ RMAT).
Ronde-cel is advancing in PiNACLE (3L+ pivotal) and PiNACLE–H2H (Phase 3 2L randomized, ~400 patients, expected enrollment by early 2026). Cash and marketable securities were ~$320M at 9/30/2025, expected to fund operations into 2027. Q3 GAAP net loss was $38.8M.
Lyell Immunopharma (Nasdaq: LYEL) acquired exclusive global rights (outside mainland China, Hong Kong, Macau and Taiwan) to LYL273, a next‑generation GCC‑targeted CAR T candidate for metastatic colorectal cancer, on Nov 10, 2025. LYL273 showed a 67% overall response rate and an 83% disease control rate at the highest dose (2 x 10^6 CAR T cells/kg) in a U.S. Phase 1 trial (12 patients; data cutoff Oct 28, 2025) with median PFS of 7.8 months at that dose.
Transaction terms include a $40M upfront payment plus 1.9M Lyell shares, up to $820M additional cash milestones, equity milestones, and tiered royalties; Lyell says cash is expected to fund operations into 2027.
Lyell (Nasdaq: LYEL) announced two oral presentations of new clinical and translational data for rondecabtagene autoleucel (ronde-cel / LYL314) in aggressive large B-cell lymphoma at the 67th ASH Annual Meeting on Dec 7, 2025. As of the abstract data cut-off June 27, 2025, Lyell reports high overall and complete response rates in high-risk LBCL patients treated with ronde-cel and an encouraging safety profile across second-line and third-or-later-line settings. Ronde-cel is a dual-targeting CD19/CD20 CAR T designed to improve response durability and has received FDA RMAT and Fast Track designations for relapsed/refractory diffuse LBCL. Lyell is enrolling the PiNACLE registration trial and initiating a randomized trial versus approved CD19 CAR T in the second-line setting.
Lyell Immunopharma (Nasdaq: LYEL) has initiated PiNACLE - H2H, a groundbreaking Phase 3 head-to-head CAR T-cell therapy trial comparing rondecabtagene autoleucel (ronde-cel) against approved CD19 CAR T-cell therapies for large B-cell lymphoma (LBCL) in second-line treatment.
Ronde-cel, a dual-targeting CD19/CD20 CAR T-cell therapy with FDA's RMAT and Fast Track designations, is designed to improve complete response rates and durability. The trial will enroll approximately 400 patients starting early 2026, with event-free survival as the primary endpoint.
The company has formed a distinguished Steering Committee of lymphoma experts and is simultaneously advancing a single-arm pivotal trial (PiNACLE) for third-line-plus LBCL treatment, targeting approximately 120 patients.
Lyell Immunopharma (Nasdaq: LYEL), a late-stage clinical company focused on next-generation CAR T-cell therapies for cancer treatment, has announced its participation in two upcoming investor conferences in September 2025.
The company will present at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8th at 9:15 AM ET and the H.C. Wainwright 27th Annual Global Investment Conference on September 10th at 8:00 AM ET. Investors can access the live webcasts through Lyell's website, with replays available after the presentations.