On August 6, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported financial results and business highlights for the second quarter ended June 30, 2026.
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Second Quarter Updates and Recent Business Highlights
Rondecabtagene Autoleucel (Ronde-cel): A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies for the treatment of large B-cell lymphoma (LBCL)
Ronde-cel is an autologous CAR T-cell product candidate under evaluation in two pivotal trials in patients with relapsed/refractory (R/R) LBCL in the third- or later-line (3L+) setting (PiNACLE) and the second-line (2L) setting (PiNACLE‑H2H). Ronde-cel targets B cells that express either CD19 or CD20 with a true ‘OR’ logic gate to achieve full potency at either target and is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. The U.S. Food and Drug Administration (FDA) has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the treatment of adults with R/R diffuse large B-cell lymphoma (DLBCL) in the 3L+ setting and also RMAT designation for the treatment of large B-cell lymphoma (LBCL) in the 2L setting. The FDA has also granted ronde‑cel Orphan Drug Designation for the treatment of DLBCL/HGBCL with MYC and BCL2 rearrangements.
•In June 2026, Lyell presented updated safety data and translational insights for ronde-cel in two presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden.
◦Safety data from more than 100 patients with R/R LBCL treated with ronde-cel (65 in the 3L+ setting and 43 in the 2L setting) were presented. There were no Grade ≥ 3 CRS events and low rates of Grade ≥ 3 ICANS reported in the Phase 1/2 trial as of the data cutoff date of May 5, 2026, supporting the potential for outpatient administration. The manufacturing success rate was 97%.
◦Translational analyses were presented providing a biological basis for ronde-cel’s durable responses, including enhanced memory potential of cytotoxic effector cells from CD62L+ enrichment and CD19/CD20 dual-targeting to overcome low antigen expression.
•The PiNACLE pivotal single-arm trial, a seamless expansion of the 3L+ cohort in the Phase 1/2 multi‑cohort trial, is ongoing. Additional data from this trial are expected in the second half of 2026, and pivotal data are expected in mid-2027 with submission of a Biologics License Application (BLA) to the FDA expected to follow in the second half of 2027. The primary endpoint of the trial is overall response rate, including an evaluation of duration of response.
•PiNACLE-H2H, the first-of-its-kind Phase 3 randomized controlled trial evaluating ronde-cel versus investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel in patients with R/R LBCL in the 2L setting continues to enroll patients. A progress update for this trial is expected in the second half of 2026. The trial’s primary endpoint is event-free survival.
LYL273: A next-generation guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate for the treatment of relapsed/refractory metastatic colorectal cancer (mCRC) and other GCC-expressing cancers
LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. In November 2025, Lyell acquired global rights (excluding mainland China, Hong Kong, Macau and Taiwan) to LYL273, which has shown promising dose-dependent clinical activity in patients with advanced R/R mCRC in a Phase 1 trial conducted in the U.S. following proof of concept in 15 patients in China. The FDA granted LYL273 Fast Track designation for the treatment of mCRC.
•In June 2026, Lyell reported updated safety data from patients with 3L+ R/R mCRC in the ongoing U.S. Phase 1 trial, including 19 patients, of which 10 were treated with gastrointestinal (GI) prophylaxis and a new safety management protocol and 9 were treated without GI prophylaxis across Dose Levels 1 and 2 (1 and 2 x 106 CAR+ cells/kg, respectively) as of the data cutoff date of May 5, 2026. The GI prophylaxis regimen included treatment with infliximab, vedolizumab and budesonide prior to the development of symptoms.
◦The rate of Grade ≥ 2 diarrhea or colitis was reduced from 55% to 10%, and there were no reported cases of Grade ≥ 3 diarrhea or colitis in patients treated with GI prophylaxis.
◦No patients treated with GI prophylaxis experienced Grade ≥ 3 CRS or ICANS.
◦GCC CAR T-cell expansion kinetics were similar in patients treated with and without GI prophylaxis.
◦Dose escalation continues, and the maximum tolerated dose has not been determined.
•Based on the new safety data, Lyell amended the ongoing U.S. Phase 1 trial to a Phase 1/2 design, enabling seamless expansion into a potential pivotal single-arm Phase 2 trial once the recommended Phase 2 dose is determined and subject to discussions with the FDA. The amendment adds new cohorts, including a 2L cohort and a cohort evaluating a combination strategy with radiotherapy.
•Additional U.S. Phase 1 clinical data in patients with R/R mCRC in the 3L+ setting and an End-of-Phase 1 meeting with the FDA are expected in the second half of 2026.
Second Quarter 2026 Financial Results
Lyell reported a net loss of $44.8 million for the second quarter ended June 30, 2026, compared to a net loss of $42.7 million for the same period in 2025. The $2.1 million increase in net loss was primarily due to a $4.7 million increase in research and development expenses driven by increased clinical trial activity and lower interest income, partially offset by lower property and equipment disposal losses, and a $1.4 million long-lived asset impairment charge that did not recur. Non‑GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of the Securities Purchase Agreement put/call asset relating to the Company’s July 2025 private placement transaction and success payment liabilities, increased by $2.8 million to $40.6 million for the second quarter ended June 30, 2026, compared to $37.8 million for the same period in 2025, primarily due to increased clinical trial activity and lower interest income.
(Press release, Lyell Immunopharma, AUG 6, 2026, View Source [SID1234669799])