Earnings summaries and quarterly performance for Lyell Immunopharma.
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Recent press releases and 8-K filings for LYEL.
Lyell Immunopharma Presents Positive Clinical Data for Rona-cel and LYL273
LYEL
New Projects/Investments
Guidance Update
- Lyell Immunopharma (LYEL) presented new clinical and translational data for ronacabtagene autoleucel (Rona-cel), a dual-targeting CD19/CD20 CAR T-cell candidate, at ASH 2025. In the third or later line setting for large B-cell lymphoma, Rona-cel achieved a 93% overall response rate and a 76% complete response rate, with a median progression-free survival of 18 months. The safety profile was appropriate for outpatient administration, with no Grade 3 or higher CRS events.
- The company's pivotal trial, Pinnacle, is ongoing, with a BLA submission planned for the end of 2027, and the Pinnacle Head-to-Head trial will begin enrollment by early 2026.
- Lyell also highlighted positive Phase 1 clinical data for LYL273, a novel CAR T-cell therapy for metastatic colorectal cancer, showing a 67% overall response rate and an 83% disease control rate at the highest dose in refractory patients.
- LYL273 is targeting a $6 billion market projected to reach $12 billion by 2032, with updated clinical data expected twice in 2026 and initiation of a pivotal program in early 2027.
- Lyell's cash runway extends into 2027.
Dec 8, 2025, 1:30 PM
Lyell Immunopharma Highlights Positive Clinical Data for Ronde-cel and LYL273 and Outlines Development Milestones
LYEL
New Projects/Investments
Guidance Update
- Lyell Immunopharma presented new clinical data for ronde-cel, a CD19/CD20 CAR T-cell candidate, at the American Society of Hematology Conference, showing a 93% overall response rate and 76% complete response rate with a median progression-free survival of 18 months in the third or later line setting for large B-cell lymphoma. The safety profile included no Grade 3 or higher CRS and less than 5% Grade 3 or higher ICANS with dexamethasone prophylaxis.
- The company is advancing two pivotal trials for ronde-cel: the ongoing PiNACLE trial and the PiNACLE Head-to-Head Phase 3 trial, which is expected to begin enrollment by early 2026. A Biologics License Application (BLA) submission is planned for the end of 2027.
- Lyell also provided an update on LYL273, a novel CAR T-cell therapy for metastatic colorectal cancer, reporting a 67% overall response rate and 83% disease control rate in a Phase 1 clinical trial at the highest dose, with a manageable safety profile including no Grade 3 or higher CRS. The pivotal program for LYL273 is expected to initiate in early 2027.
- Lyell owns and operates its manufacturing center, capable of producing over 1,200 CAR T-cell doses per year at full capacity, and has a cash runway expected to extend into 2027.
Dec 8, 2025, 1:30 PM
Lyell Presents Positive Clinical Data for CAR T-Cell Therapies and Outlines Future Milestones
LYEL
New Projects/Investments
Guidance Update
- Lyell presented new clinical and translational data at ASH 2025 for rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell candidate for relapsed and/or refractory large B-cell lymphoma (LBCL).
- In the 3L+ LBCL setting, ronde-cel achieved a 93% Overall Response Rate (ORR) and a 76% Complete Response Rate (CRR), with a median Progression-Free Survival (mPFS) of 18 months. For 2L LBCL, it showed an 83% ORR and 61% CRR.
- The company is advancing ronde-cel with a pivotal trial (PINACLE) underway for 3L+ LBCL and a second pivotal trial (PINACLE – H2H) to begin enrollment by early 2026 for 2L LBCL, aiming for a Biologics License Application (BLA) submission in 2027 for 3L+ LBCL.
- Lyell's cash runway extends into 2027, supporting multiple expected clinical milestones, including the development of LYL273 for metastatic colorectal cancer, with a pivotal trial initiation planned for 1H 2027.
Dec 8, 2025, 1:30 PM
Lyell Provides Clinical and Pipeline Updates for CAR T-Cell Therapies
LYEL
New Projects/Investments
- Lyell presented new clinical data for ronacabtagene autoleucel (Rhondacell), its CD19/CD20 CAR T-cell candidate for relapsed or refractory large B-cell lymphoma, demonstrating a 93% overall response rate and 76% complete response rate with a median progression-free survival of 18 months in the third or later line setting, along with a manageable safety profile suitable for outpatient administration.
- The company is advancing Rhondacell through two pivotal trials: Pinnacle, which is ongoing, and Pinnacle Head-to-Head, a phase 3 randomized controlled trial against approved CD19 CAR T-cell therapies, expected to begin enrollment by early 2026.
- Lyell also highlighted its newest next-generation CAR T-cell therapy candidate, LYL273, for metastatic colorectal cancer, which showed a 67% overall response rate and an 83% disease control rate in a Phase 1 clinical trial at the highest dose evaluated.
- Lyell operates its own manufacturing center with a capacity to produce over 1,200 CAR T-cell doses per year and projects a cash runway into 2027.
Dec 8, 2025, 1:30 PM
Lyell Immunopharma Presents Positive Clinical Data for Ronde-cel at ASH Meeting
LYEL
New Projects/Investments
- Lyell Immunopharma, Inc. presented positive clinical and translational data for its CAR T-cell product candidate, rondecabtagene autoleucel (ronde-cel), in patients with relapsed and/or refractory large B-cell lymphoma (LBCL) at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition on December 7, 2025.
- In the third-line or later (3L+) setting, ronde-cel demonstrated an overall response rate of 93% (27/29 patients) and a complete response rate of 76% (22/29 patients) among 29 efficacy-evaluable patients, with a median progression-free survival of 18 months.
- For patients in the second-line (2L) setting, including 94% with primary refractory disease, the overall response rate was 83% (15/18 patients) and the complete response rate was 61% (11/18 patients) among 18 efficacy-evaluable patients.
- The safety profile was manageable, with no Grade 3 or greater cytokine release syndrome (CRS) observed and low rates of Grade 1 (32%) or Grade 2 (29%) CRS across 69 patients.
- Translational data indicated that ronde-cel had a higher proportion of memory-cell phenotype and achieved up to three-fold higher expansion in patients after infusion compared to approved CD19 CAR T-cell products.
Dec 8, 2025, 11:02 AM
Lyell Immunopharma Reports Q3 2025 Financial Results and Key Clinical Milestones
LYEL
Earnings
New Projects/Investments
Guidance Update
- Lyell Immunopharma reported a net loss of $38.8 million for the third quarter ended September 30, 2025, compared to a net loss of $44.6 million for the same period in 2024.
- As of September 30, 2025, the company held approximately $320 million in cash, cash equivalents, and marketable securities, which is expected to support advancing its pipeline into 2027 through key clinical milestones.
- Lyell acquired exclusive global rights to LYL273, a novel GCC-targeted CAR T-cell product candidate for metastatic colorectal cancer, which demonstrated a 67% overall response rate at the highest dose level in a Phase 1 clinical trial.
- The U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for ronde-cel for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) in the second-line (2L) setting.
- The company announced the initiation of PiNACLE \u2013 H2H, a Phase 3 head-to-head CAR T-cell therapy clinical trial for aggressive LBCL in the 2L setting, with enrollment anticipated by early 2026.
Nov 12, 2025, 9:12 PM
Lyell Immunopharma Reports Q3 2025 Financial Results and Pipeline Progress
LYEL
Earnings
Guidance Update
New Projects/Investments
- Lyell Immunopharma reported approximately $320 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is projected to support pipeline advancement into 2027.
- The company received RMAT designation from the U.S. FDA for ronde-cel for relapsed or refractory large B-cell lymphoma (LBCL) in the second-line setting and initiated PiNACLE - H2H, a Phase 3 head-to-head clinical trial for ronde-cel in 2L LBCL, with enrollment expected to begin by early 2026.
- Lyell acquired exclusive global rights to LYL273, a novel CAR T-cell product candidate that achieved a 67% overall response rate and 83% disease control rate at the highest dose level in a Phase 1 trial for refractory metastatic colorectal cancer.
- For the third quarter ended September 30, 2025, the GAAP net loss was $(38,846) thousand.
Nov 12, 2025, 9:05 PM
Lyell Immunopharma acquires global rights to novel cell therapy and provides pipeline updates
LYEL
M&A
New Projects/Investments
Guidance Update
- Lyell Immunopharma has acquired exclusive global rights to Lyell 273, a novel clinical-stage CAR T-cell therapy for metastatic colorectal cancer, for an upfront payment of $40 million and 1.9 million shares of Lyell stock to Innovative Cellular Therapeutics (ICT).
- Initial data from a U.S. Phase 1 clinical trial for Lyell 273 in patients with refractory metastatic colorectal cancer showed a 67% overall response rate and an 83% disease control rate at the highest dose level, with a manageable safety profile. The colorectal cancer market is projected to reach $12 billion in worldwide net sales by 2032.
- The company also provided updates on RhondaCell, which received Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed or refractory large B-cell lymphoma in the second-line setting, and expects a Biologics License Application (BLA) submission for its Pinnacle trial in 2027.
- Lyell reported a strong balance sheet with $347 million of cash as of the end of the second quarter, which is expected to provide a cash runway into 2027, inclusive of the Lyell 273 transaction.
Nov 10, 2025, 1:30 PM
Lyell Immunopharma Acquires Global Rights to LYL273 and Reports Positive Phase I Data
LYEL
M&A
New Projects/Investments
- Lyell Immunopharma has acquired exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) to LYL273, a novel clinical-stage CAR T-cell therapy for metastatic colorectal cancer, from Innovative Cellular Therapeutics (ICT).
- Under the agreement, ICT received an upfront payment of $40 million and 1.9 million shares of Lyell stock, with eligibility for additional cash and equity payments based on clinical, regulatory, and commercial milestones, including up to $30 million in clinical milestones.
- In a U.S. Phase I clinical trial, LYL273 demonstrated a 67% overall response rate (ORR) and an 83% disease control rate (DCR) at the highest dose level in patients with refractory metastatic colorectal cancer, with a median progression-free survival of 7.8 months and median overall survival not reached at dose level two.
- The colorectal cancer market is estimated at $6 billion, projected to reach $12 billion in worldwide net sales by 2032.
- Lyell is also advancing RhondaCell, a dual-targeting CAR T-cell product for large B-cell lymphoma, which has received Regenerative Medicine Advanced Therapy (RMAT) designation in both second-line and third or later line settings, with a BLA submission expected in 2027.
Nov 10, 2025, 1:30 PM
Lyell Immunopharma Acquires Global Rights to LYL273 for Metastatic Colorectal Cancer
LYEL
M&A
New Projects/Investments
Guidance Update
- Lyell Immunopharma, Inc. acquired exclusive global rights to LYL273, a novel CAR T-cell product candidate for metastatic colorectal cancer, from Innovative Cellular Therapeutics, effective November 6, 2025.
- The acquisition included an upfront payment of $40 million in cash and 1.9 million shares of Lyell common stock to ICT Holdings, with potential contingent payments up to $820 million in milestones and tiered royalties.
- In a U.S. Phase 1 clinical trial, LYL273 achieved a 67% overall response rate and an 83% disease control rate at the highest dose level in patients with refractory metastatic colorectal cancer.
- Lyell anticipates its cash will be sufficient to fund operations into 2027 and updated its 2025 net cash use guidance to between $155 million and $160 million, excluding the upfront payment.
Nov 10, 2025, 12:32 PM
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