Lyell Immunopharma, Inc. Stock Price, News & Analysis

Lyell Immunopharma (LYEL) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its LYL314 therapy, targeting relapsed/refractory large B-cell lymphoma. The designation was based on promising data from an ongoing Phase 1/2 trial.

Key clinical results include:

• 94% overall response rate (16/17 patients)
• 71% complete response rate (12/17 patients)
• 71% of patients maintaining response at last follow-up
• Median follow-up of 6.3 months
• No Grade 3+ cytokine release syndrome reported

LYL314 is a dual-targeting CD19/CD20 CAR T-cell therapy designed to improve complete response rates compared to existing treatments. The company plans to initiate two pivotal programs: one in mid-2025 for 3rd+ line treatment and another in early 2026 for 2nd line treatment. Additional clinical updates are expected throughout 2025.

Lyell Immunopharma (LYEL) reported its Q4 and full-year 2024 results, highlighting significant developments in its CAR T-cell therapy pipeline. The company's lead program, IMPT-314, showed promising Phase 1 data with a 94% overall response rate and 71% complete response rate in large B-cell lymphoma patients.

Key financial metrics include a net loss of $191.9M for Q4 and $343.0M for full-year 2024. Cash position stands at $383.5 million, expected to fund operations into 2027. The company plans to initiate pivotal trials for IMPT-314 in mid-2025 for 3rd line treatment and early 2026 for 2nd line treatment.

Research and development expenses were $48.7M in Q4 and $171.6M for the full year. The company acquired ImmPACT Bio, incurring $87.2M in IPR&D expenses, and recorded a $51.3M impairment charge on long-lived assets due to stock price decline.

Lyell Immunopharma (Nasdaq: LYEL), a clinical-stage company focused on developing next-generation CAR T-cell therapies for cancer patients, has announced its participation in two upcoming investor conferences. The company's senior management team will present at:

• The H.C. Wainwright 3rd Annual Cell Therapy Virtual Conference on February 25th at 2:30 pm Eastern Time
• The TD Cowen's 45th Annual Health Care Conference on March 3rd at 11:50 am Eastern Time

Interested parties can access live webcasts of the presentations through the Investors section of Lyell's website (www.lyell.com). Replay options will be available on the company's website following the live presentations.

Lyell Immunopharma (LYEL) announced significant pipeline updates focusing on IMPT-314, their dual-targeting CD19/CD20 CAR T-cell therapy for large B-cell lymphoma. The company plans to initiate pivotal trials in both 3rd line+ setting (mid-2025) and 2nd line setting (early 2026). Initial clinical data showed promising results with a 94% overall response rate and 71% complete response rate in 3rd-line+ patients.

To optimize resources, Lyell is discontinuing development of LYL119 (ROR1-targeting CAR T-cell product) and IMPT-514 (autoimmune disease program) to focus on IMPT-314 and early-stage solid tumor programs. The company projects net cash use of $175-185 million for 2025, extending their cash runway into 2027. Additional clinical data from ongoing trials will be presented in mid-2025, including mature data from 3rd line+ cohort and initial 2nd line data.

Lyell Immunopharma (NASDAQ: LYEL) has announced positive initial clinical data from its Phase 1-2 trial of IMPT-314, a dual-targeting CD19/CD20 CAR T-cell therapy for B-cell lymphoma. The trial demonstrated a 94% objective response rate and 71% complete response rate in CAR T-naïve patients with large B-cell lymphoma.

The study involved 23 patients, with 17 being efficacy evaluable. Safety data showed no Grade 3+ cytokine release syndrome, and only 13% experienced Grade 3 ICANS, which resolved with standard treatment. The drug demonstrated robust expansion with peak cell expansion occurring between Days 7-28 post-infusion. Based on these results, Lyell plans to initiate a pivotal trial in 2025 for CAR T-naive patients with large B-cell lymphoma in the 3rd-line+ setting.

Lyell Immunopharma (NASDAQ: LYEL) reported Q3 2024 financial results and business highlights. The company acquired ImmPACT Bio and strengthened its pipeline with IMPT-314, a dual-targeting CD19/CD20 CAR T-cell product. Net loss was $44.6 million compared to $50.9 million in Q3 2023. Cash position stands at $460.7 million as of September 30, 2024, expected to fund operations into 2027. The company plans to present initial data from IMPT-314's Phase 1 trial at ASH 2024 and expects to initiate a pivotal trial in 2025.

Lyell Immunopharma (Nasdaq: LYEL) announced that initial clinical data from their Phase 1-2 study of IMPT-314 in large B-cell lymphoma will be presented at the 2024 ASH Annual Meeting. IMPT-314 is a dual-targeting CD19/CD20 CAR T-cell therapy being developed for aggressive B-cell non-Hodgkin's lymphoma and has received Fast Track Designation from the FDA. The presentation will be delivered by Dr. Sarah M. Larson from UCLA's David Geffen School of Medicine on December 9, 2024, focusing on the first results of this autologous bispecific CAR therapy in enriched naive and central memory T cells.

Lyell Immunopharma (NASDAQ: LYEL) has completed its acquisition of ImmPACT Bio, a private clinical-stage cell therapy company. The acquisition adds IMPT-314, a dual-targeting CD19/CD20 CAR T-cell product candidate, to Lyell's pipeline, with pivotal development expected to start in 2025 for B-cell non-Hodgkin lymphoma patients. Former ImmPACT Bio CEO Sumant Ramachandra joins Lyell's Board of Directors. The company expects its cash balance to fund operations into 2027, supporting clinical milestones across its pipeline programs.

Lyell Immunopharma has announced its acquisition of ImmPACT Bio, strengthening its clinical pipeline with IMPT-314, a dual-targeting CD19/CD20 CAR T-cell therapy. The deal involves $30 million in cash and 37.5 million Lyell shares upfront, plus potential milestone-based shares and royalties. Data from IMPT-314's Phase 1-2 trial in large B-cell lymphoma will be presented later this year, with a pivotal trial expected in 2025. Lyell is discontinuing development of LYL797, LYL845, and earlier TIL programs to focus on next-generation CAR T-cell therapies. The company expects its cash runway to extend into 2027 following the transaction's close in Q4 2024.