LYEL

SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Lyell Immunopharma Inc. (LYEL) on Wednesday reported a loss of $24.2 million in its first quarter. The South San Francisco, California-based company said it had a loss of $1.10 per share. The biotechnology firm posted revenue of $2,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LYEL at https://www.zacks.com/ap/LYEL

PiNACLE pivotal clinical trial evaluating ronde-cel in patients with LBCL in third- or later-line setting on track to report additional data in second half of 2026, with pivotal data expected mid-2027 and BLA submission expected to follow in 2027 PiNACLE-H2H, a first of its kind Phase 3 clinical trial evaluating ronde-cel head-to-head against standard-of-care CD19 CAR T-cell therapies in the LBCL second-line setting, commenced patient dosing Phase 1 clinical trial of LYL273 continues to enroll patients with metastatic colorectal cancer, with commencement of patient dosing at Dose Level 3 Closed second $50 million tranche of $100 million private placement at $25.61 per share, with approximately $261 million in cash as of March 31, 2026, expected to provide runway into Q3 2027 SOUTH SAN FRANCISCO, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- 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, today reported financial results and business highlights for the first quarter ended March 31, 2026. First Quarter Updates and Recent Business Highlights 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 with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency 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) designation in the third- and later-line (3L+) and second-line (2L) settings, as well as Fast Track designation for the treatment of adults with relapsed/refractory large B-cell lymphoma (R/R LBCL). Two pivotal trials for ronde-cel in LBCL are underway. The ongoing 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 expecte...

SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Lyell Immunopharma Inc. (LYEL) on Thursday reported a loss of $140.7 million in its fourth quarter. On a per-share basis, the South San Francisco, California-based company said it had a loss of $7.68. The biotechnology firm posted revenue of $6,000 in the period. For the year, the company reported a loss of $274.4 million, or $16.06 per share. Revenue was reported as $36,000. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LYEL at https://www.zacks.com/ap/LYEL

Patient dosing has commenced in first-of-its-kind Phase 3 head-to-head CAR T-cell 2L randomized controlled clinical trial (PiNACLE-H2H) in patients with large B-cell lymphoma, and the 3L+ pivotal trial (PiNACLE) evaluating ronde-cel is ongoing Phase 1 trial is ongoing for LYL273, an enhanced GCC-targeted CAR T-cell candidate for metastatic colorectal cancer; seven new patients treated without dose-limiting toxicity and including dose escalation to Dose Level 3 Smital Shah was appointed Chief Financial and Business Officer in March 2026 Second $50 million tranche of $100 million equity private placement closed in March 2026 after achievement of clinical milestone for ronde-cel Cash of approximately $247.2 million at the end of 2025 excluding the $50 million tranche; current cash expected to advance pipeline into the second quarter of 2027, including through multiple key clinical milestones SOUTH SAN FRANCISCO, Calif., March 12, 2026 (GLOBE NEWSWIRE) -- 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, today reported financial results and business highlights for the fourth quarter and year ended December 31, 2025. Lyell has since commenced patient dosing in the first-of-its-kind Phase 3 head-to-head CAR T-cell randomized controlled clinical trial of rondecabtagene autoleucel (ronde-cel) versus investigator’s choice of axicabtagene ciloleucel (axi-cel) or lisocabtagene maraleucel (liso-cel) in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) with disease progression on at least one prior line of therapy (PiNACLE-H2H). Lyell has dosed seven new patients with metastatic colorectal cancer (mCRC) with LYL273, an enhanced guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate, since its November 2025 acquisition, without dose-limiting toxicity and including dose escalation to Dose Level 3. Lyell also recently announced it has closed the sale of an additional $50 million of shares of its common stock to investors from its July 2025 equity private placement of up to $100 million, following achievement of a clinical milestone within its PiNACLE pivotal trial evaluating ronde-cel in patients with R/R LBCL in the third- or later-line setting (3L+), and the appointment of Smital Shah as its Chief Financial and...

Acquired exclusive global rights to LYL273, a novel GCC-targeted CAR T-cell product candidate that has demonstrated a 67% overall response rate, an 83% disease control rate and a manageable safety profile at the highest dose level studied to date in patients with refractory metastatic colorectal cancer in an ongoing U.S. Phase 1 clinical trial Received RMAT designation from the U.S. FDA for ronde-cel for the treatment of patients with relapsed or refractory LBCL receiving treatment in the second-line (2L) setting Announced that two abstracts highlighting new clinical and translational data from the Phase 1/2 clinical trial of ronde‑cel for the treatment of aggressive large B-cell lymphoma have been accepted for oral presentation at the ASH 67th Annual Meeting and Exposition in December Announced the initiation of PiNACLE - H2H, a Phase 3 head-to-head CAR T-cell therapy clinical trial in aggressive large B-cell lymphoma in the 2L setting Formed a PiNACLE – H2H Steering Committee comprised of a distinguished group of lymphoma and cell therapy experts Cash of approximately $320 million at the end of the third quarter of 2025; current cash is expected to support advancing pipeline into 2027 through key clinical milestones SOUTH SAN FRANCISCO, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today reported financial results and business highlights for the third quarter ended September 30, 2025. Lyell’s lead clinical program, rondecabtagene autoleucel (ronde-cel, or LYL314), is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate under evaluation in PiNACLE, a single-arm pivotal trial enrolling patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the third- or later-line (3L+) setting and in a Phase 1/2 trial in the 2L setting. A second pivotal trial, PiNACLE – H2H, which is a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial of ronde-cel for LBCL in the 2L, is expected to begin by early 2026. The U.S. Food and Drug Administration (FDA) granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of patients with R/R LBCL receiving treatment in the 2L setting in November 2025 to compl...

SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Lyell Immunopharma Inc. (LYEL) on Wednesday reported a loss of $38.8 million in its third quarter. The South San Francisco, California-based company said it had a loss of $2.13 per share. The biotechnology firm posted revenue of $15,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LYEL at https://www.zacks.com/ap/LYEL

SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Lyell Immunopharma Inc. (LYEL) on Tuesday reported a loss of $42.7 million in its second quarter. The South San Francisco, California-based company said it had a loss of $2.89 per share. The biotechnology firm posted revenue of $8,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LYEL at https://www.zacks.com/ap/LYEL

Presented positive new clinical data demonstrating high rates of durable complete responses from the Phase 1/2 trial of LYL314 for the treatment of aggressive large B-cell lymphoma Initiated the PiNACLE pivotal trial of LYL314 in patients with large B-cell lymphoma receiving treatment in the third‑ or later-line (3L+) setting; remain on track to initiate a pivotal trial in the second-line (2L) setting by early 2026 Entered into a securities purchase agreement for a private placement for gross proceeds of up to approximately $100 million Pro-forma cash of approximately $347 million inclusive of the initial proceeds from the private placement to support advancing pipeline into mid-2027 through key clinical milestones SOUTH SAN FRANCISCO, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, today reported financial results and business highlights for the second quarter ended June 30, 2025. Lyell’s lead clinical program, LYL314, is a next-generation autologous dual-targeting CD19/CD20 CAR T-cell product candidate under evaluation in PiNACLE, a single-arm pivotal trial enrolling patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the 3L+ setting and in a Phase 1/2 study in the 2L setting. “Based on the high rate of durable complete responses achieved by LYL314 in patients with aggressive LBCL presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland, in June, we believe that our CD19/CD20 CAR T-cell therapy will disrupt the therapeutic landscape by delivering meaningfully increased complete response rates and improved durability over the currently approved CD19 CAR T-cell therapies,” said Lynn Seely, M.D., President and CEO of Lyell. “Our recent private placement with well-respected investors significantly derisks our business, extends our cash runway into mid-2027 and enables us to focus on rapidly advancing the clinical development of LYL314. We have initiated the PiNACLE single-arm pivotal trial for patients with LBCL receiving treatment in the third- or later-line setting and are on track to begin a second pivotal trial of LYL314 for patients with LBCL in the second-line setting by early 2026.” Second Quarter Updates and Recent Business Highlights Lyell is advancing a pipel...

SOUTH SAN FRANCISCO, Calif. (AP) — SOUTH SAN FRANCISCO, Calif. (AP) — Lyell Immunopharma Inc. (LYEL) on Tuesday reported a loss of $52.2 million in its first quarter. On a per-share basis, the South San Francisco, California-based company said it had a loss of 18 cents. The results topped Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 19 cents per share. The biotechnology firm posted revenue of $7,000 in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on LYEL at https://www.zacks.com/ap/LYEL

Presenting new clinical data from Phase 1/2 multi-center clinical trial of LYL314, a next-generation dual‑targeting CD19/CD20 CAR T-cell product candidate for the treatment of relapsed and/or refractory large B‑cell lymphoma at the 18th International Conference on Malignant Lymphoma. Received Regenerative Medicine Advanced Therapy (RMAT) designation from the United States Food and Drug Administration (FDA) for LYL314 for the treatment of relapsed and/or refractory diffuse large B-cell lymphoma in the third- or later-line setting. LYL314 clinical supply now manufactured at Lyell’s LyFE Manufacturing Center™, following successful technology transfer and clearance by the FDA of an Investigational New Drug Amendment. Remain on track to initiate a pivotal trial of LYL314 in the third- or later-line setting in mid-2025 and expect to initiate a pivotal trial in the second-line setting by early 2026. Cash, cash equivalents and marketable securities of $330.1 million as of March 31, 2025 support advancing pipeline into 2027 through multiple clinical milestones. SOUTH SAN FRANCISCO, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today reported financial results and business highlights for the first quarter ended March 31, 2025. Lyell’s lead clinical program, LYL314 (formerly known as IMPT-314), is an autologous CD19/CD20 dual-targeting CAR T-cell product candidate under evaluation in a Phase 1/2 trial enrolling patients with relapsed and/or refractory large B-cell lymphoma (LBCL). LYL314 was recently granted RMAT designation by the United States FDA in recognition of its potential to address significant unmet needs in patients with aggressive LBCL in the third- or later-line setting. “We are pleased with the progress we are making with our LYL314 clinical development strategy and look forward to presenting new clinical data from patients with aggressive large B-cell lymphoma who have not previously received CAR T-cell therapy at the International Conference on Malignant Lymphoma in Lugano, Switzerland in June,” said Lynn Seely, M.D., President and CEO of Lyell. “Based on promising clinical data, Lyell remains on track to initiate two pivotal programs for LYL314: one for patients in the third- or later-line setting by mid-20...