Core Viewpoint - Lyell Immunopharma is advancing its lead CAR T-cell therapy, LYL314, which targets relapsed and/or refractory large B-cell lymphoma, showing promising clinical results and securing funding to support its development through mid-2027 [2][5][11]. Financial Results - For Q2 2025, Lyell reported a net loss of $42.7 million, a decrease from a net loss of $45.8 million in Q2 2024, primarily due to reduced stock-based compensation expenses [11][15]. - Cash, cash equivalents, and marketable securities as of June 30, 2025, were approximately $297 million, down from $384 million at the end of 2024, but expected to be sufficient to support operations into mid-2027 [13][19]. Clinical Development - LYL314 is currently in the pivotal PiNACLE trial for patients with relapsed and/or refractory large B-cell lymphoma in the third-line or later setting, with plans to initiate a second pivotal trial for the second-line setting by early 2026 [2][4][9]. - The Phase 1/2 trial data presented showed an overall response rate of 88% in the 3L+ cohort and 91% in the 2L cohort, with complete response rates of 72% and 64%, respectively [9]. Business Highlights - The company completed a private placement for gross proceeds of up to approximately $100 million, which will extend its cash runway and support the advancement of its clinical programs [5][8]. - LYL314 has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, facilitating more frequent communication regarding its development [4][9]. Pipeline and Future Plans - Lyell is advancing a pipeline of next-generation CAR T-cell therapies, with plans to submit an Investigational New Drug (IND) application for a solid tumor candidate in 2026 [7][14]. - An update on the progress of the PiNACLE trial is expected in late 2025, with data anticipated to support a Biologics License Application submission to the FDA in 2027 [9].

SOUTH SAN FRANCISCO, Calif., July 25, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing next-generation CAR T-cell therapies for patients with cancer, today announced that it has entered into a securities purchase agreement for a private placement with certain institutional and other accredited investors, for gross proceeds of up to approximately $100 million. The initial closing of approximately $50 million of common stock at a price of $13.32 per share is ...

Core Insights - Lyell Immunopharma, Inc. is participating in the H.C. Wainwright "HCW@Home" Series on June 25, 2025, to discuss new clinical data for its lead product candidate LYL314 [1][2] Group 1: Company Overview - Lyell Immunopharma is a clinical-stage company focused on next-generation CAR T-cell therapies for cancer patients, particularly those with hematologic malignancies and solid tumors [4] - The company utilizes advanced technologies to enhance CAR T cells, aiming for durable tumor cytotoxicity and long-lasting clinical responses [4] - Lyell's manufacturing facility, the LyFE Manufacturing Center™, has the capacity to produce over 1,200 CAR T-cell doses at full capacity [4] Group 2: Product Candidate Details - LYL314 is an autologous dual-targeting CD19/CD20 CAR T-cell product candidate, currently in pivotal-stage development for patients with relapsed and/or refractory large B-cell lymphoma (LBCL) [2] - The product has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. FDA, indicating its potential clinical benefits [2] - LYL314 aims to improve complete response rates and prolong the duration of responses compared to existing CD19-targeted CAR T-cell therapies for LBCL [2]

Core Insights - Lyell Immunopharma, Inc. announced positive clinical data for LYL314, a CAR T-cell therapy for relapsed/refractory large B-cell lymphoma (LBCL), showing an 88% overall response rate and a 72% complete response rate in patients treated in the third- or later-line setting [1][3][4] Clinical Data Summary - In a Phase 1/2 trial, 25 patients in the 3L+ setting demonstrated an 88% overall response rate and a 72% complete response rate, with 71% of those achieving complete response remaining so at ≥ 6 months [1][3][4] - The efficacy evaluable population included 36 patients, with a median follow-up of 9 months for 3L+ patients and 5 months for 2L patients [2][3] - Among 51 CAR T-naive patients, 70% of those with primary refractory disease achieved a complete response [4] Safety Profile - The safety profile of LYL314 was manageable for outpatient administration, with no Grade ≥ 3 cytokine release syndrome reported and low rates of Grade 1 (22%) and Grade 2 (35%) adverse events [3][5] - Immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 6% (Grade 1), 2% (Grade 2), and 14% (Grade ≥ 3) of patients, with a median resolution time of 5 days [5] Ongoing Trials - The pivotal single-arm PiNACLE trial is currently underway, targeting approximately 120 patients with relapsed/refractory LBCL in the third- or later-line setting [6][12] - The trial aims to evaluate the overall response rate as the primary endpoint [12] Regulatory Designations - LYL314 has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for the treatment of relapsed/refractory aggressive B-cell lymphoma [11] Manufacturing and Technology - LYL314 is designed to target B cells expressing either CD19 or CD20, utilizing a proprietary manufacturing process to enhance T-cell activity [10][9] - The Lyell LyFE Manufacturing Center™ has the capacity to produce over 1,200 CAR T-cell doses at full capacity [13]

Core Insights - Lyell Immunopharma, Inc. reported financial results and business highlights for Q1 2025, focusing on its lead clinical program LYL314, a CAR T-cell therapy for relapsed and/or refractory large B-cell lymphoma (LBCL) [1][2][3] Financial Performance - The company reported a net loss of $52.2 million for Q1 2025, an improvement from a net loss of $60.7 million in Q1 2024, primarily due to the absence of impairment expenses recognized in the prior year [8][18] - Cash, cash equivalents, and marketable securities totaled $330.1 million as of March 31, 2025, down from $383.5 million at the end of 2024, which is expected to support operations into 2027 [12][19] Clinical Development - LYL314 has received RMAT designation from the FDA, indicating its potential to address significant unmet needs in aggressive LBCL [4][5] - The company plans to present new clinical data for LYL314 at the International Conference on Malignant Lymphoma in June 2025, with pivotal trials expected to start in mid-2025 for the third- or later-line setting and early 2026 for the second-line setting [2][5][6] Research and Development - R&D expenses for Q1 2025 were $43.4 million, slightly up from $43.2 million in Q1 2024, driven by increased personnel costs related to workforce reductions [15][18] - The company is advancing a pipeline of next-generation CAR T-cell therapies, with a focus on overcoming T-cell exhaustion and enhancing durability in hostile tumor environments [7][13] Manufacturing Capabilities - The LyFE Manufacturing Center in Bothell, Washington, is now producing clinical supplies for LYL314 following successful technology transfer and FDA clearance [5][9] - The facility has the capacity to manufacture over 1,000 CAR T-cell therapy doses per year, supporting ongoing and planned pivotal trials [9][19]

Core Insights - Lyell Immunopharma, Inc. is advancing a pipeline of next-generation CAR T-cell therapies for cancer patients, with new clinical data for LYL314 to be presented at the ICML 2025 [1][2] - LYL314 is a dual-targeting CD19/CD20 CAR T-cell product candidate specifically for aggressive large B-cell lymphoma, having received FDA designations for advanced therapy and fast track [2] Company Overview - Lyell is a clinical-stage company focused on CAR T-cell therapies for hematologic malignancies and solid tumors, employing technologies to enhance CAR T-cell durability and efficacy in challenging tumor environments [3] Presentation Details - The presentation on LYL314 will occur on June 18, 2025, at 5:40 pm CEST, featuring Dr. Akil Merchant from Cedars-Sinai Medical Center [5]