Lyell(LYEL) - 2025 Q1 - Quarterly Results

Business Highlights Lyell Immunopharma reported significant progress in its clinical development for the first quarter of 2025, primarily centered on its lead CAR T-cell therapy candidate, LYL314 - The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to LYL314 for treating relapsed/refractory diffuse large B-cell lymphoma (LBCL) in the third- or later-line setting[2][5][6] - Manufacturing of LYL314 clinical supply has been successfully transferred to Lyell's LyFE Manufacturing Center following FDA clearance of an IND amendment[3][6][9] - Lyell plans to initiate a pivotal trial for LYL314 in third- or later-line LBCL by mid-2025 and a second pivotal trial in the second-line setting by early 2026[3][6] - New clinical data for LYL314, including more mature third-line and initial second-line data, will be presented at the International Conference on Malignant Lymphoma in June 2025[3][6][9] LYL314 Program Updates LYL314 is a next-generation CAR T-cell product candidate designed to improve response rates and durability for LBCL - LYL314 is a next-generation, autologous, dual-targeting (CD19/CD20) CAR T-cell product candidate designed to improve response rates and durability compared to existing CD19-targeted therapies for LBCL[2][5] - Initial data from a Phase 1/2 trial presented in December 2024 showed a 94% overall response rate (ORR) and a 71% complete response (CR) rate in 17 efficacy-evaluable patients[9] - In a safety population of 23 patients, LYL314 was well-tolerated, with no Grade 3 or greater cytokine release syndrome (CRS) reported. Grade 3 ICANS occurred in 13% of patients and resolved quickly[9] Preclinical Pipeline and Manufacturing The company's preclinical pipeline focuses on fully-armed CAR T-cell candidates and robust manufacturing capabilities - The preclinical pipeline focuses on fully-armed CAR T-cell candidates designed to overcome T-cell exhaustion and the hostile tumor microenvironment in solid tumors[7] - The first Investigational New Drug (IND) application for a fully-armed CAR T-cell product candidate targeting solid tumors is expected in 2026[9] - The LyFE Manufacturing Center has the capacity to produce over 1,000 CAR T-cell therapy doses per year, sufficient for pivotal trials and potential commercial launch[9] Financial Results For Q1 2025, Lyell reported a GAAP net loss of $52.2 million, a decrease from Q1 2024, with $330.1 million cash expected to fund operations into 2027 Financial Performance Summary Key financial metrics for Q1 2025 show a reduced net loss and stable operating expenses Q1 2025 Key Financial Metrics (GAAP) | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | | :--- | :--- | :--- | :--- | | Net Loss | $52.2 | $60.7 | Decreased $8.5 | | R&D Expenses | $43.4 | $43.2 | Increased $0.2 | | G&A Expenses | $14.0 | $13.5 | Increased $0.5 | - The decrease in net loss was primarily driven by a $13.0 million impairment expense recognized in Q1 2024 that did not recur in Q1 2025[8] - Cash, cash equivalents, and marketable securities totaled $330.1 million as of March 31, 2025, which is expected to fund operations into 2027[6][12] Net Loss Comparison (in millions) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | GAAP Net Loss | $(52.2) | $(60.7) | | Non-GAAP Net Loss | $(46.3) | $(37.5) | Operating Expenses Comparison (in millions) | Expense Category | Q1 2025 (GAAP) | Q1 2024 (GAAP) | Q1 2025 (Non-GAAP) | Q1 2024 (Non-GAAP) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $43.4 | $43.2 | $41.1 | $38.9 | | G&A Expenses | $14.0 | $13.5 | $10.4 | $8.1 | - The increase in R&D expenses was mainly due to a $3.1 million rise in personnel costs, including severance from a facility closure[15] - The increase in G&A expenses was driven by a $2.4 million rise in personnel costs from higher headcount and severance expenses[15] - Cash, cash equivalents, and marketable securities decreased from $383.5 million at year-end 2024 to $330.1 million at the end of Q1 2025[12][18] Selected Consolidated Financial Data Detailed unaudited financial statements provide a comprehensive view of the company's Q1 2025 performance and balance sheet Unaudited Selected Consolidated Statement of Operations Data (in thousands) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | 2025 | 2024 | | Revenue | $7 | $3 | | Total operating expenses | $57,374 | $55,578 | | Loss from operations | $(57,367) | $(55,575) | | Net loss | $(52,195) | $(60,667) | Unaudited Selected Balance Sheet Data (in thousands) | | As of March 31, 2025 | As of December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $330,126 | $383,541 | | Total assets | $429,798 | $490,859 | | Total stockholders' equity | $336,521 | $382,824 | Non-GAAP Financial Measures and Reconciliations Non-GAAP financial measures provide a clearer view of core operational performance by excluding specific non-cash items - The company uses non-GAAP measures to enhance comparability by excluding non-cash items like stock-based compensation, changes in fair value of success payment liabilities, and non-cash investment charges[19] Reconciliation of GAAP to Non-GAAP Net Loss (in thousands) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | 2025 | 2024 | | Net loss - GAAP | $(52,195) | $(60,667) | | Stock-based compensation expense | $6,024 | $9,155 | | Impairment of other investments | — | $13,001 | | Net loss - Non-GAAP | $(46,296) | $(37,543) | Reconciliation of GAAP to Non-GAAP R&D and G&A Expenses (in thousands) | Expense | GAAP (Q1 2025) | Non-GAAP (Q1 2025) | GAAP (Q1 2024) | Non-GAAP (Q1 2024) | | :--- | :--- | :--- | :--- | :--- | | R&D | $43,447 | $41,059 | $43,174 | $38,857 | | G&A | $14,046 | $10,410 | $13,494 | $8,131 |