Lyell(LYEL) - 2025 Q2 - Quarterly Report

Special Note Regarding Forward-Looking Statements This section highlights forward-looking statements in the 10-Q report, subject to risks and uncertainties that could cause actual results to differ materially Overview of Forward-Looking Statements This section highlights forward-looking statements in the 10-Q report, subject to risks and uncertainties that could cause actual results to differ materially - The report contains forward-looking statements about future results, financial position, business strategy, product candidates, clinical trials, R&D costs, regulatory approvals, and commercialization plans[12] - These statements involve known and unknown risks, uncertainties, and other important factors that may cause actual results to be materially different from those expressed or implied[12] - Key forward-looking statements include the sufficiency of cash to fund operations, accuracy of expense estimates, scope and results of LYL314 development, timing of regulatory approvals, commercialization plans, market opportunities, reliance on third parties, and intellectual property protection[13][16] PART I—FINANCIAL INFORMATION This part presents the unaudited condensed consolidated financial statements and management's discussion and analysis Item 1. Financial Statements (unaudited) This section presents Lyell Immunopharma's unaudited condensed consolidated financial statements, including balance sheets, operations, equity, cash flows, and detailed notes Condensed Consolidated Balance Sheets Balance sheets show decreased total assets and equity from December 2024 to June 2025, due to reduced marketable securities and increased accumulated deficit Balance Sheet Summary (in thousands) | ASSETS (in thousands) | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :---------------- | | Cash and cash equivalents | $98,804 | $105,597 | | Marketable securities | $177,986 | $264,930 | | Total current assets | $282,214 | $379,594 | | Total assets | $385,453 | $490,859 | | LIABILITIES AND STOCKHOLDERS' EQUITY (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------------------------- | :------------ | :---------------- | | Total current liabilities | $36,903 | $53,788 | | Total liabilities | $86,530 | $108,035 | | Total stockholders' equity | $298,923 | $382,824 | | Accumulated deficit | $(1,439,985) | $(1,345,106) | - Total assets decreased by approximately $105.4 million from December 31, 2024, to June 30, 2025, primarily due to a reduction in marketable securities[19] - Total stockholders' equity decreased by approximately $83.9 million, largely driven by an increase in accumulated deficit[19] Condensed Consolidated Statements of Operations and Comprehensive Loss The company reported a reduced net loss for Q2 and YTD June 2025, driven by lower operating expenses and increased other income, net Statements of Operations and Comprehensive Loss Summary (in thousands, except per share amounts) | (in thousands, except per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $8 | $13 | $15 | $16 | | Research and development | $34,857 | $40,261 | $78,304 | $83,435 | | General and administrative | $9,786 | $12,256 | $23,832 | $25,750 |\ | Total operating expenses | $47,148 | $51,541 | $104,522 | $107,119 | | Net loss | $(42,684) | $(45,809) | $(94,879) | $(106,476) | | Net loss per common share, basic and diluted | $(2.89) | $(3.59) | $(6.42) | $(8.36) | - Net loss for the three months ended June 30, 2025, was $(42.7) million, a decrease from $(45.8) million in the prior year period[24] - Net loss for the six months ended June 30, 2025, was $(94.9) million, an improvement from $(106.5) million in the prior year period, driven by lower operating expenses and higher other income, net[24] Condensed Consolidated Statements of Stockholders' Equity Stockholders' equity decreased from December 2024 to June 2025 due to net loss, partially offset by stock-based compensation; a 1-for-20 reverse stock split was effected Stockholders' Equity Summary (in thousands) | (in thousands) | Balance as of Dec 31, 2024 | Net Loss | Stock-based Compensation | Issuance of Common Stock | Balance as of Jun 30, 2025 | | :------------- | :------------------------- | :------- | :----------------------- | :----------------------- | :------------------------- | | Total Stockholders' Equity | $382,824 | $(94,879) | $11,028 | $184 | $298,923 | - Total stockholders' equity decreased from $382.8 million at December 31, 2024, to $298.9 million at June 30, 2025[27] - The company effected a 1-for-20 reverse stock split on May 30, 2025, retroactively adjusting all historical per share data and share counts[41] Condensed Consolidated Statements of Cash Flows Net cash used in operating activities increased for the six months ended June 30, 2025, while cash provided by investing activities also increased due to marketable securities maturities Cash Flows Summary (in thousands) | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :----------------------------- | :----------------------------- |\ | Operating activities | $(89,196) | $(80,110) | | Investing activities | $82,113 | $67,001 | | Financing activities | $184 | $889 | | Net decrease in cash, cash equivalents and restricted cash | $(6,899) | $(12,220) | | Cash, cash equivalents and restricted cash at end of period | $100,388 | $133,711 | - Net cash used in operating activities was $89.2 million for the six months ended June 30, 2025, compared to $80.1 million in the prior year, reflecting a higher net loss and a decrease in accrued liabilities[188][189] - Net cash provided by investing activities increased to $82.1 million in 2025 from $67.0 million in 2024, primarily due to net maturities and purchases of marketable securities[190] Notes to Unaudited Condensed Consolidated Financial Statements The notes provide detailed explanations of the company's financial statements, covering organization, accounting policies, contingent liabilities, and recent events 1. Organization Lyell Immunopharma is a late-stage clinical cell therapy company developing next-generation autologous CAR T-cell product candidates for hematologic malignancies and solid tumors, with LYL314 as its lead - Lyell Immunopharma, Inc. is a late-stage clinical cell therapy company developing proprietary next-generation autologous CAR T-cell product candidates[37] - The lead product candidate, LYL314, is a dual-targeting CD19/CD20 CAR T-cell therapy in a pivotal clinical trial for large B-cell lymphoma (3L+) and a Phase 1/2 study (2L)[37] 2. Summary of Significant Accounting Policies This section outlines the basis of presentation for the unaudited condensed consolidated financial statements, detailing the 1-for-20 reverse stock split and affirming liquidity for the next 12 months - The company effected a **1-