Lyell(LYEL) - 2024 Q1 - Quarterly Results

Business Highlights and Pipeline Update Lyell Immunopharma advanced its T-cell therapy pipeline in Q1 2024, anticipating key clinical data readouts and IND submissions, backed by a strong cash position - The company's strong cash position of $526.3 million is expected to fund operations through multiple clinical milestones into 2027[3][6] - Lyell is advancing four wholly-owned product candidates: LYL797 and LYL845 are in Phase 1 clinical development, while LYL119 and a second-generation TIL product are in preclinical development[4] - Key upcoming milestones include initial clinical data for LYL797 this quarter, initial data for LYL845 in the second half of 2024, and an IND submission for LYL119 this quarter[6] LYL797 Program The Phase 1 clinical trial for LYL797, a ROR1-targeted CAR T-cell therapy, is enrolling patients with TNBC and NSCLC, with initial data expected this quarter - The Phase 1 trial for LYL797 is currently enrolling patients with relapsed or refractory TNBC or NSCLC[7] - Initial clinical and translational data from at least 20 patients in the Phase 1 trial are expected to be shared this quarter[7] LYL845 Program The Phase 1 clinical trial for LYL845, an epigenetically enhanced TIL product, is enrolling patients across multiple solid tumors, with initial data anticipated in H2 2024 - The Phase 1 trial for LYL845 is enrolling patients with relapsed or refractory metastatic or locally advanced melanoma, NSCLC, and colorectal cancer[7] - Initial clinical and translational data from the LYL845 trial are expected in the second half of 2024[7] LYL119 Program LYL119, a next-generation ROR1-targeted CAR T-cell product, is on track for IND submission this quarter, showing reduced T-cell exhaustion in preclinical models - An Investigational New Drug (IND) application for LYL119 is expected to be submitted this quarter[7] - LYL119 incorporates four novel genetic and epigenetic reprogramming technologies: c-Jun overexpression, NR4A3 knockout, Epi-R manufacturing, and Stim-R T-cell activation[7] - At the AACR Annual Meeting 2024, nonclinical data showed LYL119 had reduced T-cell exhaustion, enhanced function, and sustained antitumor activity in a mouse xenograft model compared to CAR T cells with fewer reprogramming technologies[8] First Quarter Financial Results Lyell reported a reduced GAAP net loss of $60.7 million and Non-GAAP net loss of $37.5 million in Q1 2024, maintaining a strong cash position Q1 2024 Key Financials | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | GAAP Net Loss | ($60.7 million) | ($67.0 million) | | Non-GAAP Net Loss | ($37.5 million) | ($44.8 million) | Cash Position | Date | Cash, Cash Equivalents and Marketable Securities (in millions) | | :--- | :--- | | March 31, 2024 | $526.3 | | December 31, 2023 | $562.7 | Operating Expenses Operating expenses decreased in Q1 2024, with R&D at $43.2 million and G&A at $13.5 million, primarily due to reduced personnel costs R&D Expenses (in millions) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | GAAP R&D | $43.2 | $44.6 | | Non-GAAP R&D | $38.9 | $40.6 | G&A Expenses (in millions) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | GAAP G&A | $13.5 | $19.3 | | Non-GAAP G&A | $8.1 | $10.0 | - The decrease in both R&D and G&A expenses was primarily driven by a reduction in personnel-related expenses associated with the November 2023 reduction in workforce[12] Consolidated Financial Statements Unaudited consolidated financial statements for Q1 2024 show a loss from operations of $55.6 million and total assets of $694.2 million Statement of Operations Data (Unaudited, in thousands) | Line Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Total operating expenses | $55,578 | $62,621 | | Loss from operations | $(55,575) | $(62,556) | | Net loss | $(60,667) | $(66,959) | Balance Sheet Data (Unaudited, in thousands) | Line Item | As of March 31, 2024 | As of December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $526,300 | $562,729 | | Total assets | $694,220 | $750,029 | | Total stockholders' equity | $603,157 | $654,952 | Non-GAAP Financial Measures and Reconciliations Reconciliations of GAAP to Non-GAAP financial measures are provided, with Q1 2024 Non-GAAP net loss at $37.5 million excluding non-cash items Reconciliation of GAAP to Non-GAAP Net Loss (in thousands) | Line Item | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net loss - GAAP | $(60,667) | $(66,959) | | Impairment of other investments | $13,001 | $10,000 | | Stock-based compensation expense | $9,155 | $13,882 | | Change in fair value of success payment liabilities | $968 | $(1,708) | | Net loss - Non-GAAP | $(37,543) | $(44,785) | Corporate Information and Forward-Looking Statements Lyell Immunopharma is a clinical-stage T-cell reprogramming company focused on solid tumor therapies, with forward-looking statements subject to inherent risks - Lyell is a clinical-stage T-cell reprogramming company developing cell therapies for solid tumors, with a focus on overcoming T-cell exhaustion and lack of durable stemness[13] - The company is currently enrolling two Phase 1 clinical trials for a ROR1-targeted CAR T-cell therapy and a reprogrammed TIL therapy[13] - The report includes forward-looking statements concerning business plans, clinical trial progress, and financial runway, which are subject to risks detailed in SEC filings[14]