Instil Bio(TIL) - 2025 Q2 - Quarterly Results

Report Overview Q2 2025 Financial Results and Corporate Update Instil Bio reported Q2 2025 financial results, highlighting US IND approval for AXN-2510/IMM2510 ('2510') and upcoming clinical trial initiation - US IND for AXN-2510/IMM2510 ('2510') has been approved, with US clinical trials expected to commence by late 2025[1] - ImmuneOnco will present updated data on '2510 monotherapy for squamous non-small cell lung cancer at the IASLC 2025 World Lung Cancer Conference[1] - Instil Bio is a clinical-stage biopharmaceutical company focused on developing novel therapies[1] Recent Corporate and Clinical Highlights Key Milestones Achieved Instil Bio achieved key corporate and clinical milestones, including a new CMO appointment, FDA IND approval for '2510, and preliminary Phase II data for '2510 in NSCLC - In June 2025, Jamie Freedman, M.D., Ph.D. was appointed Chief Medical Officer[6] - In July 2025, the IND application for '2510 received US FDA approval[6] - In July 2025, partner ImmuneOnco announced preliminary safety and efficacy data from its Phase II study of '2510 combined with chemotherapy for advanced non-small cell lung cancer[6] - In August 2025, ImmuneOnco announced its abstract was accepted by the IASLC 2025 World Lung Cancer Conference, providing updated results for '2510 monotherapy in relapsed/refractory squamous non-small cell lung cancer[6] Financial Performance Analysis Financial Position and Liquidity Instil Bio's cash and investments decreased to $103.6 million by June 30, 2025, but are projected to fund operations beyond 2026 Selected Condensed Consolidated Balance Sheet Data ($ thousand) | Metric | June 30, 2025 | December 31, 2024 | | :----------------------------------------------------------------- | :------------- | :-------------- | | Cash, cash equivalents, restricted cash, marketable securities, and long-term investments | $103,632 | $115,145 | | Total assets | $230,986 | $263,567 | | Total liabilities | $99,316 | $94,131 | | Total stockholders' equity | $131,670 | $169,436 | - The company expects its cash, cash equivalents, marketable securities, and long-term investments as of June 30, 2025, to support its operating plan beyond 2026[3] Operating Results and Expenses Instil Bio's operating expenses and net loss significantly increased in Q2 and H1 2025, driven by new in-process R&D and higher R&D costs Condensed Consolidated Statements of Operations Data ($ thousand) | Operating Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------- | :----------------------- | :----------------------- | :----------------------- | :----------------------- | | In-process research and development expense | $10,000 | $— | $10,000 | $— | | Research and development expense | $6,743 | $2,921 | $12,114 | $10,177 | | General and administrative expense | $6,157 | $10,706 | $15,266 | $23,130 | | Restructuring and impairment expense | $540 | $508 | $16,622 | $4,783 | | Total operating expenses | $23,440 | $14,135 | $54,002 | $38,090 | | Operating loss | $(23,440) | $(14,135) | $(54,002) | $(38,090) | | Net loss | $(21,394) | $(14,917) | $(49,594) | $(39,219) | | Net loss per share (basic and diluted) | $(3.24) | $(2.29) | $(7.55) | $(6.03) | - In-process research and development expense was $10 million for both Q2 and H1 2025, compared to zero in the corresponding periods of 2024[4][17] - Research and development expense increased to $6.7 million in Q2 2025 (from $2.9 million in Q2 2024) and to $12.1 million in H1 2025 (from $10.2 million in H1 2024)[4][17] - General and administrative expense decreased to $6.2 million in Q2 2025 (from $10.7 million in Q2 2024) and to $15.3 million in H1 2025 (from $23.1 million in H1 2024)[5][17] GAAP and Non-GAAP Net Loss Analysis Instil Bio's GAAP net loss and EPS increased, with non-GAAP metrics adjusted for non-cash stock-based compensation and restructuring expenses Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss Per Share ($ thousand, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :----------------------- | :----------------------- | :----------------------- | :----------------------- | | Net loss (GAAP) | $(21,394) | $(14,917) | $(49,594) | $(39,219) | | Adjustments: | | | | | | Non-cash stock-based compensation expense | $1,824 | $4,173 | $5,319 | $8,688 | | Restructuring and impairment expense | $540 | $508 | $16,622 | $4,783 | | Non-GAAP net loss | $(19,030) | $(10,236) | $(27,653) | $(25,748) | | Net loss per share (GAAP) | $(3.24) | $(2.29) | $(7.55) | $(6.03) | | Adjustments (per share): | | | | | | Non-cash stock-based compensation expense | $0.28 | $0.64 | $0.81 | $1.34 | | Restructuring and impairment expense | $0.08 | $0.08 | $2.53 | $0.74 | | Non-GAAP net loss per share | $(2.88) | $(1.57) | $(4.21) | $(3.95) | - Non-GAAP financial measures (non-GAAP net loss and non-GAAP net loss per share) are calculated by excluding non-cash stock-based compensation and restructuring and impairment expenses to provide a more complete understanding of operating performance[9] Additional Company Information Company Profile Instil Bio is a clinical-stage biopharmaceutical company developing novel therapies, with AXN-2510 as its lead asset for solid tumors - Instil Bio is a clinical-stage biopharmaceutical company focused on developing novel therapies[10] - The company's lead asset, AXN-2510, is a novel PD-L1xVEGF bispecific antibody being developed for multiple solid tumors[10] Forward-Looking Statements and Risks Forward-looking statements regarding AXN-2510/IMM2510's potential and clinical development are subject to significant risks, including high development costs and regulatory uncertainties - Forward-looking statements involve the therapeutic potential of AXN-2510/IMM2510, clinical development (including clinical trial initiation and data generation), R&D plans, and Instil's capital position and cash flow[11] - Risks and uncertainties include the costly and time-consuming nature of drug product development, uncertainty of clinical success, reliance on partners and third parties, regulatory approval risks, macroeconomic conditions, and the sufficiency of Instil's cash resources[11][12] Investor Relations Contact Investor relations contact information is provided for inquiries, including phone and email details - Investor Relations contact information: Phone 1-972-499-3350, Email investorrelations@instilbio.com[13]