Immunome(IMNM) - 2025 Q2 - Quarterly Results

Corporate and Pipeline Update Immunome provides updates on its Q2 2025 progress, highlighting advancements in clinical programs and pipeline milestones Management Commentary The CEO highlighted significant Q2 2025 progress, with clinical programs advancing towards key milestones and anticipated data releases - Immunome expects to share topline data for the RINGSIDE trial of varegacestat before the end of 2025 and is positioned to support a new drug application[2] - The dose escalation study of IM-1021 (ROR1 ADC) has dosed its third cohort of patients[2] - The company is making progress towards IND submission for three additional ADCs utilizing its proprietary HC74 TOP1 inhibitor payload technology[2] Pipeline Highlights Immunome provided updates across its clinical and preclinical pipeline, including progress for varegacestat, IM-1021, IM-3050, and preclinical ADCs Varegacestat Updates on the Phase 3 RINGSIDE study, including expected topline data and Orphan Drug Designation - Topline data for the Phase 3 RINGSIDE Part B study is expected before the end of 2025[6] - The European Medicines Agency granted Orphan Drug Designation to varegacestat in July 2025, following the FDA's designation in November 2023[6] - Two additional analyses of the Phase 2 RINGSIDE Part A study were presented at the 2025 ASCO Annual Meeting[6] IM-1021 Progress of the Phase 1 clinical trial with patient dosing at the third level - The Phase 1 clinical trial is ongoing, with patients recently dosed at the third dose level, including participants with advanced B-cell lymphomas and solid tumors[4] IM-3050 IND clearance received and anticipated initiation of a Phase 1 clinical trial - Received IND clearance in April 2025 and a Phase 1 clinical trial is expected to be initiated before the end of 2025[4] Preclinical Pipeline Advancement of three preclinical ADCs into IND-enabling work - Three preclinical ADCs (IM-1617, IM-1340, and IM-1335) are currently undergoing IND-enabling work, incorporating the HC74 payload and targeting solid tumors[5] Second Quarter 2025 Financial Results Immunome's financial performance for Q2 2025, including key financial metrics and statements Financial Summary Immunome reported a net loss of $43.4 million in Q2 2025, ending with $268.0 million in cash, expected to fund operations into 2027 Q2 2025 Financial Highlights | Metric | Amount (in millions) | | :--- | :--- | | Cash, Cash Equivalents & Marketable Securities | $268.0 | | Research and Development Expenses | $40.5 | | General and Administrative Expenses | $10.0 | | Net Loss | $43.4 | - The company's current cash position of $268.0 million is expected to fund operations into 2027[10] Condensed Consolidated Balance Sheets Total assets increased to $296.3 million, while total liabilities decreased to $27.0 million, leading to higher stockholders' equity Condensed Consolidated Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total current assets | $277,432 | $221,339 | | Total assets | $296,290 | $240,241 | | Total current liabilities | $22,878 | $54,307 | | Total liabilities | $27,020 | $59,076 | | Total stockholders' equity | $269,270 | $181,165 | Condensed Consolidated Statement of Operations Collaboration revenue increased to $4.0 million, but higher operating expenses led to a net loss of $43.4 million for Q2 2025 Statement of Operations Summary (Unaudited; in thousands, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Collaboration revenue | $4,015 | $2,364 | | Total operating expenses | $50,493 | $42,373 | | Loss from operations | ($46,478) | ($40,009) | | Net loss | ($43,397) | ($36,122) | | Net loss per share, basic and diluted | ($0.50) | ($0.60) | | Weighted-average shares outstanding | 87,010,742 | 59,936,703 | - Total share-based compensation expense increased to $5.3 million in Q2 2025 from $3.2 million in Q2 2024, with increases in both R&D and G&A categories[16] About Immunome & Forward-Looking Statements Information about Immunome's business and a cautionary statement regarding forward-looking information About Immunome, Inc. Immunome is a clinical-stage oncology company developing targeted cancer therapies, including ADCs, a gamma secretase inhibitor, and a radioligand - Immunome is a clinical-stage targeted oncology company developing therapies like ADCs, a gamma secretase inhibitor, and a radioligand[8] - Key pipeline programs include varegacestat (Phase 3), IM-1021 (Phase 1), IM-3050 (IND cleared), and preclinical ADCs IM-1617, IM-1335, and IM-1340[8] Cautionary Statement Regarding Forward-Looking Statements This section cautions that forward-looking statements are subject to risks and uncertainties, which may cause actual results to differ materially - The press release contains forward-looking statements concerning clinical program progress, data release timing, potential drug applications, and expected cash runway[9] - These statements are subject to risks and uncertainties, including regulatory delays, clinical trial failures, and capital requirements, which could cause actual results to differ[9]