IO Biotech(IOBT) - 2025 Q1 - Quarterly Results

IO Biotech Q1 2025 Financial Results and Business Highlights Business Highlights and Strategic Outlook IO Biotech advanced its pivotal Phase 3 Cylembio® trial for melanoma, preparing for 2025 BLA submission and 2026 U.S. launch, while securing EIB financing - Primary focus on delivering Phase 3 data for Cylembio®, preparing for BLA submission, and commercialization planning[3] - Pivotal Phase 3 trial (IOB-013/KN-D18) for advanced melanoma expects PFS readout in Q3 2025[2][4][5] - BLA submission to FDA planned for 2025, with potential U.S. launch for Cylembio® in 2026[4] - In May 2025, €10.0 million (tranche A) drawn from EIB loan facility[9] - Recognized by Fast Company as one of the World's Most Innovative Companies of 2025[5][9] Clinical Pipeline Update IO Biotech's pipeline, centered on Cylembio®, includes a fully enrolled pivotal Phase 3 melanoma trial and two Phase 2 basket trials with data expected H2 2025 Pivotal Phase 3 Trial (IOB-013/KN-D18) The Phase 3 trial evaluates Cylembio® with pembrolizumab in 407 advanced melanoma patients, targeting PFS as primary endpoint with Q3 2025 data - Patient Population: 407 patients with previously untreated, unresectable or metastatic (advanced) melanoma[13] - Primary Endpoint: Progression-Free Survival (PFS)[13] - Expected Readout: Top-line data anticipated in Q3 2025[13] Phase 2 Solid Tumor Basket Trials Two Phase 2 basket trials, IOB-022 and IOB-032, are fully enrolled, investigating Cylembio® in NSCLC, SCCHN, and melanoma, with data expected H2 2025 - IOB-022/KN-D38 investigates Cylembio® plus pembrolizumab in first-line metastatic NSCLC and SCCHN[14] - IOB-032/PN-E40 enrollment completed in January 2025, investigating neo-adjuvant/adjuvant treatment in resectable SCCHN and melanoma[9][15] - Data from both Phase 2 trials (IOB-032 initial, IOB-022 longer-term) expected in H2 2025[9] Financial Performance First Quarter 2025 Financial Results IO Biotech reported a net loss of $22.4 million in Q1 2025 due to increased expenses, ending with $37.1 million cash, projecting runway into Q2 2026 Q1 2025 Key Financial Metrics (vs. Q1 2024) | Financial Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Loss (Millions USD) | $22.4 | $19.5 | | R&D Expenses (Millions USD) | $16.4 | $14.3 | | G&A Expenses (Millions USD) | $6.2 | $5.9 | | Net Loss Per Share (USD) | $0.34 | $0.30 | Cash Position | Metric | As of Mar 31, 2025 (Millions USD) | As of Dec 31, 2024 (Millions USD) | | :--- | :--- | :--- | | Cash and Cash Equivalents | $37.1 | $60.0 | - Current cash, supplemented by first three tranches of EIB loan facility, expected to fund operations into Q2 2026[10] Consolidated Financial Statements Consolidated financial statements show a net loss of $22.4 million for Q1 2025, with total assets of $45.7 million and equity of $26.4 million as of March 31, 2025 Consolidated Statements of Operations and Comprehensive Loss Total operating expenses reached $22.6 million for Q1 2025, resulting in a net loss of $22.4 million or $0.34 per share Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | 2025 (Thousands USD) | 2024 (Thousands USD) | | Operating Expenses | | | | Research and development | $16,375 | $14,311 | | General and administrative | $6,209 | $5,886 | | Total operating expenses | $22,584 | $20,197 | | Loss from operations | ($22,584) | ($20,197) | | Net loss | ($22,421) | ($19,457) | | Net loss per common share (USD) | ($0.34) | ($0.30) | Consolidated Balance Sheets As of March 31, 2025, total assets were $45.7 million, with total liabilities of $19.3 million and stockholders' equity of $26.4 million Consolidated Balance Sheet Highlights (in thousands) | | March 31, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $37,086 | $60,031 | | Total current assets | $42,342 | $64,951 | | Total assets | $45,736 | $67,699 | | Liabilities & Equity | | | | Total current liabilities | $18,286 | $19,486 | | Total liabilities | $19,314 | $20,684 | | Total stockholders' equity | $26,422 | $47,015 |