IO Biotech Reports Third Quarter 2025 Financial Results and Provides Business Highlights

Core Insights - IO Biotech is focused on developing novel immune-modulatory, off-the-shelf cancer therapies targeting various tumors, including melanoma, lung, and head and neck cancers [2][15] - The IOB-013 study showed improvements in progression-free survival (PFS) but narrowly missed statistical significance on the primary endpoint, which the company believes has de-risked the program [2][5] - The company plans to discuss the next Phase 3 study design for Cylembio with the FDA in December 2025 [2][5] Recent Business Highlights - The company presented topline data from the Phase 3 clinical trial (IOB-013) at the ESMO congress, indicating clinically relevant improvements in PFS across various subgroups [5][6] - A meeting with the FDA is scheduled for December to align on the design of a potential new Phase 3 registrational trial for IO102-IO103 in advanced melanoma [5][6] - Pre-clinical data for additional candidates targeting arginase 1 and TGF-β were presented at the SITC Annual Meeting [5][6] Financial Results - For Q3 2025, total operating expenses were $19.4 million, down from $26.5 million in Q3 2024 [12][20] - Research and development expenses decreased to $13.7 million from $20.2 million year-over-year [12][20] - Cash and cash equivalents as of September 30, 2025, were approximately $31 million, expected to support operations through Q1 2026 [5][12] Clinical Trials Overview - The IOB-013/KN-D18 trial evaluated Cylembio in combination with Merck's KEYTRUDA in 407 patients with advanced melanoma, with enrollment completed by December 2023 [11][12] - The primary endpoint of the trial was progression-free survival, with secondary endpoints including overall response rate and safety [11][13] - The company is also conducting a Phase 2 basket trial (IOB-022/KN-D38) for advanced non-small cell lung cancer and head and neck cancer [14]