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

Core Insights - IO Biotech reported significant advancements in its cancer therapy pipeline, particularly with the Phase 3 trial results for Cylembio, an immune-modulatory cancer vaccine for advanced melanoma [2][6][7] - The company plans to engage with the FDA regarding the trial results and potential submission of a Biologics License Application (BLA) [2][6] Recent Business Highlights - The company achieved clinical improvement in progression-free survival (PFS) in the Phase 3 trial of Cylembio combined with KEYTRUDA, although statistical significance was narrowly missed [6][7] - IO Biotech ended Q2 2025 with approximately $28.1 million in cash and cash equivalents, expecting this to fund operations into Q1 2026 [6][12] - Upcoming presentations at the Morgan Stanley Global Healthcare Conference and H.C. Wainwright Global Investment Conference are scheduled for September 2025 [6][7] Financial Results - For Q2 2025, IO Biotech reported a net loss of $26.2 million, compared to a net loss of $20.7 million in Q2 2024 [5][12] - Research and development expenses increased to $16.7 million in Q2 2025 from $15.8 million in Q2 2024, while general and administrative expenses rose to $6.5 million from $5.7 million in the same period [12][20] - The total comprehensive loss for Q2 2025 was $26.4 million, compared to $20.8 million in Q2 2024 [20] Clinical Trials Overview - The pivotal Phase 3 trial (IOB-013/KN-D18) enrolled 407 patients and evaluated Cylembio in combination with KEYTRUDA against KEYTRUDA alone for advanced melanoma [10][11] - The company is also conducting two Phase 2 trials: IOB-022/KN-D38 for advanced solid tumors and IOB-032/PN-E40 for resectable squamous cell carcinoma and melanoma [11][13] - Initial data from the ongoing Phase 2 trials is expected in the second half of 2025 [7][10] Company Background - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its T-win platform [14] - The company is headquartered in Copenhagen, Denmark, with a US office in New York [14]