IO Biotech Reports $95.5 Million Net Loss for 2024, Highlights Clinical Trial Progress

IO Biotech, Inc. reported a net loss of $95.5 million for the year ended December 31, 2024, compared to a net loss of $86.1 million in 2023. The company's research and development expenses increased by $3.7 million to $71.5 million in 2024, primarily due to increased clinical trial activities for Cylembio®, its lead therapeutic cancer vaccine candidate, and higher personnel costs. This increase was partially offset by a decrease in chemistry, manufacturing, and control costs. General and administrative expenses remained relatively flat at $23.7 million. Other income (expense), net decreased significantly to $1.1 million in 2024 from $6.2 million in 2023, primarily due to lower interest income and unfavorable foreign currency exchange rates.

Significant developments during the year included the completion of enrollment in the Phase 3 IOB-013/KN-D18 trial for Cylembio® in combination with pembrolizumab for advanced melanoma, ahead of schedule with 407 patients enrolled. The company also completed enrollment in its Phase 2 IOB-022/KN-D38 basket trial investigating Cylembio® in non-small cell lung cancer and squamous cell carcinoma of the head and neck. Positive results from the SCCHN cohort of this trial were presented at the European Society for Medical Oncology conference. Furthermore, IO Biotech initiated a Phase 2 IOB-032/PN-E40 basket trial evaluating Cylembio® in a perioperative setting, completing enrollment ahead of schedule in January 2025. Preclinical development continued for IO112, targeting Arginase 1, with an anticipated IND filing in 2025.

The company's financial position as of December 31, 2024, showed $60.0 million in cash and cash equivalents. The company anticipates that its existing cash resources will be sufficient to fund operations into the second quarter of 2026, assuming the drawdown of committed tranches from its term loan facility with the European Investment Bank. To fund operations beyond this period, IO Biotech will need to secure additional funding. The company's workforce totaled 80 full-time employees as of December 31, 2024, with 29 holding Ph.D. or M.D. degrees.

IO Biotech's strategy focuses on advancing Cylembio® toward approval, broadening its clinical development into other solid tumor settings, leveraging its T-win® platform to develop a portfolio of product candidates, and strengthening its position in the immunotherapy field through collaborations. The company expects the readout of the primary endpoint (PFS) in the IOB-013/KN-D18 trial in the third quarter of 2025, with plans to submit a Biologics License Application to the FDA in 2025 and potentially launch Cylembio® in the U.S. in 2026. The company also highlighted numerous risks associated with its business, including those related to its limited operating history, financial position, capital requirements, clinical development, regulatory approvals, manufacturing, commercialization, reliance on third parties, competition, intellectual property, and compliance with various laws and regulations. A material weakness in internal control over financial reporting was identified, and the company is actively working on remediation.