IO Biotech, Inc. SEC 10-Q Report

IO Biotech, Inc. released its Q3 2025 10-Q report, highlighting a decrease in operating expenses and net loss compared to 2024. The company is advancing its T-win® platform and clinical trials, despite the FDA's recommendation against a BLA submission based on current data. IO Biotech is restructuring, reducing its workforce by 50%, and focusing on new studies and ongoing trials. The report underscores progress in clinical programs and operational strategies.

IO Biotech, Inc., a biotechnology company focused on the development of immune-modulating cancer therapies, has released its Form 10-Q report for the third quarter of 2025. The report provides a comprehensive overview of the company's financial performance and key business developments, highlighting both the progress and challenges faced in its ongoing clinical trials and operational strategies.

Financial Highlights

For the nine months ended September 30, 2025, IO Biotech, Inc. reported the following financial metrics:

Total Operating Expenses: $65.1 million, a decrease from $68.2 million for the same period in 2024, reflecting cost reduction measures.
Loss from Operations: $(65.1) million, compared to $(68.2) million for the same period in 2024, indicating a slight improvement in operational efficiency.
Net Loss: $(57.0) million, compared to $(64.2) million for the same period in 2024, showing a reduction in net loss due to improved cost management.
Net Loss Per Common Share, Basic and Diluted: $(0.86), compared to $(0.97) for the same period in 2024, reflecting a decrease in net loss per share.

Business Highlights

IO Biotech, Inc. has made significant strides in its clinical and preclinical programs, as well as in its operational strategies:

T-win® Platform: The company is advancing its T-win® platform, designed to activate T cells to target immunosuppressive mechanisms in the tumor microenvironment. This platform is central to the development of therapeutic cancer vaccines.
Phase 3 IOB-013/KN-D18 Trial: Completed enrollment of 407 patients in its Phase 3 trial for IO102-IO103 in combination with pembrolizumab for advanced melanoma. The trial showed clinical improvement in progression-free survival, although statistical significance was narrowly missed.
Phase 2 IOB-022/KN-D38 Basket Trial: Investigating IO102-IO103 in combination with pembrolizumab across multiple solid tumor indications. The trial has shown promising results in NSCLC and SCCHN, with encouraging progression-free survival and disease control rates.
Phase 2 IOB-032/PN-E40 Basket Trial: Initiated a trial to evaluate IO102-IO103 in combination with pembrolizumab in a perioperative setting for melanoma and SCCHN. Enrollment has been completed ahead of schedule, with data expected in 2026.
Preclinical Development: Advancing IO112, targeting Arginase 1, and IO170, targeting TGFβ, with promising preclinical data. An IND for IO112 is anticipated in 2026, and IND-enabling studies for IO170 are ongoing.
Recent Developments: The FDA recommended against submitting a BLA based on current Phase 3 trial data. The company plans to discuss potential new registrational studies with the FDA and European regulators.
Restructuring and Workforce Reduction: In response to recent trial outcomes, IO Biotech is implementing a restructuring plan to conserve capital, including a 50% reduction in workforce.
Future Outlook: The company is focused on aligning with regulatory bodies for potential new studies and continuing its ongoing trials, with a strategic emphasis on advancing its T-win® platform and pipeline.

SEC Filing: IO Biotech, Inc. [ IOBT ] - 10-Q - Nov. 14, 2025