Summary of IO Biotech FY Conference Call Company Overview - **Company**: IO Biotech (NasdaqGS: IOBT) - **Focus**: Development of SilentBio™, an immune modulatory cancer vaccine targeting advanced melanoma and other cancers Key Industry Insights - **Market Opportunity**: The market for first-line advanced melanoma is significant, with 15,000 new diagnoses annually in the US and a growth rate of 9% per year, representing a billion-dollar opportunity [4][11] - **Unmet Need**: 50% of patients treated with current standard care do not benefit, highlighting the need for better treatment options [4][11] Core Product Insights - **SilentBio™**: - Combination of IO102 and IO103, showing promising results in clinical trials - Demonstrated a median progression-free survival (PFS) of 19.4 months compared to 11.0 months for the control group [3][7] - Hazard ratio of 0.77 and a p-value of 0.056, indicating a near statistical significance [3][7] - Improved PFS observed across all pre-specified subgroups without added systemic toxicity [3][9] Clinical Trial Results - **Phase 3 Trial**: - Conducted in over 100 centers globally with 407 patients enrolled [6][7] - Notable results include: - Median PFS of 24.8 months for patients without prior anti-PD-1 exposure [8] - Dramatic PFS improvement in PD-L1 negative patients, with 16.6 months versus 3 months in the control group [8] - Overall survival (OS) trends favoring the combination arm, with a hazard ratio of 0.79 [9][10] Regulatory and Market Readiness - **FDA Engagement**: - Preparing for a Biologics License Application (BLA) submission by the end of 2025 [4][16] - Discussions with the FDA are ongoing, with a meeting scheduled for Q3 2025 [4][20] - **Manufacturing and Distribution**: - Secured supply chain and commercial-scale manufacturing in place [5][11] Future Pipeline and Expansion - **Additional Trials**: - Two Phase 2 trials for SilentBio™ in lung and head and neck cancers are underway [13] - Plans to expand into earlier clinical stages and other indications [16][17] - **New Targets**: - Development of IO112 (arginase) and IO170 (TGF-beta) for broader indications [15][17] Financial Position - **Cash Reserves**: - Cash balance of $28 million as of Q2 2025, sufficient to fund operations into Q1 2026 [20] Conclusion - IO Biotech is positioned to potentially set a new standard in the treatment of advanced melanoma with SilentBio™, backed by promising clinical data and a robust pipeline for future growth [11][12]