IO Biotech Phase 3 Cylembio trial misses statistical significance; PFS improved 19.4 vs 11.0 mo

IO Biotech, Inc.

Primary endpoint PFS HR=0.77 (CI 0.58-1.00), p=0.056, missed significance threshold p≤0.045.
Median PFS 19.4 months (Cylembio+pembrolizumab) vs 11.0 months (pembrolizumab alone).
PD-L1 negative subgroup median PFS 16.6 vs 3.0 months (HR 0.54, nominal p=0.006).
OS trend HR=0.79 (CI 0.57-1.10); company expects OS maturity in 6-9 months.
Estimated cash $28.1M as of June 30, plus €12.5M drawn July 4; runway into Q1 2026.

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