Summit submits BLA for ivonescimab in EGFRm NSCLC; $710M cash; GSK collaboration

Summit Therapeutics Inc.

BLA submitted to FDA for ivonescimab + chemo in 2L+ EGFR-mutated NSCLC based on Phase III HARMONi; FDA decision expected Q4 2026.
Preliminary cash, cash equivalents, and short-term investments of ~$710M as of Dec 31, 2025.
Clinical collaboration with GSK to evaluate ivonescimab + risvutatug rezetecan (B7-H3 ADC) across solid tumors; dosing expected mid-2026.
Over 14,000 patients in the US annually eligible for 2L+ treatment of EGFRm NSCLC.

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