Summit plans BLA for ivonescimab in Q4 2025; HARMONi-6 meets endpoint

Summit Therapeutics Inc.

Plans to submit BLA for ivonescimab plus chemotherapy in EGFRm NSCLC in Q4 2025 based on HARMONi study.
HARMONi-6: ivonescimab + chemo reduced risk of progression/death by 40% vs tislelizumab+chemo in 1L squamous NSCLC (HR=0.60, p<0.0001).
HARMONi-3 split into squamous and non-squamous analyses; squamous enrollment completion expected H1 2026, data H2 2026.
New global Phase III HARMONi-GI3 in 1L CRC initiated; targets 600 patients, PFS primary endpoint.
Q3 2025 GAAP net loss $231.8M ($0.31/sh), non-GAAP net loss $101.0M ($0.13/sh); cash $238.6M at Sept 30.

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