---
schema_version: "secwatch.filing_event.v1"
accession: "0001599298-25-000156"
form_type: "8-K"
ticker: "SMMT"
cik: "0001599298"
company_name: "Summit Therapeutics Inc."
filed_at: "2025-10-20T23:59:59+00:00"
generated_at: "2026-05-17T03:13:48.743331+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001599298-25-000156
- form_type: 8-K
- ticker: SMMT
- cik: 0001599298
- company_name: Summit Therapeutics Inc.
- filed_at: 2025-10-20T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1599298/000159929825000156/0001599298-25-000156-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1599298/000159929825000156/smmt-20251017.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001599298-25-000156
- JSON: https://secwatch.observer/filing/0001599298-25-000156.json
- Plain text: https://secwatch.observer/filing/0001599298-25-000156.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.