Summit Therapeutics (SMMT) investor relations material

Strategic partnerships and pipeline overview

• Entered a strategic partnership with Akeso Inc. for ivonescimab, securing rights in major global markets outside China and Korea.

• Rapid progression into late-stage clinical studies, expanding from China-specific to global trials.

• Currently running four phase 3 studies: three in non-small cell lung cancer and one in microsatellite stable colorectal cancer.

• Over 4,000 patients dosed in clinical studies, with more than 60,000 treated commercially in China.

• More than 140 clinical trials registered globally, with significant investigator-initiated interest.

Clinical data and study results

• Four phase 3 studies have read out with positive progression-free survival data; three showed clinically meaningful overall survival improvements.

• HARMONi-A achieved statistical significance in overall survival in China for post-TKI EGFR mutant lung cancer.

• HARMONi-2 and HARMONi-6 studies demonstrated superiority over PD-1 inhibitors in both monotherapy and chemo combination settings.

• Ivonescimab showed a hazard ratio of 0.51 for PFS in monotherapy versus pembrolizumab, and 0.60 in chemo combination.

• High tolerability profile observed, with positive feedback from treating physicians.

Upcoming milestones and regulatory outlook

• HARMONi-3 squamous cohort completed enrollment; interim PFS analysis expected in Q2, final PFS and interim OS in H2 2026.

• Non-squamous cohort to complete enrollment in H2 2024, with final PFS and interim OS in H1 2027.

• PDUFA date for BLA submission from HARMONi study set for November 2026.

• Interim and final analyses designed to accelerate regulatory conversations and potential patient access.