Strong cash position and no debt
Ended FY2025 with approximately $713.4 million in cash and no debt, supporting continued clinical development and commercial readiness activities.
Multiple positive Phase III readouts and regulatory progress
Ivonescimab has read out 4 Phase III studies to date, all positive, leading to 2 approvals in China. Summit's BLA for the HARMONi indication was accepted by the FDA with a PDUFA target action date of November 14, 2026.
HARMONi-3 squamous cohort enrollment completed and interim PFS planned
Screening for the HARMONi-3 squamous cohort is complete with the last patient to be randomized imminently. An interim PFS analysis for the squamous cohort is planned in Q2 2026, enabled by accelerated enrollment (600 squamous patients enrolled ahead of plan).
Clinically meaningful PFS benefits demonstrated in prior trials
Prior Phase III results supporting the program include HARMONi-2 PFS HR = 0.51 with median PFS improvement >5 months, HARMONi-6 showing HR = 0.60, and Akeso trials reporting >40% improvement in PFS for ivonescimab arms—data that informed the decision to add interim PFS analyses.
Broad global development and patient exposure
15 randomized Phase III trials announced/ongoing, 44 clinical trials initiated since 2019 between Summit and Akeso, 142 total trials listed including investigator-initiated/collaborative studies, and over 4,000 patients enrolled in Summit- or Akeso-sponsored trials. Commercially in China, >60,000 patients have received ivonescimab across two approved indications.
New and expanding collaborations/trials
New cooperative group-led ILLUMINE Phase III in PD-L1+ head & neck SCC (~780 patients) to begin enrollment early next quarter; first patient dosed in Revolution Medicines collaboration (ivonescimab + RAS(ON) inhibitors); clinical collaboration with GSK (B7-H3 ADC) expected to begin dosing mid-2026; initiated HARMONi-GI3 in colorectal cancer.
Manufacturing and commercial readiness progress
Successfully transferred and validated the production process of ivonescimab to a U.S.-based manufacturer. Commercial readiness ramp accelerated in anticipation of potential U.S. approval for EGFR-mutant NSCLC post-TKI therapy.
Disciplined G&A and controlled spending
Full-year 2025 G&A (excluding stock-based compensation) was approximately $43 million with a quarterly run rate of ~$10–11 million, demonstrating cost discipline while R&D spend increases to support pivotal trials.