Summit Therapeutics Inc. Q4 FY2025 earnings call

Dave Gancarz welcomes attendees. Mahkam Zanganeh discusses ivonescimab's development, including HARMONi-3 study updates, new Phase III study ILLUMINE, clinical collaborations with Revolution Medicines and GSK. Manmeet Soni provides financial update: ended 2025 with $713.4M cash, GAAP operating expenses decreased in Q4 2025, non-GAAP operating expenses increased due to R&D, and operational progress like accelerated squamous patient enrollment and commercial readiness activities.

Anticipate interim PFS analysis for HARMONi-3 squamous cohort in Q2 2026, final PFS and interim OS data in second half of 2026, HARMONi-3 non-squamous cohort enrollment completion in 2026, final PFS data in first half of 2027, potential first approval for ivonescimab in U.S. around November 14 PDUFA date based on HARMONi BLA filing, and continued expansion of global clinical studies pipeline in 2026 including new studies and collaborations.

Q: Mark on for Salveen Richter asks about HARMONi-3 interim PFS analysis decision, expectations for data and OS significance.

A: Dave Gancarz explains decision based on HARMONi-2 and HARMONi-6 data, interim PFS analysis in Q2 2026, OS immature at that time.

Q: Yigal Nochomovitz on HARMONi-3 interim PFS decision basis.

A: Dave Gancarz says data-backed from HARMONi-2 and 6, no change in final PFS and interim OS timing.

Q: Yigal Nochomovitz on ILLUMINE study components.

A: Dave Gancarz and Allen Yang discuss ESMO 2024 data showing ivonescimab plus ligufalimab had higher response rate, GORTEC's role.

Q: Bradley Canino on HARMONi-3 interim PFS benefit for regulatory discussions.

A: Dave Gancarz and Manmeet Soni say interim analysis allows early data discussion to accelerate patient access.

Q: Josh on for Cory Kasimov on head and neck Phase III study with co-op group.

A: Dave Gancarz and Allen Yang say working with cooperative groups expands trials, GORTEC's enthusiasm.

Q: Tyler Van Buren on HARMONi-6 and HARMONi-2 OS data, PFS to OS translation.

A: Dave Gancarz and Allen Yang discuss HARMONi-2 and 6 not powered for OS, PFS data translation confidence from China studies.

Q: Asthika Goonewardene on commercial footprint for EGFR and squamous.

A: Manmeet Soni says synergies exist, ramp-up in SG&A expense.

Q: Asthika Goonewardene on regulatory requirements for cooperative group studies.

A: Dave Gancarz and Allen Yang say cooperative groups familiar with health authority thought processes, Chinese data used for Project Optimus.

Q: Xiaochuan Dai on HARMONi-A trial FDA interactions and OS stance.

A: Allen Yang says FDA wanted OS for BLA, submission accepted.

Q: Xiaochuan Dai on GSK collaboration B7-H3 ADC indication.

A: Dave Gancarz says small cell lung cancer is explored.

Q: Mitchell Kapoor on expansion opportunities and gating items.

A: Dave Gancarz and Allen Yang say multiple data from ivonescimab, Akeso's moves help decide next steps.

Q: Eric Schmidt on HARMONi-3 interim PFS disclosable info.

A: Dave Gancarz and Allen Yang say analysis run, disclosure depends on data and next steps.

Q: Faisal Khurshid on FDA review for HARMONi.

A: Dave Gancarz says interactions with agency are confidential, respect for FDA.