Summit Therapeutics Inc. Q3 FY2025 earnings call

1. Announced expansion of Phase III clinical development programs, including a global Phase III study in first-line colorectal cancer. 2. Presented HARMONi-6 data at ESMO 2025 showing ivonescimab plus chemotherapy improved progression-free survival vs tislelizumab plus chemotherapy in advanced squamous non-small cell lung cancer. 3. Plan to submit BLA for ivonescimab this quarter based on HARMONi study results. 4. Updates on Phase III clinical trials: HARMONi-3 enrolling ahead of goals, HARMONi-7 activating over 50% of sites globally, new HARMONi-GI3 study in first-line unresectable colorectal cancer. 5. Financial update: cash position of ~$238.6M at end of Q3 2025, GAAP operating expenses $234.2M in Q3 2025, non-GAAP operating expenses $103.4M in Q3 2025.

1. Intention to submit BLA for ivonescimab in Q4 2025. 2. HARMONi-3 expects to complete enrollment in squamous cohort in first half of 2026 and reach progression-free survival analysis in second half of 2026; non-squamous cohort expects to complete enrollment in second half of 2026 and reach progression-free survival analysis in first half of 2027. 3. HARMONi-GI3 plans to enroll 600 patients with sites in US to begin activating by end of 2025.

1. Forward-looking statements subject to risks and uncertainties that may cause actual results to differ materially. 2. Regulatory risks related to BLA submission and FDA review. 3. Uncertainties in clinical trial timelines and data readouts.

Q: When could we expect to see the first OS cut from HARMONi-6 and implications for OS powering?

A: Dave Gancarz stated they don't get in front of Akeso with details, but it's likely something to be reviewed in 2026 and events driven.

Q: Questions around funding and raising additional capital?

A: Dave Gancarz mentioned an ATM with ~$350M and inbound interest in additional capital.

Q: Color on interactions with FDA regarding BLA submission for ivonescimab?

A: Urte Gayko said they are actively finalizing the BLA and have continued interaction with FDA, and the totality of data is a strong package.

Q: Strategic thinking on submitting HARMONi study BLA now vs waiting for HARMONi-3?

A: Urte Gayko said they think the totality of data is a strong package and are moving forward with submission as announced.

Q: Qualitative on colorectal Phase III study data and when to expect more?

A: Dave Gancarz said they have data from Akeso's Phase II and expansion to US, with multiple chemo backbones reviewed and confidence in ivonescimab's opportunity.

Q: Understanding PD-L1 status in HARMONi-6 and translational work?

A: Howard West said differential effect in PD-L1 negative patients, not necessarily outperforming others, and subsets need further analysis.

Q: Protocol amendments to HARMONi-3 and impact on powering?

A: Dave Gancarz said it accelerates frontline lung cancer opportunity, reduces regulatory risks, and allows cleaner assessment of data.

Q: Thoughts on OS benefit and which side of molecule is important?

A: Howard West and Allen Yang said to focus on clinical outcomes rather than supposition of which side is more important, and data shows 2 sides cooperating better than sum of parts.

Q: Plans for colorectal cancer Phase III study stratification by liver vs non-liver mets?

A: Dave Gancarz said they have stratification factors but didn't specify public details yet.

Q: HARMONi filing with FDA and need for new data cut?

A: Dave Gancarz said they maintain communication with FDA and are working on the submission process.

Q: Rationale for increasing target size in HARMONi-3 squamous cohort?

A: Urte Gayko said it's to power for both endpoints of PFS and OS and is appropriate for the study.

Q: Regulatory precedents for PFS benefit without OS benefit at filing and business development?

A: Urte Gayko mentioned relevant approvals last year, and Bob Duggan talked about business development excitement and product potential.

Q: HARMONi-6 safety profile and addressing with KOLs?

A: Howard West said differences based on tumor characteristics, and education needed for oncologists to liberalize eligibility.