Summit Therapeutics (SMMT) investor relations material

Strategic focus and development approach

• Ivonescimab is positioned as a leading PD-1/VEGF bispecific, with a focus on lung cancer and expansion into CRC and head and neck cancers through multiple ongoing studies and collaborations.

• The company is pursuing both monotherapy and combination approaches, leveraging validated targets and aiming for broad applicability across tumor types.

• Key studies include HARMONi-3, HARMONi-7, and HARMONi-GI3, with business decisions guiding indication prioritization based on competitive benchmarks like pembrolizumab.

• Strategic options remain open: going it alone, partnering, or merging, with a focus on patient benefit and value creation.

• Access to capital is strong, with ongoing fundraising and an active ATM facility supporting development and commercialization plans.

Clinical trial progress and milestones

• HARMONi-3 final PFS readout for squamous lung cancer is expected in 2026, with non-squamous data in early 2027; two market opportunities will read out between late 2024 and early 2025.

• Patient enrollment is ahead of schedule in several trials, including HARMONi-7 and CRC studies.

• A BLA for post-TKI EGFR mutant lung cancer is under review, with a PDUFA date in November 2024.

• Interim PFS analysis in HARMONi-3 squamous did not reach significance due to a higher statistical bar and event maturity, but final analysis is expected to be more favorable.

• Confidence in non-squamous cohort outcomes is supported by consistent phase II and III data, with larger cohort size to ensure robust event capture.

Clinical data highlights and differentiation

• HARMONi-6 demonstrated a 34% survival benefit over pembrolizumab, marking the first randomized phase III to show both PFS and OS benefit over PD-1 plus chemo.

• OS and PFS benefits are highly correlated, with hazard ratios well below the 0.8 benchmark considered clinically meaningful.

• Benefit was observed across all patient subgroups, including those over 65, with no hazard ratio crossing one.

• Four phase III trials consistently show benefit, reinforcing confidence in broad applicability.

• Mechanistic advantages are attributed to PD-1 targeting, cooperative binding, and tetravalent bispecific technology, differentiating ivonescimab from competitors.