Summit Therapeutics Inc. Q1 FY2025 earnings call

Bob Duggan

• Akeso received NMPA approval for ivonescimab as frontline monotherapy for NSCLC with PD-L1 positive tumors, based on HARMONi-2 trial PFS results. Akeso's HARMONi-6 Phase III trial met PFS primary endpoint in frontline squamous NSCLC. Global Phase III trials for ivonescimab ongoing, with top line data expected mid-2025 for HARMONi.

Maky Zanganeh

• Over 2,300 patients treated in ivonescimab trials since 2019. 4 Phase III trials completed enrollment, 5 ongoing. Details on HARMONi, HARMONi-3 (amended to include all frontline non-small cell lung cancer), HARMONi-7 (enrollment ongoing), collaborations with MD Anderson and Pfizer, and market opportunity for ivonescimab.

Manmeet Soni

• Ended Q1 2025 with $361 million cash, debt-free. GAAP R&D expenses $51.2M, G&A expenses $15.6M. Progress in clinical, commercial, and manufacturing operations, including strengthening commercial leadership and manufacturing know-how transfer.

No detailed product segment financial performance with revenue contribution % provided in the transcript.

• Expect top line data from HARMONi global Phase III trial in mid-2025.
• HARMONi-3 and HARMONi-7 trials ongoing with results expected later in the year.
• Full data set for HARMONi-6 to be presented at a major medical conference later in 2025.
• Plan to provide more clinical development details beyond lung cancer later in 2025.

• Forward-looking statements subject to risks and uncertainties causing actual results to differ from forward-looking statements. Risks include clinical trial outcomes, regulatory approvals, and market acceptance of ivonescimab.

Q: On upcoming HARMONi EGFR data set, what's the bar for success and profile hoped for in HARMONi?

A: Dave Gancarz mentioned overall data package consistency with China data is important; Jack West discussed the need for alternatives with different toxicity profiles in EGFR mutation positive NSCLC.

Q: Could you be more specific on geographic data for HARMONi?

A: Dave Gancarz stated top line data will provide context on geographic breakdowns like North America/Europe vs China, potentially with a forest plot.

Q: On HARMONi timing and OS importance for US filing?

A: Dave Gancarz said HARMONi has 2 primary endpoints, and Allen Yang noted OS precedent not needed for approval but clear benefit is desired.

Q: On Pfizer partnership and other ADC targets?

A: Allen Yang and Jack West mentioned openness to other collaborations and evaluating various ADC targets in lung cancer.

Q: On HARMONi-3 enrollment and HARMONi-7 OS benefit?

A: Allen Yang said enrollment objectives for squamous and non-squamous in HARMONi-3 are to have equal amounts; Jack West and Allen Yang discussed clinically meaningful OS improvement as a plan-changing threshold.

Q: On Chinese NMPA label and OS curves for HARMONi-2?

A: Dave Gancarz said NMPA label availability is specific to China, and details on OS curves are from Akeso's trial disclosures.

Q: On HARMONi-3 FDA discussions and PD-L1 negative patients?

A: Dave Gancarz said discussions with FDA align trials based on feedback; Jack West and Dave Gancarz discussed PD-L1 negative patients needing separate trials like HARMONi-3 and HARMONi-6.

Q: On HARMONi OS maturity and VEGF/PD-1 combination outside lung cancer?

A: Dave Gancarz and Jack West discussed OS maturity variability and Allen Yang mentioned considering Phase II data and tumor type prevalence for non-lung cancer indications.