Summit Therapeutics Inc. Q4 FY2024 earnings call

Bob Duggan:

• Pleased with recent accomplishments of Team Summit and progress on Ivonescimab. Announced clinical trial collaboration with Pfizer evaluating Ivonescimab with Pfizer ADCs. HARMONi global Phase III trial completed enrollment and received Fast Track designation. HARMONi-3 protocol expanded to include squamous and non-squamous histologies. HARMONi-7 Phase III trial initiated in early 2025.

Maky Zanganeh:

• Over 2,300 patients treated with Ivonescimab in trials. HARMONi top-line data expected mid-2025. Collaboration with Pfizer to evaluate Ivonescimab with Pfizer vedotin based ADCs in multiple tumor types. Expansion of sponsored clinical development beyond non-small cell lung cancer. Engagement with investigators for investigator-sponsored trials. Update on MD Anderson collaboration and IST approvals.

Manmeet Soni:

• Ended 2024 with $412 million cash, debt-free. GAAP R&D expenses $150.8M in 2024 vs $59.4M in 2023. G&A expenses increased due to stock-based comp. Progress on HARMONi-3 non-squamous enrollment and HARMONi-7 site activation. Tech transfer for manufacturing progress.

No specific product segment financial performance details on absolute revenue and contribution percentages provided in the transcript.

Bullet points:

• HARMONi top-line data expected in mid-2025.
• Intend to expand sponsored clinical development beyond non-small cell lung cancer in 2025-2026.
• Clinical trial collaboration with Pfizer expected to start mid-2025.

Bullet points:

• Forward-looking statements subject to risks and uncertainties as per SEC filings, including those that may cause actual results to differ from forward-looking statements.

Q: Yigal Nochomovitz asked about timing of HARMONi-2 OS, HARMONi trial data readout, and Pfizer collaboration details.

A: Dave Gancarz and others responded, mentioning Akeso's expected interim analysis end 2025, HARMONi-3 enrollment timing, and Pfizer collaboration on multiple ADCs in solid tumors.

Q: Bradley Canino asked about Pfizer collaboration perspective and HARMONi EGFR data presentation.

A: Allen Yang and Dave Gancarz responded, discussing ADCs in solid tumors and data comparability in Western vs China patients.

Q: Kelly Shi asked about HARMONi trial design, Pfizer collaboration details.

A: Allen Yang and Bob Duggan responded, discussing primary analysis of HARMONi-3 population and upcoming details on Pfizer collaboration.

Q: Sadia Rahman asked about HARMONi trial patient populations and Pfizer collaboration toxicities.

A: Allen Yang and Dave Gancarz responded, clarifying patient eligibility and safety in combinations.

Q: Mitchell Kapoor asked about BD opportunities and HARMONi-3 enrollment.

A: Dave Gancarz and Manmeet Soni responded, discussing open BD opportunities and HARMONi-3 enrollment overlap with HARMONi-7.

Q: Asthika Goonewardene asked about HARMONi-3 analysis and Pfizer collaboration rationale.

A: Allen Yang responded, discussing primary analysis approach and rationale for Pfizer collaboration.

Q: Reni Benjamin asked about next solid tumor indications and HARMONi-7 site activation.

A: Bob Duggan and Manmeet Soni responded, discussing expansion beyond non-small cell lung cancer and site activation timelines.