Summit Therapeutics, Inc. Q4 FY2023 earnings call

• Partnership with Akeso completed one year ago, with significant progress on ivonescimab.
• Ivonescimab is in ongoing Phase 3 trials: HARMONi (enrollment ongoing, planned to complete in second half of 2024 for non-small cell lung cancer patients with EGFR mutations post-third-generation TKI) and HARMONi-3 (first-line squamous non-small cell lung cancer, head-to-head vs pembrolizumab + chemotherapy).
• Data from Phase 2 trials of ivonescimab + chemotherapy in lung cancer settings show promising results (e.g., 24-month overall survival rate of 64.8% in first-line advanced squamous non-small cell lung cancer without actionable genomic alterations; median overall survival of 22.5 months in EGFR mutation-positive non-small cell lung cancer post-EGFR TKI).
• Ivonescimab has a differentiated mechanism of action: cooperative binding of PD-1 and VEGF, potentially steering more drugs to the tumor microenvironment.
• Upcoming milestones in 2024: Chinese regulatory decision on AK112-301 data (submitted last year), top-line results from Akeso's Phase 3 trial, interim analysis for AK112-303 (monotherapy vs pembrolizumab in first-line advanced lung cancer), and plan to complete enrollment in HARMONi study in second half of 2024.
• Cash position: $160 - $186 million in cash and investments as of end-2023; cash runway extended to April 2025 by amending the $100 million note.
• Non-GAAP operating expenses for Q4 2023: $27.7 million, with $22.4 million in R&D (focused on ivonescimab clinical development) and $5.3 million in G&A.

There is no traditional product segment breakdown with revenue contribution. The focus is on the development of ivonescimab, the lead investigational compound. Ivonescimab is involved in two Phase 3 trials: HARMONi (second-line non-small cell lung cancer with EGFR mutations) and HARMONi-3 (first-line squamous non-small cell lung cancer). Over 1,600 patients have been treated with ivonescimab globally, and Akeso is conducting 19 clinical trials evaluating ivonescimab, including 4 in Phase 3 and 7 in solid tumors beyond non-small cell lung cancer.

• Extended cash runway to April 2025 by amending the $100 million note, providing funding for ivonescimab development.
• Plan to complete enrollment in HARMONi study in the second half of 2024.
• Anticipated key milestones in 2024 include Chinese regulatory decision on AK112-301 data, top-line results from Akeso's Phase 3 trial, and interim analysis for AK112-303.

Forward-looking statements are subject to risks and uncertainties as per SEC filings; actual results may differ from forward-looking statements.

Q: Brad Canino asked about interpreting the upcoming Chinese regulatory action on ivonescimab for EGFR-mutant lung in relation to the HARMONi study.

A: Allen Yang explained that the Chinese data correlates with the global study, PFS tracks with OS, and co-primary endpoints are different from Akeso's study.

Q: Hartaj Singh asked about differentiation of ivonescimab in the head-to-head study against pembrolizumab chemo combo and the next clinical and regulatory steps.

A: Allen Yang noted the benchmark is KEYNOTE 407 study, and ivonescimab's VEGF component and cooperative binding differentiate it; next steps include enrollment in HARMONi-3 and completion of HARMONi enrollment in 2024.