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- **Breakthrough NSCLC Data**: ivonescimab + chemo delivered 4.24-month PFS improvement (HR 0.60) in HARMONi-6, outperforming tislelizumab across PD-L1 subgroups.
- **Global Expansion**: 14 Phase III studies underway, including first colorectal cancer trial with 600-patient enrollment.
- **FDA Filing Momentum**: BLA submission for EGFR-mutant NSCLC planned Q4 2025; $238.6M cash runway supports aggressive development.
- **Safety Validation**: ivonescimab tolerable in high-risk squamous NSCLC patients with central tumors and hemoptysis history.

**【Management Opening Remarks】**
- Announced Phase III expansion into colorectal cancer and global Phase III study for ivonescimab.
- Highlighted HARMONi-6 data showing 4.24-month PFS improvement vs. tislelizumab in squamous NSCLC.
- BLA submission for ivonescimab + chemo in EGFR-mutant NSCLC planned Q4 2025.

**【CEO Commentary】**
- **HARMONi-6 Results**: 11.14m vs. 6.90m PFS (HR 0.60, p<0.0001), benefit across PD-L1 subgroups, tolerable safety profile.
- Expanded Phase III program to 14 studies across 6 tumor types, including colorectal cancer.
- Protocol amendment for HARMONi-3 to separate squamous and non-squamous analyses, increasing sample size to 1,600 patients.

**【CFO Financial Update】**
- Q3 2025 cash position: $238.6M.
- GAAP operating expenses: $234.2M (down 56% vs. Q2 2025 due to $348M stock comp reversal).
- Non-GAAP operating expenses: $103.4M (up 15% vs. Q2 2025 due to R&D spend on HARMONi-3/7).

**【Q&A Highlights】**
- **FDA Interactions**: BLA submission includes mature data; FDA requires OS benefit for approval, but totality of data (PFS, ORR, safety) supports filing.
- **Funding Strategy**: $350M ATM available; no immediate plans for equity raise, but open to strategic options.
- **Colorectal Trial**: Phase III HARMONi-GI3 to enroll 600 patients, U.S. sites activating Q4 2025.
- **OS Data Timing**: HARMONi-6 OS analysis expected 2026; HARMONi-3 squamous cohort PFS readout Q2 2026.


Summit Therapeutics Inc. (SMMT) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

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Research and Development Expenses

Loss on Bad Debts

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Loss on Disposal of Assets

Other Operating Expenses

Operating Income

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Other Non-Operating Income (Loss)

Net Interest Expense

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Net Income

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Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

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SMMT

SMMT fundamentals

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