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Summit Therapeutics (SMMT) investor relations material
Summit Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary20 Oct, 2025
Executive summary
Ivonescimab plus chemotherapy demonstrated significant progression-free survival (PFS) benefit over tislelizumab plus chemotherapy in phase III HARMONi-6 for advanced squamous NSCLC, with higher and more durable tumor response rates and a manageable safety profile; global expansion includes multiple phase III trials in NSCLC and colorectal cancer.
Positive trend in overall survival (OS) observed in 2L+ EGFRm NSCLC, with longer-term follow-up showing improved nominal p-value and consistent benefit across subgroups.
Intention to submit a Biologics License Application (BLA) for ivonescimab in the U.S. in Q4 2025, supported by HARMONi data.
Expanded licensing agreement with Akeso covers Latin America, Middle East, and Africa, with additional milestone and royalty obligations.
Ongoing and planned global studies for ivonescimab in NSCLC and CRC, with a total of 14 phase III trials across multiple solid tumors.
Financial highlights
Ended Q3 2025 with $238.6 million in cash and cash equivalents, with a net loss of $231.8 million for Q3 2025 and $860.4 million for the nine months ended September 30, 2025.
GAAP operating expenses for Q3 2025 were $234.2 million, down from $568.4 million in Q2 2025, mainly due to lower stock-based compensation.
Non-GAAP operating expenses rose to $103.4 million from $89.6 million sequentially, driven by increased R&D for HARMONi-3 and HARMONi-7.
Stock-based compensation expense surged to $130.8 million for Q3 and $620.6 million for the nine months, due to modifications to performance-based options.
Cash is insufficient to fund operations for the next 12 months; additional capital will be required.
Outlook and guidance
BLA submission for ivonescimab planned for Q4 2025; FDA requires statistically significant OS benefit for approval.
HARMONi-3 squamous cohort enrollment expected to complete in H1 2026, with PFS analysis in H2 2026; non-squamous cohort to complete in H2 2026, with PFS analysis in H1 2027.
HARMONi-GI3 trial in colorectal cancer to begin U.S. site activation by end of 2025, targeting 600 patients; HARMONi-G13 trial also planned.
Expects continued operating losses and significant cash outflows as clinical development progresses.
Current cash is insufficient to fund operations for the next 12 months; additional capital will be required.
Rationale for HARMONi BLA despite OS concern?
How do HARMONi-3 changes accelerate approval?
Funding strategy for expanded Phase III pipeline?
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Next Summit Therapeutics earnings date
Q4 202525 Feb, 2026
Next Summit Therapeutics earnings date
Q4 202525 Feb, 2026
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Frequently asked questions
Summit Therapeutics Inc., headquartered in Menlo Park, California, is a biopharmaceutical company engaged in the research and development of oncology therapies in the United States and the United Kingdom. Its lead pipeline product, ivonescimab, is a novel, bispecific antibody targeting both PD-1 and VEGF. Summit Therapeutics has also initiated two clinical trials with ivonescimab. Additionally, the company's product pipeline includes SMT-738, a novel class of precision antibiotics aimed at treating multidrug-resistant infections, including carbapenem-resistant Enterobacteriaceae infections. The company is headquartered in Menlo Park, California, and its shares are listed on the Nasdaq.
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