SUMMIT THERAPEUTICS PLC (SMMT) Q4 2025 Earnings Call Transcript
Bullish Biotechnology 11.87B USA
Next Earnings
2026-05-07
Summit Therapeutics Inc., a biopharmaceutical company, focuses on discovery, development, and commercialization of patient, physician, caregiver, and societal friendly medicinal therapies. Its lead development candidate is ivonescimab, a bispecific antibody for immunotherapy through blockade of PD-1 with the anti-angiogenesis, as well as in Phase III clinical trials for the treatment of non-small lung cancer. The company was founded in 2003 and is headquartered in Miami, Florida.
HARMONi-6 data show a robust PFS benefit for ivonescimab; the company intends a Q4 2025 FDA BLA submission and expanded Phase III program with GI and retooled lung studies, alongside a confirmed cash runway and rising R&D spend.
⭐ Key Highlights
HARMONi-6 PFS readout
HARMONi-6 demonstrated a significant PFS benefit with ivonescimab plus chemotherapy vs tislelizumab plus chemotherapy (HR 0.60, p<0.0001; median 11.14 vs 6.90 months).
BLA submission plan
Company plans to submit a BLA for ivonescimab plus chemotherapy to the FDA in Q4 2025 based on HARMONi-6 results, with OS data to be discussed during review.
HARMONi-3 design refinement
HARMONi-3 will add a separate squamous and non-squamous ITT analysis, increasing enrollment targets to 600 squamous and 1,000 non-squamous to power both endpoints.
GI cancer program expansion
Announced HARMONi-GI3, a global Phase III study of ivonescimab plus chemo vs bevacizumab plus chemo as first-line unresectable colorectal cancer; US sites planned to activate by year-end 2025.
Financials and runway
Q3 2025 cash ~ $238.6M; GAAP OPEX $234.2M (Q3) vs $568.4M (Q2); non-GAAP OPEX $103.4M (Q3) vs $89.6M (Q2).
✔Positive Signals
- HARMONi-6 demonstrated a statistically significant PFS benefit (HR 0.60) across PD-L1 subgroups.
- Plan to file a BLA with the FDA for ivonescimab plus chemotherapy in Q4 2025.
- Expansion of the Phase III program to 14 studies, including HARMONi-GI3 in colorectal cancer.
- HARMONi-3 re-design to separately power squamous and non-squamous cohorts, accelerating potential regulatory path.
- Strong progress on HARMONi-3 enrollment (80% of squamous target) and ongoing site activations.
✖Negative Signals
- OS data not yet statistically significant; FDA will assess OS during review.
- Safety signals include VEGF-related events and bleeding risk in squamous patients, requiring education and monitoring.
- Significant near-term cash burn with high GAAP opex and reliance on ATM for runway.
- HARMONi-6 data were generated by Akeso; dependence on partner data disclosure and interpretation.
- OS readout timing remains uncertain, potentially impacting regulatory expectations.
📊Financial Results
- Q3 2025 cash position: approximately $238.6 million.
- GAAP operating expenses Q3 2025: $234.2 million, down from $568.4 million in Q2 2025 due to stock-based compensation: ~$348.2 million recognized in Q2.
- Non-GAAP operating expenses Q3 2025: $103.4 million, up from $89.6 million in Q2 2025, driven by higher R&D spend on HARMONi-3 and HARMONi-7.
- Revenue: not disclosed in transcript; primarily a development-stage company with operating losses.
- Cash burn and headcount reductions implied by decreasing GAAP OPEX in Q3 vs Q2.
🔮Future Guidance
- BLA submission for ivonescimab plus chemo planned in Q4 2025; OS data will be discussed with FDA during review.
- HARMONi-3 squamous cohort enrollment expected to complete in Q1 2026;OS readout timing anticipated in 2H 2026.
- HARMONi-3 non-squamous enrollment expected to complete in 2H 2026 with PFS and OS analyses proceeding thereafter.
- Enrollment for HARMONi-7 ongoing with 50% site activation; full data readouts and regulatory plans to be provided as they materialize.
- HARMONi-GI3 US site activations planned by end of 2025; 600-patient trial designed to compare ivonescimab plus chemo against bevacizumab plus chemo.
💡Interesting Insights
- The company is pursuing independent ITT analyses by histology (squamous vs non-squamous) in HARMONi-3 to de-risk regulatory outcomes and potentially accelerate approval timelines per FDA expectations.
Detailed Analysis
AI-generated summary of SUMMIT THERAPEUTICS PLC earnings call transcript.
Summit Therapeutics announced positive HARMONi-6 Phase III results for ivonescimab plus chemotherapy in first-line advanced squamous NSCLC, showing a HR of 0.60 for progression-free survival and a median PFS improvement of 4.24 months over tislelizumab plus chemotherapy, with a consistent benefit across PD-L1 subgroups and manageable safety. The company disclosed plans to submit a BLA with the FDA in Q4 2025, while expanding the global Phase III program to include HARMONi-GI3 for first-line unresectable colorectal cancer and enhancing HARMONi-3 with separate squamous/non-squamous analyses to accelerate readouts. Operational progress includes strong enrollment in HARMONi-3 (80% of 600 squamous); US and global trial activity; and early-stage BD discussions. Financially, Q3 2025 showed $238.6M cash and a large swing from Q2 GAAP to non-GAAP OPEX driven by stock-based compensation and increased R&D activity. The company also emphasized ongoing FDA interactions and a strategic emphasis on pursuing multiple combination strategies with ivonescimab in collaboration with partners, while acknowledging the need for OS confirmation and real-world safety considerations.
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