The ASCO 2026 presentation of HARMONi-6 OS data on May 31 is the next major catalyst. The HARMONi-3 squamous interim PFS analysis did not stop early, but the final PFS readout in H2 2026 remains a key event. The PDUFA date in November 2026 provides a longer-term binary catalyst. Monitor cash burn trajectory given $598.7M in cash.
Price Chart
Executive Summary
Summit Therapeutics reported Q1 2026 financial results and operational progress. The company posted a GAAP net loss of $189.4M ($0.24/share), wider than the $62.9M loss in Q1 2025, driven by increased R&D and stock-based compensation. Key catalysts include the upcoming ASCO 2026 presentation of HARMONi-6 overall survival data as a late-breaking abstract and the HARMONi-3 squamous cohort final PFS data expected in H2 2026, with the PDUFA date for ivonescimab BLA set for November 14, 2026.
Key Financial Metrics
Key Facts
- GAAP net loss of $189.4M ($0.24/share) in Q1 2026 vs $62.9M ($0.09/share) in Q1 2025
- Cash and short-term investments at $598.7M as of March 31, 2026, down from $713.4M at year-end 2025
- HARMONi-6 overall survival data selected as late-breaking abstract for ASCO 2026 Plenary Session on May 31, 2026
- HARMONi-3 squamous cohort interim PFS analysis completed; iDMC recommended study continue; final PFS data expected H2 2026
- FDA PDUFA goal date for ivonescimab BLA is November 14, 2026
- Non-GAAP net loss was $116.6M ($0.15/share) in Q1 2026 vs $51.8M ($0.07/share) in Q1 2025
Financial Impact
No revenue reported; operating cash burn of $122.3M in Q1 2026 vs $61.1M in Q1 2025
Risk Factors
- Clinical trial failure risk for ivonescimab in ongoing Phase III studies
- Cash burn rate increasing; $598.7M may not be sufficient to fund all planned trials to completion
- Regulatory risk: FDA may not approve ivonescimab by PDUFA date or may require additional data
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001599298-26-000037 |
| Document: smmt-20260430.htm | 0001599298-26-000037 |
| Document: 0001599298-26-000037-index-headers.html | 0001599298-26-000037 |
| Document: 0001599298-26-000037-index.html | 0001599298-26-000037 |
| Document: 0001599298-26-000037.txt | 0001599298-26-000037 |
| 8-K Data (Synthetic) | 0001599298-26-000037 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 15, 2026 17d ago | 8-K | $17.40 $17.85 | ▲ +2.59% | ▲ +1.77% | $16.75 (−3.71%) |
Sep 14, 2026 18d ago | 8-K | $18.42 $16.90 | ▼ −8.25% | ▼ −8.36% | $16.75 (−9.04%) |
Sep 3, 2026 29d ago | 8-K | $17.13 $17.55 | ▲ +2.45% | ▲ +3.60% | $16.75 (−2.19%) |
Aug 26, 2026 5w ago | 8-K | $14.23 $14.60 | ▲ +2.60% | ▲ +2.72% | $16.75 (+17.74%) |
Aug 5, 2026 8w ago | 8-K | $13.53 $15.10 | ▲ +11.60% | ▲ +11.25% | $16.75 (+23.84%) |
Jul 22, 2026 10w ago | 8-K | $14.74 $12.80 | ▼ −13.16% | ▼ −10.76% | $16.75 (+13.67%) |
Jun 12, 2026 16w ago | Insider Cluster | $14.01 $13.75 | ▼ −1.86% | ▼ −2.53% | $16.75 (+19.59%) |
Jun 12, 2026 16w ago | Institutional Cluster | $14.01 $13.75 | ▼ −1.86% | ▼ −2.53% | $16.75 (+19.59%) |
Jun 11, 2026 16w ago | Institutional Cluster | $13.08 $14.07 | ▲ +7.57% | ▲ +7.14% | $16.75 (+28.10%) |
Jun 9, 2026 16w ago | S-3ASR | $13.05 $13.88 | ▼ −6.36% | ▼ −2.93% | $16.75 (−28.39%) |
US Market Status
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