Summit Therapeutics Inc.
SMMT evidence brief
What we can confirm
- BioSniper Score:
- 7.1 / 10
- Market Cap:
- $14.69B
- Lead Asset:
- ivonescimab (Phase 3)
What it means
What to watch
Prepared research question
What matters most for SMMT—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · SMMT
Summit Therapeutics Inc. (SMMT) is a biopharmaceutical company focused on oncology, with its lead investigational drug ivonescimab, a PD-1/VEGF-A bispecific antibody, currently in Phase 3 trials for non-small cell lung cancer and other indications, and a BLA accepted for EGFR-mutant NSCLC with a PDUFA date of November 14, 2026.
Key risk: Single-asset dependency
BioSniper Score
Based on 5 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 22 clinical trials · 1 catalyst for Summit Therapeutics Inc..
Summit Therapeutics Inc. (SMMT) is a biopharmaceutical company focused on oncology, with its lead investigational drug ivonescimab, a PD-1/VEGF-A bispecific antibody, currently in Phase 3 trials for non-small cell lung cancer and other indications, and a BLA accepted for EGFR-mutant NSCLC with a PDUFA date of November 14, 2026.
- Lead candidate ivonescimab is a PD-1/VEGF-A bispecific antibody with a cooperative binding mechanism, licensed from partner Akeso, Inc. for development and commercialization in the U.S., Canada, Europe, Japan, Latin America, Middle East and Africa [pipeline].
- Ivonescimab's BLA has been accepted by the FDA for 2L EGFR-mutant NSCLC, with a PDUFA date of November 14, 2026 [news · published 2026-07-22][catalyst_timeline].
- Positive Phase 3 HARMONi-GI1 data from China showed ivonescimab plus chemotherapy achieved statistically significant overall survival, progression-free survival, and response rate benefits over durvalumab plus chemotherapy in first-line advanced biliary tract cancer [news · published 2026-08-27].
- As of June 30, 2026, Summit Therapeutics reported cash & equivalents of $419.4M, net income of -$215.7M, and shareholders' equity of $630.0M [sec].
- The company's stock surged 28% in September 2026 following positive ivonescimab clinical trial results [news · published 2026-09-07].
What works
- Ivonescimab has demonstrated positive Phase 3 results in two distinct indications (NSCLC and biliary tract cancer), suggesting broad potential [news · published 2026-08-27][news · published 2026-09-07].
- The company has a substantial cash position of $419.4M as of June 30, 2026, providing financial runway for development and commercialization [sec].
- The BLA acceptance for ivonescimab in EGFR-mutant NSCLC with a PDUFA date in November 2026 represents a near-term regulatory catalyst [news · published 2026-07-22][catalyst_timeline].
What to weigh
- The company reported a net loss of -$215.7M for the period ending June 30, 2026, indicating significant cash burn [sec].
- Ivonescimab faces competition from established therapies such as pembrolizumab (Keytruda) and bevacizumab, as noted in the pipeline overview [pipeline][news · published 2026-06-15].
- The company is heavily reliant on a single lead asset (ivonescimab) and its partner Akeso for clinical data and regulatory progress, concentrating risk [pipeline][news · published 2026-08-27].
From the filings
Quoted directly from source documents.
Ivonescimab is a PD-1/VEGF-A bispecific antibody with a cooperative binding mechanism.
“PD-1/VEGF-A bispecific antibody that blocks PD-1 from binding to PD-L1 and PD-L2, and blocks VEGF-A from binding to VEGF receptors with cooperative binding mechanism”
Ivonescimab plus chemotherapy outperformed durvalumab plus chemotherapy in Phase 3 biliary tract cancer trial.
“ivonescimab plus chemotherapy achieved statistically significant and clinically meaningful overall survival, progression-free survival, and response rate benefits over durvalumab plus chemotherapy in first-line advanced biliary tract cancer”
News · August 27, 2026
The BLA for ivonescimab in EGFR-mutant NSCLC has been accepted by the FDA.
“FDA acceptance of its BLA for ivonescimab + chemotherapy in EGFR-mutant NSCLC”
News · July 22, 2026
Catalyst timeline
- 2026-11-14 · PDUFA · ivonescimab — FDA decision on the BLA for ivonescimab in 2L EGFR-mutant NSCLC; approval would mark the company's first commercial product.
Risks & what to watch (3)›
Key risks
- Single-asset dependency — Summit's pipeline is centered on ivonescimab; any clinical or regulatory setback would severely impact the company [pipeline].
- Cash burn rate — Net loss of -$215.7M for the period ending June 30, 2026, against cash of $419.4M, implies a finite runway [sec].
- Competitive landscape — Ivonescimab faces entrenched competitors like pembrolizumab and bevacizumab in NSCLC and biliary tract cancer [pipeline][news · published 2026-06-15].
What to watch
- PDUFA decision for ivonescimab on November 14, 2026, which will determine FDA approval for EGFR-mutant NSCLC [catalyst_timeline].
- Further Phase 3 data from the HARMONi-3 and HARMONi-7 trials comparing ivonescimab to pembrolizumab in NSCLC [pipeline].
- Summit's cash position and burn rate in upcoming quarterly financial reports, given the net loss of -$215.7M as of June 30, 2026 [sec].
- Partner Akeso's ongoing clinical progress in China and potential expansion into other indications [news · published 2026-08-27].
Sources: News · Pipeline · Generated October 13, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.19 · 0% dilution
Lead: Phase 3
1 candidate
1 upcoming, next in ~31d
6 buys · 0 sells (180d)
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
224
Total value held
$2.09B
| Holder | Shares | Value |
|---|---|---|
| baker bros. advisors lp | 36,391,063 | $690.0M |
| fmr llc | 10,853,199 | $205.8M |
| blackrock, inc. | 9,653,758 | $183.0M |
| state street corp | 7,028,160 | $133.3M |
| vanguard capital management llc | 5,711,802 | $108.3M |
| vanguard portfolio management llc | 5,233,252 | $99.2M |
| ubs group ag | 3,680,315 | $69.8M |
| geode capital management, llc | 3,315,854 | $62.9M |
| d. e. shaw & co., inc. | 2,242,229 | $42.5M |
| morgan stanley | 1,650,591 | $31.3M |
Showing top 10 of 224 institutional holders of Summit Therapeutics Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 22, 2026- % of float
- 21.6%
- Days to cover
- 7.6
- Shares short
- 29,194,577
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
SMMT short interestGovernance
Frequently asked questions
What is the AI investment thesis for Summit Therapeutics Inc.?
Summit Therapeutics Inc. (SMMT) is a biopharmaceutical company focused on oncology, with its lead investigational drug ivonescimab, a PD-1/VEGF-A bispecific antibody, currently in Phase 3 trials for non-small cell lung cancer and other indications, and a BLA accepted for EGFR-mutant NSCLC with a PDUFA date of November 14, 2026.
What is Summit Therapeutics Inc.'s lead drug candidate?
Summit Therapeutics Inc.'s most advanced tracked candidate is ivonescimab (Phase 3) for Non-Small Cell Lung Cancer.
What is Summit Therapeutics Inc.'s next catalyst?
Summit Therapeutics Inc.'s next tracked catalyst is a PDUFA event — "PDUFA: ivonescimab" — expected November 14, 2026.
Who is the CEO of Summit Therapeutics Inc.?
Mr. Robert W. Duggan is the chief executive officer of Summit Therapeutics Inc. (SMMT).
Where is Summit Therapeutics Inc. headquartered?
Summit Therapeutics Inc. (SMMT) is headquartered in Miami, FL, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.