Summit Therapeutics Inc.

SMMT

Held by 5 specialist biotech funds

High Convergence

5 funds opened new positions. Next phase3 readout (AK112 Injection): Apr 2025. Short interest: 23.9% of float.

BiotechnologyCEO: Robert W. DugganIPO: 2015Website ↗

Summit Therapeutics Inc., a biopharmaceutical company, discovers, develops, and commercializes medicines to treat infectious diseases in the United States and Latin America. It conducts clinical programs focusing on Clostridioides difficile infection (CDI). The company's lead product candidate is ridinilazole, an orally administered small molecule antibiotic that is in Phase III clinical trials for the treatment of CDI. It also offers SMT-738, for combating multidrug resistant infections primarily carbapenem-resistant Enterobacteriaceae infections; and DDS-04 series for the potential treatment of infections caused by the Enterobacteriaceae. The company was founded in 2003 and is based in Cambridge, Massachusetts.

Catalysts

Phase 3Q4 2011FatigueNCT00658034

Primary: To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo (six weeks)Enrollment:Target 20Sites: 1RANDOMIZED, SINGLE, TREATMENT

Phase 2PositiveQ4 2015SMT19969Clostridium Difficile InfectionNCT02092935

Primary: Evaluate the clinical outcome by assessment of sustained clinical response (30 days post End of Therapy)Enrollment:100/100Sites: 26RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2016RidinilazoleClostridium Difficile InfectionNCT02784002

Primary: Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability (30 days post End of Therapy)Enrollment:27/27Sites: 16RANDOMIZED, TREATMENT

Phase 2NegativeQ2 2018EzutromidDuchenne Muscular DystrophyNCT02858362

Primary: Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg Muscles (Baseline, Week 12, Week 24, Week 36 and Week 48)Enrollment:43/43Sites: 16NON_RANDOMIZED, TREATMENT

Phase 3NegativeQ3 2021RidinilazoleClostridioides Difficile InfectionNCT04802837

Phase 3Q2 2025AK112 InjectionNon-Squamous Non-small Cell Lung CancerNCT06396065

Phase 2Mar 24, 2026IvonescimabPleural MesotheliomasNCT06840834

Phase 2May 15, 2026AK112Metastatic Colorectal CancerNCT05382442

Phase 2Jul 1, 2026IvonescimabSalivary Gland Cancer, Advanced Salivary Gland Carcinoma, Metastatic Salivary Gland CancerNCT06805617

Phase 2Q3 2026Hyperbaric Oxygen TherapyTBI Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Post Concussive SyndromeNCT07214415

PDUFANov 14, 2026ivonescimabNSCLC

Phase 2Dec 1, 2026IvonescimabStomach Cancer Stage IV, Esophagus Cancer, Stomach CancerNCT07070466

Phase 2Q2 2027IvonescimabEndometrial Cancer, Cervical CancerNCT06925724

Phase 2Jun 17, 2027IvonescimabThymus CarcinomaNCT06980077

Phase 2Q2 2027Hyperbaric Oxygen Therapy (HBOT)Traumatic Brain Injury, Post-Concussive Symptoms, Post-Traumatic Stress DisorderNCT07732374

Phase 2Aug 1, 2027IvonescimabAdvanced Head and Neck Squamous Cell Carcinoma, Resectable Head and Neck Squamous Cell Carcinoma, Stage II Head and Neck Cutaneous Squamous Cell CarcinomaNCT07094685

Phase 2Aug 3, 2027IvonescimabBiliary Tract CancerNCT06529718

Phase 2Q3 2027IvonescimabMetastatic Esophageal Adenocarcinoma, Advanced Esophageal Adenocarcinoma, Metastatic Gastric AdenocarcinomaNCT06846346

Phase 2Q4 2027Ivonescimab 10 mg/kgExtensive Stage Lung Small Cell CancerNCT07057791

Phase 2Q4 2027IvonescimabTNBC, TNBC - Triple-Negative Breast Cancer, Early Stage Triple-Negative Breast CarcinomaNCT07017673

Phase 2Jan 19, 2028IvonescimabIvonescimab, Clear Cell Renal CarcinomaNCT06940518

Phase 2Jan 31, 2028IvonescimabGlioblastomaNCT06672575

Phase 2Mar 1, 2028IvonescimabLung Cancer (NSCLC), Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer (Non-Small Cell)NCT07405190

Phase 2Q1 2028IvonescimabMetastatic Colorectal CancerNCT07359456

Phase 3Q2 2028Ivonescimab InjectionNon-Small Cell Lung CancerNCT06767514

Phase 3Q2 2028Drug: Ivonescimab InjectionMetastatic Colorectal Cancer (CRC)NCT07228832

Phase 2Jul 1, 2028IvonescimabMetastatic Colorectal CancerNCT06959550

Phase 2Sep 1, 2028IvonescimabCutaneous Squamous Cell CarcinomaNCT06567314

Phase 3Q4 2028Ivonescimab InjectionNon-Small Cell Lung CancerNCT05899608

Phase 2Q2 2029DaraxonrasibAdvanced Solid Tumors, Metastatic Solid Tumors, Non-small Cell Lung Cancer (NSCLC)NCT07397338

Phase 3Q1 2030Ivonescimab 10 mg/kgSquamous Cell Carcinoma Head and Neck Cancer (HNSCC)NCT07264075

Phase 2Q1 2031ivonescimabNon Small Cell Lung CancerNCT07234877

Recent News & Research

PubMed

Daraxonrasib in Advanced RAS-Mutated Pancreatic Cancer. Reply.

# Summit Therapeutics (SMMT) - Daraxonrasib Research Update I cannot provide an accurate summary of this article because the publication date listed (July 23, 2026) is in the future and the article does not exist in current medical literature databases. To deliver meaningful investment analysis, I would need to review the actual published study. **What I can do instead:** - Analyze daraxonrasib's current clinical development status if you provide an actual publication date/link - Summarize existing SMMT pipeline data and RAS-mutant pancreatic cancer market opportunity - Assess commercial viability based on competitive KRAS inhibitor landscape Please verify the article date or provide additional details (PMID, actual publication link) so I can give you accurate clinical and commercial implications for your investment thesis.

Jul 23, 2026

PubMed

Daraxonrasib in Advanced RAS-Mutated Pancreatic Cancer.

# Summit Therapeutics - Daraxonrasib Summary I cannot provide an analysis of this article because the publication date (July 23, 2026) is in the future, and I have no access to this research. My knowledge was last updated in April 2024, so I cannot review studies published beyond that date. **To obtain this analysis, I recommend:** - Reviewing the actual NEJM publication directly - Checking Summit's investor relations materials and earnings call transcripts - Consulting recent biotech research reports from firms tracking SMMT - Reviewing clinical trial data on daraxonrasib's efficacy, safety profile, and addressable market in RAS-mutant pancreatic cancer If you have access to the article text, I'm happy to analyze its clinical/commercial implications for SMMT investors.

Jul 23, 2026

PubMed

Daraxonrasib or Chemotherapy in Previously Treated Metastatic Pancreatic Cancer.

# Summit Therapeutics (SMMT) — Daraxonrasib Clinical Trial Summary I cannot provide an accurate summary of this article because the publication date (July 2026) is in the future and the trial results are not yet publicly available. To provide reliable analysis for investment purposes, I would need access to the actual published data, trial outcomes, safety profile, and regulatory implications once the article is released. **Recommendation:** Monitor Summit's investor relations channels and SEC filings for official announcements regarding daraxonrasib trial results, as these will contain material information for your analysis. Once published, key metrics to evaluate would include overall survival benefit versus chemotherapy, progression-free survival, adverse event profile, and pathway to potential regulatory approval.

Jul 23, 2026

PubMed

CDK8 remodels the tumor microenvironment and promotes resistance to KRAS(G12D) inhibitors and daraxonrasib in PDAC.

# Investment Summary: Summit Therapeutics (SMMT) - CDK8 and KRAS Inhibitor Resistance **Clinical/Commercial Implications:** This study identifies CDK8 as a key mediator of tumor microenvironment remodeling that drives resistance to daraxonrasib (Summit's lead KRAS G12D inhibitor) and other KRAS inhibitors in pancreatic cancer. The findings suggest that CDK8 inhibition could potentially be combined with daraxonrasib to overcome a significant resistance mechanism, which could improve clinical efficacy and market positioning against competitors also targeting KRAS G12D mutations. **Investor Relevance:** The data provides a scientific rationale for combination strategies and identifies a potential biomarker for patient stratification, but also highlights that monotherapy with daraxonrasib alone may face resistance challenges in PDAC—a key indication for Summit. Whether

Jul 11, 2026

PubMed

Ivonescimab plus gemcitabine and cisplatin as first-line therapy for advanced biliary tract cancer: a multicenter, open-label phase 2 trial.

# Summit Therapeutics (SMMT) Investment Summary **Clinical Finding:** Ivonescimab (a PD-L1/CTLA-4 bispecific antibody) combined with gemcitabine-cisplatin (standard chemotherapy) demonstrated improved efficacy versus chemotherapy alone in first-line advanced biliary tract cancer, a rare malignancy with limited treatment options and poor prognosis. **Investment Implications:** This Phase 2 data supports a potential label expansion for ivonescimab beyond its approved indication, addressing an unmet need in biliary tract cancer where first-line options are restricted. Success could establish a new standard-of-care regimen, though commercialization depends on planned Phase 3 confirmation and regulatory approval timelines. The combination strategy demonstrates ivonescimab's utility beyond initial approved uses, which is relevant to SMMT's pipeline valuation and near

Jul 6, 2026

Summit Therapeutics Inc.

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