Summit Therapeutics Inc.

SMMT

Held by 5 specialist biotech funds

High Convergence

5 funds opened new positions. Next phase3 readout (Ridinilazole): Sep 2021. Short interest: 27.3% 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 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 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

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

PubMed

Bispecific Antibody Ivonescimab Added to Chemotherapy in EGFR-Variant Non-Small Cell Lung Cancer: Research Summary.

# Summit Therapeutics - Ivonescimab Clinical Data Summary **Clinical Finding:** Ivonescimab, a bispecific antibody targeting EGFR and MET, demonstrated clinical benefit when combined with chemotherapy in EGFR-variant NSCLC, addressing a patient population with limited treatment options and potential resistance mechanisms. **Investment Implications:** This JAMA-published data supports ivonescimab's differentiation in the competitive EGFR+ NSCLC market by tackling dual-pathway resistance; however, commercial viability depends on regulatory approval timeline, reimbursement positioning versus existing TKIs and checkpoint inhibitors, and the addressable size of the EGFR-variant subset. The combination approach may face uptake challenges if safety/tolerability burden or cost-effectiveness doesn't clearly exceed standard-of-care alternatives in clinical practice.

Jun 17, 2026

PubMed

Bispecific Antibody Ivonescimab Added to Chemotherapy in EGFR-Variant Non-Small Cell Lung Cancer: The HARMONi-A Randomized Clinical Trial.

# HARMONi-A Trial Summary for SMMT Investors **Clinical Finding:** Ivonescimab, a bispecific antibody targeting EGFR and MET, demonstrated efficacy when combined with chemotherapy in EGFR-variant NSCLC patients, establishing a potential treatment pathway for a genetically defined patient population. **Commercial Implication:** The trial validates ivonescimab's mechanism in a specific molecular subset, which could support label expansion beyond standard EGFR mutations and differentiate the compound in a competitive EGFR space; however, market uptake depends on whether combination chemotherapy positioning offers advantages over emerging third-generation EGFR TKIs that dominate current treatment paradigms. **Investor Consideration:** This JAMA-level data strengthens ivonescimab's clinical profile but investors should assess whether the EGFR-variant indication represents a

Jun 17, 2026

PubMed

Positive results for daraxonrasib for previously treated metastatic pancreatic cancer.

# Summit Therapeutics (SMMT) - Daraxonrasib Clinical Update **Summary:** Daraxonrasib demonstrated positive efficacy in previously treated metastatic pancreatic cancer, a patient population with limited therapeutic options and poor prognosis, potentially positioning the asset as a meaningful treatment alternative in a high-mortality indication. The results support advancement toward potential regulatory submissions and could establish commercial viability in pancreatic cancer, addressing a significant unmet medical need in an oncology market segment with limited competitor density. **Investment Relevance:** This data point is material for de-risking the daraxonrasib program and validates its clinical utility beyond initial development assumptions, though investor assessment should also weigh competing pipeline assets, trial durability data, and regulatory pathway clarity ahead of potential approvals.

Jun 12, 2026

PubMed

Daraxonrasib effective in metastatic pancreatic ductal adenocarcinoma.

# Investment Summary: Daraxonrasib in mPDAC **Clinical Finding:** Daraxonrasib demonstrates efficacy in metastatic pancreatic ductal adenocarcinoma (mPDAC), a disease with limited treatment options and historically poor outcomes. **Investor Implications:** This result validates Summit's mechanism in a high-mortality indication with substantial commercial potential, though clinical benefit magnitude and comparative positioning versus standard-of-care therapies would require examination of the full data to assess peak sales potential and development timeline. mPDAC represents a significant market opportunity given the disease's prevalence and unmet need, potentially supporting label expansion and justifying continued clinical investment.

Jun 12, 2026

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