What Summit Therapeutics does

Summit Therapeutics Inc. (NASDAQ: SMMT) is a clinical-stage biopharmaceutical oncology company headquartered in Miami, Florida. The company in-licensed ivonescimab (SMT112) — a novel potential first-in-class PD-1/VEGF bispecific antibody — from Akeso, Inc. (HKEX: 9926.HK) under an exclusive license covering the United States, Canada, Europe, Japan, Latin America, the Middle East, and Africa. Summit is running four concurrent global Phase III trials in non-small cell lung cancer (HARMONi, HARMONi-3, HARMONi-7) and metastatic colorectal cancer (HARMONi-GI3), with combination studies underway in clear cell renal cell carcinoma (with Arcus Biosciences' casdatifan, announced July 2026) and head and neck squamous cell carcinoma (via the GORTEC ILLUMINE study). The FDA has accepted the BLA for ivonescimab in EGFR-mutated NSCLC with a PDUFA goal date of November 14, 2026; the application is supported by HARMONi Phase III data showing an overall survival hazard ratio of 0.76 across both the full ITT population and the western patient subgroup. To date, more than 4,000 patients have been treated with ivonescimab across all clinical trials globally.

Summit's business model is pre-commercial: revenue is not yet generated in its license territories (the product is approved only in China via Akeso) and the company reported a Q2 2026 GAAP net loss of $215.7 million. The company held $690.7 million in cash and cash equivalents as of Q2 2026 after raising $230.8 million via its at-the-market (ATM) equity facility during the quarter, providing runway to advance the Phase III program and prepare for commercialization. To narrow focus, Summit divested its non-core Phase III antibiotic asset ridinilazole to Biossil, Inc. on July 14, 2026 for $500,000 upfront plus up to $104.5 million in regulatory and commercial milestones plus tiered royalties. Strategic collaborations beyond Akeso include Arcus Biosciences (ccRCC), GSK, Revolution Medicines, and GORTEC (HNSCC), each contributing clinical development capacity and combination-study optionality. Governance is led by Co-CEO and Chairman Bob Duggan and Co-CEO and President Dr. Maky Zanganeh. The principal forward-looking catalyst is the November 14, 2026 FDA PDUFA decision on ivonescimab in EGFR-mutated NSCLC, which will determine the company's transition from a pre-revenue clinical developer to a commercial-stage oncology company across its seven-region license territory.

Name

Summit Therapeutics

Legal name

Summit Therapeutics Inc.

Website

https://summittxinc.com

Company type

Public

Founded year

2003

Operating status

Operating

Headcount range

251–500 employees

Short description

Summit Therapeutics is a Miami-based, NASDAQ-listed clinical-stage biopharmaceutical oncology company commercializing-in-licensed rights to ivonescimab, a potential first-in-class PD-1/VEGF bispecific antibody, awaiting an FDA PDUFA decision on November 14, 2026 in EGFR-mutated NSCLC.

Ownership category

akta.pro rank

Product category

Oncology Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Oncology Specialty Pharmaceuticals (HLAIACAA)

akta.pro secondary industry

Oncology & Hematology Pharmaceuticals (HLAIAAAC)

Keywords

• Oncology therapeutics
• Bispecific antibodies
• Cancer immunotherapy
• Clinical development
• Biopharmaceutical products

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Product Commercialization: Pre-commercial stage; awaiting FDA approval for ivonescimab in EGFR-mutated NSCLC with PDUFA date of November 14, 2026. If approved, the company will commercialize the therapy in its license territories: United States, Canada, Europe, Japan, Latin America, Middle East, and Africa.
2. Asset Divestiture: Sold ridinilazole antibiotic asset to Biossil for $500,000 upfront plus up to $104.5 million in regulatory and commercial milestones plus tiered royalties on net sales
3. ATM Facility: Raised $230.8 million through its at-the-market (ATM) facility during Q2 2026

Go-to-market motion1 record

Marketing channels4 records

Core offering

Summit Therapeutics is a biopharmaceutical oncology company developing and commercializing ivonescimab (SMT112), a novel investigational potential first-in-class PD-1/VEGF bispecific antibody for the treatment of non-small cell lung cancer (NSCLC), metastatic colorectal cancer, and other solid tumors. The therapy is in-licensed from Akeso, Inc. and is being advanced through multiple global Phase III clinical trials, with an FDA PDUFA goal date of November 14, 2026 for EGFR-mutated NSCLC. The company currently has no commercial product sales and is pre-revenue from its lead asset.

Product overview

Summit Therapeutics is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver-, and societal-friendly medicinal therapies. The company's lead product candidate is ivonescimab (SMT112), a novel bispecific antibody targeting both PD-1 and VEGF, which is currently in multiple Phase III clinical trials for non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Ivonescimab is being developed through a partnership with Akeso, with Summit holding license territories for the United States, Canada, Europe, Japan, Latin America, the Middle East, and Africa.

Differentiator

Problem solved

Functional benefit

Products and services

• Ivonescimab (SMT112) Novel potential first-in-class investigational bispecific antibody combining immunotherapy via PD-1 blockade with anti-angiogenesis effects associated with blocking VEGF into a single tetravalent molecule. It displays cooperative binding with each of its intended targets, with higher affinity in the presence of both PD-1 and VEGF. Currently in Phase III clinical development for non-small cell lung cancer (NSCLC) and metastatic colorectal cancer, with FDA PDUFA goal date of November 14, 2026 for EGFR-mutated NSCLC.

Quantifiable outcome

• 49% greater efficacy than Merck's Keytruda in original study
• +2 more outcomes

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Arcus BiosciencescoreStrategic or Co-development Partner · 22 July 2026Clinical trial collaboration to evaluate the combination of Arcus's casdatifan (HIF-2α inhibitor) with Summit's ivonescimab (PD-1/VEGF bispecific antibody) in clear cell renal cell carcinoma. The combination study will be added as a new cohort to Arcus's existing ARC-20 platform study. Arcus will sponsor and conduct the trial while Summit supplies ivonescimab; both companies will share costs and retain commercial rights to their respective molecules. Initial data expected by mid-2027.
• Biossil, Inc.minorOthers · 14 July 2026Summit sold its Phase III antibiotic asset ridinilazole to Toronto-based Biossil for $500,000 upfront plus up to $104.5 million in regulatory and commercial milestones plus tiered royalties on net sales. The divestment allows Summit to focus on its core oncology strategy and ivonescimab development.
• Akeso, Inc.coreStrategic or Co-development PartnerSummit Therapeutics has an exclusive license agreement with Akeso for ivonescimab (known as SMT112 in Summit's license territories and AK112 in Akeso's territories). Summit has rights to develop and commercialize ivonescimab in United States, Canada, Europe, Japan, Latin America, Middle East, and Africa. Akeso retains rights for the rest of world. Akeso developed ivonescimab and has conducted multiple Phase III trials in China.
• GSKminorStrategic or Co-development PartnerEntered into new clinical collaboration with GSK as part of the company's strategy to expand clinical collaborations with multiple partners.
• Revolution MedicinesminorStrategic or Co-development PartnerExpanded partnership with Revolution Medicines for clinical collaboration development.
• GORTECminorStrategic or Co-development PartnerILLUMINE is a cooperative group study between GORTEC (global lead and EU Sponsor), Akeso (collaborator and China Sponsor), and Summit (collaborator) for 1L recurrent or metastatic PD-L1 positive HNSCC.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Emerging players

• Genmab: Antibody-focused biopharma with bispecific platform (DuoBody, HexaBody) developing oncology therapeutics. Comparable technology-platform peer with bispecific antibody expertise relevant to ivonescimab's mechanism.
• Innovent Biologics: China-based biopharma developing PD-1 inhibitor Tyvyt and a pipeline of oncology bispecifics including PD-1/VEGF candidates. Comparable emerging player with overlapping bispecific strategy and NSCLC focus.
• BeiGene: Global oncology biopharma with approved PD-1 inhibitor (tislelizumab) used as a comparator in Summit's HARMONi-6 study (HR 0.66 for ivonescimab vs tislelizumab). BeiGene is a directly comparable peer in immuno-oncology.
• Arcus Biosciences: Clinical-stage oncology biopharma with HIF-2α inhibitor casdatifan (partnered with Summit for ivonescimab combo in RCC). Arcus is an emerging peer with overlapping oncology pipeline and complementary mechanism.

Broad incumbents

• Regeneron Pharmaceuticals: Co-markets Libtayo (cemiplimab) with Sanofi in NSCLC and other indications, and is developing additional oncology bispecifics. Regeneron is a comparable innovator biopharma with PD-1 franchise overlap and bispecific pipeline.
• Roche: Markets Tecentriq (atezolizumab) and a broad oncology portfolio including bevacizumab (Avastin). Roche is a relevant broad incumbent given its PD-1 inhibitor position and its historical role in combining immunotherapy with anti-VEGF approaches.
• Merck & Co. Markets Keytruda (pembrolizumab), the standard-of-care PD-1 inhibitor against which ivonescimab demonstrated 49% greater efficacy in HARMONi. Merck is the incumbent Summit most directly seeks to displace in NSCLC and other oncology indications.
• AstraZeneca: Markets Imfinzi (durvalumab) and is actively pursuing PD-1/VEGF combinations (e.g., with its bevacizumab biosimilar and novel bispecifics), making AZ a broad incumbent peer with overlapping mechanism and indication strategy.
• Bristol-Myers Squibb: Markets Opdivo (nivolumab) and the Opdivo+Yervoy combination, established PD-1/PD-1+CTLA-4 regimens across NSCLC and other tumors. BMS is a broad incumbent competing in the same oncology immunotherapy space Summit is entering.

Direct peers

• Akeso, Inc. Originator of ivonescimab (AK112) and Summit's exclusive licensor for Western territories. Akeso is the closest direct peer — a Chinese oncology biopharma developing the same bispecific antibody molecule for the rest of world, with parallel Phase III programs in NSCLC.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/SMMT_TX
• Facebookfacebook.com/smmttxinc
• LinkedInlinkedin.com/company/summit-therapeutics
• Instagraminstagram.com/summittherapeutics.inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Summit Therapeutics