Summit Therapeutics

What Summit Therapeutics does

Summit Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and future commercialization of oncology therapies, with its strategic centerpiece being ivonescimab (SMT112 in Summit's territories, AK112 in Akeso's), a novel tetravalent PD-1/VEGF bispecific antibody with cooperative binding and an Fc-null architecture. The molecule was engineered by Akeso Inc. and was in-licensed by Summit in December 2022 for $500 million upfront; Summit holds exclusive commercialization rights in the United States, Canada, Europe, Japan, Latin America, the Middle East, and Africa, while Akeso retains rest-of-world rights. Ivonescimab is approved and commercially sold in China by Akeso (RMB3,033.1 million in 2025, 51.48% YoY growth, included in China's National Reimbursement Drug List) but is not yet approved by any other regulatory authority. Summit is running multiple Phase III trials — HARMONi, HARMONi-3, HARMONi-6, HARMONi-7, HARMONi-GI3, and ILLUMINE — across NSCLC, colorectal cancer, and head and neck cancer indications, with the FDA having accepted its Biologics License Application in January 2026 and set a PDUFA goal date of November 14, 2026 for second-line EGFR-mutant NSCLC.

Summit currently generates zero product revenue and reported a GAAP net loss of $1.08 billion in 2025 (driven significantly by $732.4M of stock-based compensation), ending the fiscal year with approximately $713.4 million in cash and zero debt. The company has financed operations through cumulative equity raises exceeding $1.635 billion between 2022 and 2025, with a $500 million private placement completed in October 2025 as the most recent round. Headcount is reported at 101-250 employees, with offices in Miami (headquarters), Palo Alto, Princeton (US commercial operations hub), Dublin, and Abingdon, UK. The company is building US commercial infrastructure (market access, sales operations, patient marketing) in advance of anticipated FDA approval, with field medical teams (Regional Medical Science Directors and Medical Science Liaisons) already engaging oncologists. Co-CEOs Robert Duggan (~85% insider ownership) and Dr. Maky Zanganeh lead the company, supported by clinical collaborations with GSK (B7-H3 ADC combinations) and Revolution Medicines (RAS inhibitor combinations).

The business model is a pre-launch, single-asset pharmaceutical model: Summit pays milestones and royalties to Akeso, develops and will commercialize ivonescimab through traditional pharma channels (specialty pharmacies, hospital GPOs, direct sales to oncologists), and depends entirely on ivonescimab's regulatory and commercial success across its seven-territory licensing footprint. Strategic intent centers on positioning ivonescimab as a first-in-class PD-1/VEGF bispecific antibody and potential replacement or alternative to Merck's Keytruda in first-line NSCLC.

Name

Summit Therapeutics

Legal name

Summit Therapeutics Inc.

Website

https://smmttx.com

Company type

Public

Founded year

2003

Operating status

Operating

Headcount range

251–500 employees

Short description

Summit Therapeutics is a clinical-stage biopharmaceutical company developing ivonescimab, a first-in-class PD-1/VEGF bispecific antibody in-licensed from Akeso Inc., targeting non-small cell lung cancer and colorectal cancer across US, Canada, Europe, Japan, Latin America, Middle East, and Africa with an FDA PDUFA date of November 14, 2026.

Ownership category

akta.pro rank

Product category

Oncology Biopharmaceuticals

NAICS

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

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Antibody-Drug Conjugates (ADCs) & Antibody Conjugates (HLAAAAAE)

akta.pro secondary industries

Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF)

Keywords

• Oncology therapeutics
• Bispecific antibodies
• Clinical-stage biopharmaceuticals
• Lung cancer treatment
• Immunotherapy drug development

Headquarters

HQ city

Abingdon

HQ country

United Kingdom

HQ region

Europe

Offices5 records

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. Pharmaceutical Product Sales (if approved): Summit Therapeutics is a pre-revenue clinical-stage company. Upon FDA approval of ivonescimab, the primary revenue stream will be product sales of a prescription oncology drug dispensed through specialty pharmacies and hospital buying groups. The company has built US commercial infrastructure including sales operations, marketing, and market access teams. Summit holds license territories for ivonescimab covering US, Canada, Europe, Japan, Latin America, Middle East, and Africa. Ivonescimab is already approved and commercially sold in China by Akeso.
2. Licensing Royalties / Milestone Payments: As a licensee of Akeso's ivonescimab, Summit is responsible for development and commercialization costs in its license territories and may owe milestone payments and royalties to Akeso. The original license agreement was signed in December 2022 with Summit acquiring rights for $500 million upfront. Potential obligations of up to $4.56 billion to partner Akeso have been cited in financial analyses.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Summit Therapeutics is developing ivonescimab (SMT112), an investigational first-in-class PD-1/VEGF bispecific antibody in-licensed from Akeso Inc. for the treatment of solid tumors including non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (CRC). The drug is being advanced through multiple Phase III clinical trials (HARMONi, HARMONi-3, HARMONi-6, HARMONi-7, HARMONi-GI3) toward regulatory approval, with an FDA-accepted BLA and PDUFA target action date of November 14, 2026 in second-line EGFR-mutant NSCLC. Summit retains commercialization rights in the US, Canada, Europe, Japan, Latin America, the Middle East, and Africa, while Akeso owns the rest of world.

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 primary product candidate is ivonescimab (also known as SMT112 in Summit's license territories and AK112 in Akeso's territories), a novel bispecific antibody targeting PD-1 and VEGF. Ivonescimab is currently in multiple Phase III clinical trials for non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) indications. The company operates in partnership with Akeso Inc., with Summit holding license rights for the US, Canada, Europe, Japan, Latin America, Middle East, and Africa. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's NMPA.

Differentiator

Problem solved

Functional benefit

Products and services

• Ivonescimab (SMT112) Investigational first-in-class PD-1/VEGF bispecific antibody in-licensed from Akeso Inc. for the treatment of solid tumors including non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (CRC), combining PD-1 blockade (immunotherapy) with VEGF anti-angiogenesis in a single tetravalent molecule with cooperative binding.

Quantifiable outcome

• HARMONi-6 Phase III: 34% reduction in risk of death (HR 0.66, p=0.0017) in first-line squamous NSCLC vs. tislelizumab plus chemotherapy; median OS 27.89 months vs. 23.69 months; 24-month OS rate 64.7% vs. 48.6%
• +4 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered minor and core.

• Revolution Medicines, Inc.minorStrategic or Co-development Partner · 26 February 2026Summit Therapeutics entered into a clinical collaboration with Revolution Medicines to evaluate ivonescimab in combination with RAS(ON) inhibitors for the treatment of cancer. The collaboration includes the APEX-103 study assessing ivonescimab with Revolution's RAS inhibitor pipeline. Both companies retain rights to their respective products.
• GSK plccoreStrategic or Co-development Partner · 12 January 2026Summit Therapeutics announced a clinical trial collaboration with GSK to evaluate ivonescimab in combination with GSK's B7-H3 antibody drug conjugate (ADC) risvutatug rezetecan across multiple solid tumor settings including small cell lung cancer. Under the agreement, Summit supplies ivonescimab while GSK manages day-to-day clinical operations. Patient dosing is expected to begin in mid-2026. Each party retains rights to their respective products, and the collaboration is non-exclusive.
• CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator)minorStrategic or Co-development Partner · 3 March 2023CARB-X provided funding to Summit Therapeutics for developing a new antibiotic targeting multidrug-resistant infections caused by CRE (Carbapenem-Resistant Enterobacteriaceae) bacteria. The project involves clinical development stages with potential additional funding if milestones are met. This partnership relates to Summit's legacy antibiotic pipeline (ridinilazole for C. difficile), outside its current strategic focus on ivonescimab oncology.
• Akeso Inc. (HKEX: 9926.HK)coreStrategic or Co-development Partner · 6 December 2022Summit Therapeutics entered into a definitive partnership with Akeso Inc. in December 2022 to in-license ivonescimab (SMT112 in Summit territories, AK112 in Akeso territories). Summit paid $500 million upfront for rights in US, Canada, Europe, Japan, Latin America, Middle East, and Africa. Akeso retains rights in the rest of world (China, Australia, etc.). Akeso has 7 commercially approved drugs in China, 50+ drug development programs, and over 3,000 employees with complete in-house functions from discovery to sales. Michelle Xia, Ph.D., Akeso Co-Founder, Chairwoman, President and CEO, serves on Summit's Board of Directors.
• GORTEC (Head and Neck Radiation Oncology Group)minorStrategic or Co-development PartnerThe ILLUMINE study is a cooperative group Phase III clinical trial sponsored by GORTEC (global lead and EU Sponsor) in collaboration with Akeso (China Sponsor) and Summit (collaborator). The trial evaluates ivonescimab monotherapy and ivonescimab plus ligufalimab vs. pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

Scale indicators9 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Akeso Inc. Chinese biotech that developed and commercialized ivonescimab in China, generating RMB3B+ in 2025 sales. Akeso is Summit's licensor and the originator of the PD-1/VEGF bispecific technology, making it the closest direct peer despite operating in a different geographic market.

Broad incumbents

• Merck & Co. Owns Keytruda (pembrolizumab), the anti-PD-1 standard of care in NSCLC generating ~$30B annual revenue. Merck is Summit's primary competitive target as ivonescimab directly challenges Keytruda's first-line NSCLC dominance across multiple indications.
• Bristol-Myers Squibb: Markets Opdivo (nivolumab), the first approved anti-PD-1 inhibitor, and has a broad oncology biologics portfolio. BMS is a direct competitor in the PD-1/IO space and serves similar oncologist customers treating NSCLC and other solid tumors.
• AstraZeneca: Markets Imfinzi (durvalumab) and Tagrisso (osimertinib for EGFR-mutant NSCLC). AstraZeneca competes directly in both the IO and EGFR-mutant NSCLC spaces where ivonescimab is positioned, with overlapping customer base of thoracic oncologists.
• Genmab A/S: Develops antibody therapeutics including bispecific platforms (e.g., DuoBody technology). Genmab is a relevant peer given its bispecific antibody expertise and partnerships with major pharma, comparable to Summit's PD-1/VEGF bispecific approach.
• Regeneron Pharmaceuticals: Major oncology biologics player with antibody platform (e.g., Libtayo/cemiplimab competing in NSCLC) and an active bispecific antibody pipeline. Comparable as a publicly-traded, large-cap antibody-therapy innovator in oncology.
• BeiGene (now BeOne Medicines): Global oncology biotech with PD-1 inhibitor tislelizumab (used in HARMONi-6 comparator arm) and a broad hematology/oncology pipeline. BeiGene is both a comparator in Summit's trials and a commercial competitor in the global PD-1 market.

Emerging players

• MacroGenics: Clinical-stage biotech with a focused bispecific antibody pipeline (e.g., vobramitamab duocarmazine, MGD024). Comparable to Summit as a smaller bispecialist with similar oncology-focused clinical-stage profile and mechanism-driven differentiation.
• Arcus Biosciences: Clinical-stage immuno-oncology biotech developing adenosine receptor antagonists (e.g., quemliclustat, etrumadenant) and anti-PD-1 combinations. Arcus is comparable as a focused IO company with similar pre-commercial stage and combinations targeting tumor microenvironment.
• Cullinan Oncology: Clinical-stage oncology biotech developing targeted therapies including IO agents. Comparable as a smaller, oncology-pure-play biotech with multiple clinical-stage assets and similar pre-revenue business model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/Summitplc
• Facebookfacebook.com/smmttxinc
• LinkedInlinkedin.com/company/summit-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds19 records

Investors7 records

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M&A2 records

Investments

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

Frequently asked questions about Summit Therapeutics