On July 23, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) reported its financial results for the second quarter and six months ended June 30, 2026 and provided an update on clinical and operational progress.
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"The clinical momentum of ivonescimab continues to build, with two recent key data readouts that significantly bolster our development progress. At ASCO (Free ASCO Whitepaper), the landmark HARMONi-6 results established the first head-to-head Phase III study in any tumor type to demonstrate a meaningful overall survival advantage over anti-PD-1 inhibitors in combination with chemotherapy, representing an important milestone for cancer patients and for the broader immuno-oncology field," said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. "This was followed by updated overall survival data from the HARMONi trial, in which western patients replicated the survival benefit seen in Asian patients and further reinforces our confidence in the regional consistency of the efficacy results of ivonescimab."
"These new data continue to demonstrate the differentiated profile of ivonescimab," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. "In HARMONi-6, we saw an outcome that underscores the potential impact of our bispecific PD-1 / VEGF program. Equally important, the updated HARMONi overall survival analysis provided additional evidence of consistency of efficacy outcomes across patient populations. We also presented encouraging Phase II colorectal cancer data at ASCO (Free ASCO Whitepaper) that adds to the growing body of evidence supporting the potential of ivonescimab as a differentiated PD-1 / VEGF bispecific antibody across tumor types. We believe these results meaningfully strengthen the overall body of evidence supporting ivonescimab and provide important validation as we advance our global development program across multiple solid tumors."
Clinical & Operational Updates
Clinical and operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:
Summit in-licensed ivonescimab from Akeso Inc. (Akeso, HKEX Code: 9926.HK) in January 2023. In total, over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients have been treated in the commercial setting with ivonescimab in China, as noted and updated by Akeso. Summit has exclusive rights to develop and commercialize ivonescimab in North America, South America, Europe, the Middle East, Africa, and Japan, while Akeso retains development and commercialization rights for remaining territories, including China.
Summit is developing ivonescimab in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), specifically conducting multiregional Phase III clinical trials in the following proposed indications:
HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI);
HARMONi-3: Ivonescimab combined with chemotherapy in patients with first-line metastatic NSCLC, with two distinct cohorts to be analyzed separately for squamous tumors and non-squamous tumors;
HARMONi-7: Ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression; and
HARMONi-GI3: Ivonescimab combined with chemotherapy in patients with first-line unresectable metastatic CRC.
HARMONi
In January 2026, the U.S. Food and Drug Administration (FDA) accepted for filing Summit’s Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have received prior EGFR TKI therapy. The BLA was submitted based on the overall results of the global Phase III HARMONi trial. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
In July 2026, Summit announced results of a new updated overall survival (OS) analysis from the HARMONi study, which showed a consistent OS trend amongst western and Asian patients as western patients were followed for additional time on study. These encouraging results provide further evidence of the geographic translatability of ivonescimab across the globe, including western patients from North America and Europe. In this new analysis, western patients increased their time on study, reaching a median follow-up of 23.2 months; Asian patients remained locked with a median follow-up time of 32.7 months. A hazard ratio of 0.76 was observed for the full ITT population; the same 0.76 hazard ratio was observed in both Asian and western patient subgroups, respectively, in this analysis. Ivonescimab continued to demonstrate an acceptable and manageable safety profile that was consistent with previous Phase III data of ivonescimab plus chemotherapy. No additional safety signals were observed. These results have been made available to the FDA, and more detailed data are intended to be presented at an upcoming medical meeting.
HARMONi-3
Enrollment in both the squamous and non-squamous NSCLC cohorts of the global HARMONi-3 study is now complete. The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the second half of 2026, and a planned early interim analysis for OS is expected to take place in conjunction with the primary PFS analysis. An interim analysis for overall survival independent of PFS is planned for the first half of 2027. For the non-squamous cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027.
In a similar patient population to the squamous cohort of HARMONi-3, Akeso’s HARMONi-6 study evaluated ivonescimab plus platinum-based chemotherapy compared with tislelizumab, a PD-1 inhibitor, plus platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. HARMONi-6 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso with all relevant data exclusively generated and analyzed by Akeso.
Positive OS data for HARMONi-6 was presented in May 2026 as a part of the Plenary Session at the ASCO (Free ASCO Whitepaper) 2026 Annual Meeting; previously, positive PFS results for the HARMONi-6 trial were presented in October 2025 as part of the Presidential Symposium at the ESMO (Free ESMO Whitepaper) 2025 Annual Congress. In the recently presented HARMONi-6 analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement in OS when compared to tislelizumab in combination with chemotherapy, with a hazard ratio of 0.66 (95% CI: 0.50, 0.87; p=0.0017). For both PFS and OS, a clinically meaningful benefit was demonstrated across clinical subgroups, including those with either PD-L1 negative or positive expression. The HARMONi-6 results represent the first regimen to achieve a statistically significant and clinically meaningful OS benefit over an anti-PD-(L)1 antibody combined with chemotherapy in a Phase III clinical trial in any tumor type including front-line NSCLC.
Additional Ivonescimab Development Updates
Summit’s global Phase III trials HARMONi-7 and HARMONi-GI3 continue to enroll. In addition to the multiregional studies conducted and sponsored by Summit, Akeso is enrolling several single-region Phase III studies exclusively in China in multiple indications, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma (HNSCC), small cell lung cancer, colorectal cancer, and pancreatic cancer.
Summit plans to continue further expansion of the global clinical development program for ivonescimab, including additional Phase III studies, in additional settings and tumor types. The company will continue to provide more details in the coming months with respect to additional Phase III studies evaluating ivonescimab beyond NSCLC, CRC, and HNSCC.
Summit’s clinical trial collaborations continue to progress as planned.
In July 2026, Summit announced a clinical collaboration with Arcus Biosciences, Inc. to evaluate ivonescimab in combination with Arcus’ novel HIF-2α inhibitor, casdatifan, in renal cell carcinoma. Data from the study under this collaboration agreement is expected to be generated by mid-2027.
In the second quarter of 2025, the company announced a clinical collaboration with Revolution Medicines, Inc. (RevMed) to evaluate ivonescimab in combination with three RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805), and G12C-selective inhibitor elironrasib (RMC-6291), in solid tumor settings with RAS mutations. As previously announced, the initial study under this collaboration, sponsored by RevMed, began enrolling patients in the first quarter of 2026.
In the first quarter of 2026, Summit announced a clinical collaboration with GORTEC, a European Head and Neck Oncology and Radiotherapy Group based in France, to evaluate ivonescimab monotherapy and ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, against monotherapy pembrolizumab in a randomized three-arm study. The Phase III study, GORTEC 2024-04 ILLUMINE (NCT07264075), is sponsored by GORTEC and is intended to be conducted in multiple countries in Europe and in China; Summit may consider the expansion of this study into the United States. ILLUMINE began enrolling patients in the second quarter of 2026.
In the first quarter of 2026, the company announced a clinical collaboration with GSK plc to evaluate ivonescimab in combination with GSK’s novel B7-H3 ADC, risvutatug rezetecan, in multiple solid tumors. The initial study under this collaboration agreement is expected to begin dosing patients later this quarter.
Clinical trial collaborations and investigator sponsored trials (ISTs) with leading academic organizations, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Dana Farber Cancer Institute, among others, continue to progress and expand evaluating ivonescimab in solid tumors. Summit is currently supporting more than 65 ISTs, of which 24 are actively enrolling.
In July 2026, Summit sold ridinilazole, an investigational Phase III precision antibiotic asset, to Biossil, Inc. Under the terms of the agreement, Summit will receive $500,000 upfront and up to $104.5 million in regulatory and commercial milestones, plus tiered royalties on net sales.
Financial Highlights
Cash and Cash Equivalents and Short-Term Investments
Aggregate cash and cash equivalents and short-term investments were $690.7 million and $713.4 million at June 30, 2026 and December 31, 2025, respectively.
During the second quarter of 2026, the company raised $230.8 million in gross proceeds through its ATM facility. Subsequent to June 2026, the company raised an additional $68.4 million in gross proceeds through its ATM facility.
GAAP and Non-GAAP Operating Expenses
GAAP operating expenses were $220.5 million for the second quarter of 2026, compared to $568.4 million for the same period of the prior year. The decrease in GAAP operating expenses was due to the decrease in stock-based compensation expense of $410.1 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025.
Non-GAAP operating expenses were $151.8 million for the second quarter of 2026, compared to $89.6 million for the same period of the prior year. The increase in Non-GAAP operating expenses was primarily driven by the expansion of clinical studies and development costs related to ivonescimab.
GAAP and Non-GAAP Research and Development (R&D) Expenses
GAAP R&D expenses were $157.7 million for the second quarter of 2026, compared to $208.0 million for the same period of the prior year. The decrease was due to the decrease in stock-based compensation expense of $104.5 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025.
Non-GAAP R&D expenses were $133.6 million for the second quarter of 2026, compared to $79.4 million for the same period of the prior year. The increase was primarily driven by the initiation of new clinical trials and expansion of current clinical trials from last year.
GAAP and Non-GAAP General and Administrative (G&A) Expenses
GAAP G&A expenses were $62.8 million for the second quarter of 2026, compared to $360.4 million for the same period of the prior year. The decrease was due to the decrease in stock-based compensation expense of $305.6 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025.
Non-GAAP G&A expenses were $18.2 million for the second quarter of 2026, compared to $10.2 million for the same period of the prior year. The increase was primarily driven by the expansion of infrastructure and headcount to support the development of ivonescimab.
GAAP and Non-GAAP Net Loss
GAAP net loss in the second quarter of 2026 and 2025 was $215.7 million or $(0.28) per basic and diluted share, and $565.7 million or $(0.76) per basic and diluted share, respectively.
Non-GAAP net loss in the second quarter of 2026 and 2025 was $147.0 million or $(0.19) per basic and diluted share, and $86.9 million or $(0.12) per basic and diluted share, respectively.
(Press release, Summit Therapeutics, JUL 23, 2026, View Source [SID1234669403])