On April 30, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported its financial results and provides an update on clinical and operational progress for the first quarter ended March 31, 2026.
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Clinical & Operational Updates
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:
Since in-licensing ivonescimab, from Akeso Inc. (Akeso, HKEX Code: 9926.HK) in January 2023, 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 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
HARMONi-GI3: Ivonescimab combined with chemotherapy in patients with first-line unresectable metastatic CRC
HARMONi-6
Overall survival data from the Phase III HARMONi-6 trial, conducted in China and sponsored by Akeso, will be presented in the Plenary Session of the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. According to ASCO (Free ASCO Whitepaper), Late-breaking Abstracts are released at 8:00am ET on the day of the presentation, currently scheduled for Sunday, May 31, 2026.
The HARMONi-6 study evaluated ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, a PD-1 inhibitor, in combination with 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.
HARMONi-3 Squamous
Previously, Summit announced its intention to perform an interim PFS analysis for the squamous cohort of the HARMONi-3 study in the second quarter of 2026. As previously communicated, the purpose of this interim analysis was to provide a potential opportunity to speak with the regulatory authorities, including the US Food & Drug Administration, earlier than the timing of the preplanned final PFS analysis in the second half of 2026. To achieve statistical significance, there was a meaningfully higher bar than the upcoming planned final PFS analysis based on the minimal alpha spent on the interim analysis. At this early interim PFS analysis reviewed exclusively by the Independent Data Monitoring Committee (iDMC), the iDMC recommended that the study continue as planned. No safety concerns were noted, and the study continues to be double-blinded. There is no change to the previously guided timing of the preplanned final PFS analysis in the second half of 2026.
HARMONi-3 Non-Squamous
Enrollment in the non-squamous NSCLC cohort continues and enrollment is now expected to complete by the end of the second quarter of 2026. We expect to have PFS data for this cohort in the first half of 2027.
HARMONi
In January 2026, we announced that the U.S. Food & 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.
Additional Ivonescimab Development Updates
Summit’s clinical trial collaborations continue to progress as planned.
In June 2025, we 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 January 2026, we announced a clinical collaboration with GSK plc (GSK) to evaluate ivonescimab in combination with GSK’s novel B7-H3, risvutatug rezetecan, in multiple solid tumors. The initial study under this collaboration agreement is expected to begin dosing patients mid-2026.
In February 2026, we 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. The primary endpoint for the study is overall survival and is expected to enroll approximately 780 patients with PD-L1 positive, recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Patient enrollment is expected to begin in the second quarter of 2026.
Summit’s global Phase III trials, the non-squamous cohort of HARMONi-3, HARMONi-7, and HARMONi-GI3, continue to enroll. In addition to the multiregional studies conducted and sponsored by Summit, our partners at Akeso are 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, small cell lung cancer, colorectal cancer, and pancreatic cancer.
We plan to continue further expansion of the global Phase III clinical development program for ivonescimab in additional settings and tumor types. We intend to continue to provide more details in the coming months with respect to additional Phase III studies evaluating ivonescimab beyond NSCLC, CRC, and HNSCC.
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 supporting more than 65 ISTs, of which 20 are actively enrolling.
Financial Highlights
Cash and Cash Equivalents and Short-term Investments
Aggregate cash and cash equivalents and short-term investments were $598.7 million and $713.4 million at March 31, 2026 and December 31, 2025, respectively.
GAAP and Non-GAAP Operating Expenses
GAAP operating expenses were $195.2 million for the first quarter of 2026, compared to $66.8 million for the same period of the prior year. The increase in GAAP operating expenses was due to the increase in stock-based compensation expense of $61.7 million primarily related to the modification to our performance-based stock option awards during the second quarter of 2025.
Non-GAAP operating expenses were $122.4 million for the first quarter of 2026, compared to $55.7 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 $132.6 million for the first quarter of 2026, compared to $51.2 million for the same period of the prior year. The increase was due to the increase in stock-based compensation expense of $20.3 million primarily related to the modification to our performance-based stock option awards during the second quarter of 2025.
Non-GAAP R&D expenses were $108.2 million for the first quarter of 2026, compared to $47.1 million for the same period of the prior year. The increase was primarily driven by initiating new clinical trials and expanding current clinical trials from last year.
GAAP and Non-GAAP General and Administrative (G&A) Expenses
GAAP G&A expenses were $62.6 million for the first quarter of 2026, compared to $15.6 million for the same period of the prior year. The increase was due to the increase in stock-based compensation expense of $41.4 million primarily related to the modification to our performance-based stock option awards during the second quarter of 2025.
Non-GAAP G&A expenses were $14.2 million for the first quarter of 2026, compared to $8.6 million for the same period of the prior year. The increase was primarily driven by the expansion of our infrastructure and management team to support the development of ivonescimab.
GAAP and Non-GAAP Net Loss
GAAP net loss in the first quarter of 2026 and 2025 was $189.4 million or $(0.24) per basic and diluted share, and $62.9 million or $(0.09) per basic and diluted share, respectively.
Non-GAAP net loss in the first quarter of 2026 and 2025 was $116.6 million or $(0.15) per basic and diluted share, and $51.8 million or $(0.07) per basic and diluted share, respectively.
Use of Non-GAAP Financial Measures
This release includes measures that are not in accordance with U.S. generally accepted accounting principles (Non-GAAP measures). These Non-GAAP measures should be viewed in addition to, and not as a substitute for, Summit’s reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these Non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. For further information regarding these Non-GAAP measures, please refer to the tables presenting reconciliations of our Non-GAAP results to our U.S. GAAP results and the "Notes on our Non-GAAP Financial Information" that accompany this press release.
(Press release, Summit Therapeutics, APR 30, 2026, View Source [SID1234664986])