Summit Therapeutics (NASDAQ:SMMT) executives used the company’s latest earnings call to emphasize updated survival data for ivonescimab, outline the timing of key late-stage trial readouts and detail the company’s cash position as it prepares for a potential U.S. regulatory decision later this year.
Chairman and Co-Chief Executive Officer Bob Duggan said Summit remains focused on ivonescimab, its PD-1/VEGF bispecific antibody and lead investigational asset. Duggan said ivonescimab has produced positive data in four Phase III clinical studies to date, leading to two approvals in China, with one additional filing under review there. He said 15 Phase III trials are ongoing or have read out across multiple tumor types, and that Summit and partner Akeso have initiated 52 clinical trials evaluating the drug.
Updated HARMONi Data Submitted to FDA
President and Co-Chief Executive Officer Dr. Maky Zanganeh highlighted an updated overall survival analysis from the global Phase III HARMONi trial, which evaluated ivonescimab plus chemotherapy versus chemotherapy alone in patients with EGFR-mutated non-small cell lung cancer after TKI therapy.
Zanganeh said the latest analysis, with a June 2026 data cutoff, showed Western patients had reached a median follow-up of more than 23 months, while Asian patients remained at a median follow-up of 33 months. The company reported an overall survival hazard ratio of 0.76 in both the total population and the Western regional data.
“The hazard ratio for Western patients has improved with more follow-up time,” Zanganeh said, adding that the Western results are now consistent with the magnitude of overall survival benefit seen in Asian patients, who had longer follow-up at the primary analysis.
Summit said no new safety signals were observed in the latest data cut, and that the safety profile remained acceptable and manageable, consistent with previous Phase III results of ivonescimab plus chemotherapy.
Zanganeh said Summit has made the updated results available to the U.S. Food and Drug Administration. The company’s biologics license application for ivonescimab plus chemotherapy in the EGFR-mutated non-small cell lung cancer post-TKI setting remains under FDA review, with a target PDUFA date of Nov. 14. Zanganeh noted that the FDA has previously said a statistically significant overall survival benefit is necessary to support marketing authorization in this setting.
Key Trial Timelines Remain in Focus
Summit also provided updates on several global Phase III studies. HARMONi-3 is evaluating ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in first-line metastatic non-small cell lung cancer in both squamous and non-squamous histologies, which will be analyzed separately.
Zanganeh said enrollment has been completed in both cohorts. Summit expects to reach the number of events needed for a progression-free survival analysis in the squamous cohort in the second half of this year, along with an early interim look at overall survival. The company expects a separate overall survival interim analysis in the first half of 2027. For the non-squamous cohort, Summit expects to reach the number of events for a progression-free survival analysis in the first half of 2027.
In the question-and-answer session, Chief Business and Strategy Officer Dave Gancarz said the HARMONi-3 squamous PFS timing is likely “towards the middle to back end of 2026,” rather than in the near term. He said the first-half 2027 overall survival analysis should have median follow-up generally consistent with the HARMONi-6 analysis and the updated Western patient data from HARMONi.
Summit said HARMONi-7, which compares ivonescimab monotherapy against pembrolizumab monotherapy in first-line non-small cell lung cancer with high PD-L1 expression, continues to enroll. HARMONi-GI3 is evaluating ivonescimab plus chemotherapy versus bevacizumab plus chemotherapy as first-line therapy in unresectable colorectal cancer.
Combination Collaborations Expand Development Plans
Zanganeh also reviewed Summit’s collaborations with Revolution Medicines, GSK and Arcus Biosciences. The Revolution Medicines collaboration began enrolling in the first quarter and is evaluating ivonescimab with three novel RAS inhibitors across solid tumor settings including pancreatic, colorectal and non-small cell lung cancers.
Summit expects its GSK collaboration, which will evaluate ivonescimab with GSK’s B7-H3 antibody-drug conjugate in multiple solid tumors, to enroll its first patient later this quarter. The company also announced a collaboration with Arcus to evaluate ivonescimab with Arcus’ HIF-2α inhibitor casdatifan in first-line metastatic clear cell renal cell carcinoma. Summit expects initial data from that collaboration by mid-next year.
The company also pointed to ILLUMINE, a Phase III head and neck cancer study sponsored by European cooperative group GORTEC, which is enrolling in Europe and is expected to begin in China later this year.
Cash Position Rises, Expenses Increase
Chief Operating Officer and Chief Financial Officer Manmeet Soni said Summit ended the second quarter of 2026 with $690.7 million in cash, up from $598.7 million at the end of the first quarter. Soni attributed the $92 million increase primarily to $231 million raised through the company’s at-the-market facility, partially offset by approximately $140 million used in operating activities during the quarter.
Soni said Summit filed a prospectus supplement for a new ATM facility of up to $380 million to provide additional financing flexibility. He also said the company currently has no debt on its balance sheet.
Total GAAP operating expenses were $220.5 million in the second quarter, compared with $195.2 million in the first quarter. Non-GAAP operating expenses, which exclude stock-based compensation, were $151.8 million, compared with $122.4 million in the prior quarter. Soni said the increase was primarily driven by higher research and development expenses related to clinical trial costs for HARMONi-GI3, HARMONi-3 and HARMONi-7.
Commercial Preparation Underway
In response to an analyst question, Soni said Summit is preparing for a possible U.S. commercial launch ahead of the Nov. 14 PDUFA date. He said the company has hired its commercial leadership team, market access staff and marketing personnel, while field force hiring would typically occur closer to the regulatory date. Gancarz added that the company has also ramped up medical science liaisons.
Duggan closed the call by reiterating management’s confidence in ivonescimab. “We know that ivonescimab works,” he said. “The question I leave you with is, what if ivonescimab works really well?”
About Summit Therapeutics (NASDAQ:SMMT)
Summit Therapeutics plc is a clinical‐stage biotechnology company dedicated to the discovery and development of precision medicines for serious and life‐threatening diseases. The company applies a targeted approach to drug design, focusing on novel mechanisms of action that differentiate its candidates from existing therapies.
Summit’s lead asset, ridinilazole (formerly SMT19969), is being developed to treat Clostridioides difficile infections and has received both Fast Track and Qualified Infectious Disease Product designations from the U.S.
