Summit Therapeutics (NASDAQ:SMMT) saw its stock decline 3.53% in premarket trading Monday following the release of its third-quarter earnings.
The company posted a non-GAAP net loss of $0.13 per share, beating analyst expectations of a $0.17 loss. Operating expenses jumped to $103.4 million on a non-GAAP basis from $39.0 million in the same period last year, reflecting expanded clinical work on its lead asset, ivonescimab. As of September 30, Summit reported $238.6 million in cash and cash equivalents, down from $412.3 million at the end of 2024.
Summit also outlined plans to submit a Biologics License Application (BLA) for ivonescimab in the fourth quarter of 2025. The submission will be based on data from its global Phase III HARMONi trial in patients with EGFR-mutated non-small cell lung cancer (NSCLC).
The company’s decision comes even after prior guidance from the U.S. Food and Drug Administration that a statistically significant overall survival benefit would be required for approval. In the HARMONi study, ivonescimab reduced the risk of disease progression or death by 48% compared with chemotherapy alone, though it did not show a statistically significant improvement in overall survival.
“After careful consideration of the safety and efficacy profile of the current FDA-approved options for patients in this setting, the positive results of the Phase III multiregional study, including regional consistency, as well as discussions with key opinion leaders and those physicians who have administered ivonescimab to patients in a clinical study setting, we believe that the safety and efficacy data generated in the HARMONi study demonstrates that patients suffering from epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) in this setting can benefit from the ivonescimab regimen despite the lack of a statistically significant showing on overall survival,” the company stated.
In addition to the lung cancer program, Summit announced plans to launch HARMONi-GI3, a new global Phase III trial evaluating ivonescimab in first-line unresectable metastatic colorectal cancer, with additional Phase III studies expected in Q1 2026.
Summit Therapeutics stock price
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