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MIAMI - On Monday, Summit Therapeutics Inc. (NASDAQ:SMMT) reported a third-quarter non-GAAP net loss of $0.13 per share, better than analyst estimates of $0.17 per share. Operating expenses increased significantly to $103.4 million on a non-GAAP basis compared to $39.0 million in the same period last year, primarily due to expanded clinical studies for ivonescimab. Cash and cash equivalents stood at $238.6 million as of September 30, down from $412.3 million at the end of 2024.
The biopharmaceutical company’s shares fell 3.53% in pre-market trading after the release.
The company also announced plans to submit a Biologics License Application (BLA) for ivonescimab in the fourth quarter of 2025, based on results from its global Phase III HARMONi study in EGFR-mutated non-small cell lung cancer (NSCLC).
Summit’s BLA submission decision comes despite the FDA’s previous indication that a statistically significant overall survival benefit would be necessary for marketing authorization. While ivonescimab demonstrated a 48% reduction in disease progression or death risk compared to chemotherapy alone in the HARMONi trial, it did not achieve statistically significant overall survival improvement.
"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.
Summit is also expanding its ivonescimab development program, announcing plans to initiate HARMONi-GI3, a new global Phase III study in first-line unresectable metastatic colorectal cancer, with additional Phase III studies to be detailed in Q1 2026.
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