Summit Therapeutics' earnings report missed expectations, leading to a decline in stock price despite progress in projects

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Investing.com – Summit Therapeutics Inc. (NASDAQ:SMMT) announced on Monday that its fourth-quarter results fell short of analyst expectations, with an adjusted loss per share of £0.29, compared to the market expectation of a loss of £0.08.

The company’s full-year adjusted net loss for fiscal 2025 was $347.2 million, or a loss of $0.46 per share, compared to $170.3 million, or a loss of $0.24 per share, in 2024. The increased loss was mainly due to expanded clinical research and higher development costs related to ivonescimab, the company’s investigational bispecific antibody. After-hours trading on Monday saw the stock decline by 2.4%.

Summit announced that patient enrollment screening for its HARMONi-3 Phase III squamous cell carcinoma cohort was completed in the first quarter of 2026. The company expects to conduct an interim analysis of progression-free survival (PFS) in the second quarter of 2026, with final PFS data and interim overall survival data planned for release in the second half of 2026.

The company also disclosed that the European Organization for Research and Treatment of Cancer (GORTEC) will begin clinical trial sites for the Phase III ILLUMINE study in early Q2 2026. This study will evaluate the efficacy of ivonescimab monotherapy and its combination with ligufalimab compared to pembrolizumab in approximately 780 patients with PD-L1 positive recurrent and/or metastatic head and neck squamous cell carcinoma.

In January of this year, the U.S. FDA accepted Summit’s biologics license application (BLA) for ivonescimab in combination with chemotherapy for EGFR-mutant NSCLC, with a PDUFA target action date of November 14, 2026.

Summit reported that as of December 31, 2025, cash, cash equivalents, and short-term investments totaled $713.4 million, up from $412.3 million as of December 31, 2024. Full-year adjusted operating expenses for fiscal 2025 were $362 million, compared to $175 million in 2024.

This article was translated with the assistance of artificial intelligence. For more information, please see our Terms of Use.

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