Cardiff Oncology (NASDAQ:CRDF) saw its shares drop nearly 30% in premarket trading Tuesday following the release of updated Phase 2 clinical data for onvansertib administered with standard-of-care regimens in first-line RAS-mutated metastatic colorectal cancer.
The clinical-stage company reported that adding onvansertib to FOLFIRI/bevacizumab produced a dose-dependent increase in confirmed objective response rates compared with the standard regimen alone. In the 30mg dose arm, the confirmed objective response rate was 72.2%, versus 43.2% observed with the standard treatment arm, and progression-free survival for that cohort had not yet been reached.
Cardiff described the findings as positive and said it intends to advance the 30mg dose into a registrational trial later this year. Despite that characterization, investors reacted negatively to the update, driving the sizable premarket decline. The market response suggests participants may have anticipated stronger efficacy signals or were unsettled by questions around the statistical significance of some of the trial’s results.
The company also reported tolerability data, stating that onvansertib in combination with both chemotherapy regimens was generally well-tolerated and that no major or unexpected toxicities were observed. The most common treatment-emergent adverse event identified was neutropenia.
Management changes
Alongside the clinical update, Cardiff announced a leadership transition. Board member Mani Mohindru, PhD, has been named interim chief executive officer, replacing Mark Erlander. The company said chief financial officer James Levine has stepped down, and Brigitte Lindsay has been promoted to Chief Accounting Officer.
Cardiff said it expects to present final trial data and outline registrational plans in the first half of 2026 as it finalizes the trial design in consultation with the U.S. Food and Drug Administration.
The company’s regulatory and development timeline, tolerability observations, dose-specific response rates, and recent executive changes are central to how investors are re-evaluating risk and near-term prospects for the program.