Cardiff Oncology, Inc.

Cardiff Oncology, Inc. is a clinical-stage biotechnology company dedicated to developing novel therapeutic options for cancer patients. Headquartered in San Diego, California, the company's core mission revolves around leveraging Polo-like Kinase 1 (PLK1) inhibition to create innovative therapies that address significant unmet medical needs across various cancers.

The company's lead asset is onvansertib, an oral and selective PLK1 inhibitor. Cardiff Oncology is evaluating onvansertib in combination with standard-of-care (SoC) therapeutics across multiple clinical programs. These programs target indications such as RAS-mutated metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), metastatic triple-negative breast cancer (mTNBC), and Chronic Myelomonocytic Leukemia (CMML). The development strategy aims to target tumor vulnerabilities, overcome treatment resistance, and deliver superior clinical benefits compared to existing SoC treatments.

In recent leadership changes, Mani Mohindru was appointed President and Chief Executive Officer in April 2026, having served as interim CEO since January 2026. Josh Muntner joined as Chief Financial Officer and Ajay Aggarwal as Chief Operating Officer in April 2026. Cardiff Oncology announced in April 2026 that it would present updated data from its CRDF-004 Phase 2 clinical trial at the American Society of Clinical Oncology (ASCO) Annual Meeting. This trial investigates onvansertib in first-line RAS-mutated mCRC, building on previous positive updates that demonstrated robust objective response rates and improved progression-free survival. The company reported positive full-year 2025 results in February 2026, emphasizing strong clinical momentum for onvansertib, and plans to engage with the FDA in the first half of 2026 to discuss a registrational program for the drug in RAS-mutated mCRC.