Cardiff Oncology Reports Third Quarter 2025 Results and Provides Business Update

Core Insights - Cardiff Oncology announced positive data from the ongoing Phase 2 CRDF-004 trial evaluating onvansertib in combination with standard of care for first-line RAS-mutated metastatic colorectal cancer (mCRC) [1][2] - The company expects to report an update from the Phase 2 CRDF-004 trial in Q1 2026 [1] - As of September 30, 2025, the company had cash and investments totaling $60.6 million, projected to fund operations into Q1 2027 [1][5] Clinical Trial Results - The CRDF-004 trial demonstrated a 19% improvement in confirmed objective response rate (ORR) for the 30mg onvansertib cohort compared to the control arm as of the July 8, 2025 data cutoff [2][6] - Early progression-free survival (PFS) data show a trend favoring the 30mg onvansertib arm versus control, although median PFS has not yet been reached [6] - Onvansertib continues to be well-tolerated, with no major or unexpected toxicities observed [6] Financial Performance - For the third quarter of 2025, net cash used in operating activities was approximately $10.8 million, an increase from $10.5 million in the same period in 2024 [4] - Total operating expenses for the quarter were approximately $12.1 million, a decrease from $12.8 million for the same period in 2024, primarily due to reduced clinical trial expenses [6][7] - The company reported a net loss of $11.3 million for the third quarter of 2025, compared to a net loss of $11.9 million in the same period in 2024 [12] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies leveraging PLK1 inhibition for various cancers, with onvansertib as its lead asset [8] - The company is targeting significant medical needs in oncology, particularly for RAS-mutated mCRC, with approximately 150,000 new cases diagnosed annually in the U.S. [2][8]