Cardiff Oncology Reports Full Year 2025 Results and Provides Business Update

Core Insights - Cardiff Oncology reported positive results from the Phase 2 CRDF-004 trial for first-line RAS-mutated metastatic colorectal cancer (mCRC), showing a robust objective response rate (ORR) of 72.2% with the 30 mg onvansertib + FOLFIRI/bev combination, compared to 43.2% with standard of care (SoC) [1][5] - The trial also demonstrated a significant improvement in progression-free survival (PFS) with a hazard ratio (HR) of 0.37, indicating a strong potential for onvansertib to enhance patient outcomes [1][5] - The company plans to advance the 30 mg dose of onvansertib into a registrational program, with detailed data and plans expected in the first half of 2026 [1][2] Clinical Development - The CRDF-004 trial results indicate a consistent, dose-dependent treatment benefit, with nearly a 30% improvement in response rate over the control arm and encouraging durability trends in PFS [2][5] - The company has not observed significant added toxicity with the 30 mg onvansertib dose in combination with FOLFIRI/bev, supporting its advancement into registrational development [5] Financial Performance - For the year ended December 31, 2025, Cardiff Oncology reported total operating expenses of approximately $49.6 million, a slight increase from $49.3 million in 2024, primarily due to higher selling, general, and administrative expenses [8][14] - The company reported a net loss of $45.876 million for 2025, compared to a net loss of $45.455 million in 2024, with a net loss per common share of $0.69 [14] - As of December 31, 2025, Cardiff had approximately $58.3 million in cash and cash equivalents, sufficient to fund operations into the first quarter of 2027 [7] Leadership Changes - In January 2026, Cardiff announced executive leadership changes to support its transition into late-stage clinical development, appointing Mani Mohindru as interim Chief Executive Officer [4] - The company is actively searching for a permanent Chief Executive Officer and Chief Financial Officer to strengthen its leadership team [4]