Cardiff Oncology Posts 72.2% ORR in Phase 2, Secures 30 mg Onvansertib Dose for Phase 3
Cardiff completed an End-of-Phase 2 FDA meeting and selected a 30 mg onvansertib plus FOLFIRI/bevacizumab regimen for its registrational Phase 3 trial in first-line RAS-mutated mCRC. Phase 2 trial showed 72.2% response versus 43.2% standard care and 0.38 PFS HR, while $46.1M cash funds through Q1 2027.
1. Q1 Financial Results
In the first quarter ended March 31, 2026, Cardiff Oncology reported approximately $46.1 million in cash and equivalents, with net operating cash use of $12.3 million versus $12.8 million in Q1 2025. Operating expenses were $12.9 million, down from $14.5 million, extending runway into Q1 2027.
2. Phase 2 Clinical Data
The randomized Phase 2 CRDF-004 trial in first-line RAS-mutated metastatic colorectal cancer delivered a 72.2% confirmed objective response rate versus 43.2% for standard care, and achieved a progression-free survival hazard ratio of 0.38, without significant added toxicity.
3. FDA Meeting and Phase 3 Plans
In April, Cardiff completed an End-of-Phase 2 meeting with FDA, aligning on a 30 mg onvansertib dose combined with FOLFIRI/bevacizumab for the planned registrational Phase 3 trial. Additional design elements and regulatory strategy details are expected by mid-2026, with data presentation scheduled at the ASCO Annual Meeting.
4. Leadership and Preclinical Updates
Corporate updates include the appointments of Mani Mohindru as permanent CEO, Josh Muntner as CFO, and Ajay Aggarwal as COO. Preclinical findings also showed onvansertib enhanced the activity of HER2-targeted ADC trastuzumab deruxtecan in HER2-low breast cancer models.