Clinical TrialMay 14, 2026, 04:12 PM
Cardiff Oncology advances onvansertib to Phase 3 after FDA meeting
AI Summary
Cardiff Oncology announced a successful End-of-Phase 2 meeting with the FDA, aligning on key design elements for its Phase 3 registrational trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer. The company selected the 30 mg dose of onvansertib with FOLFIRI/bev for the Phase 3 trial and will present updated Phase 2 CRDF-004 data at the upcoming ASCO Annual Meeting. Additionally, Cardiff Oncology reported Q1 2026 financial results, including a net loss of $(12.3) million and $46.1 million in cash, projecting a cash runway into Q1 2027, alongside key leadership appointments.
Key Highlights
- Cardiff Oncology completed a successful End-of-Phase 2 meeting with the FDA.
- Onvansertib 30 mg with FOLFIRI/bev selected for Phase 3 trial in RAS-mutated mCRC.
- Updated Phase 2 CRDF-004 data to be presented at ASCO (May 29–June 2).
- Q1 2026 net loss was $(12.3) million, an improvement from $(13.4) million in Q1 2025.
- Cash, cash equivalents, and short-term investments totaled $46.1 million as of March 31, 2026.
- Company projects cash runway into the first quarter of 2027.
- Total operating expenses decreased to $12.9 million in Q1 2026 from $14.5 million in Q1 2025.
- Mani Mohindru appointed CEO, Josh Muntner CFO, and Ajay Aggarwal COO.