Clinical TrialAug 11, 2026, 04:14 PM
Cardiff Oncology Advances Onvansertib to Phase 3; Secures $10M
AI Summary
Cardiff Oncology announced positive Phase 2 CRDF-004 data for onvansertib in first-line RAS-mutated metastatic colorectal cancer, presented at ASCO. Following a successful End-of-Phase 2 meeting, the company aligned with the FDA on key elements for a registrational Phase 3 trial, which is planned to start in Q1 2027, contingent on additional financing. The company also completed a $10 million Registered Direct offering, extending its cash runway into Q3 2027. For Q2 2026, Cardiff Oncology reported a net loss of $(9.2) million.
Key Highlights
- Positive Phase 2 CRDF-004 data presented at ASCO for onvansertib in RAS-mutated mCRC.
- Achieved 72.2% confirmed ORR with 30 mg onvansertib plus FOLFIRI/bev vs. 42.1% for SoC.
- Successful End-of-Phase 2 meeting with FDA, aligning on registrational Phase 3 trial design.
- Planned initiation of Phase 3 trial in Q1 2027, subject to securing additional financing.
- Completed $10 million Registered Direct offering, extending cash runway.
- Cash, cash equivalents, and short-term investments totaled $34.5 million as of June 30, 2026.
- Current cash resources are sufficient to fund operations into Q3 2027.
- Reported Q2 2026 net loss of $(9.2) million.
Price Impact
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