Clinical TrialMay 14, 2026, 04:20 PM
Cardiff Oncology Advances Onvansertib to Phase 3; Q1 Net Loss $(12.3M)
AI Summary
Cardiff Oncology announced its first-quarter 2026 financial results and provided a business update, highlighting significant progress in its clinical programs. The company successfully completed an End-of-Phase 2 meeting with the FDA, aligning on key design elements for its planned Phase 3 registrational trial for onvansertib in first-line RAS-mutated metastatic colorectal cancer, including selecting the 30 mg dose with FOLFIRI/bev. The company also reported a net loss of $(12.3) million for Q1 2026 and strengthened its executive team with key leadership appointments.
Key Highlights
- Completed End-of-Phase 2 FDA meeting, selecting 30 mg onvansertib dose with FOLFIRI/bev for Phase 3 trial.
- Will present updated Phase 2 CRDF-004 trial data at ASCO Annual Meeting (May 29–June 2).
- Q1 2026 net loss was $(12.3) million, an improvement from $(13.4) million in Q1 2025.
- Q1 2026 net loss per common share was $(0.18), compared to $(0.20) in Q1 2025.
- Cash, cash equivalents, and short-term investments totaled $46.1 million as of March 31, 2026.
- Cash resources are sufficient to fund operations into the first quarter of 2027.
- Appointed Mani Mohindru as CEO, Josh Muntner as CFO, and Ajay Aggarwal as COO.
- Q1 2026 total operating expenses decreased to $12.9 million from $14.5 million in Q1 2025.