$CRDFAug 11, 2026, 8:10 PMAI processed
Positive Phase 2 onvansertib data supports planned Phase 3 in Q1 2027; $10M raise
AI Summary
Cardiff (CRDF) presented positive Phase 2 CRDF-004 ASCO data showing 30 mg onvansertib + FOLFIRI/bev produced a confirmed ORR of 72.2% vs 42.1% for FOLFIRI/bev alone, with deeper, durable responses, PFS hazard ratios ~0.55–0.57 (wide CIs) and no added toxicities, supporting an FDA-aligned registrational dose and regimen. The company plans a randomized Phase 3 in first-line RAS-mutated mCRC targeted to start in Q1 2027 subject to financing, completed a $10M registered direct offering, reports ~$34.5M in cash as of June 30 (proceeds from the offering post-quarter not included) and is involved in litigation with its licensor over a purported license termination.
Positives
- CRDF-004 Phase 2 arm (30 mg onvansertib + FOLFIRI/bev) showed confirmed ORR 72.2% vs 42.1% for SoC and deeper, durable responses
- No additive adverse events observed; regimen described as well tolerated
- Completed End-of-Phase 2 meeting with FDA and aligned on Phase 3 design; plans to initiate randomized Phase 3 in Q1 2027 (subject to financing)
Negatives
- PFS hazard ratios have wide confidence intervals and the Phase 2 dataset is still limited/ongoing (small numbers remain on study)
- Phase 3 start is contingent on securing additional financing
- Company is in litigation with licensor Nerviano over an alleged license termination, posing legal/IP risk