The 72% ORR and durable PFS signal in a hard-to-treat RAS-mutated mCRC population, combined with FDA alignment on a registrational path, represent a major catalyst. Monitor for initiation of the Phase 3 CRDF-005 trial and any partnership or financing announcements to fund the ~640-patient study.
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Executive Summary
Cardiff Oncology released an investor presentation detailing interim Phase 2 CRDF-004 data for onvansertib in first-line RAS-mutated metastatic colorectal cancer. The 30 mg dose combined with FOLFIRI/bevacizumab showed a 72.2% objective response rate (vs 42.1% for FOLFIRI/bev alone) and median PFS not yet reached vs 12.2 months in the control arm. The company has aligned with the FDA on a registrational Phase 3 trial design targeting accelerated approval via ORR.
Key Facts
- Phase 2 CRDF-004 trial: 30 mg onvansertib + FOLFIRI/bev achieved 72.2% ORR (13/18) vs 42.1% (8/19) for FOLFIRI/bev alone — a 30% improvement.
- Median PFS not yet reached for onvansertib 30 mg + FOLFIRI/bev vs 12.22 months (investigator-assessed) for FOLFIRI/bev; HR 0.57 (0.2, 1.65).
- 9 of 14 patients remaining on study treatment are on onvansertib + FOLFIRI/bev; some patients on treatment for >18 months.
- FDA End-of-Phase 2 meeting completed in Q2 2026; registrational Phase 3 trial (CRDF-005) designed with dual primary endpoints of ORR and PFS, ~640 patients, >90% power.
- No unexpected or overlapping toxicities; safety profile consistent with background therapy.
- Onvansertib showed no consistent meaningful benefit when combined with FOLFOX/bev (ORR 47.4% vs 44.4% for FOLFOX/bev alone).
Financial Impact
No financial data reported; clinical-stage biotech with no revenue. The positive Phase 2 data and FDA alignment for a registrational trial significantly de-risk the development path for onvansertib in a large underserved market (~150,000 newly diagnosed CRC patients/year in U.S., 20% metastatic).
Risk Factors
- Phase 3 trial may fail to replicate Phase 2 results in a larger, more diverse population.
- Onvansertib only showed synergy with FOLFIRI/bev, not FOLFOX/bev, limiting the addressable patient subset.
- Company will need significant additional capital to fund the registrational trial; dilution risk exists.
- Pending litigation with Nerviano Medical Sciences S.r.l. regarding the license agreement could create overhang.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-254658 |
| Document: crdf-ex99_1.htm | 0001193125-26-254658 |
| Document: 0001193125-26-254658-index-headers.html | 0001193125-26-254658 |
| Document: 0001193125-26-254658-index.html | 0001193125-26-254658 |
| Document: 0001193125-26-254658.txt | 0001193125-26-254658 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 22, 2026 5w ago | Institutional Cluster | $1.33 $1.17 | ▲ +12.03% | ▲ +10.84% | $0.8801 (+33.83%) |
Sep 14, 2026 6w ago | 8-K | $1.31 $1.37 | ▲ +4.58% | ▲ +4.47% | $0.8801 (−32.82%) |
Aug 11, 2026 10w ago | Press Release | $0.9900 $0.8979 | ▲ +9.30% | ▲ +8.86% | $0.8801 (+11.10%) |
Jul 16, 2026 14w ago | Insider Cluster | $0.8800 $0.8381 | ▼ −4.76% | ▼ −4.07% | $0.8801 (+0.01%) |
Jul 16, 2026 14w ago | 8-K | $0.8745 $0.8381 | ▲ +4.16% | ▲ +2.49% | $0.8801 (−0.64%) |
Jul 16, 2026 14w ago | 424B5 | $0.8745 $0.8381 | ▲ +4.16% | ▲ +2.49% | $0.8801 (−0.64%) |
Jun 22, 2026 18w ago | Insider Cluster | $1.30 $1.25 | ▼ −3.85% | ▼ −1.78% | $0.8801 (−32.30%) |
Jun 11, 2026 19w ago | Institutional Cluster | $1.59 $1.18 | ▲ +25.79% | ▲ +26.22% | $0.8801 (+44.65%) |
Jun 3, 2026 20w ago | 8-K | $1.40 $1.48 | ▲ +5.71% | ▲ +9.53% | $0.8801 (−37.14%) |
Jun 2, 2026 21w ago | Press Release | $1.51 $1.53 | ▲ +1.32% | ▲ +4.29% | $0.8801 (−41.72%) |
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