CRDF Cardiff Oncology, Inc.
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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.
Actionable Insight
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.
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
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 | ||||
|---|---|---|---|---|---|
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Jun 11, 2026
3d ago
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Institutional Cluster
| $1.60 awaiting T+1 | awaiting T+1 | — | $1.54 (+3.75%) |
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Jun 3, 2026
11d ago
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8-K
| $1.40 $1.55 | ▲ +10.71% | ▲ +10.32% | $1.54 (+10.00%) |
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Jun 2, 2026
12d ago
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Press Release
| $1.51 $1.40 | ▼ −7.28% | ▼ −6.59% | $1.54 (+1.99%) |
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May 29, 2026
16d ago
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8-K
| $1.48 $1.51 | ▼ −2.03% | ▼ −1.88% | $1.54 (−4.05%) |
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May 21, 2026
24d ago
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Press Release
| $1.78 $1.94 | ▲ +8.99% | ▲ +8.40% | $1.54 (−13.48%) |
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May 19, 2026
26d ago
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8-K
| $1.84 $1.79 | ▲ +2.72% | ▲ +2.91% | $1.54 (+16.30%) |
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May 14, 2026
4w ago
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8-K
| $1.67 $1.69 | ▲ +1.20% | ▲ +1.26% | $1.54 (−7.78%) |
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Apr 17, 2026
8w ago
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Press Release
| $1.78 $1.65 | ▼ −7.30% | ▼ −6.65% | $1.54 (−13.48%) |
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Mar 19, 2026
12w ago
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Press Release
| $1.82 $1.80 | ▼ −1.10% | ▲ +0.64% | $1.54 (−15.38%) |
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Feb 25, 2026
15w ago
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8-K
| $1.91 $1.96 | ▲ +2.62% | ▲ +3.16% | $1.54 (−19.37%) |
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