CRDF Cardiff Oncology, Inc.
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Executive Summary
Cardiff Oncology announced positive Phase 2 data for onvansertib in first-line RAS-mutated mCRC at ASCO 2026, showing a 72.2% confirmed ORR vs 42.1% for SOC, and median PFS not yet reached. The company has aligned with the FDA on a registrational Phase 3 trial design, marking a key de-risking milestone that transforms the development pathway for this early-stage biotech.
Actionable Insight
This is a pivotal de-risking event for a single-asset biotech — the ORR improvement, PFS HR, and FDA alignment on Phase 3 design materially increase the probability of eventual approval in RAS-mutated mCRC (large unmet need, no approved RAS-targeted therapies outside KRAS G12C). Traders should watch the June 3 webcast for Phase 3 timeline details and any partnership signals. Given the $101M market cap and strong Phase 2 data, this stock could re-rate significantly as the market prices in the Phase 3 pathway.
Key Facts
- Phase 2 CRDF-004 trial met primary goal of selecting efficacious/safe dose (30 mg onvansertib + FOLFIRI/bevacizumab) for registrational program
- Confirmed ORR of 72.2% for onvansertib arm vs 42.1% for SOC alone — a 30% absolute improvement
- Median PFS not yet reached in either onvansertib (20 or 30 mg) + FOLFIRI/bev arms; nine of 14 patients remain on treatment
- PFS hazard ratio of 0.55 (BICR) and 0.57 (investigator) vs SOC
- End-of-Phase 2 meeting with FDA completed; registrational Phase 3 trial design aligned — randomized, controlled trial of onvansertib 30 mg + FOLFIRI/bev vs SOC
- No additive toxicities; onvansertib well-tolerated with infrequent Grade 3+ AEs
- Investor webcast scheduled for June 3, 2026 to review data and registrational plans
Financial Impact
Phase 2 efficacy signal (72.2% ORR vs 42.1% SOC) and FDA alignment on Phase 3 design are transformational for a clinical-stage biotech with $101M market cap — could enable partnership value or significantly increase valuation on Phase 3 initiation
Risk Factors
- Phase 3 trial may fail to replicate Phase 2 results — single-arm and small N in active arm (n=18) limits statistical reliability
- No efficacy advantage seen with FOLFOX backbone, limiting combinability
- Registrational trial enrollment and execution risk for a small company; may require partnership or financing
- Patient retention is early — median PFS not reached but data are immature; durability tail could still shrink
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3305287 |
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Jun 3, 2026
2d ago
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8-K
| $1.40 awaiting T+1 | awaiting T+1 | — | $1.52 (+8.57%) |
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Jun 2, 2026
3d ago
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Press Release
| $1.51 $1.40 | ▼ −7.28% | ▼ −6.59% | $1.52 (+0.66%) |
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May 29, 2026
6d ago
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8-K
| — | awaiting T+1 | — | — |
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May 21, 2026
14d ago
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Press Release
| — | awaiting T+1 | — | — |
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May 19, 2026
16d ago
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8-K
| — | awaiting T+1 | — | — |
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May 14, 2026
21d ago
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8-K
| — | awaiting T+1 | — | — |
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Apr 17, 2026
6w ago
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Press Release
| $1.78 $1.65 | ▼ −7.30% | ▼ −6.65% | $1.52 (−14.61%) |
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Mar 19, 2026
11w ago
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Press Release
| $1.82 $1.80 | ▼ −1.10% | ▲ +0.64% | $1.52 (−16.48%) |
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Feb 25, 2026
14w ago
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8-K
| $1.91 $1.96 | ▲ +2.62% | ▲ +3.16% | $1.52 (−20.42%) |
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Feb 24, 2026
14w ago
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8-K
| $1.91 $1.96 | ▲ +2.62% | ▲ +3.16% | $1.52 (−20.42%) |
US Market Status
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