The strong Phase 2 data and clear path to a Phase 3 trial represent a major value inflection point. Traders should monitor for the detailed data presentation and registrational strategy announcement in 1H 2026, as well as any partnership or licensing discussions that may arise due to the compelling efficacy and safety profile.
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Executive Summary
Cardiff Oncology released positive Phase 2 data for its drug onvansertib in first-line RAS-mutant metastatic colorectal cancer (mCRC), showing a 72% confirmed objective response rate (ORR) in the 30mg dose arm, a 30% improvement over standard of care. Median progression-free survival (PFS) was not yet reached, and the data supports advancing to a Phase 3 registrational trial in 2026. The drug was well-tolerated with no significant added toxicity.
Key Facts
- Phase 2 CRDF-004 trial showed a confirmed ORR of 72% in the 30mg onvansertib + FOLFIRI/bev arm, a 30% improvement over FOLFIRI SoC.
- Median PFS was not yet reached in either the 20mg or 30mg onvansertib + FOLFIRI/bev arms, with a hazard ratio of 0.37 vs. SoC (p=0.048).
- The data supports selecting the 30mg dose of onvansertib with FOLFIRI/bev for a registrational program in first-line RAS-mutant mCRC.
- Onvansertib demonstrated a favorable safety profile with no significant added toxicity compared to standard of care.
- A Phase 3 registrational trial (CRDF-005) is planned to initiate in 2H 2026, pending FDA feedback.
- The company has $58.3 million in cash, sufficient to fund operations into Q1 2027.
Financial Impact
The positive data significantly de-risks the clinical program and increases the probability of commercial success for onvansertib, a drug with 'blockbuster potential' in a large market. This could lead to substantial revenue if approved.
Risk Factors
- The trial is ongoing and the data is interim; final results could differ.
- The Phase 3 trial has not yet been initiated and is subject to FDA agreement on the final design.
- The drug is still years away from potential approval and commercialization, facing the inherent risks of late-stage clinical development.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (CRDF) — Batch item 1 | 0001193125-26-068668 |
| Document: crdf-20260225.htm | 0001193125-26-068668 |
| Document: 0001193125-26-068668-index-headers.html | 0001193125-26-068668 |
| Document: 0001193125-26-068668-index.html | 0001193125-26-068668 |
| Document: 0001193125-26-068668.txt | 0001193125-26-068668 |
| 8-K Filing (CRDF) — Batch item 6 | 0001193125-26-068668 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 22, 2026 4w ago | Institutional Cluster | $1.33 $1.17 | ▲ +12.03% | ▲ +10.84% | $0.8175 (+38.53%) |
Sep 14, 2026 6w ago | 8-K | $1.31 $1.37 | ▲ +4.58% | ▲ +4.47% | $0.8175 (−37.60%) |
Aug 11, 2026 10w ago | Press Release | $0.9900 $0.8979 | ▲ +9.30% | ▲ +8.86% | $0.8175 (+17.42%) |
Jul 16, 2026 14w ago | Insider Cluster | $0.8800 $0.8381 | ▼ −4.76% | ▼ −4.07% | $0.8175 (−7.10%) |
Jul 16, 2026 14w ago | 8-K | $0.8745 $0.8381 | ▲ +4.16% | ▲ +2.49% | $0.8175 (+6.52%) |
Jul 16, 2026 14w ago | 424B5 | $0.8745 $0.8381 | ▲ +4.16% | ▲ +2.49% | $0.8175 (+6.52%) |
Jun 22, 2026 18w ago | Insider Cluster | $1.30 $1.25 | ▼ −3.85% | ▼ −1.78% | $0.8175 (−37.12%) |
Jun 11, 2026 19w ago | Institutional Cluster | $1.59 $1.18 | ▲ +25.79% | ▲ +26.22% | $0.8175 (+48.58%) |
Jun 3, 2026 20w ago | 8-K | $1.40 $1.48 | ▲ +5.71% | ▲ +9.53% | $0.8175 (−41.61%) |
Jun 2, 2026 21w ago | Press Release | $1.51 $1.53 | ▲ +1.32% | ▲ +4.29% | $0.8175 (−45.86%) |
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