The strong clinical data significantly de-risks the onvansertib program and positions it for potential approval. Traders should monitor upcoming FDA discussions in H1 2026 for registrational pathway details. The improved cash runway reduces near-term dilution risk.
Price Chart
Executive Summary
Cardiff Oncology reported positive Phase 2 clinical trial results for its lead drug onvansertib in first-line RAS-mutated metastatic colorectal cancer, showing a 72.2% objective response rate and significant progression-free survival improvement compared to standard of care. The company plans to advance into a registrational program. Financially, it reported $58.3 million in cash, sufficient to fund operations into Q1 2027, while net loss per share improved to $0.69 from $0.95 year-over-year.
Key Facts
- Phase 2 CRDF-004 trial showed 72.2% ORR for onvansertib + FOLFIRI/bev vs 43.2% for SoC, with HR 0.37 (p<0.05) for PFS
- Company plans to advance 30 mg onvansertib dose into registrational development with FDA discussions planned in H1 2026
- Cash, cash equivalents, and short-term investments totaled $58.3 million as of December 31, 2025
- Cash runway expected to fund operations into Q1 2027
- Net loss per share improved to $0.69 (2025) from $0.95 (2024)
- Interim CEO appointed and search initiated for permanent CEO and CFO
Financial Impact
Cash position of $58.3 million supports operations into Q1 2027; net loss attributable to common stockholders was $45.876 million in 2025 vs $45.455 million in 2024
Risk Factors
- Clinical trial results are from a Phase 2 study and may not be predictive of success in larger registrational trials
- The company will require significant additional funding to complete registrational trials and potential commercialization
- Stock-based compensation and executive transitions could impact execution
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 10 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (CRDF) — Batch item 1 | 0001193125-26-067476 |
| Document: crdf-20260224.htm | 0001193125-26-067476 |
| Document: 0001193125-26-067476-index-headers.html | 0001193125-26-067476 |
| Document: 0001193125-26-067476-index.html | 0001193125-26-067476 |
| Document: 0001193125-26-067476.txt | 0001193125-26-067476 |
| 8-K Filing (CRDF) — Batch item 6 | 0001193125-26-067476 |
| Document: crdf-20260224.htm | 0001193125-26-067476 |
| Document: 0001193125-26-067476-index-headers.html | 0001193125-26-067476 |
| Document: 0001193125-26-067476-index.html | 0001193125-26-067476 |
| Document: 0001193125-26-067476.txt | 0001193125-26-067476 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 22, 2026 5w ago | Institutional Cluster | $1.33 $1.17 | ▲ +12.03% | ▲ +10.84% | $0.8751 (+34.20%) |
Sep 14, 2026 6w ago | 8-K | $1.31 $1.37 | ▲ +4.58% | ▲ +4.47% | $0.8751 (−33.20%) |
Aug 11, 2026 10w ago | Press Release | $0.9900 $0.8979 | ▲ +9.30% | ▲ +8.86% | $0.8751 (+11.61%) |
Jul 16, 2026 14w ago | Insider Cluster | $0.8800 $0.8381 | ▼ −4.76% | ▼ −4.07% | $0.8751 (−0.56%) |
Jul 16, 2026 14w ago | 8-K | $0.8745 $0.8381 | ▲ +4.16% | ▲ +2.49% | $0.8751 (−0.07%) |
Jul 16, 2026 14w ago | 424B5 | $0.8745 $0.8381 | ▲ +4.16% | ▲ +2.49% | $0.8751 (−0.07%) |
Jun 22, 2026 18w ago | Insider Cluster | $1.30 $1.25 | ▼ −3.85% | ▼ −1.78% | $0.8751 (−32.68%) |
Jun 11, 2026 19w ago | Institutional Cluster | $1.59 $1.18 | ▲ +25.79% | ▲ +26.22% | $0.8751 (+44.96%) |
Jun 3, 2026 20w ago | 8-K | $1.40 $1.48 | ▲ +5.71% | ▲ +9.53% | $0.8751 (−37.49%) |
Jun 2, 2026 21w ago | Press Release | $1.51 $1.53 | ▲ +1.32% | ▲ +4.29% | $0.8751 (−42.05%) |
US Market Status
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