H.C. Wainwright has maintained a Buy recommendation and set a $10.00 price objective for Cardiff Oncology (NASDAQ:CRDF) following the company’s release of updated clinical data. The $10 target implies considerable upside from the stock’s approximately $2 trading level and sits alongside a strong analyst consensus recommendation of 1.33, which corresponds to a "Strong Buy" stance. Analyst target prices on record span from $2.50 to $19.
Cardiff provided new results from the CRDF-004 study, which is testing onvansertib in combination with FOLFIRI chemotherapy and bevacizumab (Avastin) versus standard-of-care treatments for patients with first-line RAS-positive metastatic colorectal cancer. The company, with a market capitalization of $134.72 million, is quoted near its computed fair value, even as the stock has exhibited recent volatility.
The reported efficacy measures in the CRDF-004 data were notable. Patients treated with onvansertib 30 mg in combination with FOLFIRI and bevacizumab achieved a 72.2% confirmed objective response rate (ORR), compared with a 43.2% confirmed ORR in the standard-of-care arm. That represents a 29% absolute difference; the accompanying p-value was 0.051.
Beyond response rate, the onvansertib-containing regimen appeared to lower the risk of disease progression or death by 52% relative to standard treatment in this dataset. Six-month progression-free survival (PFS) rates were reported at 94.1% for the onvansertib 30 mg cohort versus 88.8% for the control arm.
Management has said it intends to pursue a randomized Phase 3 trial later this year to compare the onvansertib 30 mg combination against standard-of-care, contingent on feedback from the U.S. Food and Drug Administration. More mature data from CRDF-004 are anticipated in the first half of 2026. Cardiff’s next scheduled earnings release is on February 26.
On the company’s financial position, available analysis indicates Cardiff holds more cash than debt on its balance sheet, though the company is consuming cash at a rapid pace.
Additional clinical updates cited by the company include positive interim Phase 2 results for onvansertib combined with standard care as a first-line therapy in RAS-mutated metastatic colorectal cancer, which showed a dose-dependent rise in overall response rates and again highlighted the 30 mg group’s 72.2% confirmed ORR versus 43.2% for standard therapy. Separately, Cardiff reported data from a Phase 1 study of onvansertib in chronic myelomonocytic leukemia; in that trial the drug was reported to be well tolerated and to show preliminary efficacy in roughly 40% of patients.
Cardiff has also undergone recent executive changes. Mani Mohindru, PhD, was appointed interim chief executive officer following the departures of former CEO Mark Erlander and CFO James Levine. To maintain continuity in finance operations, Brigitte Lindsay has been elevated to Chief Accounting Officer. In the research and ratings arena, Noble Capital has initiated coverage with an Outperform rating, citing the potential of onvansertib in metastatic colorectal cancer.
The company said it plans to present its leukemia trial findings at the upcoming American Society of Hematology Annual Meeting. Investors and analysts will be watching the planned Phase 3 submission pathway, the timing of additional CRDF-004 data, the company’s cash runway, and the impact of recent management changes on execution.
Key points:
- H.C. Wainwright reiterates Buy and $10 price target for Cardiff Oncology, implying substantial upside versus the current share price; analyst targets range from $2.50 to $19.
- CRDF-004 data: onvansertib 30 mg plus FOLFIRI and bevacizumab produced a 72.2% confirmed ORR versus 43.2% for standard-of-care; p-value reported at 0.051, and six-month PFS of 94.1% versus 88.8%.
- Company to consider a randomized Phase 3 comparison of the 30 mg regimen later this year pending FDA feedback, with more mature CRDF-004 results expected in H1 2026.
Risks and uncertainties:
- The statistical threshold for the reported ORR difference is borderline; the p-value of 0.051 is just above conventional significance levels, which introduces uncertainty around definitive efficacy conclusions.
- Cardiff’s cash consumption is rapid despite holding more cash than debt, creating financial risk if clinical or regulatory timelines extend or additional capital is required.
- Recent senior leadership departures and interim executive appointments could affect operational continuity during a critical clinical and regulatory period.