Every patient still enrolled in the 30 mg onvansertib plus FOLFIRI/bevacizumab arm of Cardiff Oncology’s Phase 2 trial has now passed 21 months on treatment, with the longest reaching beyond 29 months. That durability matters because the control arms of the same trial hit a median progression-free survival of roughly 11 months, consistent with historical benchmarks for FOLFIRI/bevacizumab in this setting. Median PFS in the 30 mg arm has not been reached.
The separation between arms is what Cardiff is leaning on as it prepares a registrational Phase 3 trial in first-line RAS-mutated metastatic colorectal cancer, with a potential start in Q1 2027. The patient numbers still on treatment are small: as of late September, six patients remain on the FOLFIRI/bevacizumab regimen, with five in the onvansertib-containing FOLFIRI/bev arms and one on standard-of-care FOLFIRI/bev alone. That is the reality of a maturing Phase 2 dataset, where duration of response in the remaining patients is now the primary signal Cardiff is surfacing ahead of a pivotal program. First-line RAS-mutated mCRC remains a setting where there are currently no treatment options specifically approved for patients with pan RAS-mutated mCRC.
Financially, Cardiff carries $33.8 million in cash and short-term investments as of September 30, against roughly $33.9 million burned in operating activities over the first nine months of 2026. The company estimates that runway extends through the end of Q3 2027, helped by a $9.1 million net raise completed in July. R&D spending dropped by $12.5 million year-over-year as the Phase 2 trial wound down and CMC activities were completed as the company prepares for its planned Phase 3 trial, though SG&A rose $3.1 million, largely from legal costs tied to a licensing dispute with Nerviano Medical Sciences that was resolved in September, as well as employee severance costs.
The practical question now is whether Cardiff’s cash position survives long enough to generate Phase 3 enrollment data. With a Phase 3 start targeted for early 2027 and the runway stopping at Q3 2027, the company will likely need additional financing before the first interim readout from that trial. Watch for any capital raise announcement in Q1 2027, which will tell investors whether Cardiff can keep the Phase 3 on schedule without dilutive pressure forcing a pause.
Source link: https://www.sec.gov/Archives/edgar/data/1213037/000119312526458500/crdf-20261110.htm
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
