Cardiff Oncology reports Q2 2026 results, plans Phase 3 mCRC trial for early 2027

Cardiff Oncology reported second quarter 2026 results and a business update on August 11, 2026. Following a successful End-of-Phase 2 meeting with the FDA, the company said it is preparing to initiate the planned Phase 3 trial in the first quarter of 2027, subject to securing additional financing.¹ The company said it aligned with the FDA on key design elements for the registrational Phase 3 trial, which is expected to evaluate 30 mg onvansertib in combination with FOLFIRI/bevacizumab compared to standard-of-care FOLFIRI/bevacizumab as first-line therapy in patients with RAS-mutated metastatic colorectal cancer.¹

The plan follows Phase 2 CRDF-004 data presented at the 2026 ASCO Annual Meeting in June. The selected regimen, 30 mg onvansertib in combination with FOLFIRI/bevacizumab, demonstrated deep and durable tumor shrinkage, including improvements in confirmed objective response rate and progression-free survival compared to standard of care alone, with no additive adverse events observed, according to the company.¹ Based on a March 18, 2026 data cut, the 30 mg onvansertib plus FOLFIRI/bevacizumab arm achieved a confirmed ORR of 72.2% compared to 42.1% for FOLFIRI/bevacizumab alone, with responses described as deeper and more durable in the onvansertib arm.¹ Secondary PFS hazard ratios were 0.55 (95% CI: 0.15–2.09) by Blinded Independent Central Review and 0.57 (95% CI: 0.20–1.65) by investigator assessment.¹ As of a June 23, 2026 data cut, 12 patients remained on the ongoing Phase 2 trial.¹

On the corporate side, in February 2026 the company received notice from its licensor, Nerviano Medical Sciences S.r.l., alleging material breach of the license agreement, which NMS then purported to terminate; Cardiff filed suit in May 2026 in the U.S. District Court for the Southern District of California seeking a declaratory judgment and injunctive relief.¹ In July, Cardiff announced a $10 million registered direct offering of common stock and warrants to support working capital and general corporate purposes.¹

As of June 30, 2026, Cardiff had approximately $34.5 million in cash, cash equivalents, and short-term investments, not including proceeds from the July offering.¹ The company said it believes current cash resources are sufficient to fund operations into the third quarter of 2027.¹