Cardiff Oncology Narrows Third-Quarter Loss; Phase 2 PFS Remains Unreached in 30 mg Arm
Third-quarter 2026 royalty revenues rose to $171,000 from $120,000 a year earlier. Median progression-free survival remains unreached in the 30 mg onvansertib plus FOLFIRI/bev arm as the company readies a Phase 3 start in the first quarter of 2027.
Cardiff Oncology, Inc. (CRDF), a clinical-stage biotechnology company developing the PLK1 inhibitor onvansertib for RAS-mutated cancers, reported a net loss of $8.86 million, or $0.12 a share, for the three months ended September 30, 2026, compared with a loss of $11.26 million, or $0.17 a share, a year earlier. Royalty revenues for the quarter rose to $171,000 from $120,000 a year earlier.
The company said it is preparing a registrational Phase 3 trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer, with a potential start in the first quarter of 2027. Its randomized Phase 2 study remains ongoing. Median progression-free survival has not been reached in the 30 mg onvansertib plus FOLFIRI/bevacizumab arm, the proposed Phase 3 regimen, versus a median PFS of approximately 11 months in the combined standard-of-care arms.
As of September 28, 2026, six patients remained on the FOLFIRI/bev regimen: five in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one on standard-of-care FOLFIRI/bev. Patients remaining in the 30 mg onvansertib plus FOLFIRI/bev arm had been on treatment for at least 21 months, with the longest duration over 29 months.
President and Chief Executive Officer Mani Mohindru said the company was “greatly encouraged by the performance of onvansertib in first-line RAS-mutated mCRC” and that, as the data mature, the benefit of onvansertib in combination with FOLFIRI/bev is becoming more evident, with growing separation between the onvansertib and control arms. The company said there are currently no treatment options specifically approved for patients with pan RAS-mutated mCRC in the first-line setting and that it believes onvansertib has the potential to become an important new treatment for those patients.
Royalty revenues were $171 thousand in the three months ended September 30, 2026, versus $120 thousand a year earlier. Total operating expenses were $9.39 million, down from $12.09 million. Research and development expenses were $5.03 million, compared with $8.20 million. Selling, general and administrative expenses were $4.36 million, versus $3.90 million. Loss from operations was $9.22 million.
For the nine months ended September 30, 2026, total operating expenses were approximately $32.0 million, a decrease of $9.5 million from $41.5 million for the same period in 2025. Research and development expenses decreased by $12.5 million, which the company said reflected completion of clinical trials, fewer patients on treatment in the Phase 2 mCRC trial, a reduction in preclinical activities, and completion of chemistry, manufacturing and controls activities as it prepares for the planned Phase 3 mCRC trial. Selling, general and administrative expenses increased by $3.1 million, driven by legal and professional fees related to the dispute with licensor Nerviano Medical Sciences S.r.l., which was resolved on September 14, 2026, and by employee severance costs. Net loss for the nine months was $30.4 million, compared with $38.6 million for the prior year period.
As of September 30, 2026, Cardiff had approximately $33.8 million in cash, cash equivalents, and short-term investments. Net cash used in operating activities for the nine months ended September 30, 2026 was approximately $33.9 million, an increase of $2.0 million from $31.9 million for the same period in 2025. In July 2026 the company raised net proceeds of approximately $9.1 million in a registered direct offering of common stock and warrants.
Based on its current expectations and projections, the company said its cash resources are sufficient to fund operations to the end of the third quarter of 2027. In September, Cardiff and Nerviano Medical Sciences resolved all outstanding disputes regarding global rights to onvansertib and amended their 2017 exclusive license agreement. In October, the company appointed Leila Alland, MD, as interim Chief Medical Officer.
Management is scheduled to present at the UBS Global Biopharma Conference on November 16–17, 2026. Updated data from an investigator-sponsored trial in CMML are set for presentation at the American Society of Hematology Annual Meeting on December 13, 2026.