Cardiff Oncology Announces Positive Update from its Randomized Phase 2 Trial of Onvansertib in First-line RAS-mutated mCRC

– Onvansertib added to FOLFIRI/bev first-line standard of care regimen showed dose-dependent improvement in overall response rates and durability trends as measured by progression-free survival in patients with RAS-mutated mCRC –

– Data support selection of 30 mg onvansertib dose for registrational program in first-line RAS-mutated mCRC –

– Data validate previously reported positive results from Phase 2 trial of onvansertib with FOLFIRI/bev in second-line mCRC bev-naïve patients, as published in the Journal of Clinical Oncology –

– Onvansertib continues to be safe and well-tolerated –

– Company expects to provide final data and registrational plans in first half of 2026 –

Excerpt from the Press Release:

SAN DIEGO, Jan. 27, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced a positive update from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line (1L) RAS-mutated metastatic colorectal cancer (mCRC). In an intent-to-treat analysis, the clinical data show dose-dependent benefits across multiple efficacy measures in patients receiving onvansertib with FOLFIRI/bev compared to patients receiving either SoC regimen. In this trial, onvansertib with FOLFIRI/bev also performed better than onvansertib with FOLFOX/bev.

Based on these results, the Company has selected the 30 mg dose of onvansertib with FOLFIRI/bev to bring forward in a registrational trial in 1L patients with RAS-mutated mCRC. Cardiff Oncology plans to initiate a registrational program later this year pending finalization of the trial design in consultation with the FDA, in which the Company expects to compare onvansertib with FOLFIRI/bev to SoC regimens, FOLFIRI/bev or FOLFOX/bev.

“These data demonstrate promising enhanced benefits of onvansertib when combined with FOLFIRI/bev in RAS-mutated mCRC patients,” said Mani Mohindru, PhD, interim Chief Executive Officer. “We observed a consistent, dose-dependent treatment benefit across multiple measures of efficacy, including achieving statistical significance for PFS compared to SoC even with relatively small patient numbers.

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