Cardiff Oncology (CRDF) Study result summary

Management transition and strategic focus

• Leadership transition aims to position the company for late-stage development and maximize onvansertib's value in RAS-mutated metastatic colorectal cancer (mCRC).

• The transition is driven by promising clinical data, not by issues with the drug program.

• The interim CEO is supported by experienced operational, scientific, and clinical teams, ensuring continuity.

• Strategic partnerships and expansion into additional indications are being actively explored.

• Recruitment for leadership and clinical teams will focus on late-stage development and commercialization expertise.

Phase II study design and patient population

• The CRDF-004 phase II trial evaluated two doses of onvansertib with FOLFIRI-Bev or FOLFOX-Bev in first-line RAS-mutated mCRC.

• Patients were randomized to receive 20 mg or 30 mg onvansertib plus standard of care, or standard of care alone.

• Endpoints included objective response rate, progression-free survival, duration of response, and safety.

• The patient population represents about 50% of all metastatic CRC cases, highlighting significant unmet need.

• Baseline characteristics were balanced, with no significant outliers affecting results.

Efficacy and safety results

• The 30 mg onvansertib plus FOLFIRI-Bev arm showed a confirmed objective response rate (ORR) of 72.2% and median progression-free survival not reached, significantly outperforming standard regimens.

• Dose-dependent efficacy was observed, with greater benefit at 30 mg; FOLFOX combinations showed less consistent results.

• The PFS hazard ratio for 30 mg onvansertib plus FOLFIRI-Bev was 0.37 versus standard regimens, achieving statistical significance.

• Onvansertib with FOLFIRI-Bev was well-tolerated, with no major or unexpected toxicities; neutropenia was the most common grade 3+ adverse event.

• Results validate previous positive findings from a Phase 2 trial in second-line, bevacizumab-naïve patients.