Cardiff Oncology (CRDF) investor relations material

Key clinical insights

• Onvansertib, a selective PLK1 inhibitor, shows strong efficacy in RAS-mutated metastatic colorectal cancer, especially in bevacizumab-naive patients, with response rates far exceeding historical controls.

• Combination with bevacizumab and chemotherapy demonstrates synergistic effects, leading to significant tumor shrinkage and improved progression-free survival in both preclinical and clinical settings.

• The ongoing first-line trial (CARDIV-004) reports a 19% higher response rate at 30 mg dosing versus control, with rapid and deep tumor responses and several complete responses observed.

• Safety profile remains favorable, with no significant increase in adverse events compared to standard care, supporting longer treatment durations.

• Early data suggest durable responses, with a comprehensive update on progression-free survival and duration of response expected in Q1 next year.

Strategic and regulatory developments

• FDA alignment has been achieved for the clinical development path, including a planned registrational trial designed for both accelerated and full approval.

• The company pivoted from second-line to first-line development based on FDA guidance and strong unmet need in RAS-mutated, bevacizumab-naive patients.

• Two new patents have been issued, extending exclusivity to at least 2043, following novel mechanistic findings and clinical results.

• Pfizer holds a 3% equity stake and supports trial execution through Pfizer Ignite, providing expertise and high data quality standards without restrictive terms.

• Sufficient cash runway is projected through 2027, supporting ongoing and future clinical milestones.

Market and economic implications

• Onvansertib’s selectivity and tolerability enable longer treatment durations, potentially increasing drug utilization and hospital acquisition.

• The large, underserved market of RAS-mutated metastatic colorectal cancer represents a significant commercial opportunity.

• Positive clinical outcomes and economic potential are expected to drive interest from both investors and strategic partners.

• The company’s approach to partnerships emphasizes leveraging expertise and execution while maintaining independence.

• The current clinical progress and regulatory clarity position the company as an attractive investment opportunity in the oncology space.