Cardiff Oncology(US:CRDF)2025-10-09 19:02Summary of Cardiff Oncology Conference Call - October 09, 2025 Company Overview - Company: Cardiff Oncology (NasdaqCM:CRDF) - Lead Asset: Onvansertib, a small molecule targeting PLK1, a known cancer therapy target Industry Context - Disease Focus: Colorectal cancer, the third most common cancer globally, with increasing incidence, particularly in individuals under 50 in the U.S. - Market Need: High unmet need in RAS-mutated metastatic colorectal cancer (MCRC), with limited innovation in the last 20 years Key Points and Arguments 1. Onvansertib's Mechanism: - First-in-class PLK1 inhibitor that is well tolerated and can be combined with chemotherapy for colorectal cancer treatment [2][3] - Demonstrates 5,000-fold greater specificity for PLK1 compared to other PLKs, contributing to its tolerability [3] 2. Clinical Trial Insights: - The CARDIFF-004 trial is a Phase II study focusing on first-line RAS-mutated MCRC, combining onvansertib with standard chemotherapy [7] - Confirmed objective response rate of 49%, a nearly 20% improvement over control [8] - Early signs of progression-free survival (PFS) separation observed, particularly in the 30 mg dose group [11][12] 3. Patient Response: - Significant depth of response noted, with some patients previously considered unresectable being referred for curative surgery [11] - High patient compliance due to the oral administration and low toxicity profile [13] 4. Safety Profile: - Minimal additive toxicity observed when combined with standard chemotherapy, with no significant increase in grade III or higher adverse events [13] 5. Strategic Partnerships: - Pfizer invested $15 million in Cardiff Oncology in 2021 and has a member on the Scientific Advisory Board, indicating strategic interest in onvansertib [19] - Pfizer is acting as a contract research organization for the ongoing trial, while Cardiff retains full ownership of onvansertib [20] 6. Financial Position: - As of June 30, 2025, Cardiff had $71 million in cash, funding operations into early 2027 [21] - Anticipated updates from the CARDIFF-004 trial in Q1 2026, expected to provide more data on durability and PFS [27] 7. Commercial Opportunity: - Analysts estimate peak sales for onvansertib between $2 billion and $3 billion annually, with a favorable competitive landscape in first-line RAS-mutated MCRC [31] - Rapid adoption expected if efficacy is demonstrated without additional toxicity [32] 8. Market Positioning: - Onvansertib targets RAS-mutated MCRC, which constitutes about 50% of the patient population, while competitors like Meris focus on RAS wild type patients, thus not seen as direct competition [35] Additional Important Content - Future Directions: Cardiff is exploring other indications for onvansertib, including triple-negative breast cancer and small cell lung cancer, while maintaining focus on colorectal cancer [24] - Research Findings: Novel findings regarding the synergy between onvansertib and bevacizumab published in top journals, with patents extending the commercial runway for onvansertib [18] This summary encapsulates the critical insights from the conference call, highlighting Cardiff Oncology's strategic positioning, clinical advancements, and market potential for onvansertib in treating colorectal cancer.