Cardiff Oncology (NasdaqCM:CRDF) FY Conference Transcript

Summary of Cardiff Oncology FY Conference Call Company Overview - Company: Cardiff Oncology (NasdaqCM:CRDF) - Focus: Development of onvansertib, a specific inhibitor of PLK1, targeting RAS mutated metastatic colorectal cancer [5][6] Key Points Clinical Development and Pipeline - Current Trial: CARD004 trial focusing on first-line RAS mutated metastatic colorectal cancer [6] - Upcoming Data: Expected data release in Q1 2026, focusing on durability, progression-free survival (PFS), and duration of response [6][29] - Mechanism of Action: Onvansertib shows synthetic lethality in RAS mutant backgrounds, synergy with topoisomerase one inhibitors, and with Bevacizumab [9][10][12] Unmet Need in Colorectal Cancer - Prevalence: Colorectal cancer is the third most common malignancy globally, with increasing incidence, especially in younger patients [14][15] - Current Treatment Landscape: Limited options with only Bevacizumab approved in the last 20 years for advanced colorectal cancer [15] - Target Population: Focus on first-line treatment for previously untreated metastatic colorectal cancer, addressing a significant unmet need [16] Clinical Trial Insights - Response Rates: High response rates observed in patients naive to Bevacizumab, with some achieving complete responses [11][25] - Safety Profile: Onvansertib demonstrated a favorable safety profile with no significant increase in adverse events compared to standard care [26][27] Regulatory and Market Strategy - Regulatory Pathway: Plans for a pivotal study with a seamless design for accelerated approval based on response rates and full approval based on PFS [31] - Market Opportunity: The first-line metastatic colorectal cancer market is described as a multi-billion dollar opportunity [35] - Competitive Landscape: Cardiff Oncology is uniquely positioned as the only company targeting the RAS mutated population in this setting [36] Financial Position - Cash Reserves: As of Q3, the company reported over $60 million in cash, providing a runway into 2027 [38] Future Development Opportunities - Potential Expansion: Interest in exploring onvansertib's application in other tumor types, including triple-negative breast cancer and EGFR rechallenge in colorectal cancer [40][42] Additional Insights - Intellectual Property: Issuance of new patents for patient selection in colorectal cancer, extending IP protection to 2043 [12] - Clinical Trial Design: Emphasis on randomized trial structure to ensure data integrity and reduce bias [19] This summary encapsulates the critical aspects of Cardiff Oncology's conference call, highlighting the company's strategic focus, clinical advancements, and market potential in the oncology space.