Cardiff Oncology(US:CRDF)2026-02-25 19:22Summary of Cardiff Oncology FY Conference Call Company Overview - Company: Cardiff Oncology (NasdaqCM:CRDF) - Lead Program: Onvansertib, a highly selective PLK1 inhibitor targeting first-line RAS mutated metastatic colorectal cancer (mCRC) [2][3] Core Points and Arguments - Market Opportunity: The colorectal cancer market is significant, with approximately 150,000 new cases annually and over 55,000 expected deaths by 2027. The five-year survival rate for metastatic colorectal cancer remains low at 15% [7][8]. - Unmet Need: There are currently no approved drugs specifically for RAS mutated mCRC, highlighting a substantial unmet medical need [8][9]. - Efficacy Data: - Onvansertib demonstrated a confirmed overall response rate (ORR) of 72% when combined with FOLFIRI and bevacizumab, representing a 30% improvement over the standard of care [4][20]. - The median progression-free survival (PFS) has not yet been reached in the onvansertib arm, while the standard of care arm has a median PFS of approximately 11 months [21][22]. - The study showed favorable dose-dependent trends and PFS hazard ratios, indicating potential for practice-changing outcomes in underserved populations [5][22]. - Regulatory Path: The company plans to finalize a path to registration for onvansertib in frontline RAS-mutated mCRC after discussions with the FDA, aiming to provide a full plan within the first half of 2026 [6][27]. Competitive Landscape - Current Treatments: The standard of care for first-line mCRC has remained largely unchanged, primarily involving combinations of chemotherapy with bevacizumab [8][9]. - Unique Positioning: Onvansertib is positioned as the only program specifically designed for the entire RAS-mutated population, differentiating it from mutation-specific therapies currently in development [9][10]. Additional Insights - Combination Potential: Onvansertib shows promise not only in mCRC but also in other RAS-driven cancers, such as chronic myelomonocytic leukemia (CMML) [30][31]. - Cash Position: Cardiff Oncology reported $58.3 million in cash equivalents, sufficient to fund operations into the first quarter of 2027, although this does not include significant investments for the phase 3 study [33][34]. - Clinical Benefit: The company believes that the totality of data, including ORR, PFS, and hazard ratios, supports the clinical benefit of onvansertib, which is compelling for regulatory discussions [36][39]. Future Outlook - Upcoming Milestones: Cardiff Oncology plans to share more detailed data from the ongoing phase 2 study and regulatory feedback in the first half of 2026, with a focus on advancing to phase 3 trials [31][32][27].