Financial Data and Key Metrics Changes - As of December 31, 2024, cash and short-term investments totaled 40 million capital raise completed in December [22] - Cash used in operating activities was $10.3 million in Q4 2024, consistent with typical quarterly cash burn [22] - Current cash resources are projected to provide a runway into the first quarter of 2027 based on forecasted cash spend for ongoing clinical programs [22] Business Line Data and Key Metrics Changes - The CRDF-004 trial in first-line RAS-Mutated Metastatic Colorectal Cancer (mCRC) showed a 64% overall response rate (ORR) for the 30 mg dose of onvansertib compared to a 33% ORR in the control arm [9] - The 30 mg arm demonstrated deeper tumor responses, with the five deepest tumor regressions occurring in patients receiving this dose [10] - Over 380 patients have been dosed with onvansertib across multiple clinical trials, indicating a favorable safety profile [11] Market Data and Key Metrics Changes - The FDA approval of Pfizer's encorafenib in Q4 2024 validates the registrational strategy for onvansertib in mCRC, as both drugs target different patient populations [13][14] - The regulatory pathway used by Pfizer for encorafenib's accelerated approval is similar to the plans agreed with the FDA for onvansertib [14] Company Strategy and Development Direction - The company aims to complete enrollment of 90 evaluable patients in the CRDF-004 trial in early 2025, with the trial now closed to new patients [12] - The intellectual property strategy was strengthened with a new patent covering the use of onvansertib in combination with bevacizumab for KRAS-mutated mCRC patients [15] - The company is exploring new opportunities to convert discoveries related to PLK1 inhibition into new intellectual property [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the efficacy results from the CRDF-004 trial and plans to share additional updates in the first half of 2025 [24] - The company believes onvansertib has the potential to change the treatment paradigm for RAS-Mutated mCRC patients [25] Other Important Information - The company filed a shelf registration statement on Form S-3, maintaining an active registration statement for future capital needs [23] Q&A Session Summary Question: Timing of data update and number of evaluable patients - Management aims to provide a more mature update in the first half of the year, but PFS data may not be available until later [28] Question: Dose selection decision and FDA interactions - The goal is to meet with the FDA soon to discuss dose selection and trial design for the registrational trial [32][34] Question: Response rate comparison with BREAKWATER trial - The response rate observed in the BREAKWATER trial aligns with the results seen in the CRDF-004 study [36] Question: Tumor size reduction and endpoints - Previous data indicates that earlier and deeper responses correlate with greater PFS and OS, which may inform approvable endpoints [43] Question: Patient numbers for accelerated approval - The company is considering the patient numbers used in the BREAKWATER trial for their discussions with the FDA regarding accelerated approval [44] Question: KRAS G12C inhibitors and their impact - The G12C inhibitors are not expected to impact the company's first-line strategy as they target a small subset of patients [50] Question: Enrollment completion and patient inclusion in updates - Management confirmed that enrollment is expected to complete soon, and they aim for a substantive update in the first half of the year [57]
Cardiff Oncology(CRDF) - 2024 Q4 - Earnings Call Transcript