
Financial Data and Key Metrics Changes - As of September 30, 2023, the company's cash and short-term investments totaled $81.4 million, with net cash used in operating activities for Q3 2023 approximately $8 million, indicating sufficient cash resources to fund operations into 2025 [26][66]. Business Line Data and Key Metrics Changes - The lead program in KRAS-mutated metastatic colorectal cancer showed a threefold increase in response rate and a doubling in median progression-free survival (PFS) in bevacizumab-naive patients compared to historical controls [36][37]. - In the CRDF-001 trial for pancreatic ductal adenocarcinoma (PDAC), four out of 21 patients achieved an objective partial response (PR), with one confirmed PR reported [19][29]. Market Data and Key Metrics Changes - The company reported a median PFS of five months for evaluable patients in the pancreatic cancer trials, approaching the benchmark of 5.5 months for first-line treatment [44]. Company Strategy and Development Direction - The primary focus is on the lead program in RAS-mutated metastatic colorectal cancer, with plans to execute the CRDF-004 clinical trial in collaboration with Pfizer Ignite [34][62]. - The company aims to explore new therapeutic indications for onvansertib, including combinations with FDA-approved treatments for various cancers [59]. Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging environment for publicly listed biotech companies but emphasized the strengths of Cardiff Oncology, including strong clinical data and financial resources [8][62]. - The company remains confident in generating interim data from the CRDF-004 trial by mid-2024, despite the trial not yet starting patient dosing [69]. Other Important Information - The company is conducting a preclinical program to investigate the underlying science of onvansertib and its combination with bevacizumab, which has shown promising results [14][15]. Q&A Session Summary Question: Can you discuss the expense trajectory as the first-line trial and colorectal starts to ramp up? - Management expects overall expenses to increase but not significantly, with current cash resources sufficient to extend operations into 2025 [55][66]. Question: Have any of the unconfirmed PDAC responses been confirmed recently? - Management confirmed that one additional patient has shown a deepening response, resulting in a second confirmed PR [29][63]. Question: What is the confidence level in generating interim data by mid-2024? - Management expressed confidence in being able to provide information by mid-next year, as the trial is open-label and progress can be monitored [69][71]. Question: Is there a strategy to minimize adverse events in the new trials? - The strategy to minimize adverse events from switching between bolus and infusional 5-FU will continue in the new trials [74][78].