Summary of Cardiff Oncology Conference Call Company Overview - Cardiff Oncology is a clinical stage oncology company based in San Diego, California, focusing on developing onvansertib, a selective PLK1 inhibitor [3][4] Pipeline and Clinical Trials - The lead program targets KRAS mutated metastatic colorectal cancer, currently enrolling in a randomized trial [5] - Other programs include trials for pancreatic cancer, triple negative breast cancer, and small cell lung cancer [6] Mechanism of Action - PLK1 is a critical target in cancer therapy due to its role in the tumor cell cycle [7] - Onvansertib inhibits PLK1, preventing tumor cells from repairing DNA and promoting cell death [9] Clinical Data Highlights - In a single-arm trial for KRAS mutated metastatic colorectal cancer, response rates were significantly higher than historical data, with a 36% response rate from 14 evaluable patients and a 35% response rate from 48 evaluable patients [13] - A subset of bevacizumab-naive patients showed a 69% response rate and a median progression-free survival (PFS) of 13.5 months, compared to the typical 25% response rate and 6.9 months PFS [14] Randomized Trial Design - The randomized trial aims to demonstrate the efficacy of onvansertib in combination with standard care, with an 80% power to detect a meaningful difference in response rates [20] - The trial has started with six sites activated, aiming for a total of 40 sites [20] Pancreatic Cancer Program - A single-arm trial for pancreatic cancer is ongoing, targeting patients who have failed standard treatments [27] - Historical response rates for this patient population are low, with median PFS around three months [28] - Initial data showed one partial response and three stable diseases among five evaluable patients [28] Investigator Initiated Trials - Exciting trials are ongoing for triple negative breast cancer, combining onvansertib with paclitaxel, with data expected by the end of the year [31] Biomarker Data - The company plans to share biomarker data for pancreatic cancer and triple negative breast cancer trials, focusing on CA19-9 and KRAS mutations [34][35] Financial Overview - As of September 30, the company had approximately $114 million in cash, with a quarterly burn rate of $7 million, providing a runway into 2025 [37][38] Key Takeaways - Cardiff Oncology is advancing its clinical trials with promising data in colorectal cancer and ongoing efforts in pancreatic cancer and breast cancer - The company is strategically positioned for potential accelerated approval based on trial outcomes and has a solid financial foundation to support its initiatives [18][38]