Clinical Trials and Efficacy - Onvansertib, a highly selective PLK1 inhibitor, has shown a 29% objective response rate (ORR) in the ongoing TROV-054 trial for KRAS-mutated metastatic colorectal cancer (mCRC) with a median duration of response of 12.0 months[67]. - The CRDF-004 trial for first-line treatment in RAS-mutated mCRC is expected to enroll approximately 90 evaluable patients, with initial data anticipated in the second half of 2024[63]. - In the ONSEMBLE trial, patients who were bevacizumab naïve had an ORR of 73% and a median progression-free survival of 15 months, significantly higher than historical controls[71]. - The Phase 2 trial in first-line mPDAC will assess the combination of onvansertib with Gemzar and Abraxane, with the primary endpoint being ORR[75]. - The objective response rate (ORR) in the Phase 2 trial for mPDAC was 19%, significantly higher than the historical control of 7.7%[79]. - Median progression-free survival (mPFS) in the same trial was 5.0 months, compared to 3.1 months with standard care[79]. - The disease control rate (DCR) in the Phase 2 trial for SCLC was 57%, with 4 out of 7 patients showing either confirmed partial response or stable disease[82]. Safety and Tolerability - Onvansertib has demonstrated favorable safety and tolerability, with no Grade 4 treatment-emergent adverse events (TEAEs) observed in the combination arms of the trials[71]. - Onvansertib has shown synergistic effects in combination with various cytotoxic agents, enhancing its potential efficacy across multiple cancer therapies[60]. Financial Performance - Total revenues for Q1 2024 were $205,000, up from $83,000 in Q1 2023, reflecting a significant increase in sales-based royalties[86]. - Research and development expenses decreased by $1.0 million to $8.0 million in Q1 2024 compared to $9.1 million in Q1 2023, primarily due to reduced clinical trial costs[88]. - As of March 31, 2024, the company had working capital of $58.1 million, down from $67.0 million at the end of 2023[91]. - Net cash used in operating activities for Q1 2024 was $7.7 million, a slight improvement from $8.7 million in Q1 2023[96]. - The company reported a net loss of $10.0 million for Q1 2024, compared to a net loss of $11.2 million in Q1 2023[97]. - Cash and cash equivalents totaled $67.2 million as of March 31, 2024, sufficient to meet funding requirements for at least the next 12 months[92]. - Net cash provided by investing activities for Q1 2024 was $4.6 million, down from $7.3 million in Q1 2023[99]. Future Plans and Regulatory Aspects - The company plans to initiate CRDF-005, a Phase 3 trial with registrational intent, contingent upon the results of CRDF-004, focusing on objective response rate as an interim endpoint[64]. - The ongoing clinical programs include five trials targeting various cancers, including mCRC and metastatic pancreatic ductal adenocarcinoma (mPDAC)[61]. - The FDA has agreed that a seamless trial design with ORR as an interim endpoint is acceptable for pursuing accelerated approval for onvansertib[64]. - The company emphasizes the importance of tumor genomics and biomarker assays in refining patient response assessments in its clinical development programs[57].
Cardiff Oncology(CRDF) - 2024 Q1 - Quarterly Report