Cardiff Oncology(US:CRDF)2025-11-06 21:00Financial Performance - Total revenues for Q3 2025 were $0.1 million, down from $0.2 million in Q3 2024, primarily from sales-based royalties unrelated to onvansertib[80]. - Net cash used in operating activities was $32.0 million for the nine months ended September 30, 2025, compared to $27.4 million in 2024[94]. - The company reported net losses of $38.6 million for the nine months ended September 30, 2025, compared to $33.6 million in 2024[95]. - Interest income remained stable at $2.5 million for the nine months ended September 30, 2025, consistent with the same period in 2024[89]. - Net cash provided by financing activities was $28,000 for the nine months ended September 30, 2025, down from $9.6 million in 2024[98]. Research and Development - Research and development expenses decreased by $1.4 million to $8.2 million in Q3 2025, mainly due to reduced clinical trial expenses[82]. - Research and development expenses increased by $3.1 million to $30.3 million for the nine months ended September 30, 2025, compared to $27.1 million in 2024[87]. - The company is focusing on leveraging PLK1 inhibition to develop therapies for cancers with significant unmet medical needs, including mCRC, mPDAC, SCLC, and mTNBC[63]. Clinical Trials - Onvansertib demonstrated a 49% confirmed objective response rate (ORR) in combination with standard-of-care treatments for RAS-mutated metastatic colorectal cancer (mCRC) in the ongoing CRDF-004 trial[71]. - The CRDF-004 trial enrolled 110 patients and is assessing the efficacy of onvansertib in combination with FOLFIRI or FOLFOX and bevacizumab[68]. - The FDA agreed to a seamless Phase 3 trial (CRDF-005) for onvansertib with an interim endpoint of ORR, aiming for accelerated approval[69]. - In the Phase 1b/2 trial for metastatic pancreatic ductal adenocarcinoma (mPDAC), onvansertib is being evaluated in combination with the newly approved NALIRIFOX[73]. - The Phase 2 trial for small cell lung cancer (SCLC) is designed to enroll 15 patients, with preliminary data showing a disease control rate of 57%[76]. - Onvansertib in combination with paclitaxel showed a 40% objective response rate in a Phase 1b trial for metastatic triple-negative breast cancer (mTNBC)[81]. Expenses and Cash Position - Selling, general and administrative expenses increased by $0.8 million to $3.9 million in Q3 2025, primarily due to an employee severance agreement[83]. - Selling, general and administrative expenses rose by $1.8 million to $11.2 million for the nine months ended September 30, 2025, compared to $9.5 million in 2024[88]. - As of September 30, 2025, the company had working capital of $47.1 million, down from $81.6 million as of December 31, 2024[90]. - The company had $60.6 million in cash, cash equivalents, and short-term investments as of September 30, 2025, sufficient to meet funding requirements for at least the next 12 months[91]. - Net cash used in investing activities was $9.4 million for the nine months ended September 30, 2025, compared to a net cash provided of $9.2 million in 2024[97]. - The company expects to continue incurring losses and will require additional capital to advance clinical trial programs[93].