Core Insights - Cardiff Oncology, Inc. announced positive results from a Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel for metastatic triple-negative breast cancer (mTNBC), showing a 40% objective response rate [1][2][5] - The trial demonstrated that the combination was well-tolerated with a manageable toxicity profile, primarily myelosuppression being the most common adverse event [5] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies leveraging PLK1 inhibition across various cancers, with onvansertib as its lead asset [4] - The company is also exploring onvansertib in combination with standard of care treatments for other indications, including RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, and small cell lung cancer [4] Clinical Trial Details - The Phase 1b trial was led by Antonio Giordano, MD, PhD, at Dana-Farber Cancer Institute, focusing on the safety, pharmacokinetics, and pharmacodynamics of the drug combination [5] - The study's primary endpoint was to assess safety and determine the recommended Phase 2 dose (RP2D), with secondary endpoints including pharmacokinetics and pharmacodynamics [5] - Patients in the trial had a median of 3 prior lines of chemotherapy, and the highest dose of onvansertib (18 mg/m²) resulted in a 40% objective response rate [5]

Core Insights - Cardiff Oncology, Inc. reported financial results for Q1 2025, highlighting progress in clinical trials and intellectual property expansion [1][4][6] Financial Performance - As of March 31, 2025, the company had approximately $79.9 million in cash, cash equivalents, and short-term investments [6][9] - Net cash used in operating activities for Q1 2025 was approximately $12.8 million, an increase of about $5.1 million from $7.7 million in Q1 2024 [6][11] - Total operating expenses for the three months ended March 31, 2025, were approximately $14.5 million, up from $11.1 million in the same period in 2024 [11][16] - The net loss attributable to common stockholders for Q1 2025 was $13.4 million, compared to a net loss of $10.0 million in Q1 2024 [16] Clinical Development - The company completed enrollment in the Phase 2 CRDF-004 trial for onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC) [2][10] - The trial involved 41 clinical sites in the U.S. and evaluated onvansertib in combination with standard of care therapies [10] - Additional clinical data from the ongoing CRDF-004 trial is expected in the first half of 2025 [3] Intellectual Property - Cardiff Oncology expanded its intellectual property portfolio with the issuance of a second patent covering the treatment of mCRC for bev-naïve patients [5][9] - The new U.S. patent No. 12,263,173 is set to expire no earlier than 2043 and covers the use of onvansertib in combination with bevacizumab across all lines of therapy for mCRC patients [5][9] Future Outlook - The company believes its current cash resources are sufficient to fund operations into Q1 2027 [7][9]

Core Viewpoint - Cardiff Oncology has received a patent for the use of onvansertib in combination with bevacizumab for treating all bev-naïve metastatic colorectal cancer (mCRC) patients, which is expected to enhance its market opportunities and growth potential [1][2]. Group 1: Patent and Treatment Scope - The newly issued patent covers the combination treatment of onvansertib and bevacizumab for all bev-naïve mCRC patients, including those with RAS mutations and RAS wild type, across all lines of therapy until at least 2043 [1]. - This patent expands the applicability of onvansertib beyond the current focus on first-line RAS-mutated patient populations, potentially redefining the standard of care for mCRC [2]. Group 2: Clinical Development - Onvansertib is currently being evaluated in a Phase 2 clinical trial (CRDF-004) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab for RAS-mutated mCRC patients [2]. - Initial data from the ongoing CRDF-004 trial was announced in December 2024, with additional clinical data expected in the first half of 2025 [2]. Group 3: Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing therapies leveraging PLK1 inhibition for various cancers, with onvansertib as its lead asset [3]. - The company is targeting treatment-resistant tumors and aims to deliver superior clinical benefits compared to standard of care in indications such as mCRC, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple-negative breast cancer [3].

Core Insights - Cardiff Oncology has completed patient enrollment in the Phase 2 CRDF-004 trial for onvansertib in RAS-mutated metastatic colorectal cancer (mCRC) [1][2] - The trial aims to evaluate the efficacy of onvansertib in combination with standard of care treatments [2] - Additional clinical data from the trial is expected to be reported in the first half of 2025 [3] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing therapies leveraging PLK1 inhibition for various cancers [4] - The lead asset, onvansertib, is being tested in combination with standard treatments for RAS-mutated mCRC and other cancers [4] - The company aims to address treatment resistance and improve clinical outcomes compared to standard therapies [4]