Cardiff Oncology(US:CRDF)2024-08-10 15:18Financial Data and Key Metrics Changes - As of June 30, 2024, cash and short-term investments totaled $60.3 million, with cash used in operating activities amounting to $9.2 million in Q2 2024 [13] - The company updated its cash runway guidance, now expecting to have sufficient resources through the end of Q3 2025, an extension from previous expectations [13] Business Line Data and Key Metrics Changes - The CRDF-004 trial is currently active in 33 sites, with plans to enroll 90 patients randomized to receive either a 20-milligram or a 30-milligram dose of onvansertib plus standard of care [6] - The pancreatic cancer program is shifting focus to an investigator-initiated trial combining onvansertib with NALIRIFOX, following the approval of NALIRIFOX for first-line metastatic PDAC [9] Market Data and Key Metrics Changes - The company is targeting a large patient population of nearly 50,000 new patients annually in the U.S. for RAS-mutated metastatic colorectal cancer [4] - There are currently no new therapies approved for RAS-mutated mCRC patients in the past 20 years, and no competing clinical trials exist for this patient population [4] Company Strategy and Development Direction - The company is focused on clinical execution of the CRDF-004 trial and is optimistic about the potential of onvansertib to change the treatment paradigm for RAS-mutated mCRC [14] - There is ongoing exploration of onvansertib's efficacy in other cancer indications, including ovarian cancer, where it has shown potential to overcome resistance to PARP inhibitors [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical development strategy for RAS-mutated mCRC and enthusiasm for the upcoming data readout of CRDF-004 later this year [14] - The company is encouraged by preclinical data demonstrating onvansertib's activity in various cancer indications with unmet clinical needs [10] Other Important Information - The company is leveraging Pfizer's resources to enhance patient enrollment in clinical trials [6] - Preclinical studies have shown onvansertib's potential in RAS wild-type mCRC, ER-positive breast cancer, triple-negative breast cancer, and platinum-resistant ovarian cancer [10] Q&A Session Summary Question: Enrollment trends in the CRDF-004 trial - Management confirmed that enrollment is tracking well and is on schedule for an initial data look later this year, aided by the partnership with Pfizer Ignite [15] Question: Adoption of NALIRIFOX in pancreatic cancer - Management explained that the combination of onvansertib with NALIRIFOX is based on previous positive data and good tolerability, making it a suitable choice for the first-line regimen [16][17] Question: Scientific validation of the change in pancreatic cancer trial - Management highlighted the synergy of onvansertib with irinotecan as a key reason for the new trial direction and noted the enthusiasm of the investigator involved [20] Question: Potential entry into ovarian cancer with ADCs - Management indicated that preclinical work is ongoing to explore combinations of onvansertib with ADCs across various cancer types, not limited to ovarian cancer [20]