Release Date: August 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Cardiff Oncology Inc (CRDF, Financial) is actively enrolling patients in the CRDF-004 trial for RAS-mutated metastatic colorectal cancer, with 33 active sites and plans to enroll 90 patients.
- The company is leveraging Pfizer Ignite's resources to drive enrollment, which is progressing well and on track for an initial data readout later this year.
- Onvansertib has shown potential to shift the treatment paradigm for RAS-mutated mCRC, with no new therapies approved for this population in the past 20 years.
- The company is exploring onvansertib's efficacy in other cancer indications, including ovarian cancer resistant to PARP inhibitors, with promising preclinical data published in a peer-reviewed journal.
- Cardiff Oncology Inc (CRDF) has a strong financial position with $60.3 million in cash and short-term investments, providing a cash runway through the end of the third quarter of 2025.
Negative Points
- Enrollment in the CRDF-004 trial had previously been slower than anticipated, although it is now tracking well.
- The pancreatic cancer program is undergoing changes, with a shift to a new first-line trial combining onvansertib with NALIRIFOX, which may not be widely adopted as a standard of care.
- The company is still determining its path forward in ovarian cancer, indicating uncertainty in strategic direction for this indication.
- There are significant risks and uncertainties associated with forward-looking statements, which could materially affect actual results and timing of events.
- The company's cash runway guidance has been updated, indicating a potential need for additional funding beyond the third quarter of 2025.
Q & A Highlights
Q: Has the enrollment for the CRDF-004 trial improved since last quarter?
A: Enrollment is tracking well and aligns with our guidance for an initial data look later this year. Our partnership with Pfizer Ignite has been instrumental in driving enrollment, and the lack of new drugs and competing trials for RAS-mutated mCRC patients has also contributed positively. - Mark Erlander, CEO
Q: Why choose NALIRIFOX for the pancreatic cancer trial when its adoption as a standard of care is uncertain?
A: NALIRIFOX includes three of the four chemo agents we've previously combined with onvansertib, showing good data. Onvansertib has shown good tolerability with these agents, and we believe this regimen shows superior efficacy in first-line treatment. - Mark Erlander, CEO
Q: Can you comment on the scientific validation for the change in the pancreatic cancer trial and potential ovarian cancer entry?
A: The synergy with irinotecan is a key reason for choosing NALIRIFOX. Our investigator is experienced with our drug and enthusiastic about first-line trials. For ovarian cancer, we are exploring ADC combinations with onvansertib preclinically, not limited to ovarian cancer. - Mark Erlander, CEO
Q: What is the financial outlook for Cardiff Oncology?
A: As of June 30, 2024, we have $60.3 million in cash and short-term investments. Our cash resources are expected to provide runway through the end of Q3 2025. - James Levine, CFO
Q: What are the next steps for the ovarian cancer program?
A: We are encouraged by recent data showing onvansertib's ability to resensitize ovarian cancer to treatment. We are still determining our path forward but are exploring ADC combinations preclinically. - Mark Erlander, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
