Release Date: May 02, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Cardiff Oncology presented promising data at AACR, including five posters demonstrating the efficacy of onvansertib in various cancer indications.
- The company has a strong focus on RAS-mutated metastatic colorectal cancer (mCRC), a large patient population with significant unmet medical needs.
- Onvansertib showed significant efficacy in bev-naive patients, indicating potential as a first-line treatment in combination with standard care.
- Pre-clinical data supports the hypothesis that onvansertib works synergistically with bevacizumab, enhancing anti-tumor activity.
- Cardiff Oncology's financial position remains strong, with a cash runway extending into the third quarter of 2025, supporting ongoing clinical trials.
Negative Points
- The timing of the initial data readout for the CRDF-004 trial has been pushed back due to slower than expected enrollment rates.
- There are inherent risks and uncertainties in clinical trials, which could affect the anticipated outcomes and future plans.
- The company faces intense competition in the oncology sector, particularly in developing treatments for mCRC.
- While pre-clinical results are promising, the transition to successful clinical outcomes is not guaranteed and poses significant challenges.
- The need for further data to confirm onvansertib's efficacy in RAS wild-type mCRC could delay potential expansion into broader indications.
Q & A Highlights
Q: Can you clarify how much of the small push-out was really the enrollment pace once sites are open versus maybe just some delays getting the sites up and running as quickly as you'd hoped?
A: Mark Erlander, CEO of Cardiff Oncology, explained that the enthusiasm from principal investigators, based on previous data and the novel treatment option provided by onvansertib, is high. The slight delay in the interim data availability from CRDF-004 is due to the dynamic nature of site activation and enrollment, not due to operational inefficiencies. The company is leveraging Pfizer Ignite's resources to ensure effective trial execution.
Q: Could you read some of the scenario planning that you and the team are going through in terms of the data? Is there a scenario where it could get shut down, or on the other end of the spectrum, make you want to accelerate plans to open up 005 even faster and not have to wait for all 90 patients?
A: Mark Erlander, CEO, mentioned that the upcoming data share in Q3/Q4 will include about half of the trial's patients with at least one post-baseline scan. The focus is on confirming the dose with the FDA, which is crucial for progressing to the registrational trial. The company is not considering accelerating or shutting down based on this interim data but is focused on confirming the appropriate dose for further trials.
Q: With the slight push in the initial readout from 004, is there a possibility of maybe seeing another cut of the ONSEMBLE cohort before then, just getting a longer follow-up, a better sense of the durability of responses, and how that's shaking out between the arms of the trial the bev naive has experienced?
A: Mark Erlander, CEO, stated that there are currently no plans to follow up on the ONSEMBLE data as the focus is on the CRDF-004 trial. The data from ONSEMBLE already provides robust support for the ongoing trial.
Q: On the pre-clinical work at AACR on the RAS wild-type mCRC scenario, could you elaborate whether there's opportunity to explore that clinically and think about that population of patients within the context of a potential future pivotal front-line trial?
A: Mark Erlander, CEO, highlighted the different biological behaviors of RAS wild-type versus RAS-mutant tumors. The company is considering trial designs for RAS wild-type settings based on encouraging pre-clinical findings with cetuximab but has not yet moved forward with clinical trials in this area. The current focus remains on the CRDF-004 trial.
Q: In terms of clinical sites, you mentioned 24 sites are currently activated with a goal of 35. Could this number change during the trial?
A: Mark Erlander, CEO, confirmed that while 35 sites are the target, this number is dynamic. Sites that are not performing well might be replaced, reflecting the ongoing adjustments to optimize trial execution.
Q: Is it conceivable to bring two doses in the pivotal study? What is the FDA looking for beyond confirmation of safety and efficacy before giving the okay to start a pivotal study?
A: Mark Erlander, CEO, clarified that the company plans to enter the registrational trial with a single confirmed dose. The FDA will evaluate the efficacy and safety differences between the doses used in the CRDF-004 trial to approve the dose for the pivotal trial.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
