Cardiff Oncology, Inc. Q4 FY2024 earnings call

Key Points

• CRDF-004 Trial: Reviewed data from December showing 64% ORR in 30 mg dose of onvansertib vs 33% in control arm for first-line RAS-mutated mCRC; enrollment in CRDF-004 expected to complete in next few weeks. FDA approval of Pfizer's BREAKWATER trial validated registrational strategy for onvansertib in mCRC.
• Intellectual Property: Strengthened IP portfolio with a new patent for onvansertib in combination with bev for KRAS-mutated mCRC, expiring no earlier than 2043.
• Preclinical Posters: Presented at San Antonio Breast Cancer Symposium on onvansertib in breast cancer, showing synergistic activity with paclitaxel and ENHERTU.
• Financial Position: Cash and short-term investments totaled $91.7M as of Dec. 31, 2024; cash used in operating activities $10.3M in Q4 2024; cash resources provide runway into Q1 2027; filed shelf registration statement.

No specific product segment performance details provided as the transcript does not detail multiple product segments.

• Expect to release additional clinical data from CRDF-004 trial in the first half of 2025.
• Current cash resources provide runway into Q1 2027.

Forward-looking statements involve significant risks and uncertainties as detailed in the company's Form 10-K Risk Factors.

Q: Can you give us any sense of when exactly in the first half that data update is coming and in what context? And then in that update how many new patients do you expect will become valuable for ORR? And also how mature do you expect those PFS curves to be?

A: At this point, goal is to give a more mature update since the 30-patient update. PFS curves not expected to be mature in first half.

Q: Can you just speak to your thoughts around when you will make the dose selection decision and whether that will come together with your interactions with the FDA and converting 004 to a potential registrational trial. Just maybe walk through the cadence of those decision points?

A: Goal is to get in front of FDA soon, talking about dose (30 vs 20) and finalizing trial design for registrational trial 005; meeting with FDA will gate into 005 trial.

Q: Whether the response rate delta that they observed in that trial that supported an accelerated approval aligns with what you've seen thus far in the 004 study?

A: Yes, consistent; their ORR was 61% vs 40%, consistent with 004 study's first 30 patients.

Q: Your evolving thinking in terms of the velocity of tumor size reduction. So basically looking at the December data one of the most obvious observations is really the slope of the control arm is relatively flat over time. And then it deepens as you alluded to Mark on the call for the 20-milligram and 30 milligram. So, I'm curious if that data based on some of the prior CRC experience could de-risk or inform how you think about endpoints approvable endpoints such as PFS and OS?

A: Earlier responses and deeper responses correlate with greater PFS and OS, which is known in CRC.

Q: In that trial the patient number that's required for the accelerated approval was about 100 patients each arm. So, I'm curious if that's kind of that could potentially form the framework of your upcoming discussion with the FDA in the context of the accelerated approval pathway?

A: BREAKWATER's 110 per arm for interim is considered, will talk to FDA about trial design specifics.

Q: Obviously we know about the CodeBreak 301 trial. And although KRAS G12C is a minor component in colorectal cancer I wanted to get your thoughts as to how you view that agent especially also the pan-RAS agents that are also being developed in the space?

A: G12C inhibitors are in second line for a small subset of RAS-mutated patients (4%), not impacting first-line work; keeping eye on RevMed's G12X program.

Q: I was just wondering it's great to see the enrollment is going to complete over the next few weeks here. So do you think we'll be able to see all of the 90 patients included in this first half update?

A: Yes, within a couple of weeks of finishing enrollment, goal is to have a substantive first half update with all relevant data.