Cardiff Oncology's Q4 2024: Contradictions in Clinical Trials, Strategic Focus, and Dose Selection

These are the key contradictions discussed in Cardiff Oncology's latest 2024Q4 earnings call, specifically including: Clinical Trial Progress and Enrollment, Strategic Focus on KRAS-mutated Cancers, and Dose Selection and Registrational Trial Design:



Onvansertib Efficacy in CRDF-004 Trial:
- Cardiff Oncology reported promising ORR results from its CRDF-004 trial, with patients on the 30 mg dose of onvansertib demonstrating a 64% ORR compared to 33% in the control arm.
- The trial showed deeper tumor responses in the 30 mg arm, indicating a biologically active drug candidate for treating mCRC.

CRDF-004 Enrollment and Regulatory Strategy:
- The CRDF-004 trial reached its planned enrollment of 90 evaluable patients, with complete enrollment expected within a few weeks.
- Pfizer's BREAKWATER trial accelerated approval for encorafenib validated Cardiff Oncology's registrational strategy for onvansertib in mCRC, using ORR as a primary endpoint.

Intellectual Property and Patent Expansion:
- Cardiff Oncology strengthened its intellectual property with a new patent covering the use of onvansertib in combination with bevacizumab for treating KRAS-mutated mCRC patients.
- This patent aligns with the lead mCRC program and has an expected expiration date of no earlier than 2043.

Preclinical Breast Cancer Program Advancements:
- The company presented preclinical data on onvansertib in combination with paclitaxel and ENHERTU, showing promising antitumor activity in HR-positive breast cancer models.
- These findings highlight the broad potential of onvansertib and are currently being evaluated in investigator-initiated trials.

Financial Position and Cash Runway:
- Cardiff Oncology closed the year with $91.7 million in cash and short-term investments, including proceeds from a successful $40 million capital raise.
- With the current cash spend forecast, the company anticipates having runway into the first quarter of 2027.