Cardiff Oncology Announces Q3 2024 Results and Business Update

Cardiff Oncology, Inc., a clinical-stage biotechnology company listed on Nasdaq with the ticker symbol CRDF, has published its financial results and recent highlights for the third quarter ending September 30, 2024. The company focuses on developing novel cancer therapies by leveraging PLK1 inhibition.

A notable achievement for Cardiff Oncology this quarter was the publication of the Phase 2 clinical trial results for onvansertib in combination with FOLFIRI and bevacizumab (bev) in the prestigious Journal of Clinical Oncology. This study targeted second-line KRAS-mutant metastatic colorectal cancer (mCRC). The results indicated that onvansertib, when combined with FOLFIRI and bev, was well-tolerated and significantly more effective in bev-naïve patients, showing a 7.7 times greater clinical benefit compared to those previously treated with bev.

Mark Erlander, Ph.D., CEO of Cardiff Oncology, expressed his enthusiasm about the published findings, noting that they support the ongoing CRDF-004 trial, which examines onvansertib plus chemotherapy in the first-line treatment of mCRC, where all patients are bev-naïve. He highlighted the potential of onvansertib to become a significant treatment for the approximately 50,000 new U.S. patients diagnosed with RAS-mutated mCRC annually, who have seen few new treatment options in recent decades.

Looking forward, Cardiff Oncology anticipates an initial data readout from the first-line RAS-mutated mCRC randomized CRDF-004 trial by the end of 2024. This trial is part of the company's broader strategy to leverage Pfizer’s resources and capabilities.

In addition to mCRC, Cardiff Oncology published promising preclinical data showing the synergy between onvansertib and alpelisib in PIK3CA-mutated HR-positive breast cancer that is resistant to palbociclib and endocrine therapy. This data, published in the journal Cancers, revealed that the combination significantly inhibited cell viability, suppressed PI3K signaling, and induced G2/M arrest and apoptosis in PI3K-activated cell lines. The combination showed superior anti-tumor activity compared to single agents in three patient-derived xenograft (PDX) models, suggesting potential for clinical evaluation.

Financially, Cardiff Oncology reported approximately $57.7 million in cash, cash equivalents, and short-term investments as of September 30, 2024. The net cash used in operating activities for the third quarter of 2024 was around $10.5 million, an increase from $8.0 million during the same period in 2023. Based on current projections, the company believes its cash resources are sufficient to fund operations into the first quarter of 2026.

The company's total operating expenses for the quarter amounted to about $12.8 million, up from $11.0 million in the third quarter of 2023. This increase was primarily due to costs associated with clinical programs and services related to the development of onvansertib.

Cardiff Oncology's lead asset, onvansertib, is a PLK1 inhibitor under evaluation in combination with standard-of-care therapies across various clinical programs. These include indications such as RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple-negative breast cancer. The company aims to target tumor vulnerabilities and overcome treatment resistance, offering potentially greater clinical benefits compared to standard therapies alone.