Cardiff Oncology Q1 2024 Results and Business Update

Cardiff Oncology, a clinical-stage biotechnology company, has reported its financial results for the first quarter ending March 31, 2024, alongside a business update. The company is leveraging PLK1 inhibition to develop innovative therapies for various cancers. During early 2024, the company presented new data supporting its first-line RAS-mutated metastatic colorectal cancer (mCRC) strategy and the broader application of its lead asset, onvansertib.

The ONSEMBLE trial results indicated a strong efficacy signal in bevacizumab (bev) naïve patients, mirroring findings from earlier trials. These results, presented at the AACR, underscore the potential of onvansertib in treating RAS-mutated mCRC. The CEO of Cardiff Oncology, Mark Erlander, highlighted the significance of these findings, which were also published in Clinical Cancer Research. Upcoming data from the first-line trial in RAS-mutated mCRC could potentially revolutionize treatment in this area.

The company has adjusted its expectations for an initial readout from the first-line RAS-mutated mCRC randomized CRDF-004 trial to the second half of 2024, based on current enrollment trends. Key highlights for the quarter include:

1. Updated Data at AACR: Cardiff Oncology presented clinical and preclinical data at the AACR Annual Meeting 2024 supporting its ongoing first-line RAS-mutated mCRC study. The data showed that onvansertib inhibits the hypoxia pathway through HIF1α regulation, leading to significantly better outcomes for bev naïve patients.

2. First Patient Dosed: The company announced dosing the first patient in its randomized first-line Phase 2 trial, CRDF-004, aimed at confirming the onvansertib dose for future trials. Interim topline results are expected in the latter half of 2024, which could pave the way for a Phase 3 trial with registrational intent.

3. ONSEMBLE Trial Update: Data from the Phase 2 randomized second-line ONSEMBLE trial in mCRC further demonstrated the efficacy of onvansertib in combination with standard care for bev naïve patients, supporting the ongoing lead program.

4. Publication in Clinical Cancer Research: Cardiff Oncology published findings from its Phase 1b study in second-line KRAS-mutated mCRC, highlighting the safety and promising efficacy of onvansertib in combination with standard care.

In addition to progress in RAS-mutated mCRC, Cardiff Oncology presented data at AACR in other areas:
- RAS Wild-Type mCRC: Onvansertib showed significant antitumor activity both as a monotherapy and in combination with cetuximab in RAS wild-type mCRC models.
- Small Cell Lung Cancer (SCLC): Onvansertib combined with paclitaxel demonstrated superior efficacy over monotherapies in SCLC models.
- Ovarian Cancer: Onvansertib combined with gemcitabine or carboplatin showed antitumor activity in platinum-resistant ovarian cancer models, suggesting potential improvement in standard care treatments.

For the first quarter of 2024, Cardiff Oncology reported $67.2 million in cash and equivalents, projecting their runway into the third quarter of 2025. Operating expenses for the quarter were $11.1 million, a decrease from the previous year primarily due to lower chemistry, manufacturing, and control costs. The net cash used in operating activities was approximately $7.7 million.

Cardiff Oncology will hold a conference call to discuss these results and updates. The company focuses on developing onvansertib, a PLK1 inhibitor, in combination with standard therapies across various cancer indications, including RAS-mutated mCRC, metastatic pancreatic ductal adenocarcinoma, SCLC, and triple-negative breast cancer. Their goal is to target tumor vulnerabilities to overcome treatment resistance and provide superior clinical benefits.

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