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SAN DIEGO - Cardiff Oncology, Inc. (NASDAQ:CRDF), a clinical-stage biotechnology company with a market capitalization of $223 million, has announced positive outcomes from a Phase 1b clinical trial for onvansertib in combination with paclitaxel, targeting metastatic triple-negative breast cancer (mTNBC), one of the most aggressive subtypes of breast cancer. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 6.22, though it’s currently in its development phase and not yet profitable. The trial results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held from May 30 to June 3, 2025, in Chicago, Illinois.
The trial, led by Dr. Antonio Giordano at the Dana-Farber Cancer Institute, aimed to determine the safety and optimal dosing of the drug combination and to observe its pharmacokinetics and pharmacodynamics. The study’s primary endpoint was the characterization of dose-limiting toxicities and establishing the recommended Phase 2 dose. Secondary endpoints included evaluating the combination’s pharmacokinetics and pharmacodynamics.
Patients in the trial, who had received a median of three prior lines of chemotherapy, showed a 40% objective response rate at the highest onvansertib dose of 18mg/m2. This included two confirmed partial responses and two unconfirmed partial responses. The combination therapy was well-tolerated with a manageable safety profile, with myelosuppression reported as the most common adverse event.
These findings are particularly significant given the majority of the patients were heavily pretreated, and three out of the four objective responses occurred in patients who had prior exposure to paclitaxel. The observed dose-response relationship further supports the potential of onvansertib plus paclitaxel as a treatment for mTNBC. The market has responded positively to these developments, with InvestingPro data showing the stock has gained 12.5% in the past week and 28.2% over the last six months.
Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies by leveraging PLK1 inhibition to target a range of cancers. Onvansertib, their lead asset, is being evaluated in combination with standard care therapeutics in various clinical programs, including metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, and triple-negative breast cancer.
The company’s Chief Medical Officer, Dr. Fairooz Kabbinavar, expressed optimism about the robust efficacy signal and the tolerable safety profile observed in the trial. He highlighted that these results provide clinical validation for previously reported preclinical data showing synergy between onvansertib and paclitaxel.
The press release notes that the information presented is based on statements from Cardiff Oncology and cautions that actual results may differ materially due to various factors, including but not limited to, the lengthy and uncertain process of clinical trials and the risks associated with obtaining regulatory approval. Analyst sentiment remains optimistic, with price targets ranging from $10 to $20 per share, significantly above current trading levels. For deeper insights into Cardiff Oncology’s financial health and growth prospects, including 13 additional ProTips and comprehensive valuation metrics, investors can access the full analysis through InvestingPro’s detailed research report, part of its coverage of over 1,400 US stocks.
In other recent news, Cardiff Oncology has been the focus of several analyst updates. H.C. Wainwright increased its price target for Cardiff Oncology to $18.00 from $17.00, maintaining a Buy rating, based on promising data from the CRDF-004 trial involving onvansertib for RAS-mutated colorectal cancer. Piper Sandler also initiated coverage with an Overweight rating and a $10.00 price target, citing interim results from the same trial and emphasizing Cardiff’s financial stability, with cash reserves projected to last into 2027. Lucid Capital Markets joined in, setting a $14.00 price target and a Buy rating, highlighting the drug’s potential in colorectal cancer and other indications. The firm noted that onvansertib could potentially reach $2.9 billion in peak sales if clinical data remains positive. Cardiff Oncology plans to release more data from the CRDF-004 trial in the second quarter of 2025 and is preparing for a Phase III trial set to begin in early 2026. The company ended 2024 with approximately $92 million in cash, which analysts believe will support operations into 2027. These developments reflect a strong interest in Cardiff Oncology’s lead asset, onvansertib, and its future potential in treating various cancers.
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