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On Friday, H.C. Wainwright analyst Raghuram Selvaraju increased the price target for Cardiff Oncology (NASDAQ:CRDF) to $17.00, up from the previous target of $13.00, while reiterating a Buy rating on the stock. According to InvestingPro data, the stock has shown remarkable strength with a 123% return over the past year, despite recent volatility. The revision is based on the anticipation of updated results from the company’s CRDF-004 clinical trial, which are expected in the first half of 2025. Analyst consensus remains strongly bullish, with price targets ranging from $10 to $20.
As of December 2024, 60 patients have received dosing in the CRDF-004 trial, which is nearing completion of enrollment. The study is designed to evaluate the efficacy of onvansertib in combination with chemotherapy and bevacizumab (Avastin) as a first-line treatment for RAS-mutated colorectal cancer (mCRC). The trial aims to enroll approximately 90 patients, randomized into three groups to receive either the standard-of-care (SoC) alone or SoC combined with two different dosages of onvansertib. Cardiff maintains a strong financial position to support this clinical development, with InvestingPro data showing a healthy current ratio of 7.08 and more cash than debt on its balance sheet.
Preliminary results released late last year indicated that the higher dose of onvansertib (30mg) with SoC achieved a 64% objective response rate (ORR) in 11 patients, significantly higher than the 33% ORR observed in the SoC-only arm, consisting of 9 patients. The benchmark for success in the trial is defined as an ORR delta of 20%.
Selvaraju noted that if the onvansertib 30mg + SoC continues to show an ORR delta similar to the initial data, Cardiff Oncology plans to transition the CRDF-004 study into a registrational trial. This could potentially lead to an accelerated approval pathway for onvansertib. Given the promising data observed thus far, the analyst expressed a high level of optimism about the future prospects of onvansertib for the mCRC indication.
In other recent news, Cardiff Oncology reported its financial results for the fourth quarter of 2024, highlighting strategic advancements in its lead program and a strong cash position. The company completed a $40 million capital raise, which has bolstered its cash reserves, projecting a cash runway extending into the first quarter of 2027. Cardiff’s lead program, ONVANSERTIB, demonstrated promising results in clinical trials for metastatic colorectal cancer, showing a favorable safety profile and efficacy. As of December 31, 2024, Cardiff Oncology’s cash and short-term investments totaled $91.7 million, with $10.3 million used in operating activities for the quarter. The company plans to release additional clinical data in the first half of 2025 and engage with the FDA regarding its registrational strategy for ONVANSERTIB. Additionally, Cardiff Oncology strengthened its intellectual property portfolio with a new patent covering the use of ONVANSERTIB in combination with BEV for KRAS mutated colorectal cancer patients. This recent development aligns with the company’s focus on addressing significant unmet medical needs in oncology.
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