Cardiff Oncology reported a net loss of $45.9 million, or $0.69 per share, for the full year ended December 31 2025, an improvement from the $45.5 million loss ($0.95 per share) reported in 2024. Cash, cash equivalents, and short‑term investments totaled $58.3 million, giving the company a runway that extends into the first quarter of 2027 and providing a financial cushion for the planned CRDF‑005 registrational trial and potential partnership discussions.
The company’s lead asset, onvansertib, delivered a 72.2% objective response rate in the CRDF‑004 phase‑2 trial of onvansertib plus FOLFIRI/bevacizumab versus 43.2% in the combined standard‑of‑care arm. The trial, with a data cutoff of January 22 2026, also showed a progression‑free survival hazard ratio of 0.37 (p < 0.05), underscoring the drug’s potential to improve outcomes in first‑line RAS‑mutant metastatic colorectal cancer.
Interim CEO Mani Mohindru said, "Cardiff Oncology has entered 2026 with strong clinical momentum and a clear path for advancing onvansertib, our lead program, in first‑line RAS‑mutated metastatic colorectal cancer." He added, "Our focus in 2025 was on rigorous clinical execution, which allowed us to generate increasingly compelling evidence supporting onvansertib's potential to improve patient outcomes in RAS‑mutated mCRC..." and noted, "Given that it has been over two decades since there has been meaningful innovation for this patient population, we believe these results represent a transformative step forward."
Investors reacted positively to the announcement, reflecting confidence in the robust clinical data and the company’s cash runway. The strong phase‑2 results position Cardiff for a potential accelerated approval pathway and could attract partnership or financing opportunities that would materially enhance the company’s valuation.
Despite the optimism, the company faces headwinds. Future funding for the CRDF‑005 registrational trial remains a critical requirement, and the company must navigate regulatory hurdles and competition in the mCRC space. Past market volatility has been driven by funding concerns and leadership changes, underscoring the importance of sustained financial and operational execution.
The combination of a compelling clinical signal, a solid cash position, and a clear path to a registrational program places Cardiff Oncology in a favorable position to pursue accelerated approval and potential partnerships. However, as a pre‑revenue, pre‑profitability company, its long‑term success will hinge on the regulatory outcome of onvansertib and the company’s ability to secure additional capital to support the next development phase.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.