Cardiff Oncology, Inc. (CRDF) is trading sharply lower in the pre-market, down 30%, as the company released two significant updates today - one highlighting encouraging clinical results from its randomized Phase 2 trial on Onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC), and another announcing a major transition in executive leadership as the company prepares for late-stage development.
The company reported a positive update from its CRDF-004 Phase 2 dose-finding trial evaluating Onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line (1L) RAS-mutated metastatic colorectal cancer (mCRC).
In an intent-to-treat analysis, the company observed dose-dependent improvements in multiple efficacy measures, including objective response rate and progression-free survival, with the 30 mg Onvansertib plus FOLFIRI/bevacizumab arm outperforming both standard-of-care arms.
The regimen was well-tolerated, with no major or unexpected toxicities and no additive adverse events. Based on these findings, Cardiff has selected the 30 mg dose to advance into a registrational program, with final data and trial design discussions expected in the first half of 2026.
Alongside the clinical update, Cardiff announced a leadership transition intended to support its shift toward late-stage development.
Mani Mohindru, PhD, a member of the company's Board since 2021 and an experienced biotechnology executive, has been appointed interim CEO. Mark Erlander, PhD, has stepped down as CEO, and James Levine has departed from his role as Chief Financial Officer.
To ensure continuity within the finance function, Brigitte Lindsay, who has been with the company for more than 14 years, has been promoted to Chief Accounting Officer role. Cardiff has initiated searches for a permanent CEO and CFO as it advances Onvansertib toward potential registrational studies.
Onvansertib, a highly specific oral PLK1 inhibitor, is being developed for RAS-mutated mCRC, a population that represents roughly half of all metastatic colorectal cancer cases and has seen limited therapeutic progress over the past two decades. The candidate is also being evaluated in multiple investigator-initiated studies across other PLK1-driven cancers, including metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, triple-negative breast cancer, and chronic myelomonocytic leukemia.
Despite the encouraging clinical data and the company's efforts to strengthen its leadership structure, shares are under pressure in early trading. The decline appears tied to investor reaction to the abrupt CEO and CFO departures, which can introduce uncertainty during a pivotal development phase, even when accompanied by positive trial results.
As of September 30, 2025, Cardiff Oncology had approximately $60.6 million in cash, cash equivalents, and short-term investments, which are expected to fund operations into the first quarter of 2027.
CRDF has traded between $1.90 and $4.99 over the past year. The stock is currently trading in the pre-market at $2.05, down 30.04%.
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