Cardiff Oncology Presents Onvansertib Efficacy Data at ASH Meeting, 40% Patient Response
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 08 2025
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Source: Globenewswire
- Clinical Trial Results: In a Phase 1 dose escalation trial for chronic myelomonocytic leukemia (CMML), approximately 40% of the 9 patients showed preliminary efficacy with onvansertib as a monotherapy, indicating its potential despite the company's decision not to pursue further development for CMML.
- Tolerance Assessment: The trial results demonstrated that onvansertib was relatively well-tolerated, with one patient achieving an optimal marrow response at the 9 mg/m2 dose, highlighting its application prospects in both hematologic and solid tumors.
- Multiple Indication Development: Cardiff Oncology is evaluating onvansertib in combination with standard care for various cancers, including RAS-mutated metastatic colorectal cancer, aiming to overcome treatment resistance and deliver superior clinical benefits compared to standard therapies.
- Future Outlook: While there are no plans to develop onvansertib for CMML, its research results in other indications, such as small cell lung cancer, provide critical data support for the company's future clinical strategy.
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Analyst Views on CRDF
Wall Street analysts forecast CRDF stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CRDF is 13.67 USD with a low forecast of 10.00 USD and a high forecast of 19.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 1.615
Low
10.00
Averages
13.67
High
19.00
Current: 1.615
Low
10.00
Averages
13.67
High
19.00
About CRDF
Cardiff Oncology, Inc. is a clinical-stage biotechnology company. It is leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with unmet medical need. It is focused on clinical programs in indications, such as RAS-mutated metastatic colorectal cancer (mCRC), and in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple negative breast cancer (TNBC). Its lead drug candidate, Onvansertib, is an oral, small-molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life. It has other ongoing and planned clinical trials of onvansertib: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, relapsed SCLC and unresectable locally advanced or metastatic TNBC.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Cardiff Oncology Management Shakeup and Trial Update
- Management Changes: Cardiff Oncology announced the resignation of CEO Mark Erlander and CFO James Levine, with board member Mani Mohindru appointed as interim CEO, reflecting a focus on execution and clinical advancement that may impact investor confidence negatively.
- Clinical Trial Data Update: In the CRDF-004 Phase 2 trial for RAS-mutated metastatic colorectal cancer, the 30 mg dose group achieved a confirmed objective response rate of 72.2%, significantly higher than the 43.2% in the standard care group, indicating the potential efficacy of the new drug and possibly driving future registrational trials.
- Registrational Trial Plans: Based on clinical data, Cardiff Oncology plans to initiate a registrational trial later this year comparing onvansertib with standard care for 1L patients, which, if successful, could help expand market share.
- Analyst Perspective: William Blair lowered the probability of success from 50% to 45%, suggesting that the abrupt management changes and narrow focus on onvansertib may limit market opportunities, leading to a 31.9% drop in stock price to $2, close to the 52-week low.
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Cardiff Oncology Shares Plunge 35% Following CEO and CFO Resignations
- Executive Departures: Cardiff Oncology's CEO Mark Erlander and CFO James Levine resigned, causing shares to plummet approximately 35% to a new 52-week low, indicating market concerns over leadership instability.
- Interim Leadership: The board appointed veteran biotech executive Mani Mohindru as interim CEO to replace Erlander, ensuring operational continuity during the executive transition period.
- Financial Stability: Brigitte Lindsay was promoted to Chief Accounting Officer to maintain the finance department's functionality, reflecting the company's commitment to financial management amid leadership changes.
- Clinical Trial Update: Cardiff announced plans to further test a 30 mg dose of its lead drug onvansertib in combination with FOLFIRI/bevacizumab, with a registrational trial expected to begin later this year pending FDA design confirmation, aiming to provide new treatment options for RAS-mutated metastatic colorectal cancer.
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