Cardiff Unveils Phase 1 Results of Onvensertib for Chronic Myelomonocytic Leukemia at ASH 2025
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 09 2025
0mins
Source: NASDAQ.COM
Clinical Trial Results: Cardiff Oncology presented new data from a Phase 1 trial of onvansertib, a PLK1 inhibitor, for treating relapsed/refractory chronic myelomonocytic leukemia (CMML) at the ASH Annual Meeting, showing preliminary efficacy in about 40% of patients.
Drug Tolerability: Onvansertib was well-tolerated as a monotherapy, with manageable treatment-emergent adverse events reported among the nine enrolled patients.
Future Development Plans: Although Cardiff Oncology does not plan to further develop onvansertib for CMML, the results support its potential in treating various hematologic and solid tumors.
Stock Performance: Following the announcement, Cardiff Oncology's stock rose by 10.90% to $2.34, with a slight increase in after-hours trading, reflecting positive investor sentiment.
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Analyst Views on CRDF
Wall Street analysts forecast CRDF stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 1.840
Low
10.00
Averages
13.67
High
19.00
Current: 1.840
Low
10.00
Averages
13.67
High
19.00
About CRDF
Cardiff Oncology, Inc. is a clinical-stage biotechnology company advancing cancer treatments focused on Polo-like Kinase 1 (PLK1) inhibition, a validated oncology target with practice-changing potential. The Company's lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor being evaluated in a Phase II trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML). The Company's clinical development programs incorporate tumor genomics and biomarker assays to refine patient selection and assessment of patient response to treatment.
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 to Host Investor Webcast on June 3, 2026
- Clinical Trial Update: Cardiff Oncology will present updated data from the CRDF-004 trial at the 2026 ASCO Annual Meeting on June 2, focusing on treatment for patients with RAS-mutated metastatic colorectal cancer, which is expected to provide critical insights for the company's future clinical strategies.
- Investor Webcast: The company has scheduled an investor webcast for June 3, 2026, at 8:30 am ET, where management will discuss the latest CRDF-004 data in detail, aiming to bolster investor confidence in the company's research and development progress.
- Combination Therapy Efficacy: In a randomized Phase 2 trial, the combination of onvansertib with FOLFIRI/bevacizumab demonstrated dose-dependent improvements in overall response rates and progression-free survival compared to standard treatment alone, indicating the drug's potential in treating RAS-mutated patients.
- Multi-Cancer Research: Beyond colorectal cancer, onvansertib is also being investigated in various cancers, including small cell lung cancer and triple-negative breast cancer, showcasing its broad application potential as a PLK1 inhibitor and possibly opening new market opportunities for the company.
See More
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- Executive Appointments: Cardiff Oncology has appointed Mani Mohindru as President and CEO, who previously served as interim CEO and will remain on the Board, a move aimed at ensuring leadership stability and continuity within the company.
- Financial and Operational Leadership: Josh Muntner has been appointed CFO and Ajay Aggarwal as COO, effective April 6 and April 27 respectively, with Muntner having prior experience as CFO at Imvax and Mesoblast, while Aggarwal brings expertise from his role as Senior VP at Aclaris Therapeutics, enhancing the company's leadership depth.
- Strategic Execution Capability: The addition of these executives is expected to bolster Cardiff Oncology's capabilities in clinical development and financial management, particularly in advancing its treatment strategies for RAS-mutated metastatic colorectal cancer, potentially accelerating clinical strategy implementation.
- Market Reaction: Despite the leadership changes, the market remains cautious about Onvansertib's potential in first-line colorectal cancer treatment, reflecting investor concerns and expectations regarding the company's future trajectory.
See More
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- New Appointments: Josh Munter and Jay Aggarwal have been appointed as Chief Financial Officers (CFOs) at Cardiff Oncology.
- Effective Dates: Josh Munter's appointment is effective from April 6, while Jay Aggarwal's is effective from April 27.
See More
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Leadership Announcement: Manihindru has been appointed as the President and CEO of Cardiff Oncology.
Board Membership: He will continue to serve as a member of the board.
See More
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- Financial Overview: Cardiff Oncology reported royalty revenues of $0.6 million for 2025, a slight decrease from $0.7 million in 2024, while total operating expenses remained stable at $49.6 million, resulting in a net loss of $45.9 million or $0.69 per share, which is an improvement over the previous year's loss of $45.5 million or $0.95 per share, indicating better financial management.
- Clinical Trial Progress: The Phase 2 CRDF-004 trial for RAS-mutated metastatic colorectal cancer showed that the 30 mg Onvansertib combined with FOLFIRI/bev achieved a 72.2% objective response rate, significantly higher than the 43.2% in standard care arms, laying a solid foundation for advancing into a registrational program, with detailed data and regulatory plans expected in the first half of 2026.
- Cash Position: As of 2025, Cardiff's cash, cash equivalents, and short-term investments totaled $58.3 million, which is expected to fund operations into the first quarter of 2027, demonstrating strong financial management and providing a buffer for ongoing research and development.
- Leadership Changes: In January 2026, Cardiff announced executive changes with Mani Mohindru appointed as interim CEO and Brigitte Lindsay promoted to Chief Accounting Officer, reflecting the company's strategic restructuring to support late-stage development while actively searching for a permanent CEO and CFO to enhance management stability.
See More
Cardiff Oncology Reports FY EPS Beat Amid Revenue Decline
- Earnings Highlights: Cardiff Oncology reported a FY GAAP EPS of -$0.69, beating expectations by $0.08, indicating some financial resilience despite still being in negative territory.
- Revenue Trends: The company generated $0.59M in revenue, a 13.2% year-over-year decline, yet it surpassed market expectations by $0.14M, suggesting a stable customer base amid challenges.
- Leadership Changes: Following the earnings release, Cardiff Oncology experienced a leadership shakeup, which could impact the company's strategic direction and investor confidence, necessitating close monitoring of management stability.
- Future Outlook: Despite current challenges, the market remains cautiously optimistic about Cardiff Oncology's future performance, particularly with the upcoming Phase II data update for Onvansertib in RAS-mutated mCRC, which may present new growth opportunities.
See More
Cardiff Oncology to Host Investor Webcast on June 3, 2026
- Clinical Trial Update: Cardiff Oncology will present updated data from the CRDF-004 trial at the 2026 ASCO Annual Meeting on June 2, focusing on treatment for patients with RAS-mutated metastatic colorectal cancer, which is expected to provide critical insights for the company's future clinical strategies.
- Investor Webcast: The company has scheduled an investor webcast for June 3, 2026, at 8:30 am ET, where management will discuss the latest CRDF-004 data in detail, aiming to bolster investor confidence in the company's research and development progress.
- Combination Therapy Efficacy: In a randomized Phase 2 trial, the combination of onvansertib with FOLFIRI/bevacizumab demonstrated dose-dependent improvements in overall response rates and progression-free survival compared to standard treatment alone, indicating the drug's potential in treating RAS-mutated patients.
- Multi-Cancer Research: Beyond colorectal cancer, onvansertib is also being investigated in various cancers, including small cell lung cancer and triple-negative breast cancer, showcasing its broad application potential as a PLK1 inhibitor and possibly opening new market opportunities for the company.
See More
Cardiff Oncology Appoints New CEO and Executives
- Executive Appointments: Cardiff Oncology has appointed Mani Mohindru as President and CEO, who previously served as interim CEO and will remain on the Board, a move aimed at ensuring leadership stability and continuity within the company.
- Financial and Operational Leadership: Josh Muntner has been appointed CFO and Ajay Aggarwal as COO, effective April 6 and April 27 respectively, with Muntner having prior experience as CFO at Imvax and Mesoblast, while Aggarwal brings expertise from his role as Senior VP at Aclaris Therapeutics, enhancing the company's leadership depth.
- Strategic Execution Capability: The addition of these executives is expected to bolster Cardiff Oncology's capabilities in clinical development and financial management, particularly in advancing its treatment strategies for RAS-mutated metastatic colorectal cancer, potentially accelerating clinical strategy implementation.
- Market Reaction: Despite the leadership changes, the market remains cautious about Onvansertib's potential in first-line colorectal cancer treatment, reflecting investor concerns and expectations regarding the company's future trajectory.
See More
CARDIFF ONCOLOGY INC NAMES JOSH MUNTNER CFO STARTING APRIL 6 AND AJAY AGGARWAL COO BEGINNING APRIL 27
- New Appointments: Josh Munter and Jay Aggarwal have been appointed as Chief Financial Officers (CFOs) at Cardiff Oncology.
- Effective Dates: Josh Munter's appointment is effective from April 6, while Jay Aggarwal's is effective from April 27.
See More
CARDIFF ONCOLOGY INC NAMES MANI MOHINDRU PRESIDENT AND CEO; HE WILL REMAIN ON THE BOARD
Leadership Announcement: Manihindru has been appointed as the President and CEO of Cardiff Oncology.
Board Membership: He will continue to serve as a member of the board.
See More
Cardiff Oncology Reports 2025 Financial Results and Business Update
- Financial Overview: Cardiff Oncology reported royalty revenues of $0.6 million for 2025, a slight decrease from $0.7 million in 2024, while total operating expenses remained stable at $49.6 million, resulting in a net loss of $45.9 million or $0.69 per share, which is an improvement over the previous year's loss of $45.5 million or $0.95 per share, indicating better financial management.
- Clinical Trial Progress: The Phase 2 CRDF-004 trial for RAS-mutated metastatic colorectal cancer showed that the 30 mg Onvansertib combined with FOLFIRI/bev achieved a 72.2% objective response rate, significantly higher than the 43.2% in standard care arms, laying a solid foundation for advancing into a registrational program, with detailed data and regulatory plans expected in the first half of 2026.
- Cash Position: As of 2025, Cardiff's cash, cash equivalents, and short-term investments totaled $58.3 million, which is expected to fund operations into the first quarter of 2027, demonstrating strong financial management and providing a buffer for ongoing research and development.
- Leadership Changes: In January 2026, Cardiff announced executive changes with Mani Mohindru appointed as interim CEO and Brigitte Lindsay promoted to Chief Accounting Officer, reflecting the company's strategic restructuring to support late-stage development while actively searching for a permanent CEO and CFO to enhance management stability.
See More
Cardiff Oncology Reports FY EPS Beat Amid Revenue Decline
- Earnings Highlights: Cardiff Oncology reported a FY GAAP EPS of -$0.69, beating expectations by $0.08, indicating some financial resilience despite still being in negative territory.
- Revenue Trends: The company generated $0.59M in revenue, a 13.2% year-over-year decline, yet it surpassed market expectations by $0.14M, suggesting a stable customer base amid challenges.
- Leadership Changes: Following the earnings release, Cardiff Oncology experienced a leadership shakeup, which could impact the company's strategic direction and investor confidence, necessitating close monitoring of management stability.
- Future Outlook: Despite current challenges, the market remains cautiously optimistic about Cardiff Oncology's future performance, particularly with the upcoming Phase II data update for Onvansertib in RAS-mutated mCRC, which may present new growth opportunities.
See More
