Cardiff Oncology (CRDF) Company Report

Cardiff Oncology's lead program, onvansertib, a highly selective PLK1 inhibitor, shows blockbuster potential in first-line RAS-mutated metastatic colorectal cancer (mCRC).
In an ongoing Phase 2 study, the 30 mg dose of onvansertib combined with FOLFIRI and bevacizumab achieved a confirmed overall response rate of 72%, significantly outperforming the 42.1% seen in the FOLFIRI/bev standard of care arm.
Median progression-free survival (PFS) has not yet been reached in the onvansertib treatment arms, while the standard of care arm recorded 11 months.
The company anticipates finalizing and announcing its registrational path and full Phase 3 trial design for onvansertib in frontline RAS-mutated mCRC within the first half of 2026, following discussions with the FDA.
Cardiff Oncology's cash equivalents of $58.3 million are projected to fund operations into the first quarter of 2027, excluding significant investments for the planned Phase 3 study.

3 days ago

Transcript

Cardiff Oncology Provides Update on Onvansertib's Phase II Data and Regulatory Path, Reports Cash Position

CRDF

New Projects/Investments

Guidance Update

Cardiff Oncology's lead program, onvansertib, a PLK1 inhibitor, demonstrated promising efficacy in first-line RAS-mutated metastatic colorectal cancer (mCRC), achieving a 72% confirmed overall response rate at the 30mg dose in a Phase II study, which represents an approximately 30% improvement over the standard of care arm.
The company is actively finalizing a path to registration for onvansertib in frontline RAS-mutated mCRC, with plans to provide regulatory feedback and the full Phase III trial design within the first half of 2026 following discussions with the US FDA.
Cardiff Oncology reported $58.3 million in cash equivalents, which is projected to provide a cash runway into Q1 2027; however, this guidance does not include any significant investment into the Phase III study.
Cardiff retains full rights and ownership of the onvansertib program, despite Pfizer acting as a CRO partner and having made a $15 million investment.

3 days ago

Transcript

Cardiff Oncology Presents Positive Onvansertib Phase 2 Data and Regulatory Path

CRDF

New Projects/Investments

Guidance Update

Cardiff Oncology's lead program, onvansertib, a PLK1 inhibitor, demonstrated a 72% confirmed overall response rate in first-line RAS-mutated metastatic colorectal cancer (mCRC) when combined with FOLFIRI and bevacizumab, representing a 30% improvement over the standard of care. The median progression-free survival (PFS) for the onvansertib arm has not yet been reached, while the standard of care arm reached 11 months.
The company is finalizing a path to registration for onvansertib in first-line RAS-mutated mCRC, with regulatory feedback and the full Phase 3 trial design expected in the first half of 2026.
Cardiff Oncology reported $58.3 million in cash equivalents as of February 24, 2026, which is projected to fund operations into Q1 2027, though this guidance does not include significant investment for the planned Phase 3 study.

3 days ago

Transcript

Cardiff Oncology Reports Positive Phase 2 Onvansertib Data and Outlines Registrational Strategy

CRDF

New Projects/Investments

Guidance Update

Cardiff Oncology, Inc. reported positive interim results from its CRDF-004 Phase 2 trial for Onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC), with data cut as of January 22, 2026.
The 30 mg Onvansertib + FOLFIRI/bev arm demonstrated a confirmed Objective Response Rate (ORR) of 72.2%, which is a 30% improvement over the FOLFIRI standard of care (SoC), and a Progression-Free Survival (PFS) Hazard Ratio of 0.37 (p-value = 0.048) versus SoC.
The company plans an FDA meeting in H1 2026 to review the registrational program and intends to initiate a Phase 3 trial in 2H 2026 for first-line RAS-mutated mCRC, selecting the 30 mg Onvansertib dose for the registrational program.
Cardiff Oncology has $58.3 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into the first quarter of 2027.

3 days ago

8-K

Cardiff Oncology Reports Full Year 2025 Results and Provides Business Update

CRDF

Earnings

Guidance Update

Management Change

Cardiff Oncology reported a net loss of $45.851 million for the full year ended December 31, 2025, with total operating expenses of $49.553 million.
As of December 31, 2025, the company had approximately $58.3 million in cash, cash equivalents, and short-term investments, which are projected to fund operations into the first quarter of 2027.
The company announced a positive update from its Phase 2 CRDF-004 trial for onvansertib in first-line RAS-mutated metastatic colorectal cancer, demonstrating a 72.2% objective response rate and significant improvement in progression-free survival with the 30 mg onvansertib + FOLFIRI/bev arm.
Based on these results, Cardiff Oncology plans to advance the 30 mg onvansertib dose into a proposed registrational program, with detailed data and plans expected in the first half of 2026.
In January 2026, Mani Mohindru was appointed interim Chief Executive Officer as part of executive leadership changes to support late-stage development.

3 days ago

8-K

Cardiff Oncology Reports Full Year 2025 Results and Provides Business Update

CRDF

Earnings

CEO Change

Guidance Update

Cardiff Oncology reported a net loss of $(45.851) million for the full year ended December 31, 2025, with a net loss per common share of $(0.69).
As of December 31, 2025, the company had approximately $58.3 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into the first quarter of 2027.
The company announced a positive update from the Phase 2 CRDF-004 trial for onvansertib in first-line RAS-mutated mCRC, with the 30 mg onvansertib + FOLFIRI/bev arm demonstrating a 72.2% objective response rate and significant improvement in progression-free survival.
Based on these results, Cardiff Oncology plans to advance the 30 mg dose of onvansertib into a registrational program, with detailed data and plans expected in the first half of 2026 after discussions with the FDA.
Mani Mohindru, PhD, was appointed interim Chief Executive Officer in January 2026, and a search for a permanent CEO and CFO has been initiated.

3 days ago

Press Release

Cardiff Oncology announces executive leadership changes

CRDF

CEO Change

CFO Change

Management Change

Cardiff Oncology, Inc. announced executive leadership changes, with Mani Mohindru, PhD, appointed as interim Chief Executive Officer, effective January 27, 2026.
Mark Erlander, PhD, and James Levine have stepped down from their roles as CEO and CFO, respectively.
Brigitte Lindsay has been promoted to Chief Accounting Officer, and the company has initiated a search for a permanent Chief Executive Officer and Chief Financial Officer.
These leadership changes are designed to support the company's next phase of growth and advancement toward late-stage clinical development.

Jan 27, 2026, 9:01 PM

8-K

Cardiff Oncology Announces Interim CEO Appointment and Positive Onvansertib Phase 2 Data

CRDF

Management Change

New Projects/Investments

Cardiff Oncology announced a management transition, appointing Mani Mohindru as Interim Chief Executive Officer.
The company provided an update on onvansertib's promising Phase 2 data from the CRDF-004 trial in first-line RAS-mutated metastatic colorectal cancer (mCRC).
The 30-milligram dose of onvansertib combined with FOLFIRI Bev demonstrated a 72.2% confirmed overall objective response rate (ORR), significantly higher than the 42.1% for FOLFIRI plus Bev standard of care alone.
Median Progression-Free Survival (PFS) has not yet been reached in the onvansertib FOLFIRI arms, compared to approximately 11 months for standard of care regimens, with a statistically significant PFS hazard ratio of 0.37 for the 30mg onvansertib arm.
Cardiff Oncology plans to advance the 30-milligram dose of onvansertib in combination with FOLFIRI-bev into a registrational study in RAS-mutated mCRC, with initiation expected later this year.

Jan 27, 2026, 1:30 PM

Transcript

Cardiff Oncology Appoints Interim CEO and Reports Positive Onvansertib Phase II Data

CRDF

CEO Change

New Projects/Investments

Cardiff Oncology announced the appointment of Mani Mohindru as Interim Chief Executive Officer.
The company reported promising updated Phase II data for onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC) patients.
The 30 mg dose of onvansertib combined with FOLFIRI Bev demonstrated a 72.2% confirmed overall objective response rate (ORR) compared to 43.2% for combined standard of care regimens, and a statistically significant PFS hazard ratio of 0.37 versus combined standard of care arms.
Cardiff Oncology plans to initiate a registrational program later in 2026 for onvansertib in this indication and expects to provide more mature clinical data and receive FDA feedback on the registration plan by the end of the first half of 2026.

Jan 27, 2026, 1:30 PM

Transcript

Cardiff Oncology Announces Interim CEO Appointment and Positive Onvansertib Phase 2 Data

CRDF

CEO Change

New Projects/Investments

Cardiff Oncology announced a management transition, with Mani Mohindru appointed Interim Chief Executive Officer.
The company reported promising updated Phase 2 data for onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC) patients.
The 30 mg dose of onvansertib combined with FOLFIRI Bev achieved a 72.2% confirmed overall objective response rate (ORR) and statistically significant progression-free survival (PFS) with a hazard ratio of 0.37 compared to standard of care regimens.
Cardiff plans to initiate a registrational study later this year using the 30 mg onvansertib plus FOLFIRI-bev regimen in the frontline setting for RAS-mutated mCRC.