Cardiff Oncology (CRDF) Company Report

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.

3 days ago

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.

3 days ago

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.

3 days ago

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.

3 days ago

Transcript

Cardiff Oncology announces positive Phase 2 trial results for onvansertib in mCRC

CRDF

New Projects/Investments

Cardiff Oncology announced positive results from its randomized Phase 2 clinical trial (CRDF-004) for onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC).
The trial demonstrated dose-dependent benefits, with the combination of onvansertib and FOLFIRI/bevacizumab showing superior performance compared to standard of care regimens.
The 30 mg dose of onvansertib with FOLFIRI/bevacizumab achieved a 72.2% confirmed Objective Response Rate (ORR) and a 0.37 Progression-Free Survival (PFS) Hazard Ratio (p-value = 0.048) compared to standard of care.
The company has selected the 30 mg dose of onvansertib with FOLFIRI/bevacizumab for a registrational program in 1L RAS-mutated mCRC, which it plans to initiate later in 2026.

3 days ago

Press Release

Cardiff Oncology Provides Update on Onvansertib for Colorectal Cancer

CRDF

New Projects/Investments

Guidance Update

Cardiff Oncology (CRDF) is developing onvansertib, a first-in-class PLK1 inhibitor, for first-line RAS-mutated metastatic colorectal cancer. The company pivoted its clinical development path to first-line treatment following FDA alignment, addressing a significant unmet need.
Interim data from the ongoing CARDIV-004 first-line trial showed encouraging results, with a 19% difference in objective response rate (ORR) for the 30 mg dose compared to control, and a doubling of confirmed responses at six months. The drug was also noted to be well-tolerated, with no significant increase in grade 3 or greater neutropenia compared to the control arm.
Pfizer is an investor in Cardiff Oncology, holding approximately 3% ownership, and collaborates through its Pfizer Ignite program for trial execution.
The company expects to provide a more comprehensive update on durable data, including progression-free survival (PFS) and duration of response (DOR), in Q1 of next year.
Cardiff Oncology has a cash runway that extends into 2027.

Dec 11, 2025, 9:00 PM

Transcript

Cardiff Oncology Updates on Onvansertib for Colorectal Cancer

CRDF

New Projects/Investments

Guidance Update

Cardiff Oncology is developing onvansertib, a first-in-class PLK1 inhibitor, for first-line RAS-mutated metastatic colorectal cancer, targeting a large and underserved patient population.
The ongoing first-line CARDIV-004 trial showed encouraging efficacy, with the 30 mg dose demonstrating a 19% difference in objective response rate (ORR) compared to control and a doubling of confirmed responses at six months.
Onvansertib has been shown to be well-tolerated when combined with existing chemotherapies, with no significant increase in grade 3 or greater safety issues.
The company has received FDA alignment for a single registrational trial designed for both accelerated and full approval, and has cash to fund operations into 2027.

Dec 11, 2025, 9:00 PM

Transcript

Cardiff Oncology Provides Update on Onvansertib for Metastatic Colorectal Cancer

CRDF

New Projects/Investments

Guidance Update

Cardiff Oncology is developing onvansertib, a first-in-class PLK1 inhibitor, for first-line RAS-mutated metastatic colorectal cancer.
The ongoing CARDIV-004 first-line trial showed encouraging results, with the 30 mg dose demonstrating a 19% higher objective response rate (ORR) compared to control, and a doubling of confirmed responses at six months (46% vs. 22%).
Onvansertib has shown synergy with bevacizumab and is well-tolerated when combined with chemotherapies, without a significant increase in severe side effects.
The company has FDA alignment for a single registrational trial designed for both accelerated and full approval, with updates on durable data from CARDIV-004 expected in Q1 2026.
Pfizer is an investor with approximately 3% ownership and collaborates on trial execution through Pfizer Ignite; Cardiff Oncology has cash to fund operations into 2027.

Dec 11, 2025, 9:00 PM

Transcript

CRDF Provides Update on Onvansertib Phase 2 Data and Phase 3 Plans

CRDF

New Projects/Investments

Guidance Update

CRDF's onvansertib, a first-in-class, oral, and selective PLK1 inhibitor, demonstrated dose-dependent improvements in efficacy in the Phase 2 CRDF-004 study for first-line RAS mutant metastatic colorectal cancer. The 30 mg dose showed a 19% difference in confirmed objective response rate compared to standard of care, with no significant increase in toxicity.
The company plans to initiate Phase 3 trials in 2026 for onvansertib in RAS mutated metastatic colorectal cancer, seeking FDA alignment on a registrational trial design that could support both accelerated and full approval.
CRDF reported over $60 million in cash at the end of Q3 2025, providing a cash runway into Q1 2027.

Dec 2, 2025, 2:30 PM

Transcript

Cardiff Oncology Outlines Onvansertib Phase III Strategy and Q1 2026 Data Update

CRDF

New Projects/Investments

Guidance Update

Cardiff Oncology (CRDF) plans to initiate Phase III trials next year for its oral PLK1 inhibitor, onvansertib, targeting RAS mutated metastatic colorectal cancer.
The company reported positive Phase II CRDF-004 data, highlighting a 19% difference in confirmed objective response rate with the 30 mg dose of onvansertib combined with standard of care in first-line RAS mutant CRC.
An update on more mature durability data, including Progression-Free Survival (PFS) and duration of response, is expected in Q1 2026.
Cardiff Oncology ended Q3 with over $60 million in cash, providing funding into Q1 2027, with additional capital needed for the Phase III trial.