Cardiff Oncology Reports Full Year 2025 Results & Business Update: Major Clinical Milestone in Metastatic Colorectal Cancer

Key Highlights from the Report

• Positive Phase 2 Clinical Data for Onvansertib in First-Line RAS-Mutated mCRC:
  • 72.2% Objective Response Rate (ORR) in the 30 mg onvansertib + FOLFIRI/bev arm, significantly higher than the 43.2% ORR seen in the combined standard of care (SoC) arms (FOLFOX/bev and FOLFIRI/bev).
  • Marked improvement in progression-free survival (PFS) with a hazard ratio (HR) of 0.37 (p<0.05) versus combined SoC.
  • No significant added toxicity observed with the onvansertib combination.
• Planned Advancement to Registrational Development:
  • Cardiff Oncology plans to advance the 30 mg onvansertib + FOLFIRI/bev regimen into a registrational program following FDA discussions in the first half of 2026.
  • Detailed Phase 2 data and registrational plans expected in H1 2026.
• Leadership Transition for Late-Stage Development:
  • Mani Mohindru, PhD, appointed interim CEO; internal promotion of Brigitte Lindsay to Chief Accounting Officer.
  • Search initiated for permanent CEO and CFO to support late-stage advancement.
• Additional Clinical Data in Hematology:
  • Investigator-sponsored Phase 1 trial data in chronic myelomonocytic leukemia (CMML) presented at ASH 2025, showing onvansertib was well-tolerated and demonstrated preliminary efficacy (~40% of patients).
• Financial Position and Results:
  • Cash, cash equivalents, and short-term investments of \$58.3 million as of December 31, 2025; sufficient to fund operations into Q1 2027.
  • Total operating expenses for 2025 were \$49.6 million, slightly up from \$49.3 million in 2024, mainly due to advisory services and employee separation costs.
  • Net loss for 2025 was \$45.9 million, compared to \$45.5 million in 2024.

Detailed Business Update

Clinical Progress in Metastatic Colorectal Cancer (mCRC)

Cardiff Oncology’s lead asset, onvansertib, a highly specific oral PLK1 inhibitor, made substantial progress in 2025. The company’s randomized Phase 2 CRDF-004 trial for first-line RAS-mutated mCRC achieved a robust confirmed objective response rate of 72.2% in the 30 mg onvansertib + FOLFIRI/bev arm, compared to 43.2% in the combined SoC arms. This marks a nearly 30% improvement in response rates, signaling a potentially transformative advancement for a patient population that has seen little innovation in over two decades.

The combination also demonstrated encouraging durability as measured by progression-free survival, with a hazard ratio of 0.37 versus SoC, and no significant additional toxicity. The company plans to move the 30 mg dose of onvansertib plus FOLFIRI/bev into registrational development, with detailed data and regulatory plans to be released after FDA consultation in the first half of 2026.

Leadership Changes to Support Late-Stage Development

To facilitate this transition into late-stage clinical development, Cardiff made key executive changes. Dr. Mani Mohindru, a board member since 2021, was appointed interim CEO. Brigitte Lindsay was promoted to Chief Accounting Officer, ensuring continuity in finance. Cardiff has initiated a search for permanent CEO and CFO roles, reflecting its commitment to operational excellence as it advances toward potential commercialization.

Expansion into Hematologic Malignancies

In December 2025, data from an investigator-sponsored Phase 1 trial of onvansertib monotherapy in CMML was presented at the American Society of Hematology (ASH) Annual Meeting. The trial showed that onvansertib was generally well-tolerated and had preliminary efficacy in approximately 40% of patients, including one optimal bone marrow response, highlighting the potential of onvansertib in other cancer types.

Financial Overview

• As of December 31, 2025, Cardiff Oncology had \$58.3 million in cash, cash equivalents, and short-term investments. Management expects this to fund operations into the first quarter of 2027.
• Total operating expenses for 2025 were \$49.6 million, up marginally from \$49.3 million in 2024, primarily due to higher SG&A costs from strategic advisory services and some employee separation expenses. This was partially offset by lower R&D costs due to reduced clinical trial activity.
• Net loss attributable to common stockholders for 2025 was \$45.88 million (\$0.69 per share), compared to \$45.46 million (\$0.95 per share) in 2024, with the increase in weighted-average shares outstanding reflecting prior financings.

Balance Sheet Snapshot

• Total assets at year-end were \$61.9 million, down from \$97.2 million a year prior, reflecting operational spend and R&D investments.
• Total liabilities stood at \$16.5 million, up slightly from \$14.2 million in 2024.
• Stockholders’ equity decreased to \$45.4 million, down from \$82.9 million in 2024, consistent with reported net losses and cash spend.

Potential Share Price Impact & Shareholder Considerations

• Strong Clinical Data: The significant improvement in ORR and PFS, coupled with manageable toxicity and a clear path toward registrational development, positions onvansertib as a potential new standard of care for first-line RAS-mutated mCRC. This is a major inflection point and could be highly price sensitive as investors anticipate pivotal trial initiation and regulatory engagement.
• Upcoming Catalysts: Detailed Phase 2 data and FDA discussions planned for H1 2026 represent key near-term catalysts. Positive outcomes could materially re-rate the company’s valuation.
• Funding Runway: Sufficient cash to fund operations into Q1 2027 reduces near-term financing risk, an important consideration for shareholder confidence.
• Leadership Transition: Ongoing executive search and interim appointments bear watching; successful recruitment of experienced late-stage leaders could further support share price momentum.
• Pipeline Expansion: Early positive signals in hematologic malignancies (CMML) expand the company’s opportunity set, though these are still in early development.

About Cardiff Oncology

Cardiff Oncology is a clinical-stage biotechnology company focused on advancing innovative cancer therapies through PLK1 inhibition. Its lead asset, onvansertib, is being developed for RAS-mutated mCRC and other PLK1-driven cancers, aiming to overcome treatment resistance and improve outcomes for patients with high unmet medical needs.

For more information, visit Cardiff Oncology’s website.

Disclaimer: This news article is for informational purposes only and is not investment advice. Forward-looking statements are subject to risks and uncertainties, including but not limited to clinical trial outcomes, regulatory approvals, and market dynamics. Investors should review official SEC filings and consult with their financial advisors before making investment decisions. The company undertakes no obligation to update forward-looking statements as events unfold.

View Cardiff Oncology, Inc. Historical chart here