On November 6, 2025 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"This quarter was marked by highly encouraging data from our ongoing CRDF-004 trial evaluating onvansertib in combination with standard of care for first-line RAS-mutated mCRC. At the July 8, 2025 data cutoff, the 30mg onvansertib cohort demonstrated a 19% improvement in confirmed ORR, faster time to response, deeper tumor regression, and early signs of separation in the progression-free survival curves when compared to standard of care alone," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "The study is on track for the next clinical update in the first quarter of 2026, where we’ll look for a continuation of onvansertib’s favorable tolerability profile and more mature duration of response and progression-free survival data."

Continued Dr. Erlander, "Onvansertib is uniquely positioned to address a significant medical need and commercial opportunity, with approximately 150,000 new CRC patients diagnosed annually in the U.S. alone. With median progression-free survival of less than 12 months on standard of care and few promising therapies in development for RAS-mutated mCRC, we are optimistic that onvansertib has the potential to redefine first-line care for patients."

Company highlights for the quarter ended September 30, 2025:

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Announced positive data from the ongoing CRDF-004 Phase 2 randomized trial evaluating two doses of onvansertib in combination with standard of care ("SoC") for the treatment of first-line RAS-mutated metastatic colorectal cancer ("mCRC")
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As of the July 8, 2025 data cut-off, the Phase 2 CRDF-004 trial demonstrated a 19% improvement in confirmed objective response rate ("ORR") in the 30mg onvansertib arm compared to the control arm in the intent-to-treat population.
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While the median progression-free survival ("PFS") has not yet been reached, early PFS data show a trend favoring the 30mg onvansertib arm versus control.
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Dose dependent responses were observed across all endpoints, including ORR, PFS, early tumor shrinkage, and depth of response.
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Onvansertib continues to be well-tolerated, with no major or unexpected toxicities observed.

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An update from the ongoing Phase 2 CRDF-004 trial in first-line RAS-mutated mCRC is expected in 1Q 2026.

Third Quarter 2025 Financial Results:

Liquidity, cash burn, and cash runway

As of September 30, 2025, Cardiff Oncology had approximately $60.6 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the third quarter of 2025 was approximately $10.8 million, an increase of $0.3 million from $10.5 million for the same period in 2024.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2027.

Operating results

Total operating expenses were approximately $12.1 million for the three months ended September 30, 2025, a decrease of $0.7 million from $12.8 million for the same period in 2024. The decrease in operating expenses was primarily due to a reduction in clinical trial expenses and a decrease in preclinical activities.

(Press release, Cardiff Oncology, NOV 6, 2025, View Source [SID1234659558])