Cardiff Oncology (CRDF -5.62%), a biotechnology company focused on developing therapies for cancer patients with high unmet needs, reported its second quarter 2025 earnings on July 29, 2025. The headline news was the completion of patient enrollment for its crucial Phase 2 clinical trial in RAS-mutated metastatic colorectal cancer, a major milestone for its lead drug candidate, onvansertib. The company reported a GAAP net loss per share of $(0.21) for Q2 2025, which was better than the expected $(0.19). It also reported $121 thousand in GAAP revenue for Q2 2025, slightly above the $110 thousand analyst estimate. Operating expenses grew to $14.9 million, reflecting ongoing investments in clinical trials and staff. Overall, the quarter showed steady research progress but highlighted persistent operating losses typical of a clinical-stage biotech company, with a healthy cash cushion supporting future development.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.21) | $(0.19) | $(0.26) | 19.2% improvement |
| Revenue (GAAP) | $121 thousand | $110 thousand | $163 thousand | (25.8%) |
| Total Operating Expenses | $14.9 million | $12.7 million | 17.3% | |
| Net Loss Attributable to Common Stockholders | $(13.95 million) | $(11.78 million) | (18.4% increase) | |
| Cash, Cash Equivalents & Short-Term Investments (end of period) | $71.0 million | $91.7 million | (21.3%) |
Source: Analyst estimates for the quarter provided by FactSet.
About Cardiff Oncology and Its Recent Focus
Cardiff Oncology operates as a clinical-stage biotechnology company developing precision cancer medicines. Its business centers on advancing novel therapies that target specific cancer-driving genetic mutations, aiming to bring new treatments to patients with few options.
The company’s current strategic push centers on its experimental oral drug onvansertib. This is a type of targeted therapy designed to inhibit a protein called polo-like kinase 1 (PLK1), which is involved in cancer cell growth. The company’s approach focuses on specific cancer populations where existing therapies are limited, with RAS-mutated metastatic colorectal cancer (mCRC) as the lead indication. Success now depends heavily on demonstrating clinical benefit in these high-need patient groups and navigating the path to regulatory approval.
Quarterly Highlights: Clinical, Financial, and Strategic Developments
The most notable event this period was the completion of enrollment in the Phase 2 CRDF-004 trial for patients with first-line RAS-mutated mCRC. This trial evaluates onvansertib in combination with standard therapies across 41 clinical sites in the United States. The company regards this as a key step toward future data releases that could support regulatory approval and potential commercialization, leaving investors watching for future updates.
On the clinical front, Cardiff Oncology also reported updated data from an early-stage metastatic triple-negative breast cancer (mTNBC) trial. At the annual American Society of Clinical Oncology (ASCO) conference in 2025, management shared outcomes for the onvansertib plus paclitaxel drug combination. In a small group of 10 patients, the combination achieved a 40% objective response rate (ORR) by RECIST 1.1 at the RP2D of 18 mg/m2, with two confirmed and two unconfirmed partial responses, as reported at ASCO 2025. The safety profile was described as generally tolerable, with myelosuppression (a decrease in bone marrow activity) being the most common side effect. While promising, this data set was limited in size, so it does not yet change the overall risk profile of the company’s pipeline.
Operational spending increased noticeably during Q2 2025. Total operating expenses increased to $14.9 million, up from $12.7 million in the prior-year period, reflecting heightened clinical trial activity and investment in personnel. Research and development costs, the largest expense category, were driven by both the mCRC and mTNBC trial programs. Higher spending on salaries and new hires, including option grants, contributed as well.
There were no new partnership announcements or expanded collaborations this quarter, but the company did strengthen its executive team. Cardiff Oncology appointed Dr. Roger Sidhu as Chief Medical Officer. The company also broadened its intellectual property moat with the issuance of a new patent for the onvansertib therapy in mCRC, potentially extending market exclusivity into 2043.
Looking Ahead: Financial Guidance and Milestones
Management did not provide new financial guidance for future quarters or the remainder of fiscal 2025. However, It stated that the company’s $71.0 million in cash and investments as of June 30, 2025, is expected to fund operations through Q1 2027, assuming current spending levels continue.
With the Phase 2 mCRC trial now fully enrolled, attention will focus on the timing and outcome of efficacy and survival data releases, as these will be critical milestones. Investors should also monitor ongoing clinical programs for new safety or efficacy signals, partnerships with larger biopharmaceutical firms, and any regulatory interactions that could accelerate the commercialization timeline. The company does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
