Cardiff Oncology Targets Registrational Trial Pending Further Financing
Cardiff Oncology completed a $10 million offering after quarter-end, but said its planned Phase 3 cancer trial still required additional financing.
Cardiff Oncology, Inc. (CRDF), a clinical-stage biotechnology company developing cancer therapies through PLK1 inhibition, set a financing-dependent target for starting its planned Phase 3 colorectal cancer trial in the first quarter of 2027. The program had progressed from dose selection toward a planned registrational study across its recent updates, while funding remained a condition for taking that next step.
In February, Cardiff outlined plans to advance onvansertib into registrational development after discussions with the Food and Drug Administration. By May, the company had selected the dose and chemotherapy combination in consultation with the agency. The latest update supplied a planned start window following an end-of-Phase 2 meeting that Cardiff said had aligned key trial design elements with the FDA.
Cardiff held approximately $34.5 million in cash, cash equivalents and short-term investments at June 30. That balance excluded the $10 million registered direct offering of common stock and warrants completed in July for working capital and general corporate purposes. The company said its current cash resources would fund operations into the third quarter of 2027, while separately making the trial launch conditional on further financing.
The second-quarter loss narrowed as research spending fell. Net loss attributable to common stockholders was $9.238 million, against $13.949 million a year earlier. Research and development expenses were $5.915 million, compared with $11.580 million in the same quarter of 2025. Selling, general and administrative expenses totaled $3.804 million, and royalty revenue was $104 thousand.
For the six months ended June 30, operating expenses fell to approximately $22.6 million from $29.4 million. Cardiff attributed the reduction primarily to completed clinical trials, fewer patients remaining on treatment in its Phase 2 colorectal cancer study and reduced preclinical activity as it focused on the planned Phase 3 trial. Those changes reduced spending on the earlier development work.
The six-month expense reduction did not translate into lower operating cash use. Cash used in operations totaled approximately $24.1 million in the first half of 2026, compared with $21.1 million in the corresponding period of 2025. The release did not attribute that increase to a specific cause. The distinction left cash consumption, alongside the planned trial’s financing requirement, central to the company’s update.
The clinical foundation for the next study was the randomized CRDF-004 trial in previously untreated patients with RAS-mutated metastatic colorectal cancer. At the June ASCO meeting, Cardiff presented results showing a confirmed objective response rate of 72.2% for 30 mg onvansertib combined with FOLFIRI and bevacizumab, compared with 42.1% for FOLFIRI and bevacizumab alone. Those results used a March 18 data cutoff.
Cardiff said the study achieved its primary goal of selecting a dose and treatment regimen for registrational development. For the secondary progression-free survival endpoint, the hazard ratio under blinded independent central review was 0.55, with a 95% confidence interval of 0.15–2.09. That interval spanned 1; the release presented the result as part of an ongoing dose-finding trial.
The company also reported that four patients remained on onvansertib treatment beyond 15 months, including two beyond 20 months. Cardiff said the combinations remained well tolerated, with no major or unexpected toxicities and no additive adverse events observed. The Phase 2 study remained underway at the latest June cutoff.
A licensing dispute accompanied the preparations. Licensor Nerviano Medical Sciences alleged a material breach in February and subsequently purported to terminate the agreement. Cardiff filed suit in May seeking a declaration that it was not in material breach and an injunction requiring Nerviano to continue performing. The company said the purported termination was ineffective and that it plans to continue performing under the agreement. Attorney costs related to the dispute were among the reasons Cardiff gave for higher administrative expenses in the first half.
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