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Cardiff Oncology Inc

Cardiff Oncology, Inc. is a clinical-stage biotechnology company that develops novel therapies for various cancers in the United States. Its lead drug candidate is Onvansertib, an oral and selective polo-like kinase 1 inhibitor for treating RAS-mutated metastatic colorectal cancer. The company also conducts clinical programs including investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, metastatic triple negative breast cancer, and chronic myelomonocytic leukemia; CRDF-004, a Phase 2 open-label randomized multi-center trial of onvansertib in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab for patients with confirmed metastatic and unresectable colorectal cancer with a KRAS or NRAS mutation; and TROV-054, a Phase 1b/2 single-arm trial in KRAS-mutated metastatic colorectal cancer. Formerly known as Trovagene, Inc., it changed its name to Cardiff Oncology, Inc. in May 2012, was founded in 1999, and is headquartered in San Diego, California.

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Biotech & Genomic Medicine

Cardiff Oncology Q2 Loss Narrows 34%, Plans Phase 3 Onvansertib Trial in Q1 2027

Cardiff Oncology reported a narrower second-quarter net loss of $9.24 million, down 34% from $13.95 million a year earlier, driven by lower operating expenses. Total operating expenses fell to $9.72 million from $14.89 million, primarily due to a $5.67 million decrease in R&D expenses following the completion of clinical trials and reduced preclinical activity. The company plans to initiate a Phase 3 trial of its lead candidate onvansertib in first-line RAS-mutated metastatic colorectal cancer in the first quarter of 2027, subject to securing additional financing. Cardiff ended the quarter with $34.52 million in cash, cash equivalents and short-term investments, which it believes will fund operations through the third quarter of 2027. The company also disclosed an ongoing license dispute with Nerviano Medical Sciences and a $10 million registered direct offering completed in July.
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Biotech & Genomic Medicine

Cardiff Oncology's onvansertib shows strong Phase 2 data amid licensing dispute

Cardiff Oncology reported positive Phase 2 data for its lead drug onvansertib in first-line RAS-mutated metastatic colorectal cancer, while facing a licensing dispute with Nerviano Medical Sciences. The 30 mg onvansertib plus FOLFIRI/bevacizumab regimen achieved a 72.2% confirmed objective response rate versus 42.1% for standard therapy alone, with longer progression-free survival and no increased safety concerns. The company finalized the design of a registrational Phase 3 study following FDA discussions. Lucid Capital analyst Christopher Liu lowered the price target to $4 from $10 but kept a Buy rating, citing legal uncertainty over onvansertib ownership rights, though the firm expects a near-term resolution and sees future clinical data as a potential catalyst.
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