Cardiff Oncology Stock Price, News & Analysis

Cardiff Oncology, Inc. (Nasdaq: CRDF) is a clinical-stage biotechnology company focused on developing cancer therapies that leverage PLK1 (Polo-like kinase 1) inhibition, a well-validated oncology drug target. The company is advancing novel therapeutics designed to address tumor vulnerabilities and overcome treatment resistance across a range of cancers.

The company’s development efforts center on its lead asset, onvansertib, an oral PLK1 inhibitor. Onvansertib is being evaluated primarily in combination with standard-of-care (SoC) therapeutics in multiple clinical programs. A key area of focus is first-line RAS-mutated metastatic colorectal cancer (mCRC), where onvansertib is studied alongside established chemotherapy and biologic regimens. According to company disclosures, onvansertib is also being evaluated in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and metastatic triple negative breast cancer (mTNBC), and has been studied as a monotherapy in chronic myelomonocytic leukemia (CMML).

Business focus and development strategy

Cardiff Oncology describes itself as a clinical-stage biotechnology company, which means its primary activities relate to research and clinical development rather than commercial sales. Its programs and broader development strategy are described as being designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver clinical benefit beyond what is achieved with standard-of-care alone. This approach is reflected in the company’s emphasis on combination regimens, such as onvansertib plus SoC in RAS-mutated mCRC and onvansertib plus paclitaxel in mTNBC.

In RAS-mutated mCRC, the company is conducting the CRDF-004 randomized Phase 2 trial, which evaluates two doses of onvansertib in combination with SoC regimens (FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab) compared with SoC alone. The primary endpoint of this trial is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), duration of response, and safety. Additional prespecified endpoints include early tumor shrinkage (ETS) and depth of response (DpR), which the company notes are established predictors for PFS in first-line mCRC based on published data.

In mTNBC, Cardiff Oncology has reported data from an investigator-initiated Phase 1b study of onvansertib in combination with paclitaxel. The company states that this combination demonstrated objective responses and a tolerability profile characterized by myelosuppression as the most common adverse event, supporting further exploration of this regimen in metastatic triple negative breast cancer.

Lead asset: onvansertib

Onvansertib is described by Cardiff Oncology as a novel, oral PLK1 inhibitor. The company is evaluating onvansertib in several settings:

• First-line RAS-mutated metastatic colorectal cancer (mCRC) in the CRDF-004 randomized Phase 2 trial, where onvansertib is added to standard-of-care chemotherapy plus bevacizumab.
• Metastatic pancreatic ductal adenocarcinoma (mPDAC) in ongoing or planned investigator-initiated trials.
• Small cell lung cancer (SCLC) in investigator-initiated trials, where previously announced data have been cited as supporting onvansertib’s single-agent activity in solid tumors.
• Metastatic triple negative breast cancer (mTNBC) in an investigator-initiated trial combining onvansertib with paclitaxel.
• Chronic myelomonocytic leukemia (CMML) in an investigator-sponsored Phase 1 dose escalation trial of onvansertib monotherapy, which the company reports showed that onvansertib was relatively well-tolerated and demonstrated preliminary efficacy in a subset of patients. Cardiff Oncology has stated that it is not currently planning to develop onvansertib for CMML.

Across these programs, the company emphasizes that onvansertib is intended to exploit tumor vulnerabilities and to potentially improve outcomes when used with existing standards of care. Data disclosed from the CRDF-004 trial indicate dose-dependent responses in endpoints such as ORR, PFS trends, early tumor shrinkage, and depth of response, and that onvansertib in combination with chemotherapy and bevacizumab has been described as well-tolerated, with no major or unexpected toxicities observed in the reported analysis.

Intellectual property and regulatory aspects

Cardiff Oncology has reported the issuance of intellectual property related to onvansertib. For example, the company has disclosed a U.S. patent (No. 12,263,173) covering the method of using onvansertib in combination with bevacizumab in any line of therapy for the treatment of metastatic colorectal cancer in bevacizumab-naïve patients. The company states that this patent encompasses all mCRC patients, including those with RAS-mutated and RAS wild-type disease, and that it has an expiration date of no earlier than 2043.

The company’s SEC filings, such as its Form 8-Ks, reference risk factors and regulatory considerations common to clinical-stage biotechnology companies, including the length and cost of clinical trials, the uncertainty of clinical outcomes, potential safety risks that could affect approval, the need for additional financing, competitive pressures, and the risk of not obtaining necessary regulatory approvals.

Corporate and capital markets profile

Cardiff Oncology’s common stock trades on the Nasdaq under the ticker symbol CRDF. The company identifies itself as a clinical-stage biotechnology company in the oncology space and reports that it operates its clinical programs and business activities in the United States. SEC filings show that the company holds annual meetings of stockholders, maintains an equity incentive plan, and uses equity-based compensation, including inducement grants, to attract and retain key personnel.

The company’s reports of quarterly financial results highlight that its primary expenditures relate to research and development and selling, general and administrative expenses associated with advancing onvansertib and supporting corporate operations. Cardiff Oncology has also reported royalty revenues, though these are modest relative to its operating expenses, consistent with its description as a clinical-stage company.

Clinical and scientific engagement

Cardiff Oncology regularly communicates clinical and corporate updates through press releases and investor events. The company has reported participation in major healthcare and oncology conferences, including meetings organized by industry and financial institutions, as well as scientific congresses such as the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH). At these venues, the company or its collaborators present data from clinical trials of onvansertib, including investigator-sponsored studies.

For example, Cardiff Oncology has announced presentations of positive data from the CRDF-004 randomized Phase 2 trial in first-line RAS-mutated mCRC, data from an investigator-initiated trial of onvansertib plus paclitaxel in mTNBC, and clinical results from an investigator-sponsored trial of onvansertib monotherapy in CMML. These activities illustrate the company’s engagement with the oncology research community and its effort to share emerging clinical evidence on PLK1 inhibition.

Geographic footprint

According to available company descriptions, Cardiff Oncology operates in the United States. Its clinical trials referenced in public disclosures involve clinical sites in the U.S., and the company’s principal executive offices are located in San Diego, California, as reflected in SEC filings that list the city and state of its headquarters.

Position within the biotechnology sector

Within the broader biotechnology and pharmaceutical landscape, Cardiff Oncology fits within the oncology-focused, clinical-stage biotechnology segment. Its work centers on a specific molecular target, PLK1, and a single lead drug candidate, onvansertib, that is being tested across multiple tumor types and in combination with established therapies. The company’s disclosures emphasize the goal of improving outcomes in cancers with significant unmet medical need, particularly RAS-mutated metastatic colorectal cancer, where standard-of-care regimens have limitations in progression-free survival and long-term disease control.

FAQs about Cardiff Oncology (CRDF)

• What does Cardiff Oncology, Inc. do?
  

  Cardiff Oncology is a clinical-stage biotechnology company developing cancer therapies based on PLK1 inhibition. Its lead asset, onvansertib, is being evaluated in combination with standard-of-care treatments and in investigator-initiated trials across several tumor types, including RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, small cell lung cancer and metastatic triple negative breast cancer.

• What is onvansertib?
  

  Onvansertib is Cardiff Oncology’s lead drug candidate, described as a novel, oral PLK1 inhibitor. It is being studied in clinical trials as a monotherapy and, more commonly, in combination with standard-of-care regimens to target tumor vulnerabilities and potentially overcome treatment resistance in multiple cancers.

• Which cancer indications is Cardiff Oncology focusing on?
  

  The company’s primary focus is on first-line RAS-mutated metastatic colorectal cancer, where onvansertib is evaluated in the CRDF-004 randomized Phase 2 trial. In addition, onvansertib is being studied in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, metastatic triple negative breast cancer, and has been evaluated in chronic myelomonocytic leukemia.

• How is onvansertib being studied in metastatic colorectal cancer?
  

  In the CRDF-004 Phase 2 trial, patients with RAS-mutated metastatic colorectal cancer receive standard-of-care chemotherapy plus bevacizumab, with or without onvansertib at different dose levels. The trial’s primary endpoint is objective response rate, with secondary endpoints including progression-free survival, duration of response and safety, as well as prespecified measures such as early tumor shrinkage and depth of response.

• What evidence has Cardiff Oncology reported about onvansertib’s activity?
  

  Cardiff Oncology has reported that onvansertib has shown dose-dependent improvements in objective response rate and trends in progression-free survival in the CRDF-004 trial, and that it has been well-tolerated in combination with chemotherapy and bevacizumab. The company has also cited preliminary efficacy and tolerability in investigator-initiated studies, such as onvansertib plus paclitaxel in metastatic triple negative breast cancer and onvansertib monotherapy in chronic myelomonocytic leukemia.

• Does Cardiff Oncology have any issued patents related to onvansertib?
  

  Yes. The company has disclosed the issuance of U.S. patent No. 12,263,173, which covers methods of using onvansertib in combination with bevacizumab for the treatment of metastatic colorectal cancer in bevacizumab-naïve patients, across RAS-mutated and RAS wild-type disease. The company states that this patent has an expiration date of no earlier than 2043.

• Where is Cardiff Oncology headquartered and where does it operate?
  

  Cardiff Oncology’s principal executive offices are located in San Diego, California, as indicated in its SEC filings. The company states that it operates in the United States, and its referenced clinical trials are conducted at sites within the U.S.

• On which exchange does Cardiff Oncology trade and what is its ticker symbol?
  

  Cardiff Oncology’s common stock trades on the Nasdaq under the ticker symbol CRDF.

• What stage of development is Cardiff Oncology in?
  

  The company describes itself as a clinical-stage biotechnology company. This means its primary activities involve conducting clinical trials and related research rather than commercial marketing of approved products.

• How does Cardiff Oncology describe the risks associated with its business?
  

  In its public disclosures and SEC filings, Cardiff Oncology notes risks typical of clinical-stage biotechnology companies, including the uncertainty and cost of clinical trials, potential safety issues that could halt development, the need for additional financing, competition, dependence on key personnel and third parties, and the risk of not obtaining regulatory approvals or achieving commercial success.