Cardiff Oncology, Inc.

Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing onvansertib, an oral and highly selective PLK1 inhibitor, for cancer indications with high unmet medical need. The company’s core approach is to combine onvansertib with standard-of-care therapies and use biomarker-driven patient selection to improve response rates. Its lead development efforts are centered on RAS-mutated metastatic colorectal cancer, with additional investigator-initiated studies in pancreatic cancer, small cell lung cancer, triple negative breast cancer, and CMML. Cardiff Oncology is still pre-commercial and depends on clinical progress, regulatory success, and external financing to advance its pipeline.

−8 194,9 %

−7 732,0 %

−13,2 %

3.67

3.67

— Cardiff Oncology, Inc.
%
Lead drug candidate0% Onvansertib, an oral small-molecule PLK1 inhibitor being developed for multiple cancers.
Clinical development programs0% Combination trials pairing onvansertib with standard-of-care therapies in selected tumor types.
Biomarker and genomics-enabled development0% Tumor genomics and biomarker assays used to refine patient selection and response assessment.
Royalty income100% Sales-based or usage-based royalties from other intellectual property licenses unrelated to onvansertib.

Cardiff Oncology does not sell an approved commercial drug today, so its direct economic counterparties are primarily...

  • Clinical trial investigators and sitesprimary

    Academic and community oncology centers enroll patients, run protocols, and generate the clinical data needed to advance onvansertib.

  • Patients with high-unmet-need cancersprimary

    Patients with RAS-mutated metastatic colorectal cancer and other advanced cancers participate in trials because standard options are limited.

  • Oncology prescribers and treatment centerssecondary

    If approved, oncologists and cancer centers would use onvansertib in combination regimens for biomarker-selected patients.

  • Intellectual property licenseessecondary

    Third parties using licensed IP generate small royalty revenue unrelated to the lead oncology program.

Cardiff Oncology is headquartered in the United States and is listed on Nasdaq Capital Market under CRDF...

  • •Headquartered in the United States
  • •Listed on Nasdaq Capital Market under CRDF
  • •Clinical trials run mainly through U.S. oncology centers
  • •U.S. patent protection is important for mCRC claims
  • •Foreign regulatory exposure exists through drug development and supply chains

The company’s strategy is to validate onvansertib as a differentiated PLK1 inhibitor in biomarker-defined cancer...

01
Advance lead mCRC programshort-term

The lead indication is the clearest path to value creation and potential partnering or approval.

02
Broaden clinical proof-of-concept across tumor typesmedium-term

Additional data in other cancers can support platform credibility and optionality.

03
Maintain financing runwayshort-term

The company has substantial doubt about continuing as a going concern without additional capital.

Cardiff Oncology is a clinical-stage company with no approved product revenue, so its business depends on successful...

critical

Clinical development failure

The lead asset is still in development, and efficacy or safety results may not support approval or partnering.

Scope
Onvansertib oncology pipeline
Materiality
high
critical

Insufficient capital / going concern

The company expects its current resources to fund operations only into the first quarter of 2027 and has disclosed substantial doubt about continuing as a going concern.

Scope
Corporate liquidity
Materiality
high
high

Third-party manufacturing dependence

The company does not own manufacturing capacity and relies on GMP contract manufacturers for clinical supply.

Scope
Clinical trial supply chain
Materiality
high
high

Regulatory approval and compliance

Drug development is subject to extensive FDA and foreign regulation, and noncompliance can delay or block development.

Scope
Clinical and future commercial programs
Materiality
high
high

Competition from larger oncology developers

Better-funded competitors may develop safer, more effective, or cheaper therapies in the same indications.

Scope
mCRC and other oncology markets
Materiality
medium
Accrued clinical trial expenses
Quarterly operating loss and balance sheet accruals
Usage-based royalty revenue recognition
Small but variable revenue line
Stock-based compensation
Operating expense and net loss
Going-concern assessment
Investor assessment of solvency and financing risk

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: 28/04/2026