What Cardiff Oncology does

Cardiff Oncology, Inc. is a clinical-stage biopharmaceutical company headquartered in San Diego, California, developing small-molecule inhibitors of PLK1 (Polo-Like Kinase 1) for the treatment of cancer. The company's lead asset, onvansertib, is an oral PLK1 inhibitor designed to exploit tumor dependence on PLK1-mediated DNA damage repair, thereby enhancing the activity of standard-of-care chemotherapy and targeted agents. The company's core program targets first-line RAS-mutated metastatic colorectal cancer (mCRC), an indication representing approximately 45-50% of colorectal cancer patients with limited effective treatment options. Beyond the lead mCRC program, onvansertib is being evaluated through investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), triple-negative breast cancer, small cell lung cancer, ovarian cancer, chronic myelomonocytic leukemia, metastatic castration-resistant prostate cancer, and medulloblastoma, in collaboration with academic centers including Mayo Clinic, Oregon Health & Science University, Dana-Farber Cancer Institute, and the University of Colorado.

The company has no commercial products and operates in a pre-revenue clinical development posture. Q1 2026 reported revenue was approximately $240,000, with a Q1 2026 net loss of $12.3 million and a full-year 2025 net loss of $45.9 million. As of March 31, 2026, cash, cash equivalents, and short-term investments stood at $46.1 million, providing stated runway into Q1 2027 excluding Phase 3 costs. The capital structure is supplemented by a $15 million strategic investment and CRO services partnership with Pfizer supporting the planned global registrational Phase 3 CRDF-005 trial, while Cardiff retains full program rights to onvansertib. A December 2024 financing raised approximately $40 million.

The business model is contingent on successful Phase 3 execution, FDA approval, and either self-commercialization or partnership-based monetization. The company is publicly listed on NASDAQ under ticker CRDF, with a market capitalization of approximately $129.9 million as of early June 2026 and a consensus analyst price target of $10.10. Notable risks include an active license dispute with Nerviano Medical Sciences over onvansertib intellectual property, limited near-term cash runway relative to Phase 3 funding requirements, and binary clinical-trial outcomes.

Name

Cardiff Oncology

Legal name

Cardiff Oncology, Inc.

Website

https://cardiffoncology.com

Company type

Public

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

Cardiff Oncology is a clinical-stage biopharmaceutical company developing onvansertib, an oral PLK1 inhibitor, primarily for first-line RAS-mutated metastatic colorectal cancer, with additional investigator-initiated programs across multiple solid tumor and hematologic indications. It is publicly listed on NASDAQ as CRDF and has no commercial products.

Ownership category

akta.pro rank

Product category

Oncology Therapeutics

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Oncology & Hematology Pharmaceuticals (HLAIAAAC)

akta.pro secondary industry

Oncology Specialty Pharmaceuticals (HLAIACAA)

Keywords

• PLK1 inhibitor therapy
• Oncology drug development
• Clinical stage biotechnology
• Kinase inhibitor drugs
• Metastatic colorectal cancer

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Distribution channels1 record

Marketing channels6 records

Core offering

Cardiff Oncology is a clinical-stage biotechnology company developing onvansertib, an oral PLK1 (Polo-Like Kinase 1) inhibitor designed to be combined with standard-of-care chemotherapy and targeted therapies across multiple cancer indications. The lead program targets first-line RAS-mutated metastatic colorectal cancer in combination with FOLFIRI/bevacizumab, advancing toward a global registrational Phase 3 trial, with additional investigator-initiated programs in pancreatic, breast, lung, ovarian, prostate cancers, and CMML.

Product overview

Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies. The company's primary product is onvansertib, an oral PLK1 inhibitor evaluated in combination with standard-of-care therapeutics across multiple clinical programs targeting RAS-mutated metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), chronic myelomonocytic leukemia (CMML), small cell lung cancer, triple-negative breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and ovarian cancer. The company operates clinical programs including the CRDF-004 Phase 2 randomized trial for first-line RAS-mutated mCRC treatment.

Differentiator

Problem solved

Functional benefit

Products and services

• Onvansertib Onvansertib is an oral PLK1 (Polo-like kinase 1) inhibitor being evaluated in combination with standard-of-care therapeutics across multiple cancer indications. It targets tumor vulnerabilities to overcome treatment resistance by inhibiting PLK1's ability to repair DNA damage caused by chemotherapy and targeted cancer drugs. Lead indication is first-line RAS-mutated metastatic colorectal cancer in combination with FOLFIRI/bevacizumab.

Quantifiable outcome

• 72.2% confirmed objective response rate (ORR) at 30 mg dose vs 43.2% for standard-of-care in first-line RAS-mutated mCRC (Phase 2 CRDF-004 trial)
• +4 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Five partnerships are on record, tiered core and minor.

• Nerviano Medical SciencescoreOEM/ Whitelabel/ Licensing Partner · 5 June 2026Nerviano Medical Sciences previously held a license agreement for onvansertib. On May 27, 2026, Nerviano terminated the license citing material breach including failure to correct patent inventorship to include a Nerviano employee and failure to use commercially reasonable efforts to develop onvansertib and obtain regulatory approvals. Cardiff responded with a lawsuit challenging the termination.
• Mayo ClinicminorStrategic or Co-development PartnerMayo Clinic, specifically Mrinal Patnaik who leads the Acute Leukemia and Myeloid Neoplasms group, is leading an investigator-initiated trial of onvansertib single-agent clinical activity in chronic myelomonocytic leukemia (CMML). Mayo Clinic logo appears in Cardiff's pipeline page alongside other academic collaborators.
• Oregon Health & Science UniversityminorStrategic or Co-development PartnerOregon Health & Science University (OHSU) is listed in Cardiff's onvansertib pipeline, collaborating on investigator-initiated trials for onvansertib in metastatic castration-resistant prostate cancer (mCRPC) in combination with abiraterone.
• Dana-Farber Cancer InstituteminorStrategic or Co-development PartnerDana-Farber Cancer Institute is listed in Cardiff's pipeline as a collaborator on onvansertib investigator-initiated trials, likely in the ovarian cancer/PARP inhibitor combination program.
• University of Colorado (Denver)minorStrategic or Co-development PartnerUniversity of Colorado (Denver) is listed in Cardiff's pipeline as a collaborator, contributing to medulloblastoma investigator-initiated trials combining onvansertib with radiation therapy.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Revolution Medicines: Revolution Medicines is a clinical-stage oncology company developing RAS(ON) inhibitors targeting KRAS G12C, G12D, and pan-RAS variants. It is the most direct comparator to Cardiff given shared focus on RAS-driven cancers and similar clinical-stage, single-mechanism-platform profile.
• Erasca: Erasca is a clinical-stage precision oncology company developing a portfolio of RAS/MAPK pathway-targeting therapies for RAS-mutated solid tumors. Like Cardiff, it focuses on addressing RAS-driven cancers through differentiated mechanisms and operates at similar clinical-stage scale.
• Mirati Therapeutics: Mirati Therapeutics developed Krazati (adagrasib), a KRAS G12C inhibitor, and was acquired by Bristol Myers Squibb. Its commercial-stage RAS oncology franchise overlaps directly with Cardiff's RAS-mutated mCRC focus and represents the leading competitive benchmark for PLK1 inhibitor combinations.
• BridgeBio Pharma: BridgeBio is a clinical-stage biopharmaceutical company developing RAS-pathway and oncology therapeutics alongside its rare disease portfolio. Its oncology programs targeting KRAS-driven cancers and similar clinical-development-stage profile make it a relevant comparable.
• Foghorn Therapeutics: Foghorn Therapeutics is a clinical-stage oncology company developing precision medicines targeting the chromatin regulatory system. While mechanistically distinct, its similar market cap, clinical-stage profile, and oncology focus make it a relevant peer.
• Kronos Bio: Kronos Bio is a clinical-stage oncology company developing therapies targeting dysregulated transcription and signaling pathways in cancer. Its similar small-cap, clinical-stage profile and oncology pipeline orientation make it a relevant comparable.
• Black Diamond Therapeutics: Black Diamond Therapeutics is a clinical-stage precision oncology company developing allosteric mutation-targeted therapies. Its similar market capitalization, clinical-stage profile, and focus on oncogene-driven cancers make it a relevant peer comparable.

Broad incumbents

• Amgen: Amgen is a global biopharmaceutical incumbent with the commercialized KRAS G12C inhibitor Lumakras (sotorasib). It competes broadly in the RAS-mutated oncology space and serves as the dominant commercial benchmark for any approved RAS-pathway therapy in mCRC.
• Roche: Roche is a global oncology leader with established colorectal cancer franchises including bevacizumab (Avastin). Its incumbent position in 1L mCRC combination therapy makes it a strategic reference for any new agent seeking to combine with FOLFIRI/bevacizumab.
• Pfizer: Pfizer is a global biopharmaceutical incumbent that has invested $15M and serves as CRO partner for Cardiff's Phase 3 trial. While already a strategic partner rather than pure competitor, it overlaps in oncology drug development and remains a likely acquirer or commercialization partner if onvansertib succeeds.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/cardiffoncology
• Xx.com/trovagene
• Facebookfacebook.com/trovagene

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds10 records

Investors5 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cardiff Oncology