Press Releases May 21, 2026 05:00 PM

Cardiff Oncology Announces Webcast to Discuss Updated Phase 2 CRDF-004 Data for Onvansertib in First-Line RAS-Mutated mCRC

Cardiff Oncology to webcast updated Phase 2 data for Onvansertib in RAS-mutated metastatic colorectal cancer

By Hana Yamamoto CRDF

Cardiff Oncology announced a webcast on June 3, 2026, to discuss updated Phase 2 clinical trial data of Onvansertib, their PLK1 inhibitor drug candidate combined with standard-of-care treatments for first-line RAS-mutated metastatic colorectal cancer. Updated results show dose-dependent improvements in overall response rate and progression-free survival, supporting advancement to a registrational trial.

Cardiff Oncology Announces Webcast to Discuss Updated Phase 2 CRDF-004 Data for Onvansertib in First-Line RAS-Mutated mCRC
CRDF

Key Points

  • Updated Phase 2 trial (CRDF-004) data indicates Onvansertib combined with FOLFIRI/bevacizumab improves response and progression-free survival in first-line RAS-mutated metastatic colorectal cancer.
  • The 30 mg dose was selected for further registrational trials, signaling confidence in efficacy and safety profile.
  • Onvansertib is also being investigated in other hard-to-treat cancers including pancreatic, small cell lung, triple-negative breast cancer, and chronic myelomonocytic leukemia.
  • Sectors impacted include biotechnology, oncology therapeutics, and cancer treatment markets.

SAN DIEGO, Calif., May 21, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced that it will host an investor webcast featuring members of management on June 3, 2026 at 8:30 am ET to review updated data from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care regimens (FOLFIRI/bevacizumab or FOLFOX/bevacizumab) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).

The updated CRDF-004 data will first be presented during a rapid oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2026 at 8:00 am CT/9:00 am ET and will build on the CRDF-004 data previously presented in January 2026. More details about the oral presentation are available on the Company’s website here and the full abstract is now available on the ASCO website.

Investor Webcast Details
The investor webcast will take place on June 3 at 8:30 am ET. To register for and access the live webcast, please visit the “Events” page of the Cardiff Oncology website.

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.

Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact:
Candice Masse
astr partners
[email protected]

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
[email protected]


Risks

  • Clinical trials inherently carry risk including potential delays, unfavorable results, or safety concerns which could derail regulatory approval or commercialization.
  • Dependence on successful FDA clearances and reimbursement policies creates regulatory and market access uncertainties.
  • Competition from other oncology therapies and potential patent or commercialization challenges could impact market adoption.

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