Cardiff Oncology Announces Clinical Data from Investigator-Sponsored Trial with Onvansertib in Chronic Myelomonocytic Leukemia at ASH 2025

Rhea-AI Summary

Cardiff Oncology (Nasdaq: CRDF) announced clinical data from an investigator-sponsored Phase 1 poster on onvansertib in chronic myelomonocytic leukemia (CMML) to be presented at ASH 2025.

In a dose-escalation trial (N=9), onvansertib monotherapy was reported as relatively well-tolerated and showed preliminary efficacy in approximately 40% of patients, with one patient achieving an optimal marrow response at the 9 mg/m2 dose. The company is not currently planning to develop onvansertib for CMML.

Poster details: Dec 8, 2025, 6:00-8:00 PM EST; Speaker: Mrinal Patnaik, MD; Session 637, Poster III.

Key Figures

Sample size N=9 patients Phase 1 CMML dose escalation trial of onvansertib monotherapy

Preliminary efficacy rate 40% of patients Patients showing preliminary efficacy signals in Phase 1 CMML trial

Optimal marrow response dose 9 mg/m2 Dose level where one patient had an optimal marrow response

Meeting edition 67th ASH Annual Meeting Venue for presentation of CMML trial poster

Presentation time window 6:00–8:00 PM EST Poster session time on December 8, 2025

Market Reality Check

$2.34 Last Close

Volume Volume 403,253 is 0.55x the 20-day average of 733,593, indicating subdued trading ahead of this update. low

Technical Shares at $2.11 are below the $2.87 200-day MA and closer to the $1.90 52-week low than the $5.64 high.

Peers on Argus

Peer biotech names show mixed but mostly negative moves: ACTU -1.74%, GNLX -1.07%, AVTX -1.46%, SKYE -1.64%, while ONCY is up 1.23%. With CRDF down 2.31% pre-news and no sector momentum flags, trading appears more stock-specific than part of a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 24	Investor conference	Neutral	+2.5%	Announcement of participation in Piper Sandler healthcare conference and investor meetings.
Nov 06	Earnings & update	Positive	-2.7%	Q3 2025 results plus positive Phase 2 mCRC data and runway into Q1 2027.
Nov 04	Investor conferences	Neutral	+0.9%	Planned participation in two November 2025 investor conferences and webcasts.
Oct 02	Investor conferences	Neutral	+4.3%	Participation in two virtual oncology and emerging growth equity conferences.
Aug 28	Investor conferences	Neutral	+1.0%	Planned attendance at three major September 2025 healthcare investor conferences.

Pattern Detected

Recent news flow has been dominated by conferences and one earnings update. Even clearly positive clinical/financial updates have not consistently produced sustained gains, and prior clinical-trial news has shown large but directionally mixed reactions.

Recent Company History

Over the last several months, Cardiff’s disclosures have focused on investor outreach and ongoing development of onvansertib. Conference participation in August–November 2025 generated modest positive moves, while the Nov 6, 2025 Q3 update combined positive Phase 2 mCRC data with a cash runway into Q1 2027 but saw a small decline. Today’s CMML Phase 1 data add to the drug’s single-agent profile, complementing earlier solid-tumor and mCRC updates while management keeps development focus away from CMML.

Market Pulse Summary

This announcement adds early Phase 1 data for onvansertib in CMML, showing it was relatively well-tolerated and produced preliminary efficacy in about 40% of a small N=9 cohort, including an optimal marrow response at 9 mg/m2. The company explicitly is not planning CMML development, so the key takeaway is additional validation of single-agent activity alongside prior hematologic and solid-tumor data. Investors may watch how these findings inform broader onvansertib strategy, especially in mCRC.

Key Terms

phase 1 medical

"In this Phase 1 dose escalation trial (N=9), onvansertib"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

monotherapy medical

"onvansertib as a monotherapy was shown to be relatively well-tolerated"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

dose escalation medical

"In this Phase 1 dose escalation trial (N=9), onvansertib"

Dose escalation is the process of gradually increasing the amount of a treatment or substance over time. In finance, it can refer to slowly raising investments or commitments to manage risk and assess performance. For investors, understanding dose escalation helps gauge how companies or strategies adjust their approaches, which can impact future growth or stability.

AI-generated analysis. Not financial advice.

SAN DIEGO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that clinical data from an investigator-sponsored trial with onvansertib in chronic myelomonocytic leukemia (CMML) will be presented in a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting.

In this Phase 1 dose escalation trial (N=9), onvansertib as a monotherapy was shown to be relatively well-tolerated, and demonstrated preliminary efficacy in approximately 40% of patients, with one patient having an optimal marrow response at the 9 mg/m² dose. These results, along with previously announced data from an investigator-sponsored trial in small cell lung cancer, validate onvansertib’s single agent activity in both hematologic and solid tumors. Cardiff Oncology is not currently planning to develop onvansertib for CMML.

Poster Details:
Title: Phase 1 clinical trial assessing the safety and efficacy of onvansertib, a novel, oral, PLK1 inhibitor in Relapsed/Refractory myeloproliferative chronic myelomonocytic leukemia (CMML)
Session-Type: Poster Abstract Session
Speaker: Mrinal Patnaik, MD, MBBS, Mayo Clinic, Rochester, MN, United States
Date: Monday, December 8, 2025 at 6:00-8:00 PM EST
Part of Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster III

The abstract can be found on the ASH Annual Meeting website, https://submit.hematology.org/program/presentation/674309

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in ongoing investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. 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 the outbreak of COVID-19 coronavirus and 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, 2024, 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.

Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com

Investor Contact:
Candice Masse
Astr Partners
candice.masse@astrpartners.com

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com

FAQ

What data will Cardiff Oncology (CRDF) present about onvansertib at ASH on Dec 8, 2025?

Cardiff will present Phase 1 investigator-sponsored data showing onvansertib was relatively well-tolerated with preliminary efficacy in ~40% of CMML patients (N=9).

What was the dosing outcome reported for onvansertib in the CMML Phase 1 trial (CRDF)?

The poster reports one patient had an optimal marrow response at a 9 mg/m2 dose in the Phase 1 dose-escalation trial (N=9).

Will Cardiff Oncology (CRDF) develop onvansertib for CMML following the ASH 2025 poster?

The company indicated it is not currently planning to develop onvansertib for CMML.

When and where is the Cardiff onvansertib poster presented at ASH 2025?

The poster is scheduled for December 8, 2025, 6:00-8:00 PM EST in Session 637 (Myelodysplastic Syndromes: Poster III); speaker Mrinal Patnaik, MD.

How large was the investigator-sponsored CMML trial for onvansertib reported by CRDF?

The Phase 1 dose-escalation trial enrolled N=9 patients.

Where can I find the abstract for the onvansertib CMML poster from ASH 2025?

The abstract is available on the ASH Annual Meeting website under the presentation listing for the poster (presentation ID provided in the announcement).