# EDGAR Filing Document

**Accession Number:** 0001213037
**File Stem:** 0001193125-26-024375
**Filing Date:** 2026-1
**Character Count:** 28249
**Document Hash:** d62d7d5d9ded09c44928fdade7ca8500
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-26-024375.hdr.sgml**: 20260127

**ACCESSION NUMBER**: 0001193125-26-024375

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20260127

**ITEM INFORMATION**: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260127

**DATE AS OF CHANGE**: 20260127

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Cardiff Oncology, Inc.
- **CENTRAL INDEX KEY:** 0001213037
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 272004382
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-35558
- **FILM NUMBER:** 26565320

**BUSINESS ADDRESS:**
- **STREET 1:** 11055 FLINTKOTE AVENUE
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121
- **BUSINESS PHONE:** 858-952-7570

**MAIL ADDRESS:**
- **STREET 1:** 11055 FLINTKOTE AVENUE
- **CITY:** SAN DIEGO
- **STATE:** CA
- **ZIP:** 92121

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Trovagene, Inc.
- **DATE OF NAME CHANGE:** 20130304

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** TrovaGene Inc.
- **DATE OF NAME CHANGE:** 20110830

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** XENOMICS INC
- **DATE OF NAME CHANGE:** 20040719

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## FORM 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** January 27, 2026<br>

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Cardiff Oncology, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-35558 | 27-2004382 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 11055 Flintkote Avenue |  |  |
| San Diego**,** California |  | 92121 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** (858) 952-7570<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock | CRDF | The Nasdaq Stock Market LLC |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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**Item 5.02 Departure of Directors or Certain Officers: Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.**

On January 27, 2026, Dr. Mark Erlander, Ph.D., CEO of Cardiff Oncology, Inc. (the "Company"), and James Levine, CFO of the Company stepped down from their respective roles at the Company as part of a strategic leadership review. The Board of Directors of the Company has appointed Dr. Mani Mohindru, a member of the Company's Board of Directors, as interim CEO of the Company. In addition, Brigitte Lindsay, the Company's Senior Vice President, Finance has been promoted to Chief Accounting Officer.

Dr. Mohindru is an experienced biotechnology executive with leadership experience spanning drug development, corporate strategy, and capital markets. She is the founder of Roshon Therapeutics, a private biotechnology company focused on developing novel therapies for cancer and inflammatory diseases and currently serves on the Board of Directors of CytomX Therapeutics, Inc. (Nasdaq: CTMX). Previously, Dr. Mohindru served as Chief Executive Officer and Board Director of Novasenta and CereXis, and held senior leadership roles at public biotechnology companies including Cara Therapeutics, Inc. and Curis, Inc.

Earlier in her career, Dr. Mohindru was an equity research analyst covering the biotechnology sector at UBS, Credit Suisse, and ThinkEquity. She currently serves on the Executive Advisory Board of the CLP Institute at Northwestern University and the Scientific Investment Advisory Committee of the Gates Institute at the University of Colorado. Dr. Mohindru holds a PhD in Neurosciences from Northwestern University, as well as a BS in Human Biology and a Master's degree in Biotechnology from the All India Institute of Medical Sciences in New Delhi, India.

A copy of the press release is filed as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

**Item 8.01 Other Events.** 

On January 27, 2026, the Company issued a press release (the "Press Release") announcing a positive update from CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) regimens (FOLFIRI/bevacizumab(bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). A copy of the press release is attached as Exhibit 99.2 hereto. The information in the Press Release, except for the information set forth in the third paragraph of the Press Release containing a quote by Dr. Mani Mohindru, interim Chief Executive Officer of the Company and the fourth paragraph of the Press Release containing a quote by Dr. J Randolph Hecht, MD, Professor of Clinical Medicine at the David Geffen School of Medicine at UCLA, is incorporated herein by reference.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits.

99.1 [<u>Press Release of Cardiff Oncology, Inc. dated January 27, 2026.</u>](crdf-ex99_1.htm)

99.2 [<u>Press Release of Cardiff Oncology, Inc. dated January 27, 2026.</u>](crdf-ex99_2.htm)

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | | |
|:---|:---|:---|:---|
|  |  |  | CARDIFF ONCOLOGY, INC. |
| Date: | January 27, 2026 | By:  | /s/ Mani Mohindru |
|  |  |  | Mani Mohindru<br>Interim Chief Executive Officer |

---

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## Exhibit 99.1

![img186708884_0.jpg](img186708884_0.jpg)

**Cardiff Oncology Announces Executive Leadership Changes as it Transitions to Late-Stage Clinical Development**

**SAN DIEGO — January 27, 2026 —** Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced a leadership transition designed to support the Company's next phase of growth and advancement toward late-stage development and key clinical and corporate milestones.

Mani Mohindru, PhD, a member of Cardiff Oncology's Board of Directors since 2021 and a seasoned biotech executive, has been appointed interim Chief Executive Officer, effective immediately. Mark Erlander, PhD, Chief Executive Officer, and James Levine, Chief Financial Officer, have stepped down from their respective roles.

As part of this transition, Ms. Brigitte Lindsay has been promoted to the role of Chief Accounting Officer, ensuring continuity within the finance function. She has been with the Company for more than 14 years and was most recently the Senior Vice President of Finance. The Company has initiated a search for a permanent Chief Executive Officer and Chief Financial Officer.

Cardiff Oncology's lead product candidate, onvansertib, a highly specific, oral PLK1 inhibitor, is currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer (mCRC) and is also being evaluated as a single agent and in combinations across multiple additional cancers in investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, triple-negative breast cancer, and chronic myelomonocytic leukemia. The leadership transition reflects the Company's focus on execution and clinical advancement as its programs mature.

"As Cardiff Oncology prepares for the next stage of clinical and corporate development, the Board concluded that this was the right moment to align executive and financial leadership with the Company's evolving needs," said Rodney S. Markin, MD, PhD, Chairman of the Board. "We want to express our sincere gratitude to Mark and Jamie for their significant contributions in guiding Cardiff to where it stands today—especially in the progress of our lead product candidate in first-line RAS-mutated mCRC, an area of high unmet need where there have not been any significant advancements in many years. Looking forward, we are confident in Dr. Mohindru's ability to lead the Company at this key moment in onvansertib's clinical development, as she brings a rare combination of deep scientific training, operational leadership, and capital markets expertise."

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"Cardiff Oncology has built a strong scientific and clinical foundation around PLK1 inhibition, with onvansertib demonstrating encouraging activity in a challenging to treat patient population," said Mani Mohindru, PhD, interim Chief Executive Officer. "Given onvansertib's activity in RAS-mutated mCRC as well as encouraging single agent data, there is potential to extend its benefit to other solid tumors and hematologic malignancies. I look forward to working closely with the Board and the team to sharpen our strategic priorities, advance our clinical programs, and thoughtfully position the Company for late-stage development while maintaining a disciplined approach to capital and execution."

Dr. Mohindru is an experienced biotechnology executive with leadership experience spanning drug development, corporate strategy, and capital markets. She is the founder of Roshon Therapeutics, a private biotechnology company focused on developing novel therapies for cancer and inflammatory diseases, and currently serves on the Board of Directors of CytomX Therapeutics, Inc. (Nasdaq: CTMX). Previously, Dr. Mohindru served as Chief Executive Officer and Board Director of Novasenta and CereXis, and held senior leadership roles at public biotechnology companies including Cara Therapeutics, Inc. and Curis, Inc.

Earlier in her career, Dr. Mohindru was an equity research analyst covering the biotechnology sector at UBS, Credit Suisse, and ThinkEquity. She currently serves on the Executive Advisory Board of the CLP Institute at Northwestern University and the Scientific Investment Advisory Committee of the Gates Institute at the University of Colorado. Dr. Mohindru holds a PhD in Neurosciences from Northwestern University, as well as a BS in Human Biology and a Master's degree in Biotechnology from the All India Institute of Medical Sciences in New Delhi, India.

**About Cardiff Oncology, Inc.**<br>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, our ability to conduct a successful search for and hire a permanent CEO and

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CFO, 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.

**Investor Contact:**<br>Candice Masse<br>Astr Partners<br>candice.masse@astrpartners.com

**Media Contact:**<br>Amy Bonanno<br>Lyra Strategic Advisory<br>abonanno@lyraadvisory.com

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## Exhibit 99.2

![img187632405_0.jpg](img187632405_0.jpg)

**Cardiff Oncology Announces Positive Update from its Randomized Phase 2 Trial of Onvansertib in First-line RAS-mutated mCRC**

- *Onvansertib added to FOLFIRI/bev first-line standard of care regimen showed dose-dependent improvement in overall response rates and durability trends as measured by progression-free survival in patients with RAS-mutated mCRC –*

*- Data support selection of 30 mg onvansertib dose for registrational program in first-line RAS-mutated mCRC –*

*- Data validate previously reported positive results from Phase 2 trial of onvansertib with FOLFIRI/bev in second-line mCRC bev-naïve patients, as published in the Journal of Clinical Oncology –*

*- Onvansertib continues to be safe and well-tolerated –*

*- Company expects to provide final data and registrational plans in first half of 2026 –*

*- Company to hold conference call today at 8:30 a.m. ET/5:30 a.m. PT -*

**SAN DIEGO, January 27, 2026** -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced a positive update from CRDF-004, a randomized dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard of care (SoC) regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line (1L) RAS-mutated metastatic colorectal cancer (mCRC). In an intent-to-treat analysis, the clinical data show dose-dependent benefits across multiple efficacy measures in patients receiving onvansertib with FOLFIRI/bev compared to patients receiving either SoC regimen. In this trial, onvansertib with FOLFIRI/bev also performed better than onvansertib with FOLFOX/bev.

Based on these results, the Company has selected the 30 mg dose of onvansertib with FOLFIRI/bev to bring forward in a registrational trial in 1L patients with RAS-mutated mCRC. Cardiff Oncology plans to initiate a registrational program later this year pending finalization of the trial design in consultation with the FDA, in which the Company expects to compare onvansertib with FOLFIRI/bev to SoC regimens, FOLFIRI/bev or FOLFOX/bev.

"These data demonstrate promising enhanced benefits of onvansertib when combined with FOLFIRI/bev in RAS-mutated mCRC patients," said Mani Mohindru, PhD, interim Chief Executive Officer. "We observed a consistent, dose-dependent treatment benefit across multiple measures of efficacy, including achieving statistical significance for PFS compared to SoC even with relatively small patient numbers. The 30 mg onvansertib–FOLFIRI/bev arm outperformed both SoC arms with no significant additive toxicity, supporting findings from our previous Phase 2 trial in second-line RAS-mutated mCRC. While we continue to review data from the ongoing trial, our plan is to rapidly move forward with the onvansertib 30 mg dose in combination with FOLFIRI/bev and we believe confirmatory data from a

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registrational trial has the potential to make this regimen a new SoC for 1L treatment of RAS-mutated mCRC."

**Topline Results in intent-to-treat (ITT) population, data cut-off as of January 22, 2026**

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| | | | | |
|:---|:---|:---|:---|:---|
| &nbsp;&nbsp;**Parameter** | &nbsp;&nbsp;**SoC**<sup>c</sup> **(FOLFIRI/bev+FOLFOX/bev) (n=37)** | &nbsp;&nbsp;**FOLFIRI/bev**<br>**(n=19)** | &nbsp;&nbsp;**Onv 20 mg** <br>**+FOLFIRI/bev**<br>**(n=18)** | &nbsp;&nbsp;**Onv 30 mg** <br>**+FOLFIRI/bev**<br>**(n=18)** |
| &nbsp;&nbsp;**Objective Response Rate (per BICR)**<sup>a</sup> | &nbsp;&nbsp;**Objective Response Rate (per BICR)**<sup>a</sup> | &nbsp;&nbsp;**Objective Response Rate (per BICR)**<sup>a</sup> | &nbsp;&nbsp;**Objective Response Rate (per BICR)**<sup>a</sup> | &nbsp;&nbsp;**Objective Response Rate (per BICR)**<sup>a</sup> |
| &nbsp;&nbsp;Confirmed Responders | 16 | &nbsp;&nbsp;&nbsp;&nbsp;8 | &nbsp;&nbsp;&nbsp;&nbsp;8 | &nbsp;&nbsp;13 |
| &nbsp;&nbsp;Confirmed ORR (%) | &nbsp;&nbsp;43.2  | &nbsp;&nbsp;42.1 | &nbsp;&nbsp;44.4 | &nbsp;&nbsp;&nbsp;72.2<br>p-value = 0.051<sup>f</sup> (vs SoC) |
| &nbsp;&nbsp;**Progression Free Survival**<sup>b</sup> | &nbsp;&nbsp;**Progression Free Survival**<sup>b</sup> | &nbsp;&nbsp;**Progression Free Survival**<sup>b</sup> | &nbsp;&nbsp;**Progression Free Survival**<sup>b</sup> | &nbsp;&nbsp;**Progression Free Survival**<sup>b</sup> |
| &nbsp;&nbsp;Median PFS (months, 95% CI) | &nbsp;&nbsp;10.97 (9.43-15.44) | &nbsp;&nbsp;10.97 (7.52-NR) | &nbsp;&nbsp;NR (7.49-NR) | &nbsp;&nbsp;NR (9.72-NR) |
| &nbsp;&nbsp;PFS HR (vs FOLFIRI/bev) |  |  | &nbsp;&nbsp;0.56 (0.18-1.73)<sup>d</sup> | &nbsp;&nbsp;0.38 (0.12-1.17)<sup>d</sup> |
| &nbsp;&nbsp;PFS HR (vs SoC) |  |  | &nbsp;&nbsp;0.57 (0.21-1.58)<sup>e</sup> | &nbsp;&nbsp;&nbsp;0.37 (0.13-1.02)<sup>e</sup><br>p-value = 0.048<sup>g</sup> (vs SoC) |
| &nbsp;&nbsp;PFS Rate at 6 months (95% CI) | &nbsp;&nbsp;88.8 (77.4-100) | &nbsp;&nbsp;79.5 (61.1-100) | &nbsp;&nbsp;88.1 (73.9-100) | &nbsp;&nbsp;94.1 (83.6-100) |

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Bev=bevacizumab; BICR=Blinded Independent Central Review; CI=confidence interval; HR=hazard ratio; NR=not reached; Onv=onvansertib; ORR=objective response rate; PFS=progression-free survival; SoC=standard of care.

<sup>a</sup>ORR is confirmed responses

<sup>b</sup>Progressive disease events were based on combined BICR and Investigator assessments due to very small number of events in BICR assessment. The earliest reported date was used for a conservative estimate.

<sup>c</sup>SoC is the combination of the FOLFIRI/bev and FOLFOX/bev arms

<sup>d</sup>PFS HR is the comparison of the onvansertib arm to FOLFIRI/bev

<sup>e</sup>PFS HR is the comparison of the onvansertib arm to SoC

<sup>f</sup>Fisher's exact test

<sup>g</sup>Log-rank test

"There is a clear need for improved first-line treatment options for patients with mCRC, especially the half of those with RAS-mutated disease," said Dr. J Randolph Hecht, MD, Professor of Clinical Medicine at the David Geffen School of Medicine at UCLA. "Unfortunately, first-line treatment for these patients hasn't improved significantly for more than two decades. Onvansertib has a novel mechanism of action and these preliminary responses and PFS results in combination with FOLFIRI/bevacizumab are encouraging enough to test in a large Phase 3 trial. If such a trial were positive, it could become a new standard of care for these patients."

Onvansertib in combination with both chemo/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and standard of care arms.

**Conference Call and Webcast**

Cardiff Oncology will host a conference call and live webcast today, January 27, 2026 at 8:30 a.m. ET / 5:30 a.m. PT. Individuals interested in listening may do so by using the link in the "Events" section of the Company's website. A replay will be available in the investor relations section on the Company's website following the completion of the call.

**CRDF-004 Trial Design**

The CRDF-004 Phase 2 trial was designed to evaluate two doses of onvansertib to identify the lowest maximally effective dose and to assess the safety, efficacy, and pharmacokinetics of onvansertib in

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combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The trial's endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety.

For additional information about the trial, please visit www.clinicaltrials.gov (Trial ID: NCT06106308).

**About Onvansertib**

Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It 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). Promising monotherapy clinical results from an ongoing CMML trial were recently presented at the American Society of Hematology annual meeting in December 2025. CMML represents a rare disease with significant unmet need.

**About Cardiff Oncology, Inc.**<br>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**<br>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

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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.

**Investor Contact:**<br>Candice Masse<br>Astr Partners<br>candice.masse@astrpartners.com

**Media Contact:**<br>Amy Bonanno<br>Lyra Strategic Advisory<br>abonanno@lyraadvisory.com

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