# EDGAR Filing Document

**Accession Number:** 0001213037
**File Stem:** 0000950170-25-099631
**Filing Date:** 2025-7
**Character Count:** 70467
**Document Hash:** 1b0c011d60e6553f71ca38499d9d5930
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-099631.hdr.sgml**: 20250729

**ACCESSION NUMBER**: 0000950170-25-099631

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 58

**CONFORMED PERIOD OF REPORT**: 20250729

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20250729

**DATE AS OF CHANGE**: 20250729

**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:** 251161960

**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):** July 29, 2025<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)** |

---

**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 2.02 Results of Operations and Financial Condition.** 
On July 29, 2025, Cardiff Oncology, Inc. (the "Company") issued a press release announcing company highlights and financial results for the second quarter ended June 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

**Item 7.01 Regulation FD Disclosure.**

On July 29, 2025, the Company plans to present in a conference call presentation materials related to the announcement of positive data from ongoing randomized phase 2 first-line RAS-mutated metastatic colorectal cancer (mCRC) clinical trial CRDF-004. A copy of the presentation materials is furnished as Exhibit 99.2 to this Form 8-K.

The information in this report, including the press release furnished as Exhibit 99.1 hereto, shall not be deemed to be "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. In addition, the exhibit furnished herewith contain statements intended as "forward-looking statements" that are subject to the cautionary statements about forward-looking statements set forth in such exhibit.

**Item 8.01 Other Events.** 

On July 29, 2025, the Company issued a press release (the "Press Release") announcing positive data from ongoing randomized phase 2 first-line RAS-mutated metastatic colorectal cancer (mCRC) clinical trial CRDF-004. A copy of the press release is attached as Exhibit 99.3 hereto. The information in the Press Release, except for the information set forth in the 2nd paragraph of the Press Release containing a quote by Roger Sidhu, MD, Chief Medical Officer of the Company and the 8th paragraph of the Press Release containing a quote by Mark Erlander, Chief Executive Officer of the Company, is incorporated herein by reference.

## **Item 9.01 Financial Statements and Exhibits.** 
(d) Exhibits.

99.1 [<u>Press Release of Cardiff Oncology, Inc. dated July 2</u>](crdf-ex99_1.htm) [<u>9, 2025</u>](crdf-ex99_1.htm)

99.2 [<u>Cardiff Oncology, Inc. Corporate Presentation</u>](crdf-ex99_2.htm)

99.3 [<u>Press Release of Cardiff Oncology, Inc. dated July 29, 2025</u>](crdf-ex99_3.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: | July 29, 2025 | By:  | /s/ Mark Erlander |
|  |  |  | Mark Erlander<br>Chief Executive Officer |

---

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## Exhibit 99.1

![img186708884_0.jpg](img186708884_0.jpg)

**Cardiff Oncology Reports Second Quarter 2025 Results and Provides Business Update**

*- Appointed Dr. Roger Sidhu as Chief Medical Officer –*

*- Completed enrollment in randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care for the treatment of first-line RAS-mutated metastatic colorectal cancer ("mCRC") –*

*- Announced positive data from investigator-initiated trial of onvansertib in combination with paclitaxel in mTNBC at ASCO 2025 -*

*- Cash and investments of $71.0 million as of June 30, 2025, projected runway into Q1 2027 –*

*- Company to hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT to share updated clinical data from the CRDF-004 trial -*

**SAN DIEGO, July 29, 2025** -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced financial results for the second quarter ended June 30, 2025, and provided a business update.

"In the second quarter, we achieved an important milestone by completing enrollment in our ongoing CRDF-004 trial evaluating onvansertib plus standard of care for the treatment of first-line RAS-mutated mCRC," said Mark Erlander, Chief Executive Officer of Cardiff Oncology. "As we evolve into a late-stage clinical development company, we were excited to appoint Dr. Sidhu as our new Chief Medical Officer to provide expert guidance in advancing onvansertib through the registrational phase of development. We're pleased to welcome him to the team and are confident that his expertise will be instrumental as we work toward bringing this potential therapy to patients."

**Conference Call and Webcast on Clinical Data from Ongoing CRDF-004 Trial in mCRC**

Cardiff Oncology will host a live conference call and webcast at 4:30 p.m. ET/1:30 p.m. PT on July 29, 2025 to share clinical data from the ongoing CRDF-004 trial in first-line RAS-mutated mCRC. Individuals interested in listening to the live conference call may do so by using the webcast link in the "<u>Investors</u>" section of the company's website at https://investors.cardiffoncology.com/news-events/events. A replay will be available in the investor relations section on the company's website following the completion of the call.

**Company highlights for the quarter ended June 30, 2025, and subsequent weeks include:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Appointed Dr. Roger Sidhu as Chief Medical Officer**

oIn June 2025, the company appointed Roger Sidhu, MD, as Chief Medical Officer. Dr. Sidhu is a veteran executive and clinician with over 20 years of experience and a strong track record of success in oncology research, development, and regulatory strategy.

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Announced positive data from investigator-initiated trial of onvansertib in combination with paclitaxel in metastatic triple negative breast cancer (mTNBC) at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025**

oThe Phase 1b study of onvansertib in combination with paclitaxel in mTNBC was led by Antonio Giordano, MD, PhD at Dana-Farber Cancer Institute, a principal teaching affiliate of Harvard Medical School. Onvansertib in combination with paclitaxel demonstrated a 40% objective response rate (ORR) by RECIST 1.1 at RP2D of 18mg/m<sup>2</sup> (n=10), with two confirmed partial responses and two unconfirmed partial responses. The combination was well-tolerated and demonstrated a safe and manageable toxicity profile with myelosuppression being the most common adverse event. Overall, this clinical data further supports the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Announced a second patent issuance from the United States Patent and Trademark Office (USPTO) for the treatment of mCRC for bev-naïve patients**

oU.S. patent No. 12,263,173 has an expiration date of no earlier than 2043. The claims of the new patent cover the method of using onvansertib in combination with bev in any line of therapy for the treatment of mCRC patients who have not previously been treated with bev. The newly issued patent encompasses all mCRC patients, with RAS-mutated or RAS wild-type mCRC.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•**Announced completion of enrollment in Phase 2, randomized, CRDF-004 trial evaluating onvansertib + standard of care (SoC) for the treatment of first-line RAS-mutated mCRC** 

oThe Phase 2 CRDF-004 trial reached the targeted enrollment of patients with first-line mCRC across 41 clinical sites in the U.S. The Company is holding a conference call today to share an update on the ongoing trial.

**<u>Second Quarter 2025 Financial Results:</u>**

*Liquidity, cash burn, and cash runway*

As of June 30, 2025, Cardiff Oncology had approximately $71.0 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the second quarter of 2025 was approximately $8.3 million, a decrease of $0.9 million from $9.2 million for the same period in 2024.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2027.

*Operating results*

Total operating expenses were approximately $14.9 million for the three months ended, June 30, 2025, an increase of $2.2 million from $12.7 million for the same period in 2024. The increase in operating expenses was primarily due to costs associated with our CRDF-004 clinical trial, other clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, as well as salaries and wages for key hires and additional stock option grants.

**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

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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 and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and metastatic triple negative breast cancer (mTNBC). 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 <u>https://www.cardiffoncology.com</u>.

**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:**

Kiki Patel, PharmD

Gilmartin Group

332-895-3225

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kiki@gilmartinir.com

**Media Contact:**

Meghan Bianco

Taft Communications

609-544-5446

Meghan.bianco@rfbinder.com

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**Cardiff Oncology, Inc.**

**Condensed Statements of Operations**

**(in thousands, except for per share amounts)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(unaudited)**

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended June 30,** | **Three Months Ended June 30,** | **Six Months Ended June 30,** | **Six Months Ended June 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
| Royalty revenues | $121 | $163 | $230 | $368 |
| Costs and expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 11580 | 9493 | 22057 | 17501 |
| &nbsp;&nbsp;&nbsp;&nbsp;Selling, general and administrative | 3318 | 3215 | 7332 | 6345 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 14898 | 12708 | 29389 | 23846 |
| Loss from operations | (14777) | (12545) | (29159) | (23478) |
| Other income (expense), net: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Interest income, net | 835 | 805 | 1776 | 1731 |
| &nbsp;&nbsp;&nbsp;&nbsp;Other income (expense), net | (1) | (38) | 6 | (42) |
| Total other income (expense), net | 834 | 767 | 1782 | 1689 |
| Net loss | (13943) | (11778) | (27377) | (21789) |
| &nbsp;&nbsp;&nbsp;&nbsp;Preferred stock dividend | (6) | (6) | (12) | (12) |
| Net loss attributable to common stockholders | $(13949) | $(11784) | $(27389) | $(21801) |
| Net loss per common share — basic and diluted | $(0.21) | $(0.26) | $(0.41) | $(0.49) |
| Weighted-average shares outstanding — basic<br> and diluted | 66526 | 44825 | 66525 | 44752 |

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**Cardiff Oncology, Inc.**

**Condensed Balance Sheets**

**(in thousands)**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**(unaudited)**

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| | | |
|:---|:---|:---|
|  | **June 30,<br>2025** | **December 31,<br>2024** |
| Assets |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $10784 | $51470 |
| &nbsp;&nbsp;&nbsp;&nbsp;Short-term investments | 60173 | 40276 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts receivable and unbilled receivable | 526 | 773 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 2213 | 2535 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 73696 | 95054 |
| Property and equipment, net | 743 | 898 |
| Operating lease right-of-use assets | 899 | 1169 |
| Other assets | 401 | 69 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total Assets | $75739 | $97190 |
| Liabilities and Stockholders' Equity |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | $6010 | $4821 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accrued liabilities | 9938 | 7897 |
| &nbsp;&nbsp;&nbsp;&nbsp;Operating lease liabilities | 721 | 710 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 16669 | 13428 |
| Operating lease liabilities, net of current portion | 464 | 813 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total Liabilities | 17133 | 14241 |
| Stockholders' equity | 58606 | 82949 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities and stockholders' equity | $75739 | $97190 |

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## Exhibit 99.2

![Slide 1](crdf-ex99_2s1.jpg)

JULY 29, 2025 CRDF-004 Trial Update 1st Line RAS-mutated mCRC

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![Slide 2](crdf-ex99_2s2.jpg)

Forward-looking statements Certain statements in this presentation are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern our expectations, strategy, plans or intentions. These forward-looking statements are based on our 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 our 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 we do not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

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![Slide 3](crdf-ex99_2s3.jpg)

Mark Erlander, PhD Chief Executive Officer

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![Slide 4](crdf-ex99_2s4.jpg)

Onvansertib specifically targets PLK1, a well-established cancer target Onvansertib First oral, well-tolerated PLK1-selective inhibitor ENZYME IC50 (µM) PLK1 0.002 PLK2 >10.000 PLK3 >10.000 CK2 0.400 FLT3 0.400 CDK1/CycB >10.000 42 other kinasesand >140 in the Millipore panel >10.000 Exquisitely specific for PLK1 SPECIFICITY PROPERTIES Small molecule Oral dosing 24-hour half-life

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![Slide 5](crdf-ex99_2s5.jpg)

We designed the CRDF-004 trial to address four objectives 2024 2025 CRDF-004 Ph2 trialRAS-mut mCRC shift from2nd line to 1st line Aug 7, 2023 INTENT 1. Select a Ph3 dose – per FDA's Project Optimus 2. Assess efficacy signal 3. Characterize safety profile in 1st line setting 4. Basis for meeting with FDA to agree Ph3 trial 2023 mCRC, metastatic colorectal cancer; mut, mutated

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![Slide 6](crdf-ex99_2s6.jpg)

Dr. Sidhu brings a wealth of clinical development experience Dr. Sidhu served as Executive Vice President and Chief Medical Officer at Roivant Sciences. He was also the Chief Medical Officer at Eterna Therapeutics, Inc. and Cell Design Labs, up until its acquisition by the Gilead subsidiary Kite, where he subsequently served as VP, Clinical Development. He was most recently the Chief Medical Officer and acting CEO at Treadwell Therapeutics. Dr. Sidhu is a Fellow of the Royal College of Physicians and Surgeons of Canada in both internal medicine and medical oncology. He earned his medical degree from Queen's University in Kingston, Ontario Canada and his bachelor's degree in biochemistry from the University of Alberta in Edmonton, Alberta. Dr. Sidhu trained in internal medicine at Queen's University and medical oncology at the British Columbia Cancer Agency in Vancouver, British Columbia and the Cross Cancer Institute in Edmonton, Alberta. CAREER Deep Expertise in mCRC and Drug Development PRACTICAL EXPERIENCE AT AMGEN Advanced multiple therapeutic candidates in oncology and hematology Led multiple Ph3 clinical trials of panitumumab (Vectibix®, approved US and globally) Dr. Sidhu is a leader in advancing RAS biology and therapeutics in mCRC, with publications in peer-reviewed journals, including the New England Journal of Medicine. A LEADER IN mCRC RAS BIOLOGY

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![Slide 7](crdf-ex99_2s7.jpg)

Roger Sidhu, MD Chief Medical Officer

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![Slide 8](crdf-ex99_2s8.jpg)

ORR efficacy and safety PFS analyses Registrational program path forward AGENDA 1st line RAS-mut mCRC program update mCRC, metastatic colorectal cancer; Mut, mutant; ORR, objective response rate; PFS, progression free survival

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![Slide 9](crdf-ex99_2s9.jpg)

CRC: High unmet need with limited therapies for RAS-mut mCRC COLORECTAL CANCER 3rd most common cancer worldwide 150,000 Annually in the United States new cases 50,000 deaths 15% 5-year relative OS Less than 12 months Median PFS For patients with metastatic CRC 1st LINE STANDARD of CARE RAS-mutated mCRC 1990 2000 2010 2020 1996 FOLFOX 2002 FOLFIRI 2004 Bevacizumab(Avastin®) Morris et al., J Clin Oncol 2023, Shi et al., J Clin Oncol 2025. CRC, colorectal cancer; mCRC, metastatic colorectal cancer; mut, mutant; OS, overall survival; PFS, progression free survival 2014 FOLFOXIRI

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![Slide 10](crdf-ex99_2s10.jpg)

Prior 1st line Ph3 mCRC trials provide benchmarks for current SoC Targeted agent Trial Mechanism of action Trial population Sample size ORR Exp. vs Ctrl. ORR delta PFS (months) Exp. vs Ctrl. Hazardratio Bevacizumab IFL/bev vs IFL Antiangiogenic KRAS WT or mutant All ITT patients Mutant only1 813 78 45% vs 35% 43% vs 41% 10% 2% 10.6 vs 6.2 9.3 vs 5.5 0.54 p<0.0001 0.41 FOLFOXIRI/bev (TRIBE trial) FOLFOXIRI/bevvs FOLFIRI/bev Chemo RAS WT or mutant All ITT patients Mutant only1 508 236 65% vs 54% 66% vs 55% 11% 11% 12.3 vs 9.7 12.0 vs 9.5 0.77 p=0.006 0.78 Data from Positive 1st line mCRC Chemo/bev Phase 3 Clinical Trials by RAS-mut Status\* \* Source: Bevacizumab: USPI from accessdata.fda.gov, Hurwitz H, et al. The Oncologist 2009. FOLFOXIRI: Cremolini C, et al. Lancet Oncol 2015. 1. RAS mutation was evaluated retrospectively and tumor samples for RAS analysis were not available for all patients. mCRC, metastatic colorectal cancer; SoC, standard of care; ORR, objective response rate; ITT, intent-to-treat; Exp, experimental arm; Ctrl, control arm; PFS, progression free survival; WT, wild type; bev, bevacizumab; p, p-value

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![Slide 11](crdf-ex99_2s11.jpg)

Trial design of CRDF-004: 1st line RAS-mutated mCRC Phase 2 trial 1st line SoC: Chemo + bevacizumab 1st line SoC: Chemo + bevacizumab 28 DAY CYCLE 6 7 8 9 10 11 12 13 14 20 21 22 23 24 25 26 27 28 ONVANSERTIB ONVANSERTIB ENROLLMENT CRITERIA ENDPOINTS\* Primary: Secondary: ORR DoR and PFS KRAS+/NRAS+ Unresectable First-line mCRC N=90 R No prior bev Onv 30mg + Onv 20mg + SoC alone 6 RANDOMIZATION ARMS \* Assessed by blinded independent central review (BICR) Patient's tumors are scanned every 8 weeks 1. FOLFIRI/bev 2. FOLFOX/bev 3. FOLFIRI/bev 4. FOLFOX/bev 5. FOLFIRI/bev 6. FOLFOX/bev mCRC, metastatic colorectal cancer; ORR, objective response rate; DoR, duration of response; PFS, progression free survival; SoC, standard of care; onv, onvansertib; bev, bevacizumab

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![Slide 12](crdf-ex99_2s12.jpg)

As of July 8, 2025, a majority of CRDF-004 patients remain on treatment Population, n Control (SoC alone) Onv 20mg + SoC Onv 30mg + SoC Total Intent-to-treat (ITT) 37 36 37 110 Safety population (dosed) 34 34 36 104 Patients still on trial 18 19 23 60 Patients with only a 2-month scan and remain on trial 3 2 1 6 Median follow up time for all patients is ~6 months \* CRDF-004 population data as of July 8, 2025 from an ongoing trial and unlocked database. SoC, standard of care; onv, onvansertib Study Populations as of July 8, 2025\*

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![Slide 13](crdf-ex99_2s13.jpg)

Dose-dependent increase in objective response rates observed with onvansertib+SoC Intent-to-treat (ITT) (N=110) Control (SoC alone) (n=37) Onv 20mg + SoC (n=36) Onv 30mg + SoC (n=37) Onv 30mg vs. Control Confirmed ORR1 n, [95% CI] 30% n=11 [16-47] 42% n=15 [26–59] 49% n=18 [32–66] 19% p=0.018 Confirmed ORR at 6 months 22% n=8 33% n=12 46% n=17 \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. 1. Confirmed ORR includes positively confirmed CRs and PRs per RECIST 1.1. SoC, standard of care; ORR, objective response rate; CI, confidence interval; p, p-value; onv, onvansertib Objective Response Rates per RECIST 1.1\*

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![Slide 14](crdf-ex99_2s14.jpg)

Dose-dependent increase in objective response rates observed with onvansertib+SoC Intent-to-treat (ITT) (N=110) Control (SoC alone) (n=37) Onv 20mg + SoC (n=36) Onv 30mg + SoC (n=37) Onv 30mg vs. Control Confirmed ORR1 n, [95% CI] 30% n=11 [16-47] 42% n=15 [26–59] 49% n=18 [32–66] 19% p=0.018 Confirmed ORR at 6 months 22% n=8 33% n=12 46% n=17 ORR2 n, [95% CI] 43% n=16 [27–61] 50% n=18 [33–67] 59% n=22 [42–75] Best response on trial Complete Response (CR) 1 (3%) 1 (3%) 2 (5%) Partial Response (PR) 15 (41%) 17 (47%) 20 (54%) Unconfirmed (will not confirm) PR/CR 3 (8%) 3 (8%) 1 (3%) Stable Disease (SD) 9 (24%) 10 (28%) 8 (22%) Progressive Disease (PD) 0 0 1 (3%) Death 1 (3%) 0 1 (3%) Not evaluable 8 (22%) 5 (14%) 4 (11%) \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. 1. Confirmed ORR includes positively confirmed CRs and PRs per RECIST 1.1. 2. ORR includes positively confirmed CRs and PRs and unconfirmed PRs who were still on treatment and may yet be confirmed. SoC, standard of care; ORR, objective response rate; CI, confidence interval; p, p-value; onv, onvansertib Objective Response Rates per RECIST 1.1\*

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![Slide 15](crdf-ex99_2s15.jpg)

Deeper tumor regression observed with onvansertib+SoC Best Radiographic Response BY ONVANSERTIB DOSE\* Best % Change from Baseline Best Response CR PR PD SD Confirmed CR Confirmed PR Patient number FOLFIRI FOLFOX Unconfirmed PR Intent-to-treat (ITT) Control (SoC alone) Onv 20mg+ SoC Onv 30mg+ SoC Confirmed ORR1 30% 42% 49% ORR2 43% 50% 59% > On treatment Onvansertib 20mg plus SoC Onvansertib 30mg plus SoC SoC Experimental Arms Control Arm \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. A PR with no circle above is an unconfirmed PR with treatment discontinued (will never confirm) and is not considered a responder for ORR calculation. Patients 1003-065 (unconfirmed PR) and 1011-106 (Non-CR/Non-PD) do not appear on the waterfall plot as they had no target lesions. 1. Confirmed ORR includes positively confirmed CRs and PRs per RECIST 1.1. 2. ORR includes positively confirmed CRs and PRs and unconfirmed PRs who were still on treatment and may yet be confirmed. SoC, standard of care; ORR, objective response rate; onv, onvansertib; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease

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![Slide 16](crdf-ex99_2s16.jpg)

Best Response Progressive Disease Stable Disease Partial Response Complete Response Progressive Disease Stable Disease Partial Response Complete Response Scan Response Onvansertib 20mg plus SoC Onvansertib 30mg plus SoC SoC Experimental Arms Control Arms % Change from Baseline Deeper tumor regression over time observed with onvansertib+SoC Radiographic Response over Time\* Best Response CR PR PD SD \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. SoC, standard of care; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease

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![Slide 17](crdf-ex99_2s17.jpg)

Deeper tumor regression observed when adding onvansertib to either chemo backbone vs SoC alone Best Radiographic Response BY CHEMO BACKBONE\* Best Response CR PR PD SD Confirmed CR Confirmed PR Patient number Onv 20mg+SoC Onv 30mg+SoC Unconfirmed PR Best % Change from Baseline Intent-to-treat (ITT) Control SoC + Onv Control SoC + Onv Confirmed ORR1 26% 44% 33% 46% ORR2 47% 50% 39% 59% FOLFIRI FOLFOX > On treatment FOLFIRI / bev (Control) FOLFIRI / bev / onvansertib (Experimental) FOLFIRI Arms FOLFOX / bev / onvansertib (Experimental) FOLFOX Arms FOLFOX / bev (Control) \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. A PR with no circle above is an unconfirmed PR with treatment discontinued (will never confirm) and is not considered a responder for ORR calculation. Patients 1003-065 (unconfirmed PR) and 1011-106 (Non-CR/Non-PD) do not appear on the waterfall plot as they had no target lesions. 1. Confirmed ORR includes positively confirmed CRs and PRs per RECIST 1.1. 2. ORR includes positively confirmed CRs and PRs and unconfirmed PRs who were still on treatment and may yet be confirmed. SoC, standard of care; ORR, objective response rate; onv, onvansertib; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease

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![Slide 18](crdf-ex99_2s18.jpg)

Higher number of 30mg onvansertib patients remain on trial vs. control Radiographic Response over Time\* Onv 20mg + SoC Control arms Onv 30mg + SoC Time on Trial by Best Response CR/PR PD SD CR PR FOLFOX FOLFIRI First response scan > On treatment Safety Population (Dosed) Control (SoC alone) Onv 20mg+ SoC Onv 30mg+ SoC Patients on treatment 18 (53%) 19 (56%) 23 (64%) Patients discontinued treatment: 16 (47%) 15 (44%) 13 (36%) To pursue surgery 3 3 5 Progressive disease 5 6 3 Adverse events/toxicity1 1 3 2 Median follow up time for all patients is ~6 months Adverse event To pursue surgery Progressive disease Physician decision Patient decision Reason for discontinuation(per EDC) \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. 1. One control, one 20mg and two 30mg patients discontinued due to adverse events / toxicity prior to their first post-baseline scan and are not included in the swimmer plot. SoC, standard of care; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; onv, onvansertib; EDC, electronic data capture system On follow up

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![Slide 19](crdf-ex99_2s19.jpg)

Several patients in onvansertib arms achieved deep responses, CR, and surgery referrals\* 47-year-old female Metastatic disease on enrollment. Right sided colon cancer. Target lesions in peritoneum (SLD 27mm) with non-target lesions throughout peritoneum. Achieved CR and went to curative surgery after 6 cycles of treatment. 30mg onv + FOLFIRI/bev 69-year-old male Adjuvant FOLFOX for stage 3 colon cancer 1 year prior to study. Right sided colon cancer. Target lesions paracolic gutter and peritoneum (SLD 39 mm) with non-target lesions peritoneal nodules throughout abdomen. Achieved CR of target lesions and confirmed 100% PR. Continues on treatment. 20mg onv + FOLFOX/bev 49-year-old male Neoadjuvant CAPOX for stage 3 colon cancer 1 year prior to study. Bilateral disease (right and left) colon cancer. Target lesions in lung and seminal vesicles (SLD 50 mm) with non-target lesions in retroperitoneum and liver. Achieved CR after 4 cycles of treatment. Continues on treatment. 20mg onv + FOLFOX/bev 62-year-old male Metastatic disease. Right sided colon cancer. Target lesions in liver (SLD 32mm), non-target lesions in liver and adrenal gland. Achieved CR after 6 cycles. Referred for curative surgery. 30mg onv + FOLFIRI/bev \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. SLD, sum of the longest diameters; onv, onvansertib; bev, bevacizumab; CR, complete response; PR, partial response

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![Slide 20](crdf-ex99_2s20.jpg)

CRDF-004 demographics and baseline characteristics\* \* Demographics and baseline characteristics are as of July 8, 2025 from an ongoing trial and unlocked database. Bev, bevacizumab; onv, onvansertib Safety Population (Dosed) FOLFIRI/bev FOLFIRI/bev/onv 20 FOLFIRI/bev/onv 30 FOLFOX/bev FOLFOX/bev/onv 20 FOLFOX/bev/onv 30 Total (n=17) (n=17) (n=18) (n=17) (n=17) (n=18) (n=104) Age (years) Median 53 (32, 81) 52 (30, 78) 60 (34, 81) 57 (34, 82) 66 (34, 79) 59.5 (39, 86) 57 (30, 86) Gender, n (%) Male 10 (58.8) 10 (58.8) 10 (55.6) 11 (64.7) 7 (41.2) 11 (61.1) 59 (56.7) Female 7 (41.2) 7 (41.2) 8 (44.4) 6 (35.3) 10 (58.8) 7 (38.9) 45 (43.3) Race, n (%) White 13 (76.5) 15 (88.2) 15 (83.3) 12 (70.6) 13 (76.5) 13 (72.2) 81 (77.9) Black or African American 2 (11.8) 0 1 (5.6) 1 (5.9) 0 2 (11.1) 6 (5.8) Asian 1 (5.9) 0 1 (5.6) 1 (5.9) 2 (11.8) 1 (5.6) 6 (5.8) Native Hawaiian or Other Pacific Islander 0 1 (5.9) 0 1 (5.9) 0 0 2 (1.9) Not reported 0 1 (5.9) 0 2 (11.8) 1 (5.9) 1 (5.6) 5 (4.8) Unknown 1 (5.9) 0 1 (5.6) 0 1 (5.9) 1 (5.6) 4 (3.8) ECOG, n (%) 0 6 (35.3) 14 (82.4) 11 (61.1) 7 (41.2) 10 (58.8) 11 (61.1) 59 (56.7) 1 11 (64.7) 3 (17.6) 7 (38.9) 10 (58.8) 7 (41.2) 7 (38.9) 45 (43.3) Stage at Initial Diagnosis, n (%) STAGE I 0 1 (5.9) 0 0 1 (5.9) 1 (5.6) 3 (2.9) STAGE II 3 (17.6) 2 (11.8) 2 (11.1) 2 (11.8) 3 (17.6) 1 (5.6) 13 (12.5) STAGE III 4 (23.5) 4 (23.5) 2 (11.1) 6 (35.3) 2 (11.8) 3 (16.7) 21 (20.2) STAGE IV 9 (52.9) 10 (58.8) 14 (77.8) 9 (52.9) 11 (64.7) 13 (72.2) 66 (63.5) Missing 1 (5.9) 0 0 0 0 0 1 (1.0) Side of Tumor, n (%) Bilateral 6 (35.3) 2 (11.8) 6 (33.3) 4 (23.5) 2 (11.8) 7 (38.9) 27 (26.0) Left 6 (35.3) 7 (41.2) 6 (33.3) 5 (29.4) 8 (47.1) 4 (22.2) 36 (34.6) Right 5 (29.4) 8 (47.1) 6 (33.3) 8 (47.1) 7 (41.2) 7 (38.9) 41 (39.4) Liver metastasis at study entry, n (%) No 7 (41.2) 8 (47.1) 5 (27.8) 9 (52.9) 5 (29.4) 4 (22.2) 38 (36.5) Yes 10 (58.8) 9 (52.9) 13 (72.2) 8 (47.1) 12 (70.6) 14 (77.8) 66 (63.5) Liver only disease, n (%) No 15 (88.2) 15 (88.2) 11 (61.1) 14 (82.4) 16 (94.1) 15 (83.3) 86 (82.7) Yes 2 (11.8) 2 (11.8) 7 (38.9) 3 (17.6) 1 (5.9) 3 (16.7) 18 (17.3) Number of organs involved at baseline, n (%) <3 organs 13 (76.5) 9 (52.9) 10 (55.6) 12 (70.6) 11 (64.7) 8 (44.4) 63 (60.6) >=3 organs 4 (23.5) 7 (41.2) 8 (44.4) 5 (29.4) 6 (35.3) 10 (55.6) 40 (38.5) Missing 0 1 (5.9) 0 0 0 0 1 (1.0) Prior adjuvant or neo-adjuvant chemotherapy, n (%) No 13 (76.5) 12 (70.6) 14 (77.8) 12 (70.6) 12 (70.6) 16 (88.9) 79 (76.0) Yes 4 (23.5) 5 (29.4) 4 (22.2) 5 (29.4) 5 (29.4) 2 (11.1) 25 (24.0)

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![Slide 21](crdf-ex99_2s21.jpg)

Safety Population (Dosed) All Control Arms(N=34) Onv 20mg + SoC (N=34) Onv 30mg + SoC(N=36) N (% of total) All Grades Gr >=3 All Grades Gr >=3 All Grades Gr >=3 Any Adverse Events 33 (97.1) 21 (61.8) 34 (100.0) 24 (70.6) 36 (100.0) 28 (77.8) Fatigue 16 (47.1) 2 (5.9) 24 (70.6) 1 (2.9) 21 (58.3) 0 Nausea 17 (50.0) 1 (2.9) 25 (73.5) 0 17 (47.2) 0 Diarrhoea 17 (50.0) 1 (2.9) 19 (55.9) 2 (5.9) 16 (44.4) 0 Neutrophil count decreased 18 (52.9) 11 (32.4) 13 (38.2) 6 (17.6) 17 (47.2) 11 (30.6) Hypertension 7 (20.6) 1 (2.9) 12 (35.3) 4 (11.8) 12 (33.3) 3 (8.3) Vomiting 8 (23.5) 1 (2.9) 13 (38.2) 0 8 (22.2) 0 Constipation 5 (14.7) 1 (2.9) 13 (38.2) 0 10 (27.8) 0 Epistaxis 7 (20.6) 0 11 (32.4) 0 9 (25.0) 0 Peripheral sensory neuropathy 8 (23.5) 0 10 (29.4) 2 (5.9) 9 (25.0) 1 (2.8) Abdominal pain 5 (14.7) 2 (5.9) 10 (29.4) 1 (2.9) 11 (30.6) 1 (2.8) Anaemia 7 (20.6) 1 (2.9) 8 (23.5) 0 11 (30.6) 4 (11.1) Decreased appetite 9 (26.5) 0 11 (32.4) 0 6 (16.7) 0 Platelet count decreased 9 (26.5) 2 (5.9) 8 (23.5) 0 9 (25.0) 1 (2.8) Alopecia 7 (20.6) 0 8 (23.5) 0 8 (22.2) 0 Headache 8 (23.5) 0 10 (29.4) 0 3 (8.3) 0 White blood cell count decreased 10 (29.4) 0 4 (11.8) 0 7 (19.4) 1 (2.8) Dizziness 6 (17.6) 0 7 (20.6) 0 7 (19.4) 0 Dysgeusia 6 (17.6) 0 6 (17.6) 0 8 (22.2) 0 Weight decreased 8 (23.5) 1 (2.9) 4 (11.8) 0 8 (22.2) 0 Hypokalaemia 5 (14.7) 1 (2.9) 6 (17.6) 2 (5.9) 8 (22.2) 3 (8.3) Stomatitis 8 (23.5) 0 8 (23.5) 0 2 (5.6) 0 Insomnia 1 (2.9) 0 9 (26.5) 0 7 (19.4) 0 Paraesthesia 3 (8.8) 0 7 (20.6) 0 6 (16.7) 0 Lymphocyte count decreased 5 (14.7) 0 3 (8.8) 0 7 (19.4) 2 (5.6) Cough 5 (14.7) 0 4 (11.8) 0 5 (13.9) 0 Pyrexia 4 (11.8) 0 6 (17.6) 1 (2.9) 4 (11.1) 1 (2.8) Blood alkaline phosphatase increased 7 (20.6) 0 1 (2.9) 0 4 (11.1) 0 Dyspepsia 2 (5.9) 0 5 (14.7) 0 5 (13.9) 0 Proteinuria 2 (5.9) 0 6 (17.6) 0 4 (11.1) 0 \* Data consists of all adverse events entered into the electronic data capture (EDC) system as of July 8, 2025, from an ongoing trial and unlocked EDC database. N: number of patients; events shown occurred in ≥10% of total patients; numbers indicate number of patients experiencing the event, (regardless of causality); each patient is only counted once and only for the highest grade of a given event. Columns show the absolute # of patients and (%) of the population. Onv, onvansertib; SoC, standard of care CRDF-004 treatment emergent adverse events (TEAE) data\*

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![Slide 22](crdf-ex99_2s22.jpg)

Dose intensity is similar and high across all trial arms Safety Population (Dosed) FOLFIRI/bev(n=17) FOLFIRI/bev/onv 20(n=17) FOLFIRI/bev/onv 30(n=18) FOLFOX/bev(n=17) FOLFOX/bev/onv 20(n=17) FOLFOX/bev/onv 30(n=18) Relative dose intensity (%) Mean (Std) 91.84 (12.8) 90.37 (12.6) 91.39 (9.8) 91.34 (11.0) 93.34 (9.1) 86.89 (15.1) Median 96.93 96.32 93.24 93.24 96.5 91.22 \* Data as of July 8, 2025 from an ongoing trial and unlocked database. Bev, bevacizumab; onv, onvansertib; Std, standard deviation Relative Dose Intensity: actual amount of study drug a patient receives over time compared to the planned dose and schedule\*

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![Slide 23](crdf-ex99_2s23.jpg)

AGENDA 1st line RAS-mut mCRC program update ORR efficacy and safety PFS analyses Registrational program path forward mCRC, metastatic colorectal cancer; mut, mutant; ORR, objective response rate; PFS, progression free survival

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![Slide 24](crdf-ex99_2s24.jpg)

PFS as of July 8, 2025 data cutoff shows initial separation between 30mg onv and control arms \* Progression determined per electronic data capture system as of July 8, 2025 from an ongoing trial and unlocked database. SoC, standard of care; PFS, progression free survival; HR, hazard ratio; CI, confidence interval; onv, onvansertib Progression Free Survival – Median PFS Not Reached\* Onv 30mg + SoC Strata Control arm Onv 20mg + SoC PFS Probability Number at risk Onv 30mg + SoC Control arm Onv 20mg + SoC Hazard Ratio (HR) HR 95% CI Control vs. all onv arms 0.69 0.25, 1.90 Control vs. onv 20mg + SoC Control vs. onv 30mg + SoC 0.89 0.52 0.28, 2.77 0.15,1.83 Median follow up is ~6 months Censored patients: Control (23/29); 20mg onv+SoC (25/31); 30mg onv+SoC (29/33)

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![Slide 25](crdf-ex99_2s25.jpg)

In 1st line mCRC, two response metrics predict PFS and OS Early Depth Tumor Shrinkage (ETS) of Response (DpR) ≥20% reduction in tumor size at 2-month scan Deepest reduction in tumor size while on therapy on trial Proof-of-Principle Meta Analysis Validation Oct, 2013 Feb, 2015 Use of Early Tumor Shrinkage to Predict Long-Term Outcome in mCRC Treated With Cetuximab Piessevaux, et. al. Early Tumor Shrinkage and Depth of Response Predict Long-term Outcome in mCRC Patients Treated with 1st-line Chemo+bev Cremolini, et. al. Apr, 2025 Bando, et. al. Associations Between Early Tumor Shrinkage/Depth of Response and Survival from the ARCAD Database TRIBE FOLFOXIRI+bev vs. FOLFIRI+bev CRYSTALFOLFIRI+cetux.vs FOLFIRI OPUS FOLFOX-4+cetux. vs. FOLFOX-4 8 randomized trials Ph3 TRIAL DATA\* \* First-line mCRC trials in which ETS and/or DpR were evaluated as predictors of PFS and OS comparing a control arm of chemo alone vs. an experimental arm of chemo + an active agent including bevacizumab (TRIBE) and cetuximab (CRYSTAL and OPUS). mCRC, metastatic colorectal cancer; PFS, progression free survival; OS, overall survival; bev, bevacizumab; cetux, cetuximab.

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![Slide 26](crdf-ex99_2s26.jpg)

Greater number of onvansertib 30mg dose patients achieved Early Tumor Shrinkage 1. First-line mCRC trials in which ETS and/or DpR were evaluated as predictors of PFS and OS comparing a control arm of chemo alone vs. an experimental arm of chemo + an active agent including bevacizumab (TRIBE) and cetuximab (CRYSTAL and OPUS). Piessevaux, et al, J Clin Oncol 2013; Cremolini, et al, Ann Oncol 2015; Van Cutsem, et. al, N Engl J Med 2009 (HR for CRYSTAL); Bokemeyer et al, Ann Oncol 2011 (HR for OPUS). ETS, early tumor shrinkage; mCRC, metastatic colorectal cancer; WT, wild type; mut., mutated; PFS, progression free survival; bev, bevacizumab; onv, onvansertib. Control Arm Early Tumor Shrinkage (ETS) ≥20% reduction in tumor size at 2-month scan. Final data: All patients on trial have had a 2-month scan. ETS Delta p-value % of patients with ETS TRIBE CRYSTAL OPUS 63% 62% 69% 13% 23% 11% Hazard Ratio 0.79 0.68 0.57 Improvement in PFS 2.0 mo 4.4 mo 3.7 mo 0.025 0.02 0.006 Experimental Arm 63% 69% 52% 49% 46% 41% 22% 28% 0.114 0.038 (19/30) (22/32) (11/27) Onv 20mg Onv 30mg CRDF-004 Previous Ph3 1st Line mCRC Trials1 RAS WT/mut. RAS WT RAS WT RAS mut.

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![Slide 27](crdf-ex99_2s27.jpg)

Best Response Progressive Disease Stable Disease Partial Response Complete Response Progressive Disease Stable Disease Partial Response Complete Response Scan Response Tumor regression vs. baseline is deeper over time with onv 30mg dose Control Onv20mg Onv30mg Radiographic Response over Time\* Onvansertib 20mg plus SoC Onvansertib 30mg plus SoC SoC Experimental Arms Control Arms Best % Change from Baseline Best Response CR PR PD SD % Change from Baseline \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. SoC, standard of care; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; onv, onvansertib; p, p-value

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![Slide 28](crdf-ex99_2s28.jpg)

Depth of Response is deeper for the onv 30mg dose arm Depth of Response (DpR) Maximum tumor shrinkage at nadir on trial Interim data: Patients on trial may achieve deeper tumor regression Control Arm DpR Delta p-value % Tumor Shrinkage 43% 51% 58% 18% 27% 5% Hazard Ratio 0.79 0.68 0.57 Improvement in PFS 2.0 mo 4.4 mo 3.7 mo Experimental Arm 41% 48% 38% 33% 31% 32% 9% 16% 0.066 0.011 Onv 20mg Onv 30mg TRIBE CRYSTAL OPUS CRDF-004 Previous Ph3 1st Line mCRC Trials1 RAS WT/mut. RAS WT RAS WT RAS mut. 1. First-line mCRC trials in which ETS and/or DpR were evaluated as predictors of PFS and OS comparing a control arm of chemo alone vs. an experimental arm of chemo + an active agent including bevacizumab (TRIBE) and cetuximab (CRYSTAL and OPUS). 1. Cremolini, et al, Ann Oncol 2015; Piessevaux, et al, J Clin Oncol 2013; Mansmann, et al, Ann Oncol 2013 ; Van Cutsem, et. al, N Engl J Med 2009 (HR for CRYSTAL); Bokemeyer et al, Ann Oncol 2011 (HR for OPUS). DpR, depth of response; mCRC, metastatic colorectal cancer; WT, wild type; mut., mutated; PFS, progression free survival; onv, onvansertib.

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![Slide 29](crdf-ex99_2s29.jpg)

AGENDA 1st line RAS-mut mCRC program update ORR efficacy and safety PFS analyses Registrational program path forward mCRC, metastatic colorectal cancer; Mut, mutant; ORR, objective response rate; PFS, progression free survival

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![Slide 30](crdf-ex99_2s30.jpg)

Current CRDF-004 trial data are supportive of a 30mg dose 2024 2025 INTENT 1. Select a Ph3 dose – per FDA's Project Optimus 2. Assess efficacy signal 3. Characterize safety profile in first-line setting 4. Basis for meeting with FDA to agree Ph3 trial 2026 Progress to date Data supports focus on onvansertib 30mg dose CRDF-004 Ph2 trial 1st line RAS-mut mCRC mCRC, metastatic colorectal cancer; mut., mutated

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![Slide 31](crdf-ex99_2s31.jpg)

Dose response observed across ORR, ETS and DpR efficacy signals and may predict longer PFS 2024 2025 INTENT 1. Select a Ph3 dose – per FDA's Project Optimus 2. Assess efficacy signal 3. Characterize safety profile in first-line setting 4. Basis for meeting with FDA to agree Ph3 trial 2026 Progress to date ORR: meaningful deltas in context of 1st line mCRC PFS: early PFS separation and correlative response signals Dose-dependent response CRDF-004 Ph2 trial 1st line RAS-mut mCRC mCRC, metastatic colorectal cancer; mut., mutated; ORR, objective response rate; PFS, progression free survival

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![Slide 32](crdf-ex99_2s32.jpg)

Onvansertib in combination with SoC is generally well-tolerated 2024 2025 INTENT 1. Select a Ph3 dose – per FDA's Project Optimus 2. Assess efficacy signal 3. Characterize safety profile in first-line setting 4. Basis for meeting with FDA to agree Ph3 trial 2026 Progress to date Onvansertib is generally well-tolerated in combination with both chemo backbones and bev CRDF-004 Ph2 trial 1st line RAS-mut mCRC SoC, standard of care; mCRC, metastatic colorectal cancer; mut., mutated; bev, bevacizumab

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![Slide 33](crdf-ex99_2s33.jpg)

We intend to discuss our registrational trial protocol with FDA 2024 2025 INTENT 1. Select a Ph3 dose – per FDA's Project Optimus 2. Assess efficacy signal 3. Characterize safety profile in first-line setting 4. Basis for meeting with FDA to agree Ph3 trial 2026 Seek FDA Agreement for Ph3 CRDF-005registrational protocol 4 Progress to date Totality of data supports moving forward with FDA interactions on the registrational program CRDF-004 Ph2 trial 1st line RAS-mut mCRC mCRC, metastatic colorectal cancer; mut., mutated

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![Slide 34](crdf-ex99_2s34.jpg)

We believe CRDF-004 data positions onvansertib for registrational trial PHASE 2 DOSE-CONFIRMATION TRIAL PHASE 3 REGISTRATIONAL TRIAL 1st line RAS-mutated mCRC clinical development program Agreed with FDA June 2023 Type C meeting Designed for accelerated and full-approval Endpoint for accelerated approval:- ORR with DoR Endpoint for full approval:- PFS / lack of detriment on OS mCRC, metastatic colorectal cancer; ORR, objective response rate; DoR, duration of response; PFS, progression free survival; OS, overall survival

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![Slide 35](crdf-ex99_2s35.jpg)

APPENDIX

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![Slide 36](crdf-ex99_2s36.jpg)

Dec 2024: Initial data showed deeper tumor shrinkage with onvansertib that appeared dose-dependent Radiographic Response over Time\* – as of November 26, 2024 Onvansertib 20mg plus SoC Onvansertib 30mg plus SoC SoC Experimental Arms Control Arms Initial 30 patients data disclosedDec 10, 2024 \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of November 26, 2024 from an ongoing trial and unlocked database. Response data for one control arm patient changed from the November 26, 2024 data cut as a result of the radiologist at the blinded independent central review modifying the target lesions. SoC, standard of care; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease % Change from Baseline Best Response CR PR PD SD

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![Slide 37](crdf-ex99_2s37.jpg)

July 2025: Data for same 30 patients continued to show deeper dose-dependent responses in onvansertib arms Radiographic Response over Time\* – as of July 8, 2025 Initial 30 patients data disclosedJuly 29, 2025 Onvansertib 20mg plus SoC Onvansertib 30mg plus SoC SoC Experimental Arms Control Arms % Change from Baseline \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. SoC, standard of care; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease Best Response CR PR PD SD

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![Slide 38](crdf-ex99_2s38.jpg)

Swimmer Plot for Stable Disease patients still on trial Radiographic Response over Time\* Onv 20mg + SoC Control arms Onv 30mg + SoC Best Response # Stable Disease # indicates % change from baseline > On Treatment Chemotherapy Backbone FOLFIRI FOLFOX \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. Patient 1011-106 in the onvansertib 20mg arm has only non-target lesions. SoC, standard of care; onv, onvansertib

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![Slide 39](crdf-ex99_2s39.jpg)

No baseline characteristic has a significant impact on ORR \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. SoC, standard of care; ECOG, Eastern Cooperative Oncology Group Forest Plot of the Treatment Effect on ORR by Baseline Characteristic\*

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![Slide 40](crdf-ex99_2s40.jpg)

Baseline measures of tumor burden (by sum of longest diameters) \* Radiographic response determined per RECIST 1.1 by blinded independent central review as of July 8, 2025 from an ongoing trial and unlocked database. 1. Kruskal-Wallis rank sum test; Pearson's Chi-squared test; Fisher's exact test. SLD, sum of longest diameters; SoC, standard of care Safety population - Baseline Sum of Longest Dimensions\* (SLD) Characteristic Control Arm (SoC) N = 34 SoC + onvansertib 20 mg N = 34 SoC + onvansertib 30 mg N = 36 p-value1 Baseline sum of longest dimensions: Mean (Min, Max) Median (Q1,Q3) 91 (15, 281) 75 (39,121) 90 (10, 298) 67 (28,134) 83 (16, 270) 74 (43,114) 0.921 Unknown 6 4 3 The mean and median sum of the longest diameters was similar (not significantly different) for control, onvansertib 20mg and onvansertib 30mg arms

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![Slide 41](crdf-ex99_2s41.jpg)

CRDF-004 treatment emergent adverse events (TEAE) data\* \* Data consists of all adverse events entered into the electronic data capture (EDC) system as of July 8, 2025, from an ongoing trial and unlocked EDC database. N: number of patients; events shown occurred in ≥10% of total patients; numbers indicate number of patients experiencing the event, (regardless of causality); each patient is only counted once and only for the highest grade of a given event. Columns show the absolute # of patients and (%) of the population. Bev, bevacizumab; onv, onvansertib Safety Population (Dosed) N (% of total) FOLFIRI/bev (n=17) FOLFIRI/bev/onv 20mg (n=17) FOLFIRI/bev/onv 30mg (n=18) FOLFOX/bev (n=17) FOLFOX/bev/onv 20mg (n=17) FOLFOX/bev/onv 30mg (n=18) All Control Arms(n=34) All Experimental Arms(n=70) All Grades Gr >=3 All Grades Gr >=3 All Grades Gr >=3 All Grades Gr >=3 All Grades Gr >=3 All Grades Gr >=3 All Grades Gr >=3 All Grades Gr >=3 Any Adverse Events 17 (100.0) 12 (70.6) 17 (100.0) 14 (82.4) 18 (100.0) 15 (83.3) 16 (94.1) 9 (52.9) 17 (100.0) 10 (58.8) 18 (100.0) 13 (72.2) 33 (97.1) 21 (61.8) 70 (100.0) 52 (74.3) Fatigue 7 (41.2) 0 12 (70.6) 0 11 (61.1) 0 9 (52.9) 2 (11.8) 12 (70.6) 1 (5.9) 10 (55.6) 0 16 (47.1) 2 (5.9) 45 (64.3) 1 (1.4) Nausea 6 (35.3) 1 (5.9) 13 (76.5) 0 9 (50.0) 0 11 (64.7) 0 12 (70.6) 0 8 (44.4) 0 17 (50.0) 1 (2.9) 42 (60.0) 0 Diarrhea 10 (58.8) 1 (5.9) 12 (70.6) 1 (5.9) 9 (50.0) 0 7 (41.2) 0 7 (41.2) 1 (5.9) 7 (38.9) 0 17 (50.0) 1 (2.9) 35 (50.0) 2 (2.9) Neutrophil count decreased 8 (47.1) 4 (23.5) 4 (23.5) 1 (5.9) 6 (33.3) 3 (16.7) 5 (29.4) 5 (29.4) 6 (35.3) 3 (17.6) 7 (38.9) 4 (22.2) 13 (38.2) 9 (26.5) 23 (32.9) 11 (15.7) Neutropenia 2 (11.8) 1 (5.9) 1 (5.9) 0 4 (22.2) 4 (22.2) 3 (17.6) 1 (5.9) 2 (11.8) 2 (11.8) 0 0 5 (14.7) 2 (5.9) 7 (10.0) 6 (8.6) Hypertension 4 (23.5) 1 (5.9) 8 (47.1) 3 (17.6) 6 (33.3) 1 (5.6) 3 (17.6) 0 4 (23.5) 1 (5.9) 6 (33.3) 2 (11.1) 7 (20.6) 1 (2.9) 24 (34.3) 7 (10.0) Vomiting 5 (29.4) 1 (5.9) 7 (41.2) 0 6 (33.3) 0 3 (17.6) 0 6 (35.3) 0 2 (11.1) 0 8 (23.5) 1 (2.9) 21 (30.0) 0 Constipation 3 (17.6) 1 (5.9) 5 (29.4) 0 5 (27.8) 0 2 (11.8) 0 8 (47.1) 0 5 (27.8) 0 5 (14.7) 1 (2.9) 23 (32.9) 0 Epistaxis 4 (23.5) 0 8 (47.1) 0 6 (33.3) 0 3 (17.6) 0 3 (17.6) 0 3 (16.7) 0 7 (20.6) 0 20 (28.6) 0 Peripheral sensory neuropathy 4 (23.5) 0 2 (11.8) 0 1 (5.6) 0 4 (23.5) 0 8 (47.1) 2 (11.8) 8 (44.4) 1 (5.6) 8 (23.5) 0 19 (27.1) 3 (4.3) Abdominal pain 3 (17.6) 2 (11.8) 4 (23.5) 1 (5.9) 6 (33.3) 1 (5.6) 2 (11.8) 0 6 (35.3) 0 5 (27.8) 0 5 (14.7) 2 (5.9) 21 (30.0) 2 (2.9) Anaemia 4 (23.5) 1 (5.9) 6 (35.3) 0 4 (22.2) 1 (5.6) 3 (17.6) 0 2 (11.8) 0 7 (38.9) 3 (16.7) 7 (20.6) 1 (2.9) 19 (27.1) 4 (5.7) Decreased appetite 6 (35.3) 0 5 (29.4) 0 4 (22.2) 0 3 (17.6) 0 6 (35.3) 0 2 (11.1) 0 9 (26.5) 0 17 (24.3) 0 Platelet count decreased 2 (11.8) 1 (5.9) 1 (5.9) 0 2 (11.1) 0 7 (41.2) 1 (5.9) 7 (41.2) 0 7 (38.9) 1 (5.6) 9 (26.5) 2 (5.9) 17 (24.3) 1 (1.4) Alopecia 5 (29.4) 0 4 (23.5) 0 6 (33.3) 0 2 (11.8) 0 4 (23.5) 0 2 (11.1) 0 7 (20.6) 0 16 (22.9) 0 Headache 4 (23.5) 0 6 (35.3) 0 2 (11.1) 0 4 (23.5) 0 4 (23.5) 0 1 (5.6) 0 8 (23.5) 0 13 (18.6) 0 White blood cell count decreased 4 (23.5) 0 4 (23.5) 0 5 (27.8) 0 6 (35.3) 0 0 0 2 (11.1) 1 (5.6) 10 (29.4) 0 11 (15.7) 1 (1.4) Dizziness 3 (17.6) 0 3 (17.6) 0 2 (11.1) 0 3 (17.6) 0 4 (23.5) 0 5 (27.8) 0 6 (17.6) 0 14 (20.0) 0 Dysgeusia 2 (11.8) 0 1 (5.9) 0 3 (16.7) 0 4 (23.5) 0 5 (29.4) 0 5 (27.8) 0 6 (17.6) 0 14 (20.0) 0 Weight decreased 6 (35.3) 1 (5.9) 2 (11.8) 0 5 (27.8) 0 2 (11.8) 0 2 (11.8) 0 3 (16.7) 0 8 (23.5) 1 (2.9) 12 (17.1) 0 Hypokalaemia 3 (17.6) 0 3 (17.6) 2 (11.8) 4 (22.2) 2 (11.1) 2 (11.8) 1 (5.9) 3 (17.6) 0 4 (22.2) 1 (5.6) 5 (14.7) 1 (2.9) 14 (20.0) 5 (7.1) Stomatitis 3 (17.6) 0 6 (35.3) 0 1 (5.6) 0 5 (29.4) 0 2 (11.8) 0 1 (5.6) 0 8 (23.5) 0 10 (14.3) 0 Insomnia 0 (0.0) 0 4 (23.5) 0 3 (16.7) 0 1 (5.9) 0 5 (29.4) 0 4 (22.2) 0 1 (2.9) 0 16 (22.9) 0 Paraesthesia 1 (5.9) 0 2 (11.8) 0 0 0 2 (11.8) 0 5 (29.4) 0 6 (33.3) 0 3 (8.8) 0 13 (18.6) 0 Lymphocyte count decreased 3 (17.6) 0 2 (11.8) 0 4 (22.2) 0 2 (11.8) 0 1 (5.9) 0 3 (16.7) 2 (11.1) 5 (14.7) 0 10 (14.3) 2 (2.9) Cough 4 (23.5) 0 4 (23.5) 0 2 (11.1) 0 1 (5.9) 0 0 0 3 (16.7) 0 5 (14.7) 0 9 (12.9) 0 Pyrexia 2 (11.8) 0 3 (17.6) 1 (5.9) 3 (16.7) 1 (5.6) 2 (11.8) 0 3 (17.6) 0 1 (5.6) 0 4 (11.8) 0 10 (14.3) 2 (2.9) Blood alkaline phosphatase increased 3 (17.6) 0 1 (5.9) 0 1 (5.6) 0 4 (23.5) 0 0 0 3 (16.7) 0 7 (20.6) 0 5 (7.1) 0 Dyspepsia 1 (5.9) 0 4 (23.5) 0 2 (11.1) 0 1 (5.9) 0 1 (5.9) 0 3 (16.7) 0 2 (5.9) 0 10 (14.3) 0 Proteinuria 2 (11.8) 0 3 (17.6) 0 2 (11.1) 0 0 0 3 (17.6) 0 2 (11.1) 0 2 (5.9) 0 10 (14.3) 0

## Exhibit 99.3

![img188555926_0.jpg](img188555926_0.jpg)

**EMBARGOED FOR 4:07 EST 7/29**

**Cardiff Oncology Announces Positive Data from Ongoing Randomized Phase 2 First-line RAS-mutated mCRC Clinical Trial (CRDF-004)**

*– Trial demonstrates 49% confirmed ORR in the 30mg onvansertib dose arm versus 30% confirmed ORR in the control arm in intent-to-treat population (N=110) –*

*– Early PFS data show a trend favoring 30mg onvansertib dose arm vs. control arm –*

*– Onvansertib continues to be well-tolerated and demonstrates a dose dependent response for all endpoints including ORR, early tumor shrinkage and depth of response –* 

*– Company will hold a conference call today at 4:30 p.m. ET / 1:30 p.m. PT –*

**SAN DIEGO, July 29, 2025** -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced positive data from the ongoing CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Efficacy data represents intent-to-treat patients as of a July 8, 2025 data cut-off, and is determined by blinded, independent central review (BICR) of each patient's tumor scans.

"We are highly encouraged by the 19% improvement in confirmed ORR as well as the shorter time to response and deeper tumor regression observed in our trial with onvansertib combined with SoC compared to SoC alone. Furthermore, early PFS data shows a trend favoring the 30mg dose of onvansertib vs. control," said Roger Sidhu, MD, Chief Medical Officer of Cardiff Oncology. "The totality of the data we are releasing today strengthens the initial findings from our December 2024 data release in a significantly larger patient population, compares favorably to previous practice-changing Phase 3 trials, and demonstrates that onvansertib could be a novel therapy for the treatment of first-line RAS-mutated mCRC."

**Trial Design**

The CRDF-004 phase 2 trial enrolled patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. Patients were randomized to one of six arms including 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response (DOR) and safety. Additional prespecified endpoints include early tumor shrinkage (ETS), defined as a ≥20% reduction in tumor size at the 2-month scan, and depth of response (DpR), defined as the greatest reduction in tumor size achieved while on therapy during the trial. ETS and DpR are well-established predictors for PFS in first-line mCRC as demonstrated in multiple peer-reviewed publications.<sup>1-3</sup>

**Efficacy Data**

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![img188555926_0.jpg](img188555926_0.jpg)

Efficacy data in the intent-to-treat population (ITT) from the CRDF-004 clinical trial, as of the July 8, 2025 data cut-off, are shown below.

---

| | | | |
|:---|:---|:---|:---|
|  | &nbsp;&nbsp;**Control Arm**<br>**(SoC alone)**<br>**(n=37)** | &nbsp;&nbsp;**20mg dose of onvansertib + SoC**<br>**(n=36)** | &nbsp;&nbsp;**30mg dose of onvansertib + SoC**<br>**(n=37)** |
| &nbsp;&nbsp;Confirmed ORR<sup>a</sup> | &nbsp;&nbsp;30%<br>(11 of 37) | &nbsp;&nbsp;42%<br>(15 of 36) | &nbsp;&nbsp;49%<br>(18 of 37) |
| &nbsp;&nbsp;Confirmed ORR at <br>6-months<sup>a</sup> | &nbsp;&nbsp;22%<br>(8 of 37) | &nbsp;&nbsp;33%<br>(12 of 36) | &nbsp;&nbsp;46%<br>(17 of 37) |
| &nbsp;&nbsp;ORR<sup>b</sup> | &nbsp;&nbsp;43%<br>(16 of 37) | &nbsp;&nbsp;50%<br>(18 of 36) | &nbsp;&nbsp;59%<br>(22 of 37) |

---

<sup>a</sup>Confirmed Objective Response Rate (ORR) per RECIST v1.1 includes those patients who had a complete response (CR) or partial response (PR) confirmed by repeat imaging ≥4 weeks after response criteria first met. <sup>b</sup>ORR per RECIST v1.1 includes confirmed CRs/PRs and unconfirmed PRs who were still on treatment and may yet be confirmed

Spider Plots, displaying the change in tumor size from baseline for each patient over time, demonstrate deeper responses in patients receiving the 30mg dose of onvansertib in combination with the SoC compared to both the control arm and 20mg dose of onvansertib arm.

![img188555926_1.jpg](img188555926_1.jpg)

Note: Radiographic response was determined per RECIST 1.1 by blinded independent central review. Spider plot reflects data as of July 8, 2025 from an ongoing trial and unlocked database.

**Progression-free Survival (PFS) Data**

Both the 20mg and 30mg onvansertib arms demonstrated an early separation of the PFS curves compared to the control arm at a median follow up time of 6 months. While the median PFS has not been reached, there was a dose dependent effect in favor of the 30mg onvansertib dose.

**Safety and Tolerability**

The safety analysis was conducted for the 104 patients who were dosed in the trial. Onvansertib in combination with chemo/bevacizumab was well-tolerated and there were no major or unexpected toxicities observed. Grade 3 or higher adverse events were infrequent, with

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![img188555926_0.jpg](img188555926_0.jpg)

neutropenia being the most common treatment-emergent adverse event associated with onvansertib.

"We are highly encouraged by the strength of our data which achieves the key objectives we set for the trial, and positions us to engage in discussions with the FDA as we advance toward our registrational CRDF-005 trial," said Mark Erlander, Chief Executive Officer of Cardiff Oncology. "Looking ahead, we are optimistic about onvansertib's potential to redefine the first-line treatment for RAS-mutated mCRC and will provide an update on our first-line mCRC program by Q1 2026."

**Upcoming expected milestones**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;•Update on first-line mCRC program expected by 1Q 2026

**Conference Call and Webcast**

Cardiff Oncology will host a conference call and live webcast at 4:30 p.m. ET / 1:30 p.m. PT on July 29, 2025. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Events" section of the company's website. A webcast replay will be available in the investor relations section on the company's website following the completion of the call.

**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 and planned 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.

**References**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.Cremolini, et al. Early tumor shrinkage and depth of response predict long-term outcome in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab: results from phase III TRIBE trial by the Gruppo Oncologico del Nord Ovest. *Ann Oncol*. 2015;26(6):1188–1194. doi: 10.1093/annonc/mdv112

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2.Piessevaux, et al. Use of early tumor shrinkage to predict long-term outcome in metastatic colorectal cancer treated with cetuximab. *J Clin Oncol*. 2013 Oct 20;31(30):3764-75. doi: 10.1200/JCO.2012.42.8532

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![img188555926_0.jpg](img188555926_0.jpg)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3.Bando H, et al. Associations between early tumor shrinkage/depth of response and survival from the ARCAD database. JNCI Cancer Spectr. 2025 Apr 30;9(3):pkaf042. doi: 10.1093/jncics/pkaf042

**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<br>jlevine@cardiffoncology.com

**Investor Contact:**

Kiki Patel, PharmD

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![img188555926_0.jpg](img188555926_0.jpg)

Gilmartin Group

332-895-3225<br>Kiki@gilmartinir.com

**Media Contact:**

Meghan Bianco

Taft Communications, a division of RF\|Binder

609-544-5446

meghan.bianco@rfbinder.com

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### Attached PDF Documents

**Attachment 1:** `crdf-ex99_2.pdf`

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