CRDF

EX-99.1

2 crdf-ex99_1.htm

EX-99.1

EX-99.1

Cardiff Oncology Reports Second Quarter 2026 Results and Provides Business Update

Positive Phase 2 CRDF-004 data presented in an oral session at ASCO support advancement of 30 mg onvansertib plus FOLFIRI/bevacizumab into planned registrational program for first-line RAS-mutated mCRC

Following successful End-of-Phase 2 meeting with FDA, Company aligned on key elements of registrational trial; plans to initiate study in Q1 2027, subject to securing additional financing

Completed $10 million Registered Direct offering, extending cash runway

SAN DIEGO, Calif., August 11, 2026 — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced financial results for the second quarter ended June 30, 2026, and provided a business update.

“The second quarter was an important period of progress for Cardiff, highlighted by the presentation of positive Phase 2 data at ASCO and our continued progress in preparation for a planned registrational trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. “The updated CRDF-004 results reinforced our confidence in the selected registrational dose and regimen of 30 mg onvansertib in combination with FOLFIRI/bevacizumab. This regimen has demonstrated deep and durable tumor shrinkage over time, reflecting the synergistic mechanisms of action, while maintaining a well-tolerated safety profile with no overlapping or new toxicities when added to standard-of-care therapy.”

Dr. Mohindru continued, “Following our successful End-of-Phase 2 meeting with the FDA, we are preparing to initiate the planned Phase 3 trial in the first quarter of 2027, subject to securing additional financing. We believe the totality of data generated to date strengthens onvansertib’s potential to become an important new treatment option for patients with first-line RAS-mutated metastatic colorectal cancer, an area where there remains significant unmet need.”

Clinical and Regulatory Highlights

Presented Positive Results from Randomized, Controlled Phase 2 CRDF-004 Trial at the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting

In June, Cardiff presented positive results from CRDF-004, its ongoing, randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (“SoC”) regimens in patients with first-line RAS-mutated metastatic colorectal cancer (“mCRC”), in a rapid oral presentation at the 2026 ASCO Annual Meeting.

The trial achieved its primary goal of selecting the efficacious and safe dose of onvansertib plus SoC regimen for the registrational program. The selected regimen, 30 mg onvansertib in combination with FOLFIRI/bevacizumab (“bev”), demonstrated deep and durable tumor shrinkage, including clinically

meaningful improvements in confirmed objective response rate (“ORR”) and progression-free survival (“PFS”) compared to SoC alone, with no additive adverse events observed. Data highlights from the ongoing Phase 2 trial, based on a March 18, 2026 data cut, are listed below, with the full press release available here:

• The 30 mg onvansertib plus FOLFIRI/bev arm achieved a confirmed ORR of 72.2% compared to 42.1% for FOLFIRI/bev alone, a 30% ORR improvement over SoC. The responses were deeper and more durable in the onvansertib arm.

• Secondary endpoint of PFS hazard ratio ("HR") of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) for patients treated with 30 mg onvansertib plus FOLFIRI/bev vs. FOLFIRI/bev by Blinded Independent Central Review ("BICR") and investigator assessment ("IA"), respectively.

• Four patients remained on onvansertib treatment beyond 15 months, including two patients beyond 20 months.

• Onvansertib in combination with SoC regimens continued to be well-tolerated, with no major or unexpected toxicities and no additive adverse events observed.

The Phase 2 trial is still ongoing and as of a June 23, 2026 data cut, 12 patients remain on trial, with 8 patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC.

Completed Successful End-of-Phase 2 (“EoP2”) Meeting with FDA and Advanced Phase 3 Readiness Activities

• Following completion of a successful EoP2 meeting, Cardiff aligned with the FDA on key design elements for its planned registrational Phase 3 trial of onvansertib in first-line RAS-mutated mCRC.

• The planned randomized, controlled Phase 3 trial is expected to evaluate 30 mg onvansertib in combination with FOLFIRI/bev compared to SoC FOLFIRI/bev as first-line therapy in patients with RAS-mutated mCRC. Cardiff is preparing to initiate the trial in the first quarter of 2027, subject to securing additional financing.

Preclinical Highlights

Presented New Preclinical Data at the 2026 American Association for Cancer R

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8-K

0001213037false00012130372025-11-062025-11-06

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

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

Date of Report (Date of earliest event reported): November 06, 2025

Cardiff Oncology, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-35558

27-2004382

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer 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

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

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:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

CRDF

The Nasdaq Stock Market LLC

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. ☐

Item 2.02 Results of Operations and Financial Condition. On November 6, 2025, Cardiff Oncology, Inc. (the "Company") issued a press release announcing company highlights and financial results for the third quarter ended September 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

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

99.1

Press Release of Cardiff Oncology, Inc. dated November 6, 2025

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.

CARDIFF ONCOLOGY, INC.

Date:

November 6, 2025

By:

/s/ Mark Erlander

Mark Erlander

Chief Executive Officer