Onvansertib Phase 2 results and 2025 loss at Cardiff Oncology (NASDAQ: CRDF)

Rhea-AI Filing Summary

Cardiff Oncology reported full-year 2025 results and highlighted strong Phase 2 data for onvansertib in first-line RAS-mutated metastatic colorectal cancer. In the CRDF-004 trial, the 30 mg onvansertib + FOLFIRI/bevacizumab arm achieved a confirmed objective response rate of 72.2%, versus 43.2% across combined standard-of-care arms, and showed significantly longer progression-free survival (hazard ratio 0.37, p<0.05).

The company plans to advance the 30 mg dose with FOLFIRI/bevacizumab into a planned registrational program, with detailed data and registrational plans expected in the first half of 2026 after FDA discussions. Leadership was realigned for late-stage development, including appointing Mani Mohindru as interim CEO.

Financially, 2025 royalty revenue was $593,000 and total operating expenses were $49.6 million. Net loss attributable to common stockholders was $45.9 million, or $0.69 per share, with weighted-average shares outstanding of 66.8 million. Cash, cash equivalents and short-term investments totaled $58.3 million as of December 31, 2025, which the company believes will fund operations into the first quarter of 2027.

Insights

Biotech and earnings analyst

Promising Phase 2 efficacy, but finances still reflect a loss-making clinical-stage profile.

Cardiff Oncology reported compelling Phase 2 data for onvansertib in first-line RAS-mutated mCRC, with a 72.2% objective response rate for 30 mg onvansertib + FOLFIRI/bevacizumab versus 43.2% for combined standard of care and a progression-free survival hazard ratio of 0.37 (p<0.05). These results underpin plans for a registrational program, pending FDA discussions.

On the financial side, 2025 royalty revenue was modest at $593,000, while total operating expenses reached $49.6 million, leading to a net loss attributable to common stockholders of $45.9 million or $0.69 per share. Cash, cash equivalents and short-term investments were $58.3 million as of December 31, 2025, which management believes supports operations into the first quarter of 2027.

The investment case hinges on whether the Phase 2 performance of onvansertib translates into successful registrational outcomes in first-line RAS-mutated mCRC. Subsequent disclosures around detailed CRDF-004 data and the final registrational trial design, expected in the first half of 2026, will be important to understand risk, required sample size and potential timelines through late-stage development.

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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): February 24, 2026

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 February 24, 2026, Cardiff Oncology, Inc. (the "Company") issued a press release announcing financial results for the full year ended December 31, 2025 and a business update. 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 February 24, 2026

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:	February 24, 2026	By:	/s/ Mani Mohindru
			Mani Mohindru Interim Chief Executive Officer

Cardiff Oncology Reports Full Year 2025 Results and Provides Business Update

Reported positive update from Phase 2 CRDF-004 trial in first-line RAS-mutated mCRC, with the 30 mg onvansertib + FOLFIRI/bev arm demonstrating:

•Robust ORR of 72.2% (vs 43.2% with combined SoC of FOLFOX/bev and FOLFIRI/bev)

•Significant improvement in PFS over combined SoC (HR: 0.37, p<0.05)

Data support selection of 30 mg onvansertib dose in combination with FOLFIRI/bev for planned registrational program; detailed data and registrational plans expected in the first half of 2026

SAN DIEGO, CA – Feb 24, 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 financial results for the full year ended December 31, 2025, and provided a business update.

“Cardiff Oncology has entered 2026 with strong clinical momentum and a clear path for advancing onvansertib, our lead program, in first-line RAS-mutated metastatic colorectal cancer,” said Mani Mohindru, PhD, interim Chief Executive Officer. “Our focus in 2025 was on rigorous clinical execution, which allowed us to generate increasingly compelling evidence supporting onvansertib’s potential to improve patient outcomes in RAS-mutated mCRC, culminating in the latest positive data cut announced earlier this year. The CRDF-004 trial demonstrated a consistent, dose-dependent treatment benefit when onvansertib was added to FOLFIRI/bev, including a near 30% improvement in response rate over the control arm and encouraging durability trends as measured by progression-free survival. These data are in line with what we had previously seen in our second-line trial in bev-naive patients treated with onvansertib + FOLFIRI/bev. Given that it has been over two decades since there has been meaningful innovation for this patient population, we believe these results represent a transformative step forward.”

Continued Dr. Mohindru, “Based on these results, we plan to advance the 30 mg dose of onvansertib with FOLFIRI/bev into our proposed registrational program and expect to provide detailed data and registrational plans after discussions with the FDA in the first half of 2026. As we transition into late-stage clinical development and continue to strengthen our leadership and operational teams, we remain focused on disciplined execution, progressing our lead program toward a potential new standard of care in first-line RAS-mutated mCRC.”

Company highlights for the quarter ended December 31, 2025, and subsequent weeks

Positive update from randomized Phase 2 CRDF-004 trial in first-line RAS-mutated metastatic colorectal cancer (“mCRC”) support advancement of the onvansertib program into registrational development

•In January 2026, Cardiff reported a positive update from CRDF-004, a randomized Phase 2 trial evaluating onvansertib in combination with standard of care (“SoC”) regimens in patients with first-line RAS-mutated mCRC. As of the January 22, 2026 cutoff in the intent-to-treat population, the 30 mg onvansertib + FOLFIRI/bev arm achieved a confirmed objective response rate (“ORR”) of 72.2%, compared to 43.2% across the combined SoC arms. The 30 mg onvansertib dose in combination with FOLFIRI/bev also demonstrated marked improvement in progression-free survival (“PFS”) versus FOLFIRI/bev (HR: 0.38) and combined SoC of FOLFOX/bev and FOLFIRI/bev (HR: 0.37, p<0.05), with no significant added toxicity observed.

•Based on these results, the Company expects to advance the 30 mg dose of onvansertib in combination with FOLFIRI/bev into planned registrational development. Cardiff expects to share detailed Phase 2

CRDF-004 data and, after discussions with the FDA, provide registrational plans for onvansertib in combination with FOLFIRI/bev in first-line RAS-mutated mCRC in the first half of 2026.

Executive leadership team transitioned to support late-stage development

•In January 2026, Cardiff announced executive leadership changes to support the Company’s transition into late-stage clinical development and advancement toward key clinical and corporate milestones. Mani Mohindru, PhD, a member of Cardiff’s Board of Directors since 2021 and an experienced biotechnology executive, was appointed interim Chief Executive Officer. Brigitte Lindsay was promoted to Chief Accounting Officer, ensuring continuity within the Company’s finance function. The Company has initiated a search for a permanent Chief Executive Officer and Chief Financial Officer.

Presentation of investigator-sponsored clinical data in chronic myelomonocytic leukemia (“CMML”) at the American Society of Hematology (“ASH”) Annual Meeting

•In December 2025, clinical data from an investigator-sponsored Phase 1 trial evaluating onvansertib monotherapy in CMML were presented at ASH 2025. In the dose-escalation trial (N=9), onvansertib was generally well-tolerated and demonstrated preliminary efficacy in approximately 40% of patients, including one patient achieving an optimal bone marrow response. These clinical findings further validate onvansertib’s potential activity across both hematologic and solid tumors.

Full Year 2025 Financial Results

Liquidity and Cash Runway

As of December 31, 2025, Cardiff Oncology had approximately $58.3 million in cash, cash equivalents, and short-term investments. Based on its current operating and clinical plans and projected expenditures, the Company believes that its existing cash resources are sufficient to fund operations into the first quarter of 2027.

Operating Results

Total operating expenses for the year ended December 31, 2025 were approximately $49.6 million, compared to $49.3 million for the year ended December 31, 2024. The $0.3 million increase was primarily attributable to an increase in SG&A expense, driven mainly by strategic advisory services and incremental employee separation costs recorded in the current period. This increase was partially offset by lower R&D expenses related to clinical trial activity and outside services. The reduction in R&D expenses was partially offset by an increase in stock-based compensation expense during the current period.

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

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

Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not

limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including 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, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact: Candice Masse astr partners

candice.masse@astrpartners.com

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

Cardiff Oncology, Inc.

Condensed Statements of Operations

(in thousands, except for per share amounts)

		Year Ended December 31,
		2025				2024
Royalty revenues		$	593			$	683
Costs and expenses:
Research and development			35,329				36,852
Selling, general and administrative			14,224				12,482
Total operating expenses			49,553				49,334
Loss from operations			(48,960	)			(48,651	)
Other income (expense), net:
Interest income			3,104				3,259
Other income (expense), net			5				(39	)
Total other income (expense), net			3,109				3,220
Net loss			(45,851	)			(45,431	)
Preferred stock dividend			(25	)			(24	)
Net loss attributable to common stockholders		$	(45,876	)		$	(45,455	)
Net loss per common share — basic and diluted		$	(0.69	)		$	(0.95	)
Weighted-average shares outstanding — basic    and diluted			66,841				47,650

Cardiff Oncology, Inc.

Condensed Balance Sheets

(in thousands)

		December 31, 2025				December 31, 2024
Assets
Current assets:
Cash and cash equivalents		$	17,470			$	51,470
Short-term investments			40,834				40,276
Accounts receivable and unbilled receivable			182				773
Prepaid expenses and other current assets			1,642				2,535
Total current assets			60,128				95,054
Property and equipment, net			578				898
Operating lease right-of-use assets			629				1,169
Other assets			549				69
Total Assets		$	61,884			$	97,190
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	8,087			$	4,821
Accrued liabilities			7,577				7,897
Operating lease liabilities			730				710
Total current liabilities			16,394				13,428
Operating lease liabilities, net of current portion			102				813
Total Liabilities			16,496				14,241
Stockholders’ equity			45,388				82,949
Total liabilities and stockholders’ equity		$	61,884			$	97,190

FAQ

How did Cardiff Oncology (CRDF) perform financially in full-year 2025?

Cardiff Oncology reported 2025 royalty revenue of $593,000 and total operating expenses of $49.6 million. Net loss attributable to common stockholders was $45.9 million, or $0.69 per share, reflecting continued investment in clinical development rather than commercial operations.

What were the key Phase 2 CRDF-004 trial results for onvansertib reported by Cardiff Oncology?

The 30 mg onvansertib plus FOLFIRI/bevacizumab arm achieved a confirmed objective response rate of 72.2% versus 43.2% for combined standard-of-care arms. Progression-free survival also improved, with a hazard ratio of 0.37 versus combined standard of care and p<0.05, suggesting a meaningful efficacy signal.

What are Cardiff Oncology’s next steps for onvansertib in RAS-mutated metastatic colorectal cancer?

Cardiff Oncology plans to advance the 30 mg onvansertib dose with FOLFIRI/bevacizumab into a planned registrational development program. The company expects to share detailed Phase 2 CRDF-004 data and, after FDA discussions, outline its registrational plans in the first half of 2026.

How much cash runway does Cardiff Oncology (CRDF) report as of December 31, 2025?

As of December 31, 2025, Cardiff Oncology held about $58.3 million in cash, cash equivalents, and short-term investments. Based on current operating and clinical plans, management believes this cash balance will fund operations into the first quarter of 2027.

What leadership changes did Cardiff Oncology make to support late-stage development?

In January 2026, Cardiff Oncology appointed Mani Mohindru, PhD as interim Chief Executive Officer and promoted Brigitte Lindsay to Chief Accounting Officer. The company also began searches for a permanent CEO and CFO to support its move into late-stage clinical development.

How did Cardiff Oncology’s 2025 net loss compare with 2024?

Cardiff Oncology’s 2025 net loss attributable to common stockholders was $45.9 million, compared with $45.5 million in 2024. Operating expenses rose slightly to $49.6 million, driven mainly by higher selling, general and administrative spending and stock-based compensation, partly offset by lower R&D expenses.

What other clinical data on onvansertib were highlighted besides mCRC?

Investigator-sponsored Phase 1 data in chronic myelomonocytic leukemia (CMML) were presented, where onvansertib monotherapy in nine patients was generally well-tolerated and showed preliminary efficacy in about 40% of patients, including one optimal bone marrow response, supporting potential activity in hematologic malignancies.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 189.0 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 23.3 KB