Cardiff Oncology Inc.

02/24/2026 | Press release | Distributed by Public on 02/24/2026 16:08

Annual Report for Fiscal Year Ending December 31, 2025 (Form 10-K)

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Company Overview

We are a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with the greatest unmet medical need. Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard-of-care ("SoC") therapeutics. We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), metastatic triple negative breast cancer ("mTNBC") and Chronic Myelomonocytic Leukemia ("CMML"). Our clinical development programs incorporate tumor genomics and biomarker assays to refine patient selection and assessment of patient response to treatment. Our common stock is listed on the Nasdaq Capital Market under the ticker symbol "CRDF".

Our accumulated deficit through December 31, 2025 is $430.0 million. To date, we have generated minimal revenues, unrelated to onvansertib, and expect to incur additional losses to perform further research and development activities.

Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drug. The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses, and competing technologies being developed by organizations with significantly greater resources.

Recent Developments

Appointment of Interim Chief Executive Officer and Chief Accounting Officer

On January 27, 2026, we announced that Mani Mohindru, PhD, a member of Cardiff Oncology's Board of Directors since 2021 and a seasoned biotech executive, has been appointed interim Chief Executive Officer, effective immediately. Mark Erlander, PhD, Chief Executive Officer, and James Levine, Chief Financial Officer, have stepped down from their respective roles.

As part of this transition, Brigitte Lindsay was promoted to the role of Chief Accounting Officer, ensuring continuity within the finance function.

Critical Accounting Policies and Estimates

Our accounting policies are described in Part II, Item 8. Financial Statements-Note 2 Basis of Presentation and Summary of Significant Accounting Policiesin this Annual Report on Form 10-K. The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. We believe that the following discussion represents our critical accounting policies and estimates.

Accrued Clinical Trial Expenses

We accrue and expense research and development expenditures as incurred, which include costs related to clinical trial activities. We accrue costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by the Clinical Research Organizations ("CROs"), professional service providers, and other vendors providing clinical trial services (collectively, the "service providers"). We consider several elements including the key terms of the clinical trial agreements, budgets, contract amendments, and the progress of clinical trials toward completion (which includes consideration of patient

enrollment) in estimating the clinical trial accrual. We accrue costs based on estimated work completed in accordance with agreements established with our service providers. We determine the estimated costs through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Due to the nature of estimates, we cannot assure you that we will not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical trial activities.

Results of Operations

Years Ended December 31, 2025 and 2024

Revenues

Total revenues were $0.6 million for the year ended December 31, 2025, as compared to $0.7 million for the same period in 2024. Revenues are from our sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib. Revenue recognition of the royalty depends on the timing and overall sales activities of the licensees.

Research and Development Expenses

Research and development expenses consisted of the following:

Year Ended December 31,

(in thousands)

2025

2024

Increase
(Decrease)

Salaries and staff costs

$

7,131

$

6,903

$

228

Stock-based compensation

2,376

1,660

716

Clinical trials, outside services, and lab supplies

23,954

26,472

(2,518

)

Facilities and other

1,868

1,817

51

Total research and development

$

35,329

$

36,852

$

(1,523

)

Research and development expenses decreased by $1.5 million for the year ended December 31, 2025, compared to the same period in 2024. The overall decrease in expenses was primarily due to a reduction in clinical trial expenses and a decrease in preclinical activities. The increase in stock based compensation was due to new stock option grants during the current period.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consisted of the following:

Year Ended December 31,

(in thousands)

2025

2024

Increase
(Decrease)

Salaries and staff costs

$

3,973

$

3,286

$

687

Stock-based compensation

3,317

3,100

217

Outside services and professional fees

5,262

4,369

893

Facilities and other

1,672

1,727

(55

)

Total selling, general and administrative

$

14,224

$

12,482

$

1,742

Selling, general and administrative expenses increased by $1.7 million for the year ended December 31, 2025, compared to the same period in 2024. The overall increase in expenses was primarily within professional fees and was primarily from strategic advisory services utilized during the current period and an increase in patent fees. Salaries and staff costs increased due to employee severance agreements which were expensed during the current period.

Interest Income

Interest income was $3.1 million for the year ended December 31, 2025 as compared to $3.3 million for the same period of 2024. Our interest income is primarily from our short-term investment portfolios and money market accounts. The amount of interest income earned varies each period based on the balance of our accounts and interest rates.

Liquidity and Capital Resources

As of December 31, 2025, and December 31, 2024, we had working capital of $43.7 million and $81.6 million, respectively.

We have incurred net losses since our inception and have negative operating cash flows. As of December 31, 2025, we had $58.3 million in cash, cash equivalents and short-term investments. Based on our current projections, we expect that our capital resources are sufficient to fund our operations into the first quarter of 2027, which is not sufficient to meet our funding requirements for at least the next 12 months following the issuance of our financial statements. Management has performed an analysis and concluded that there exists a substantial doubt about the Company's ability to continue as a going concern, see Note 1 Business Overview and Liquidityto the financial statements for additional details.

Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drug candidates. The risk of completion of any program is high because of the many uncertainties involved in developing new drug candidates to market, including the long duration of clinical testing, the specific performance of proposed products under stringent clinical trial protocols, extended regulatory approval and review cycles, our ability to raise additional capital, the nature and timing of research and development expenses, and competing technologies being developed by organizations with significantly greater resources.

For the foreseeable future, we expect to continue to incur losses and require additional capital to further advance our clinical trial programs and support our other operations. We cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience additional dilution.

Cash Flow Summary

Year Ended December 31,

(in thousands)

2025

2024

Net cash used in operating activities

$

(37,923

)

$

(37,693

)

Net cash provided by investing activities

1,342

13,728

Net cash provided by financing activities

2,581

53,780

Net change in cash and cash equivalents

$

(34,000

)

$

29,815

Operating Activities

Net cash used in operating activities for the year ended December 31, 2025, was $37.9 million. Our primary use of cash was from our net loss of $45.9 million, adjusted for non-cash items of $5.7 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $2.2 million.

Net cash used in operating activities for the year ended December 31, 2024, was $37.7 million. Our primary use of cash was from our net loss of $45.4 million, adjusted for non-cash items of $5.1 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $2.6 million.

Investing Activities

Net cash provided by investing activities for the year ended December 31, 2025, was $1.3 million, primarily related to maturities and sales in excess of purchases of marketable securities.

Net cash provided by investing activities for the year ended December 31, 2024, was $13.7 million, primarily related to maturities and sales in excess of purchases of marketable securities.

Financing Activities

Net cash provided by financing activities for the year ended December 31, 2025, was $2.6 million, from the exercise of warrants and employee stock options exercises.

Net cash provided by financing activities for the year ended December 31, 2024, was $53.8 million from the net proceeds from the sale of common stock.

Cardiff Oncology Inc. published this content on February 24, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on February 24, 2026 at 22:08 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]