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    SEC Form 10-Q filed by Cardiff Oncology Inc.

    5/14/26 4:00:37 PM ET
    $CRDF
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $CRDF alert in real time by email
    10-Q
    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    Table of Contents

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

    Form 10-Q

     

    (Mark One)

     

    ☒

    QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

     

    For the quarterly period ended March 31, 2026

    ☐

    TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

    For the transition period from to

    COMMISSION FILE NUMBER 001-35558

    CARDIFF ONCOLOGY, INC.

    (Exact Name of registrant as specified in its charter)

     

    Delaware

     

    27-2004382

    (State or other jurisdiction of incorporation or organization)

     

    (I.R.S. Employer Identification No.)

     

     

     

    11055 Flintkote Avenue, San Diego, California

     

    92121

    (Address of principal executive offices)

     

    (Zip Code)

     

     

     

    (858) 952-7570

    (Registrant’s telephone number, including area code)

     

    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 issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

     

    Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐

     

    Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

     

    Large accelerated filer ☐

     

    Accelerated filer ☐

     

    Non-accelerated filer ☒

     

     

    Smaller reporting company ☒

     

    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. ☐

     

    Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

     

    As of May 7, 2026, the issuer had 68,369,896 shares of Common Stock issued and outstanding.

     

     

     

     


    Table of Contents

    CARDIFF ONCOLOGY, INC.

    Table of Contents

     

     

     

    Page

    PART I

    FINANCIAL INFORMATION

    3

     

     

     

    Item 1.

    Financial Statements (unaudited)

    3

     

     

     

     

    Condensed Balance Sheets

    3

     

     

     

     

    Condensed Statements of Operations

    4

     

     

     

     

    Condensed Statements of Comprehensive Loss

    5

     

     

     

     

    Condensed Statements of Stockholders’ Equity

    6

     

     

     

     

    Condensed Statements of Cash Flows

    8

     

     

     

     

    Notes to Condensed Financial Statements

    9

     

     

     

    Item 2.

    Management’s Discussion and Analysis of Financial Condition and Results of Operations

    16

     

     

     

    Item 3.

    Quantitative and Qualitative Disclosures About Market Risk

    21

     

     

     

    Item 4.

    Controls and Procedures

    21

     

     

     

    PART II

    OTHER INFORMATION

    23

     

     

     

    Item 1.

    Legal Proceedings

    23

     

     

     

    Item 1A.

    Risk Factors

    23

     

     

     

    Item 2.

    Unregistered Sales of Equity Securities and Use of Proceeds

    23

     

     

     

    Item 3.

    Defaults Upon Senior Securities

    23

     

     

     

    Item 4.

    Mine Safety Disclosures

    23

     

     

     

    Item 5.

    Other Information

    23

     

     

     

    Item 6.

    Exhibits

    23

     

     

     

    SIGNATURES

    24

     

    2


    Table of Contents

    PART I. FINANCIAL INFORMATION

    ITEM 1. FINANCIAL STATEMENTS

    CARDIFF ONCOLOGY, INC.

    CONDENSED BALANCE SHEETS

    (in thousands, except par value)

    (Unaudited)

     

     

    March 31,
    2026

     

     

    December 31,
    2025

     

    Assets

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    8,544

     

     

    $

    17,470

     

    Short-term investments

     

     

    37,512

     

     

     

    40,834

     

    Accounts receivable and unbilled receivable

     

     

    191

     

     

     

    182

     

    Prepaid expenses and other current assets

     

     

    1,095

     

     

     

    1,642

     

    Total current assets

     

     

    47,342

     

     

     

    60,128

     

    Property and equipment, net

     

     

    491

     

     

     

    578

     

    Operating lease right-of-use assets

     

     

    495

     

     

     

    629

     

    Other assets

     

     

    844

     

     

     

    549

     

    Total Assets

     

    $

    49,172

     

     

    $

    61,884

     

     

     

     

     

     

     

     

    Liabilities and Stockholders’ Equity

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

    $

    5,480

     

     

    $

    8,087

     

    Accrued liabilities

     

     

    8,337

     

     

     

    7,577

     

    Operating lease liabilities

     

     

    646

     

     

     

    730

     

    Total current liabilities

     

     

    14,463

     

     

     

    16,394

     

    Operating lease liabilities, net of current portion

     

     

    —

     

     

     

    102

     

    Total Liabilities

     

     

    14,463

     

     

     

    16,496

     

     

     

     

     

     

     

    Commitments and contingencies (Note 6)

     

     

     

     

     

     

     

     

     

     

     

     

    Stockholders’ equity:

     

     

     

     

     

     

    Preferred stock, $0.001 par value, 20,000 shares
       authorized;
    277 designated as Series A Convertible Preferred Stock;
       
    61 shares outstanding at March 31, 2026 and December 31, 2025
       with liquidation preference of $
    1,123 and $1,117 at
       March 31, 2026 and December 31, 2025, respectively

     

     

    —

     

     

     

    —

     

    Common stock, $0.0001 par value, 150,000 shares authorized; 68,370 and
       
    68,305 shares issued and outstanding at March 31, 2026
       and December 31, 2025, respectively

     

     

    7

     

     

     

    7

     

    Additional paid-in capital

     

     

    477,126

     

     

     

    475,361

     

    Accumulated other comprehensive gain (loss)

     

     

    (49

    )

     

     

    50

     

    Accumulated deficit

     

     

    (442,375

    )

     

     

    (430,030

    )

    Total stockholders’ equity

     

     

    34,709

     

     

     

    45,388

     

    Total liabilities and stockholders’ equity

     

    $

    49,172

     

     

    $

    61,884

     

     

    See accompanying notes to the unaudited condensed financial statements.

    3


    Table of Contents

    CARDIFF ONCOLOGY, INC.

    CONDENSED STATEMENTS OF OPERATIONS

    (in thousands, except per share amounts)

    (Unaudited)

     

     

    Three Months Ended March 31,

     

     

    2026

     

     

    2025

     

    Royalty revenues

     

    $

    41

     

     

    $

    109

     

    Costs and expenses:

     

     

     

     

     

     

    Research and development

     

     

    6,765

     

     

     

    10,477

     

    Selling, general and administrative

     

     

    6,126

     

     

     

    4,014

     

    Total operating expenses

     

     

    12,891

     

     

     

    14,491

     

     

     

     

     

     

     

    Loss from operations

     

     

    (12,850

    )

     

     

    (14,382

    )

     

     

     

     

     

     

    Other income (expense), net:

     

     

     

     

     

     

    Interest income

     

     

    506

     

     

     

    941

     

    Other income (expense), net

     

     

    (1

    )

     

     

    7

     

    Total other income (expense), net

     

     

    505

     

     

     

    948

     

     

     

     

     

     

     

    Net loss

     

     

    (12,345

    )

     

     

    (13,434

    )

     

     

     

     

     

     

    Preferred stock dividend payable on Series A
       Convertible Preferred Stock

     

     

    (6

    )

     

     

    (6

    )

     

     

     

     

     

     

    Net loss attributable to common stockholders

     

    $

    (12,351

    )

     

    $

    (13,440

    )

     

     

     

     

     

     

    Net loss per common share — basic and diluted

     

    $

    (0.18

    )

     

    $

    (0.20

    )

     

     

     

     

     

     

    Weighted-average shares outstanding — basic
       and diluted

     

     

    68,350

     

     

     

    66,524

     

     

    See accompanying notes to the unaudited condensed financial statements.

    4


    Table of Contents

     

    CARDIFF ONCOLOGY, INC.

    CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

    (in thousands)

    (Unaudited)

     

     

    Three Months Ended March 31,

     

     

    2026

     

     

    2025

     

    Net loss

     

    $

    (12,345

    )

     

    $

    (13,434

    )

    Other comprehensive loss:

     

     

     

     

     

     

    Unrealized loss on securities available-
       for-sale

     

     

    (99

    )

     

     

    (7

    )

    Total comprehensive loss

     

     

    (12,444

    )

     

     

    (13,441

    )

     

     

     

     

     

     

    Preferred stock dividend payable on Series A
       Convertible Preferred Stock

     

     

    (6

    )

     

     

    (6

    )

     

     

     

     

     

     

    Comprehensive loss attributable to common
       stockholders

     

    $

    (12,450

    )

     

    $

    (13,447

    )

     

    See accompanying notes to the unaudited condensed financial statements.

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    CARDIFF ONCOLOGY, INC.

    CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

    (in thousands)

    (Unaudited)

     

     

    Preferred
    Stock
    Shares

     

     

    Preferred
    Stock
    Amount

     

     

    Common
    Stock
    Shares

     

     

    Common
    Stock
    Amount

     

     

    Additional
    Paid-In
    Capital

     

     

    Accumulated
    Other
    Comprehensive
    Gain (Loss)

     

     

    Accumulated
    Deficit

     

     

    Total
    Stockholders’
    Equity

     

    Balance, December 31, 2025

     

     

    61

     

     

    $

    —

     

     

     

    68,305

     

     

    $

    7

     

     

    $

    475,361

     

     

    $

    50

     

     

    $

    (430,030

    )

     

    $

    45,388

     

    Stock-based compensation

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    1,660

     

     

     

    —

     

     

     

    —

     

     

     

    1,660

     

    Issuance of common stock upon
       exercise of stock options

     

     

    —

     

     

     

    —

     

     

     

    65

     

     

     

    —

     

     

     

    105

     

     

     

    —

     

     

     

    —

     

     

     

    105

     

    Other comprehensive loss

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    (99

    )

     

     

    —

     

     

     

    (99

    )

    Net loss

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    (12,345

    )

     

     

    (12,345

    )

    Balance, March 31, 2026

     

     

    61

     

     

    $

    —

     

     

     

    68,370

     

     

    $

    7

     

     

    $

    477,126

     

     

    $

    (49

    )

     

    $

    (442,375

    )

     

    $

    34,709

     

     

     


     

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    CARDIFF ONCOLOGY, INC.

    CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

    (in thousands)

    (Unaudited)

     

     

    Preferred
    Stock
    Shares

     

     

    Preferred
    Stock
    Amount

     

     

    Common
    Stock
    Shares

     

     

    Common
    Stock
    Amount

     

     

    Additional
    Paid-In
    Capital

     

     

    Accumulated
    Other
    Comprehensive
    Gain

     

     

    Accumulated
    Deficit

     

     

    Total
    Stockholders’
    Equity

     

    Balance, December 31, 2024

     

     

    61

     

     

    $

    —

     

     

     

    66,524

     

     

    $

    7

     

     

    $

    467,087

     

     

    $

    34

     

     

    $

    (384,179

    )

     

    $

    82,949

     

    Stock-based compensation

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    1,365

     

     

     

    —

     

     

     

    —

     

     

     

    1,365

     

    Issuance of common stock upon
       exercise of stock options

     

     

    —

     

     

     

    —

     

     

     

    2

     

     

     

    —

     

     

     

    3

     

     

     

    —

     

     

     

    —

     

     

     

    3

     

    Other comprehensive loss

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    (7

    )

     

     

    —

     

     

     

    (7

    )

    Net loss

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    (13,434

    )

     

     

    (13,434

    )

    Balance, March 31, 2025

     

     

    61

     

     

    $

    —

     

     

     

    66,526

     

     

    $

    7

     

     

    $

    468,455

     

     

    $

    27

     

     

    $

    (397,613

    )

     

    $

    70,876

     

     

    See accompanying notes to the unaudited condensed financial statements.

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    CARDIFF ONCOLOGY, INC.

    CONDENSED STATEMENTS OF CASH FLOWS

    (in thousands)

    (Unaudited)

     

     

    Three Months Ended March 31,

     

     

    2026

     

     

    2025

     

    Operating activities

     

     

     

     

     

     

    Net loss

     

    $

    (12,345

    )

     

    $

    (13,434

    )

    Adjustments to reconcile net loss to net cash used in operating activities:

     

     

     

     

     

     

    Depreciation

     

     

    87

     

     

     

    93

     

    Stock-based compensation expense

     

     

    1,660

     

     

     

    1,365

     

    Amortization of right-of-use assets

     

     

    134

     

     

     

    135

     

    Accretion of discounts on short-term investments, net

     

     

    (93

    )

     

     

    (137

    )

    Changes in operating assets and liabilities:

     

     

     

     

     

     

    Accounts receivable and unbilled receivable

     

     

    (9

    )

     

     

    368

     

    Prepaid expenses and other current assets

     

     

    606

     

     

     

    216

     

    Other assets

     

     

    (295

    )

     

     

    (188

    )

    Accounts payable and accrued liabilities

     

     

    (1,847

    )

     

     

    (1,045

    )

    Operating lease liabilities

     

     

    (186

    )

     

     

    (167

    )

    Net cash used in operating activities

     

     

    (12,288

    )

     

     

    (12,794

    )

     

     

     

     

     

     

    Investing activities

     

     

     

     

     

     

    Maturities of short-term investments

     

     

    15,826

     

     

     

    21,228

     

    Purchases of short-term investments

     

     

    (12,569

    )

     

     

    (35,812

    )

    Net cash provided by (used in) investing activities

     

     

    3,257

     

     

     

    (14,584

    )

     

     

     

     

     

     

    Financing activities

     

     

     

     

     

     

    Proceeds from exercise of options

     

     

    105

     

     

     

    3

     

    Net cash provided by financing activities

     

     

    105

     

     

     

    3

     

    Net change in cash and cash equivalents

     

     

    (8,926

    )

     

     

    (27,375

    )

    Cash and cash equivalents—Beginning of period

     

     

    17,470

     

     

     

    51,470

     

    Cash and cash equivalents—End of period

     

    $

    8,544

     

     

    $

    24,095

     

     

     

     

     

     

     

     

    Supplementary disclosure of cash flow activity:

     

     

     

     

     

     

    Supplemental disclosure of non-cash investing activities:

     

     

     

     

     

     

    Purchases of unsettled short-term investments included in
       accrued liabilities

     

    $

    —

     

     

    $

    902

     

     

    See accompanying notes to the unaudited condensed financial statements.

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    CARDIFF ONCOLOGY, INC.

    NOTES TO CONDENSED FINANCIAL STATEMENTS

    (Unaudited)

    1. Organization and Basis of Presentation

    Business Organization and Overview

    Cardiff Oncology, Inc. (“Cardiff Oncology” or the “Company”) headquartered in San Diego, California, is a clinical-stage biotechnology company advancing innovative cancer treatments focused on Polo-like Kinase 1 (“PLK1”) inhibition, a validated oncology target with practice-changing potential. The Company’s 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 investigator-initiated trials such as metastatic pancreatic ductal adenocarcinoma (“mPDAC”), small cell lung cancer (“SCLC”), metastatic triple negative breast cancer (“mTNBC”), and chronic myelomonocytic leukemia ("CMML"). These programs and the Company’s broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver improved clinical outcomes for patients. The Company's common stock is listed on the Nasdaq Capital Market under the ticker symbol "CRDF".

    Basis of Presentation

    The accompanying unaudited interim condensed financial statements of Cardiff Oncology have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and the results of its operations and cash flows for the periods presented. The unaudited condensed balance sheet at December 31, 2025, has been derived from the audited financial statements at that date but does not include all of the information and disclosures required by GAAP for annual financial statements. The operating results presented in these unaudited interim condensed financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2025, included in the Company’s annual report on Form 10-K filed with the SEC on February 24, 2026.

    Going Concern Uncertainty

    The Company has incurred net losses since its inception and has negative operating cash flows. As of March 31, 2026, the Company had $46.1 million in cash, cash equivalents and short-term investments, which is not sufficient to meet its funding requirements for at least the next 12 months following the filing of this form 10-Q. Management has performed an analysis and concluded that there exists a substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.

    The Company's ability to continue as a going concern is dependent upon its ability to obtain additional equity or debt financing, obtain government grants or reduce expenditures. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company’s stockholders may experience additional dilution.

     

    2. Summary of Significant Accounting Policies

    During the three months ended March 31, 2026, there have been no changes to the Company’s significant accounting policies as described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2025.

    Segment Reporting

    The Company operates in one business segment in the United States, which includes all activities related to the development of novel therapies across a range of cancers. The Company's chief operating decision-maker is its chief executive officer. The chief

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    operating decision-maker allocates resources based on available cash, cash equivalents and short-term investments. The primary measure of performance reviewed by the chief operating decision-maker is net loss which is compared to the annual budget and quarterly forecasts.

    All financial information required for segment reporting that is provided to the chief operating decision-maker is contained within the financial statements and notes to financial statements, with the exception of the disaggregated amounts contained in the table below:

     

     

     

    Three Months Ended March 31,

     

    (in thousands)

     

    2026

     

     

    2025

     

    Research and development:

     

     

     

     

     

     

    Salaries and staff costs

     

    $

    1,744

     

     

    $

    1,969

     

    Stock-based compensation

     

     

    319

     

     

     

    515

     

    Clinical trials, outside services, and lab supplies

     

     

    4,260

     

     

     

    7,497

     

    Facilities and other

     

     

    442

     

     

     

    496

     

    Total research and development

     

    $

    6,765

     

     

    $

    10,477

     

    Selling, general and administrative:

     

     

     

     

     

     

    Salaries and staff costs

     

    $

    2,929

     

     

    $

    925

     

    Stock-based compensation

     

     

    1,341

     

     

     

    850

     

    Outside services and professional fees

     

     

    1,429

     

     

     

    1,798

     

    Facilities and other

     

     

    427

     

     

     

    441

     

    Total selling, general and administrative

     

    $

    6,126

     

     

    $

    4,014

     

    Net Loss Per Share

    Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding during the period. Preferred dividends are included in net loss attributable to common stockholders in the computation of basic and diluted earnings per share. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.

    The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their effect was anti-dilutive:

     

     

     

    March 31,

     

     

     

    2026

     

     

    2025

     

    Options to purchase Common Stock

     

     

    10,929,508

     

     

     

    10,823,072

     

    Warrants to purchase Common Stock

     

     

    432

     

     

     

    2,807,353

     

    Series A Convertible Preferred Stock

     

     

    877

     

     

     

    877

     

     

     

    10,930,817

     

     

     

    13,631,302

     

    Investment Securities

    Investment transactions are recorded on the trade date, and purchases of investments that are settled after the balance sheet date are included in accrued liabilities. All investments have been classified as “available-for-sale” and are carried at fair value as determined based upon quoted market prices or pricing models for similar securities at period end. Investments with contractual maturities less than 12 months at the balance sheet date are considered short-term investments. Investments with contractual maturities beyond one year are also classified as short-term due to the Company’s ability to liquidate the investment for use in operations within the next 12 months.

    Realized gains and losses on investment securities are included in earnings and are derived using the specific identification method for determining the cost of securities sold. The Company has not realized any significant gains or losses on sales of available-for-sale investment securities during any of the periods presented. As all the Company’s investment holdings are in the form of debt securities or certificates of deposit, unrealized gains and losses that are determined to be temporary in nature are reported as a component of accumulated other comprehensive loss. A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the establishment of a new cost basis for the security. Interest income is recognized when earned and is included in interest income, net, as are the amortization of purchase premiums and accretion of purchase discounts on investment securities.

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    Recent Accounting Pronouncement Not Yet Adopted

    In November 2024, the FASB issued ASU 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures, to enhance the transparency of certain expense disclosures. The update requires disclosure of specific expense categories in the notes to the financial statements at interim and annual reporting periods. The update requires disaggregated information about certain prescribed expense categories underlying any relevant income statement expense caption. The amendments in this update are effective for public entities for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027. The amendments may be adopted either prospectively or retrospectively. Early adoption is permitted. The Company is currently evaluating the impact of this guidance on its financial statement disclosures.

    3. Fair Value Measurements

    The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of March 31, 2026, and December 31, 2025:

     

     

    Fair Value Measurements at
    March 31, 2026

     

    (in thousands)

     

    Quoted Prices in Active Markets for Identical Assets and Liabilities
    (Level 1)

     

     

    Significant Other Observable Inputs
    (Level 2)

     

     

    Significant Unobservable Inputs
    (Level 3)

     

     

    Total

     

    Assets:

     

     

     

     

     

     

     

     

     

     

     

     

    Money market fund

     

    $

    8,359

     

     

    $

    —

     

     

    $

    —

     

     

    $

    8,359

     

    Total included in cash and cash equivalents

     

     

    8,359

     

     

     

    —

     

     

     

    —

     

     

     

    8,359

     

     

     

     

     

     

     

     

     

     

     

     

     

    Available for sale investments:

     

     

     

     

     

     

     

     

     

     

     

     

    Certificate of deposit

     

     

    —

     

     

     

    698

     

     

     

    —

     

     

     

    698

     

    Corporate debt securities

     

     

    —

     

     

     

    22,487

     

     

     

    —

     

     

     

    22,487

     

    Commercial paper

     

     

    —

     

     

     

    1,566

     

     

     

    —

     

     

     

    1,566

     

    U.S. government agencies

     

     

    —

     

     

     

    1,891

     

     

     

    —

     

     

     

    1,891

     

    U.S. treasury securities

     

     

    10,870

     

     

     

    —

     

     

     

    —

     

     

     

    10,870

     

    Total available for sale investments

     

     

    10,870

     

     

     

    26,642

     

     

     

    —

     

     

     

    37,512

     

     

     

     

     

     

     

     

     

     

     

     

     

    Total assets measured at fair value on a recurring basis

     

    $

    19,229

     

     

    $

    26,642

     

     

    $

    —

     

     

    $

    45,871

     

     

     

    Fair Value Measurements at
    December 31, 2025

     

    (in thousands)

     

    Quoted Prices in Active Markets for Identical Assets and Liabilities
    (Level 1)

     

     

    Significant Other Observable Inputs
    (Level 2)

     

     

    Significant Unobservable Inputs
    (Level 3)

     

     

    Total

     

    Assets:

     

     

     

     

     

     

     

     

     

     

     

     

    Money market fund

     

    $

    17,169

     

     

    $

    —

     

     

    $

    —

     

     

    $

    17,169

     

    Total included in cash and cash equivalents

     

     

    17,169

     

     

     

    —

     

     

     

    —

     

     

     

    17,169

     

     

     

     

     

     

     

     

     

     

     

     

     

    Available for sale investments:

     

     

     

     

     

     

     

     

     

     

     

     

    Certificate of deposit

     

     

    —

     

     

     

    143

     

     

     

    —

     

     

     

    143

     

    Corporate debt securities

     

     

    —

     

     

     

    28,669

     

     

     

    —

     

     

     

    28,669

     

    Commercial paper

     

     

    —

     

     

     

    413

     

     

     

    —

     

     

     

    413

     

    U.S. government agencies

     

     

    —

     

     

     

    2,876

     

     

     

    —

     

     

     

    2,876

     

    U.S. treasury securities

     

     

    8,733

     

     

     

    —

     

     

     

    —

     

     

     

    8,733

     

    Total available for sale investments

     

     

    8,733

     

     

     

    32,101

     

     

     

    —

     

     

     

    40,834

     

     

     

     

     

     

     

     

     

     

     

     

     

    Total assets measured at fair value on a recurring basis

     

    $

    25,902

     

     

    $

    32,101

     

     

    $

    —

     

     

    $

    58,003

     

     

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    The Company’s policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 3 during the three months ended March 31, 2026, and 2025.

    4. Supplementary Balance Sheet Information

    Investments available for sale

    Investments available for sale consisted of the following:

     

     

     

    As of March 31, 2026

     

    (in thousands)

     

    Amortized Cost

     

     

    Gross Unrealized Gains

     

     

    Gross Unrealized Losses

     

     

    Fair Market Value

     

    Maturity less than 1 year:

     

     

     

     

     

     

     

     

     

     

     

     

    Certificate of deposit

     

    $

    698

     

     

    $

    —

     

     

    $

    —

     

     

    $

    698

     

    Corporate debt securities

     

     

    13,196

     

     

     

    4

     

     

     

    (11

    )

     

     

    13,189

     

    Commercial paper

     

     

    1,566

     

     

     

    —

     

     

     

    —

     

     

     

    1,566

     

    U.S. government agencies

     

     

    1,891

     

     

     

    —

     

     

     

    —

     

     

     

    1,891

     

    U.S. treasury securities

     

     

    6,553

     

     

     

    1

     

     

     

    (2

    )

     

     

    6,552

     

    Total maturity less than 1 year

     

     

    23,904

     

     

     

    5

     

     

     

    (13

    )

     

     

    23,896

     

    Maturity 1 to 2 years:

     

     

     

     

     

     

     

     

     

     

     

     

    Corporate debt securities

     

     

    9,328

     

     

     

    3

     

     

     

    (33

    )

     

     

    9,298

     

    U.S. treasury securities

     

     

    4,329

     

     

     

    2

     

     

     

    (13

    )

     

     

    4,318

     

    Total maturity 1 to 2 years

     

     

    13,657

     

     

     

    5

     

     

     

    (46

    )

     

     

    13,616

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Total short-term investments

     

    $

    37,561

     

     

    $

    10

     

     

    $

    (59

    )

     

    $

    37,512

     

     

     

    As of December 31, 2025

     

    (in thousands)

     

    Amortized Cost

     

     

    Gross Unrealized Gains

     

     

    Gross Unrealized Losses

     

     

    Fair Market Value

     

    Maturity less than 1 year:

     

     

     

     

     

     

     

     

     

     

     

     

    Certificate of deposit

     

    $

    143

     

     

    $

    —

     

     

    $

    —

     

     

    $

    143

     

    Corporate debt securities

     

     

    23,699

     

     

     

    18

     

     

     

    (2

    )

     

     

    23,715

     

    Commercial paper

     

     

    413

     

     

     

    —

     

     

     

    —

     

     

     

    413

     

    U.S. government agencies

     

     

    2,872

     

     

     

    4

     

     

     

    —

     

     

     

    2,876

     

    U.S. treasury securities

     

     

    4,798

     

     

     

    2

     

     

     

    —

     

     

     

    4,800

     

    Total maturity less than 1 year

     

     

    31,925

     

     

     

    24

     

     

     

    (2

    )

     

     

    31,947

     

    Maturity 1 to 2 years:

     

     

     

     

     

     

     

     

     

     

     

     

    Corporate debt securities

     

     

    4,940

     

     

     

    15

     

     

     

    (1

    )

     

     

    4,954

     

    U.S. treasury securities

     

     

    3,919

     

     

     

    14

     

     

     

    —

     

     

     

    3,933

     

    Total maturity 1 to 2 years

     

     

    8,859

     

     

     

    29

     

     

     

    (1

    )

     

     

    8,887

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Total short-term investments

     

    $

    40,784

     

     

    $

    53

     

     

    $

    (3

    )

     

    $

    40,834

     

     

    The Company periodically reviews its portfolio of debt securities to determine if any investment is impaired due to credit loss or other potential valuation concerns. For debt securities where the fair value of the investment is less than the amortized cost basis, we have assessed at the individual security level for various quantitative factors including, but not limited to, the nature of the investments, changes in credit ratings, interest rate fluctuations, industry analyst reports, and the severity of impairment. Unrealized losses in investments available for sale debt securities at March 31, 2026, were substantially due to changes in interest rates, not due to increased credit risks associated with specific securities. Accordingly, the Company has not recorded an allowance for credit losses. It is not more likely than not that we will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.

    There were no unrealized loss positions greater than one year as of March 31, 2026 and December 31, 2025.

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    Property and equipment

    Property and equipment consisted of the following:

     

    (in thousands)

     

    As of March 31,
    2026

     

     

    As of December 31,
    2025

     

    Furniture and office equipment

     

    $

    1,051

     

     

    $

    1,051

     

    Leasehold improvements

     

     

    2,568

     

     

     

    2,568

     

    Laboratory equipment

     

     

    1,426

     

     

     

    1,426

     

    Property and equipment, gross

     

     

    5,045

     

     

     

    5,045

     

    Less—accumulated depreciation

     

     

    (4,554

    )

     

     

    (4,467

    )

    Property and equipment, net

     

    $

    491

     

     

    $

    578

     

     

    Depreciation expense for property and equipment recognized in operating results are as follows:

     

     

     

    Three Months Ended March 31,

     

    (in thousands)

     

    2026

     

     

    2025

     

    Total depreciation expense

     

    $

    87

     

     

    $

    93

     

    Accrued Liabilities

    Accrued liabilities consisted of the following:

     

    (in thousands)

     

    As of March 31,
    2026

     

     

    As of December 31,
    2025

     

    Clinical trials

     

    $

    2,933

     

     

    $

    3,805

     

    Accrued compensation

     

     

    4,528

     

     

     

    2,430

     

    Unsettled investments payable

     

     

    —

     

     

     

    744

     

    Research agreements and services

     

     

    268

     

     

     

    311

     

    Other accrued liabilities

     

     

    608

     

     

     

    287

     

    Total accrued liabilities

     

    $

    8,337

     

     

    $

    7,577

     

     

    5. Stockholders’ Equity

    Stock Options

    Stock-based compensation expense related to Cardiff Oncology equity awards have been recognized in operating results as follows:

     

     

     

    Three Months Ended March 31,

     

    (in thousands)

     

    2026

     

     

    2025

     

    Included in research and development expense

     

    $

    319

     

     

    $

    515

     

    Included in selling, general and administrative expense

     

     

    1,341

     

     

     

    850

     

    Total stock-based compensation expense

     

    $

    1,660

     

     

    $

    1,365

     

     

    The unrecognized compensation cost related to non-vested stock options outstanding at March 31, 2026, net of estimated forfeitures, was $6.0 million, which is expected to be recognized over a weighted-average remaining vesting period of 2.7 years. The weighted-average remaining contractual term of outstanding options as of March 31, 2026, was approximately 6.6 years. The total fair value of stock options vested during the three months ended March 31, 2026 and 2025, were $2.2 million and $2.1 million, respectively.

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    The estimated fair value of stock option awards was determined on the date of grant using the Black-Scholes option valuation model with the following assumptions during the following periods indicated:

     

     

     

    Three Months Ended March 31,

     

     

     

    2026

     

     

    2025

     

    Risk-free interest rate

     

    3.67% - 3.97%

     

     

     

    4.06

    %

    Dividend yield

     

     

    0

    %

     

     

    0

    %

    Expected volatility

     

    101% - 102%

     

     

     

    106

    %

    Expected term (in years)

     

    5.9

     

     

    6.1

     

    The weighted-average fair value per share of all options granted during the three months ended March 31, 2026 and 2025, estimated as of the grant date using the Black-Scholes option valuation model, was $1.29 and $2.99 per share, respectively.

     

    A summary of stock option activity and changes in stock options outstanding is presented below:

     

     

     

    Total Options

     

     

    Weighted-Average
    Exercise Price
    Per Share

     

     

    Intrinsic
    Value

     

    Balance outstanding, December 31, 2025

     

     

    10,757,293

     

     

    $

    3.87

     

     

    $

    2,678,115

     

    Granted

     

     

    1,000,000

     

     

    $

    1.60

     

     

     

     

    Exercised

     

     

    (64,761

    )

     

    $

    1.63

     

     

     

     

    Forfeited

     

     

    (645,472

    )

     

    $

    3.35

     

     

     

     

    Expired

     

     

    (117,552

    )

     

    $

    13.13

     

     

     

     

    Balance outstanding, March 31, 2026

     

     

    10,929,508

     

     

    $

    3.60

     

     

    $

    58,756

     

    Exercisable at March 31, 2026

     

     

    6,854,799

     

     

    $

    3.99

     

     

    $

    39,223

     

    Vested and expected to vest at March 31, 2026

     

     

    10,687,453

     

     

    $

    3.63

     

     

    $

    57,081

     

     

    2021 Equity Incentive Plan

    In June 2021, the Company's stockholders approved the 2021 Omnibus Equity Incentive Plan ("2021 Plan"). As of March 31, 2026, the number of authorized shares in the 2021 Plan is equal to the sum of (i) 12,150,000 shares, plus (ii) the number of shares of Common Stock reserved, but unissued under the 2014 Plan; and (iii) the number of shares of Common Stock underlying forfeited awards under the 2014 Plan. As of March 31, 2026, there were 4,613,468 shares available for issuance under the 2021 Plan.

    2014 Equity Incentive Plan

    Subsequent to the adoption of the 2021 Plan, no additional equity awards can be made under the terms of the 2014 Plan.

    Inducement Grants

    The Company issues equity awards to certain new employees as inducement grants outside of its 2021 Plan. As of March 31, 2026, an aggregate of 1,515,216 shares were issuable upon the exercise of inducement grant stock options approved by the Company.

    Stock Option Modifications

    The Company recorded $0.5 million of additional stock based compensation expense during the three months ended March 31, 2026 from stock option modifications. These modifications were the result of separation agreements entered into with Dr. Mark Erlander, former CEO, and James Levine, former CFO, on March 27, 2026 ("Agreement Date"). The modification date and valuation inputs were based on the Agreement Date. Dr. Erlander's stock options will continue to vest through June 11, 2026, and all vested options will be exercisable until June 11, 2027. Mr. Levine's vested stock options will be exercisable until March 27, 2027. All of the additional stock based compensation expense from these modifications was recorded during the three months ended March 31, 2026.

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    Table of Contents

     

    Warrants

    A summary of warrant activity and changes in warrants outstanding, classified as equity is presented below:

     

     

     

    Total Warrants

     

     

    Weighted-Average Exercise Price Per Share

     

     

    Weighted-Average Remaining Contractual Term

    Balance outstanding, December 31, 2025

     

     

    432

     

     

    $

    348.48

     

     

    0.6 years

    Balance outstanding, March 31, 2026

     

     

    432

     

     

    $

    348.48

     

     

    0.3 years

     

    6. Commitments and Contingencies

    Executive Agreements

    Certain executive agreements provide for severance payments in case of terminations without cause or certain change of control scenarios.

    Research and Development Agreements

    In March 2017, the Company entered into a license agreement with Nerviano which granted the Company development and commercialization rights to NMS-1286937, which the Company refers to as onvansertib. Terms of the agreement also provide for the Company to pay development milestones up to an aggregate of $15 million, commercial milestones, and royalties based on sales volume. These potential development milestones include: (a) dosing of the first subject in the first Phase III Clinical Trial for the first Product, a registration enabling Phase II Clinical Trial, or after completion of a Phase II Clinical Trial that is used as the basis for an NDA submission; and (b) upon filing of the first NDA or equivalent for the first product candidate. During the three months ended March 31, 2026, and 2025, no milestone or royalty payments were made.

    The Company is a party to various agreements under which it licenses technology on an exclusive basis in the field of oncology therapeutics. These agreements include License fees, Royalties and Milestone payments. For the three months ended March 31, 2026, and 2025, payments have not been material. The Company also has a legacy license agreement in the field of oncology diagnostics under which royalty payments are due to the Company. These royalty payments are calculated as a percent of revenue.

    Litigation

    From time to time, the Company may become involved in various lawsuits and legal proceedings that arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in matters may arise from time to time that may harm the Company’s business. As of the date of this report, management believes that there are no claims against the Company, which could result in a material adverse effect on the Company’s business or financial condition.

    License Agreement

    As disclosed on February 24, 2026, the Company received a written notice from Nerviano alleging that it is in material breach of the license agreement with respect to (i) alleged joint ownership of certain of Cardiff's U.S. patents nos. 12.144.813 and 12.263.173 (the “Cardiff Patents”) and (ii) the filing of a joint invention continuation patent application. The Company does not believe that there has been any breach of the license agreement and is currently engaged in discussions with Nerviano.

    The claimed inventions of the Cardiff Patents were based on innovations from the Company’s TROV-054 study with claims that cover methods of using onvansertib in combination with bevacizumab for the treatment of metastatic colorectal cancer patients who have not previously been treated with bevacizumab. If the Company is unable to resolve the allegations, then the Company will be required to vigorously defend its rights under the license agreement. Furthermore, if the Company is unable to resolve the dispute with Nerviano, the license agreement may be terminated. This would have a material adverse effect on the Company’s business, financial condition, and results of operations, which cannot be reasonably estimated at this time.

     

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    Table of Contents

     

    ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

    Forward-Looking Statements

    This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding the future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions.

    In addition, our business and financial performance may be affected by the factors that are discussed under “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2025, filed on February 24, 2026. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for us to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

    You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

    The following discussion and analysis is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the financial statements and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q. This discussion should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best present assessment of our management.

    Overview

    We are a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology drug 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 investigator-initiated trials such as metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and metastatic triple negative breast cancer ("mTNBC"). Additionally, onvansertib has also shown robust single agent activity in an investigator-initiated trial in chronic myelomonocytic leukemia ("CMML"). These programs and our broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver improved clinical outcomes in patients. Our clinical development programs incorporate tumor genomics and biomarker assays to refine patient selection and assessment of patient response to treatment.

    Our Lead Drug Candidate, Onvansertib

    We believe the attributes of onvansertib and its early clinical evidence of favorable safety and efficacy, with expected on-target, manageable and tolerable side effects, may prove beneficial in addressing clinical therapeutic needs across a variety of cancers. Key attributes of onvansertib include:

    •
    Highly potent and highly selective against the PLK1 enzyme (IC50 = 2nM; IC50 is the concentration for 50% inhibition), compared to prior PLK1 inhibitors that were pan-inhibitors of several PLK targets. Low or no activity of onvansertib was observed on a panel of 63 kinases (IC50>500 nM), including the PLK members PLK2 and PLK3 (IC50>10,000 nM);
    •
    Orally bioavailable, allowing for relative ease and flexibility of dosing;
    •
    Relatively short drug half-life of 24 hours, allowing for flexible dosing and scheduling that has demonstrated a favorable safety profile across multiple clinical trials.

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    Table of Contents

     

    In vitro studies have shown synergistic effects when onvansertib was administered in combination with different cytotoxic agents including microtubule-targeting agents, topoisomerase 1 inhibitors, antimetabolites, alkylating agents, proteasome inhibitors, kinase inhibitors, PARP inhibitors, BCL-2 inhibitors, and androgen biosynthesis inhibitors.

    In addition, in vivo combination studies have confirmed the positive results obtained in vitro and additive or synergistic effects on efficacy have been observed in xenograft models of onvansertib in combination with irinotecan, 5-fluorouracil ("5-FU"), abiraterone, PARP inhibitors, venetoclax, paclitaxel, or bevacizumab. Combining onvansertib with standard of care ("SoC") cancer agents may provide opportunities for synergy with many cancer therapies.

    There are several ongoing clinical trials of onvansertib in multiple indications: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, first-line CMML as monotherapy, second-line relapsed SCLC as monotherapy, and second-line unresectable locally advanced or metastatic TNBC.

    RAS-mutated mCRC Program:

    CRDF-004 Randomized Clinical Trial in First-Line RAS-mutated mCRC

    CRDF-004 is a Phase 2, randomized, open label multi-center clinical trial to assess the efficacy of two different doses of onvansertib (20mg and 30mg) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab, compared with FOLFIRI or FOLFOX and bevacizumab SoC alone, for the treatment of confirmed mCRC in patients with a KRAS or NRAS mutation in the first-line setting. Trial endpoints include objective response rate ("ORR"), progression-free survival ("PFS") and duration of response ("DoR") together with pharmacokinetics, pharmacodynamics and safety assessments. Selection of the recommended Phase 3 onvansertib dose will be based on a benefit-risk assessment of the totality of the evidence, including numerical differences between the onvansertib and SoC arms. The trial enrolled 110 patients in the intent-to-treat ("ITT") population and is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies. For more information, please visit NCT06106308 at www.clinicialtrials.gov.

    Data provided in the press release dated January 27, 2026 included updated data from the ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. The 30 mg onvansertib + FOLFIRI/bev arm achieved a confirmed objective response rate (“ORR”) if 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. The results as of the data cut-off date of January 22, 2026, are shown below.

    Parameter

    SoCc (FOLFIRI/bev+FOLFOX/bev) (n=37)

    SoC

    FOLFIRI/bev

    (n=19)

    Onv 20 mg

    +FOLFIRI/bev

    (n=18)

    Onv 30 mg

    +FOLFIRI/bev

    (n=18)

    Objective Response Rate (per BICR)a

    Confirmed Responders

    16

      8

      8

    13

    Confirmed ORR (%)

    43.2

    42.1

    44.4

    72.2

    p-value = 0.051f (vs SoC)

    Progression Free Survivalb

    Median PFS (months, 95% CI)

    10.97 (9.43-15.44)

    10.97 (7.52-NR)

    NR (7.49-NR)

    NR (9.72-NR)

    PFS HR (vs FOLFIRI/bev)

     

     

    0.56 (0.18-1.73)d

    0.38 (0.12-1.17)d

    PFS HR (vs SoC)

     

     

    0.57 (0.21-1.58)e

    0.37 (0.13-1.02)e

    p-value = 0.048g (vs SoC)

    PFS Rate at 6 months (95% CI)

    88.8 (77.4-100)

    79.5 (61.1-100)

    88.1 (73.9-100)

    94.1 (83.6-100)

     

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

    aORR is confirmed responses

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

    cSoC is the combination of the FOLFIRI/bev and FOLFOX/bev arms

    dPFS HR is the comparison of the onvansertib arm to FOLFIRI/bev

    ePFS HR is the comparison of the onvansertib arm to SoC

    fFisher’s exact test

    gLog-rank test

     

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    Table of Contents

     

    We will report detailed updated data from our randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO Annual Meeting, taking place May 29–June 2 in Chicago.

    Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC

    In consultation with the U.S. Food and Drug Administration (FDA), Cardiff selected the 30 mg dose of onvansertib for evaluation with FOLFIRI/bev chemotherapy regimen for the Phase 3 trial in patients with first-line RAS-mutated mCRC. Additional details of the clinical trial will be shared by mid-2026.

     

    Other Clinical Programs:

    We support certain investigator-initiated trials by supplying onvansertib to academic clinicians who conduct clinical trials independently. These studies allow us to tap into the expertise of independent clinicians and academic investigators to explore new therapeutic indications or new dosage regimens at a low cost to us. By facilitating independent research, we have the opportunity to gain valuable evidence and safety data that can inform future regulatory decisions or improve our understanding of onvansertib’s efficacy. Furthermore, supporting investigator-initiated trials acts as a collaborative effort that strengthens relationships with KOLs.

    Phase 1b/2 Investigator-Initiated Clinical Trial in First-Line mPDAC

    In February 2024, the FDA approved NALIRIFOX as a first-line treatment option for mPDAC. As a result, we are currently supporting an investigator-initiated mPDAC Phase 1b/2 trial of onvansertib in combination with first-line SoC NALIRIFOX, which is open for enrollment at the University of Kansas Medical Center. For more information, please visit NCT06736717 at www.clinicaltrials.gov.

    The primary objective in this study is to determine anti-tumor activity by measuring ORR. The secondary objectives are to determine treatment safety based on toxicities in participants who have received at least one dose of onvansertib, to determine anti-tumor activity by PFS, to determine anti-tumor activity by Disease Control Rate ("DCR"), to determine Overall Survival ("OS").

    Phase 2 Investigator-Initiated Clinical Trial in SCLC

    A single-arm, two-stage, Phase 2 trial of onvansertib monotherapy in patients with relapsed SCLC is open for enrollment at the University of Maryland, Baltimore. The trial is designed to enroll 15 patients in Stage 1, with the study proceeding to Stage 2 if 2 or more Stage 1 patients achieve an objective response. Stage 2 is designed to enroll an additional 20 patients. The primary endpoint of the trial is ORR, while key secondary endpoints include PFS and OS. For more information, please visit NCT05450965 at www.clinicialtrials.gov.

    An examination of the safety data from the first six patients by the institutional review board confirmed the trial can continue to enroll as planned. Preliminary efficacy data for seven patients presented on September 26, 2023, showed one confirmed partial response (“PR”), three stable disease (“SD”) and three progressive disease (“PD”). The DCR, including PR and SD, is 57% (4 of 7 patients).

    Phase 1b Investigator-Initiated Clinical Trial in mTNBC

    A single-arm, phase 1b trial of onvansertib in combination with paclitaxel in patients with unresectable locally advanced or metastatic TNBC at Dana Farber Cancer Institute ("DFCI") has completed enrollment. The trial was designed to treat approximately 14-16 patients with different doses of onvansertib in combination with a fixed dose of paclitaxel to determine the maximum tolerated dose and the safety and efficacy of onvansertib in combination with paclitaxel. For more information, please visit NCT05383196 at www.clinicialtrials.gov.

     

    In June 2025, the investigator presented promising data from this trial at ASCO:

    •
    Patients enrolled in the trial received a median of 3 prior lines of chemotherapy.
    •
    Onvansertib in combination with paclitaxel demonstrated 40% objective response rate by RECIST 1.1 at RP2D of 18mg/m2 (n=10), with two confirmed partial responses and two unconfirmed partial responses.

    18


    Table of Contents

     

    •
    The combination of onvansertib and paclitaxel was well-tolerated and demonstrated a safe and manageable toxicity profile with myelosuppression being the most common adverse event.
    •
    Collectively, this clinical data further supports the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC.

     

    Phase 1 Investigator-Initiated Clinical Trial in CMML

    This phase 1 trial is designed to evaluate the safety, effectiveness, and best dose of onvansertib as a monotherapy for the treatment of patients with CMML and Myelodysplastic syndrome/myeloproliferative neoplasm ("MDS/MPN") overlap neoplasms that has come back (recurrent) or that does not respond to treatment (refractory). For more information, please visit NCT05549661 at www.clinicialtrials.gov.

     

    Data presented at the American Society of Hematology ("ASH") meeting on December 8, 2025, from this ongoing Phase 1 dose-escalation trial (N=9) showed that onvansertib monotherapy was generally well-tolerated and demonstrated preliminary efficacy in approximately 40% of patients. One patient achieved an optimal marrow response at the 9 mg/m² dose and three patients achieved clinical benefit at 6 mg/m2 and 12 mg/m2. Dose expansion is currently open and recruiting at the 12 mg/m2 dose.

    These findings, together with previously reported results from an investigator-sponsored trial in small cell lung cancer, support onvansertib’s single-agent activity across both hematologic and solid tumors.

    Recent Updates

    Appointment of Chief Executive Officer, Chief Financial Officer, and Chief Operating Officer

    On April 9, 2026, we announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO. She will continue as a member of the Board of Directors. We also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff's commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.

    Presented Preclinical Data on PLK1 Inhibitor Onvansertib in Combination with Her2-Targeted ADC at AACR Annual Meeting

    On April 19, 2026, we presented new preclinical data in a poster at the American Association for Cancer Research ("AACR"). The data highlight the potential of onvansertib in combination with the HER-2 targeted antibody-drug conjugate ("ADC"), trastuzumab deruxtecan ("T-DXd"), demonstrating robust antitumor activity and the ability to overcome resistance in HER2-low breast cancer models.

    Critical Accounting Estimates

    Our accounting policies are described in ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS of our Annual Report on Form 10-K as of and for the year ended December 31, 2025, filed with the SEC on February 24, 2026. There have been no changes to our critical accounting estimates since December 31, 2025.

    RESULTS OF OPERATIONS

    Three Months Ended March 31, 2026 and 2025

    Revenues

    Total revenues were $41,000 for the three months ended March 31, 2026, as compared to $109,000 for the same period in 2025. 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:

     

    19


    Table of Contents

     

     

     

    Three Months Ended March 31,

     

    (in thousands)

     

    2026

     

     

    2025

     

     

    Increase
    (Decrease)

     

    Salaries and staff costs

     

    $

    1,744

     

     

    $

    1,969

     

     

    $

    (225

    )

    Stock-based compensation

     

     

    319

     

     

     

    515

     

     

     

    (196

    )

    Clinical trials, outside services, and lab supplies

     

     

    4,260

     

     

     

    7,497

     

     

     

    (3,237

    )

    Facilities and other

     

     

    442

     

     

     

    496

     

     

     

    (54

    )

    Total research and development

     

    $

    6,765

     

     

    $

    10,477

     

     

    $

    (3,712

    )

     

    Research and development expenses decreased by $3.7 million for the three months ended March 31, 2026, compared to the same period in 2025. The overall decrease in expenses was primarily due to a reduction in clinical trial expenses and a decrease in preclinical activities.

    Selling, General and Administrative Expenses

    Selling, general and administrative expenses consisted of the following:

     

     

     

    Three Months Ended March 31,

     

    (in thousands)

     

    2026

     

     

    2025

     

     

    Increase
    (Decrease)

     

    Salaries and staff costs

     

    $

    2,929

     

     

    $

    925

     

     

    $

    2,004

     

    Stock-based compensation

     

     

    1,341

     

     

     

    850

     

     

     

    491

     

    Outside services and professional fees

     

     

    1,429

     

     

     

    1,798

     

     

     

    (369

    )

    Facilities and other

     

     

    427

     

     

     

    441

     

     

     

    (14

    )

    Total selling, general and administrative

     

    $

    6,126

     

     

    $

    4,014

     

     

    $

    2,112

     

     

    Selling, general and administrative expenses increased by $2.1 million for the three months ended March 31, 2026, compared to the same period in 2025. The overall increase in expenses was primarily from employee severance agreements recorded to salaries and staff costs within the current period. The increase in stock based compensation was due the modification of stock options from employee severance agreements.

    Interest Income, Net

    Interest income, net was $0.5 million for the three months ended March 31, 2026 as compared to $0.9 million for the same period of 2025. 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 March 31, 2026, and December 31, 2025, we had working capital of $32.9 million and $43.7 million, respectively.

    We have incurred net losses since our inception and have negative operating cash flows. As of March 31, 2026, we had $46.1 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 our ability to continue as a going concern, see Note 1 Business Organization and Overview - Going Concern Uncertainty to 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

    20


    Table of Contents

     

    at all. To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience additional dilution.

    Cash Flow Summary

     

     

    Three Months Ended March 31,

     

    (in thousands)

     

    2026

     

     

    2025

     

    Net cash used in operating activities

     

    $

    (12,288

    )

     

    $

    (12,794

    )

    Net cash provided by (used in) investing activities

     

     

    3,257

     

     

     

    (14,584

    )

    Net cash provided by financing activities

     

     

    105

     

     

     

    3

     

    Net change in cash and cash equivalents

     

    $

    (8,926

    )

     

    $

    (27,375

    )

     

    Operating Activities

    Net cash used in operating activities for the three months ended March 31, 2026, was $12.3 million. Our primary use of cash was from our net loss of $12.3 million, adjusted for non-cash items of $1.8 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $1.7 million.

    Net cash used in operating activities for the three months ended March 31, 2025, was $12.8 million. Our primary use of cash was from our net loss of $13.4 million, adjusted for non-cash items of $1.5 million primarily related to stock-based compensation. The net change in our operating assets and liabilities decreased cash used in operations by $0.8 million.

    At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.

    Investing Activities

    Net cash provided by investing activities for the three months ended March 31, 2026 was $3.3 million, primarily related to maturities in excess of purchases of marketable securities.

    Net cash used in investing activities for the three months ended March 31, 2025 was $14.6 million, primarily related to purchases in excess of maturities and sales of marketable securities.

    Financing Activities

    Net cash provided by financing activities for the three months ended March 31, 2026 was $105,000, from employee stock options exercises.

    Net cash provided by financing activities for the three months ended March 31, 2025 was $3,000, from employee stock options exercises.

    ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

    Not applicable.

    ITEM 4. CONTROLS AND PROCEDURES

    Evaluation of Disclosure Controls and Procedures

    We have performed an evaluation under the supervision and with the participation of our management, including our principal executive officer (CEO) and principal financial officer (CFO), of the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of March 31, 2026, to provide reasonable assurance that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

    21


    Table of Contents

     

    Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives as specified above. Management does not expect, however, that our disclosure controls and procedures will prevent or detect all errors and fraud. Any control system, no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within our company have been detected.

    Changes in Internal Control over Financial Reporting

    There was no change in our internal control over financial reporting during the three months ended March 31, 2026, that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

    22


    Table of Contents

     

    PART II. OTHER INFORMATION

    ITEM 1. LEGAL PROCEEDINGS

    The information called for by this item is incorporated herein by reference to the information set forth in "Note 6. Commitments and Contingencies” in the Notes to Consolidated Financial Statements included in Item 1 of this Report.

    ITEM 1A. RISK FACTORS

    There have been no material changes from the risk factors disclosed in our Form 10-K for the year ended December 31, 2025.

    ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

    None.

    ITEM 3. DEFAULTS UPON SENIOR SECURITIES

    None.

    ITEM 4. MINE SAFETY DISCLOSURES

    Not applicable.

    ITEM 5. OTHER INFORMATION

    During the three months ended March 31, 2026, none of the Company’s directors or officers adopted or terminated any “Rule 10b5-1 trading arrangements” or any “non-Rule 10b5-1 trading arrangements,” as each term is defined in Item 408 of Regulation S-K.

    ITEM 6. EXHIBITS

     

    Exhibit

    Number

     

    Description of Exhibit

     

     

     

    10.1

     

    Separation Agreement dated March 27, 2026 by and between Cardiff Oncology, Inc. and Mark Erlander.

     

     

     

    10.2

     

    Separation Agreement dated March 27, 2026 by and between Cardiff Oncology, Inc. and James Levine.

     

     

     

    31.1

     

    Certification of Principal Executive Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act.

     

     

     

    31.2

     

    Certification of Principal Financial Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act.

     

     

     

    32.1

     

    Certification of Principal Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

     

     

     

    32.2

     

    Certification of Principal Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

     

     

     

    101.INS

     

    Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.

     

     

     

    101.SCH

     

    Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents

     

     

     

    104

     

    Cover Page Interactive Data File (embedded within the Inline XBRL document)

     

    23


    Table of Contents

     

    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, thereunto duly authorized.

     

     

    CARDIFF ONCOLOGY, INC.

     

     

     

    May 14, 2026

    By:

    /s/ Mani Mohindru

     

     

    Mani Mohindru

     

     

    Chief Executive Officer

     

     

    (Principal Executive Officer)

     

     

     

     

    CARDIFF ONCOLOGY, INC.

     

     

     

    May 14, 2026

    By:

    /s/ Josh Muntner

     

     

    Josh Muntner

     

     

    Chief Financial Officer

     

     

    (Principal Financial Officer)

     

    24


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    SEC Form SC 13G/A filed by Cardiff Oncology Inc. (Amendment)

    SC 13G/A - Cardiff Oncology, Inc. (0001213037) (Subject)

    2/6/24 4:01:34 PM ET
    $CRDF
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    SEC Form SC 13G/A filed by Cardiff Oncology Inc. (Amendment)

    SC 13G/A - Cardiff Oncology, Inc. (0001213037) (Subject)

    2/14/23 12:47:09 PM ET
    $CRDF
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    SEC Form SC 13G filed by Cardiff Oncology Inc.

    SC 13G - Cardiff Oncology, Inc. (0001213037) (Subject)

    1/26/23 1:30:22 PM ET
    $CRDF
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care