Cardiff Oncology, Inc.
For the period ended Jun 30, 2025. Filed Jul 29, 2025.
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Jun 30, 2025 · Filed Jul 29, 2025
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Notes to Condensed Financial Statements
- 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 leveraging Polo-like Kinase 1 (“PLK1”) inhibition, to develop novel therapies across a range of cancers. The Company’s lead asset is onvansertib, a PLK1 inhibitor that is being evaluated in combination with standard-of-care ("SoC") therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (“mCRC”), as well as investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (“mPDAC”), small cell lung cancer (“SCLC”), and metastatic triple negative breast cancer (“mTNBC”). These programs and the Company’s broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to SoC alone. 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, 2024, 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, 2024, included in the Company’s annual report on Form 10-K filed with the SEC on February 27, 2025.
Liquidity
The Company has incurred net losses since its inception and has negative operating cash flows. As of June 30, 2025, the Company had$71.0 million in cash, cash equivalents and short-term investments and believes it has sufficient cash to meet its funding requirements for at least the next 12 months following the issuance date of these financial statements.
For the foreseeable future, the Company expects to continue to incur losses and require additional capital to further advance its clinical trial programs and support its other operations. 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.
- Summary of Significant Accounting Policies
During the six months ended June 30, 2025, 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, 2024.
Segment Reporting
The Company operates inone 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 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 June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| (in thousands) | 2025 | 2024 | 2025 | 2024 |
| Research and development: | ||||
| Salaries and staff costs | $2,134 | $1,714 | $4,103 | $3,582 |
| Stock-based compensation | 672 | 397 | 1,187 | 786 |
| Clinical trials, outside services, and lab supplies | 8,306 | 6,950 | 15,803 | 12,202 |
| Facilities and other | 468 | 432 | 964 | 931 |
| Total research and development | $11,580 | $9,493 | $22,057 | $17,501 |
| Selling, general and administrative: | ||||
| Salaries and staff costs | $849 | $807 | $1,775 | $1,714 |
| Stock-based compensation | 1,011 | 782 | 1,861 | 1,517 |
| Outside services and professional fees | 1,062 | 1,167 | 2,860 | 2,150 |
| Facilities and other | 396 | 459 | 836 | 964 |
| Total selling, general and administrative | $3,318 | $3,215 | $7,332 | $6,345 |
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.
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:
| June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Options to purchase Common Stock | 11,701,432 | 8,351,122 |
| Warrants to purchase Common Stock | 2,787,714 | 2,807,353 |
| Series A Convertible Preferred Stock | 877 | 877 |
| 14,490,023 | 11,159,352 | |
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.
Recent Accounting Pronouncement Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, “Improvements to Income Tax Disclosures.” ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024 and for private businesses for annual periods beginning after December 15, 2025, with early adoption permitted. The Company is currently evaluating the impact of this guidance on its financial statement disclosures.
In November 2024, the FASB issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation 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.
- 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 June 30, 2025, and December 31, 2024:
| (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 | $9,072 | $— | $— | $9,072 |
| U.S. treasury securities | 1,615 | — | — | 1,615 |
| Total included in cash and cash equivalents | 10,687 | — | — | 10,687 |
| Available for sale investments: | ||||
| Corporate debt securities | — | 35,769 | — | 35,769 |
| Commercial paper | — | 389 | — | 389 |
| U.S. government agencies | — | 4,614 | — | 4,614 |
| U.S. treasury securities | 19,401 | — | — | 19,401 |
| Total available for sale investments | 19,401 | 40,772 | — | 60,173 |
| Total assets measured at fair value on a recurring basis | $30,088 | $40,772 | $— | $70,860 |
| (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 | $50,499 | $— | $— | $50,499 |
| U.S. treasury securities | 393 | — | — | 393 |
| Total included in cash and cash equivalents | 50,892 | — | — | 50,892 |
| Available for sale investments: | ||||
| Corporate debt securities | — | 23,489 | — | 23,489 |
| Commercial paper | — | 313 | — | 313 |
| U.S. treasury securities | 16,474 | — | — | 16,474 |
| Total available for sale investments | 16,474 | 23,802 | — | 40,276 |
| Total assets measured at fair value on a recurring basis | $67,366 | $23,802 | $— | $91,168 |
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 six months ended June 30, 2025, and 2024.
- Supplementary Balance Sheet Information
Investments available for sale
Investments available for sale consisted of the following:
| (in thousands) | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Market Value |
|---|---|---|---|---|
| Maturity less than 1 year: | ||||
| Corporate debt securities | $29,706 | $14 | $(12) | $29,708 |
| Commercial paper | 389 | — | — | 389 |
| U.S. government agencies | 2,086 | — | — | 2,086 |
| U.S. treasury securities | 18,204 | — | (6) | 18,198 |
| Total maturity less than 1 year | 50,385 | 14 | (18) | 50,381 |
| Maturity 1 to 2 years: | ||||
| Corporate debt securities | 6,044 | 18 | (1) | 6,061 |
| U.S. government agencies | 2,529 | 1 | (2) | 2,528 |
| U.S. treasury securities | 1,198 | 5 | — | 1,203 |
| Total maturity 1 to 2 years | 9,771 | 24 | (3) | 9,792 |
| Total short-term investments | $60,156 | $38 | $(21) | $60,173 |
| (in thousands) | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Market Value |
|---|---|---|---|---|
| Maturity less than 1 year: | ||||
| Corporate debt securities | $17,192 | $27 | $(1) | $17,218 |
| Commercial paper | 312 | 1 | — | 313 |
| U.S. treasury securities | 16,475 | 3 | (4) | 16,474 |
| Total maturity less than 1 year | 33,979 | 31 | (5) | 34,005 |
| Maturity 1 to 2 years: | ||||
| Corporate debt securities | 6,263 | 11 | (3) | 6,271 |
| Total maturity 1 to 2 years | 6,263 | 11 | (3) | 6,271 |
| Total short-term investments | $40,242 | $42 | $(8) | $40,276 |
We periodically review our 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 June 30, 2025, were substantially due to changes in interest rates, not due to increased credit risks associated with specific securities. Accordingly, we have 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 wereno unrealized loss positions greater than one year as of June 30, 2025 and December 31, 2024.
Property and equipment
Property and equipment consisted of the following:
| (in thousands) | As of June 30,2025 | As of December 31,2024 |
|---|---|---|
| Furniture and office equipment | $1,053 | $1,053 |
| Leasehold improvements | 2,568 | 2,568 |
| Laboratory equipment | 1,446 | 1,414 |
| Property and equipment, gross | 5,067 | 5,035 |
| Less—accumulated depreciation | (4,324) | (4,137) |
| Property and equipment, net | $743 | $898 |
Depreciation expense for property and equipment recognized in operating results are as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| (in thousands) | 2025 | 2024 | 2025 | 2024 |
| Total depreciation expense | $94 | $105 | $187 | $207 |
Accrued Liabilities
Accrued liabilities consisted of the following:
| (in thousands) | As of June 30,2025 | As of December 31,2024 |
|---|---|---|
| Clinical trials | $7,125 | $4,443 |
| Accrued compensation | 2,245 | 2,746 |
| Research agreements and services | 365 | 478 |
| Other accrued liabilities | 203 | 230 |
| Total accrued liabilities | $9,938 | $7,897 |
- 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 June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| (in thousands) | 2025 | 2024 | 2025 | 2024 |
| Included in research and development expense | $672 | $397 | $1,187 | $786 |
| Included in selling, general and administrative expense | 1,011 | 782 | 1,861 | 1,517 |
| Total stock-based compensation expense | $1,683 | $1,179 | $3,048 | $2,303 |
The unrecognized compensation cost related to non-vested stock options outstanding at June 30, 2025, net of estimated forfeitures, was$13.7 million, which is expected to be recognized over a weighted-average remaining vesting period of 3.0 years. The weighted-average remaining contractual term of outstanding options as of June 30, 2025, was approximately 7.8 years. The total fair value of stock options vested during the six months ended June 30, 2025 and 2024, were$3.7 million and$2.7 million, respectively.
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 weighted-average assumptions during the following periods indicated:
| Six Months Ended June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Risk-free interest rate | 4.06% | 4.06% |
| Dividend yield | 0% | 0% |
| Expected volatility of Cardiff Oncology common stock | 106% | 106% |
| Expected term | 6.2 years | 5.8 years |
A summary of stock option activity and changes in stock options outstanding is presented below:
| Total Options | Weighted-AverageExercise PricePer Share | IntrinsicValue | |
|---|---|---|---|
| Balance outstanding, December 31, 2024 | 8,334,765 | $3.88 | $11,668,989 |
| Granted | 3,368,632 | $3.59 | |
| Exercised | (1,672) | $1.72 | |
| Forfeited and expired | (293) | $600.39 | |
| Balance outstanding, June 30, 2025 | 11,701,432 | $3.78 | $4,762,925 |
| Exercisable at June 30, 2025 | 6,031,484 | $4.25 | $3,392,492 |
| Vested and expected to vest at June 30, 2025 | 11,421,239 | $3.80 | $4,669,472 |
2021 Equity Incentive Plan
In June 2021, the Company's stockholders approved the 2021 Omnibus Equity Incentive Plan ("2021 Plan"). As of June 30, 2025 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 June 30, 2025, there were 4,425,413 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 June 30, 2025, an aggregate of 2,015,288 shares were issuable upon the exercise of inducement grant stock options approved by the Company.
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, 2024 | 2,807,353 | $2.40 | 0.9 years |
| Expired | (19,639) | $2.27 | |
| Balance outstanding, June 30, 2025 | 2,787,714 | $2.40 | 0.5 years |
- 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 Cardiff Oncology refers to as onvansertib. Terms of the agreement also provide for the Company to pay development and 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 six months ended June 30, 2025, and 2024, 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 six months ended June 30, 2025, and 2024, 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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.