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Cardiff Oncology Inc

For the period ended Mar 31, 2024. Filed May 2, 2024.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2024 · Filed May 2, 2024

CRDF$0.80+5.3%Stored close · as of Nov 6, 2026

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Notes to Condensed Financial Statements

  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 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 triple negative breast cancer (“TNBC”). 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 the 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, 2023, 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, 2023, included in the Company’s annual report on Form 10-K filed with the SEC on February 29, 2024.

Liquidity

The Company has incurred net losses since its inception and has negative operating cash flows. As of March 31, 2024, the Company had $67.2 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.

  1. Summary of Significant Accounting Policies

During the three months ended March 31, 2024, 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, 2023.

Net Loss Per Share

Basic and diluted net loss per common share is determined by dividing net loss applicable 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:

March 31,
20242023
Options to purchase Common Stock8,297,2926,396,895
Warrants to purchase Common Stock2,807,9484,296,472
Series A Convertible Preferred Stock877877
11,106,11710,694,244

Recently Adopted Accounting Pronouncement

In August 2020, the FASB issued ASU No. 2020-06 ("ASU 2020-06"), Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The amendments in this update are effective for the Company on January 1, 2024. The amendment is to be adopted through either a fully retrospective or modified retrospective method of transition. Early adoption is permitted. The Company adopted this standard as of January 1, 2024 using the modified-retrospective method. As a result of the adoption the Company reversed the accretion of preferred stock dividends originally recorded in 2005 related to the Series A Convertible Preferred Stock of $793,000.

  1. 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, 2024, and December 31, 2023:

Fair Value Measurements atMarch 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$18,330$—$—$18,330
Total included in cash and cash equivalents18,330——18,330
Available for sale investments:
Certificate of deposit—6,511—6,511
Corporate debt securities—18,328—18,328
Commercial paper—5,289—5,289
U.S. treasury securities18,401——18,401
Total available for sale investments18,40130,128—48,529
Total assets measured at fair value on a recurring basis$36,731$30,128$—$66,859
Fair Value Measurements atDecember 31, 2023
(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$21,606$—$—$21,606
Total included in cash and cash equivalents21,606——21,606
Available for sale investments:
Certificate of deposit—8,333—8,333
Corporate debt securities—19,373—19,373
Commercial paper—6,202—6,202
U.S. government agencies—834—834
U.S. treasury securities18,426——18,426
Total available for sale investments18,42634,742—53,168
Total assets measured at fair value on a recurring basis$40,032$34,742$—$74,774

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, 2024.

  1. Supplementary Balance Sheet Information

Investments available for sale

Investments available for sale consist of the following:

As of March 31, 2024
(in thousands)Amortized CostGross Unrealized GainsGross Unrealized LossesFair Market Value
Maturity less than 1 year:
Certificate of deposit$6,501$10$—$6,511
Corporate debt securities14,6866(27)14,665
Commercial paper5,2882(1)5,289
U.S. treasury securities16,342—(112)16,230
Total maturity less than 1 year42,81718(140)42,695
Maturity 1 to 2 years:
Corporate debt securities3,65413(4)3,663
U.S. treasury securities2,190—(19)2,171
Total maturity 1 to 2 years5,84413(23)5,834
Total short-term investments$48,661$31$(163)$48,529
As of December 31, 2023
(in thousands)Amortized CostGross Unrealized GainsGross Unrealized LossesFair Market Value
Maturity less than 1 year:
Certificate of deposit$8,317$16$—$8,333
Corporate debt securities10,9488(16)10,940
Commercial paper6,1939—6,202
Non U.S. government835—(1)834
Total maturity less than 1 year26,29333(17)26,309
Maturity 1 to 2 years:
Corporate debt securities8,4376(10)8,433
U.S. treasury securities18,505—(79)18,426
Total maturity 1 to 2 years26,9426(89)26,859
Total short-term investments$53,235$39$(106)$53,168

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 March 31, 2024, were substantially due to increases 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.

Investments available for sale that have been in a continuous unrealized loss position for greater than one-year consist of the following:

As of March 31, 2024
(in thousands)Fair Market ValueGross Unrealized Loss
Corporate debt securities$1,546$(6)
As of December 31, 2023
(in thousands)Fair Market ValueGross Unrealized Loss
Corporate debt securities$397$(3)

Property and equipment

Property and equipment consist of the following:

(in thousands)As of March 31,2024As of December 31,2023
Furniture and office equipment$1,067$1,067
Leasehold improvements2,5682,568
Laboratory equipment1,4191,355
5,0544,990
Less—accumulated depreciation and amortization(3,855)(3,752)
Property and equipment, net$1,199$1,238

Accrued Liabilities

Accrued liabilities consisted of the following:

(in thousands)As of March 31,2024As of December 31,2023
Accrued compensation$1,234$2,737
Clinical trials3,7834,309
Research agreements and services692530
Other accrued liabilities247207
Total accrued liabilities$5,956$7,783
  1. 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)20242023
Included in research and development expense$389$394
Included in selling, general and administrative expense735670
Total stock-based compensation expense$1,124$1,064

The unrecognized compensation cost related to non-vested stock options outstanding at March 31, 2024, net of estimated forfeitures, was $10.2 million, which is expected to be recognized over a weighted-average remaining vesting period of 2.1 years. The weighted-average remaining contractual term of outstanding options as of March 31, 2024, was approximately

8.1 years. The total fair value of stock options vested during the three months ended March 31, 2024 and 2023, were $1.4 million and $1.9 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:

Three Months Ended March 31,
20242023
Risk-free interest rate4.04%3.58%
Dividend yield0%0%
Expected volatility of Cardiff Oncology common stock107%110%
Expected term5.8 years5.3 years

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

Total OptionsWeighted-AverageExercise PricePer ShareIntrinsicValue
Balance outstanding, December 31, 20236,650,954$4.27$23,926
Granted1,720,896$3.51
Exercised(33,222)$3.22
Forfeited and expired(41,336)$10.11
Balance outstanding, March 31, 20248,297,292$4.09$17,780,158
Exercisable at March 31, 20243,735,195$5.10$7,103,808
Vested and expected to vest at March 31, 20248,050,310$4.13$17,126,855

2021 Equity Incentive Plan

In June 2021 the Company's stockholders approved the 2021 Omnibus Equity Incentive Plan ("2021 Plan"). The number of authorized shares in the 2021 Plan is equal to the sum of (i)3,150,000 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. On June 9, 2022, the shareholders approved an increase of shares authorized in the 2021 Plan to 5,150,000 from 3,150,000. As of March 31, 2024, there were 307,279 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, 2024, an aggregate of 1,380,248 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, including both liability and equity classifications is presented below:

Total WarrantsWeighted-AverageExercise PricePer ShareWeighted-AverageRemaining ContractualTerm
Balance outstanding, December 31, 20232,807,948$2.451.9 years
Balance outstanding, March 31, 20242,807,948$2.451.7 years
  1. 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 three months ended March 31, 2024 and 2023 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. The Company also has a legacy license agreement in the field of oncology diagnostics under which royalty payments are due. These royalty payments are calculated as a percent of revenue. For the three months ended March 31, 2024 and 2023, payments have not been material.

Litigation

Cardiff Oncology does not believe that it has legal liabilities that are probable or reasonably possible that require either accrual or disclosure. 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.

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