ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Company Overview
We are a clinical-stage biotechnology company, headquartered in San Diego, CA, leveraging Polo-like Kinase 1 (“PLK1”) inhibition to develop novel therapies across a range of cancers. Our lead asset is onvansertib, a PLK1 inhibitor that is being evaluated in combination with standard of care therapies in clinical programs targeting indications such as KRAS/NRAS-mutated metastatic colorectal cancer, metastatic pancreatic cancer, as well as investigator-initiated trials in triple negative breast cancer and small cell lung cancer. These programs and our broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the standard of care alone. Our common stock is listed on the Nasdaq Capital Market under the ticker symbol "CRDF".
Company Updates
On February 2, 2023 we announced the appointment of Fairooz Kabbinavar, M.D., FACP, as Chief Medical Officer.
On January 11, 2022 we announced the appointment of Tod Smeal, Ph.D., as Chief Scientific Officer and Charles Monahan, R.Ph., as Senior Vice President, Regulatory Affairs.
Our accumulated deficit through December 31, 2022 is $298.1 million. To date, we have generated minimal revenues and expect to incur additional losses to perform further research and development activities.
Our drug development efforts are in their early stages, and we cannot make estimates of the costs or the time that our development efforts will take to complete, or the timing and amount of revenues related to the sale of our drugs. 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
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research and development expenses, and competing technologies being developed by organizations with significantly greater resources.
Critical Accounting Estimate
Our accounting policies are described in Part II, Item 8. Financial Statements—Note 2 Basis of Presentation and Summary of Significant Accounting Policies in this Annual Report on Form 10-K. The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. We believe that the following discussion represents our critical accounting estimates.
Accrued Clinical Trial Expenses
We accrue and expense research and development expenditures as incurred, which include costs related to clinical trial activities. We accrue costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by the Clinical Research Organizations ("CROs"), professional service providers, and other vendors providing clinical trial services (collectively, the “service providers”). We accrue costs based on estimated work completed in accordance with agreements established with our service providers. We determine the estimated costs through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Due to the nature of estimates, we cannot assure you that we will not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical trial activities.
Results of Operations
Years Ended December 31, 2022 and 2021
Revenues
Our total revenues were $386,000 and $359,000 for the years ended December 31, 2022 and 2021, respectively. Revenues are from our annual minimum or sales-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:
For the years ended December 31,
(in thousands) 2022 2021 Increase/(Decrease)
Clinical trials, outside services, and lab supplies 20,556 14,174 6,382
Research and development expenses increased by $9.7 million to $27.1 million for the year ended December 31, 2022 from $17.4 million for the year ended December 31, 2021. The overall increase in expenses was primarily related to CMC, clinical pharmacology and for studies to support the development of our lead drug candidate, onvansertib. Salaries and staff costs increased primarily due to additional hires in senior management and our clinical operations team (research and development average headcount grew by 93% over the comparative period). The increase in stock-based compensation is primarily due to additional stock option grants to employees granted subsequent to the prior period.
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Selling, General and Administrative Expenses
Selling, general and administrative expenses consisted of the following:
For the years ended December 31,
(in thousands) 2022 2021 Increase/(Decrease)
Outside services and professional fees 4,192 4,439 (247)
Selling, general and administrative expenses increased by $1.3 million to $13.2 million for the year ended December 31, 2022, from $11.8 million for the year ended December 31, 2021. Salaries and staff costs increased due to merit increases and higher headcount (average headcount grew by 30% over the comparative period). The increase in stock-based compensation is primarily due to additional stock option grants to employees granted subsequent to the prior period. Facilities and other costs increased due to higher insurance costs and the amending of our operating lease. The decrease in outside services is primarily related to strategic valuation consulting related to our lead drug candidate, onvansertib performed during the prior period.
Net Loss
Net loss and per share amounts were as follows:
For the years ended December 31,
(in thousands) 2022 2021 Increase/(Decrease)
Preferred stock dividend (24) (24) —
Net loss per common share — basic and diluted $ (0.89) $ (0.73) $ 0.16
Weighted-average shares outstanding — basic and diluted 43,600 39,030 4,570
The increase of $10.4 million in net loss attributable to common shareholders was primarily the result of an increase in operating expenses for the year ended December 31, 2022 compared to the same period in the prior year. The $0.16 increase in basic and diluted net loss per share was impacted by the increase in net loss attributable to shareholders and was partially offset by the increase in weighted average shares outstanding resulting primarily from the issuance of approximately 2.7 million shares of common stock primarily from the conversion of Series E Convertible Preferred Stock during the twelve months ended December 31, 2022.
Liquidity and Capital Resources
As of December 31, 2022, we had $16.3 million in cash and cash equivalents and $88.9 million in short-term investments. Net cash used in operating activities for the year ended December 31, 2022 was $33.8 million, compared to $23.0 million for the year ended December 31, 2021. Our use of cash was primarily a result of the net loss of $38.7 million for the year ended December 31, 2022, adjusted for non-cash items mainly related to stock-based compensation of $4.3 million, and amortization of premiums on short-term investments of $0.6 million. The net change in our operating assets and liabilities was $0.4 million increasing cash used in operations. At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow for the next several years.
Net cash provided by investing activities was $38.1 million primarily related to sales and maturities in excess of purchases of marketable securities, partially offset by purchases of capital equipment during the year ended December 31, 2022,
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compared to net cash used in investing activities of $131.4 million for net purchases of marketable securities during the same period in 2021.
Net cash provided by financing activities was $0.1 million from the exercise of stock options during the year ended December 31, 2022, compared to $35.5 million of proceeds from the sale of common stock and proceeds from warrant exercises for the same period in 2021.
As of December 31, 2022 and 2021, we had working capital of $103.5 million and $139.6 million, respectively. The decrease in working capital is primarily due to the net loss partially offset by the increase in cash and cash equivalents from financing activities during the year ended December 31, 2022.
We have incurred net losses since our inception and have negative operating cash flows. As of December 31, 2022, we had $105.3 million in cash, cash equivalents and short-term investments and we believe we have sufficient cash to meet our funding requirements for at least the next 12 months following the issuance date of these financial statements. Based on our current projections we expect that our capital resources are sufficient to fund our operations into 2025.
For the foreseeable future, we expect to continue to incur losses and require additional capital to further advance our clinical trial programs and support our other operations. We cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience additional dilution.
Our working capital requirements will depend upon numerous factors including but not limited to the nature, cost and timing of our research and development programs. To date, our sources of cash have been primarily limited to the sale of equity securities. We cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more product candidates, all of which may have a material adverse impact on our operations. We may also be required to (i) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (ii) relinquish or otherwise dispose of rights to technologies, product candidates or products that we would otherwise seek to develop or commercialize ourselves on unfavorable terms. We are evaluating all options to raise additional capital, increase revenue, as well as reduce costs, in an effort to strengthen our liquidity position, which may include the following: (1) Raising capital through public and private equity offerings; (2) Introducing operation and business development initiatives to bring in new revenue streams; (3) Reducing operating costs by identifying internal synergies; and (4) Engaging in strategic partnerships. We continually assess our spending plans to effectively and efficiently address our liquidity needs.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
All financial information required by this Item is attached hereto at the end of this report beginning on page F-1 and is hereby incorporated by reference.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Our principal executive officer and principal financial officer evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2022. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the
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Securities and Exchange Commission’s rules and forms. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Annual Report on Form 10-K.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Exchange Act Rule 13a-15(f). Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
As of December 31, 2022, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, our management concluded that, as of December 31, 2022, our internal control over financial reporting was effective based on those criteria.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting during the quarter ended December 31, 2022, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item is incorporated by reference from the information contained in our Definitive Proxy Statement to be filed with the Securities and Exchange Commission in connection with the Annual Meeting of Stockholders to be held in 2023 (the “2023 Proxy Statement”), under the heading “Election of Directors.”
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is incorporated by reference from the information contained in the 2023 Proxy Statement under the heading “Executive Compensation.”
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this item is incorporated by reference from the information contained in the 2023 Proxy Statement under the headings “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.”
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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this item is incorporated by reference from the information contained in the 2023 Proxy Statement under the headings “Family Relationships and other Arrangements.”
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this item is incorporated by reference from the information contained in the 2023 Proxy Statement under the heading “Proposal 2: Ratification of the Appointment of Our Independent Registered Public Accounting Firm for Fiscal Year Ending December 31, 2023.”
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PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
ExhibitNumber Description of Exhibit
(a)(1) Financial Statements
(b) Exhibits
ExhibitNumber Description
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23.1 Consent of BDO USA, LLP.
24 Power of Attorney (included on signature page hereto).
101.INS XBRL Instance Document.
101.SCH XBRL Taxonomy Extension Schema.
101.CAL XBRL Taxonomy Extension Calculation Linkbase.
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101.LAB XBRL Taxonomy Extension Labels Linkbase.
101.PRE XBRL Taxonomy Extension Presentation Linkbase.
101.DEF XBRL Taxonomy Extension Definition Linkbase.
+ Indicates a management contract or compensatory plan or arrangement.
* The SEC has granted confidential treatment with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC.
ITEM 16. FORM 10-K SUMMARY
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
/s/ Mark Erlander
3/2/2023 Chief Executive Officer (Principal Executive Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Mark Erlander as his or her attorney-in-fact, with full power of substitution and resubstitution, for him or her in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
SIGNATURE TITLE DATE
/s/ Mark Erlander Chief Executive Officer 3/2/2023
Mark Erlander (Principal Executive Officer)
/s/ James Levine Chief Financial Officer 3/2/2023
James Levine (Principal Financial and Accounting Officer)
/s/ Rodney S. Markin Chairman of the Board and Director 3/2/2023
Rodney S. Markin
/s/ James O. Armitage Director 3/2/2023
James O. Armitage
/s/ Mani Mohindru Director 3/2/2023
Mani Mohindru
/s/ Gary W. Pace Director 3/2/2023
Gary W. Pace
/s/ Renee Tannenbaum Director 3/2/2023
Renee Tannenbaum
/s/ Lâle White Director 3/2/2023
Lâle White
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CARDIFF ONCOLOGY, INC.
Index to Financial Statements
Balance Sheets F-4
Statements of Operations F-5
Statements of Comprehensive Loss F-6
Statements of Stockholders’ Equity F-7
Statements of Cash Flows F-8
Notes to Financial Statements F-9
F-1
Report of Independent Registered Public Accounting Firm
Board of Directors and Stockholders
Cardiff Oncology, Inc.
San Diego, California
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Cardiff Oncology, Inc. (the “Company”) as of December 31, 2022 and 2021, the related statements of operations, comprehensive loss, stockholders’ equity, and cash flows for the years then ended, and related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee of the Company’s board of directors and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.
Accrued clinical trial expenses
As disclosed in Note 2 to the financial statements, the Company expenses research and development expenditures as incurred, which include costs relating to clinical trial activities. The Company accrues costs for clinical trial activities based upon estimates of the services performed and costs incurred that have not been invoiced by the service providers. The Company’s clinical trial accrual balance at December 31, 2022 is $2.3 million, and the Company’s related 2022 clinical trial expenses are included in research and development expense of $27.1 million for the year ended December 31, 2022.
We identified accrued clinical trial expenses as a critical audit matter. When estimating clinical trial expenses, the Company considers several factors including clinical trial budgets, contract amendments and the progress toward completion. These
F-2
factors are our principal considerations due to the level of management estimation involved. Auditing these elements involves especially challenging auditor judgment due to the nature and extent of audit effort required to address these matters.
The primary procedures we performed to address the critical audit matter included:
•Testing management’s estimation of accrued clinical trial expenses by (i) obtaining and inspecting significant agreements, clinical trial budgets, and contract amendments, (ii) evaluating the Company’s documentation of trial progress and status (including consideration of patient enrollment and milestones achieved), (iii) confirming clinical trial expenses incurred, cash paid by the Company, and any unbilled amounts directly with third party service providers, and (iv) agreeing clinical trial accruals to the terms within the clinical trial agreements, budgets, and amendments.
•Testing the completeness of the Company’s clinical trial accruals by (i) inspecting board of directors’ minutes to identify clinical trials, (ii) evaluating publicly available information (such as press releases, investor presentations and public databases that track clinical trials) which identify and discuss the status of clinical trials, (iii) inquiring of clinical staff outside of finance to gain an understanding of the status of significant on-going clinical trials, and (iv) testing a sample of payments subsequent to year end to evaluate the completeness of clinical trial accruals.
/s/ BDO USA, LLP
We have served as the Company’s auditor since 2007.
San Diego, California
March 2, 2023
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Cardiff Oncology, Inc.
Balance Sheets
(in thousands, except par value)
Assets
Current assets:
Accounts receivable and unbilled receivable 771 535
Prepaid expenses and other current assets 5,246 4,771
Property and equipment, net 1,269 382
Operating lease right-of-use assets 2,251 2,796
Liabilities and Stockholders’ Equity
Current liabilities:
Operating lease liabilities 675 551
Other current liabilities — 42
Operating lease liabilities, net of current portion 2,040 2,568
Commitments and contingencies (Note 10)
Stockholders’ equity
Service receivable — (139)
Accumulated other comprehensive loss (395) (142)
Total Liabilities and Stockholders’ Equity $ 116,191 $ 149,544
The accompanying notes are an integral part of these financial statements.
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Cardiff Oncology, Inc.
Statements of Operations
(in thousands, except per share amounts)
Year Ended December 31,
Costs and expenses:
Other income (expense), net:
Other income (expense), net (383) 15
Net loss attributable to common stockholders $ (38,728) $ (28,315)
Net loss per common share — basic and diluted $ (0.89) $ (0.73)
Weighted-average shares outstanding — basic and diluted 43,600 39,030
The accompanying notes are an integral part of these financial statements.
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Cardiff Oncology, Inc.
Statements of Comprehensive Loss
(in thousands)
Year Ended December 31,
Other comprehensive loss:
Unrealized loss on securities available-for-sale (253) (142)
Comprehensive loss attributable to common stockholders $ (38,981) $ (28,457)
The accompanying notes are an integral part of these financial statements.
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Cardiff Oncology, Inc.
Statements of Stockholders’ Equity
(in thousands)
Stock-based compensation — — — — 3,234 — — — 3,234
Issuance of common stock upon exercise of warrants — — 771 — 1,263 — — — 1,263
Other comprehensive loss — — — — — — (142) — (142)
Release of clinical trial funding commitment — — — — — 2,032 — — 2,032
Stock-based compensation — — — — 4,256 — — — 4,256
Issuance of common stock upon exercise of stock options — — 29 — 75 — — — 75
Other comprehensive loss — — — — — (253) — (253)
Release of clinical trial funding commitment — — — — 139 — — 139
Cumulative preferred stock dividend adjustment(2) — — — — — — — 414 414
(1)Net of expenses of $0.8 million.
(2)See Note 2 to the financial statements.
The accompanying notes are an integral part of these financial statements.
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Cardiff Oncology, Inc.
Statements of Cash Flows
(in thousands)
Year ended December 31,
Operating activities
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on disposal of assets 1 1
Stock-based compensation expense 4,256 3,234
Amortization of premiums on short-term investments 632 1,607
Change in fair value of derivative financial instruments—warrants — (285)
Release of clinical trial funding commitment 139 2,032
Changes in operating assets and liabilities:
Accounts receivable and unbilled receivable (236) (215)
Prepaid expenses and other current assets (443) (2,099)
Operating lease right-of-use assets 545 607
Accounts payable and accrued expenses 1,348 719
Operating lease liabilities (404) (811)
Other liabilities (42) (156)
Net cash used in operating activities (33,820) (23,040)
Investing activities
Insurance proceeds from casualty loss 114 —
Net cash provided by (used in) investing activities 38,149 (131,448)
Financing activities
Proceeds from exercise of warrants — 1,263
Proceeds from exercise of options 75 —
Net cash provided by financing activities 75 35,450
Net change in cash and cash equivalents 4,404 (119,038)
Cash and cash equivalents—Beginning of period 11,943 130,981
Cash and cash equivalents—End of period $ 16,347 $ 11,943
Supplementary disclosure of cash flow activity:
Cash paid for taxes $ 2 $ 1
Supplemental disclosure of non-cash investing and financing activities:
Accretion of Series A Convertible Preferred Stock dividend $ — $ 24
Cumulative preferred stock dividend adjustment(1) $ (414) $ —
(1)See Note 2 to the financial statements.
The accompanying notes are an integral part of these financial statements.
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Cardiff Oncology, Inc.
Notes to Financial Statements
1. Business Overview and Liquidity
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 therapies in clinical programs targeting indications such as KRAS/NRAS-mutated metastatic colorectal cancer, metastatic pancreatic cancer, as well as investigator-initiated trials in triple negative breast cancer and small cell lung cancer. 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 standard of care alone. The Company's common stock is listed on the Nasdaq Capital Market under the ticker symbol "CRDF".
Liquidity
The Company has incurred net losses since its inception and has negative operating cash flows. As of December 31, 2022, the Company had $105.3 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.
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2. Basis of Presentation and Summary of Significant Accounting Policies
The accompanying financial statements of Cardiff Oncology have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
Segment Reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations as, and manages its business in, one operating segment in the United States.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The most significant estimate involves accrued clinical trial expenses.
Accrued Clinical Trial Expenses
The Company expenses research and development expenditures as incurred, which include costs related to clinical trial activities. The Company accrues costs for clinical trial activities based upon estimates of the services received and related expenses incurred that have yet to be invoiced by the Clinical Research Organizations ("CROs"), investigators, professional service providers, and other vendors providing clinical trial services (collectively, the “service providers”). As of December 31, 2022 the Company’s clinical trial accrual balance of $2.3 million is included in accrued liabilities. The Company’s related 2022 clinical trial expenses are included in research and development expense of $27.1 million. Certain clinical trial expenses are released from service receivables classified within equity (see Note 5) as clinical trial services are performed.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents consist of cash in readily available checking and money market accounts.
Investment Securities
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 investment income, as are the amortization of purchase premiums and accretion of purchase discounts on investment securities.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company maintains deposit accounts at financial institutions that are in excess of federally insured limits. The Company has not experienced any losses in such accounts and believes it is not exposed to significant risk on its cash due to the financial position of the depository institution in which those deposits are held. The Company limits its exposure to credit loss by generally placing its cash in high credit quality financial institutions and investment in non FDIC insured money market funds denominated and payable in U.S. dollars.
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Revenues
The Company recognizes revenue when control of its products and services are transferred to its customers in an amount that reflects the consideration it expects to receive from its customers in exchange for those products and services. This process involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. The Company considers a performance obligation satisfied once it has transferred control of goods or service to the customer, meaning the customer has the ability to use and obtain the benefit of goods or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control. For sales-based royalties, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Royalty and License Revenues
The Company licenses and sublicenses its patent rights to healthcare companies, medical laboratories and biotechnology partners. These patents are from the Company's legacy portfolio and unrelated to onvansertib. Agreements may involve multiple elements such as license fees, minimum royalties, usage-based royalties and milestone payments. Revenue is recognized when the criteria described above have been met as well as the following:
•Up-front nonrefundable license fees pursuant to agreements under which the Company has no continuing performance obligations are recognized as revenues on the effective date of the agreement and when collection is probable.
•Minimum royalties are recognized as earned, and royalties are earned based on the licensee’s use. The Company estimates and records licensee’s sales based on historical usage rate and collectability.
•For sales-based royalties, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Payment terms and conditions vary by contracts, although terms generally include a requirement of payment within 30 to 45 days after invoice. Royalties are generally due quarterly or annually.
Derivative Financial Instruments—Warrants
The Company has issued common stock warrants in connection with the execution of certain equity financings. Such warrants are classified as derivative liabilities and are recorded at their fair market value as of each reporting period as they do not meet the criteria for equity classification. Changes in fair value of derivative liabilities are recorded in the statement of operations under the caption “Change in fair value of derivative instruments—warrants.”
The fair value of warrants is determined using the Black-Scholes option-pricing model using assumptions regarding the historical volatility of Cardiff Oncology’s common stock price, the remaining life of the warrants, and the risk-free interest rates at each period end. The Company thus uses model-derived valuations where inputs are observable in active markets to determine the fair value. The use of the Black-Scholes model classifies such warrants as Level 3 (See "Fair Value of Financial Instruments" below). At December 31, 2022 and 2021, the fair value of these warrants was $0, for both periods. These warrants expire in the first quarter of 2023.
Stock-Based Compensation
Stock-based compensation expense is measured at the grant date based on the estimated fair value of the award and is recognized straight-line over the requisite service period of the individual grants, which typically equals the vesting period.
Fair Value of Financial Instruments
Financial instruments consist of cash equivalents, accounts receivable, accounts payable and derivative liabilities. The Company applies ASC 820 for financial assets and liabilities that are required to be measured at fair value and non-financial assets and liabilities that are not required to be measured at fair value on a recurring basis. These financial instruments are stated at their
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respective historical carrying amounts, which approximate fair value due to their short-term nature as they reflect current market interest rates.
The authoritative guidance establishes a fair value hierarchy that is based on the extent and level of judgment used to estimate the fair value of assets and liabilities. In general, the authoritative guidance requires us to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. An asset or liability’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the measurement of its fair value. The three levels of input defined by the authoritative guidance are as follows:
The Company measures certain assets and liabilities at fair value on a recurring basis using the three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The three tiers include:
•Level 1 — Quoted prices for identical instruments in active markets.
•Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations where inputs are observable or where significant value drivers are observable.
•Level 3 — Instruments where significant value drivers are unobservable to third parties.
Long-Lived Assets
Long-lived assets consist of property, equipment and lease right-of-use assets. The Company records property and equipment at cost. Depreciation on property and equipment is calculated using the straight-line method over the estimated useful life of the asset. Depreciation of leasehold improvements is computed based on the shorter of the life of the asset or the term of the lease. The estimated useful lives of the major classes of property and equipment are as follows:
Estimated Useful Lives
Furniture and office equipment 3 to 5 years
Leasehold improvements 4 to 6 years
Laboratory equipment 5 years
Impairment losses on long-lived assets used in operations are recorded when indicators of impairment are present and the undiscounted cash flows estimated to be generated by those assets are less than the assets carrying amount. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets.
Leases
The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease Right-of-Use (“ROU”) assets, current operating lease liabilities and non-current operating lease liabilities in the Company’s balance sheets.
ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. None of the Company’s operating leases provide an implicit rate, therefore the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The incremental borrowing rate is the rate of interest that the Company would expect to pay to borrow on a collateralized and fully amortizing basis over a similar term an amount equal to the lease payments in a similar economic environment. The operating lease ROU asset also includes any lease payments made less lease incentives received. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense is recognized on a straight-line basis over the lease term. Our facilities lease agreement contains lease and non-lease components, such as common area maintenance. We have elected to account for these lease and non-lease components of this agreement as a single lease component.
Leases with an initial term of 12 months or less are not recorded on the Company's balance sheets. These short-term leases are expensed on a straight-line basis over the lease term.
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Income Taxes
Income taxes are determined using the asset and liability approach of accounting for income taxes. Under this approach, deferred taxes represent the future tax consequences expected to occur when the reported amounts of assets and liabilities are recovered or paid. Deferred taxes result from differences between the financial statement and tax bases of Cardiff Oncology’s assets and liabilities and are adjusted for changes in tax rates and tax laws when changes are enacted. Valuation allowances are recorded to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The assessment of whether or not a valuation allowance is required often requires significant judgment.
Revision of Previously Disclosed Amounts
During the course of preparing the Company’s financial statements as of and for the year ended December 31 2022, the Company completed an Internal Revenue Code Section 382 and 383 analysis of its historical net operating loss and tax credit carryforward amounts. As a result, a portion of the prior year net operating loss and tax credit carryforwards were determined to be limited. See Note 9 - Income Taxes, for further details.
Contingencies
In the normal course of business, Cardiff Oncology is subject to loss contingencies, such as legal proceedings and claims arising out of its business, that cover a wide range of matters, including, among others, government investigations, stockholder lawsuits, product and environmental liability, and tax matters. In accordance with FASB ASC Topic 450, Contingencies, Cardiff Oncology records such loss contingencies when it is probable that a liability has been incurred and the amount of loss can be reasonably estimated. Cardiff Oncology, in accordance with this guidance, does not recognize gain contingencies until realized.
Research and Development
Research and development expenses include expenditures in connection with an in-house research and development laboratory, salaries and staff costs, clinical trials, purchased in-process research and development and regulatory and scientific consulting fees, as well as contract research and insurance. Also, patent filing and patent maintenance expenses are considered legal in nature and therefore classified as general and administrative expense, if any.
Non-refundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. As the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided, the deferred amounts are recognized as an expense.
Upfront and milestone payments to acquire contractual rights to licensed technology are expensed when incurred if there is uncertainty in the Company receiving future economic benefit from the acquired contractual rights. Certain contractual rights may require the Company to make additional milestone payments based on development and commercial milestones, and royalties based on sales volume. See Note 10 - Commitments and Contingencies, for further details.
These potential development milestones include: dosing of the first subject in the first Phase III Clinical Trial for the first Product or after completion of a Phase II Clinical Trial that is used as the basis for an NDA submission; and upon filing of the first NDA or equivalent for the first product
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. The accretion of Series A Convertible Preferred Stock dividends and deemed dividends recognized in connection with certain preferred share issuances 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. Shares used in calculating diluted net loss per common share exclude as anti-dilutive the following share equivalents:
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December 31,
Series A Convertible Preferred Stock 877 877
Series E Convertible Preferred Stock — 2,684,607
Correction of Series A Convertible Preferred Stock cumulative dividend liability
During the fourth quarter of 2022, the Company identified an immaterial error related to the accrual of a liability for the accretion of cumulative preferred dividends on the Company's Series A Convertible Preferred Stock. These cumulative preferred dividends do not meet the definition of a liability, as they have not been declared by the Company's Board of Directors. The Company has recorded an adjustment of $0.4 million within accumulated deficit and accrued liabilities for the year ended December 31, 2022 to correct this immaterial error.
Recently Adopted Accounting Pronouncement
In May 2021, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update ("ASU") No. 2021-04 ("ASU 2021-04"), Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force). The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company has prospectively adopted this standard as of January 1, 2022 for periods presented after the adoption. The adoption of ASU 2021-04 did not have a material impact on the Company's financial statements.
Recent Accounting Pronouncement Not Yet Adopted
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 is currently evaluating the impact of this standard on its financial statements and related disclosures.
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3. Supplementary Balance Sheet Information
Short-term investments available-for-sale securities consist of the following:
Maturity less than 1 year:
Maturity 1 to 2 years:
Maturity less than 1 year:
Certificate of deposit $ 1,260 $ — $ — $ 1,260
Non U.S. government 728 — — 728
Maturity 1 to 2 years:
For the year ended December 31, 2022 the net realized loss recorded within the Company's statement of operations from the sale of short-term investments was $0.2 million. The amount of gains and losses reclassified out of other comprehensive income for the period related to the sales of short-term investments was not material for the year ended December 31, 2022.
Unrealized losses in investments available for sale debt securities at December 31, 2022, were primarily due to increases in interest rates, not due to increased credit risks associated with specific securities. 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:
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(in thousands) Fair Market Value Gross Unrealized Loss
Corporate debt securities $ 17,084 $ (161)
U.S. treasury securities 3,666 (14)
Total short-term investments $ 20,750 $ (175)
Property and Equipment
Fixed assets consist of furniture and office equipment, leasehold improvements and laboratory equipment. Depreciation expense for property and equipment for the years ended December 31, 2022 and 2021 was $0.2 million and $0.5 million, respectively. Property and equipment consisted of the following:
As of December 31,
Furniture and office equipment $ 1,066 $ 955
Less—accumulated depreciation (3,413) (3,441)
Property and equipment, net $ 1,269 $ 382
Accrued Liabilities
Accrued liabilities consisted of the following:
As of December 31,
Preferred stock dividend(1) — 414
Research agreements and services 509 726
Patent, license and other fees 24 43
Other accrued liabilities 337 129
Total accrued liabilities $ 5,177 $ 4,527
(1)See Note 2 to the financial statements.
4. Leases
As a lessee, the Company’s current leases include its master facility lease and immaterial equipment leases, all of which are considered operating leases.
Master Facility Lease
During July 2021, the Company entered into an amended lease agreement to increase its occupied space, which commenced on January 1, 2022 and expires on February 28, 2027. Under the Company's prior master facility lease which expired on December 31, 2021, the Company was leasing additional suites in which it was not occupying and subleasing to third parties. The amended lease agreement retained the space that the Company was occupying, and a portion of office and lab space that was previously subleased to a third party. The remaining additional suites subleased to third parties were not included in the Company's amended sublease. The Company currently leases office and lab space in San Diego which expires on February 28, 2027. The lease currently required payments of approximately $61,000 per month with 3% annual escalation.
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Facility Subleases
As a result of corporate restructurings in previous years, the Company vacated a portion of its facility and has subleased the space to third parties under three separate sublease agreements, which all expired on December 31, 2021. Prior to the expiration of the sublease agreements, the Company as a sublessor was leasing its vacated space to third parties.
The components of lease expense were as follows:
Operating lease cost $ 754 $ 745
Operating sublease income — (403)
Net operating lease cost $ 754 $ 342
Supplemental balance sheet information related to leases was as follows:
(in thousands) As of December 31, 2022 As of December 31, 2021
Operating lease ROU assets $ 2,251 $ 2,796
Current operating lease liabilities $ 675 $ 551
Non-current operating lease liabilities 2,040 2,568
Total operating lease liabilities $ 2,715 $ 3,119
Weighted-average remaining lease term–operating leases 4.2 years 5.2 years
Weighted-average discount rate–operating leases 7 % 7 %
Supplemental cash flow and other information related to leases was as follows:
Cash paid for amounts included in the measurement of lease liabilities:
Cash paid included in operating cash flows $ 612 $ 949
ROU assets obtained in exchange for lease obligations:
Operating leases $ — $ 3,061
Total remaining annual commitments under non-cancelable operating lease agreements as of December 31, 2022, are summarized are as follows:
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(in thousands)
Year Ending December 31, Operating Leases
Total future minimum lease payments $ 3,137
Less imputed interest (422)
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5. Stockholders’ Equity
Warrants
A summary of warrant activity and changes in warrants outstanding, including both liability and equity classifications, is presented below:
Preferred Stock
A summary of our Company's classes of preferred stock is presented below:
Shares issued and outstanding
Series B Convertible Preferred Stock $ 0.001 8,860 — —
Series C Convertible Preferred Stock $ 0.001 200,000 — —
Series D Convertible Preferred Stock $ 0.0001 154,670 — —
Series A Convertible Preferred Stock
The material terms of the Series A Convertible Preferred Stock consist of:
1)Dividends. Holders of the Company’s Series A Convertible Preferred Stock are entitled to receive cumulative dividends at the rate per share of 4% per annum, payable quarterly on March 31, June 30, September 30 and December 31, beginning with September 30, 2005. Dividends are payable, at the Company’s sole election, in cash or shares of common stock. As of December 31, 2022 and 2021, the Company had $438,000 and $414,000, respectively in cumulative unpaid preferred stock dividends, included in the liquidation preference of the Series A Convertible Preferred Stock, and $24,000 and $24,000 of cumulative dividends were added to the liquidation preference of the Series A Convertible Preferred Stock during the years ended December 31, 2022 and 2021, respectively.
2)Voting Rights. Shares of the Series A Convertible Preferred Stock have no voting rights. However, so long as any shares of Series A Convertible Preferred Stock are outstanding, the Company may not, without the affirmative vote of the holders of the shares of Series A Convertible Preferred Stock then outstanding, (a) adversely change the powers, preferences or rights given to the Series A Convertible Preferred Stock, (b) authorize or create any class of stock senior or equal to the Series A Convertible Preferred Stock, (c) amend its certificate of incorporation or other charter documents, so as to affect adversely any rights of the holders of Series A Convertible Preferred Stock or (d) increase the authorized number of shares of Series A Convertible Preferred Stock.
3)Liquidation. Upon any liquidation, dissolution or winding-up of the Company, the holders of the Series A Convertible Preferred Stock are entitled to receive an amount equal to the Stated Value per share, which is currently $10 per share plus any accrued and unpaid dividends.
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4)Conversion Rights. Each share of Series A Convertible Preferred Stock is convertible at the option of the holder into that number of shares of common stock determined by dividing the Stated Value, currently $10 per share, by the conversion price, which at the time of issuance was $928.80 per share, and subsequently adjusted to $691.20 per share.
5)Subsequent Equity Sales. The conversion price is subject to adjustment for dilutive issuances for a period of 12 months beginning March 17, 2006 and the conversion price was adjusted to $691.20 per share.
6) Automatic Conversion. If the price of the Company’s common stock equals $1,857.60 per share for 20 consecutive trading days, and an average of 116 shares of common stock per day are traded during the 20 trading days, the Company will have the right to deliver a notice to the holders of the Series A Convertible Preferred Stock, requesting the holders to convert any portion of the shares of Series A Convertible Preferred Stock into shares of common stock at the applicable conversion price. As of the date of these financial statements, such conditions have not been met.
The components of the liquidation preference for the Series A Convertible Preferred Stock were as follows:
As of December 31,
Stated Value per share liquidation $ 606 $ 606
Cumulative unpaid preferred stock dividends 438 414
Liquidation preference - Series A Convertible Preferred Stock $ 1,044 $ 1,020
Series E Convertible Preferred Stock
On June 15, 2020 the Company entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which the Company agreed to offer, issue and sell to Acorn, CDK and Third Street, (i) in a registered direct offering, an aggregate of 1,984,328 shares of common stock and (ii) in a concurrent private placement, (a) an aggregate of 865,824 shares of Series E Preferred Stock (“Series E Preferred Stock”) and (b) Series N warrants to purchase up to 2,213,115 shares of Common Stock. The Series E Preferred Stock is convertible at any time determined by dividing the $10 stated value per share of the Series E Preferred Stock by a conversion price of $2.44 per share, subject to adjustment in accordance with the Certificate of Designation. The Series N Warrants will be exercisable six months following the date of issuance at an exercise price of $2.39 per share and will expire on December 16, 2025. Certain investors converted 210,780 shares of Series E Convertible Preferred stock to 863,852 shares of Common Stock during December 2020. Certain investors converted 327,535 shares of Series E Convertible Preferred stock to 1,342,357 shares of Common Stock during January 2022. Certain investors converted 327,509 shares of Series E Convertible Preferred stock to 1,342,250 shares of Common Stock during October 2022. As of December 31, 2022 no shares of Series E Convertible Preferred stock were outstanding.
In conjunction with the June 15, 2020 offering, we issued 184,426 warrants as an advisory fee. These warrants are exercisable six months following the date of issuance at an exercise price of $3.05 per share and will expire 5.5 years following the date of issuance. These warrants were classified as equity.
Sales Agreement with Jefferies LLC
During May 2021, the Company sold 2.0 million shares of its common stock under the Sales Agreement with Jefferies LLC., for gross proceeds of approximately $20.0 million.
Pfizer Breakthrough Growth Initiative
During November 2021, the Company sold 2.4 million shares of its common stock under a Securities Purchase Agreement with Pfizer Inc. ("Pfizer"), in a registered direct offering for gross proceeds of approximately $15.0 million. The investment is part of the Pfizer Breakthrough Growth Initiative, which includes an information rights agreement and Pfizer's participation on a Scientific Advisory Board for the Company. Pfizer agreed to not sell or transfer any shares for 180 days from the closing date of the agreement, which expired during May 2022.
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6. Stock-Based Compensation
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. As of December 31, 2022, there were 3,087,075 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
In July 2021, the Company began issuing equity awards to certain new employees as inducement grants outside of its 2021 Plan. As of December 31, 2022, an aggregate of 920,208 shares were issuable upon the exercise of inducement grant stock options approved by the Company.
Modification of Stock Options
In June 2022 one of the Company's directors did not seek another term on the Board of Directors. At the time of departure, the Compensation Committee passed a resolution to extend the expiration date of the vested stock options, and to immediately accelerate the vesting of the unvested options. The Company recorded incremental reduction to stock compensation expense of $0.1 million during the year ended December 31, 2022, related to the modifications.
In June 2021 two of the Company's directors' terms ended. At the conclusion of their term, the Compensation Committee passed a resolution to extend the expiration date of the departing directors vested stock options, and to immediately accelerate the vesting of one of the directors unvested options. The Company recorded incremental stock compensation expenses of $0.6 million during the year ended December 31, 2021, related to the modifications.
Stock-based compensation has been recognized in operating results as follows:
(in thousands) Years ended December 31,
Research and development expenses 1,035 491
Selling, general and administrative expenses 3,221 2,743
Total stock-based compensation $ 4,256 $ 3,234
Stock Options
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 years indicated below:
Years ended December 31,
Dividend yield 0% 0%
Expected volatility (weighted-average) 106% 108%
Expected term (in years) 6.0 years 6.0 years
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Risk-free interest rate — Based on the daily yield curve rates for U.S. Treasury obligations with maturities that correspond to the expected term of the Company’s stock options.
Dividend yield — Cardiff Oncology has not paid any dividends on common stock since its inception and does not anticipate paying dividends on its common stock in the foreseeable future.
Expected volatility — Based on the historical volatility of Cardiff Oncology’s common stock.
Expected term — The expected option term represents the period that stock-based awards are expected to be outstanding based on the simplified method, which represents the Company's best estimate following the Company's restructuring in 2018. This method averages an award’s weighted-average vesting period and expected term for “plain vanilla” share options. Options are considered to be “plain vanilla” if they have the following basic characteristics: (1) are granted “at-the-money”; (2) exercisability is conditioned upon service through the vesting date; (3) termination of service prior to vesting results in forfeiture; (4) limited exercise period following termination of service; and (5) are non-transferable and non-hedgeable.
Forfeitures — The Company estimates forfeitures based on its historical experience.
The weighted-average fair value per share of all options granted during the years ended December 31, 2022 and 2021, estimated as of the grant date using the Black-Scholes option valuation model, was $2.55 and $5.96 per share, respectively.
The unrecognized compensation cost related to non-vested stock options outstanding at December 31, 2022 was $8.8 million. The weighted-average remaining amortization period at December 31, 2022 for non-vested stock options was 2.6 years.
The total fair value of shares vested during the years ended December 31, 2022 and 2021 was $4.7 million and $1.2 million, respectively.
A summary of stock option activity and of changes in stock options outstanding is presented below:
7. Derivative Financial Instruments — Warrants
Certain warrants issued in connection with the Company’s equity financings are accounted for as derivative liabilities. Accordingly, the warrants are remeasured at each balance sheet date based on their estimated fair value using the Black-Scholes option pricing model. Changes in fair value are recorded within Company’s statements of operations.
The assumptions used to determine the fair value of the warrants using the Black-Scholes option pricing model were:
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As of December 31,
Fair value of Cardiff Oncology common stock $1.40 $6.01
Expected warrant term 0.1 years 1.1 years
Risk-free interest rate 4.12 % 0.41 %
Expected volatility of Cardiff Oncology common stock 54 % 83 %
Dividend yield 0 % 0 %
Expected volatility is based on the historical volatility of Cardiff Oncology’s common stock. The warrants have a transferability provision and based on guidance for instruments issued with such a provision, Cardiff Oncology used the remaining contractual term as the expected term of the warrants. The risk-free interest rate is based on the U.S. Treasury security rates consistent with the expected remaining term of the warrants at each balance sheet date.
The following table sets forth the components of changes in the Company’s derivative financial instruments—warrants liability balance, valued using the Black-Scholes option pricing method, for the periods indicated.
(in thousands, except for number of warrants)
Date Description Number of Warrants DerivativeInstrumentLiability
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8. 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 December 31, 2022 and 2021:
Fair Value Measurements atDecember 31, 2022
Assets:
Total included in cash and cash equivalents $ 15,722 $ — $ — $ 15,722
Available for sale investments:
Fair Value Measurements atDecember 31, 2021
Assets:
Total included in cash and cash equivalents $ 10,990 $ — $ — $ 10,990
Available for sale investments:
Certificate of deposit $ — $ 1,260 $ — $ 1,260
Non U.S. government — 728 — 728
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 years ended December 31, 2022 and 2021.
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9. Income Taxes
At December 31, 2022, Cardiff Oncology had federal net operating loss carryforwards (“NOLs”) of approximately $5.1 million which, if not used, will continue to expire through 2037, and federal net operating loss carryforwards of approximately $85.8 million, which do not expire. Cardiff Oncology also has California NOLs of approximately $17.3 million which, if not used, will begin to expire in 2029. Cardiff Oncology also has research and development tax credits available for federal and California purposes of approximately $1.0 million and $2.3 million, respectively. The federal research and development tax credits will begin to expire on January 31, 2025. The California research and development tax credits do not expire.
Pursuant to the Internal Revenue Code of 1986, as amended (the “Code”) Sections 382 and 383, annual use of a company’s NOL and research and development credit carryforwards may be limited if there is a cumulative change in ownership of greater than 50% within a three-year period. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. If limited, the related tax asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. The Company has established a valuation allowance as the realization of such deferred tax assets has not met the more likely than not threshold requirement. Due to the existence of the valuation allowance, further changes in the Company’s unrecognized tax benefits will not impact the Company’s effective tax rate.
During 2022, the Company completed an assessment of the available net operating loss and tax credit carryforwards under Section 382 and 383 and determined that the Company underwent two ownership changes during the period from 2014 to 2022. As a result, net operating loss and tax credit carryforwards attributable to the pre-ownership changes are subject to substantial annual limitations under Section 382 and 383 of Code due to the ownership changes. The Company has adjusted their net operating loss and tax credit carryforwards to address the impact of the ownership changes. This resulted in a reduction of available gross federal and state net operating loss carryforwards of approximately $123.9 million and $62.8 million, respectively which related to the year ended December 31, 2021 and prior. The tax effected federal and state NOL amounts were $26.0 million and $4.4 million respectively. This also resulted in a reduction of federal tax credit carryforwards of approximately $1.8 million related to the years ended December 31, 2021 and prior. Accordingly, the net operating loss and tax credit carryforwards presented below for the year ending December 31, 2021 were reduced by $30.4 million and $1.8 million, respectively, with a corresponding reduction to the valuation allowance of $32.2 million.
The provision for income taxes based on losses from continuing operations consists of the following at December 31:
Years ended December 31,
Current:
State $ — $ 1
Total current provision — 1
Deferred:
Total deferred (benefit) expense 23,956 (6,082)
Total income tax provision $ — $ —
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Significant components of the Company’s taxes and the rates as of December 31 are shown below:
Years ended December 31,
(in thousands, except percentages) 2022 2021
Tax computed at the federal statutory rate $ (8,128) 21 % $ (5,941) 21 %
State tax, net of federal tax benefit (518) 1 % (233) 1 %
Stock based compensation 553 (1) % 325 (1) %
Research and development credits (319) 1 % (366) 1 %
Return to provision and true ups — — % — — %
Other (1) — % 72 — %
Valuation allowance increase (decrease) (23,956) 62 % 6,081 (22) %
Provision for income taxes $ — — % $ — — %
Significant components of the Company’s deferred tax assets and liabilities from federal and state income taxes as of December 31 are shown below (in thousands):
Years ended December 31,
Deferred tax assets:
Research and development credits and other tax credits 2,743 2,226
Capitalized research and development 4,794 —
Deferred tax liabilities:
Operating lease right-of-use assets (492) (611)
Other — —
Total deferred tax liabilities (492) (611)
Net deferred tax assets before valuation allowance 30,082 21,833
Net deferred tax asset $ — $ —
Since inception the Company has incurred continuing losses and expects to continue to incur losses for the foreseeable future. The Company has recorded a full valuation allowance against its net deferred tax assets as it is more likely than not they will not be realized.
Cardiff Oncology does not have any unrecognized tax benefits. Cardiff Oncology’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense, and none have been incurred to date. The Company does not anticipate a significant change in unrecognized tax benefits over the next 12 months. The Company is subject to taxation in the U.S. and California. Due to net operating losses all tax years since inception remain open to examination.
10. Commitments and Contingencies
Executive Agreements
Certain executive agreements provide for severance payments in case of terminations without cause or certain change of control scenarios.
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Research and Development and Clinical Trial 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: dosing of the first subject in the first Phase III Clinical Trial for the first Product or after completion of a Phase II Clinical Trial that is used as the basis for an NDA submission; and upon filing of the first NDA or equivalent for the first product. During the years ended December 31, 2022 and 2021, no milestone or royalty payments were made.
The Company is a party of 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. During the years ended December 31, 2022 and 2021 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 it believes will result in a material adverse effect on the Company’s business or financial condition.
11. Employee Benefit Plan
The Company has a defined contribution retirement plan under Section 401(k) of the Internal Revenue Service ("IRS") Code covering its employees. The plan allows employees to defer, up to the maximum allowed, a percentage of their income through contributions to the plan as allowed by IRS Code. The Company does not currently make matching contributions.
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