Cardiff Oncology, Inc. 10-Q

ITEM 1. FINANCIAL STATEMENTS CARDIFF ONCOLOGY, INC. CONDENSED BALANCE SHEETS (in thousands, except par value) (Unaudited) March 31, 2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $ 15,017 $ 16,347 Short-term investments 81,951 88,920 Accounts receivable and unbilled receivable 676 771 Prepaid expenses and other current assets 4,109 5,246 Total current assets 101,753 111,284 Property and equipment, net 1,320 1,269 Operating lease right-of-use assets 2,115 2,251 Other assets 1,361 1,387 Total Assets $ 106,549 $ 116,191 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 2,914 $ 1,956 Accrued liabilities 4,555 5,177 Operating lease liabilities 679 675 Total current liabilities 8,148 7,808 Operating lease liabilities, net of current portion 1,898 2,040 Total Liabilities 10,046 9,848 Commitments and contingencies (Note 7) Stockholders’ equity Preferred stock, 20,000 shares authorized; Series A Convertible Preferred Stock liquidation preference $ 1,050 and $ 1,044 at March 31, 2023 and December 31, 2022, respectively (Note 6) — — Common stock, $ 0.0001 par value, 150,000 shares authorized; 44,677 and 44,677 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively 4 4 Additional paid-in capital 405,898 404,834 Accumulated other comprehensive loss ( 76 ) ( 395 ) Accumulated deficit ( 309,323 ) ( 298,100 ) Total stockholders’ equity 96,503 106,343 Total liabilities and stockholders’ equity $ 106,549 $ 116,191 See accompanying notes to the unaudited condensed financial statements. 3 Table of Contents CARDIFF ONCOLOGY, INC. CONDENSED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended March 31, 2023 2022 Royalty revenues $ 83 $ 74 Costs and expenses: Research and development 9,052 7,208 Selling, general and administrative 3,083 3,940 Total operating expenses 12,135 11,148 Loss from operations ( 12,052 ) ( 11,074 ) Other income (expense), net: Interest income, net 940 130 Other income (expense), net ( 111 ) ( 49 ) Total other income (expense), net 829 81 Net loss ( 11,223 ) ( 10,993 ) Preferred stock dividend payable on Series A Convertible Preferred Stock ( 6 ) ( 6 ) Net loss attributable to common stockholders $ ( 11,229 ) $ ( 10,999 ) Net loss per common share — basic and diluted $ ( 0.25 ) $ ( 0.25 ) Weighted-average shares outstanding — basic and diluted 44,677 43,231 See accompanying notes to the unaudited condensed financial statements. 4 Table of Contents CARDIFF ONCOLOGY, INC. CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (in thousands) (Unaudited) Three Months Ended March 31, 2023 2022 Net loss $ ( 11,223 ) $ ( 10,993 ) Other comprehensive loss: Unrealized gain (loss) on securities available-for-sale 319 ( 606 ) Total comprehensive loss ( 10,904 ) ( 11,599 ) Preferred stock dividend payable on Series A Convertible Preferred Stock ( 6 ) ( 6 ) Comprehensive loss attributable to common stockholders $ ( 10,910 ) $ ( 11,605 ) See accompanying notes to the unaudited condensed financial statements. 5 Table of Contents CARDIFF ONCOLOGY, INC. CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY (in thousands) (Unaudited) Preferred Stock Shares Preferred Stock Amount Common Stock Shares Common Stock Amount Additional Paid-In Capital Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders’ Equity Balance, January 1, 2023 61 $ — 44,677 $ 4 $ 404,834 $ ( 395 ) $ ( 298,100 ) $ 106,343 Stock-based compensation — — — — 1,064 — — 1,064 Other comprehensive gain — — — — — 319 — 319 Net loss — — — — — — ( 11,223 ) ( 11,223 ) Balance, March 31, 2023 61 $ — 44,677 $ 4 $ 405,898 $ ( 76 ) $ ( 309,323 ) $ 96,503 Preferred Stock Shares Preferred Stock Amount Common Stock Shares Common Stock Amount Additional Paid-In Capital Service Receivable Accumulated Other Comprehensive Loss Accumulated Deficit Total Stockholders’ Equity Balance, January 1, 2022 716 $ 1 41,964 $ 4 $ 400,503 $ ( 139 ) $ ( 142 ) $ ( 259,810 ) $ 140,417 Stock-based compensation — — — — 1,152 — — — 1,152 Other comprehensive loss — — — — — — ( 606 ) — ( 606 ) Issuance of common stock upon conversion of Series E Convertible Preferred Stock ( 328 ) ( 1 ) 1,342 — — — — — ( 1 ) Preferred stock dividend — — — — — — — ( 6 ) ( 6 ) Release of clinical trial funding commitment — — — — — 139 — — 139 Net loss — — — — — — — ( 10,993 ) ( 10,993 ) Balance, March 31, 2022 388 $ — 43,306 $ 4 $ 401,655 $ — $ ( 748 ) $ ( 270,809 ) $ 130,102 See accompanying notes to the unaudited condensed financial statements. 6 Table of Contents CARDIFF ONCOLOGY, INC. CONDENSED STATEMENTS OF CASH FLOWS (in thousands) (Unaudited) Three Months Ended March 31, 2023 2022 Operating activities Net loss $ ( 11,223 ) $ ( 10,993 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 90 31 Stock-based compensation expense 1,064 1,152 Amortization of premiums (discounts) on short-term investments ( 163 ) 346 Release of clinical trial funding commitment — 139 Changes in operating assets and liabilities: Other assets 26 51 Accounts receivable and unbilled receivable 95 88 Prepaid expenses and other assets 1,251 ( 1,141 ) Operating lease right-of-use assets 136 136 Accounts payable and accrued expenses 203 — Operating lease liabilities ( 138 ) ( 16 ) Other liabilities — ( 42 ) Net cash used in operating activities ( 8,659 ) ( 10,249 ) Investing activities: Capital expenditures ( 8 ) ( 171 ) Maturities of short-term investments 42,983 38,217 Purchases of short-term investments ( 37,327 ) ( 36,773 ) Sales of short-term investments 1,681 17,085 Net cash provided by investing activities 7,329 18,358 Financing activities: Net cash provided by financing activities — — Net change in cash and cash equivalents ( 1,330 ) 8,109 Cash and cash equivalents—Beginning of period 16,347 11,943 Cash and cash equivalents—End of period $ 15,017 $ 20,052 Supplementary disclosure of cash flow activity: Cash paid for taxes $ — $ 1 Supplemental disclosure of non-cash investing and financing activities: Acquisition of property and equipment included in accounts payable and accrued expenses $ 133 $ 27 See accompanying notes to the unaudited condensed financial statements. 7 Table of Contents CARDIFF ONCOLOGY, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited) 1. Organization and Basis of Presentation Business Organization and Overview Cardiff Oncology, Inc. (“Cardiff Oncology” or the “Company”) headquartered in San Diego, California, is a clinical-stage biotechnology company 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". 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, 2022, 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, 2022, included in the Company’s annual report on Form 10-K filed with the SEC on March 2, 2023. Liquidity The Company has incurred net losses since its inception and has negative operating cash flows. As of March 31, 2023, the Company had $ 97.0 million in cash, cash equivalents and short-term investments and believes it has sufficient cash to meet its funding requirements for at least the next 12 months following the issuance date of these financial statements. For the foreseeable future, the Company expects to continue to incur losses and require additional capital to further advance its clinical trial programs and support its other operations. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. To the extent that the Company can raise additional funds by issuing equity securities, the Company’s stockholders may experience additional dilution. 2. Summary of Significant Accounting Policies During the three months ended March 31, 2023, 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, 2022. 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. 8 Table of Contents 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, 2023 2022 Options to purchase Common Stock 6,396,895 5,467,611 Warrants to purchase Common Stock 4,296,472 4,490,159 Series A Convertible Preferred Stock 877 877 Series E Convertible Preferred Stock — 1,342,250 10,694,244 11,300,897 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 public business entities for fiscal years beginning after December 15, 2021 (or December 15, 2023, for companies who meet the SEC definition of Smaller Reporting Companies), and interim periods within those fiscal years. 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, and will adopt this standard on January 1, 2024. 3. Fair Value Measurements The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of March 31, 2023, and December 31, 2022: Fair Value Measurements at March 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 $ 14,158 $ — $ — $ 14,158 Total included in cash and cash equivalents 14,158 — — 14,158 Available for sale investments: Certificate of deposit — 13,925 — 13,925 Corporate debt securities — 32,828 — 32,828 Commercial paper — 10,398 — 10,398 U.S. government agencies — 7,842 7,842 U.S. treasury securities 16,958 — — 16,958 Total available for sale investments (1) 16,958 64,993 — 81,951 Total assets measured at fair value on a recurring basis $ 31,116 $ 64,993 $ — $ 96,109 9 Table of Contents Fair Value Measurements at December 31, 2022 (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 $ 15,722 $ — $ — $ 15,722 Total included in cash and cash equivalents 15,722 — — 15,722 Available for sale investments: Certificate of deposit — 16,023 — 16,023 Corporate debt securities — 49,535 — 49,535 Commercial paper — 13,187 — 13,187 U.S. government agencies — 2,288 — 2,288 U.S. treasury securities 7,887 — — 7,887 Total available for sale investments (1) 7,887 81,033 — 88,920 Total assets measured at fair value on a recurring basis $ 23,609 $ 81,033 $ — $ 104,642 (1) Included in short-term investments in the accompanying balance sheets. 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, 2023 . 4. Supplementary Balance Sheet Information 10 Table of Contents Investments available for sale Investments available for sale consist of the following: As of March 31, 2023 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Market Value Maturity less than 1 year: Certificate of deposit $ 13,964 $ 1 $ ( 40 ) $ 13,925 Corporate debt securities 22,258 4 ( 118 ) 22,144 Commercial paper 10,402 3 ( 7 ) 10,398 U.S. government agencies 4,049 4 — 4,053 Total maturity less than 1 year 50,673 12 ( 165 ) 50,520 Maturity 1 to 2 years: Corporate debt securities 10,687 24 ( 27 ) 10,684 U.S. government agencies 3,781 8 — 3,789 U.S. treasury securities 16,886 72 — 16,958 Total maturity 1 to 2 years 31,354 104 ( 27 ) 31,431 Total short-term investments $ 82,027 $ 116 $ ( 192 ) $ 81,951 As of December 31, 2022 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Market Value Maturity less than 1 year: Certificate of deposit $ 16,101 $ 3 $ ( 81 ) $ 16,023 Corporate debt securities 44,806 8 ( 275 ) 44,539 Commercial paper 13,203 4 ( 20 ) 13,187 Non U.S. government 2,284 4 — 2,288 U.S. treasury securities 7,905 — ( 18 ) 7,887 Total maturity less than 1 year 84,299 19 ( 394 ) 83,924 Maturity 1 to 2 years: Corporate debt securities 5,016 1 ( 21 ) 4,996 Total maturity 1 to 2 years 5,016 1 ( 21 ) 4,996 Total short-term investments $ 89,315 $ 20 $ ( 415 ) $ 88,920 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, 2023, 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. 11 Table of Contents 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, 2023 (in thousands) Fair Market Value Gross Unrealized Loss Corporate debt securities $ 8,151 $ ( 58 ) Property and equipment Property and equipment consist of the following: (in thousands) As of March 31, 2023 As of December 31, 2022 Furniture and office equipment $ 1,066 $ 1,066 Leasehold improvements 2,560 2,560 Laboratory equipment 1,153 1,056 4,779 4,682 Less—accumulated depreciation and amortization ( 3,459 ) ( 3,413 ) Property and equipment, net $ 1,320 $ 1,269 Accrued Liabilities Accrued liabilities consisted of the following: (in thousands) As of March 31, 2023 As of December 31, 2022 Accrued compensation $ 983 $ 1,849 Clinical trials 2,709 2,333 Research agreements and services 571 509 Director fees 125 125 Patent, license and other fees 59 24 Other accrued liabilities 108 337 Total accrued liabilities $ 4,555 $ 5,177 5. 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 The Company currently leases office and lab space in San Diego that expires on February 28, 2027. The lease currently requires monthly payments of approximately $ 61,000 per month with 3 % annual escalation. The components of lease expense were as follows: Three Months Ended March 31, (in thousands) 2023 2022 Operating lease cost $ 183 $ 191 Net operating lease cost $ 183 $ 191 12 Table of Contents Supplemental balance sheet information related to leases was as follows: (in thousands) As of March 31, 2023 As of December 31, 2022 Operating lease ROU assets $ 2,115 $ 2,251 Current operating lease liabilities $ 679 $ 675 Non-current operating lease liabilities 1,898 2,040 Total operating lease liabilities $ 2,577 $ 2,715 Weighted-average remaining lease term–operating leases 3.9 years 4.2 years Weighted-average discount rate–operating leases 7.0 % 7.0 % Supplemental cash flow and other information related to leases was as follows: Three Months Ended March 31, (in thousands) 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 185 $ 70 Total remaining annual commitments under non-cancelable lease agreements for each of the years ended December 31 are as follows: (in thousands) Year Ending December 31, Operating Leases 2023 (excluding the three months ended March 31, 2023) $ 491 2024 754 2025 775 2026 796 Thereafter 136 Total future minimum lease payments 2,952 Less imputed interest ( 375 ) Total $ 2,577 6. 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) 2023 2022 Included in research and development expense $ 394 $ 335 Included in selling, general and administrative expense 670 817 Total stock-based compensation expense $ 1,064 $ 1,152 The unrecognized compensation cost related to non-vested stock options outstanding at March 31, 2023, net of estimated forfeitures, was $ 10.1 million, which is expected to be recognized over a weighted-average remaining vesting period of 2.7 years. The weighted-average remaining contractual term of outstanding options as of March 31, 2023, was approximately 13 Table of Contents 8.5 years. The total fair value of stock options vested during the three months ended March 31, 2023 and 2022, were $ 1.9 million and $ 1,000 , 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, 2023 2022 Risk-free interest rate 3.58 % 1.84 % Dividend yield 0 % 0 % Expected volatility of Cardiff Oncology common stock 110 % 106 % Expected term (1) 5.3 years 6.0 years (1) The expected term for options granted after January 1, 2023 is estimated based on the Company's historical employee data. Prior to January 1, 2023, the Company used the "simplified method" to estimate expected term. A summary of stock option activity and changes in stock options outstanding is presented below: Total Options Weighted-Average Exercise Price Per Share Intrinsic Value Balance outstanding, December 31, 2022 5,069,458 $ 5.92 $ 19,322 Granted 1,806,008 $ 1.73 Canceled / Forfeited ( 1,725 ) $ 7.98 Expired ( 476,846 ) $ 6.93 Balance outstanding, March 31, 2023 6,396,895 $ 4.66 $ 34,107 Exercisable at March 31, 2023 2,427,304 $ 6.57 $ 20,517 Vested and expected to vest at March 31, 2023 6,187,656 $ 4.73 $ 33,160 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, 2023, there were 2,180,898 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, 2023, an aggregate of 1,345,208 shares were issuable upon the exercise of inducement grant stock options approved by the Company. 14 Table of Contents Warrants A summary of warrant activity and changes in warrants outstanding, including both liability and equity classifications is presented below: Total Warrants Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term Balance outstanding, December 31, 2022 4,360,968 $ 5.33 2.1 years Expired ( 64,496 ) $ 101.52 Balance outstanding, March 31, 2023 4,296,472 $ 3.89 1.8 years Preferred Stock A summary of our Company's classes of preferred stock is presented below: Shares outstanding Class Par value Shares designated As of March 31, 2023 As of December 31, 2022 Series A Convertible Preferred Stock $ 0.001 277,100 60,600 60,600 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 E Convertible Preferred Stock $ 0.001 865,824 — — 7. 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, 2023 and 2022 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, 2023 and 2022, 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 15 Table of Contents 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. 16 Table of Contents