迪卡斯 2024年度报告

FORM10-K xAnnual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934for the fiscal year endedDecember 31, 2024oTransition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934for the transition period from __________ to __________Commission file number:001-16133 DELCATH SYSTEMS, INC. (I.R.S. Employer Identification No.) (State or other jurisdiction of incorporation or organization) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YesoNoxIndicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YesoNox Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90days.YesxNoo Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growthcompany. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of theExchange Act. Large accelerated fileroNon-accelerated filerx Smaller reporting companyx If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act.o Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control overfinancial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.o If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect thecorrection of an error to previously issued financial statements.o Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of theregistrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).o The aggregate market value of the common stock held by non-affiliates of the registrant, based on the closing sale price on the Nasdaq Capital Market of $8.37 pershare, as of June30, 2024, the last business day of the registrant’s most recently completed second fiscal quarter was $205,683,217.On February28, 2025, the registrant had outstanding33,403,138shares of common stock, par value $0.01 per share. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s Proxy Statement for the 2025 Annual Meeting of Stockholders are incorporated by reference in Part III of this Annual Report on Form 10-Kto the extent stated herein. Such proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year endedDecember31, 2024. Except with respect to information specifically incorporated by reference in this Form 10-K, the Proxy Statement is not deemed to be filed as partof this Annual Report on Form 10-K. PART I Item 1.BusinessItem 1A.Risk FactorsItem 1B.Unresolved Staff CommentsItem 1C.CybersecurityItem 2.PropertiesItem 3.Legal ProceedingsItem 4.Mine Safety Disclosures PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of EquitySecurities47Item 6.[Reserved.]47Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations47Item 7A.Quantitative and Qualitative Disclosure About Market Risk53Item 8.Financial Statements and Supplementary Data53Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure55Item 9A.Controls and Procedures55Item 9B.Other Information55Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections56 PART III Item 10.Directors, Executive Officers and Corporate Governance57Item 11.Executive Compensation57Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters57Item 13.Certain Relationships and Related Transactions, and Director Independence57Item 14.Principal Accountant Fees and Services57 PART IV Item 15.Exhibits and Financial Statement Schedules57Item 16.Form 10-K Summary58 SIGNATURES62 Disclosure Regarding Forward-Looking Statements This Annual Report on Form 10-K for the period ended December31, 2024, contains certain “forward-looking statements” within themeaning of the “safe harbor” provisions of the Private Securities Litigation Reform Ac