Clene Inc 2025年度报告

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 the preceding 12 months (or for such shorter period thatthe registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding12 months (or for such shorter period that the registrant was required to submit such files). Yes☒No☐ 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 growth company. See the definitions of “largeaccelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. 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 revised financial accounting standards provided pursuant toSection 13(a) of the Exchange Act.☐ 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 over financial reporting under Section 404(b) of theSarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐ 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 the correction of an error to previously issuedfinancial statements.☐ 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 the registrant’s executive officers during therelevant recovery period pursuant to§240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes☐No☒ The aggregate market value of the registrant’s common stock held by non-affiliates as of June 30, 2025, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $40.4million, based on the closing price of the registrant’s common stock on the Nasdaq Capital Market of $3.91per share.The number of shares outstanding of the Registrant’s shares of common stock as of March 13, 2026was 11,778,307. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement relating to its 2026Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. Thedefinitive proxy statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates. CLENE INC. Annual Report on Form 10-K for the Year Ended December 31, 2025 PART I1Item 1.Business4Item 1A.Risk Factors52Item 1B.Unresolved Staff Comments87Item 1C.Cybersecurity87Item 2.Properties89Item 3.Legal Proceedings89Item 4.Mine Safety Disclosures89PART II90Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities90Item 6.[Reserved]90Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations91Item 7A.Quantitative and Qualitative Disclosures About Market Risk107Item 8.Financial Statements and Supplementary Data108Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure109Item 9A.Controls and Procedures109Item 9B.Other Information110Item 9C.Disclosures Regarding Foreign Jurisdictions that Prevent Inspections110PART III111Item 10.Directors, Executive Officers and Corporate Governance111Item 11.Executive Compensation111Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters111Item 13.Certain Relationships and Related Transactions, and Director Independence111Item 14.Principal Accountant Fees and Services111PART IV112Item 15.Exhibits and Financial Statement Schedules112Item 16.Form 10-K Summary114i PART I Throughout this Annual Report on Form 10-K (the“Annual Report”), the“Company,”and references to“we,”“us,”or similar such references should be understoodto be references to Clene Inc. and its consolidated subsidiaries. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Certain statements in this Annual Report may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statementsinclude, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future operations. Inaddition,