Entero Therapeutics Inc 2024年度报告

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes☐No☒ Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of the Securities Exchange Act of 1934 during thepreceding 12months (or for such shorter period that the registrant was required to file such reports), and (2)has been subject to such filing requirements for thepast 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of RegulationS-T (§ 232.405 of this chapter) during the preceding 12months (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 emerginggrowth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2of 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 orrevised financial accounting standards provided pursuant to Section13(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 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 auditreport.☐ 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 filingreflect the correction of an error to previously issued statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by anyof the registrant’s executive officers during the relevant recovery period pursuant to§240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Act). Yes☐No☒ The aggregate market value of common stock held by non-affiliates of the registrant, based on the closing price of a share of the registrant’s common stock onJune 28, 2024, which is the last business day of the registrant’s most recently completed second fiscal quarter, as reported by the The Nasdaq Capital Market onsuch date, was approximately $3.6million. There were4,765,729shares of the registrant’s common stock, par value $0.0001 per share (the “Common Stock”), outstanding as of April 1, 2025. ENTERO THERAPEUTICS,INC.ANNUAL REPORT ON FORM10-KYEAR ENDED DECEMBER31, 2024 TABLE OF CONTENTS Item1.Business1Item1A.Risk Factors23Item1B.Unresolved Staff Comments51Item1C.Cybersecurity51Item2.Properties52Item3.Legal Proceedings52Item4.Mine Safety Disclosures52 PARTII53 Item5.Market for Registrant’s Common Equity, Related Stockholder Matters and IssuerPurchases of Equity Securities53Item6.Reserved53Item7.Management’s Discussion and Analysis of Financial Condition and Results of Operations54Item7A.Quantitative and Qualitative Disclosures About Market Risk62Item8.Financial Statements and Supplementary Data62Item9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure62Item9A.Controls and Procedures62Item9B.Other Information63Item9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections63 PARTIII64 Item10.Directors, Executive Officers and Corporate Governance64Item11.Executive Compensation69Item12.Security Ownership of Certain Beneficial Owners and Management and RelatedStockholder Matters73Item13.Certain Relationships and Related Transactions, and Director Independence78Item14.Principal Accountant Fees and Services79 Item15.Exhibits and Financial Statement Schedules80Item16.Form10-K Summary82 CAUTIONARY NOTEREGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form10-K (“Annual Report”) contains forward-looking statements that involvesubstantial risks and uncertainties. All statements contained in this Annual Report other than statements ofhistorical facts, including statements regarding our strategy, future operations, future financial position, futurerevenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factorsthat may cause our actual results, performance or achievements to be materially different from any future results,performance or achievements expressed or implied by the forward-looking statements. The words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “targ