Entera Bio Ltd 2025年度报告

(Mark One)☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from _ to _ .Commission file number 001-38556 Entera Bio Ltd. (Exact Name of Registrant as Specified in Its Charter) Israel00-0000000(State or Other Jurisdiction ofIncorporation or Organization)(I.R.S. EmployerIdentification No.) Kiryat HadassahMinrav Building - Fifth FloorJerusalem,Israel9112002(Address of Principal Executive Offices) (Zip Code) 972-2-532-7151(Registrant’s Telephone Number, Including Area Code) Securities registered pursuant to Section 12(b) of the Act: Title of Each ClassTrading SymbolName of Each Exchange on Which RegisteredOrdinary shares,par value NIS 0.0000769 pershareENTXNasdaq Capital Market Securities registered pursuant to Section 12(g) of the Act:None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes☐No☒ 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 Section 13 or 15(d) of theSecurities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to filesuch 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 besubmitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorterperiod 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, smallerreporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☐Accelerated filer☐Non-accelerated filer☒Smaller reporting company☒Emerging growth company☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition periodfor complying with any new or revised financial accounting standards provided pursuant to Section 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 theeffectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by theregistered 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 theregistrant included in the filing reflect the correction of an error to previously issued financial 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 the relevant 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 outstanding voting stock held by non-affiliates of the registrant was approximately$84.6million as of June 30, 2025. As of March 23, 2026, the registrant had 46,622,239 ordinary shares, par value NIS 0.0000769 per share (“Ordinary Shares”)outstanding. Documents Incorporated by Reference None. Table of Contents PART I Item 1.BusinessItem 1A.Risk FactorsItem 1B.Unresolved Staff CommentsItem 1C.CybersecurityItem 2.PropertiesItem 3.Legal ProceedingsItem 4.Mine Safety Disclosures Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of EquitySecurities79Item 6.[Reserved]79Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations79Item 7A.Quantitative and Qualitative Disclosures About Market Risk90Item 8.Financial Statements and Supplementary Data91Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure119Item 9A.Controls and Procedures119Item 9B.Other Information119Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections119 PART IIIItem 10. Directors, Executive Officers and Corporate Governance118Item 11.Executive Compensation127Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters136Item 13.Certain Relationships and Related Transactions, and Director Independence139Item 14.Principal Accounting Fees