卡拉制药 2024年度报告

☒ANNUAL REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year endedDecember 31, 2024OR ☐TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF1934 For the transition period fromtoCommission file number001-38150 KALA BIO,Inc. (Exact name of registrant as specified in its charter) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule405 of the Securities Act.Yes☐No☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section13 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 the past90days.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 Rule 12b-2 ofthe 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 period for 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 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.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrantincluded 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 theregistrant’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 Exchange Act). Yes☐No☒ As of June 28, 2024, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the Common Stock held bynon-affiliates of the registrant was approximately $23.9million, based on the closing price of the registrant’s common stock on June 28, 2024. There were6,452,398shares of common stock, par value $0.001 per share, outstanding as of March 28, 2025. Table of Contents Special Note Regarding Forward-Looking Statements and Industry Data2Risk Factor Summary4 PART I Item 1.Business6Item 1A.Risk Factors49Item 1B.Unresolved Staff Comments105Item 1C.Cybersecurity105Item 2.Properties107Item 3.Legal Proceedings107Item 4.Mine Safety Disclosures107 PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and IssuerPurchases of Equity Securities108Item 6.[Reserved]108Item 7.Management’s Discussion and Analysis of Financial Condition and Results ofOperations109Item 7A.Quantitative and Qualitative Disclosures About Market Risk123Item 8.Financial Statements and Supplementary Data123Item 9.Changes in and Disagreements With Accountants on Accounting and FinancialDisclosure123Item 9A.Controls and Procedures123Item 9B.Other Information125Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections125 PARTIII Item 10.Directors, Executive Officers and Corporate Governance125Item 11.Executive Compensation129Item 12.Security Ownership of Certain Beneficial Owners and Management and RelatedStockholder Matters147Item 13.Certain Relationships and Related Transactions, and Director Independence150Item 14.Principal Accountant Fees and Services159 PARTIVItem 15.Exhibits and Financial Statement Schedules160Item 16.Form 10-K Summary163Signatures164 References to KALA Throughout this Annual Report on Form 10-K, the “Company,” “KALA”, “KALA BIO,”“we,” “us,” and “our,” except where the context requires otherwise, refer to KALA BIO, Inc. and itsconsolidated subsidiaries, and “our board of directors” refers to the board of directors of KALA