卡拉制药 2025年季度报告

For the quarterly period endedJune 30, 2025OR ☐TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 For the transition period fromtoCommission file number001-38150 KALA BIO,Inc.(Exact name of registrant as specified in its charter) (781)996-5252(Registrant’s telephone number, including area code) 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 Actof 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subjectto 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 Rule405 of Regulation S-T during the preceding 12 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 reportingcompany, or an emerging growth company. See the definitions of “large accelerated 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 withany new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act). Yes☐No☒ There were7,021,040shares of Common Stock, $0.001 par value per share, outstanding as of August 7, 2025. TABLE OF CONTENTS PagePART I – FINANCIAL INFORMATION7Item 1.Financial Statements (Unaudited)7Condensed Consolidated Balance Sheets as of June 30, 2025 and December31, 20247Condensed Consolidated Statement of Operations and Comprehensive Loss for thethree and six months ended June 30, 2025 and 20248Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) forthe three and six months ended June 30, 2025 and 20249Condensed Consolidated Statements of Cash Flows for the six months ended June 30,2025 and 202411Notes to Condensed Consolidated Financial Statements12Item 2.Management’s Discussion and Analysis of Financial Condition and Results ofOperations28Item 3.Quantitative and Qualitative Disclosures About Market Risk43Item 4.Controls and Procedures43PART II – OTHER INFORMATION43Item 1.Legal Proceedings43Item1A.Risk Factors43Item 2.Unregistered Sales of Equity Securities and Use of Proceeds107Item 5.Other Information107Item 6.Exhibits108SIGNATURES109 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRYDATA This Quarterly Report on Form 10-Q contains forward-looking statements that involvesubstantial risks and uncertainties. All statements, other than statements of historical fact, containedin this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations,future financial position, future revenue, projected costs, prospects, plans and objectives ofmanagement, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,”“estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,”“target,” “would” and similar expressions are intended to identify forward-looking statements,although not all forward-looking statements contain these identifying words. The forward-looking statements in this Quarterly Report on Form 10-Q include, amongother things, statements about: ●our expectations with respect to our dependency on and potential advantages of KPI-012, our product candidate for the treatment of persistent corneal epithelial defects, orPCED;●our development efforts for KPI-012 and our ability to discover and develop newprograms and product candidates;●the timing, progress and results of clinical trials for KPI-012, including statementsregarding the timing of initiation and completion of clinical trials, dosing of subjectsand the period during which the results of the trials will become available;●the timing, scope and likelihood of regulatory filings, including the filing of anybiologics license applications for KPI-012 and any other product candidate we maydevelop in the future;●our ability to obtain regulatory approvals for KPI-012;●our expectations regarding our abilityto comply with the covenants under our loanagreement with Oxford Finance LLC;●our expectations with respect to, and the amount of, future milestone payments we mayreceive from Alcon Pharmaceuticals Ltd. and Alcon Visions, LLC in connection withthe sale of our commercial business;●our expectations with respect to, and the amount of, future milestone payments we maypay in connection with the acquisition of Combangio, Inc., or Combangio, or theCombangio