DarioHealth Corp 2024年度报告

(Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscalyear endedDecember 31,2024 TRANSITION REPORT UNDER SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________to________________ Commission File No.001-37704 DARIOHEALTH CORP.(Exact name of registrant as specified in its charter) (972)-4 770-6377(Registrant’s telephone number, including area code)Securities Registered pursuant to Section12(b)of the Act Securities registered pursuant to Section 12(g) of the Act: Common Stock, par value $0.0001 per share; Warrants to purchase Common Stock 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 Section15(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 of1934 during the preceding 12months (or for such shorter period that the registrant was required to file such reports), and (2)has been subject tosuch filing requirements for the past 90days.Yes☑No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant toRule405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12months (or for such shorter period that the registrant was requiredto 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 “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerginggrowth company” in Rule12b-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 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 itsinternal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accountingfirm that prepared or issued its audit report.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensationreceived 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 voting and non-voting common equity held by non-affiliates computed by reference to the closing price as ofthe last business day of the registrant’s most recently completed second fiscal quarter is $31,031,352. As of March3, 2025, the registrant had outstanding41,567,016shares of common stock, $0.0001 par value per share.Documents Incorporated By Reference: None. TABLE OF CONTENTS Item 1.Business5Item1A.Risk Factors60Item1B.Unresolved Staff Comments85Item1C.Cybersecurity85Item 2.Properties86Item 3.Legal Proceedings86Item 4.Mine Safety Disclosures86 Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and IssuerPurchases of Equity Securities87Item 6.[Reserved]90Item 7.Management’s Discussion and Analysis of Financial Condition and Results ofOperations90Item7A.Quantitative and Qualitative Disclosures About Market Risk102Item 8.Financial Statements and Supplementary Data102Item 9.Changes in and Disagreements with Accountants on Accounting and FinancialDisclosure102Item9A.Controls and Procedures102Item9B.Other Information103Item 9CDisclosure Regarding Foreign Jurisdictions that Prevent Inspections103 Item10.Directors, Executive Officers and Corporate Governance104Item11.Executive Compensation110Item12.SecurityOwnership of Certain Beneficial Owners and Management andRelatedStockholder Matters117Item13.Certain Relationships and Related Transactions, and Director Independence118Item14.Principal Accounting Fees and Services120 Item15.Exhibits and Financial Statement Schedules121Item16.Form 10-K Summary125Signatures126 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS ANDSUMMARY RISK FACTORS This Annual Report on Form 10-K, or the Annual Report, contains “forward-lookingstatements,” which includes information relating to future events, future financial performance,financial projections, strategies, expectations, competitive environment and regulation. Words such as“may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,”“future,” “intends,” “plans,” “believes,” “estimates,” and similar expres