DarioHealth Corp 2025年度报告

(Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscalyear ended December 31, 2025 ☐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 The Nasdaq Capital Market LLC 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 of 1934during the preceding 12months (or for such shorter period that the registrant was required to file such reports), and (2)has been subject to such filingrequirements 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 to Rule405 ofRegulation S-T (§ 232.405 of this chapter) during the preceding 12months (or for such shorter period that the registrant was required to submit suchfiles).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 anemerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growthcompany” in Rule12b-2 of the Exchange Act. Large accelerated filer☐Non-accelerated filer☑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 newor 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 its internalcontrol over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm thatprepared 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 registrant included in thefiling 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 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☑ As of March11, 2026, the registrant had outstanding 7,300,406 shares of common stock, $0.0001 par value per share.Documents Incorporated By Reference: None. TABLE OF CONTENTS Item 1.Business5Item1A.Risk Factors36Item1B.Unresolved Staff Comments57Item1C.Cybersecurity57Item 2.Properties57Item 3.Legal Proceedings58Item 4.Mine Safety Disclosures58 PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and IssuerPurchases of Equity Securities59Item 6.[Reserved]61Item 7.Management’s Discussion and Analysis of Financial Condition and Results ofOperations61Item7A.Quantitative and Qualitative Disclosures About Market Risk75Item 8.Financial Statements and Supplementary Data76Item 9.Changes in and Disagreements with Accountants on Accounting and FinancialDisclosure76Item9A.Controls and Procedures76Item9B.Other Information77Item 9CDisclosure Regarding Foreign Jurisdictions that Prevent Inspections77 Item 10.Directors, Executive Officers and Corporate Governance77Item 11.Executive Compensation83Item 12.Security Ownership of Certain Beneficial Owners and Management andRelatedStockholder Matters89Item 13.Certain Relationships and Related Transactions, and Director Independence91Item 14.Principal Accounting Fees and Services92 Item 15.Exhibits and Financial Statement Schedules94Item 16.Form 10-K Summary96Signatures96 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND SUMMARYRISK FACTORS This Annual Report on Form 10-K (the “Annual Report”), contains “forward-looking statements,”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,”“con