DarioHealth Corp 2025年季度报告

FORM10-Q (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGEACT OF 1934 For the quarterly period endedMarch 31, 2025 ☐TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGEACT OF 1934 Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)ofthe Securities Exchange Act of 1934 during the preceding 12months (or for such shorter period that the registrantwasrequired 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 besubmitted pursuant to Rule405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12months (or forsuch 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 emerging growth company. See the definitions of “large accelerated filer,”“accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of the ExchangeAct. ☐Accelerated filer☒Smaller reporting company☐Emerging growth company ☐Large accelerated filer☒Non-accelerated filer If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transitionperiod for complying with any new or revised financial accounting standards provided pursuant to Section13(a)ofthe Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act).Yes☐No☒ As of May9, 2025, the registrant had43,949,424shares of common stock outstanding. When used in this quarterly report, the terms “Dario,” “DarioHealth,” “the Company,” “we,” “our,” and “us”refer to DarioHealth Corp., a Delaware corporation and our subsidiary LabStyle Innovation Ltd., an Israeli company,PsyInnovations Inc., a Delaware company, Twill, Inc., a Delaware company, Twill ISR Ltd, an Israeli company, andDarioHealth India Services Pvt. Ltd., an Indian company. “Dario” is registered as a trademark in the United States, Israel, China, Canada, Hong Kong, South Africa, Japan, Costa Rica, and Panama. “DarioHealth” is registered as atrademark in the United States and Israel. DarioHealth Corp. Quarterly Report on Form10-Q TABLE OF CONTENTS Page Cautionary Note Regarding Forward-Looking Statements3PART1 - FINANCIAL INFORMATIONItem 1.Condensed Consolidated Interim Financial Statements(unaudited)F-1Condensed Consolidated Interim Balance Sheets (Unaudited)F-2 – F-3Condensed Consolidated Interim Statements of Comprehensive Loss(Unaudited)F-4Condensed Consolidated Interim Statements of Changes in Stockholders’Equity (Unaudited)F- 5 – F-5Condensed Consolidated Interim Statements of Cash Flows (Unaudited)F-6Notes toCondensed Consolidated InterimFinancial StatementsF-7 – F-30Item 2.Management’s Discussion and Analysis of Financial Condition and Results ofOperations4Item 4.Control and Procedures12PARTII - OTHER INFORMATION14Item1A.Risk Factors14Item 2.Unregistered Sales of Equity Securities and Use of Proceeds17Item 6.Exhibits17SIGNATURES18 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Certain information set forth in this Quarterly Report on Form10-Q, including in Item 2,“Management’s Discussion and Analysis of Financial Condition and Results of Operations” andelsewhere herein may address or relate to future events and expectations and as such constitutes“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of1995. Statements which are not historical reflect our current expectations and projections about ourfuture results, performance, liquidity, financial condition, prospects and opportunities and are basedupon information currently available to us and our management and their interpretation of what isbelieved to be significant factors affecting our business, including many assumptions regarding futureevents. Such forward-looking statements include statements regarding, among other things: ●our current and future capital requirements and our ability to satisfy our capital needsthrough financing transactions or otherwise;●our ability to meet the requirements of our existing debt facility;●our product launches and market penetration plans;●the execution of agreements with various providers for our solution;●our ability to maintain our relationships with key partners;●our ability to complete required clinical trials of our product and obtain clearance orapproval from the United States Food and Drug Administration (the “FDA”), or otherregulatory agencies in different jurisdictions;●our ability to maintain or protect the validity of our U.S. and other patents and otherintellectual property;●our ability to retain key executive members;●our ability to internally devel