ENvue Medical Inc 2026年季度报告

FORM 10-Q ☒Quarterly REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2026 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period fromto Commission File Number: 001-36445 ENvue Medical, Inc.(Exact name of registrant as specified in its charter) Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (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 past 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant 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 smallerreporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. ☐Accelerated filer☒Smaller reporting companyEmerging growth company Large accelerated filerNon-accelerated filer If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ The number of shares outstanding of the registrant’s common stock as of May 18, 2026, was 6,091,840 shares. ENVUE MEDICAL, INC.Quarter Ended March 31, 2026 TABLE OF CONTENTS PagePART I. FINANCIAL INFORMATIONItem 1.Financial Statements (Unaudited)1Condensed Consolidated Balance Sheets as of March 31, 2026 (Unaudited) and December 31, 20251Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three EndedMarch 31, 2026 and 20252Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended March 31,2026 and 20253Unaudited Condensed Consolidated Statements of Cash Flows for the Three months Ended March 31, 2026 and20254Notes to Unaudited Condensed Consolidated Financial Statements5Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations22Item 3.Quantitative and Qualitative Disclosures about Market Risk25Item 4.Controls and Procedures25PART II. OTHER INFORMATIONItem 1.Legal Proceedings26Item 1A.Risk Factors26Item 2.Unregistered Sales of Equity Securities and Use of Proceeds26Item 3.Defaults Upon Senior Securities26Item 4.Mine Safety Disclosures26Item 5.Other Information26Item 6.Exhibits27Signatures28i ENVUE MEDICAL, INC.Interim Condensed Consolidated Balance Sheets(Amounts in thousands except share and per share data) [*] Adjusted to reflect the reverse stock splits, see Note 7. The accompanying notes are an integral part of these interim condensed consolidated financial statements ENVUE MEDICAL, INC.Interim Condensed Consolidated Statement of Stockholders’ Equity (Unaudited)(Amounts in thousands except share and per share data) The accompanying notes are an integral part of these interim condensed consolidated financial statements ENVUE MEDICAL, INC.Interim Condensed Consolidated Statements of Cash Flows (Unaudited)(Amounts in thousands except share and per share data) ENVUE MEDICAL, INC.Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)(Amounts in thousands except share and per share data) NOTE 1 - DESCRIPTION OF BUSINESS ENvue Medical, Inc. (formerly known as NanoVibronix, Inc.) (the “Company”) was incorporated as a Delaware corporation inOctober 2003. The Company is a medical device company focusing on non-invasive biological response-activating devices that targetwound healing and pain therapy and can be administered at home without the assistance of medical professionals, utilizing itsproprietary low-intensity ultrasound (acoustic) technology. The Company’s principal research and development activities areconducted in Israel through its wholly-owned subsidiary, NanoVibronix Ltd., a company registered in Israel, which commencedoperations in October 2003. On February 14, 2025, pursuant to the terms of that certain Agreement and Plan of Merger, dated as of February 14, 2025 (the “MergerAgreement”), by and among the Company, NVEH Merger Sub I, Inc., a Delaware corporation and a wholly-owned subsidiary of theCompany (“First Merger Sub”), NVEH Merger Sub II, L