enVVeno Medical Corp 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 June 30, 2026 OR ☐TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ___________________ Commission file number:001-38325 enVVeno Medical Corporation(Exact name of registrant as specified in its charter) 33-0936180 70 DopplerIrvine, California 92618(Address of principal executive offices) (949) 261-2900(Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Ticker Symbol Common Stock, $0.00001 par value 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. Large accelerated filer☐Non-accelerated filer☒ Accelerated filerSmaller reporting companyEmerging growth company 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☒ As of July 28, 2026, there were 682,722 shares of common stock outstanding. ENVVENO MEDICAL CORPORATIONTABLE OF CONTENTS PART IFINANCIAL INFORMATIONITEM 1. Financial Statements (unaudited)3Condensed Balance Sheets as of June 30, 2026 and December 31, 20253Condensed Statements of Operations for the three and six months ended June 30, 2026 and 20254Condensed Statements of Changes in Stockholders’ Equity for three and the six months ended June 30, 2026 and 20255Condensed Statements of Cash Flows for the six months ended June 30, 2026 and 20256Notes to Condensed Financial Statements7ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations11ITEM 3. Quantitative and Qualitative Disclosures About Market Risk16ITEM 4. Controls and Procedures16PART IIOTHER INFORMATION17ITEM 1. Legal Proceedings17ITEM 1A. Risk Factors17ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds17ITEM 3. Defaults Upon Senior Securities17ITEM 4. Mine Safety Disclosures17ITEM 5. Other Information17ITEM 6. Exhibits18Signatures192 ENVVENO MEDICAL CORPORATIONCONDENSED BALANCE SHEETS (In thousands except par values, unless otherwise indicated) (Unaudited) ENVVENO MEDICAL CORPORATIONCONDENSED STATEMENTS OF OPERATIONS(In thousands, except per share data) ENVVENO MEDICAL CORPORATIONCONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY(In thousands, unless otherwise indicated) ENVVENO MEDICAL CORPORATIONCONDENSED STATEMENTS OF CASH FLOWS(In thousands, unless otherwise indicated) ENVVENO MEDICAL CORPORATIONNOTES TO CONDENSED FINANCIAL STATEMENTS(unaudited) Note 1 – Business Organization and Nature of Operations The Company enVVeno Medical Corporation (the “Company”) is a late-stage medical device company focused on the advancement ofinnovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company isdeveloping a replacement venous valve for patients suffering from severe Chronic Venous Insufficiency (“CVI”) of the deep venoussystem of the leg. The Company is focused on its next-generation, non-surgical replacement venous valve, called the enVVe® System. TheenVVe System consists of the enVVe Valve, enVVe Delivery System, enVVe Nose Cone, the enVVe Delivery System Accessories, andthe enVVe Crimping System. The enVVe Valve is a first-in-class transcatheter based replacement venous valve being developed for thetreatment of severe, deep venous CVI. The enVVe Valve is designed to act as a one-way valve, to help assist in propelling blood up theveins of the leg, and back to the heart and lungs. In April 2026, the U.S. Food and Drug Administration (“FDA”) awarded the Company an Investigational Device Exemption(“IDE”) approval to proceed with a U.S. pivotal study of the enVVe System. The Transca