Envoy Medical Inc-A 2024年度报告

FORM10-K (Mark One)☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year endedDecember 31,2024 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File Number001-40133 ENVOY MEDICAL, INC.(Exact name of registrant as specified in its charter) Delaware86-1369123(State or other jurisdiction ofincorporation or organization)(I.R.S. EmployerIdentification No.) 4875 White Bear Parkway,White Bear Lake,MN55110(Address of principal executive offices) (877)900-3277(Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes☐No☒ 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. 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 has filed a report on and attestation to its management’s assessment of the effectivenessof its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registeredpublic accounting firm that prepared 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 theregistrant included in the filing 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-basedcompensation received 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 Exchange Act). Yes☐No☒ The aggregate market value of the registrant’s Class A common stock, par value $0.0001 per share, held by non-affiliates of theregistrant computed by reference to the last sales price of such stock, as of the last business day of the registrant’s most recentlycompleted second fiscal quarter, which was June 30, 2024, was approximately $16.7million. This calculation excludes shares of ClassA common stock held by the registrant’s officers and directors and each person known by the registrant to beneficially own more than5% of the registrant’s outstanding shares, as such persons may be deemed to be affiliates. This determination of affiliate status shouldnot be deemed conclusive for any other purpose. There were21,326,619shares of the registrant’s Class A common stock, par value $0.0001 per share, outstanding as of March 24,2025. DOCUMENTS INCORPORATED IN PART BY REFERENCE Portions of the registrant’s definitive proxy statement relating to its 2025 Annual Meeting of Stockholders are incorporated byreference into Part III of this Annual Report on Form 10-K. ENVOY MEDICAL, INC. Annual Report on Form 10-KFor the Year Ended December 31, 2024 Table of Contents ITEM 1.Business1ITEM 1A.Risk Factors27ITEM 1B.Unresolved Staff Comments51ITEM 1C.Cybersecurity51ITEM 2.Properties52ITEM 3.Legal Proceedings52ITEM 4.Mine Safety Disclosures52 ITEM 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of EquitySecurities53ITEM 6.[Reserved]53ITEM 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations54ITEM 7A.Quantitative and Qualitative Disclosures About Market Risk66ITEM 8.Financial Statements and Supplementary DataF-1ITEM 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure67ITEM 9A.Controls and Procedures67ITEM 9B.Other Information68ITEM 9C.Disclosure Regarding Foreign Jurisdictions t