Cardio Diagnostics Holdings Inc 2025年度报告

FORM 10-K (Mark One)☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACTOF 1934 For the fiscal year ended December 31, 2025 ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period fromto Commission File No. 001-41097 CARDIO DIAGNOSTICS HOLDINGS, INC.(Exact name of registrant as specified in its charter) Delaware87-0925574(State or Other Jurisdiction ofIncorporation or Organization)(I.R.S. Employer Identification No.) 311 West Superior Street,Suite 444Chicago, IL 60654(Address of principal executive offices and Zip Code) (855) 226-9991(Registrant’s telephone number, including area code) 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 if the registrant is not required to file reports pursuant to Section 13 or 15 (d) of the Securities Exchange 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 Securities Exchange Act duringthe preceding 12 months (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 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submitsuch files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or anemerging growth company. See the definitions of "large accelerated filer,” "accelerated filer,” "smaller reporting company,” and "emerging growthcompany” in Rule 12b-2 of the Exchange Act. Acceleratedfiler☐Smallerreportingcompany☒Emerging growth company☒ Largeacceleratedfiler☐Non-accelerated filer☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with anynew 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 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 inthe 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-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 June 30, 2025, the aggregate market value of shares held by non-affiliates of the registrant (based upon the closing sale prices of such shares onthe Nasdaq Capital Market on June 30, 2025) was approximately $5.8 million. For purposes of calculating the aggregate market value of shares heldby non-affiliates, we have assumed that all outstanding shares are held by non-affiliates, except for shares held by each of our executive officers,directors, and 5% or greater stockholders. In the case of 5% or greater stockholders, we have not deemed such stockholders to be affiliates unless thereare facts and circumstances which would indicate that such stockholders exercise any control over our company, or unless they hold 10% or more ofour outstanding common stock. These assumptions should not be deemed to constitute an admission that all executive officers, directors, and 5% orgreater stockholders are, in fact, affiliates of our company, or that there are not other persons who may be deemed to be affiliates of our company. As of March 13, 2026, there were 2,959,469 shares of common stock, par value $0.00001 issued and outstanding. Documents Incorporated by TABLE OF CONTENTS PagePART 14Item 1. Business4Item 1A. Risk Factors32Item 1B. Unresolved Staff Comments56Item 1C. Cybersecurity56Item 2. Properties57Item 3. Legal Proceedings57Item 4. Mine Safety Disclosures57PART II58Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities58Item 6. Reserved58Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations59Item 8. Financial Statements and Supplemental Data67Item 9. Changes in and Disagreements