INVO Fertility Inc 2024年度报告

FORM10-K ☒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 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 Section 15(d) of the 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. 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 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 Act). YES☐NO☒ The aggregate market value of the voting stock and non-voting common equity held by non-affiliates of the registrant as of the lastbusiness day of the registrant’s most recently completed second fiscal quarter ended June 30, 2024 was $7,381,118based upon theclosing price of the registrant’s common stock of $10.08 on the NASDAQ as of that date. The number of shares outstanding of the registrant’s common stock, $0.0001par value, as of April 29, 2025 was1,066,065. DOCUMENTS INCORPORATED BY REFERENCE None. FORM 10-KINVO FERTILITY, INC. TABLE OF CONTENTS Part I Item 1.Business4Item 1A.Risk Factors16Item 1B.Unresolved Staff Comments70Item 1C.Cybersecurity70Item 2.Properties71Item 3.Legal Proceedings71Item 4.Mine Safety Disclosures71 Item 5.Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities72Item 6.[Reserved]72Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations72Item 7A.Quantitative and Qualitative Disclosure About Market Risk86Item 8.Financial Statements and Supplementary Data87Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure88Item 9A.Controls and Procedures88Item 9B.Other Information88Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.88 Part III Item 10.Directors, Executive Officers and Corporate Governance89Item 11.Executive and Director Compensation92Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters100Item 13.Certain Relationships and Related Transactions, and Director Independence101Item 14.Principal Accountant Fees and Services102 SIGNATURES111 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans,objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-lookingstatements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 andSection 21E of the S