FEMASYS INC 10-K

Item 9A. Controls and Procedures. Evaluation of Disclosure Controls and Procedures Our management has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K. Based on this evaluation, and the information described above in this Item 9A, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective at December 31, 2022. Management’s Report on Internal Control Over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act). Our management, under the oversight of our board of directors, evaluated the effectiveness of our internal control over financial reporting as of December 31, 2022 based on the framework in Internal Control-Integrated Framework (2013), issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2022. Our independent registered accounting firm will not be required to opine on the effectiveness of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act until we are no longer an “emerging growth company” as defined in the JOBS Act. Remediation Efforts on Previously Identified Material Weakness As previously disclosed, in connection with the audit of our financial statements as of and for the year ended December 31, 2021, we identified a material weakness in our internal control over financial reporting. The material weakness identified that we did not have formalized financial reporting processes and policies in place to ensure that risks are properly assessed, controls are properly designed, and internal controls are properly monitored. We continue to focus on designing and implementing effective internal controls over financial reporting that will operate in a manner necessary to satisfy the accounting and financial reporting requirements of a public company. To address our material weakness, we added accounting personnel, including a Chief Financial Officer hired on February 28, 2022, which allowed us to implement and enhance our formalized policies and procedures regarding internal control over financial processes. Therefore, it is our assessment that the previously reported material weakness has been remediated as of December 31, 2022. Changes in Internal Control over Financial Reporting Other than the remediation efforts described above in this Item 9A, there has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2022, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Inherent Limitations on Effectiveness of Controls Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well designed and implemented, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues within a company are detected. The inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple errors or mistakes. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be detected. Item 9B. Other Information. Not applicable. Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. None 101 Table of Contents PART III Item 10. Directors, Executive Officers and Corporate Governance. The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2023 Annual Meeting of Stockholders under the captions “Proposal No. 1 — Election of Directors,” “Officers and Directors” and “Corporate Governance.” Code of Ethics The board of directors has adopted a Code of Ethics applicable to all of our directors, officers and employees, including our principal executive officer, principal financial officer and principal accounting officer. A copy of the Code of Ethics is available at our website www.femasys.com. Item 11. Executive Compensation. Compensation of Directors and Executive Officers The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2023 Annual Meeting of Stockholders under the caption “Compensation of Executive Officers and Directors - Executive Compensation.” Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. The information required by this item with respect to the security ownership of certain beneficial owners and the security ownership of management is incorporated herein by reference to our definitive proxy statement for our 2023 Annual Meeting of Stockholders under the caption “Security Ownership of Certain Beneficial Owners and Management.” Equity compensation plans The information required by this item with respect to the equity compensation plans is incorporated herein by reference to this annual report on Form 10-K, Item 5, under the caption “Equity compensation plans.” Item 13. Certain Relationships and Related Transactions, and Director Independence. The information required by this item with respect to certain relationships and related transactions is incorporated herein by reference to our definitive proxy statement for our 2023 Annual Meeting of Stockholders under the caption “Certain Relationships and Related-Person Transactions.” The information required by this item with respect to director independence is incorporated herein by reference to our definitive proxy statement for our 2023 Annual Meeting of Stockholders under the caption “Corporate Governance — Director Independence.” Item 14. Principal Accounting Fees and Services. The information required by this item is incorporated herein by reference to our definitive proxy statement for our 2023 Annual Meeting of Stockholders under the captions “Proposal No. 4 — Ratification of Appointment of our Independent Registered Public Accounting Firm” and “Audit Committee Matters — Audit and Other Fees.” 102 Table of Contents PART IV Item 15. Exhibits. Exhibit Incorporated by Reference File Number Description of Document Schedule/Form Number Exhibit Filing Date 3.1 Eleventh Amended and Restated Certificate of Incorporation of Femasys Inc. Form 8-K 001-40492 3.1 June 22, 2021 3.2 Amended and Restated Bylaws of Femasys Inc. Form 8-K 001-40492 3.2 June 22, 2021 3.3 First Amendment to the Amended and Restated Bylaws of Femasys Inc. Form 8-K 001-40492 3.1 March 30, 2023 4.1 Description of the Registrant’s Securities Form 10-K 001-40492 4.1 March 24, 2022 4.2 Form of Certificate of Common Stock Form S-1 333-256156 4.1 May 14, 2021 4.3 Form of indenture Form S-3 333-266001 4.3 July 1, 2022 10.1 Femasys Inc. 2021 Equity Incentive Plan, and forms of agreements thereunder Form S-1 333-256156 10.3 May 14, 2021 10.2 Femasys Inc. 2021 Employee Stock Purchase Plan Form S-1 333-256156 10.4 May 14, 2021 10.3 Amended and Restated Employment Agreement, by and between Femasys Inc. and Kathy Lee-Sepsick Form S-1/A 333-256156 10.6 June 14, 2021 10.4 Amended and Restated Employment Agreement, by and between Femasys Inc. and Daniel Currie Form S-1/A 333-256156 10.8 June 14, 2021 10.5 Employment Agreement, dated February 15, 2010, by and between Femasys Inc. and Gary Thompson Form S-1/A 333-256156 10.9 June 14, 2021 10.6 Femasys Inc. Non-Employee Director Compensation Policy Form S-1/A 333-256156 10.11 June 14, 2021 10.7 Form of Indemnification Agreement between Femasys Inc. and its directors and officers Form S-1 333-256156 10.12 May 14, 2021 10.8 Master Services Agreement and Statement of Work for consulting services, effective August 12, 2021, by and between Femasys Inc. and Bespoke Medical Affairs Solutions, LLC Form 10-Q 001-40492 10.1 November 12, 2021 10.9 Employment Agreement, dated as of February 28, 2022, between Femasys Inc. and Dov Elefant Form 8-K 001-40492 10.1 February 24, 2022 10.10 Form of Inducement Stock Option Agreement Form 8-K 001-40492 10.2 February 24, 2022 10.11 Sales Agreement dated as of July 1, 2022, by and between Femasys Inc. and Piper Sandler & Co. Form S-3 333-266001 1.2 July 1, 2022 23.1* Consent of KPMG LLP 24.1* Power of Attorney (included on signature page) 31.1* Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2* Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 103 Table of Contents 32.1* Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 32.2* Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101.INS* Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) 101.SCH* Inline XBRL Taxonomy Extension Schema Document 101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document 101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document 104* Cover Page Interactive Data File (formatted as inline XRBL and contained in Exhibit 101) Item 16. Form 10-K Summary. None. 104 Table of Contents SIGNATURES Pursuant to the requirements of the Securities Act, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Suwanee, State of Georgia, on this 30 day of March 2023. FEMASYS INC. Dated: March 30, 2023 By: /s/ Kathy Lee-Sepsick Kathy Lee-Sepsick POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Kathy Lee-Sepsick and Daniel Currie, and each of them as his or her true and lawful attorneys-in- fact and agents, each with the full power of substitution, for him or her and in his or her name, place or stead, in any and all capacities, to sign any and all amendments to this report, and to file the same, with exhibits thereto and other documents in connection therewith with the Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact, and each of them, or his or her substitute or substitutes may lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Signature Title Date By: /s/ Kathy Lee-Sepsick March 30, 2023 Kathy Lee-Sepsick Chair of the Board of Directors, President and Chief Executive Officer (principal executive officer) By: /s/ Dov Elefant March 30, 2023 Dov Elefant Chief Financial Officer (principal financial and accounting officer) By: /s/ John Adams, Jr. March 30, 2023 John Adams, Jr. Director By: /s/ John Dyett March 30, 2023 John Dyett Director By: /s/ Charles Larsen March 30, 2023 Charles Larsen Director By: /s/ Anne Morrissey March 30, 2023 Anne Morrissey Director By: /s/ Wendy Perrow March 30, 2023 Wendy Perrow Director By: /s/ Edward Uzialko, Jr. March 30, 2023 Edward Uzialko, Jr. Director 105