Femasys Inc 2025年季度报告

(Mark One)QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period endedMarch 31, 2025 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number:001-40492. Femasys Inc. (Exact Name of Registrant as Specified in its Charter) Delaware11-3713499(State or other jurisdiction of incorporation or organization)(IRS Employer Identification No.) Securities registered pursuant to Section 12(b) of the Act: 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), 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 during the preceding 12 months (or for such shorter period that the registrant was required to Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smallerreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller 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☑ The Registrant had27,239,885shares of common stock, $0.001 par value, outstanding as of May 7, 2025. Table of Contents SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical factscontained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-lookingstatements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,”“contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, • our ability to obtain additional financing to fund the clinical development and commercialization of our product candidateFemBloc® permanent birth control, if approved for sale, approved products and fund our operations; • our ability to pay our convertible notes due November 2025, if not converted into common stock; • our ability to obtain U.S. Food and Drug Administration (FDA) approval for our product candidate, FemBloc, for permanent birthcontrol; • our ability to successfully grow sales of FemaSeed® intratubal insemination; • estimates regarding the total addressable market for our products and product candidate; • competitive companies and technologies in our industry; • our business model and strategic plans for our products, product candidate, technologies and business, including our implementationthereof; • commercial success and market acceptance of our products and product candidate; • our ability to accurately forecast customer demand for our products and product candidate, and manage our inventory; • our ability to build, manage, and maintain our direct sales and marketing organization, and to market and sell our FemaSeed artificialinsemination product, FemBloc permanent birth control system (if approved for sale), and women-specific medical product solutions • our ability to establish, maintain, grow or increase sales and revenues; • our expectations about market trends; • our ability to continue operating as a going concern; • our ability to develop and advance our product candidate, FemBloc, and successfully initiate and complete clinical trials; • the ability of our clinical trials to demonstrate safety and effectiveness of our product candidate, FemBloc, and other positive results; • our ability to enroll subjects in the clinical trial for our product candidate, FemBloc, in order to advance the development thereof ona timely basis; • our ability to manufacture our products and product candidate, if approved, in compliance with applicable laws, regulations, andrequirements and to oversee third-party suppliers, service providers and vendors in the performance of any contracted activities in Table of Contents • our ability to hire and retain our senior management and other highly qualified personnel; • FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reformmeasures in the United States and international markets; • the timing or likelihood of regulatory filings and approvals or clearances; • our ability to establish and maintain intellectual property protection for