UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Femasys Inc. (Exact Name of Registrant as Specified in its Charter) FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 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 number: 001-40492. (State or other jurisdic ...

Financial Performance - Sales increased by $174,486, or 31.4%, to $729,394 for Q3 2025 compared to $554,908 for Q3 2024, primarily due to sales of FemBloc[8] - Net loss was $4,194,821, or ($0.10) per share for Q3 2025, compared to a net loss of $5,408,860, or ($0.24) per share for Q3 2024[8] - Cash and cash equivalents as of September 30, 2025, was approximately $4.6 million, with an accumulated deficit of approximately $141.9 million[8] Research and Development - Research and development expenses decreased by $921,219, or 40.0%, to $1,382,022 for Q3 2025 compared to $2,303,241 for Q3 2024, primarily due to commercialization of development products into inventory[8] Assets and Funding - Total assets increased to $16,290,153 as of September 30, 2025, compared to $12,445,002 as of December 31, 2024[10] - The company announced a definitive agreement for the issuance of $12 million in secured convertible notes, with total potential funding of $58 million if all warrants are exercised[4] Market Expansion - Regulatory approvals for the complete FemBloc System were secured in the U.K. and New Zealand, expanding access across Europe and the Asia-Pacific region[3] - The company received initial commercial orders from distribution partners in Spain and France, indicating early momentum in market expansion[3] - The company announced a partnership with Kebomed to commercialize FemBloc in France and the Benelux region[4] Operational Outlook - The company expects its current cash and cash equivalents will be sufficient to fund ongoing operations into September 2026[8]

– FDA Approval to Advance Final FemBloc® Trial with Clear Pathway to Potentially Achieve U.S. FDA Approval – – $12 Million Financing Strengthens Balance Sheet and Extends Cash Runway – ATLANTA, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the third quarter of 2025. Corporate Highlights from 3Q 2025 Announced seco ...

Core Insights - Femasys Inc. has announced a significant initial order valued at approximately $500,000 for the commercial launch of FemBloc in France and the Benelux region, marking continued expansion in key European markets [1][2] - FemBloc is a non-surgical permanent contraceptive solution that addresses a significant unmet need in women's reproductive health, utilizing a patented delivery system to occlude fallopian tubes without the risks associated with surgical procedures [2][4] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a broad patent-protected portfolio of products [3] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including FemSeed and FemVue, which have shown high effectiveness and patient satisfaction [3] Product Details - FemBloc is the first and only non-surgical, in-office alternative to surgical sterilization, receiving full regulatory approval in Europe, the UK, and New Zealand in 2025 [4] - The product is designed to be cost-effective, convenient, and significantly safer than traditional surgical options, with no anesthesia, incisions, or recovery time required [2][4] Strategic Partnerships - Femasys has partnered with Kebomed, a leading distributor in Europe, to facilitate the introduction of FemBloc in France and the Benelux region, reflecting a strategic approach to market access and women's healthcare advancement [2][6] - Kebomed has a strong presence across Europe and has been focused on women's health, enhancing its portfolio through partnerships with innovators in minimally invasive gynecology [6][7]

Core Insights - Femasys Inc. has received FDA Investigational Device Exemption (IDE) approval to continue enrollment in the final phase of the FINALE pivotal trial for FemBloc, a non-surgical permanent birth control solution, marking a significant step towards potential U.S. Pre-Market Approval (PMA) [1][2] - The company has secured $12 million in senior secured convertible notes, with total potential proceeds of $58 million if all warrants are exercised, indicating strong investor confidence in Femasys' mission to enhance women's health [1][2] Company Developments - The successful completion of Part A of the FINALE trial allows Femasys to advance to Part B, which is crucial for obtaining U.S. FDA approval for FemBloc [1][2] - The financing from institutional and accredited investors will be utilized to refinance existing debt and support the commercialization of Femasys' fertility and permanent birth control portfolio [1][2] Product Information - FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control that uses a patented delivery system to create natural scar tissue in the fallopian tubes, providing a safer and more convenient alternative to surgical sterilization [2][8] - The product has already received regulatory approval in Europe, the UK, and New Zealand, with commercialization efforts underway in select European countries [8] Financial Details - The convertible notes bear an interest rate of 8.5% per annum and have a 10-year maturity, convertible into approximately 16.38 million shares of common stock at a conversion price of $0.73 per share, which is a 15% premium to the stock's closing price prior to the agreement [3][4] - The accompanying warrants include multiple classes with exercise prices ranging from $0.81 to $1.10 per share, potentially generating additional proceeds of up to $46 million if exercised for cash [3][4] Market Position - Femasys aims to redefine women's reproductive care with FemBloc, addressing a significant unmet need in the market for permanent birth control options, which currently only includes surgical sterilization in the U.S. [2][8] - The company is positioned to create long-term value for shareholders in a multi-billion-dollar market by introducing innovative solutions in women's health [2][8]

Core Insights - Femasys Inc. has initiated a post-market surveillance clinical study for its FemBloc Permanent Birth Control, marking a significant step in its European commercialization strategy under the EU Medical Device Regulation [1][2][3] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [4] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including the FemBloc and FemaSeed [4] Product Details - FemBloc is a non-surgical solution for permanent birth control that uses a patented delivery system to occlude fallopian tubes without the need for anesthesia or incisions, thus avoiding surgical risks [3][5] - The product has received full regulatory approval in Europe, the UK, and New Zealand, and is positioned to meet the strong demand for safe and accessible permanent birth control options among women [5] Clinical Study and Compliance - The post-market surveillance study aims to monitor the safety and performance of FemBloc in real-world settings, complying with the rigorous requirements of the EU MDR [2][3] - The study has received approval from multiple Ethics Committees and adheres to ISO 14155:2020 for Good Clinical Practice [2] Market Potential - FemBloc addresses a significant unmet need in women's reproductive health, with no comparable alternatives currently available, indicating a broad global market potential [3][5] - The company aims to build a foundation for broader physician adoption and reimbursement through the generation of real-world data from the clinical study [3]

Core Insights - Femasys Inc. will showcase its innovative fertility solutions at the ASRM 2025 Scientific Congress & Expo in San Antonio, Texas from October 25-29 [1][4] - The company is highlighting its next-generation artificial insemination solution, FemaSeed, which has demonstrated more than double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count [2][5] - Femasys has expanded its FemaSeed portfolio to include various kits that enable gynecologists to perform sperm preparation and offer FemaSeed directly in their practices [3] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally [5] - The company has a patent-protected portfolio of therapeutic and diagnostic products, including FemaSeed and FemVue, aimed at improving reproductive health [5] - Femasys has received regulatory approvals for its products in multiple regions, including the U.S., Europe, UK, Canada, Israel, Australia, and New Zealand [2][6] Product Highlights - FemaSeed is positioned as a safe, accessible, and cost-effective alternative to IUI, particularly for patients with low male sperm count [2] - The FemBloc product, a non-surgical permanent birth control solution, received full regulatory approval in Europe, the UK, and New Zealand in 2025 [6] - The FemChec diagnostic product provides an ultrasound-based test to confirm procedural success for FemBloc [6]

Core Insights - Femasys Inc. has partnered with Kebomed to commercialize FemBloc Permanent Birth Control in France and the Benelux region, significantly enhancing market access for this innovative product [1][2] - The collaboration is a key part of Femasys' European growth strategy following the recent CE mark approval for FemBloc, which is the only non-surgical permanent birth control option available [1][4] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of products [3] - The company's lead product innovations include FemBloc and FemaSeed, with clinical data showing FemaSeed is over twice as effective as traditional IUI [3] Product Details - FemBloc is a non-surgical solution for permanent birth control that uses a patented delivery system to occlude fallopian tubes, offering a safer and more cost-effective alternative to surgical sterilization [2][4] - The product has received full regulatory approval in Europe, the UK, and New Zealand, with ongoing efforts for U.S. FDA approval through the FINALE pivotal trial [4] Strategic Partnership - Kebomed, a leading independent distributor of medical devices in Europe, will leverage its established infrastructure and expertise in women's health to drive the adoption of FemBloc [2][6] - The partnership aims to unlock significant growth potential in key European markets, particularly in France, which represents the largest market opportunity for FemBloc [2][6]

Core Insights - Femasys Inc. has announced a partnership with Medical Electronic Systems LLC to launch the FemSperm Analysis Kit, enhancing its infertility product line and enabling gynecologists to perform in-office sperm handling for FemaSeed Intratubal Insemination [1][2] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [3] - The company’s fertility portfolio includes FemaSeed Intratubal Insemination, which has demonstrated over double the pregnancy rates compared to traditional intrauterine insemination (IUI) in cases of low male sperm count [3] Product Details - The FemSperm Analysis Kit completes the FemSperm product family, which includes the Setup Kit and Insemination Prep Kit, allowing gynecologists to conduct sperm preparation and analysis in their practices [1][2] - FemaSeed is positioned as a first step in the fertility journey, providing a safe, accessible, and cost-effective alternative to IUI, and is authorized for use in multiple regions including the U.S., Europe, UK, Canada, Israel, Australia, and New Zealand [2] Recent Developments - Femasys has received full regulatory approval for its FemBloc permanent birth control in Europe, the UK, and New Zealand, marking it as the first non-surgical, in-office alternative to traditional surgical sterilization [4] - The FemChec diagnostic product complements FemBloc by providing an ultrasound-based test to confirm procedural success, with initial clinical trials showing compelling effectiveness and high satisfaction [4]

Core Insights - Femasys Inc. has launched the FemSperm Insemination Prep Kit, enhancing the sperm preparation process for FemaSeed Intratubal Insemination, aimed at increasing revenue growth through gynecologist activation [1][2][3] - The introduction of this kit is a significant step in Femasys' strategy to penetrate the underserved fertility market, providing a streamlined in-office solution for gynecologists [2][3] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [4] - The company’s fertility portfolio includes FemaSeed, which is positioned as a first-step infertility treatment, and FemVue, a diagnostic tool for fallopian tube assessment [4] Product Details - The FemSperm Insemination Prep Kit allows gynecologists to perform sperm preparation and offer FemaSeed Intratubal Insemination directly in their practices, addressing the needs of an estimated 10 million U.S. women facing infertility [3] - FemaSeed has demonstrated more than double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count, making it a safer and cost-effective alternative to IVF [3][4] Market Strategy - The commercialization of FemBloc, a non-surgical permanent birth control method, has received regulatory approvals in Europe, the UK, and New Zealand, with plans for strategic partnerships to enhance market presence [5] - Femasys aims to broaden patient access to fertility treatments and strengthen its long-term revenue growth strategy by positioning FemaSeed as a first-step treatment before IVF [2][3]