FEMY
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Earnings documents stored for FEMY.
Investor releaseQuarter not tagged2026-08-14Femasys Announces Financial Results for Quarter Ended June 30, 2026 and Provides Corporate Update
GlobeNewswire
Femasys Announces Financial Results for Quarter Ended June 30, 2026 and Provides Corporate Update
-- $30 million financing enables execution of U.S. commercial strategy for the FemaSeed® fertility portfolio and advancement of the FemBloc® clinical and regulatory program toward U.S. approval -- ATLANTA, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator developing transformative fertility and non-surgical permanent birth control solutions designed to improve the standard of care, expand access, and reduce costs for women worldwide, announces its financial results for the quarter ended June 30, 2026 and provides a corporate update. Corporate Highlights from 2Q 2026 to date Completed $30 million private placement with potential proceeds of up to $90 million upon full cash exercise of warrants. Regained compliance with Nasdaq Listing Requirements. Issuance of patents in the U.S. and key international markets that expand intellectual property protection for the blended polymer component of FemBloc. Received CE Mark approval for FemHSG™ Catheter, to complement FemVue and support streamlined in-office fertility evaluation. Advanced initial commercial use of FemaSeed Complete, expanding access to first-line fertility treatment in the OB/GYN office. Launched FemaSeed Complete at ACOG 2026, increasing provider awareness and initiating commercial efforts with OB/GYNs. Established strategic partnership with AMI Technologies to commercialize its fertility portfolio in Israel, demonstrating international market interest. Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth. “During the second quarter of 2026 and into the third quarter of 2026, we made meaningful progress strengthening our financial position, advancing our commercial strategy and expanding the reach of our innovative fertility solutions,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “The completion of our $30 million private placement and restoration of Nasdaq compliance provide a stronger foundation to execute our growth strategy. We also achieved important commercial milestones, including the launch of FemaSeed Complete at ACOG 2026 and initial commercial use, advancing our strategy to expand access to first-line fertility treatment in the OB/GYN office and potentially enable earlier intervention. With this financing in place, we are well positioned to…Read full documentShow less
-- $30 million financing enables execution of U.S. commercial strategy for the FemaSeed® fertility portfolio and advancement of the FemBloc® clinical and regulatory program toward U.S. approval -- ATLANTA, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator developing transformative fertility and non-surgical permanent birth control solutions designed to improve the standard of care, expand access, and reduce costs for women worldwide, announces its financial results for the quarter ended June 30, 2026 and provides a corporate update. Corporate Highlights from 2Q 2026 to date Completed $30 million private placement with potential proceeds of up to $90 million upon full cash exercise of warrants. Regained compliance with Nasdaq Listing Requirements. Issuance of patents in the U.S. and key international markets that expand intellectual property protection for the blended polymer component of FemBloc. Received CE Mark approval for FemHSG™ Catheter, to complement FemVue and support streamlined in-office fertility evaluation. Advanced initial commercial use of FemaSeed Complete, expanding access to first-line fertility treatment in the OB/GYN office. Launched FemaSeed Complete at ACOG 2026, increasing provider awareness and initiating commercial efforts with OB/GYNs. Established strategic partnership with AMI Technologies to commercialize its fertility portfolio in Israel, demonstrating international market interest. Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth. “During the second quarter of 2026 and into the third quarter of 2026, we made meaningful progress strengthening our financial position, advancing our commercial strategy and expanding the reach of our innovative fertility solutions,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “The completion of our $30 million private placement and restoration of Nasdaq compliance provide a stronger foundation to execute our growth strategy. We also achieved important commercial milestones, including the launch of FemaSeed Complete at ACOG 2026 and initial commercial use, advancing our strategy to expand access to first-line fertility treatment in the OB/GYN office and potentially enable earlier intervention. With this financing in place, we are well positioned to execute our commercial strategy, complete the U.S. FemBloc clinical program and advance our portfolio toward key value-creating milestones for patients and shareholders.” Financial Results for Six Months Ended June 30, 2026 Sales increased by $6,184, or 0.8%, to $756,716 in 2026 from $750,532 in 2025, primarily due to sales of FemaSeed. Research and development expenses decreased by $1,126,622, or 25.7%, to $3,256,279 in 2026 compared to $4,382,901 in 2025, primarily reflecting lower compensation costs, regulatory and professional service fees. Net loss was $3,622,995, or ($1.08) per basic and diluted share attributable to common stockholders, for the six months ended June 30, 2026, compared to a net loss of $10,482,761, or ($7.76) per basic and diluted share attributable to common stockholders, for the six months ended June 30, 2025. Cash and cash equivalents as of June 30, 2026, was approximately $1.4 million and the Company had an accumulated deficit of approximately $149.4 million. Subsequent to June 30, 2026, the Company completed a private placement transaction that generated approximately $30.0 million of gross proceeds. Management believes the additional capital provides the financial resources necessary to support the Company's strategic priorities, including the execution of its commercial initiatives, advancement of its clinical programs, and pursuit of key operational objectives. Financial Results for Quarter Ended June 30, 2026 Sales decreased by $77,441, or 18.9%, to $331,827 in 2026 from $409,268 in 2025, primarily attributable to lower sales of FemVue. Research and development expenses increased by $532,449, or 37.6%, to $1,946,878 in 2026 compared to $1,414,429 in 2025, primarily reflecting the transition of development products into inventory to support commercialization during 2025, and increased clinical costs, partially offset by reduced compensation costs. Net loss was $4,469,095, or ($1.33) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2026, compared to a net loss of $4,585,922, or ($3.18) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2025. For more information, please refer to the Company’s Form 10-Q filed August 14, 2026, which can be accessed on the SEC website. About Femasys Inc.Femasys is a leading biomedical innovator developing transformative fertility and non-surgical permanent birth control solutions designed to improve the standard of care, expand access, and reduce costs for women worldwide. The Company is focused on commercializing its fertility portfolio, led by FemaSeed® Intratubal Insemination, together with complementary diagnostic and sperm preparation products, in the U.S. and key international markets. Femasys is also advancing FemBloc®, its non-surgical, in-office permanent birth control solution, toward U.S. FDA approval through the ongoing FINALE pivotal trial (NCT05977751). FemBloc received regulatory approvals in Europe, the UK and New Zealand in 2025, supporting commercialization through strategic partnerships in select international markets. Femasys’ portfolio is supported by broad intellectual property protection and clinical data demonstrating favorable safety, encouraging effectiveness results, and high patient and practitioner satisfaction. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. Contacts: [email protected]@femasys.com
Investor releaseQuarter not tagged2026-05-09Femasys Announces Financial Results for Quarter Ended March 31, 2026 and Provides Corporate Update
GlobeNewswire
Femasys Announces Financial Results for Quarter Ended March 31, 2026 and Provides Corporate Update
-- With fertility rates at historic lows, Femasys advances access to early infertility care through FemaSeed® Complete, enabling OB/GYNs to treat patients within their own practices -- ATLANTA, May 08, 2026 (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, announces its financial results for the quarter ended March 31, 2026 and provides a corporate update. Corporate Highlights from 1Q 2026 to date Advanced initial commercial adoption of FemaSeed Complete, positioning Femasys to expand access to first-line fertility treatment through integrated, in-office care by OB/GYNs, supporting earlier intervention prior to referral to higher-cost specialty care. Launched FemaSeed Complete at ACOG 2026, advancing commercialization and expanding provider awareness to support adoption of first-line fertility treatment in the OB/GYN office. Established strategic partnership with AMI Technologies to introduce and commercialize its fertility portfolio in Israel, expanding international market opportunities. Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth. Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, enhancing leadership and strategic oversight. Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc®, advancing toward U.S. approval of a first-of-its kind, non-surgical permanent birth control. FemBloc permanent birth control system achieved Medical Device Single Audit Program (MDSAP) certification, supporting global regulatory readiness and future market access. Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed intratubal insemination (ITI), supporting future reimbursement and broader adoption in the U.S. Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed, and other portfolio products in Switzerland, expanding European market access. Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment and expanding access through community-based care. “During the first quarter of 2026 and into the second quarter of 2026, we delivered meaningful clin…Read full documentShow less
-- With fertility rates at historic lows, Femasys advances access to early infertility care through FemaSeed® Complete, enabling OB/GYNs to treat patients within their own practices -- ATLANTA, May 08, 2026 (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, announces its financial results for the quarter ended March 31, 2026 and provides a corporate update. Corporate Highlights from 1Q 2026 to date Advanced initial commercial adoption of FemaSeed Complete, positioning Femasys to expand access to first-line fertility treatment through integrated, in-office care by OB/GYNs, supporting earlier intervention prior to referral to higher-cost specialty care. Launched FemaSeed Complete at ACOG 2026, advancing commercialization and expanding provider awareness to support adoption of first-line fertility treatment in the OB/GYN office. Established strategic partnership with AMI Technologies to introduce and commercialize its fertility portfolio in Israel, expanding international market opportunities. Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth. Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, enhancing leadership and strategic oversight. Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc®, advancing toward U.S. approval of a first-of-its kind, non-surgical permanent birth control. FemBloc permanent birth control system achieved Medical Device Single Audit Program (MDSAP) certification, supporting global regulatory readiness and future market access. Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed intratubal insemination (ITI), supporting future reimbursement and broader adoption in the U.S. Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed, and other portfolio products in Switzerland, expanding European market access. Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment and expanding access through community-based care. “During the first quarter of 2026 and into the second quarter of 2026, we delivered meaningful clinical, regulatory and commercial progress across our FemBloc and FemaSeed platforms,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “We are accelerating commercialization of FemaSeed with the introduction of the FemSperm® product family, enabling OB/GYNs to deliver integrated, in-office fertility care. Concurrently, we advanced FemBloc with initiation of patient enrollment in the FINALE pivotal clinical trial, a key step toward U.S. FDA approval. We believe our current cash resources are sufficient to fund operations into the third quarter of 2026. We remain focused on scaling a broad portfolio of innovative women’s health solutions globally, addressing critical unmet needs with safe, technologically advanced products.” Financial Results for Quarter Ended March 31, 2026 Sales increased by $83,625, or 24.5%, to $424,889 in 2026 from $341,264 in 2025, primarily due to sales of FemBloc. Research and development expenses decreased by $1,659,071, or 55.9%, to $1,309,401 in 2026 compared to $2,968,472 in 2025, primarily reflecting the transition of development products into inventory to support commercialization, along with lower development, clinical, compensation, and professional service costs. Net income, including gains from changes in fair value of financial instruments, was $846,100, or $0.00 per basic and diluted share attributable to common stockholders for the quarter ended March 31, 2026, compared to a net loss of $5,896,839, or ($0.23) per basic and diluted share attributable to common stockholders, for the quarter ended March 31, 2025. Cash and cash equivalents as of March 31, 2026, was approximately $5.4 million and the Company had an accumulated deficit of approximately $145.0 million. The Company expects, based on its current operating plan, its current cash and cash equivalents will be sufficient to fund its ongoing operations into the third quarter of 2026. For more information, please refer to the Company’s Form 10-Q filed May 8, 2026, which can be accessed on the SEC website. About Femasys Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed® Intratubal Insemination (ITI), a groundbreaking first-step infertility treatment; FemSperm®, a CLIA waived sperm preparation and analysis product line; and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rate of traditional IUI, with a comparable safety profile and high patient and practitioner satisfaction.1 FemBloc® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec® diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is ongoing. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn. References 1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08. 2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05. Forward-Looking Statements This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; our ability to develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. Contacts: [email protected] [email protected]
Investor releaseQuarter not tagged2026-04-01Femasys Announces Financial Results for Year Ended December 31, 2025 and Provides Corporate Update
GlobeNewswire
Femasys Announces Financial Results for Year Ended December 31, 2025 and Provides Corporate Update
-- Enrollment underway in FDA-authorized FINALE pivotal trial demonstrating execution toward FemBloc® U.S. approval -- ATLANTA, March 31, 2026 (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 year ended December 31, 2025 and provides a corporate update. Corporate Highlights from 4Q 2025 to date Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc, advancing toward U.S. approval. Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, strengthening leadership and strategic oversight. FemBloc permanent birth control system achieved certification under the Medical Device Single Audit Program (MDSAP), supporting global regulatory readiness. Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed® intratubal insemination (ITI), supporting future reimbursement pathway. Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed and other products within the portfolio in Switzerland. Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment in community-based care. Secured FDA 510(k) clearance for the FemVue® Controlled device, supporting commercialization of an innovative solution for evaluating fallopian tube status. Completed $12 million financing, strengthening balance sheet to support ongoing clinical and commercial execution. Initiated European post-market surveillance study for FemBloc, advancing real-world evidence generation and commercialization efforts. “During the fourth quarter of 2025 and into the first quarter of 2026 we achieved significant clinical, regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination product solutions,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “We are actively expanding FemaSeed commercialization in the U.S. with the introduction of the FemSperm® product family, which enables gynecologists to perform in-office sperm preparation and analysis for use with our first-step infertility treatment. Concurrently, we are advancing FemBloc with the in…Read full documentShow less
-- Enrollment underway in FDA-authorized FINALE pivotal trial demonstrating execution toward FemBloc® U.S. approval -- ATLANTA, March 31, 2026 (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 year ended December 31, 2025 and provides a corporate update. Corporate Highlights from 4Q 2025 to date Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc, advancing toward U.S. approval. Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, strengthening leadership and strategic oversight. FemBloc permanent birth control system achieved certification under the Medical Device Single Audit Program (MDSAP), supporting global regulatory readiness. Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed® intratubal insemination (ITI), supporting future reimbursement pathway. Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed and other products within the portfolio in Switzerland. Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment in community-based care. Secured FDA 510(k) clearance for the FemVue® Controlled device, supporting commercialization of an innovative solution for evaluating fallopian tube status. Completed $12 million financing, strengthening balance sheet to support ongoing clinical and commercial execution. Initiated European post-market surveillance study for FemBloc, advancing real-world evidence generation and commercialization efforts. “During the fourth quarter of 2025 and into the first quarter of 2026 we achieved significant clinical, regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination product solutions,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “We are actively expanding FemaSeed commercialization in the U.S. with the introduction of the FemSperm® product family, which enables gynecologists to perform in-office sperm preparation and analysis for use with our first-step infertility treatment. Concurrently, we are advancing FemBloc with the initiation of patient enrollment in the FINALE pivotal clinical trial, a key step toward U.S. FDA approval. We believe we have sufficient cash to fund operations into the third quarter of 2026. We continue to strive to redefine women’s reproductive health by addressing critical gaps with innovative, safe, and technologically advanced solutions.” Financial Results for Year Ended December 31, 2025 Sales increased by $664,205, or 40.8%, to $2,293,313 in 2025 from $1,629,108 in 2024, primarily due to sales of FemBloc. Research and development expenses decreased by $638,839, or 7.8%, to $7,577,704 in 2025 compared to $8,216,543 in 2024, primarily due to commercialization of development products into inventory, reduced professional fees and compensation costs, partially offset by increased regulatory costs. Net loss was $18,627,887, or ($0.47) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2025, compared to a net loss of $18,816,628, or ($0.85) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2024. Cash and cash equivalents as of December 31, 2025, was approximately $9.3 million and the Company had an accumulated deficit of approximately $145.8 million. The Company expects, based on its current operating plan, its current cash and cash equivalents, will be sufficient to fund its ongoing operations into the third quarter of 2026. For more information, please refer to the Company’s Form 10-K filed March 31, 2026, which can be accessed on the SEC website. About Femasys Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed® Intratubal Insemination (ITI), a groundbreaking first-step infertility treatment; FemSperm®, a CLIA waived sperm preparation and analysis product line; and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rate of traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.1 FemBloc® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec® diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is ongoing. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn. References 1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08. 2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05. Forward-Looking Statements This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, when filed, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. Contacts: David Gutierrez, Dresner Corporate Services, (312) 780-7204, [email protected] Nathan Abler, Dresner Corporate Services, (714) 742-4180, [email protected]
Investor releaseQuarter not tagged2025-11-15Femasys Announces Third Quarter Financial Results for 2025
GlobeNewswire
Femasys Announces Third Quarter Financial Results for 2025
– 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 second partner order for FemBloc in Europe Announced FDA IDE approval to continue enrollment in final phase of the FINALE pivotal trial for FemBloc Announced a definitive agreement for the issuance of $12 million in secured convertible notes and accompanying warrants for total potential funding of $58 million, if all warrants are exercised for cash Announced the initiation of post-market surveillance study for FemBloc in Europe Announced partnership with Kebomed, a leading European distributor of medical devices and equipment, to commercialize FemBloc in France and the Benelux region (the Netherlands, Belgium and Luxembourg) Announced partnership with Medical Electronic Systems LLC to provide FemSperm™ Analysis Kit for use with FemaSeed® Announced FemSperm Setup and Preparation Kits, designed to fully enable gynecologists to perform FemaSeed Intratubal Insemination Announced New Zealand regulatory approval of FemBloc Announced underwritten public offering with gross proceeds of $8 million Announced United Kingdom regulatory approval of FemBloc “Our third quarter marked several pivotal milestones for Femasys as we advanced on multiple fronts, securing key regulatory approvals, strengthening our balance sheet through new financing, and expanding global partnerships for FemBloc, all reinforcing our commitment to delivering innovative solutions for women’s health,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. “Regulatory approvals of the complete FemBloc System in the U.K. and New Zealand significantly expand access to this revolutionary, non-surgical permanent birth control option across Europe and the Asia-Pacific region. With initial commercial orders received from our distribution partners in Spain and France, we are building early momentum as we pursue additional country approvals. At the same time, we continue to advance toward U.S…Read full documentShow less
– 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 second partner order for FemBloc in Europe Announced FDA IDE approval to continue enrollment in final phase of the FINALE pivotal trial for FemBloc Announced a definitive agreement for the issuance of $12 million in secured convertible notes and accompanying warrants for total potential funding of $58 million, if all warrants are exercised for cash Announced the initiation of post-market surveillance study for FemBloc in Europe Announced partnership with Kebomed, a leading European distributor of medical devices and equipment, to commercialize FemBloc in France and the Benelux region (the Netherlands, Belgium and Luxembourg) Announced partnership with Medical Electronic Systems LLC to provide FemSperm™ Analysis Kit for use with FemaSeed® Announced FemSperm Setup and Preparation Kits, designed to fully enable gynecologists to perform FemaSeed Intratubal Insemination Announced New Zealand regulatory approval of FemBloc Announced underwritten public offering with gross proceeds of $8 million Announced United Kingdom regulatory approval of FemBloc “Our third quarter marked several pivotal milestones for Femasys as we advanced on multiple fronts, securing key regulatory approvals, strengthening our balance sheet through new financing, and expanding global partnerships for FemBloc, all reinforcing our commitment to delivering innovative solutions for women’s health,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. “Regulatory approvals of the complete FemBloc System in the U.K. and New Zealand significantly expand access to this revolutionary, non-surgical permanent birth control option across Europe and the Asia-Pacific region. With initial commercial orders received from our distribution partners in Spain and France, we are building early momentum as we pursue additional country approvals. At the same time, we continue to advance toward U.S. approval of FemBloc, following the FDA’s recent IDE approval to initiate the final pivotal trial phase required for regulatory approval.” Financial Results for Quarter Ended September 30, 2025 Sales increased by $174,486, or 31.4%, to $729,394 for the three months of 2025, compared to $554,908 for the three months of 2024 primarily due to sales of FemBloc. Research and development expenses decreased by $921,219, or 40.0%, to $1,382,022 for the three months of 2025 compared to $2,303,241 for the three months of 2024 primarily due to commercialization of development products into inventory and reduced compensation costs, clinical costs and professional fees. Net loss was $4,194,821, or ($0.10) per basic and diluted share attributable to common stockholders, for the three-month period ended September 30, 2025, compared to a net loss of $5,408,860, or ($0.24) per basic and diluted share attributable to common stockholders, for the three-month period ended September 30, 2024. Cash and cash equivalents as of September 30, 2025, was approximately $4.6 million and the Company had an accumulated deficit of approximately $141.9 million. The Company expects, based on its current operating plan, our current cash and cash equivalents, which includes proceeds from our recent financing, will be sufficient to fund its ongoing operations into September 2026. Financial Results for Nine Months Ended September 30, 2025 Sales increased by $432,394, or 41.3%, to $1,479,926 for the nine months of 2025, compared to $1,047,532 for the nine months of 2024 due to sales of FemBloc and FemVue. Research and development expenses decreased by $284,924, or 4.7%, to $5,764,923 for the nine months of 2025 compared to $6,049,847 for the nine months of 2024 primarily due to commercialization of development products into inventory, reduced clinical costs and professional fees, partially offset by increased regulatory costs. Net loss was $14,677,582, or ($0.46) per basic and diluted share attributable to common stockholders, for the nine-month period ended September 30, 2025, compared to a net loss of $13,692,944, or ($0.62) per basic and diluted share attributable to common stockholders, for the same period ended September 30, 2024. For more information, please refer to the Company’s Form 10-Q filed November 14, 2025, which can be accessed on the SEC website. About Femasys Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed® Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.1 FemBloc® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec®, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn. References 1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08. 2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05. Forward-Looking Statements This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. Contacts: David Gutierrez, Dresner Corporate Services, (312) 780-7204, [email protected] Nathan Abler, Dresner Corporate Services, (714) 742-4180, [email protected]
Investor releaseQuarter not tagged2025-08-11Femasys Second Quarter 2025 Earnings: EPS Beats Expectations, Revenues Lag
Simply Wall St.
Femasys Second Quarter 2025 Earnings: EPS Beats Expectations, Revenues Lag
Explore Femasys's Fair Values from the Community and select yours Revenue: US$409.3k (up 85% from 2Q 2024). Net loss: US$4.59m (loss narrowed by 2.1% from 2Q 2024). US$0.16 loss per share (improved from US$0.21 loss in 2Q 2024). This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 65%. Earnings per share (EPS) exceeded analyst estimates by 1.5%. Looking ahead, revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Performance of the American Medical Equipment industry. The company's shares are up 10% from a week ago. Don't forget that there may still be risks. For instance, we've identified 5 warning signs for Femasys (2 can't be ignored) you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-08-09Femasys Announces Second Quarter Financial Results for 2025
GlobeNewswire
Femasys Announces Second Quarter Financial Results for 2025
-- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio -- ATLANTA, Aug. 08, 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 second quarter of 2025. Corporate Highlights from 2Q 2025 to date Announced European Union Medical Device Regulation approval of FemBloc®, the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution Secured first European order for FemBloc from Spain distribution partners for approximately $400,000 Announced Australian and New Zealand regulatory approvals for FemaSeed® and FemVue®, a cost-effective first step in fertility Announced new Chief Commercial Officer to help drive execution and global growth Announced partnership with Carolinas Fertility Institute, one of America’s best fertility clinics, to offer FemaSeed in its eight locations Announced pricing of underwritten public offering and concurrent private placement with gross proceeds of $4.5 million “Our second quarter marked several significant milestones for Femasys as we continue to secure key regulatory approvals, add partners, and strengthen our team to accelerate the commercialization of our innovative fertility portfolio across the globe,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. “European approval of the entire FemBloc System announced in June marks the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution. FemBloc is commercially available through strategic distribution partnerships in select countries in Europe beginning in Spain, who placed their initial order, and we will seek additional country approvals while continuing to enroll participants in our FDA IDE-approved late-stage pivotal trial for U.S. approval. “Regulatory approvals for FemaSeed in Australia and New Zealand announced in July also provide us with the opportunity to pursue meaningful commercial opportunities as we continue to grow revenue and broaden our global footprint. Our new partnership with Carolinas Fertility Institute will help us reach and support more patients earlier in their fertility journey. We look forward to building upon this moment…Read full documentShow less
-- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio -- ATLANTA, Aug. 08, 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 second quarter of 2025. Corporate Highlights from 2Q 2025 to date Announced European Union Medical Device Regulation approval of FemBloc®, the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution Secured first European order for FemBloc from Spain distribution partners for approximately $400,000 Announced Australian and New Zealand regulatory approvals for FemaSeed® and FemVue®, a cost-effective first step in fertility Announced new Chief Commercial Officer to help drive execution and global growth Announced partnership with Carolinas Fertility Institute, one of America’s best fertility clinics, to offer FemaSeed in its eight locations Announced pricing of underwritten public offering and concurrent private placement with gross proceeds of $4.5 million “Our second quarter marked several significant milestones for Femasys as we continue to secure key regulatory approvals, add partners, and strengthen our team to accelerate the commercialization of our innovative fertility portfolio across the globe,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. “European approval of the entire FemBloc System announced in June marks the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution. FemBloc is commercially available through strategic distribution partnerships in select countries in Europe beginning in Spain, who placed their initial order, and we will seek additional country approvals while continuing to enroll participants in our FDA IDE-approved late-stage pivotal trial for U.S. approval. “Regulatory approvals for FemaSeed in Australia and New Zealand announced in July also provide us with the opportunity to pursue meaningful commercial opportunities as we continue to grow revenue and broaden our global footprint. Our new partnership with Carolinas Fertility Institute will help us reach and support more patients earlier in their fertility journey. We look forward to building upon this momentum as we work towards transforming the fertility sector not only for patients, but also providers.” Financial Results for Quarter Ended June 30, 2025 Sales increased by $187,784, or 84.8%, to $409,268 for the three months of 2025, compared to $221,484 for the three months of 2024 due to sales of FemaSeed and FemVue. Research and development expenses decreased by $561,446, or 28.4%, to $1,414,429 for the three months of 2025 compared to $1,975,875 for the three months of 2024 primarily due to commercialization of development products into inventory and reduced clinical costs, partially offset by increased compensation costs. Net loss was $4,585,922, or ($0.16) per basic and diluted share attributable to common stockholders, for the three-month period ended June 30, 2025, compared to a net loss of $4,684,574, or ($0.21) per basic and diluted share attributable to common stockholders, for the three-month period ended June 30, 2024. Cash and cash equivalents as of June 30, 2025, was approximately $3.2 million and the Company had an accumulated deficit of approximately $137.7 million. The Company expects, based on its current operating plan, our current cash and cash equivalents will be sufficient to fund its ongoing operations into early fourth quarter of 2025. Financial Results for Six Months Ended June 30, 2025 Sales increased by $257,908, or 52.4%, to $750,532 for the six months of 2025, compared to $492,624 for the six months of 2024 due to sales of FemaSeed and FemVue. Research and development expenses increased by $636,295, or 17.0%, to $4,382,901 for the six months of 2025 compared to $3,746,606 for the six months of 2024 primarily due to increased compensation and regulatory costs, partially offset by reduced material and development costs and clinical costs. Net loss was $10,482,761, or ($0.39) per basic and diluted share attributable to common stockholders, for the six-month period ended June 30, 2025, compared to a net loss of $8,284,084, or ($0.38) per basic and diluted share attributable to common stockholders, for the same period ended June 30, 2024. For more information, please refer to the Company’s Form 10-Q filed August 8, 2025, which can be accessed on the SEC website. About Femasys Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed® Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.1 FemBloc® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec®, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn. References 1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08. 2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05. Forward-Looking Statements This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. Contacts: Investors: [email protected] Media: [email protected]
Investor releaseQuarter not tagged2025-05-09Femasys Announces Financial Results for Quarter Ended March 31, 2025, and Provides Corporate Update
GlobeNewswire
Femasys Announces Financial Results for Quarter Ended March 31, 2025, and Provides Corporate Update
-- Company delivers on mission to transform women’s health with innovative solutions, including FemaSeed® for first-line infertility treatment and FemBloc® non-surgical permanent birth control (full system approval pending in Europe) -- ATLANTA, May 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces financial results for the quarter ended March 31, 2025 and provides a corporate update. Corporate Highlights from 1Q 2025 to date Announced FemBloc permanent birth control delivery system approval in Europe; FemBloc blended polymer component successfully completed an expedited G12 Special MDR Audit for Class III devices, and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review Announced United Kingdom and Israeli regulatory approvals for FemaSeed and two diagnostic devices Announced partnership with CNY Fertility, a national conglomerate of eleven fertility centers, to offer FemaSeed Announced distribution partnerships for FemBloc in Spain Announced peer-reviewed publication of positive safety and efficacy results from FemBloc clinical trials Announced notices of intention to grant two new European patent applications for FemBloc Announced notice of allowance for new U.S. patent application for FemaSeed “Securing the first regulatory approval globally for the FemBloc delivery system marks a key milestone toward full system approval and the introduction of a first-of-its-kind, non-surgical permanent birth control option for women in Europe,” said Femasys’ CEO Kathy Lee-Sepsick. “Additionally in the first quarter of 2025, we began executing our commercialization strategy for FemaSeed, achieving a 78% quarter-over-quarter sales increase in the U.S., an encouraging early indicator of strong market momentum and the unmet need for additional fertility treatment options. We remain dedicated to closing critical gaps in women’s reproductive health through the advancement of safe, effective, accessible and innovative solutions.” Financial Results for Quarter Ended March 31, 2025 Sales increased by $70,124, or 25.9%, to $341,264 for the three months of 2025, from $271,140 for the three mo…Read full documentShow less
-- Company delivers on mission to transform women’s health with innovative solutions, including FemaSeed® for first-line infertility treatment and FemBloc® non-surgical permanent birth control (full system approval pending in Europe) -- ATLANTA, May 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces financial results for the quarter ended March 31, 2025 and provides a corporate update. Corporate Highlights from 1Q 2025 to date Announced FemBloc permanent birth control delivery system approval in Europe; FemBloc blended polymer component successfully completed an expedited G12 Special MDR Audit for Class III devices, and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review Announced United Kingdom and Israeli regulatory approvals for FemaSeed and two diagnostic devices Announced partnership with CNY Fertility, a national conglomerate of eleven fertility centers, to offer FemaSeed Announced distribution partnerships for FemBloc in Spain Announced peer-reviewed publication of positive safety and efficacy results from FemBloc clinical trials Announced notices of intention to grant two new European patent applications for FemBloc Announced notice of allowance for new U.S. patent application for FemaSeed “Securing the first regulatory approval globally for the FemBloc delivery system marks a key milestone toward full system approval and the introduction of a first-of-its-kind, non-surgical permanent birth control option for women in Europe,” said Femasys’ CEO Kathy Lee-Sepsick. “Additionally in the first quarter of 2025, we began executing our commercialization strategy for FemaSeed, achieving a 78% quarter-over-quarter sales increase in the U.S., an encouraging early indicator of strong market momentum and the unmet need for additional fertility treatment options. We remain dedicated to closing critical gaps in women’s reproductive health through the advancement of safe, effective, accessible and innovative solutions.” Financial Results for Quarter Ended March 31, 2025 Sales increased by $70,124, or 25.9%, to $341,264 for the three months of 2025, from $271,140 for the three months of 2024 due to sales of FemaSeed Research and development expenses increased by $1,197,741, or 67.6%, to $2,968,472 for the three months of 2025 from $1,770,731 for the three months of 2024 primarily due to increased regulatory costs, material and development costs, and compensation costs Net loss was $5,896,839, or ($0.23) per basic and diluted share attributable to common stockholders, for the three-month period ended March 31, 2025, compared to net loss of $3,599,510, or ($0.17) per basic and diluted share attributable to common stockholders, for the same period ended March 31, 2024 Cash and cash equivalents as of March 31, 2025, was approximately $3.8 million and the Company had an accumulated deficit of approximately $133.1 million. The Company expects, based on its current operating plan, our current cash and cash equivalents, will be sufficient to fund its ongoing operations into early third quarter of 2025. For more information, please refer to the Company’s Form 10-Q filed May 8, 2025, which can be accessed on the SEC website. About Femasys Femasys is a leading biomedical innovator focused on addressing critical unmet needs in women’s health with a broad, patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed® Intratubal Insemination, a groundbreaking first-line infertility treatment and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data show FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.1 FemBloc® permanent birth control, the first and only non-surgical, in-office alternative to centuries-old surgical sterilization, expects full regulatory approval in Europe mid-year 2025. Commercialization of this highly cost effective, convenient and significantly safer approach, will begin in Spain through engaged partnerships followed by select European countries. Alongside FemBloc, the FemChec®, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn. References1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08. 2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05. Forward-Looking Statements This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. Contacts: Investors: [email protected] Media:[email protected]
Investor releaseQuarter not tagged2025-03-27Femasys Announces Financial Results for Year Ended December 31, 2024, and Provides Corporate Update
GlobeNewswire
Femasys Announces Financial Results for Year Ended December 31, 2024, and Provides Corporate Update
-- Company expands commercial product offering with FemBloc® permanent birth control (delivery system) approval in Europe and signed partnerships for distribution in Spain -- ATLANTA, March 27, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces financial results for the year ended December 31, 2024 and provides a corporate update. Corporate Highlights from 4Q 2024 to date Announced FemBloc® permanent birth control (delivery system) approval in Europe; FemBloc blended polymer component successfully completed an expedited G12 Special MDR Audit for Class III devices, and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review Announced partnership with CNY Fertility, national conglomerate of 11 fertility centers, to offer FemaSeed® Announced strategic distribution partnerships for FemBloc in Spain Announced peer-reviewed publication of positive safety and efficacy results from FemBloc clinical trials Announced UK and Israeli regulatory approvals for FemaSeed and two diagnostic devices Announced notices of intention to grant two new European patent applications for FemBloc Announced notice of allowance for new U.S. patent application for FemaSeed Announced partnership with HRC Fertility, conglomerate provider of fertility services in Western U.S., to offer FemaSeed Announced partnership with Boston IVF, prominent network of 30 centers nationwide, to offer FemaSeed Announced peer-reviewed publication of positive safety and efficacy results from FemaSeed pivotal trial “During the fourth quarter of 2024 and first quarter of 2025 we achieved significant regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination products,” said Femasys’ CEO Kathy Lee-Sepsick. “We are focused on executing on commercialization of FemaSeed and expect U.S. revenue to increase by approximately 50% in first quarter of 2025 versus fourth quarter of 2024. We are continuing to advance our FemBloc to commercialization in Europe while executing on the clinical pivotal trial for U.S. FDA approval. We believe we have sufficient cas…Read full documentShow less
-- Company expands commercial product offering with FemBloc® permanent birth control (delivery system) approval in Europe and signed partnerships for distribution in Spain -- ATLANTA, March 27, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces financial results for the year ended December 31, 2024 and provides a corporate update. Corporate Highlights from 4Q 2024 to date Announced FemBloc® permanent birth control (delivery system) approval in Europe; FemBloc blended polymer component successfully completed an expedited G12 Special MDR Audit for Class III devices, and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review Announced partnership with CNY Fertility, national conglomerate of 11 fertility centers, to offer FemaSeed® Announced strategic distribution partnerships for FemBloc in Spain Announced peer-reviewed publication of positive safety and efficacy results from FemBloc clinical trials Announced UK and Israeli regulatory approvals for FemaSeed and two diagnostic devices Announced notices of intention to grant two new European patent applications for FemBloc Announced notice of allowance for new U.S. patent application for FemaSeed Announced partnership with HRC Fertility, conglomerate provider of fertility services in Western U.S., to offer FemaSeed Announced partnership with Boston IVF, prominent network of 30 centers nationwide, to offer FemaSeed Announced peer-reviewed publication of positive safety and efficacy results from FemaSeed pivotal trial “During the fourth quarter of 2024 and first quarter of 2025 we achieved significant regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination products,” said Femasys’ CEO Kathy Lee-Sepsick. “We are focused on executing on commercialization of FemaSeed and expect U.S. revenue to increase by approximately 50% in first quarter of 2025 versus fourth quarter of 2024. We are continuing to advance our FemBloc to commercialization in Europe while executing on the clinical pivotal trial for U.S. FDA approval. We believe we have sufficient cash to fund operations into the third quarter of 2025. We remain committed to addressing major gaps in women’s reproductive health by advancing safe and effective, technologically advanced product solutions.” Financial Results for Year Ended December 31, 2024 Sales increased by $557,138, or 52.0%, to $1,629,108 in 2024 from $1,071,970 in 2023 Research and development expenses increased by $1,007,842, or 14.0%, to $8,216,543 in 2024 from $7,208,701 in 2023 Net loss was $18,816,628, or ($0.85) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2024, compared to net loss of $14,247,124, or ($0.93) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2023 Cash and cash equivalents as of December 31, 2024, was $3.5 million and the Company had an accumulated deficit of $127.2 million. The Company expects, based on its current operating plan, our current cash and cash equivalents, which includes approximately $5.4 million we raised subsequent to year end, will be sufficient to fund its ongoing operations into third quarter of 2025. For more information, please refer to the Company’s Form 10-K filed March 27, 2025, which can be accessed on the SEC website. About Femasys Femasys is a leading biomedical innovator focused on addressing critical unmet needs in women’s health with a broad, patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. The Company, a U.S. manufacturer, has received regulatory approvals for its product portfolio worldwide, and they are currently being commercialized in the U.S. and key international markets. FemaSeed® Intratubal Insemination, a groundbreaking first-line infertility treatment, is FDA-cleared and approved in Europe, UK, Canada and Israel. Clinical trial data, published in peer-reviewed journal, demonstrate safety, effectiveness, and high satisfaction from patients and practitioners.1 FemVue®, a companion diagnostic for fallopian tube assessment, is FDA-cleared and approved in Europe, UK, Canada, Japan and Israel. FemCerv®, a tissue sampler for cervical cancer diagnosis, is FDA-cleared and approved in Europe, UK, Canada and Israel. FemBloc® permanent birth control, is the first and only non-surgical, in-office approach offering significant benefits over the costly, inconvenient, risk-laden surgical alternative. The revolutionary FemBloc delivery system is approved in Europe and the proprietary blended polymer has been recommended for approval, which is expected mid-year 2025. For U.S. FDA approval, the FINALE pivotal clinical trial (NCT05977751) is currently enrolling participants. Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.2 FemCath® and FemChec®, diagnostic products for FemBloc’s ultrasound-based confirmation test, are FDA-cleared and approved in Europe and Canada. References 1 Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. 2 Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. Forward-Looking Statements This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024, when filed, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law. Contacts: Investors: [email protected] Media:[email protected]

