Full Press Release Details
Femasys Announces Third Quarter Financial Results for 2025
- FDA Approval to Advance Final FemBloc Trial with Clear Pathway to Potentially Achieve U.S.
- $12 Million Financing Strengthens Balance Sheet and Extends Cash Runway -
ATLANTA, November 14, 2025 - 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
"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
Financial Results for Nine Months Ended September 30, 2025
For more information, please refer to the Company's Form 10-Q filed November 14, 2025, which can be accessed on the SEC
Condensed Balance Sheets
| Assets | September 30, 2025 | December 31, 2024 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,569,038 | 3,451,761 | |||||
| Accounts receivable, net | 572,199 | 488,373 | ||||||
| Inventory | 5,783,974 | 3,046,323 | ||||||
| Prepaid and other current assets | 1,321,689 | 1,035,993 | ||||||
| Total current assets | 12,246,900 | 8,022,450 | ||||||
| Property and equipment, at cost: | ||||||||
| Leasehold improvements | 1,238,886 | 1,238,886 | ||||||
| Office equipment | 78,155 | 60,921 | ||||||
| Furniture and fixtures | 417,876 | 417,876 | ||||||
| Machinery and equipment | 3,283,672 | 2,856,740 | ||||||
| Construction in progress | 687,462 | 762,445 | ||||||
| 5,706,051 | 5,336,868 | |||||||
| Less accumulated depreciation | (3,956,987 | ) | (3,740,769 | ) | ||||
| Net property and equipment | 1,749,064 | 1,596,099 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 1,419,345 | 1,805,543 | ||||||
| Intangible assets, net of accumulated amortization | 130,041 | 65,918 | ||||||
| Other long-term assets | 744,803 | 954,992 | ||||||
| Total long-term assets | 2,294,189 | 2,826,453 | ||||||
| Total assets | $ | 16,290,153 | 12,445,002 |
Condensed Balance Sheets
| Liabilities and Stockholders' Equity | September 30, 2025 | December 31, 2024 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,173,883 | 1,419,044 | |||||
| Accrued expenses | 1,028,461 | 1,151,049 | ||||||
| Note payable | 276,489 | - | ||||||
| Convertible notes payable, net (including related parties) | 6,507,354 | 5,406,228 | ||||||
| Clinical holdback - current portion | 60,543 | 88,581 | ||||||
| Lease liabilities - current portion | 494,954 | 517,967 | ||||||
| Total current liabilities | 10,541,684 | 8,582,869 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback - long-term portion | 43,955 | 39,611 | ||||||
| Lease liabilities - long-term portion | 1,148,263 | 1,518,100 | ||||||
| Total long-term liabilities | 1,192,218 | 1,557,711 | ||||||
| Total liabilities | 11,733,902 | 10,140,580 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par, 200,000,000 authorized, 47,419,596 shares issued and 47,302,373 outstanding as of September 30, 2025; and 23,473,149 shares issued and 23,355,926 outstanding as of December 31, 2024 | 47,420 | 23,473 | ||||||
| Treasury stock, 117,223 common shares | (60,000 | ) | (60,000 | ) | ||||
| Warrants | 6,727,334 | 1,860,008 | ||||||
| Additional paid-in-capital | 139,717,336 | 127,679,198 | ||||||
| Accumulated deficit | (141,875,839 | ) | (127,198,257 | ) | ||||
| Total stockholders' equity | 4,556,251 | 2,304,422 | ||||||
| Total liabilities and stockholders' equity | $ | 16,290,153 | 12,445,002 |
Condensed Statements of Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Sales | $ | 729,394 | 554,908 | 1,479,926 | 1,047,532 | |||||||||||
| Cost of sales (excluding depreciation expense) | 293,838 | 190,839 | 569,275 | 352,496 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,382,022 | 2,303,241 | 5,764,923 | 6,049,847 | ||||||||||||
| Sales and marketing | 1,143,805 | 1,572,189 | 3,037,349 | 2,847,866 | ||||||||||||
| General and administrative | 1,477,800 | 1,530,791 | 4,817,485 | 4,645,412 | ||||||||||||
| Depreciation and amortization | 85,697 | 76,288 | 256,835 | 215,144 | ||||||||||||
| Total operating expenses | 4,089,324 | 5,482,509 | 13,876,592 | 13,758,269 | ||||||||||||
| Loss from operations | (3,653,768 | ) | (5,118,440 | ) | (12,965,941 | ) | (13,063,233 | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest income | 17,315 | 124,028 | 53,488 | 532,850 | ||||||||||||
| Interest expense | (532,073 | ) | (413,290 | ) | (1,483,022 | ) | (1,163,153 | ) | ||||||||
| Other expense | (26,295 | ) | - | (286,295 | ) | - | ||||||||||
| Total other expense, net | (541,053 | ) | (289,262 | ) | (1,715,829 | ) | (630,303 | ) | ||||||||
| Loss before income taxes | (4,194,821 | ) | (5,407,702 | ) | (14,681,770 | ) | (13,693,536 | ) | ||||||||
| Income tax expense (benefit) | - | 1,158 | (4,188 | ) | (592 | ) | ||||||||||
| Net loss | $ | (4,194,821 | ) | (5,408,860 | ) | (14,677,582 | ) | (13,692,944 | ) | |||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (4,194,821 | ) | (5,408,860 | ) | (14,677,582 | ) | (13,692,944 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.10 | ) | (0.24 | ) | (0.46 | ) | (0.62 | ) | |||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 41,015,196 | 22,232,799 | 31,739,828 | 22,075,135 |
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.
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., Casta o, 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.
David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com
Nathan Abler, Dresner Corporate Services, (714) 742-4180, nabler@dresnerco.com