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
Financial Results for Year Ended
- 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 endedDecember 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 endedDecember 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
| Condensed Balance Sheets | ||||||||||||
| (unaudited) | ||||||||||||
| Assets | 2025 | 2024 | ||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 9,266,353 | 3,451,761 | |||||||||
| Accounts receivable, net | 616,600 | 488,373 | ||||||||||
| Inventory | 5,740,249 | 3,046,323 | ||||||||||
| Prepaid and other current assets | 833,133 | 1,035,993 | ||||||||||
| Total current assets | 16,456,335 | 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 | 3,065,713 | 2,856,740 | ||||||||||
| Construction in progress | 897,885 | 762,445 | ||||||||||
| 5,698,515 | 5,336,868 | |||||||||||
| Less accumulated depreciation | (3,802,940 | ) | (3,740,769 | ) | ||||||||
| Net property and equipment | 1,895,575 | 1,596,099 | ||||||||||
| Long-term assets: | ||||||||||||
| Lease right-of-use assets, net | 1,297,121 | 1,805,543 | ||||||||||
| Intangible assets, net of accumulated amortization | 134,914 | 65,918 | ||||||||||
| Other long-term assets | 940,232 | 954,992 | ||||||||||
| Total long-term assets | 2,372,267 | 2,826,453 | ||||||||||
| Total assets | $ | 20,724,177 | 12,445,002 | |||||||||
| (continued) | ||||||||||||
| Condensed Balance Sheets | |||||||||||||
| (unaudited) | |||||||||||||
| Liabilities and Stockholders’ Equity | 2025 | 2024 | |||||||||||
| Current liabilities: | |||||||||||||
| Accounts payable | $ | 1,830,124 | 1,419,044 | ||||||||||
| Accrued expenses | 1,265,773 | 1,151,049 | |||||||||||
| Convertible notes payable, net (including related parties) | — | 5,406,228 | |||||||||||
| Clinical holdback – current portion | 52,644 | 88,581 | |||||||||||
| Lease liabilities – current portion | 487,624 | 517,967 | |||||||||||
| Total current liabilities | 3,636,165 | 8,582,869 | |||||||||||
| Long-term liabilities: | |||||||||||||
| Clinical holdback – long-term portion | 52,370 | 39,611 | |||||||||||
| Convertible notes payable, net | 3,178,864 | — | |||||||||||
| Conversion option liability | 2,014,000 | — | |||||||||||
| Warrants liabilities | 4,943,000 | — | |||||||||||
| Lease liabilities – long-term portion | 1,030,476 | 1,518,100 | |||||||||||
| Total long-term liabilities | 11,218,710 | 1,557,711 | |||||||||||
| Total liabilities | 14,854,875 | 10,140,580 | |||||||||||
| Commitments and contingencies | |||||||||||||
| Stockholders’ equity: | |||||||||||||
| Common stock, | |||||||||||||
| 59,720,010 shares issued and 59,602,787 outstanding as of | |||||||||||||
| and 23,355,926 outstanding as of | 59,720 | 23,473 | |||||||||||
| (60,000 | ) | (60,000 | ) | ||||||||||
| Warrants | 5,246,150 | 1,860,008 | |||||||||||
| Additional paid-in capital | 146,449,576 | 127,679,198 | |||||||||||
| Accumulated deficit | (145,826,144 | ) | (127,198,257 | ) | |||||||||
| Total stockholders’ equity | 5,869,302 | 2,304,422 | |||||||||||
| Total liabilities and stockholders' equity | $ | 20,724,177 | 12,445,002 | ||||||||||
| Condensed Statements of Comprehensive Loss | ||||||||||||
| (unaudited) | ||||||||||||
2025 | 2024 | |||||||||||
| Sales | $ | 2,293,313 | 1,629,108 | |||||||||
| Cost of sales (excluding depreciation expense) | 872,400 | 544,903 | ||||||||||
| Operating expenses: | ||||||||||||
| Research and development | 7,577,704 | 8,216,543 | ||||||||||
| Sales and marketing | 4,443,807 | 4,030,150 | ||||||||||
| General and administrative | 6,646,037 | 6,325,999 | ||||||||||
| Depreciation and amortization | 342,034 | 297,318 | ||||||||||
| Total operating expenses | 19,009,582 | 18,870,010 | ||||||||||
| Loss from operations | (17,588,669 | ) | (17,785,805 | ) | ||||||||
| Other (expense) income: | ||||||||||||
| Interest income | 101,760 | 582,354 | ||||||||||
| Change in fair value of conversion option liability | 503,000 | — | ||||||||||
| Change in fair value of warrants liabilities | 731,000 | — | ||||||||||
| Interest expense | (1,891,119 | ) | (1,603,575 | ) | ||||||||
| Other expense | (482,562 | ) | — | |||||||||
| Total other expense, net | (1,037,921 | ) | (1,021,221 | ) | ||||||||
| Loss before income taxes | (18,626,590 | ) | (18,807,026 | ) | ||||||||
| Income tax expense | 1,297 | 9,602 | ||||||||||
| Net loss | $ | (18,627,887 | ) | (18,816,628 | ) | |||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (18,627,887 | ) | (18,816,628 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.47 | ) | (0.85 | ) | |||||||
| Weighted-average common shares and pre-funded warrants outstanding- basic and diluted | 39,549,218 | 22,267,695 | ||||||||||
About
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
Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
References
1Liu, J. H., Glassner, M., Gracia,
2Liu, J. H., Blumenthal,
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
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