ATLANTA, March 31, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. $(FEMY)$, 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$(R)$ 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(R) 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(R) 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.
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
December 31, December 31,
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)
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders' December 31, December 31,
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, $0.001 par,
200,000,000 authorized,
59,720,010 shares issued and
59,602,787 outstanding as
of
December 31, 2025; and
23,473,149 shares issued
and 23,355,926 outstanding
as of December 31, 2024 59,720 23,473
Treasury stock, 117,223
common shares (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
============ ============
FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)
December 31, December 31,
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
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