ATLANTA, Nov. 13, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. $(FEMY)$, 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 September 30, 2026 and provides a corporate update.
Corporate Highlights from 3Q 2026 to date
-- Completed $30 million private placement with potential total proceeds of
up to $85 million upon full cash exercise of warrants, to build-out the
U.S. commercial team needed to support revenue growth following recent
availability of the FemaSeed(R) fertility portfolio to OB/GYNs, and to
fund the FemBloc(R) pivotal trial to support U.S. approval.
-- Highlights for the FemaSeed Fertility Portfolio (Diagnostics: FemVue(R)
for her and SpermVueTM for him; first-step treatment: FemaSeed and
FemSperm(R)):
-- Announced a partnership with both UNC Health and Minnesota Women's
Care to introduce the entire portfolio across its OB/GYN practice
locations.
-- Announced a partnership with CapexMD to expand patient access
through financing solutions and SandsRx Pharmacy for medications
to support treatment timing.
-- Highlights for FemBloc Permanent Birth Control:
-- Issuance of patents in the U.S. and key international markets that
expand intellectual property protection for the blended polymer
component.
-- Received FDA approval of the modular premarket approval $(PMA)$
submission approach.
-- Announced the number of actively enrolling sites in the FINALE
trial to support U.S. approval doubled to twelve sites.
"We maintained a lean team and tightly managed resources as we prioritized financing from long-term institutional investors. Closing the $30 million in financing in mid-August 2026 represents an important turning point for Femasys," said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. "With U.S. fertility rates at historic lows, there is an urgent need to bring treatment to the OB/GYN office, where women already seek care. Our portfolio enables these physicians to offer a complete pathway from diagnostics through first-step treatment, supported by partnerships that simplify access to patient financing and fertility medications. Since closing the financing, we have been successfully recruiting commercial professionals with deep OB/GYN expertise and established relationships. Healthcare system partnerships and initial sales achieved with limited resources demonstrate the commercial potential of our comprehensive fertility portfolio. These results and commercial recruitment progress give us strong confidence that deploying our team in target U.S. territories will broaden adoption and drive revenue growth."
Financial Results for Quarter Ended September 30, 2026
-- Sales in the U.S. increased slightly to $347,039 in 2026 from $336,594 in
2025, while overall sales decreased by $324,797, or 44.5%, to $404,597
from $729,394. The overall decline was anticipated and reflects the
timing of international FemBloc orders, consistent with distributors'
customary bulk-ordering practices. Distributors are utilizing existing
inventory to support FemBloc post-market studies, with reorders expected
after those studies are completed.
-- Research and development expenses increased by $560,905, or 40.6%, to
$1,942,927 in 2026 compared to $1,382,022 in 2025, primarily reflecting
the transition of development products into inventory to support
commercialization during 2025, and increased clinical costs and
compensation costs during 2026.
-- Net loss was $4,564,815, or ($0.53) per basic and diluted share
attributable to common stockholders, for the quarter ended September 30,
2026, compared to a net loss of $4,194,821, or ($2.05) per basic and
diluted share attributable to common stockholders, for the quarter ended
September 30, 2025.
Financial Results for Nine Months Ended September 30, 2026
-- Sales in the U.S. increased slightly to $1,038,997 in 2026 from
$1,015,168 in 2025, while overall sales decreased by $318,613, or 21.5%,
to $1,161,313 from $1,479,926. The overall decline was anticipated and
reflects the timing of international FemBloc orders, consistent with
distributors' customary bulk-ordering practices. Distributors are
utilizing existing inventory to support FemBloc post-market studies, with
reorders expected after those studies are completed.
-- Research and development expenses decreased by $565,717, or 9.8%, to
$5,199,206 in 2026 compared to $5,764,923 in 2025, primarily reflecting
lower compensation costs, regulatory fees and outside consultant costs,
partially offset by increased clinical costs and material and development
costs.
-- Net loss was $8,187,810, or ($1.59) per basic and diluted share
attributable to common stockholders, for the nine months ended September
30, 2026, compared to a net loss of $14,677,582, or ($9.25) per basic and
diluted share attributable to common stockholders, for the nine months
ended September 30, 2025.
-- Cash and cash equivalents as of September 30, 2026, were approximately
$23.9 million and the Company had an accumulated deficit of approximately
$154.0 million.
For more information, please refer to the Company's Form 10-Q filed November 13, 2026, which can be accessed on the SEC website.
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
September 30, December 31,
Assets 2026 2025
------------- --------------
Current assets:
Cash and cash equivalents $ 23,913,946 9,266,353
Accounts receivable, net 233,778 616,600
Inventory 6,166,371 5,740,249
Prepaid and other current
assets 893,098 833,133
Total current assets 31,207,193 16,456,335
------------ -----------
Property and equipment, at
cost:
Leasehold improvements 1,238,886 1,238,886
Office equipment 91,610 78,155
Furniture and fixtures 424,586 417,876
Machinery and equipment 3,125,855 3,065,713
Construction in progress 991,124 897,885
5,872,061 5,698,515
Less accumulated depreciation (3,991,222) (3,802,940)
Net property and
equipment 1,880,839 1,895,575
------------ -----------
Long-term assets:
Lease right-of-use assets,
net 952,796 1,297,121
Intangible assets, net of
accumulated amortization 99,902 134,914
Other long-term assets 946,928 940,232
Total long-term assets 1,999,626 2,372,267
Total assets $ 35,087,658 20,724,177
============ ===========
(continued)
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders' September 30, December 31,
Equity 2026 2025
------------- ---------------
Current liabilities:
Accounts payable $ 1,958,546 1,830,124
Accrued expenses 855,377 1,265,773
Note payable 292,229 --
Clinical holdback -- current
portion 29,250 52,644
Operating lease liabilities
-- current portion 465,960 487,624
Total current
liabilities 3,601,362 3,636,165
------------ ------------
Long-term liabilities:
Clinical holdback --
long-term portion 58,179 52,370
Convertible notes payable,
net 3,717,653 3,178,864
Conversion option liability -- 2,014,000
Warrants liabilities -- 4,943,000
Operating lease liabilities
-- long-term portion 682,302 1,030,476
Total long-term
liabilities 4,458,134 11,218,710
Total liabilities 8,059,496 14,854,875
------------ ------------
Commitments and contingencies
Stockholders' equity:
Common stock, $0.001 par,
200,000,000 shares
authorized,
8,662,139 shares issued and 8,656,277
shares outstanding as of
September 30, 2026; and
2,986,116 shares issued
and 2,980,254 shares
outstanding as of December
31, 2025 8,662 2,986
Treasury stock, 5,862 common
shares (60,000) (60,000)
Warrants 19,023,695 5,246,150
Additional paid-in capital 162,069,759 146,506,310
Accumulated deficit (154,013,954) (145,826,144)
Total stockholders'
equity 27,028,162 5,869,302
------------ ------------
Total liabilities and
stockholders' equity $ 35,087,658 20,724,177
============ ============
FEMASYS INC.
Condensed Statements of Operations
(unaudited)
Three Months Ended Nine Months Ended September
September 30, 30,
--------------------------- ----------------------------
2026 2025 2026 2025
-------------- ----------- ------------ --------------
Sales $ 404,597 729,394 1,161,313 1,479,926
Cost of sales (excluding
depreciation expense) 187,496 293,838 488,538 569,275
Operating expenses:
Research and development 1,942,927 1,382,022 5,199,206 5,764,923
Sales and marketing 943,002 1,143,805 3,552,755 3,037,349
General and administrative 1,704,091 1,477,800 5,418,059 4,817,485
Depreciation and amortization 77,091 85,697 242,172 256,835
Total operating expenses 4,667,111 4,089,324 14,412,192 13,876,592
Loss from operations (4,450,010) (3,653,768) (13,739,417) (12,965,941)
---------- ---------- ----------- -----------
Other income (expense):
Interest income 85,610 17,315 155,131 53,488
Change in fair value of
Conversion Option liability -- -- 1,732,413 --
Change in fair value of
Warrants liabilities -- -- 4,228,000 --
Interest expense (200,415) (532,073) (563,072) (1,483,022)
Other expense -- (26,295) -- (286,295)
Total other income
(expense), net (114,805) (541,053) 5,552,472 (1,715,829)
---------- ---------- ----------- -----------
Loss before income taxes (4,564,815) (4,194,821) (8,186,945) (14,681,770)
Income tax expense (benefit) -- -- 865 (4,188)
---------- ---------- ----------- -----------
Net loss $(4,564,815) (4,194,821) (8,187,810) (14,677,582)
========== ========== =========== ===========
Net loss attributable to common
stockholders $(4,564,815) (4,194,821) (8,187,810) (14,677,582)
========== ========== =========== ===========
Basic and diluted loss per
share $ (0.53) (2.05) (1.59) (9.25)
Weighted-average common shares
and pre-funded warrants
outstanding, basic and
diluted 8,660,381 2,050,761 5,136,109 1,586,992
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(R) Intratubal Insemination, together with complementary diagnostic and sperm preparation products, in the U.S. and key international markets. Femasys is also advancing FemBloc(R) , 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:
IR@femasys.com
Media@femasys.com
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