FEMY 8-K
Femasys Inc (FEMY)
8-K
2026-08-14
For: 2026-08-14
View Original
Added on
August 14, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 14, 2026
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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(770 ) 500-3910
(Registrant’s telephone number, including area code)
n/a
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instructions A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Exchange Act:
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Title of each class
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Trading
Symbol(s)
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Name of each
exchange
on which registered
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 2.02 |
Results of Operations and Financial Condition.
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On August 14, 2026 Femasys Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2026 and provided a corporate update. A copy of the
press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or
otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such
filing.
| Item 9.01 |
Financial Statements and Exhibits.
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(d)
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Exhibits.
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Exhibit
No.
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Description
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Press Release of Femasys Inc. dated August 14, 2026
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL Document)
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Femasys Inc.
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By:
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/s/ Kathy Lee-Sepsick
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Names: Kathy Lee-Sepsick
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Title: Chief Executive Officer
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Date: August 14, 2026
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Exhibit 99.1
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, August 14, 2026 – 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
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Completed $30 million private placement with potential proceeds of up to $90 million upon full cash exercise of warrants.
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Regained compliance with Nasdaq Listing Requirements.
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Issuance of patents in the U.S. and key international markets that expand intellectual property protection for the blended polymer component of FemBloc.
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Received CE Mark approval for FemHSGTM Catheter, to complement FemVue and support streamlined in-office fertility evaluation.
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Advanced initial commercial use of FemaSeed Complete, expanding access to first-line fertility treatment in the OB/GYN office.
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Launched FemaSeed Complete at ACOG 2026, increasing provider awareness and initiating commercial efforts with OB/GYNs.
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Established strategic partnership with AMI Technologies to commercialize its fertility portfolio in
Israel, demonstrating international market interest.
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Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth.
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“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
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Sales increased by $6,184, or 0.8%, to $756,716 in 2026 from $750,532 in
2025, primarily due to sales of FemaSeed.
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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.
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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.
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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.
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Financial Results for Quarter Ended June 30, 2026
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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.
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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.
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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 ($3.18) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2025.
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For more information, please refer to the Company’s Form 10-Q filed August 14, 2026, which can be accessed on the SEC website.
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
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Assets
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June 30,
2026
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December 31,
2025
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Current assets:
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Cash and cash equivalents
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$
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1,443,502
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9,266,353
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Accounts receivable, net
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151,049
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616,600
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Inventory
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6,191,277
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5,740,249
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Prepaid and other current assets
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546,085
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833,133
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Total current assets
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8,331,913
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16,456,335
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Property and equipment, at cost:
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Leasehold improvements
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1,238,886
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1,238,886
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Office equipment
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87,515
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78,155
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Furniture and fixtures
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424,586
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417,876
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Machinery and equipment
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3,121,131
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3,065,713
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Construction in progress
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919,412
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897,885
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5,791,530
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5,698,515
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Less accumulated depreciation
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(3,932,324
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(3,802,940
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Net property and equipment
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1,859,206
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1,895,575
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Long-term assets:
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Lease right-of-use assets, net
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1,064,346
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1,297,121
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Intangible assets, net of accumulated amortization
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115,499
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134,914
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Other long-term assets
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918,618
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940,232
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Total long-term assets
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2,098,463
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2,372,267
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Total assets
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$
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12,289,582
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20,724,177
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(continued)
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
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Liabilities and Stockholders’ Equity
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June 30,
2026
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December 31,
2025
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Current liabilities:
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Accounts payable
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$
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2,337,354
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1,830,124
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Accrued expenses
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1,033,712
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1,265,773
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Clinical holdback – current portion
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42,726
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52,644
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Operating lease liabilities – current portion
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473,034
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487,624
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Total current liabilities
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3,886,826
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3,636,165
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Long-term liabilities:
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Clinical holdback – long-term portion
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54,598
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52,370
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Convertible notes payable, net
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3,521,226
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3,178,864
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Conversion option liability
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—
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2,014,000
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Warrants liabilities
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—
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4,943,000
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Operating lease liabilities – long-term portion
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795,985
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1,030,476
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Total long-term liabilities
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4,371,809
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11,218,710
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Total liabilities
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8,258,635
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14,854,875
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Commitments and contingencies
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Stockholders’ equity:
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Common stock, $0.001 par, 200,000,000 authorized, 3,029,829 shares issued and 3,023,967 outstanding as of June 30, 2026;
and 2,986,116 shares issued and 2,980,254 outstanding as of December 31, 2025
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3,030
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2,986
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Treasury stock, 5,862 common shares
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(60,000
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(60,000
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Warrants
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5,961,150
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5,246,150
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Additional paid-in capital
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147,575,906
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146,506,310
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Accumulated deficit
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(149,449,139
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(145,826,144
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Total stockholders’ equity
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4,030,947
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5,869,302
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Total liabilities and stockholders' equity
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$
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12,289,582
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20,724,177
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FEMASYS INC.
Condensed Statements of Operations and Comprehensive Loss
(unaudited)
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Three Months Ended June 30,
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Six Months Ended June 30,
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2026
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2025
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2026
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2025
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Sales
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$
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331,827
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409,268
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756,716
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750,532
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Cost of sales (excluding depreciation expense)
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142,436
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158,171
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301,042
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275,437
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Operating expenses:
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Research and development
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1,946,878
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1,414,429
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3,256,279
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4,382,901
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Sales and marketing
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1,293,998
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984,977
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2,609,753
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1,893,544
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General and administrative
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1,931,578
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1,616,972
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3,713,968
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3,339,685
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Depreciation and amortization
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82,811
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86,285
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165,081
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171,138
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Total operating expenses
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5,255,265
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4,102,663
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9,745,081
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9,787,268
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Loss from operations
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(5,065,874
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)
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(3,851,566
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)
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(9,289,407
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)
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(9,312,173
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Other income (expense):
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Interest income
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19,694
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17,144
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69,521
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36,173
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Change in fair value of conversion option liability
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219,000
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—
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1,732,413
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—
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Change in fair value of warrants liabilities
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545,000
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—
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4,228,000
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—
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||||||||||||
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Interest expense
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(186,050
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)
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(491,500
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)
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(362,657
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)
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(950,949
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)
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Other expense
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—
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(260,000
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)
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—
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(260,000
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)
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Total other income (expense), net
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597,644
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(734,356
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)
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5,667,277
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(1,174,776
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)
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Loss before income taxes
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(4,468,230
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)
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(4,585,922
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)
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(3,622,130
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)
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(10,486,949
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)
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Income tax expense (benefit)
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865
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—
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865
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(4,188
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)
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Net loss
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$
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(4,469,095
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)
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(4,585,922
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)
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(3,622,995
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(10,482,761
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Net loss attributable to common stockholders
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$
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(4,469,095
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(4,585,922
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(3,622,995
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(10,482,761
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Basic and diluted loss per share
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$
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(1.33
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)
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(3.18
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(1.08
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(7.76
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)
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Weighted-average common shares outstanding, basic and diluted
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3,357,117
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1,444,036
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3,344,767
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1,351,264
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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.
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