Form 8-K
8-K — FEMASYS INC
Accession: 0001140361-26-020059
Filed: 2026-05-08
Period: 2026-05-08
CIK: 0001339005
SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — ef20072749_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (ef20072749_ex99-1.htm)
XML — IDEA: XBRL DOCUMENT (R1.htm)
8-K
8-K (Primary)
Filename: ef20072749_8k.htm · Sequence: 1
false000133900500013390052026-05-082026-05-08
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): May 8, 2026
Femasys Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-40492
11-3713499
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)
3950 Johns Creek Court,
Suite 100
Suwanee, Georgia
30024
(Address of principal executive offices)
(Zip Code)
(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):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each class
Trading
Symbol(s)
Name of each
exchange
on which registered
Common Stock, par value $0.001 per share
FEMY
The Nasdaq Stock Market LLC
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.
On May 8, 2026 Femasys Inc. (the “Company”) announced its financial results for the quarter ended March 31, 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.
(d)
Exhibits.
Exhibit
No.
Description
99.1
Press Release of Femasys Inc. dated May 8, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL Document)
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.
Femasys Inc.
By:
/s/ Kathy Lee-Sepsick
Names: Kathy Lee-Sepsick
Title: Chief Executive Officer
Date: May 8, 2026
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: ef20072749_ex99-1.htm · Sequence: 2
Exhibit 99.1
Femasys Announces Financial Results for Quarter Ended March 31, 2026 and Provides Corporate Update
-- With fertility rates at historic lows, Femasys advances access to early infertility care through FemaSeed®
Complete, enabling OB/GYNs to treat patients within their own practices --
ATLANTA, May 8, 2026 – Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and
cost-effective to women worldwide, announces its financial results for the quarter ended March 31, 2026 and provides a corporate update.
Corporate Highlights from 1Q 2026 to date
•
Advanced initial commercial adoption of FemaSeed Complete, positioning Femasys to expand access to first-line fertility treatment through integrated, in-office care by OB/GYNs, supporting earlier
intervention prior to referral to higher-cost specialty care.
•
Launched FemaSeed Complete at ACOG 2026, advancing commercialization and expanding provider awareness to support adoption of first-line fertility treatment in the OB/GYN office.
•
Established strategic partnership with AMI Technologies to introduce and commercialize its fertility portfolio in Israel, expanding international market opportunities.
•
Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth.
•
Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, enhancing leadership and strategic oversight.
•
Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc®, advancing toward U.S. approval of a first-of-its kind, non-surgical permanent birth control.
•
FemBloc permanent birth control system achieved Medical Device Single Audit Program (MDSAP) certification, supporting global regulatory readiness and future market access.
•
Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed intratubal insemination (ITI), supporting future reimbursement and broader adoption in the U.S.
•
Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed, and other portfolio products in Switzerland, expanding European market
access.
•
Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment and expanding access through community-based care.
“During the first quarter of 2026 and into the second quarter of 2026, we delivered meaningful clinical, regulatory and commercial progress across our FemBloc and FemaSeed
platforms,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “We are accelerating commercialization of FemaSeed with the introduction of the FemSperm® product family, enabling OB/GYNs to deliver integrated, in-office
fertility care. Concurrently, we advanced FemBloc with initiation of patient enrollment in the FINALE pivotal clinical trial, a key step toward U.S. FDA approval. We believe our current cash resources are sufficient to fund operations into the third
quarter of 2026. We remain focused on scaling a broad portfolio of innovative women’s health solutions globally, addressing critical unmet needs with safe, technologically advanced products.”
Financial Results for Quarter Ended March 31, 2026
•
Sales increased by $83,625, or 24.5%, to $424,889 in 2026
from $341,264 in 2025, primarily due to sales of FemBloc.
•
Research and development expenses decreased by $1,659,071, or 55.9%, to $1,309,401 in 2026 compared to $2,968,472 in 2025, primarily reflecting the transition of development
products into inventory to support commercialization, along with lower development, clinical, compensation, and professional service costs.
•
Net income, including gains from changes in fair value of financial instruments, was $846,100, or $0.00 per basic and diluted share attributable to common stockholders for the quarter ended March 31,
2026, compared to a net loss of $5,896,839, or ($0.23) per basic and diluted share attributable to common stockholders, for the quarter ended March 31, 2025.
•
Cash and cash equivalents as of March 31, 2026, was approximately $5.4 million and the Company had an accumulated deficit of approximately $145.0 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-Q filed May 8, 2026, which can be accessed on the SEC website.
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Assets
March 31,
2026
December 31,
2025
Current assets:
Cash and cash equivalents
$
5,386,041
9,266,353
Accounts receivable, net
172,264
616,600
Inventory
6,105,267
5,740,249
Prepaid and other current assets
679,917
833,133
Total current assets
12,343,489
16,456,335
Property and equipment, at cost:
Leasehold improvements
1,238,886
1,238,886
Office equipment
80,941
78,155
Furniture and fixtures
421,798
417,876
Machinery and equipment
3,095,633
3,065,713
Construction in progress
955,271
897,885
5,792,529
5,698,515
Less accumulated depreciation
(3,868,518
)
(3,802,940
)
Net property and equipment
1,924,011
1,895,575
Long-term assets:
Lease right-of-use assets, net
1,178,941
1,297,121
Intangible assets, net of accumulated amortization
124,252
134,914
Other long-term assets
924,552
940,232
Total long-term assets
2,227,745
2,372,267
Total assets
$
16,495,245
20,724,177
(continued)
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders’ Equity
March 31,
2026
December 31,
2025
Current liabilities:
Accounts payable
$
1,597,591
1,830,124
Accrued expenses
1,024,706
1,265,773
Clinical holdback – current portion
52,572
52,644
Operating lease liabilities – current portion
480,286
487,624
Total current liabilities
3,155,155
3,636,165
Long-term liabilities:
Clinical holdback – long-term portion
54,487
52,370
Convertible notes payable, net
3,335,176
3,178,864
Conversion option liability
488,000
2,014,000
Warrants liabilities
1,260,000
4,943,000
Operating lease liabilities – long-term portion
912,534
1,030,476
Total long-term liabilities
6,050,197
11,218,710
Total liabilities
9,205,352
14,854,875
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par, 200,000,000 authorized, 60,507,909 shares issued and 60,390,686 outstanding as of March 31,
2026; and 59,720,010 shares issued and 59,602,787 outstanding as of December 31, 2025
60,508
59,720
Treasury stock, 117,223 common shares
(60,000
)
(60,000
)
Warrants
5,246,150
5,246,150
Additional paid-in capital
147,023,279
146,449,576
Accumulated deficit
(144,980,044
)
(145,826,144
)
Total stockholders’ equity
7,289,893
5,869,302
Total liabilities and stockholders’ equity
$
16,495,245
20,724,177
FEMASYS INC.
Condensed Statements of Comprehensive Income (Loss)
(unaudited)
Three Months Ended March 31,
2026
2025
Sales
$
424,889
341,264
Cost of sales (excluding depreciation expense)
158,606
117,266
Operating expenses:
Research and development
1,309,401
2,968,472
Sales and marketing
1,315,755
908,567
General and administrative
1,782,390
1,722,713
Depreciation and amortization
82,270
84,853
Total operating expenses
4,489,816
5,684,605
Loss from operations
(4,223,533
)
(5,460,607
)
Other income (expense):
Interest income
49,827
19,029
Change in fair value of conversion option liability
1,513,413
—
Change in fair value of warrants liabilities
3,683,000
—
Interest expense
(176,607
)
(459,449
)
Total other income (expense), net
5,069,633
(440,420
)
Income (loss) before income taxes
846,100
(5,901,027
)
Income tax benefit
—
(4,188
)
Net income (loss)
$
846,100
(5,896,839
)
Net income (loss) attributable to common stockholders
$
328,646
(5,896,839
)
Earnings (losses) per share:
Basic
$
0.00
(0.23
)
Diluted
0.00
(0.23
)
Weighted-average common shares outstanding:
Basic
66,645,591
25,149,236
Diluted
78,095,633
25,149,236
About Femasys
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 (ITI), a groundbreaking first-step infertility treatment; FemSperm®, a CLIA waived sperm preparation and analysis product line; and
FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rate of 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 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 ongoing.
Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
References
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., Castaño, 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; our ability to 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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May 08, 2026
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-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
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dei_WrittenCommunications
Namespace Prefix:
dei_
Data Type:
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Balance Type:
na
Period Type:
duration