FEMY 8-K
Femasys Inc (FEMY)
8-K
2026-06-24
For: 2026-06-23
View Original
Added on
June 24, 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): June 23, 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 8.01 |
Other Events.
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On June 23, 2026, Femasys Inc. (the “Company”) received written notice ( the “Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has
regained compliance with Nasdaq Listing Rule 5550( a)(2), the minimum bid price requirement for continued listing on The Nasdaq Capital Market, and that this matter is now closed.
As previously disclosed, on July 16, 2025, the Company received written notice from Nasdaq that the Company’s common stock had failed to maintain a minimum
bid price of $1.00 per share over the previous 30 consecutive business days as required by Nasdaq Listing Rule 5550(a)(2). The Company regained compliance following the effectiveness of its 1-for-20 reverse stock split of its common stock on June 5,
2026, after which the closing bid price of the Company’s common stock remained at or above $1.00 per share for 10 consecutive business days.
A copy of the press release issued by the Company on June 24, 2026 announcing the foregoing is attached hereto as Exhibit 99.1 and is incorporated herein by
reference.
| Item 9.01 |
Financial Statements and Exhibits.
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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 June 24, 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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Name: Kathy Lee-Sepsick
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Title: Chief Executive Officer
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Date: June 24, 2026
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Exhibit 99.1
ATLANTA – June 24, 2026 – Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and
cost-effective for women worldwide, announced today that it received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) confirming the Company has regained compliance with Listing Rule
5550(a)(2), the minimum bid price requirement for continued listing and that the matter is now closed.
Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys, stated, “Regaining compliance with
Nasdaq’s continued listing requirements is an important development for Femasys and our shareholders. With this matter now closed, we remain focused on advancing our strategic priorities, expanding access to our innovative reproductive health
solutions and building long-term value.”
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 used with the CLIA waived FemSperm® sperm preparation and analysis
product line; FemVue®, a device enabling ultrasound-based fallopian tube assessment; and FemHSG™ Catheter, used with FemVue for comprehensive fertility workup. 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 demonstrate 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; 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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