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Form 8-K

sec.gov

8-K — FEMASYS INC

Accession: 0001140361-26-026169

Filed: 2026-06-24

Period: 2026-06-23

CIK: 0001339005

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ef20076706_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20076706_ex99-1.htm)

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8-K

8-K (Primary)

Filename: ef20076706_8k.htm · Sequence: 1

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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

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 8.01

Other Events.

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.

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press Release of Femasys Inc., dated June 24, 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

Name: Kathy Lee-Sepsick

Title: Chief Executive Officer

Date: June 24, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20076706_ex99-1.htm · Sequence: 2

Exhibit 99.1

Femasys Regains Compliance with Nasdaq Listing Requirements

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.

# # #

Contacts:

IR@femasys.com

Media@femasys.com

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