Femasys Announces UK Regulatory Approval of FemBloc; Exhibit 99.1 Attached

Rhea-AI Filing Summary

Femasys Inc. reported in a Current Report on Form 8-K that on August 20, 2025 it issued a press release announcing that the company has secured UK regulatory approval for FemBloc Permanent Birth Control. The filing states the press release is furnished as Exhibit 99.1 and is incorporated by reference into the report. The 8-K does not include further operational, commercial or financial details within the filing text provided.

Positive

• UK regulatory approval announced for FemBloc Permanent Birth Control
• Press release furnished as Exhibit 99.1, making the announcement formally part of the 8-K

Negative

• Filing contains no operational, commercial, or financial details about the approval or next steps
• No approval documentation or timelines are included in the 8-K text; readers must consult Exhibit 99.1

Insights

Regulatory Affairs Specialist

TL;DR: The company confirms UK regulatory approval of FemBloc and furnishes a press release as Exhibit 99.1.

The filing explicitly states that Femasys secured regulatory approval in the United Kingdom for its FemBloc permanent birth control product and that the company issued a press release on August 20, 2025 which is attached as Exhibit 99.1. The report contains no additional regulatory documentation, approval letters, or technical details in the 8-K text itself; readers must refer to the referenced press release (Exhibit 99.1) for substantive information.

Equity Analyst

TL;DR: Material regulatory milestone announced, but the filing includes no financial or commercial detail to assess investor impact.

The Form 8-K confirms a material event—a UK regulatory approval announcement—but provides only a statement that a press release was furnished as Exhibit 99.1. The filing does not present revenue projections, commercialization plans, timing, or financial statements tied to the approval. As a result, the announcement is potentially important but the 8-K itself lacks the financial and operational data needed to quantify investor impact.

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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): August 20, 2025

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 August 20, 2025, Femasys Inc. (the “Company”) issued a press release announcing that Femasys Secures UK Regulatory Approval of FemBloc Permanent Birth Control. 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release of Femasys Inc. dated August 20, 2025.
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: August 20, 2025

FAQ

When did Femasys (FEMY) report the regulatory approval?

The Form 8-K states the company issued the press release on August 20, 2025.

What product received UK regulatory approval according to the filing?

The filing announces UK regulatory approval for FemBloc Permanent Birth Control.

Where can I find the full details of the approval announced by Femasys?

The 8-K furnishes a press release as Exhibit 99.1; the filing text does not include further details.

Does the 8-K include financial impact or commercialization plans for FemBloc?

No. The Form 8-K text provided contains no financial, commercial, or timeline details related to the approval.

What is Femasys's ticker symbol as referenced in the filing?

The filing lists the company's common stock ticker as FEMY.