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):
October 11, 2023
 

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)
(I.R.S. 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)



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:
 
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 Act:
 
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001 per value
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 or Rule 12b–2 of the Securities Exchange Act of 1934.

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 October 11, 2023, Femasys Inc. (the “Company”) announced that it had received a notice from The Nasdaq Stock Market (“Nasdaq”) informing the Company that it has regained compliance with Nasdaq’s Listing Rule 5550(a)(2) (the “Rule”) for continued listing on The Nasdaq Capital Market, as the minimum bid price of the Company’s common stock had met or exceeded $1.00 per share for a minimum of ten consecutive business days.
 
The Company previously received a notice from Nasdaq on June 1, 2023 that the Company was not in compliance with the Rule, as the minimum bid price of the Company’s common stock was below $1.00 per share for 30 consecutive business days. In order to regain compliance with the Rule, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days. This requirement was met on October 9, 2023, the tenth consecutive trading day when the closing bid price of the Company’s common stock was over $1.00. The notification of noncompliance had no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq Global Market. The Company had 180 calendar days, or until November 28, 2023, to regain compliance with the Rule.
 
A copy of the Company’s press release is attached hereto as Exhibit 99.1 and incorporated into this Item 8.01 by reference.
 
Item 9.01.
Exhibits.
 
The following exhibits are filed as part of this report
 
Exhibit Number Description

 
Femasys Inc. Press Release dated October 11, 2023.
104
Cover page Interactive Data File (embedded in the cover page formatted in Inline XBRL).


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.
     
Date: October 11, 2023
By:
/s/ Kathy Lee-Sepsick
   
Name: Kathy Lee-Sepsick
   
Title: Chief Executive Officer




Exhibit 99.1

Femasys Inc. Regains Compliance with Nasdaq Listing Requirements
 
ATLANTA, October 11, 2023 -- Femasys Inc. (Nasdaq: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative diagnostic products, today announced that it has it has received notice from The Nasdaq Stock Market LLC (Nasdaq) informing Femasys that it has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Consequently, Femasys is now in compliance with all applicable listing standards and its common stock will continue to be listed on The Nasdaq Capital Market.
 
Femasys was previously notified by Nasdaq on June 1, 2023 that it was not in compliance with the minimum bid price rule (“the Rule”) because its common stock failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. In order to regain compliance with the Rule, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days. This requirement was met on October 9, 2023, the tenth consecutive trading day when the closing bid price of the Company’s common stock was over $1.00.
 
About Femasys
 
Femasys is a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead revolutionary late-clinical stage product candidate and FDA-cleared, innovative therapeutic and diagnostic products. Femasys’ FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. Femasys’ FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is now FDA-cleared and has received regulatory approval in Canada. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada and other non-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. The Company’s diagnostic products include FemVue® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosisLearn 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,” “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 develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our product candidates; 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, 2022 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: 
 
Investors 
Chuck Padala 
LifeSci Advisors, LLC 
917-741-7792 
chuck@lifesciadvisors.com
 
Femasys Inc. 
Investor Contact: 
IR@femasys.com
 
Media Contact: 
Media@femasys.com

 
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Document and Entity Information
Oct. 11, 2023
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Document Period End Date Oct. 11, 2023
Entity File Number 001-40492
Entity Registrant Name Femasys Inc.
Entity Central Index Key 0001339005
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 11-3713499
Entity Address, Address Line One 3950 Johns Creek Court
Entity Address, Address Line Two Suite 100
Entity Address, City or Town Suwanee
Entity Address, State or Province GA
Entity Address, Postal Zip Code 30024
City Area Code 770
Local Phone Number 500-3910
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Trading Symbol FEMY
Security Exchange Name NASDAQ
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Entity Ex Transition Period true
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