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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): March 27, 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 2.02
Results of Operations and Financial Condition.Other Events

On March 27, 2025, Femasys Inc. (the “Company”) announced its financial results for the year ended December 31, 2024 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


Press Release of Femasys Inc. dated March 27, 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: March 27, 2025
  


EX-99.1 2 ef20046254_ex99-1.htm EXHIBIT 99.1
Exhibit 99.1

Femasys Announces Financial Results for Year Ended December 31, 2024, and Provides Corporate Update

-- Company expands commercial product offering with FemBloc® permanent birth control (delivery system) approval in Europe and signed partnerships for distribution in Spain --

ATLANTA, March 27, 2025 -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator addressing significant unmet needs in women’s health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces financial results for the year ended December 31, 2024 and provides a corporate update.

Corporate Highlights from 4Q 2024 to date


 •
Announced FemBloc® permanent birth control (delivery system) approval in Europe; FemBloc blended polymer component successfully completed an expedited G12 Special MDR Audit for Class III devices, and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review

•
Announced partnership with CNY Fertility, national conglomerate of 11 fertility centers, to offer FemaSeed®

•
Announced strategic distribution partnerships for FemBloc in Spain

•
Announced peer-reviewed publication of positive safety and efficacy results from FemBloc clinical trials

•
Announced UK and Israeli regulatory approvals for FemaSeed and two diagnostic devices

•
Announced notices of intention to grant two new European patent applications for FemBloc

•
Announced notice of allowance for new U.S. patent application for FemaSeed

•
Announced partnership with HRC Fertility, conglomerate provider of fertility services in Western U.S., to offer FemaSeed

•
Announced partnership with Boston IVF, prominent network of 30 centers nationwide, to offer FemaSeed

•
Announced peer-reviewed publication of positive safety and efficacy results from FemaSeed pivotal trial
 
“During the fourth quarter of 2024 and first quarter of 2025 we achieved significant regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination products.” said Femasys’ CEO Kathy Lee-Sepsick. “We are focused on executing on commercialization of FemaSeed and expect U.S. revenue to increase by approximately 50% in first quarter of 2025 versus fourth quarter of 2024. We are continuing to advance our FemBloc to commercialization in Europe while executing on the clinical pivotal trial for U.S. FDA approval. We believe we have sufficient cash to fund operations into the third quarter of 2025. We remain committed to addressing major gaps in women’s reproductive health by advancing safe and effective, technologically advanced product solutions.”
 

Financial Results for Year Ended December 31, 2024


 •
Sales increased by $557,138, or 52.0%, to $1,629,108 in 2024 from $1,071,970 in 2023

•
Research and development expenses increased by $1,007,842, or 14.0%, to $8,216,543 in 2024 from $7,208,701 in 2023

•
Net loss was $18,816,628, or ($0.85) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2024, compared to net loss of $14,247,124, or ($0.93) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2023

•
Cash and cash equivalents as of December 31, 2024, was $3.5 million and the Company had an accumulated deficit of $127.2 million. The Company expects, based on its current operating plan, our current cash and cash equivalents, which includes approximately $5.4 million we raised subsequent to year end, will be sufficient to fund its ongoing operations into third quarter of 2025.
 
For more information, please refer to the Company’s Form 10-K filed March 27, 2025, which can be accessed on the SEC website.
 

FEMASYS INC.
Balance Sheets
(unaudited)

Assets
  
December 31, 2024
    
December 31, 2023
  
Current assets:
            
Cash and cash equivalents
  
$
3,451,761
      
21,716,077
  
Accounts receivable, net
    
488,373
      
98,906
  
Inventory
    
3,046,323
      
667,118
  
Prepaid and other current assets
    
1,035,993
      
695,879
  
Total current assets
    
8,022,450
      
23,177,980
  
Property and equipment, at cost:
                
Leasehold improvements
    
1,238,886
      
1,212,417
  
Office equipment
    
60,921
      
47,308
  
Furniture and fixtures
    
417,876
      
414,303
  
Machinery and equipment
    
2,856,740
      
2,559,356
  
Construction in progress
    
762,445
      
423,077
  
     
5,336,868
      
4,656,461
  
Less accumulated depreciation
    
(3,740,769
)
    
(3,545,422
)
Net property and equipment
    
1,596,099
      
1,111,039
  
Long-term assets:
                
Lease right-of-use assets, net
    
1,805,543
      
2,380,225
  
Intangible assets, net of accumulated amortization
    
65,918
      
—
  
Other long-term assets
    
954,992
      
1,086,581
  
Total long-term assets
    
2,826,453
      
3,466,806
  
Total assets
  
$
12,445,002
      
27,755,825
  

(continued)
 

FEMASYS INC.
Balance Sheets
(unaudited)

Liabilities and Stockholders’ Equity
  
December 31, 2024
    
December 31, 2023
  
Current liabilities:
            
Accounts payable
  
$
1,419,044
      
1,137,823
  
Accrued expenses
    
1,151,049
      
1,444,296
  
Convertible notes payable, net (including related parties)
    
5,406,228
      
—
  
Clinical holdback – current portion
    
88,581
      
65,300
  
Operating lease liabilities – current portion
    
517,967
      
406,636
  
Total current liabilities
    
8,582,869
      
3,054,055
  
Long-term liabilities:
                
Clinical holdback – long-term portion
    
39,611
      
54,935
  
Convertible notes payable, net (including related parties)
    
—
      
4,258,179
  
Operating lease liabilities – long-term portion
    
1,518,100
      
2,036,067
  
Total long-term liabilities
    
1,557,711
      
6,349,181
  
Total liabilities
    
10,140,580
      
9,403,236
  
Commitments and contingencies
                
Stockholders’ equity:
                
Common stock, $.001 par, 200,000,000 authorized, 23,473,149 shares issued and 23,355,926 outstanding as of December 31, 2024; and 21,774,604 shares issued and 21,657,381 outstanding as of December 31, 2023
    
23,473
      
21,775
  
Treasury stock, 117,223 common shares
    
(60,000
)
    
(60,000
)
Warrants
    
1,860,008
      
2,787,137
  
Additional paid-in-capital
    
127,679,198
      
123,985,306
  
Accumulated deficit
    
(127,198,257
)
    
(108,381,629
)
Total stockholders’ equity
    
2,304,422
      
18,352,589
  
Total liabilities and stockholders’ equity
  
$
12,445,002
      
27,755,825
  
 

FEMASYS INC.
Statements of Comprehensive Loss
(unaudited)
 
   
December 31, 2024
    
December 31, 2023
  
Sales
  
$
1,629,108
      
1,071,970
  
Cost of sales (excluding depreciation expense)
    
544,903
      
380,069
  
                 
Operating expenses:
                
Research and development
    
8,216,543
      
7,208,701
  
Sales and marketing
    
4,030,150
      
650,126
  
General and administrative
    
6,325,999
      
6,858,008
  
Depreciation and amortization
    
297,318
      
483,481
  
Total operating expenses
    
18,870,010
      
15,200,316
  
Loss from operations
    
(17,785,805
)
    
(14,508,415
)
Other (expense) income:
                
Interest income
    
582,354
      
431,019
  
Interest expense
    
(1,603,575
)
    
(165,390
)
Total other (expense) income
    
(1,021,221
)
    
265,629
  
Loss before income taxes
    
(18,807,026
)
    
(14,242,786
)
Income tax expense
    
9,602
      
4,338
  
Net loss
  
$
(18,816,628
)
    
(14,247,124
)
                 
Net loss attributable to common stockholders, basic and diluted
  
$
(18,816,628
)
    
(14,247,124
)
Net loss per share attributable to common stockholders, basic and diluted
  
$
(0.85
)
    
(0.93
)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
    
22,267,695
      
15,384,376
  
 
About Femasys
 
Femasys is a leading biomedical innovator focused on addressing critical unmet needs in women’s health with a broad, patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. The Company, a U.S. manufacturer, has received regulatory approvals for its product portfolio worldwide, and they are currently being commercialized in the U.S. and key international markets. FemaSeed® Intratubal Insemination, a groundbreaking first-line infertility treatment, is FDA-cleared and approved in Europe, UK, Canada and Israel. Clinical trial data, published in peer-reviewed journal, demonstrate safety, effectiveness, and high satisfaction from patients and practitioners.1 FemVue®, a companion diagnostic for fallopian tube assessment, is FDA-cleared and approved in Europe, UK, Canada, Japan and Israel. FemCerv®, a tissue sampler for cervical cancer diagnosis, is FDA-cleared and approved in Europe, UK, Canada and Israel.
 
FemBloc® permanent birth control, is the first and only non-surgical, in-office approach offering significant benefits over the costly, inconvenient, risk-laden surgical alternative. The revolutionary FemBloc delivery system is approved in Europe and the proprietary blended polymer has been recommended for approval, which is expected mid-year 2025. For U.S. FDA approval, the FINALE pivotal clinical trial (NCT05977751) is currently enrolling participants. Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.2 FemCath® and FemChec®, diagnostic products for FemBloc’s ultrasound-based confirmation test, are FDA-cleared and approved in Europe and Canada.
 

References
 
1 Liu, 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.
 
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.
 
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, 2024, when filed, 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:
IR@femasys.com

Media:
Media@femasys.com