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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): May 9, 2024

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.

On May 9, 2024, Femasys Inc. (the “Company”) announced its financial results for the first quarter ended March 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 May 9, 2024
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: May 9, 2024
  


EX-99.1 2 ef20028745_ex99-1.htm EXHIBIT 99.1
Exhibit 99.1

Femasys Announces Financial Results for Quarter Ended March 31, 2024 and Provides Corporate Update
 
-- Recruitment of the commercial team for our infertility portfolio and the pivotal trial of FemBloc® for permanent non-surgical birth control continues --
 
ATLANTA, May 9, 2024 -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces financial results for the quarter ended March 31, 2024 and provides a corporate update.
 
Corporate Highlights from 1Q 2024 to date
 

 •
Company announced positive topline data from pivotal trial for FDA-cleared FemaSeed® for the treatment of infertility.

•
Company announced the first in-office commercial procedure with FDA-cleared FemaSeed infertility solution at a former investigative site.

•
Appointed Richard Spector as Chief Commercial Officer.

•
Initiated enrollment in pivotal trial (NCT05977751) of our permanent birth control candidate FemBloc at two academic sites, for a total of six active sites, the maximum permitted in the first stage.
 
“Femasys is well positioned to commercialize our infertility portfolio, led by FemaSeed in 2024 with promising top line data from the FemaSeed pivotal trial that was more than double the historic intrauterine insemination (IUI) pregnancy rates for male factor infertility (i.e., low sperm count). We are focused on completing recruitment of the commercial team and ramping up commercial operations, while continuing to support enrollment in our pivotal trial for FemBloc, our proprietary solution for permanent non-surgical birth control,” said Femasys’ CEO Kathy Lee-Sepsick. “We believe we have sufficient cash to fund operations into the second half of 2025, allowing us to continue our track record of achieving our stated milestones and moving our mission forward to deliver innovative purposely engineered solutions for women’s health that are safe, effective, accessible, and affordable.”
 
Financial Results for Quarter Ended March 31, 2024
 

 •
Research and development expenses increased by $233,292 to $1,770,731 in Q1 of 2024 from $1,537,439 in Q1 of 2023

•
Sales decreased by $22,844 to $271,140 in Q1 of 2024 from $293,984 in Q1 of 2023

•
Net loss was $3,599,510 or $0.17 per basic and diluted share attributable to common stockholders, for the quarter ended March 31, 2024, compared to net loss of $2,946,257, or $0.25 per basic and diluted share attributable to common stockholders, for the quarter ended March 31, 2023
 


 •
Cash and cash equivalents as of March 31, 2024 was $17,835,968 and the Company had an accumulated deficit of $111,981,139. The Company expects, based on its current operating plan, that its existing cash and cash equivalents will be sufficient to fund its ongoing operations into the second half of 2025
 
For more information, please refer to the Company’s Form 10-Q filed May 9, 2024, which can be accessed on the SEC website.
 
FEMASYS INC.
Condensed Balance Sheets
(unaudited)

Assets
  
March 31,
 2024
    
December 31,
2023
  
Current assets:
            
Cash and cash equivalents
  
$
17,835,968
      
21,716,077
  
Accounts receivable, net
    
120,529
      
98,906
  
Inventory, net
    
971,297
      
667,118
  
Prepaid and other current assets
    
955,539
      
695,879
  
Total current assets
    
19,883,333
      
23,177,980
  
Property and equipment, at cost:
                
Leasehold improvements
    
1,212,417
      
1,212,417
  
Office equipment
    
47,308
      
47,308
  
Furniture and fixtures
    
417,654
      
414,303
  
Machinery and equipment
    
2,582,220
      
2,559,356
  
Construction in progress
    
569,723
      
423,077
  
     
4,829,322
      
4,656,461
  
Less accumulated depreciation
    
(3,615,405
)
    
(3,545,422
)
Net property and equipment
    
1,213,917
      
1,111,039
  
Long-term assets:
                
Lease right-of-use assets, net
    
2,227,561
      
2,380,225
  
Intangible assets, net of accumulated amortization
    
33,115
      
—
  
Other long-term assets
    
1,013,034
      
1,086,581
  
Total long-term assets
    
3,273,710
      
3,466,806
  
Total assets
  
$
24,370,960
      
27,755,825
  
(continued)
                
 

FEMASYS INC.
Condensed Balance Sheets
(unaudited)
 
Liabilities and Stockholders’ Equity
  
March 31,
2024
    
December 31,
2023
  
Current liabilities:
            
Accounts payable
  
$
1,095,730
      
1,137,823
  
Accrued expenses
    
673,457
      
1,444,296
  
Clinical holdback – current portion
    
93,376
      
65,300
  
Lease liabilities – current portion
    
494,967
      
406,636
  
Total current liabilities
    
2,357,530
      
3,054,055
  
Long-term liabilities:
                
Clinical holdback – long-term portion
    
30,389
      
54,935
  
Convertible notes payable, net (including related parties)
    
4,472,456
      
4,258,179
  
Lease liabilities – long-term portion
    
1,902,991
      
2,036,067
  
Total long-term liabilities
    
6,405,836
      
6,349,181
  
Total liabilities
    
8,763,366
      
9,403,236
  
Commitments and contingencies
                
Stockholders’ equity:
                
Common stock, $.001 par, 200,000,000 authorized, 22,216,570 shares issued and 22,099,347 outstanding as of March 31, 2024; and 21,774,604 shares issued and 21,657,381 outstanding as of December 31, 2023
    
22,217
      
21,775
  
Treasury stock, 117,223 common shares
    
(60,000
)
    
(60,000
)
Warrants
    
2,631,838
      
2,787,137
  
Additional paid-in-capital
    
124,994,678
      
123,985,306
  
Accumulated deficit
    
(111,981,139
)
    
(108,381,629
)
Total stockholders’ equity
    
15,607,594
      
18,352,589
  
Total liabilities and stockholders' equity
  
$
24,370,960
      
27,755,825
  
 

FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)

   
Three Months Ended March 31,
  
   
2024
    
2023
  
Sales
  
$
271,140
      
293,984
  
Cost of sales (excluding depreciation expense)
    
88,532
      
105,120
  
                 
Operating expenses:
                
Research and development
    
1,770,731
      
1,537,439
  
Sales and marketing
    
300,487
      
244,896
  
General and administrative
    
1,502,804
      
1,315,137
  
Depreciation and amortization
    
71,228
      
133,066
  
Total operating expenses
    
3,645,250
      
3,230,538
  
Loss from operations
    
(3,462,642
)
    
(3,041,674
)
Other income (expense):
                
Interest income
    
224,684
      
97,089
  
Interest expense
    
(361,552
)
    
(1,672
)
Total other income (expense)
    
(136,868
)
    
95,417
  
Net loss
  
$
(3,599,510
)
    
(2,946,257
)
                 
Net loss attributable to common stockholders, basic and diluted
  
$
(3,599,510
)
    
(2,946,257
)
Net loss per share attributable to common stockholders, basic and diluted
  
$
(0.17
)
    
(0.25
)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
    
21,775,357
      
11,872,255
  
 
About Femasys
 
Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada. 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. 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 ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its 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 diagnosis. Learn 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,” “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 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 products and product candidates; our ability to commercialize our products and product candidates, 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, 2023, 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:
Gene Mannheimer
IR@femasys.com

Media Contact:
Kati Waldenburg
Media@femasys.com