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 8, 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 August 8, 2024, Femasys Inc. (the “Company”) announced its financial results for the quarter ended June 30, 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 August 8, 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: August 8, 2024
  

 
Exhibit 99.1

Femasys Announces Financial Results for Quarter Ended June 30, 2024 and Provides Corporate Update
 
-- Company gained CE Mark approval for four of its women’s health products and completed buildout of commercial team for its infertility portfolio --
 
ATLANTA, August 8, 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 June 30, 2024 and provides a corporate update.
 
Corporate Highlights from 2Q 2024 to date
 

 •
Company received European Union Medical Device Regulation (EU MDR) certification and CE Mark for four of its women’s health products, providing regulatory approval to begin marketing in the European Union. Further, it serves as independent validation of Femasys’ commitment to the highest standards of quality and safety for its customers and their patients.

•
Femasys completed the build-out of its initial commercial team in the U.S., which will be leading the Company’s marketing efforts. This milestone, together with the CE Mark approval for its product portfolio, enables Femasys to concurrently identify strategic distribution partners to begin commercialization of its products in the European Union.

•
CEO and Founder Kathy Lee-Sepsick met with the White House’s Gender Policy Council to discuss the Company’s reproductive health products and the future of women’s health in the United States and the White House’s Office of Science and Technology Policy to discuss the Cancer Moonshot Initiative, as well as separately with Members of Congress to raise awareness of the Company and our women’s healthcare initiatives.
 
“The recruitment and subsequent onboarding of our commercial team, consisting of highly qualified professionals with specific expertise in women’s health is complete and our team has recently begun actively marketing our products in the U.S.. We believe that our novel fertility solution FemaSeed®, which demonstrated pregnancy rates more than double the historic intrauterine insemination (IUI) pregnancy rates for male factor infertility (i.e., low sperm count), is an improved alternative and a viable option prior to in vitro fertilization (IVF) that is considerably more financially and emotionally burdensome. As we await announcement of published data for the FemaSeed prospective multi-center pivotal trial, we are actively prioritizing our U.S. efforts and concurrently identifying strategic distribution partners in Europe,” said Femasys’ CEO Kathy Lee-Sepsick.
 
Financial Results for Quarter Ended June 30, 2024
 

 •
Research and development expenses increased by $448,703 to $1,975,875 in Q2 of 2024 from $1,527,172 in Q2 of 2023.

•
Sales decreased by $99,030 to $221,484 in Q2 of 2024 from $320,514 in Q2 of 2023.

•
Net loss was $4,684,574 or ($0.21) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2024, compared to net loss of $2,893,508, or ($0.22) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2023.

•
Cash and cash equivalents as of June 30, 2024 was $13.5 million and the Company had an accumulated deficit of $116.7 million. 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 July 2025.
 
Financial Results for Six Months Ended June 30, 2024
 

 •
Research and development expenses increased by $681,995 to $3,746,606 for the first six months of 2024 from $3,064,611 for the first six months of 2023.

•
Sales decreased by $121,874 to $492,624 for the first six months of 2024 from $614,498 for the first six months of 2023.

•
Net loss was $8,284,084 or ($0.38) per basic and diluted share attributable to common stockholders, for the six month period ended June 30, 2024, compared to net loss of $5,839,765, or ($0.47) per basic and diluted share attributable to common stockholders, for the same period ended June 30, 2023.
 
For more information, please refer to the Company’s Form 10-Q filed August 8, 2024, which can be accessed on the SEC website.
 
PART I. FINANCIAL INFORMATION
ITEM I. Financial Statements

FEMASYS INC.
Condensed Balance Sheets
(unaudited)

Assets
  
June 30,
2024
    
December 31,
2023
  
Current assets:
            
Cash and cash equivalents
  
$
13,525,898
      
21,716,077
  
Accounts receivable, net
    
92,535
      
98,906
  
Inventory, net
    
1,315,580
      
667,118
  
Prepaid and other current assets
    
997,623
      
695,879
  
Total current assets
    
15,931,636
      
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
    
429,933
      
414,303
  
Machinery and equipment
    
2,599,994
      
2,559,356
  
Construction in progress
    
651,157
      
423,077
  
     
4,940,809
      
4,656,461
  
Less accumulated depreciation
    
(3,678,450
)
    
(3,545,422
)
Net property and equipment
    
1,262,359
      
1,111,039
  
Long-term assets:
                
Lease right-of-use assets, net
    
2,081,054
      
2,380,225
  
Intangible assets, net of accumulated amortization
    
44,317
      
—
  
Other long-term assets
    
957,078
      
1,086,581
  
Total long-term assets
    
3,082,449
      
3,466,806
  
                 
Total assets
  
$
20,276,444
      
27,755,825
  

(continued)
 
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
 
Liabilities and Stockholders’ Equity
  
June 30,
2024
    
December 31, 2023
  
Current liabilities:
            
Accounts payable
  
$
951,510
      
1,137,823
  
Accrued expenses
    
886,352
      
1,444,296
  
Clinical holdback – current portion
    
92,397
      
65,300
  
Lease liabilities – current portion
    
533,734
      
406,636
  
Total current liabilities
    
2,463,993
      
3,054,055
  
Long-term liabilities:
                
Clinical holdback – long-term portion
    
32,706
      
54,935
  
Convertible notes payable, net (including related parties)
    
4,758,017
      
4,258,179
  
Lease liabilities – long-term portion
    
1,771,487
      
2,036,067
  
Total long-term liabilities
    
6,562,210
      
6,349,181
  
Total liabilities
    
9,026,203
      
9,403,236
  
Commitments and contingencies
                
Stockholders’ equity:
                
Common stock, $.001 par, 200,000,000 authorized, 22,350,022 shares issued and 22,232,799 outstanding as of June 30, 2024; and 21,774,604 shares issued and 21,657,381 outstanding as of December 31, 2023
    
22,350
      
21,775
  
Treasury stock, 117,223 common shares
    
(60,000
)
    
(60,000
)
Warrants
    
2,608,642
      
2,787,137
  
Additional paid-in-capital
    
125,344,962
      
123,985,306
  
Accumulated deficit
    
(116,665,713
)
    
(108,381,629
)
Total stockholders’ equity
    
11,250,241
      
18,352,589
  
Total liabilities and stockholders' equity
  
$
20,276,444
      
27,755,825
  

The accompanying notes are an integral part of these condensed unaudited financial statements.
FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)
 
   
Three Months Ended June 30,
    
Six Months Ended June 30,
  
   
2024
    
2023
    
2024
    
2023
  
Sales
  
$
221,484
      
320,514
      
492,624
      
614,498
  
Cost of sales (excluding depreciation expense)
    
73,125
      
110,469
      
161,657
      
215,589
  
                                 
Operating expenses:
                                
Research and development
    
1,975,875
      
1,527,172
      
3,746,606
      
3,064,611
  
Sales and marketing
    
975,190
      
128,899
      
1,275,677
      
373,795
  
General and administrative
    
1,611,817
      
1,356,637
      
3,114,621
      
2,671,774
  
Depreciation and amortization
    
67,628
      
133,299
      
138,856
      
266,365
  
Total operating expenses
    
4,630,510
      
3,146,007
      
8,275,760
      
6,376,545
  
Loss from operations
    
(4,482,151
)
    
(2,935,962
)
    
(7,944,793
)
    
(5,977,636
)
Other income (expense):
                                
Interest income
    
184,138
      
42,652
      
408,822
      
139,741
  
Interest expense
    
(388,311
)
    
(198
)
    
(749,863
)
    
(1,870
)
Total other income (expense), net
    
(204,173
)
    
42,454
      
(341,041
)
    
137,871
  
Loss before income taxes
    
(4,686,324
)
    
(2,893,508
)
    
(8,285,834
)
    
(5,839,765
)
Income tax benefit
    
(1,750
)
    
—
      
(1,750
)
    
—
  
                                 
Net loss
  
$
(4,684,574
)
    
(2,893,508
)
    
(8,284,084
)
    
(5,839,765
)
                                 
Net loss attributable to common stockholders, basic and diluted
  
$
(4,684,574
)
    
(2,893,508
)
    
(8,284,084
)
    
(5,839,765
)
Net loss per share attributable to common stockholders, basic and diluted
  
$
(0.21
)
    
(0.22
)
    
(0.38
)
    
(0.47
)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
    
22,215,516
      
13,107,590
      
21,995,436
      
12,493,334
  
 
The accompanying notes are an integral part of these condensed unaudited financial statements.

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 and Europe. 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, Europe 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

Media Contact:
Kati Waldenburg