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 28, 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 March 28, 2024, Femasys Inc. (the “Company”) announced its financial results for the year ended December 31, 2023 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 28, 2024

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 28, 2024
  


Exhibit 99.1
 
Femasys Announces Financial Results for Year Ended December 31, 2023 and Provides Corporate Update
 
-- Following FDA Clearance of FemaSeed®, Company Secures Capital to Support Commercial Initiatives; Cash Expected to Fund Operations Into 2H 2025 --
 
ATLANTA, March 28, 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 year ended December 31, 2023 and provides a corporate update.
 
Corporate Highlights from 4Q 2023 to date
 

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

•
Following FDA clearance of FemaSeed, the Company’s revolutionary approach to artificial insemination, Femasys announced completion of enrollment in pivotal trial in support of commercial launch

•
Activated enrollment for remaining clinical sites of initial phase of pivotal trial for FemBloc®, the Company’s proprietary solution for permanent non-surgical birth control

•
Appointed Richard Spector as Chief Commercial Officer and James Liu, M.D. as Chief Medical Officer
 
“The end of 2023 marked a significant milestone for the Company as we achieved the FDA clearance of FemaSeed, enabling it to become a first-line accessible and cost-effective therapeutic option for couples and women experiencing infertility. We also announced positive topline data for the product’s pivotal trial earlier this month, revealing that 24% of women in the severe male factor cohort became pregnant after receiving FemaSeed.  Notably, the majority of women who became pregnant did so after the first FemaSeed procedure,” said Femasys’ CEO Kathy Lee-Sepsick. “Our focus is now on executing on commercialization of FemaSeed and our other available products, as well as advancing the clinical pivotal trial for FemBloc. 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. Women’s healthcare is severely underserved, and we are proud to be a pioneer in developing innovative solutions that are purposely engineered to be safe, effective and affordable.”
 
Financial Results for Year Ended December 31, 2023
 

 •
Research and Development expenses increased by $1,394,946 to $7,208,701 in 2023 from $5,813,755 in 2022

•
Sales decreased by $134,248 to $1,071,970 in 2023 from $1,206,218 in 2022

•
Net loss was $14,247,124 or $0.93 per basic and diluted share attributable to common stockholders, for the year ended December 31, 2023, compared to net loss of $11,394,170, or $0.96 per basic and diluted share attributable to common stockholders, for the year ended December 31, 2022
 

 •
Cash and cash equivalents as of December 31, 2023 was $21,716,077 and the Company had an accumulated deficit of $108,381,629. 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-K filed March 28, 2024, which can be accessed on the SEC website.
 
FEMASYS INC.
Balance Sheets
(unaudited)

Assets
  
December 31,
2023
    
December 31,
2022
  
Current assets:
            
Cash and cash equivalents
  
$
21,716,077
      
12,961,936
  
Accounts receivable, net
    
98,906
      
77,470
  
Inventory, net
    
667,118
      
436,723
  
Prepaid and other current assets
    
695,879
      
655,362
  
Total current assets
    
23,177,980
      
14,131,491
  
Property and equipment, at cost:
                
Leasehold improvements
    
1,212,417
      
1,195,637
  
Office equipment
    
47,308
      
99,344
  
Furniture and fixtures
    
414,303
      
419,303
  
Machinery and equipment
    
2,559,356
      
2,572,243
  
Construction in progress
    
423,077
      
413,843
  
     
4,656,461
      
4,700,370
  
Less accumulated depreciation
    
(3,545,422
)
    
(3,217,319
)
Net property and equipment
    
1,111,039
      
1,483,051
  
Long-term assets:
                
Lease right-of-use assets, net
    
2,380,225
      
319,557
  
Intangible assets, net of accumulated amortization
    
—
      
3,294
  
Other long-term assets
    
1,086,581
      
958,177
  
Total long-term assets
    
3,466,806
       1,281,028
  
                 
Total assets
  
$
27,755,825
       16,895,570
  
                 
(continued)
                
 
FEMASYS INC.
Balance Sheets
(unaudited)

Liabilities and Stockholders’ Equity
  
December 31,
2023
    
December 31,
2022
  
Current liabilities:
            
Accounts payable
  
$
1,137,823
      
510,758
  
Accrued expenses
    
1,444,296
      
456,714
  
Note payable
    
—
      
141,298
  
Clinical holdback – current portion
    
65,300
      
45,206
  
Lease liabilities – current portion
    
406,636
      
373,833
  
Total current liabilities
    
3,054,055
      
1,527,809
  
Long-term liabilities:
                
Clinical holdback – long-term portion
    
54,935
      
96,658
  
Convertible notes payable, net (including related parties)
    
4,258,179
      
—
  
Lease liabilities – long-term portion
    
2,036,067
      
28,584
  
Total long-term liabilities
    
6,349,181
      
125,242
  
Total liabilities
    
9,403,236
      
1,653,051
  
Commitments and contingencies
                
Stockholders’ equity:
                
Common stock, $.001 par, 200,000,000 authorized, 21,774,604 shares issued and 21,657,381 outstanding as of December 31, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022
                

   
21,775
      
11,987
  
Treasury stock, 117,223 common shares
    
(60,000
)
    
(60,000
)
Warrants
    
2,787,137
      
567,972
  
Additional paid-in-capital
    
123,985,306
      
108,857,065
  
Accumulated deficit
    
(108,381,629
)
    
(94,134,505
)
                 
Total stockholders’ equity
    
18,352,589
      
15,242,519
  
                 
Total liabilities and stockholders’ equity
  
$
27,755,825
      
16,895,570
  
 
FEMASYS INC.
Statements of Comprehensive Loss
(unaudited)

   
December 31,
2023
    
December 31,
2022
  
Sales
  
$
1,071,970
      
1,206,218
  
Cost of sales (excluding depreciation expense)
    
380,069
      
441,938
  
                 
Operating expenses:
                
Research and development
    
7,208,701
      
5,813,755
  
Sales and marketing
    
650,126
      
558,852
  
General and administrative
    
6,858,008
      
5,430,704
  
Depreciation and amortization
    
483,481
      
561,233
  
Total operating expenses
    
15,200,316
      
12,364,544
  
Loss from operations
    
(14,508,415
)
    
(11,600,264
)
Other income (expense):
                
Interest income
    
431,019
      
228,164
  
Interest expense
    
(165,390
)
    
(13,464
)
Other expense
    
—
      
(2,306
)
Total other income
    
265,629
      
212,394
  
Loss before income taxes
    
(14,242,786
)
    
(11,387,870
)
Income tax expense
    
4,338
      
6,300
  
                 
Net loss
  
$
(14,247,124
)
    
(11,394,170
)
                 
Net loss attributable to common stockholders, basic and diluted
  
$
(14,247,124
)
    
(11,394,170
)
Net loss per share attributable to common stockholders, basic and diluted
  
$
(0.93
)
    
(0.96
)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
    
15,384,376
      
11,815,019
  
 
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. 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 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 ex-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 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,” “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, 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:
Gene Mannheimer
[email protected]

Media Contact:
Kati Waldenburg
[email protected]