UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K/A

CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 12, 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. ☒

Explanatory Note

This Amendment to Current Report on Form 8-K/A (this “Amendment”) amends the Current Report on Form 8-K filed by Femasys Inc. (the “Company”) on November 12, 2024 (the “Original Form 8-K”). The Original Form 8-K inadvertently reported the "Date of Report (Date of earliest event reported)" on the cover page and the date referenced in the first sentence of the first paragraph under Item 2.02 as August 12, 2024, when both dates should have been reported as November 12, 2024.  The sole purpose of this Amendment is to correct the incorrect dates. No other changes are being made to the Original Form 8-K by this Amendment.

Item 2.02
Results of Operations and Financial Condition.

On November 12, 2024, Femasys Inc. (the “Company”) announced its financial results for the quarter ended September 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 November 12, 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: November 12, 2024
  

 
Exhibit 99.1

Femasys Announces Financial Results for Quarter Ended September 30, 2024, and Provides Corporate Update
 
-- Company accelerated commercialization with significant new partnerships both in the U.S. and Europe --

ATLANTA, November 12, 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 September 30, 2024 and provides a corporate update.

Corporate Highlights from 3Q 2024 to date
 

 •
Announced partnership with Boston IVF, prominent network of fertility centers, to offer FemaSeed®

•
Announced the onboarding of the first infertility medical clinic customers to offer FemaSeed infertility treatment to patients in California and Florida

•
Announced strategic distribution partnerships for CE-marked products, including FemaSeed and FemVue® in Spain, which are anticipated to generate over $1.3 million over the next year

•
Received second order from Spain strategic distribution partners after successfully completing commercial FemaSeed infertility treatments

•
Received 510(k) clearance from FDA for FemChec®, an innovative diagnostic solution for fallopian tube check

•
Received CE Mark certification and product approval from Health Canada, the Public Health Agency of Canada, for our compact, eco-friendly FemVue MINI for fallopian tube assessment

•
Announced issuance of U.S. patent covering FemBloc® device for female permanent birth control
 
“We continue to achieve significant commercial milestones with regard to our FemaSeed first-line infertility treatment and its supporting FemVue product. Notably, in 3Q we began commercialization of FemaSeed in the U.S., including a high-profile conglomerate, as well as in Europe with two partners in Spain. We look forward to collaborating with our expanding group of partners as we bring our next generation advancements to women.” said Femasys’ CEO Kathy Lee-Sepsick.

Financial Results for Quarter Ended September 30, 2024


 •
Sales increased by $310,547, or 127.1%, to $554,908 in Q3 of 2024 from $244,361 in Q3 of 2023, due to increased sales of FemaSeed and FemVue. The Company recorded its first FemaSeed U.S. and international sales for the three months ended September 30, 2024, and additional sales are expected in the 4th quarter of 2024.


•
Research and development expenses increased by $230,411, or 11.1%, to $2,303,241 in Q3 of 2024 from $2,072,830 in Q3 of 2023.

•
Net loss was $5,408,860, or ($0.24) per basic and diluted share attributable to common stockholders, for the quarter ended September 30, 2024, compared to net loss of $3,996,905, or ($0.26) per basic and diluted share attributable to common stockholders, for the quarter ended September 30, 2023.

•
Cash and cash equivalents as of September 30, 2024, was $7.6 million and the Company had an accumulated deficit of $122.1 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 Nine Months Ended September 30, 2024


 •
Sales increased by $188,673, or 22.0%, to $1,047,532 for the nine months of 2024, from $858,859 for the nine months of 2023 due to increased sales of FemaSeed and FemVue.

•
R&D expenses increased by $912,406 or 17.8%, to $6,049,847 for the nine months of 2024, from $5,137,441 for the nine months of 2023.

•
Net loss was $13,692,944, or ($0.62) per basic and diluted share attributable to common stockholders, for the nine-month period ended September 30, 2024, compared to net loss of $9,836,670, or ($0.74) per basic and diluted share attributable to common stockholders, for the same period ended September 30, 2023.

For more information, please refer to the Company’s Form 10-Q filed November 12, 2024, which can be accessed on the SEC website.

FEMASYS INC.
Condensed Balance Sheets
(unaudited)

Assets
  
September 30, 2024
    
December 31, 2023
  
Current assets:
            
Cash and cash equivalents
  
$
7,611,210
      
21,716,077
  
Accounts receivable, net
    
378,290
      
98,906
  
Inventory, net
    
1,937,670
      
667,118
  
Prepaid and other current assets
    
1,370,523
      
695,879
  
Total current assets
    
11,297,693
      
23,177,980
  
Property and equipment, at cost:
                
Leasehold improvements
    
1,238,886
      
1,212,417
  
Office equipment
    
67,231
      
47,308
  
Furniture and fixtures
    
433,584
      
414,303
  
Machinery and equipment
    
2,848,833
      
2,559,356
  
Construction in progress
    
548,149
      
423,077
  
     
5,136,683
      
4,656,461
  
Less accumulated depreciation
    
(3,748,393
)
    
(3,545,422
)
Net property and equipment
    
1,388,290
      
1,111,039
  
Long-term assets:
                
Lease right-of-use assets, net
    
1,941,624
      
2,380,225
  
Intangible assets, net of accumulated amortization
    
70,064
      
—
  
Other long-term assets
    
887,410
      
1,086,581
  
Total long-term assets
    
2,899,098
      
3,466,806
  
Total assets
  
$
15,585,081
      
27,755,825
  

(continued)

FEMASYS INC.
Condensed Balance Sheets
(unaudited)

Liabilities and Stockholders’ Equity
  
September 30, 2024
    
December 31, 2023
  
Current liabilities:
            
Accounts payable
  
$
1,121,873
      
1,137,823
  
Accrued expenses
    
1,127,645
      
1,444,296
  
Clinical holdback – current portion
    
92,170
      
65,300
  
Lease liabilities – current portion
    
525,752
      
406,636
  
Total current liabilities
    
2,867,440
      
3,054,055
  
Long-term liabilities:
                
Clinical holdback – long-term portion
    
36,081
      
54,935
  
Convertible notes payable, net (including related parties)
    
5,068,556
      
4,258,179
  
Lease liabilities – long-term portion
    
1,643,217
      
2,036,067
  
Total long-term liabilities
    
6,747,854
      
6,349,181
  
Total liabilities
    
9,615,294
      
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 September 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
    
125,473,368
      
123,985,306
  
Accumulated deficit
    
(122,074,573
)
    
(108,381,629
)
Total stockholders’ equity
    
5,969,787
      
18,352,589
  
Total liabilities and stockholders' equity
  
$
15,585,081
      
27,755,825
  

FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)

   
Three Months Ended September 30,
    
Nine Months Ended September 30,
  
   
2024
    
2023
    
2024
    
2023
  
Sales
  
$
554,908
      
244,361
      
1,047,532
      
858,859
  
Cost of sales (excluding depreciation expense)
    
190,839
      
86,186
      
352,496
      
301,775
  
                                 
Operating expenses:
                                
Research and development
    
2,303,241
      
2,072,830
      
6,049,847
      
5,137,441
  
Sales and marketing
    
1,572,189
      
70,883
      
2,847,866
      
444,678
  
General and administrative
    
1,530,791
      
1,970,408
      
4,645,412
      
4,642,182
  
Depreciation and amortization
    
76,288
      
125,318
      
215,144
      
391,683
  
Total operating expenses
    
5,482,509
      
4,239,439
      
13,758,269
      
10,615,984
  
Loss from operations
    
(5,118,440
)
    
(4,081,264
)
    
(13,063,233
)
    
(10,058,900
)
Other income (expense):
                                
Interest income
    
124,028
      
92,392
      
532,850
      
232,133
  
Interest expense
    
(413,290
)
    
(8,033
)
    
(1,163,153
)
    
(9,903
)
Total other income (expense), net
    
(289,262
)
    
84,359
      
(630,303
)
    
222,230
  
Loss before income taxes
    
(5,407,702
)
    
(3,996,905
)
    
(13,693,536
)
    
(9,836,670
)
Income tax expense (benefit)
    
1,158
      
—
      
(592
)
    
—
  
                                 
Net loss
  
$
(5,408,860
)
    
(3,996,905
)
    
(13,692,944
)
    
(9,836,670
)
                                 
Net loss attributable to common stockholders, basic and diluted
  
$
(5,408,860
)
    
(3,996,905
)
    
(13,692,944
)
    
(9,836,670
)
Net loss per share attributable to common stockholders, basic and diluted
  
$
(0.24
)
    
(0.26
)
    
(0.62
)
    
(0.74
)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
    
22,232,799
      
15,093,147
      
22,075,135
      
13,369,462
  

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® and FemVue® Mini 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, 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, 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:
Matt Blazei
IR@femasys.com

Media:
Kati Waldenburg
Media@femasys.com


v3.24.3
Document and Entity Information
Nov. 12, 2024
Cover [Abstract]  
Document Type 8-K/A
Amendment Flag false
Document Period End Date Nov. 12, 2024
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
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol FEMY
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period true
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
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