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 8, 2026

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 8, 2026 Femasys Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2026 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 8, 2026
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 8, 2026
  

 
Exhibit 99.1

Femasys Announces Financial Results for Quarter Ended March 31, 2026 and Provides Corporate Update
 
-- With fertility rates at historic lows, Femasys advances access to early infertility care through FemaSeed® Complete, enabling OB/GYNs to treat patients within their own practices --
 
ATLANTA, May 8, 2026 – Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announces its financial results for the quarter ended March 31, 2026 and provides a corporate update.
 
Corporate Highlights from 1Q 2026 to date
 

 •
Advanced initial commercial adoption of FemaSeed Complete, positioning Femasys to expand access to first-line fertility treatment through integrated, in-office care by OB/GYNs, supporting earlier intervention prior to referral to higher-cost specialty care.
 

 •
Launched FemaSeed Complete at ACOG 2026, advancing commercialization and expanding provider awareness to support adoption of first-line fertility treatment in the OB/GYN office.
 

 •
Established strategic partnership with AMI Technologies to introduce and commercialize its fertility portfolio in Israel, expanding international market opportunities.
 

 •
Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth.
 

 •
Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, enhancing leadership and strategic oversight.
 

 •
Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc®, advancing toward U.S. approval of a first-of-its kind, non-surgical permanent birth control.
 

 •
FemBloc permanent birth control system achieved Medical Device Single Audit Program (MDSAP) certification, supporting global regulatory readiness and future market access.
 

 •
Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed intratubal insemination (ITI), supporting future reimbursement and broader adoption in the U.S.
 

 •
Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed, and other portfolio products in Switzerland, expanding European market access.
 

 •
Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment and expanding access through community-based care.
 
“During the first quarter of 2026 and into the second quarter of 2026, we delivered meaningful clinical, regulatory and commercial progress across our FemBloc and FemaSeed platforms,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “We are accelerating commercialization of FemaSeed with the introduction of the FemSperm® product family, enabling OB/GYNs to deliver integrated, in-office fertility care. Concurrently, we advanced FemBloc with initiation of patient enrollment in the FINALE pivotal clinical trial, a key step toward U.S. FDA approval. We believe our current cash resources are sufficient to fund operations into the third quarter of 2026. We remain focused on scaling a broad portfolio of innovative women’s health solutions globally, addressing critical unmet needs with safe, technologically advanced products.”
 
Financial Results for Quarter Ended March 31, 2026
 

 •
Sales increased by $83,625, or 24.5%, to $424,889 in 2026 from $341,264 in 2025, primarily due to sales of FemBloc.
 

 •
Research and development expenses decreased by $1,659,071, or 55.9%, to $1,309,401 in 2026 compared to $2,968,472 in 2025, primarily reflecting the transition of development products into inventory to support commercialization, along with lower development, clinical, compensation, and professional service costs.
 

 •
Net income, including gains from changes in fair value of financial instruments, was $846,100, or $0.00 per basic and diluted share attributable to common stockholders for the quarter ended March 31, 2026, compared to a net loss of $5,896,839, or ($0.23) per basic and diluted share attributable to common stockholders, for the quarter ended March 31, 2025.
 

 •
Cash and cash equivalents as of March 31, 2026, was approximately $5.4 million and the Company had an accumulated deficit of approximately $145.0 million. The Company expects, based on its current operating plan, its current cash and cash equivalents will be sufficient to fund its ongoing operations into the third quarter of 2026.
 
For more information, please refer to the Company’s Form 10-Q filed May 8, 2026, which can be accessed on the SEC website.
 
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
 
Assets
  
March 31,
2026
    
December 31,
2025
  
Current assets:
            
Cash and cash equivalents
  
$
5,386,041
      
9,266,353
  
Accounts receivable, net
    
172,264
      
616,600
  
Inventory
    
6,105,267
      
5,740,249
  
Prepaid and other current assets
    
679,917
      
833,133
  
Total current assets
    
12,343,489
      
16,456,335
  
Property and equipment, at cost:
                
Leasehold improvements
    
1,238,886
      
1,238,886
  
Office equipment
    
80,941
      
78,155
  
Furniture and fixtures
    
421,798
      
417,876
  
Machinery and equipment
    
3,095,633
      
3,065,713
  
Construction in progress
    
955,271
      
897,885
  
     
5,792,529
      
5,698,515
  
Less accumulated depreciation
    
(3,868,518
)
    
(3,802,940
)
Net property and equipment
    
1,924,011
      
1,895,575
  
Long-term assets:
                
Lease right-of-use assets, net
    
1,178,941
      
1,297,121
  
Intangible assets, net of accumulated amortization
    
124,252
      
134,914
  
Other long-term assets
    
924,552
      
940,232
  
Total long-term assets
    
2,227,745
      
2,372,267
  
                 
Total assets
  
$
16,495,245
      
20,724,177
  

(continued)
 
FEMASYS INC.
Condensed Balance Sheets
(unaudited)

Liabilities and Stockholders’ Equity
  
March 31,
2026
    
December 31,
2025
  
Current liabilities:
            
Accounts payable
  
$
1,597,591
      
1,830,124
  
Accrued expenses
    
1,024,706
      
1,265,773
  
Clinical holdback – current portion
    
52,572
      
52,644
  
Operating lease liabilities – current portion
    
480,286
      
487,624
  
Total current liabilities
    
3,155,155
      
3,636,165
  
Long-term liabilities:
                
Clinical holdback – long-term portion
    
54,487
      
52,370
  
Convertible notes payable, net
    
3,335,176
      
3,178,864
  
Conversion option liability
    
488,000
      
2,014,000
  
Warrants liabilities
    
1,260,000
      
4,943,000
  
Operating lease liabilities – long-term portion
    
912,534
      
1,030,476
  
Total long-term liabilities
    
6,050,197
      
11,218,710
  
Total liabilities
    
9,205,352
      
14,854,875
  
Commitments and contingencies
                
Stockholders’ equity:
                
Common stock, $0.001 par, 200,000,000 authorized, 60,507,909 shares issued and 60,390,686 outstanding as of March 31, 2026; and 59,720,010 shares issued and 59,602,787 outstanding as of December 31, 2025
    
60,508
      
59,720
  
Treasury stock, 117,223 common shares
    
(60,000
)
    
(60,000
)
Warrants
    
5,246,150
      
5,246,150
  
Additional paid-in capital
    
147,023,279
      
146,449,576
  
Accumulated deficit
    
(144,980,044
)
    
(145,826,144
)
                 
Total stockholders’ equity
    
7,289,893
      
5,869,302
  
                 
Total liabilities and stockholders’ equity
  
$
16,495,245
      
20,724,177
  
 
FEMASYS INC.
Condensed Statements of Comprehensive Income (Loss)
(unaudited)

   
Three Months Ended March 31,
  
   
2026
    
2025
  
Sales
  
$
424,889
      
341,264
  
Cost of sales (excluding depreciation expense)
    
158,606
      
117,266
  
                 
Operating expenses:
                
Research and development
    
1,309,401
      
2,968,472
  
Sales and marketing
    
1,315,755
      
908,567
  
General and administrative
    
1,782,390
      
1,722,713
  
Depreciation and amortization
    
82,270
      
84,853
  
Total operating expenses
    
4,489,816
      
5,684,605
  
Loss from operations
    
(4,223,533
)
    
(5,460,607
)
Other income (expense):
                
Interest income
    
49,827
      
19,029
  
Change in fair value of conversion option liability
    
1,513,413
      
—
  
Change in fair value of warrants liabilities
    
3,683,000
      
—
  
Interest expense
    
(176,607
)
    
(459,449
)
Total other income (expense), net
    
5,069,633
      
(440,420
)
Income (loss) before income taxes
    
846,100
      
(5,901,027
)
Income tax benefit
    
—
      
(4,188
)
                 
Net income (loss)
  
$
846,100
      
(5,896,839
)
                 
Net income (loss) attributable to common stockholders
  
$
328,646
      
(5,896,839
)
                 
Earnings (losses) per share:
                
Basic
  
$
0.00
      
(0.23
)
Diluted
    
0.00
      
(0.23
)
                 
Weighted-average common shares outstanding:
                
Basic
    
66,645,591
      
25,149,236
  
Diluted
    
78,095,633
      
25,149,236
  
 
About Femasys
Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed® Intratubal Insemination (ITI), a groundbreaking first-step infertility treatment; FemSperm®, a CLIA waived sperm preparation and analysis product line; and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rate of traditional IUI, with a comparable safety profile and high patient and practitioner satisfaction.1

FemBloc® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec® diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is ongoing.

Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

References
1Liu, 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. doi: 10.33140/JGRM.08.02.08.

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. doi: 10.33140/JGRM.09.01.05.

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; our ability to 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, 2025, 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:
[email protected]
[email protected]