Femasys Announces Financial Results for Quarter Ended March 31, 2025, and Provides Corporate Update

-- Company delivers on mission to transform women's health with innovative solutions, including FemaSeed$(R)$ for first-line infertility treatment and FemBloc(R) non-surgical permanent birth control (full system approval pending in Europe) --

ATLANTA, May 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. $(FEMY)$, a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces financial results for the quarter ended March 31, 2025 and provides a corporate update.

Corporate Highlights from 1Q 2025 to date

   -- Announced FemBloc permanent birth control delivery system approval in 
      Europe; FemBloc blended polymer component successfully completed an 
      expedited G12 Special MDR Audit for Class III devices, and the Notified 
      Body has recommended for CE mark approval pending the final stages of 
      European Medical Agency (EMA) review 
 
   -- Announced United Kingdom and Israeli regulatory approvals for FemaSeed 
      and two diagnostic devices 
 
   -- Announced partnership with CNY Fertility, a national conglomerate of 
      eleven fertility centers, to offer FemaSeed 
 
   -- Announced distribution partnerships for FemBloc in Spain 
 
   -- Announced peer-reviewed publication of positive safety and efficacy 
      results from FemBloc clinical trials 
 
   -- Announced notices of intention to grant two new European patent 
      applications for FemBloc 
 
   -- Announced notice of allowance for new U.S. patent application for 
      FemaSeed 

"Securing the first regulatory approval globally for the FemBloc delivery system marks a key milestone toward full system approval and the introduction of a first-of-its-kind, non-surgical permanent birth control option for women in Europe," said Femasys' CEO Kathy Lee-Sepsick. "Additionally in the first quarter of 2025, we began executing our commercialization strategy for FemaSeed, achieving a 78% quarter-over-quarter sales increase in the U.S., an encouraging early indicator of strong market momentum and the unmet need for additional fertility treatment options. We remain dedicated to closing critical gaps in women's reproductive health through the advancement of safe, effective, accessible and innovative solutions."

Financial Results for Quarter Ended March 31, 2025

   -- Sales increased by $70,124, or 25.9%, to $341,264 for the three months of 
      2025, from $271,140 for the three months of 2024 due to sales of FemaSeed 
 
   -- Research and development expenses increased by $1,197,741, or 67.6%, to 
      $2,968,472 for the three months of 2025 from $1,770,731 for the three 
      months of 2024 primarily due to increased regulatory costs, material and 
      development costs, and compensation costs 
 
   -- Net loss was $5,896,839, or ($0.23) per basic and diluted share 
      attributable to common stockholders, for the three-month period ended 
      March 31, 2025, compared to net loss of $3,599,510, or ($0.17) per basic 
      and diluted share attributable to common stockholders, for the same 
      period ended March 31, 2024 
 
   -- Cash and cash equivalents as of March 31, 2025, was approximately $3.8 
      million and the Company had an accumulated deficit of approximately 
      $133.1 million. The Company expects, based on its current operating plan, 
      our current cash and cash equivalents, will be sufficient to fund its 
      ongoing operations into early third quarter of 2025. 

For more information, please refer to the Company's Form 10-Q filed May 8, 2025, which can be accessed on the SEC website.

 
                         FEMASYS INC. 
                   Condensed Balance Sheets 
                         (unaudited) 
 
                                   March 31,     December 31, 
            Assets                    2025           2024 
                                  ------------  -------------- 
Current assets: 
 Cash and cash equivalents       $  3,820,208     3,451,761 
 Accounts receivable, net             233,598       488,373 
 Inventory                          3,862,188     3,046,323 
 Prepaid and other current 
  assets                            1,216,258     1,035,993 
     Total current 
      assets                        9,132,252     8,022,450 
                                  -----------   ----------- 
Property and equipment, at 
cost: 
 Leasehold improvements             1,238,886     1,238,886 
 Office equipment                      68,530        60,921 
 Furniture and fixtures               417,876       417,876 
 Machinery and equipment            3,068,033     2,856,740 
 Construction in progress             600,551       762,445 
                                    5,393,876     5,336,868 
Less accumulated depreciation      (3,818,451)   (3,740,769) 
     Net property 
      and 
      equipment                     1,575,425     1,596,099 
                                  -----------   ----------- 
Long-term assets: 
 Lease right-of-use assets, net     1,673,336     1,805,543 
 Intangible assets, net of 
  accumulated amortization             58,747        65,918 
 Other long-term assets               838,043       954,992 
     Total 
      long-term 
      assets                        2,570,126     2,826,453 
     Total assets                $ 13,277,803    12,445,002 
                                  ===========   =========== 
(continued) 
 
 
 
                         FEMASYS INC. 
                   Condensed Balance Sheets 
                          (unaudited) 
Liabilities and Stockholders'      March 31,     December 31, 
            Equity                   2025            2024 
                                 -------------  --------------- 
Current liabilities: 
 Accounts payable               $   2,331,794      1,419,044 
 Accrued expenses                   1,170,288      1,151,049 
 Convertible notes payable, 
  net (including related 
  parties)                          5,762,927      5,406,228 
 Clinical holdback -- current 
  portion                              65,946         88,581 
 Lease liabilities -- current 
  portion                             510,171        517,967 
     Total current 
      liabilities                   9,841,126      8,582,869 
                                 ------------   ------------ 
Long-term liabilities: 
 Clinical holdback -- 
  long-term portion                    47,140         39,611 
 Lease liabilities -- 
  long-term portion                 1,392,820      1,518,100 
     Total long-term 
      liabilities                   1,439,960      1,557,711 
     Total 
      liabilities                  11,281,086     10,140,580 
                                 ------------   ------------ 
Commitments and contingencies 
Stockholders' equity: 
 Common stock, $.001 par, 
 200,000,000 authorized, 
  27,205,109 shares issued and 
  27,087,886 outstanding as of 
  March 31, 2025; and 
  23,473,149 shares issued 
  and 23,355,926 outstanding 
   as of December 31, 2024             27,205         23,473 
 Treasury stock, 117,223 
  common shares                       (60,000)       (60,000) 
 Warrants                           1,860,008      1,860,008 
 Additional paid-in-capital       133,264,600    127,679,198 
 Accumulated deficit             (133,095,096)  (127,198,257) 
     Total 
      stockholders' 
      equity                        1,996,717      2,304,422 
                                 ------------   ------------ 
     Total 
      liabilities 
      and 
      stockholders' 
      equity                    $  13,277,803     12,445,002 
                                 ------------   ------------ 
 
 
 
                           FEMASYS INC. 
            Condensed Statements of Comprehensive Loss 
                           (unaudited) 
                                    Three Months Ended March 31, 
                                   ------------------------------- 
                                      2025             2024 
                                   -----------      ----------- 
Sales                             $    341,264          271,140 
Cost of sales (excluding 
 depreciation expense)                 117,266           88,532 
 
Operating expenses: 
 Research and development            2,968,472        1,770,731 
 Sales and marketing                   908,567          300,487 
 General and administrative          1,722,713        1,502,804 
 Depreciation and amortization          84,853           71,228 
     Total 
      operating 
      expenses                       5,684,605        3,645,250 
     Loss from 
      operations                    (5,460,607)      (3,462,642) 
                                   -----------      ----------- 
Other (expense) income: 
 Interest income                        19,029          224,684 
 Interest expense                     (459,449)        (361,552) 
     Total other 
      (expense) 
      income, net                     (440,420)        (136,868) 
                                   -----------      ----------- 
     Loss before 
      income taxes                  (5,901,027)      (3,599,510) 
 Income tax expense (benefit)           (4,188)              -- 
                                   -----------      ----------- 
     Net loss                     $ (5,896,839)      (3,599,510) 
                                   ===========      =========== 
 
Net loss attributable to common 
 stockholders, basic and 
 diluted                          $ (5,896,839)      (3,599,510) 
                                   ===========      =========== 
Net loss per share attributable 
 to common stockholders, basic 
 and diluted                      $      (0.23)           (0.17) 
Weighted-average shares used in 
 computing net loss per share 
 attributable to common 
 stockholders, basic and 
 diluted                            25,149,236       21,775,357 

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