-- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio --

ATLANTA, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. $(FEMY)$, a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the second quarter of 2025.

Corporate Highlights from 2Q 2025 to date

   -- Announced European Union Medical Device Regulation approval of FemBloc$(R)$, 
      the first global regulatory endorsement of our groundbreaking 
      non-surgical permanent birth control solution 
 
   -- Secured first European order for FemBloc from Spain distribution partners 
      for approximately $400,000 
 
   -- Announced Australian and New Zealand regulatory approvals for FemaSeed(R) 
      and FemVue(R), a cost-effective first step in fertility 
 
   -- Announced new Chief Commercial Officer to help drive execution and global 
      growth 
 
   -- Announced partnership with Carolinas Fertility Institute, one of 
      America's best fertility clinics, to offer FemaSeed in its eight 
      locations 
 
   -- Announced pricing of underwritten public offering and concurrent private 
      placement with gross proceeds of $4.5 million 

"Our second quarter marked several significant milestones for Femasys as we continue to secure key regulatory approvals, add partners, and strengthen our team to accelerate the commercialization of our innovative fertility portfolio across the globe," said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. "European approval of the entire FemBloc System announced in June marks the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution. FemBloc is commercially available through strategic distribution partnerships in select countries in Europe beginning in Spain, who placed their initial order, and we will seek additional country approvals while continuing to enroll participants in our FDA IDE-approved late-stage pivotal trial for U.S. approval.

"Regulatory approvals for FemaSeed in Australia and New Zealand announced in July also provide us with the opportunity to pursue meaningful commercial opportunities as we continue to grow revenue and broaden our global footprint. Our new partnership with Carolinas Fertility Institute will help us reach and support more patients earlier in their fertility journey. We look forward to building upon this momentum as we work towards transforming the fertility sector not only for patients, but also providers."

Financial Results for Quarter Ended June 30, 2025

   -- Sales increased by $187,784, or 84.8%, to $409,268 for the three months 
      of 2025, compared to $221,484 for the three months of 2024 due to sales 
      of FemaSeed and FemVue. 
 
   -- Research and development expenses decreased by $561,446, or 28.4%, to 
      $1,414,429 for the three months of 2025 compared to $1,975,875 for the 
      three months of 2024 primarily due to commercialization of development 
      products into inventory and reduced clinical costs, partially offset by 
      increased compensation costs. 
 
   -- Net loss was $4,585,922, or ($0.16) per basic and diluted share 
      attributable to common stockholders, for the three-month period ended 
      June 30, 2025, compared to a net loss of $4,684,574, or ($0.21) per basic 
      and diluted share attributable to common stockholders, for the 
      three-month period ended June 30, 2024. 
 
   -- Cash and cash equivalents as of June 30, 2025, was approximately $3.2 
      million and the Company had an accumulated deficit of approximately 
      $137.7 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 fourth quarter of 2025. 

Financial Results for Six Months Ended June 30, 2025

   -- Sales increased by $257,908, or 52.4%, to $750,532 for the six months of 
      2025, compared to $492,624 for the six months of 2024 due to sales of 
      FemaSeed and FemVue. 
 
   -- Research and development expenses increased by $636,295, or 17.0%, to 
      $4,382,901 for the six months of 2025 compared to $3,746,606 for the six 
      months of 2024 primarily due to increased compensation and regulatory 
      costs, partially offset by reduced material and development costs and 
      clinical costs. 
 
   -- Net loss was $10,482,761, or ($0.39) per basic and diluted share 
      attributable to common stockholders, for the six-month period ended June 
      30, 2025, compared to a net loss of $8,284,084, or ($0.38) per basic and 
      diluted share attributable to common stockholders, for the same period 
      ended June 30, 2024. 

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

 
 
                             FEMASYS INC. 
                       Condensed Balance Sheets 
                              (unaudited) 
 
                                             June 30,     December 31, 
                 Assets                         2025          2024 
                                            -----------  -------------- 
Current assets: 
 Cash and cash equivalents                 $ 3,218,067     3,451,761 
 Accounts receivable, net                      254,584       488,373 
 Inventory                                   5,232,738     3,046,323 
 Prepaid and other current assets            1,045,591     1,035,993 
  Total current assets                       9,750,980     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                     3,211,109     2,856,740 
 Construction in progress                      548,426       762,445 
                                             5,484,827     5,336,868 
Less accumulated depreciation               (3,884,964)   (3,740,769) 
  Net property and equipment                 1,599,863     1,596,099 
                                            ----------   ----------- 
Long-term assets: 
 Lease right-of-use assets, net              1,544,724     1,805,543 
 Intangible assets, net of accumulated 
  amortization                                  55,638        65,918 
 Other long-term assets                        829,204       954,992 
  Total long-term assets                     2,429,566     2,826,453 
  Total assets                             $13,780,409    12,445,002 
                                            ==========   =========== 
 
(continued) 
 
 
 
                           FEMASYS INC. 
                     Condensed Balance Sheets 
                           (unaudited) 
 
  Liabilities and Stockholders'       June 30,      December 31, 
             Equity                      2025            2024 
                                    -------------  --------------- 
Current liabilities: 
 Accounts payable                  $   3,263,584      1,419,044 
 Accrued expenses                      1,052,752      1,151,049 
 Convertible notes payable, net 
  (including related parties)          6,080,813      5,406,228 
 Clinical holdback -- current 
  portion                                 63,990         88,581 
 Lease liabilities -- current 
  portion                                502,468        517,967 
   Total current liabilities          10,963,607      8,582,869 
                                    ------------   ------------ 
Long-term liabilities: 
 Clinical holdback -- long-term 
  portion                                 40,348         39,611 
 Lease liabilities -- long-term 
  portion                              1,269,019      1,518,100 
   Total long-term liabilities         1,309,367      1,557,711 
   Total liabilities                  12,272,974     10,140,580 
                                    ------------   ------------ 
Commitments and contingencies 
Stockholders' equity: 
 Common stock, $.001 par, 
 200,000,000 authorized, 
  32,692,630 shares issued and 
  32,575,407 outstanding as of 
  June 30, 2025; and 23,473,149 
  shares issued 
  and 23,355,926 outstanding as 
   of December 31, 2024                   32,693         23,473 
 Treasury stock, 117,223 common 
  shares                                 (60,000)       (60,000) 
 Warrants                              1,821,744      1,860,008 
 Additional paid-in-capital          137,394,016    127,679,198 
 Accumulated deficit                (137,681,018)  (127,198,257) 
   Total stockholders' equity          1,507,435      2,304,422 
                                    ------------   ------------ 
   Total liabilities and 
    stockholders' equity           $  13,780,409     12,445,002 
                                    ============   ============ 
 
 
 
                                    FEMASYS INC. 
                     Condensed Statements of Comprehensive Loss 
                                    (unaudited) 
 
                               Three Months Ended June 
                                         30,              Six Months Ended June 30, 
                               ------------------------  --------------------------- 
                                  2025         2024         2025          2024 
                               ----------   ----------   -----------   ---------- 
Sales                         $   409,268      221,484       750,532      492,624 
Cost of sales (excluding 
 depreciation expense)            158,171       73,125       275,437      161,657 
 
Operating expenses: 
 Research and development       1,414,429    1,975,875     4,382,901    3,746,606 
 Sales and marketing              984,977      975,190     1,893,544    1,275,677 

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