Femasys Announces Second Quarter Financial Results for 2025

-- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio -- ATLANTA, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: 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®, 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® and FemVue®, 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)       Assets June 30, 2025 December 31, 2024Current 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’ Equity  June 30, 2025 December 31, 2024Current 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  General and administrative 1,616,972  1,611,817  3,339,685  3,114,621  Depreciation and amortization 86,285  67,628  171,138  138,856   Total operating expenses