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Nov 14, 2025 4:10 PM

Femasys Announces Third Quarter Financial Results for 2025

– FDA Approval to Advance Final FemBloc® Trial with Clear Pathway to Potentially Achieve U.S. FDA Approval,

– $12 Million Financing Strengthens Balance Sheet and Extends Cash Runway,

ATLANTA, Nov. 14, 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 third quarter of 2025.

Corporate Highlights from 3Q 2025

Announced second partner order for FemBloc in Europe

Announced FDA IDE approval to continue enrollment in final phase of the FINALE pivotal trial for FemBloc

Announced a definitive agreement for the issuance of $12 million in secured convertible notes and accompanying warrants for total potential funding of $58 million, if all warrants are exercised for cash

Announced the initiation of post-market surveillance study for FemBloc in Europe

Announced partnership with Kebomed, a leading European distributor of medical devices and equipment, to commercialize FemBloc in France and the Benelux region (the Netherlands, Belgium and Luxembourg)

Announced partnership with Medical Electronic Systems LLC to provide FemSperm™ Analysis Kit for use with FemaSeed®

Announced FemSperm Setup and Preparation Kits, designed to fully enable gynecologists to perform FemaSeed Intratubal Insemination

Announced New Zealand regulatory approval of FemBloc

Announced underwritten public offering with gross proceeds of $8 million

Announced United Kingdom regulatory approval of FemBloc

"Our third quarter marked several pivotal milestones for Femasys as we advanced on multiple fronts, securing key regulatory approvals, strengthening our balance sheet through new financing, and expanding global partnerships for FemBloc, all reinforcing our commitment to delivering innovative solutions for women's health," said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. "Regulatory approvals of the complete FemBloc System in the U.K. and New Zealand significantly expand access to this revolutionary, non-surgical permanent birth control option across Europe and the Asia-Pacific region. With initial commercial orders received from our distribution partners in Spain and France, we are building early momentum as we pursue additional country approvals. At the same time, we continue to advance toward U.S. approval of FemBloc, following the FDA's recent IDE approval to initiate the final pivotal trial phase required for regulatory approval."

Financial Results for Quarter Ended September 30, 2025

Sales increased by $174,486, or 31.4%, to $729,394 for the three months of 2025, compared to $554,908 for the three months of 2024 primarily due to sales of FemBloc.

Research and development expenses decreased by $921,219, or 40.0%, to $1,382,022 for the three months of 2025 compared to $2,303,241 for the three months of 2024 primarily due to commercialization of development products into inventory and reduced compensation costs, clinical costs and professional fees.

Net loss was $4,194,821, or ($0.10) per basic and diluted share attributable to common stockholders, for the three-month period ended September 30, 2025, compared to a net loss of $5,408,860, or ($0.24) per basic and diluted share attributable to common stockholders, for the three-month period ended September 30, 2024.

Cash and cash equivalents as of September 30, 2025, was approximately $4.6 million and the Company had an accumulated deficit of approximately $141.9 million. The Company expects, based on its current operating plan, our current cash and cash equivalents, which includes proceeds from our recent financing, will be sufficient to fund its ongoing operations into September 2026.

Financial Results for Nine Months Ended September 30, 2025

Sales increased by $432,394, or 41.3%, to $1,479,926 for the nine months of 2025, compared to $1,047,532 for the nine months of 2024 due to sales of FemBloc and FemVue.

Research and development expenses decreased by $284,924, or 4.7%, to $5,764,923 for the nine months of 2025 compared to $6,049,847 for the nine months of 2024 primarily due to commercialization of development products into inventory, reduced clinical costs and professional fees, partially offset by increased regulatory costs.

Net loss was $14,677,582, or ($0.46) per basic and diluted share attributable to common stockholders, for the nine-month period ended September 30, 2025, compared to a net loss of $13,692,944, or ($0.62) per basic and diluted share attributable to common stockholders, for the same period ended September 30, 2024.

For more information, please refer to the Company's Form 10-Q filed November 14, 2025, which can be accessed on the SEC website.

FEMASYS INC.

 

Condensed Balance Sheets

 

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets

 

September 30, 2025

 

December 31, 2024

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

4,569,038

 

 

3,451,761

 

 

 

Accounts receivable, net

 

572,199

 

 

488,373

 

 

 

Inventory

 

 

 

5,783,974

 

 

3,046,323

 

 

 

Prepaid and other current assets

 

1,321,689

 

 

1,035,993

 

 

 

 

 

 

 

Total current assets

 

12,246,900

 

 

8,022,450

 

 

Property and equipment, at cost:

 

 

 

 

 

 

Leasehold improvements

 

1,238,886

 

 

1,238,886

 

 

 

Office equipment

 

78,155

 

 

60,921

 

 

 

Furniture and fixtures

 

417,876

 

 

417,876

 

 

 

Machinery and equipment

 

3,283,672

 

 

2,856,740

 

 

 

Construction in progress

 

687,462

 

 

762,445

 

 

 

 

 

 

 

 

 

 

5,706,051

 

 

5,336,868

 

 

Less accumulated depreciation

 

(3,956,987

)

 

(3,740,769

)

 

 

 

 

 

 

Net property and equipment

 

1,749,064

 

 

1,596,099

 

 

Long-term assets:

 

 

 

 

 

 

Lease right-of-use assets, net

 

1,419,345

 

 

1,805,543

 

 

 

Intangible assets, net of accumulated amortization

 

130,041

 

 

65,918

 

 

 

Other long-term assets

 

744,803

 

 

954,992

 

 

 

 

 

 

 

Total long-term assets

 

2,294,189

 

 

2,826,453

 

 

 

 

 

 

 

Total assets

$

16,290,153

 

 

12,445,002

 

 

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