Femasys Announces Third Quarter Financial Results for 2025

Rhea-AI Summary

Femasys (NASDAQ: FEMY) reported 3Q 2025 results and multiple corporate milestones on Nov 14, 2025. Key operational highlights include FDA IDE approval to advance the final FemBloc pivotal trial, regulatory approvals in the U.K. and New Zealand, initiation of European post-market surveillance, and new distribution partnerships and initial commercial orders in Europe.

Financing actions strengthened liquidity: a $12 million secured convertible notes agreement (with up to $58 million potential if warrants exercised) and an underwritten public offering raising $8 million. Financials: 3Q sales were $729,394 (+31.4% vs. 3Q2024); 9M sales were $1.480M (+41.3% YoY). Cash was approximately $4.6M with a stated cash runway into September 2026.

Positive

• FDA IDE approval to start final FemBloc pivotal trial (Nov 2025)
• Regulatory approvals in U.K. and New Zealand (expands markets)
• Financing: $12M secured convertible notes; $58M potential via warrants
• Underwritten public offering gross proceeds of $8M (Nov 2025)
• Sales +31.4% in 3Q2025 to $729,394; 9M sales +41.3% to $1,479,926
• Cash runway projected into September 2026 with ~$4.6M cash

Negative

• Net loss $4.19M in 3Q2025; $14.68M for nine months (2025)
• Accumulated deficit approximately $141.9M as of Sept 30, 2025
• Current liabilities $10.54M vs cash $4.57M (liquidity pressure)
• Convertible notes payable $6.51M outstanding (Sept 30, 2025)

Insights

Corporate Finance Expert

FDA IDE approval, regulatory clearances abroad, and new financing materially improve near-term development and commercial runway.

Sales growth of $729,394 in 3Q and inventory expansion show early commercial traction for FemBloc, while regulatory clearances in the U.K. and New Zealand and partner orders in Europe create visible market access channels. The FDA IDE approval enables the final pivotal FINALE trial phase, which is the discrete regulatory milestone required to pursue U.S. approval and is therefore central to U.S. commercialization plans.

Balance-sheet moves materially reduce near-term funding risk: the $12 million secured convertible note financing plus an underwritten offering of $8 million and potential warrant proceeds give the company a clearer path to fund operations into September 2026. That said, continuing net losses (net loss $4.19 million for the quarter and $14.68 million year-to-date) and an accumulated deficit of $141.9 million mean the company remains dependent on successful trial progress, further commercialization, and full exercise of announced financings to avoid additional dilution or further financing.

Watch the pace and enrollment of the FDA‑approved IDE study and milestone timing for U.S. pivotal endpoints over the next 12–18 months, early commercial uptake in partner territories and conversion of warrants into cash, and quarterly cash-burn versus realized sales growth; these items will most clearly alter the company’s financing needs and valuation trajectory within September 2026.

– 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
(continued)

FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders’ Equity									September 30, 2025			December 31, 2024
Current liabilities:
	Accounts payable							$	2,173,883			1,419,044
	Accrued expenses								1,028,461			1,151,049
	Note payable								276,489			—
	Convertible notes payable, net (including related parties)								6,507,354			5,406,228
	Clinical holdback – current portion								60,543			88,581
	Lease liabilities – current portion								494,954			517,967
					Total current liabilities				10,541,684			8,582,869
Long-term liabilities:
	Clinical holdback – long-term portion								43,955			39,611
	Lease liabilities – long-term portion								1,148,263			1,518,100
					Total long-term liabilities				1,192,218			1,557,711
					Total liabilities				11,733,902			10,140,580
Commitments and contingencies
Stockholders’ equity:
	Common stock, $0.001 par, 200,000,000 authorized,
		47,419,596 shares issued and 47,302,373 outstanding as of
		September 30, 2025; and 23,473,149 shares issued
		and 23,355,926 outstanding as of December 31, 2024							47,420			23,473
	Treasury stock, 117,223 common shares								(60,000	)		(60,000	)
	Warrants								6,727,334			1,860,008
	Additional paid-in-capital								139,717,336			127,679,198
	Accumulated deficit								(141,875,839	)		(127,198,257	)
					Total stockholders’ equity				4,556,251			2,304,422
					Total liabilities and stockholders' equity			$	16,290,153			12,445,002

FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)
									Three Months Ended September 30,						Nine Months Ended September 30,
									2025			2024			2025			2024
Sales								$	729,394			554,908			1,479,926			1,047,532
Cost of sales (excluding depreciation expense)									293,838			190,839			569,275			352,496
Operating expenses:
	Research and development								1,382,022			2,303,241			5,764,923			6,049,847
	Sales and marketing								1,143,805			1,572,189			3,037,349			2,847,866
	General and administrative								1,477,800			1,530,791			4,817,485			4,645,412
	Depreciation and amortization								85,697			76,288			256,835			215,144
					Total operating expenses				4,089,324			5,482,509			13,876,592			13,758,269
					Loss from operations				(3,653,768	)		(5,118,440	)		(12,965,941	)		(13,063,233	)
Other (expense) income:
	Interest income								17,315			124,028			53,488			532,850
	Interest expense								(532,073	)		(413,290	)		(1,483,022	)		(1,163,153	)
	Other expense								(26,295	)		—			(286,295	)		—
					Total other expense, net				(541,053	)		(289,262	)		(1,715,829	)		(630,303	)
					Loss before income taxes				(4,194,821	)		(5,407,702	)		(14,681,770	)		(13,693,536	)
	Income tax expense (benefit)								—			1,158			(4,188	)		(592	)
					Net loss			$	(4,194,821	)		(5,408,860	)		(14,677,582	)		(13,692,944	)
Net loss attributable to common stockholders, basic and diluted								$	(4,194,821	)		(5,408,860	)		(14,677,582	)		(13,692,944	)
Net loss per share attributable to common stockholders, basic and diluted								$	(0.10	)		(0.24	)		(0.46	)		(0.62	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted									41,015,196			22,232,799			31,739,828			22,075,135

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, a groundbreaking first-step infertility treatment and FemVue^®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as 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 of 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 on-going.

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; 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, 2024, 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: 

David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com
Nathan Abler, Dresner Corporate Services, (714) 742-4180, nabler@dresnerco.com

FAQ

What did Femasys (FEMY) announce on November 14, 2025 regarding FDA progress?

Femasys announced FDA IDE approval to initiate the final pivotal FemBloc trial required for U.S. approval.

How much cash did FEMY report at September 30, 2025 and how long is the runway?

Femasys reported approximately $4.6 million in cash and expects funding to support operations into September 2026.

What financing did FEMY complete in 3Q/Nov 2025 and what is the total potential funding?

Femasys announced $12 million in secured convertible notes and an underwritten offering raising $8 million, with up to $58 million potential if all warrants are exercised.

How did FEMY revenue perform in Q3 2025 and year-to-date?

3Q2025 sales were $729,394 (up 31.4% vs 3Q2024); 9M2025 sales were $1,479,926 (up 41.3% YoY).

What commercial and market approvals did FEMY secure in 3Q 2025?

Femasys received regulatory approval for FemBloc in the U.K. and New Zealand, and announced European distribution partnerships with initial orders.

What are the principal financial risks highlighted for FEMY after the announcement?

Principal risks include a $141.9M accumulated deficit, 3Q net loss of $4.19M, and current liabilities (~$10.54M) exceeding cash (~$4.6M).