Femasys (NASDAQ: FEMY) details 2025 results and FemBloc FINALE trial

Rhea-AI Filing Summary

Femasys Inc. reported 2025 results showing growing sales but continued losses while advancing its women’s health portfolio. Sales for the year ended December 31, 2025 rose to $2.29 million from $1.63 million, driven by its fertility and non-surgical permanent birth control products.

Net loss was $18.63 million, slightly better than $18.82 million in 2024, with operating expenses of $19.01 million. Cash and cash equivalents increased to $9.27 million, and the company believes this will fund operations into the third quarter of 2026.

Strategically, Femasys is expanding U.S. commercialization of its FemaSeed intratubal insemination product alongside the FemSperm sperm preparation line, while advancing FemBloc non-surgical permanent birth control through enrollment in the FINALE pivotal trial, a key step toward potential U.S. FDA approval, following prior approvals in Europe, the UK and New Zealand.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Sales: $2,293,313 Sales prior year: $1,629,108 Net loss: $18,627,887 +5 more

8 metrics

Sales $2,293,313 Year ended December 31, 2025

Sales prior year $1,629,108 Year ended December 31, 2024

Net loss $18,627,887 Year ended December 31, 2025

Net loss prior year $18,816,628 Year ended December 31, 2024

Cash and cash equivalents $9,266,353 As of December 31, 2025

Total assets $20,724,177 As of December 31, 2025

Net loss per share $0.47 Basic and diluted, 2025

Weighted-average shares 39,549,218 Basic and diluted, 2025

Key Terms

FINALE pivotal trial, conversion option liability, warrants liabilities, CLIA waived, +1 more

5 terms

FINALE pivotal trial medical

"with the initiation of patient enrollment in the FINALE pivotal clinical trial, a key step toward U.S. FDA approval."

conversion option liability financial

"Change in fair value of conversion option liability | | | 503,000"

warrants liabilities financial

"Change in fair value of warrants liabilities | | | 731,000"

Warrants liabilities are obligations a company records when it has issued warrants—contracts that give holders the right to buy stock or receive cash—but the terms make the company responsible for future payments or share changes. For investors, these items matter because they sit on the balance sheet like a potential bill or promise: they can dilute existing owners, create future cash needs, and cause earnings to swing as the warrants’ value changes, similar to a coupon that might force a store to pay out later.

CLIA waived medical

"FemSperm®, a CLIA waived sperm preparation and analysis product line;"

forward-looking statements regulatory

"This press release contains forward-looking statements that are subject to substantial risks and uncertainties."

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

Offering Details

earnings_snapshot

Offering

Offering Type earnings_snapshot

Understanding 8-K Material Events →

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 UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 31, 2026

Femasys Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-40492	11-3713499
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

3950 Johns Creek Court, Suite 100 Suwanee, Georgia		30024
(Address of principal executive offices)		(Zip Code)

(770) 500-3910

(Registrant’s telephone number, including area code)

n/a

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		FEMY		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Item 2.02 Results of Operations and Financial Condition.

On March 31, 2026 Femasys Inc. (the “Company”) announced its financial results for the year ended December 31, 2025 and provided a corporate update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press Release of Femasys Inc. dated March 31, 2026
104	Cover Page Interactive Data File (embedded within the Inline XBRL Document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Femasys Inc.
	By:	/s/ Kathy Lee-Sepsick
	Names: Kathy Lee-Sepsick
	Title: Chief Executive Officer
Date: March 31, 2026

Exhibit 99.1

Femasys Announces Financial Results for Year Ended December 31, 2025 and Provides Corporate Update

-- Enrollment underway in FDA-authorized FINALE pivotal trial demonstrating execution toward FemBloc^® U.S. approval --

ATLANTA, March 31, 2026 – 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 year ended December 31, 2025 and provides a corporate update.

Corporate Highlights from 4Q 2025 to date

• Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc, advancing toward U.S. approval.

• Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, strengthening leadership and strategic oversight.

• FemBloc permanent birth control system achieved certification under the Medical Device Single Audit Program (MDSAP), supporting global regulatory readiness.

• Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed^® intratubal insemination (ITI), supporting future reimbursement pathway.

• Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed and other products within the portfolio in Switzerland.

• Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment in community-based care.

• Secured FDA 510(k) clearance for the FemVue^® Controlled device, supporting commercialization of an innovative solution for evaluating fallopian tube status.

• Completed $12 million financing, strengthening balance sheet to support ongoing clinical and commercial execution.

• Initiated European post-market surveillance study for FemBloc, advancing real-world evidence generation and commercialization efforts.

“During the fourth quarter of 2025 and into the first quarter of 2026 we achieved significant clinical, regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination product solutions,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “We are actively expanding FemaSeed commercialization in the U.S. with the introduction of the FemSperm^® product family, which enables gynecologists to perform in-office sperm preparation and analysis for use with our first-step infertility treatment. Concurrently, we are advancing FemBloc with the initiation of patient enrollment in the FINALE pivotal clinical trial, a key step toward U.S. FDA approval. We believe we have sufficient cash to fund operations into the third quarter of 2026. We continue to strive to redefine women’s reproductive health by addressing critical gaps with innovative, safe, and technologically advanced solutions.”

Financial Results for Year Ended December 31, 2025

• Sales increased by $664,205, or 40.8%, to $2,293,313 in 2025 from $1,629,108 in 2024, primarily due to sales of FemBloc.

• Research and development expenses decreased by $638,839, or 7.8%, to $7,577,704 in 2025 compared to $8,216,543 in 2024, primarily due to commercialization of development products into inventory, reduced professional fees and compensation costs, partially offset by increased regulatory costs.

• Net loss was $18,627,887, or ($0.47) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2025, compared to a net loss of $18,816,628, or ($0.85) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2024.

• Cash and cash equivalents as of December 31, 2025, was approximately $9.3 million and the Company had an accumulated deficit of approximately $145.8 million. The Company expects, based on its current operating plan, its current cash and cash equivalents, will be sufficient to fund its ongoing operations into the third quarter of 2026.

For more information, please refer to the Company’s Form 10-K filed March 31, 2026, which can be accessed on the SEC website.

FEMASYS INC.

Condensed Balance Sheets

(unaudited)

Assets		December 31, 2025				December 31, 2024
Current assets:
Cash and cash equivalents		$	9,266,353				3,451,761
Accounts receivable, net			616,600				488,373
Inventory			5,740,249				3,046,323
Prepaid and other current assets			833,133				1,035,993
Total current assets			16,456,335				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			3,065,713				2,856,740
Construction in progress			897,885				762,445
			5,698,515				5,336,868
Less accumulated depreciation			(3,802,940	)			(3,740,769	)
Net property and equipment			1,895,575				1,596,099
Long-term assets:
Lease right-of-use assets, net			1,297,121				1,805,543
Intangible assets, net of accumulated amortization			134,914				65,918
Other long-term assets			940,232				954,992
Total long-term assets			2,372,267				2,826,453
Total assets		$	20,724,177				12,445,002

(continued)

FEMASYS INC.

Condensed Balance Sheets

(unaudited)

Liabilities and Stockholders’ Equity		December 31, 2025				December 31, 2024
Current liabilities:
Accounts payable		$	1,830,124				1,419,044
Accrued expenses			1,265,773				1,151,049
Convertible notes payable, net (including related parties)			—				5,406,228
Clinical holdback – current portion			52,644				88,581
Lease liabilities – current portion			487,624				517,967
Total current liabilities			3,636,165				8,582,869
Long-term liabilities:
Clinical holdback – long-term portion			52,370				39,611
Convertible notes payable, net			3,178,864				—
Conversion option liability			2,014,000				—
Warrants liabilities			4,943,000				—
Lease liabilities – long-term portion			1,030,476				1,518,100
Total long-term liabilities			11,218,710				1,557,711
Total liabilities			14,854,875				10,140,580
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par, 200,000,000 authorized, 59,720,010 shares issued and 59,602,787 outstanding as of December 31, 2025; and 23,473,149 shares issued and 23,355,926 outstanding as of December 31, 2024			59,720				23,473
Treasury stock, 117,223 common shares			(60,000	)			(60,000	)
Warrants			5,246,150				1,860,008
Additional paid-in capital			146,449,576				127,679,198
Accumulated deficit			(145,826,144	)			(127,198,257	)
Total stockholders’ equity			5,869,302				2,304,422
Total liabilities and stockholders’ equity		$	20,724,177				12,445,002

FEMASYS INC.

Condensed Statements of Comprehensive Loss

(unaudited)

		December 31, 2025				December 31, 2024
Sales		$	2,293,313				1,629,108
Cost of sales (excluding depreciation expense)			872,400				544,903
Operating expenses:
Research and development			7,577,704				8,216,543
Sales and marketing			4,443,807				4,030,150
General and administrative			6,646,037				6,325,999
Depreciation and amortization			342,034				297,318
Total operating expenses			19,009,582				18,870,010
Loss from operations			(17,588,669	)			(17,785,805	)
Other (expense) income:
Interest income			101,760				582,354
Change in fair value of conversion option liability			503,000				—
Change in fair value of warrants liabilities			731,000				—
Interest expense			(1,891,119	)			(1,603,575	)
Other expense			(482,562	)			—
Total other expense, net			(1,037,921	)			(1,021,221	)
Loss before income taxes			(18,626,590	)			(18,807,026	)
Income tax expense			1,297				9,602
Net loss		$	(18,627,887	)			(18,816,628	)
Net loss attributable to common stockholders, basic and diluted		$	(18,627,887	)			(18,816,628	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.47	)			(0.85	)
Weighted-average common shares and pre-funded warrants outstanding- basic and diluted			39,549,218				22,267,695

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 (ITI), a groundbreaking first-step infertility treatment; FemSperm^®, a CLIA waived sperm preparation and analysis product line; and FemVue^®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rate of 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 ongoing.

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, 2025, when filed, 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

How did Femasys (FEMY) perform financially in 2025?

Femasys grew 2025 sales but remained unprofitable. Sales rose to $2,293,313 from $1,629,108, reflecting expanding commercialization. Net loss was $18,627,887, slightly improved from $18,816,628 in 2024, as operating expenses stayed elevated to support clinical development and commercial activities.

What is Femasys’ cash position and runway as of December 31, 2025?

Femasys ended 2025 with higher liquidity. Cash and cash equivalents were $9,266,353, up from $3,451,761 a year earlier. Management stated they believe this cash is sufficient to fund operations into the third quarter of 2026, supporting ongoing trials and commercialization efforts.

What clinical progress did Femasys (FEMY) report for FemBloc?

Femasys is advancing FemBloc toward potential U.S. approval. The company has begun patient enrollment in the FDA-authorized FINALE pivotal clinical trial. FemBloc, a non-surgical permanent birth control option, already has regulatory approvals in Europe, the UK and New Zealand, with strategic partnerships planned in select European countries.

Which products are central to Femasys’ current commercialization strategy?

Femasys is focused on fertility and non-surgical birth control solutions. Key products include FemaSeed Intratubal Insemination as a first-step infertility treatment, the FemSperm CLIA-waived sperm preparation and analysis line, and FemVue and FemChec diagnostics, alongside the FemBloc non-surgical permanent contraception platform.

How did Femasys’ net loss per share change in 2025?

Net loss per share narrowed year over year. Net loss per share attributable to common stockholders, basic and diluted, was $0.47 for 2025 compared with $0.85 in 2024, reflecting higher weighted-average shares outstanding and modest improvement in total net loss.

What were Femasys’ total assets and equity at year-end 2025?

Femasys’ balance sheet expanded in 2025. Total assets reached $20,724,177 at December 31, 2025, up from $12,445,002 a year earlier. Total stockholders’ equity increased to $5,869,302 from $2,304,422, alongside higher warrants and additional paid-in capital balances.

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 169.6 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.8 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 22.2 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 16.2 KB