Form 8-K

8-K — FEMASYS INC

Accession: 0001140361-26-012346

Filed: 2026-03-31

Period: 2026-03-31

CIK: 0001339005

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ef20069346_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20069346_ex99-1.htm)

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8-K

8-K (Primary)

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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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20069346_ex99-1.htm · Sequence: 2

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

Office equipment

78,155

60,921

Furniture and fixtures

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

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