Form 8-K

8-K — FEMASYS INC

Accession: 0001140361-26-043791

Filed: 2026-11-13

Period: 2026-11-13

CIK: 0001339005

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ef20085601_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20085601_ex99-1.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: ef20085601_8k.htm · Sequence: 1

false0001339005NASDAQ00013390052026-11-132026-11-13

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): November 13, 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.

Other Events

On November 13, 2026 Femasys Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2026 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 November 13, 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: November 13, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20085601_ex99-1.htm · Sequence: 2

Exhibit 99.1

Femasys Announces Financial Results for Quarter Ended September 30, 2026 and Provides Corporate Update

-- $30 million private placement supports commercial team build-out to drive U.S. sales growth; Q3 U.S. sales increased slightly despite significant

funding constraints prior to mid-August financing --

ATLANTA, November 13, 2026 – Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator developing transformative fertility and non-surgical permanent birth

control solutions designed to improve the standard of care, expand access, and reduce costs for women worldwide, announces its financial results for the quarter ended September 30, 2026 and provides a corporate update.

Corporate Highlights from 3Q 2026 to date

•

Completed $30 million private placement with potential total proceeds of up to $85 million upon full cash exercise of warrants, to build-out the U.S. commercial team needed to support revenue growth following recent availability of the

FemaSeed® fertility portfolio to OB/GYNs, and to fund the FemBloc® pivotal trial to support U.S. approval.

•

Highlights for the FemaSeed Fertility Portfolio (Diagnostics: FemVue® for her and SpermVueTM for him; first-step treatment: FemaSeed and FemSperm®):

Announced a partnership with both UNC Health and Minnesota Women’s Care to introduce the entire portfolio across its OB/GYN practice locations.

Announced a partnership with CapexMD to expand patient access through financing solutions and SandsRx Pharmacy for medications to support treatment timing.

•

Highlights for FemBloc Permanent Birth Control:

Issuance of patents in the U.S. and key international markets that expand intellectual property protection for the blended polymer component.

Received FDA approval of the modular premarket approval (PMA) submission approach.

Announced the number of actively enrolling sites in the FINALE trial to support U.S. approval doubled to twelve sites.

“We maintained a lean team and tightly managed resources as we prioritized financing from long-term institutional investors. Closing the $30 million in financing in

mid-August 2026 represents an important turning point for Femasys,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “With U.S. fertility rates at historic lows, there is an urgent need to bring treatment to the OB/GYN

office, where women already seek care. Our portfolio enables these physicians to offer a complete pathway from diagnostics through first-step treatment, supported by partnerships that simplify access to patient financing and fertility medications.

Since closing the financing, we have been successfully recruiting commercial professionals with deep OB/GYN expertise and established relationships. Healthcare system partnerships and initial sales achieved with limited resources demonstrate the

commercial potential of our comprehensive fertility portfolio. These results and commercial recruitment progress give us strong confidence that deploying our team in target U.S. territories will broaden adoption and drive revenue growth.”

Financial Results for Quarter Ended September 30, 2026

•

Sales in the U.S.

increased slightly to $347,039 in 2026 from $336,594 in 2025, while overall sales decreased by $324,797, or 44.5%, to $404,597 from $729,394. The overall decline was anticipated and reflects the timing of international FemBloc orders,

consistent with distributors’ customary bulk-ordering practices. Distributors are utilizing existing inventory to support FemBloc post-market studies, with reorders expected after those studies are completed.

•

Research and development expenses increased by $560,905, or 40.6%, to $1,942,927 in 2026 compared to $1,382,022 in 2025, primarily reflecting the transition of development products into inventory to support

commercialization during 2025, and increased clinical costs and compensation costs during 2026.

•

Net loss was $4,564,815, or ($0.53) per basic and diluted share attributable to common stockholders, for the quarter ended September 30, 2026, compared to a net loss of $4,194,821, or ($2.05) per basic and diluted share attributable to

common stockholders, for the quarter ended September 30, 2025.

Financial Results for Nine Months Ended September 30, 2026

•

Sales in the U.S.

increased slightly to $1,038,997 in 2026 from $1,015,168 in 2025, while overall sales decreased by $318,613, or 21.5%, to $1,161,313 from $1,479,926. The overall decline was anticipated and reflects the timing of international FemBloc

orders, consistent with distributors’ customary bulk-ordering practices. Distributors are utilizing existing inventory to support FemBloc post-market studies, with reorders expected after those studies are completed.

•

Research and development expenses decreased by $565,717, or 9.8%, to $5,199,206 in 2026 compared to $5,764,923 in 2025, primarily reflecting lower compensation costs, regulatory fees and outside consultant

costs, partially offset by increased clinical costs and material and development costs.

•

Net loss was $8,187,810, or ($1.59) per basic and diluted share attributable to common stockholders, for the nine months ended September 30, 2026, compared to a net loss of $14,677,582, or ($9.25) per basic and diluted share attributable

to common stockholders, for the nine months ended September 30, 2025.

•

Cash and cash equivalents as of September 30, 2026, were approximately $23.9 million and the Company had an accumulated deficit of approximately $154.0 million.

For more information, please refer to the Company’s Form 10-Q filed November 13, 2026, which can be accessed on the SEC website.

FEMASYS INC.

Condensed Balance Sheets

(unaudited)

Assets

September 30, 2026

December 31,

2025

Current assets:

Cash and cash equivalents

23,913,946

9,266,353

Accounts receivable, net

233,778

616,600

Inventory

6,166,371

5,740,249

Prepaid and other current assets

893,098

833,133

Total current assets

31,207,193

16,456,335

Property and equipment, at cost:

Leasehold improvements

1,238,886

Office equipment

91,610

78,155

Furniture and fixtures

424,586

417,876

Machinery and equipment

3,125,855

3,065,713

Construction in progress

991,124

897,885

5,872,061

5,698,515

Less accumulated depreciation

(3,991,222

)

(3,802,940

)

Net property and equipment

1,880,839

1,895,575

Long-term assets:

Lease right-of-use assets, net

952,796

1,297,121

Intangible assets, net of accumulated amortization

99,902

134,914

Other long-term assets

946,928

940,232

Total long-term assets

1,999,626

2,372,267

Total assets

35,087,658

20,724,177

(continued)

FEMASYS INC.

Condensed Balance Sheets

(unaudited)

Liabilities and Stockholders’ Equity

September 30, 2026

December 31, 2025

Current liabilities:

Accounts payable

$1,958,546

1,830,124

Accrued expenses

855,377

1,265,773

Note payable

292,229

—

Clinical holdback – current portion

29,250

52,644

Operating lease liabilities – current portion

465,960

487,624

Total current liabilities

3,601,362

3,636,165

Long-term liabilities:

Clinical holdback – long-term portion

58,179

52,370

Convertible notes payable, net

3,717,653

3,178,864

Conversion option liability

—

2,014,000

Warrants liabilities

—

4,943,000

Operating lease liabilities – long-term portion

682,302

1,030,476

Total long-term liabilities

4,458,134

11,218,710

Total liabilities

8,059,496

14,854,875

Commitments and contingencies

Stockholders’ equity:

Common stock, $0.001 par, 200,000,000 shares authorized, 8,662,139 shares issued and 8,656,277 shares outstanding as of September 30, 2026; and

2,986,116 shares issued and 2,980,254 shares outstanding as of December 31, 2025

8,662

2,986

Treasury stock, 5,862 common shares

(60,000

)

(60,000

)

Warrants

19,023,695

5,246,150

Additional paid-in capital

162,069,759

146,506,310

Accumulated deficit

(154,013,954

)

(145,826,144

)

Total stockholders’ equity

27,028,162

5,869,302

Total liabilities and stockholders' equity

35,087,658

20,724,177

FEMASYS INC.

Condensed Statements of Operations

(unaudited)

Three Months Ended September 30,

Nine Months Ended September 30,

2026

2025

2026

2025

Sales

404,597

729,394

1,161,313

1,479,926

Cost of sales (excluding depreciation expense)

187,496

293,838

488,538

569,275

Operating expenses:

Research and development

1,942,927

1,382,022

5,199,206

5,764,923

Sales and marketing

943,002

1,143,805

3,552,755

3,037,349

General and administrative

1,704,091

1,477,800

5,418,059

4,817,485

Depreciation and amortization

77,091

85,697

242,172

256,835

Total operating expenses

4,667,111

4,089,324

14,412,192

13,876,592

Loss from operations

(4,450,010

)

(3,653,768

)

(13,739,417

)

(12,965,941

)

Other income (expense):

Interest income

85,610

17,315

155,131

53,488

Change in fair value of Conversion Option liability

—

1,732,413

—

Change in fair value of Warrants liabilities

—

4,228,000

—

Interest expense

(200,415

)

(532,073

)

(563,072

)

(1,483,022

)

Other expense

—

(26,295

)

—

(286,295

)

Total other income (expense), net

(114,805

)

(541,053

)

5,552,472

(1,715,829

)

Loss before income taxes

(4,564,815

)

(4,194,821

)

(8,186,945

)

(14,681,770

)

Income tax expense (benefit)

—

865

(4,188

)

Net loss

(4,564,815

)

(4,194,821

)

(8,187,810

)

(14,677,582

)

Net loss attributable to common stockholders

(4,564,815

)

(4,194,821

)

(8,187,810

)

(14,677,582

)

Basic and diluted loss per share

(0.53

)

(2.05

)

(1.59

)

(9.25

)

Weighted-average common shares and pre-funded warrants outstanding, basic and diluted

8,660,381

2,050,761

5,136,109

1,586,992

About Femasys Inc.

Femasys is a leading biomedical innovator developing transformative fertility and non-surgical permanent birth control solutions designed to improve the standard of care,

expand access, and reduce costs for women worldwide. The Company is focused on commercializing its fertility portfolio, led by FemaSeed® Intratubal Insemination, together with complementary diagnostic and sperm preparation products, in

the U.S. and key international markets. Femasys is also advancing FemBloc®, its non-surgical, in-office permanent birth control solution, toward U.S. FDA approval through the ongoing FINALE pivotal trial (NCT05977751). FemBloc received

regulatory approvals in Europe, the UK and New Zealand in 2025, supporting commercialization through strategic partnerships in select international markets. Femasys’ portfolio is supported by broad intellectual property protection and clinical data

demonstrating favorable safety, encouraging effectiveness results, and high patient and practitioner satisfaction.

Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

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, 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:

IR@femasys.com

Media@femasys.com

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Nov. 13, 2026

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dei_WrittenCommunications

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dei_

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xbrli:booleanItemType

Balance Type:

Period Type:

duration