DARE

dare-20260514

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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): May 14, 2026

DARÉ BIOSCIENCE, INC.

(Exact name of registrant as specified in its charter)

Delaware 001-36395 20-4139823

(State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.)

3655 Nobel Drive, Suite 260

San Diego, CA 92122

(Address of Principal Executive Offices and Zip Code)

Registrant’s telephone number, including area code: (858) 926-7655

Not Applicable

(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 Instruction 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 Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered

Common stockDARENasdaq Capital Market

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 2.02Results of Operations and Financial Condition.

On May 14, 2026, Daré Bioscience, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026, a copy of which is furnished as Exhibit 99.1 to this report.

The information in this Item 2.02 and in Exhibit 99.1 to this report is being furnished and shall not be deemed to be “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 such information be deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation by reference language in any such filing, except as the Company expressly sets forth by specific reference in such filing.

Item 9.01Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.Description

99.1 Press release issued on May 14, 2026

104Cover 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.

DARÉ BIOSCIENCE, INC.

Dated: May 14, 2026  By: /s/ Sabrina Martucci Johnson

Name: Sabrina Martucci Johnson

Title: President and Chief Executive Officer

EX-99.1

2 ex99-1.htm

EX-99.1

Exhibit 99.1

FOR

IMMEDIATE RELEASE

March 26, 2026

DARÉ

BIOSCIENCE, INC.

Daré Bioscience Reports Full Year 2025 Financial Results and Provides Business Update

Company Highlights Commercial Launch of DARE to PLAY™ Sildenafil Cream, Pipeline of Women’s Health Solutions, and Multiple Near-Term Potential Catalysts

Conference Call and Webcast Today at 4:30 p.m. ET

SAN DIEGO, CA, March 26, 2026 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today reported financial results for the year ended December 31, 2025, and provided a business update.

“We are not a company that is just getting into women’s health. We are a women’s health biotech company – and we believe 2026 is the year investors will get to see what ten years of that commitment actually looks like. We built the company to change how women experience healthcare. That change is beginning in earnest now,” said Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience.

2025

BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS

DARE

to PLAY™ Sildenafil Cream

DARE

to PLAY is a first-of-its-kind topical sildenafil cream for women. To the company’s knowledge, there is no other sildenafil topical cream manufactured under current Good Manufacturing Practice (cGMP) requirements with clinical data demonstrating increased genital blood flow in 10 to 15 minutes, and improvement in arousal, orgasm, and desire measured by clinically-validated and FDA-reviewed endpoints. An estimated 20 million women in the United States experience challenges related to genital arousal, and there is currently no FDA-approved therapy that directly addresses this need.

While there is not yet an FDA-approved therapy, DARE to PLAY was designed to fill that void. Daré is making DARE to PLAY available as a Section 503B compounded product.1

●In December 2025, prescription intake commenced through the DARE Health Hub powered by Medvantx Pharmacy, the dispensing pharmacy for DARE to PLAY, initially available in a handful of states.

1 Compounded drug products are not approved by the U.S. Food and Drug Administration (FDA). The FDA does not evaluate compounded drug products for safety, effectiveness, or quality. References to Section 503B, 503B, 503B compounding, 503B compounded product, and similar terms refer to Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) and the production and supply of compounded drugs by Section 503B-registered outsourcing facilities without patient-specific prescriptions in accordance with Section 503B.

Daré Bioscience, Inc. | NASDAQ: DARE | darebioscience.com | Page 1

●Pre-fulfillment prescribing expanded nationally: as of February 11, 2026, DARE to PLAY is available for pre-fulfillment prescriptions in all 50 states.

●Telehealth access launched on February 11, 2026, enabling women in most states to receive a DARE to PLAY prescription, if it’s appropriate for them, from a licensed clinician without an in-person office visit.

●Women are already finding their way to the DARE Health Hub, working through the telehealth process, and providers are already submitting prescriptions. The company expects dispensing to begin in the coming months, with product revenue expected to begin in Q2 2026.

●Clinical differentiation: Every custom Rx pharmacy compounded prescription sildenafil cream on the market may have been formulated to fulfill a prescription for women, but, to Daré’s knowledge, none was ever studied in women to evaluate whether or how it works in female physiology. To Daré’s knowledge, DARE to PLAY is the only clinically studied formulation — demonstrated to increase genital blood flow within approximately 10 minutes of application and manufactured in accordance with FDA’s cGMP regulations, which better ensure consistent potency and quality of product.

●Dual-path strategy: While Daré is making DARE to PLAY available as a 503B compounded product, the company is simultaneously working to advance its sildenafil cream formulation toward the 505(b)(2) NDA pathway.2

●Asset-light commercial model: The company’s 503B commercial model is digitally native, built around targeted digital awareness campaigns, telehealth access through the DARE Health Hub, and Medvantx fulfillment infrastructure. As the commercial channel matures, Daré will look to add strategic partnerships with additional telehealth platforms, platform distributors, and clinical networks.

DARE

to RESTORE™ — Vaginal Health Consumer Products

Daré is building the DARE to RESTORE brand family of consumer health products designed to support vaginal microbiome balance. The company’s first DARE to RESTORE product, Flora Sync LF5™ — a vaginal probiotic suppository developed by Probiotical, one of the world’s leading probiotic research companies — is expected to become commercially available in

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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): November 13, 2025

DARE BIOSCIENCE,

INC.

DARÉ

BIOSCIENCE, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-36395

20-4139823

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S.

Employer

Identification No.)

3655 Nobel Drive, Suite 260

San Diego, CA 92122

(Address of Principal Executive Offices and Zip Code)

Registrant’s telephone number, including area code: (858) 926-7655

Not Applicable

(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 Instruction 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 Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock

DARE

Nasdaq Capital Market

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 November 13, 2025, Daré Bioscience, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2025, a copy of which is furnished as Exhibit 99.1 to this report.

The information in this Item 2.02 and in Exhibit 99.1 to this report is being furnished and shall not be deemed to be “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 such information be deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation by reference language in any such filing, except as the Company expressly sets forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press release issued on November 13, 2025

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.

DARÉ

BIOSCIENCE, INC.

Dated: November 13, 2025 By: /s/ Sabrina Martucci Johnson

Name: Sabrina Martucci Johnson

Title: President and Chief Executive Officer