Daré Bioscience Reports Second Quarter 2025 Financial Results and Provides Corporate Update

DARE to PLAY™ Sildenafil Cream on Track for Q4 2025 Launch via 503B Compounding Pathway; Positioned for Product Revenue Beginning in Q4 2025

Positive Interim DSMB Outcome for Ovaprene® Phase 3 Study Supports Continued EnrollmentMultiple Grant-Funded Programs Advance, Including to Address HPV and Long-Acting ContraceptionFour Commercially Available Solutions for Women on the Horizon

In addition to DARE to PLAY™ Sildenafil Cream, Commercialization of Vaginal Probiotics in the Consumer Health Market Targeted to follow DARE to PLAY Sildenafil Cream availability and Proprietary Monthly Hormone Therapy via 503B Compounding Pathway Targeted for Late 2026

Creates Entry into the Estimated $4.5 Billion Compounded Hormone Therapy Market

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

Q2 2025 Highlights; Near-Term Revenue and Long-Term Value Creation Through Dual-Path Execution:

DARE to PLAY™ Sildenafil Cream: Near-Term Commercial Opportunity

On track for Q4 2025 launch through a 503B outsourcing facility

First phase of direct-to-patient campaign launched in collaboration with Rosy Wellness

Near-term revenue generation opportunity

Sildenafil Cream, 3.6%

Discussions with FDA ongoing regarding endpoint assessment for Phase 3 clinical studies of Sildenafil Cream, 3.6%

Ovaprene®: DSMB Recommendation and Positive Interim Phase 3 Results Highlight Potential of Ovaprene, Investigational Hormone-Free Intravaginal Contraceptive

Interim results support Ovaprene's differentiation as a first-in-category, hormone-free, intravaginal monthly contraceptive

Independent data safety monitoring board (DSMB) reviewed interim safety data and recommended study continuation without modification

No new safety or tolerability concerns and no serious safety concerns were identified

Interim pregnancy rate of women treated in the study was consistent with the Company's expectations based on prior postcoital test study of Ovaprene

Primary endpoint will assess the typical use pregnancy rate over 13 menstrual cycles, or the estimated Pearl Index for Ovaprene

DARE-HPV and DARE-LARC1: Progress in Grant-Funded Women's Health Innovation

DARE-HPV: Currently funded by an ARPA-H award and NIH grant; in development as a novel intravaginal therapy to treat persistent high-risk genital human papillomavirus (HPV) infections in women and reduce risk of cervical disease

DARE-LARC1: Preclinical development expected to be fully funded by a foundation grant; investigational long-acting contraceptive intended to offer multi-year protection with remote pause/resume capability; $6 million grant installment received in July 2025

Ongoing Actions to Make Three Additional Solutions Available Commercially

Two non-prescription vaginal probiotics designed to support vaginal microbiome health, complementary to Daré's prescription offerings; availability targeted to follow DARE to PLAY Sildenafil Cream availability

DARE-HRT1: Proprietary monthly intravaginal ring designed to deliver bio-identical estradiol and progesterone; Daré is pursuing both an FDA approval pathway and a 503B compounding opportunity to accelerate patient access while continuing to generate the data necessary to seek FDA approval and support long-term value creation; 503B compounded solution targeted for late 2026

SAN DIEGO, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a biopharmaceutical company with a sole focus of closing the gap in women's health between promising science and real solutions, today reported financial results for the quarter ended June 30, 2025 and provided a company update.

"Daré is rapidly transitioning its business model by executing on a dual-path strategy designed to unlock both near-term revenue and long-term value," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "With the anticipated launch of DARE to PLAY™ Sildenafil Cream through a 503B outsourcing facility in Q4, followed by other commercialization efforts including DARE-HRT1 and vaginal probiotics, we intend to build a robust commercial foundation. At the same time, we are advancing a differentiated pipeline through development, with grant-funded programs that target unmet needs in contraception, HPV, and pre-term birth. With four potential on-market solutions and a rich clinical pipeline behind them, we believe this is a pivotal time for investors to take a close look at Daré and the growth potential of our portfolio."

Financial Highlights for the Quarter Ended June 30, 2025

Cash Position: As of June 30, 2025, Daré had approximately $5.0 million in cash and cash equivalents, and a working capital deficit of approximately $12.6 million.

Subsequent Capital Raise: After quarter-end, Daré received approximately $17.6 million in net proceeds from sales of its common stock, primarily through its at-the-market offering program, and a $6.0 million grant installment payment. The additional capital significantly strengthens the company's balance sheet, enhancing the company's ability to execute its dual-path strategy.

General and Administrative Expenses: $2.4 million in Q2 2025 compared to $2.5 million in Q2 2024, with the year-over-year change primarily attributable to decreases in personnel costs, stock-based compensation expense, and general corporate overhead, partially offset by an increase in professional services expense.

Research and Development (R&D) Expenses: $1.4 million in Q2 2025 compared to $4.9 million in Q2 2024, reflecting a decrease of 71%, primarily due to an increase in contra R&D expenses (reductions to R&D expenses due to non-dilutive funding awards), as well as decreases in manufacturing costs related to Ovaprene and development costs related to Sildenafil Cream, 3.6%, partially offset by increases in costs related development activities for other clinical- and preclinical-stage R&D programs, including DARE-HPV and DARE-LARC1.

References to Section 503B, 503B, Section 503B compounding, 503B compounding pathway, 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 encourages investors to review the more detailed discussion of its financial condition, results of operations, liquidity, capital resources, and risk factors included in its Form 10-Q for the quarter ended June 30, 2025, filed today with the U.S. Securities and Exchange Commission (SEC).

Conference Call

Daré will host a conference call and live webcast today, August 14, 2025, at 4:30 p.m. Eastern Time to review its financial results for the quarter ended June 30, 2025 and to provide a company update.

To access the conference call via phone, dial (646) 307-1963 or (800) 715-9871 (toll free). The conference ID number for the call is 2684883. The live webcast can be accessed under "Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived under the same section of the company's website and available for replay until August 28, 2025.

About Daré Bioscience

Daré Bioscience is a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. Daré believes that innovation does not have to start from scratch. The company's goal is to bring to market as soon as practicable innovative evidence-based solutions that address decades of unmet needs in women's health and enhance outcomes and convenience, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. The potential products Daré identifies, in many cases, already have clinical proof of concept or existing safety data for the active ingredient that the company leverages. This provides optionality and flexibility, in many cases, in how Daré seeks to bring solutions to market in ways designed to optimize access for women in a fiscally responsible manner.

The first FDA-approved product to emerge from Daré's portfolio of women's health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré's portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil citrate, the active ingredient in an oral erectile dysfunction drug for men, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Daré's full portfolio of women's health product candidates and mission to deliver differentiated therapies for women, please visit www.darebioscience.com. 

Daré Bioscience leadership has been named on the Medicine Maker's Power List and Endpoints News' Women in Biopharma and Daré's CEO has been honored as one of Fierce Pharma's Most Influential People in Biopharma for Daré's contributions to innovation and advocacy in the women's health space.

Daré may announce material information about its finances, products and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, products and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré's website.

Forward-Looking Statements

Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "positioned," "pursue," "seek," "should," "would," "contemplate," "project," "target," "objective," "on track," or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Daré's go-to-market strategies; Daré's ...