Daré Bioscience to Receive up to $499,000 to Support Preeclampsia Research

SAN DIEGO, Sept. 24, 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 announced it has entered into an agreement with the Gates Foundation under which it will receive up to approximately $499,000 from the Gates Foundation to provide mentorship and project management support for third-party research projects addressing preeclampsia, one of the most serious and underserved complications of pregnancy.

Through this engagement, Daré will provide strategic mentorship, technical guidance, and tailored project management support to Grand Challenges grantee organizations in various geographies worldwide whose pre-clinical research projects are focused on the prevention, diagnosis, and treatment of preeclampsia. Despite its devastating impact—preeclampsia is a leading cause of maternal and infant illness and death globally—there are currently no FDA-approved treatments for this life-threatening condition.

"Preeclampsia remains one of the greatest unmet needs in women's health, with approximately 76,000 moms and 500,000 babies worldwide losing their lives to this condition each year," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "This engagement by the foundation will allow us not only to contribute our expertise to advance the work of global innovators, but also to gain invaluable insights into scientific and real-world challenges in this critical area where no approved therapies currently exist."

The multi-year engagement is designed to strengthen the impact, efficiency, and sustainability of research funded through the Gates Foundation's Grand Challenges initiative to reduce the burden of preeclampsia.

"This engagement underscores Daré's mission to improve the health and well-being of women everywhere by supporting the advancement of potential novel solutions for conditions that have been historically overlooked," added Johnson. "Our participation in this foundation initiative is aligned with our long-term strategy to lead in areas of women's health with great need and limited options."

About Preeclampsia

Preeclampsia is a pregnancy complication characterized by high blood pressure and signs of damage to other organ systems, often the liver and kidneys. It typically occurs after 20 weeks of pregnancy in women whose blood pressure had previously been normal. Globally, preeclampsia is a leading cause of maternal and neonatal morbidity and mortality. There are no FDA-approved treatments specifically indicated to prevent or treat preeclampsia.

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 @DareBioscience. 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," "predict," "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 the potential for Daré to receive up to approximately $499,000 in payments from the Foundation under the new agreement and the potential benefits to Daré in connection with its performance under the agreement in addition to payment from the Foundation. As used in this press release, "first-in-category" is a forward-looking statement relating to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication for which it is being developed because Daré believes it would address a need in women's health that is not being met by existing U.S. Food and Drug Administration (FDA)-approved products. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré's ability to successfully provide the required services and comply with its other obligations under its new agreement with the Foundation, including due to factors outside of its control such as lack of engagement by the grantee organizations; Daré's obligations to relinquish rights to deliverables resulting from its performance of services under the agreement and grant licenses to background materials incorporated into or required to be used with such deliverables to the Foundation and/or the Foundation's grantee organizations; the Foundation's ability to terminate the agreement without cause; Daré's ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; Daré's dependence on grants and other financial awards from governmental entities and the Foundation; Daré's reliance on third parties to execute its business strategy, including to develop products and bring solutions to market, and the risk that those third parties may not perform as expected; the loss of, or inability to attract, key personnel; Daré's ability to adequately protect or enforce its, or its licensor's, intellectual property rights; product liability claims; governmental investigations or actions relating to Daré's products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré's ability to raise additional capital or on Daré's operations, financial results and condition, and ability to achieve current plans and objectives; Daré's ability to maintain compliance with Nasdaq's continued listing requirements and continue to have its common stock listed on The Nasdaq Capital Market; cybersecurity incidents or similar events that compromise Daré's technology systems or those of third parties on which it relies and/or significantly disrupt Daré's business; and disputes or other developments concerning Daré's intellectual property rights. Daré's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré's risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré's recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts:

Daré Bioscience Investor Relations

[email protected]

Source: Daré Bioscience, Inc.