Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 225

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 225
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 still lags behind. We continuously hear from healthcare providers, researchers, and women themselves about the urgent need for access to evidence-based treatment options. Our goal is to fulfill that need by bringing to market as soon as practicable innovative evidence-based treatment 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 - areas in women's health that we believe represent compelling and meaningful market opportunities. The needed medical treatment solutions we aim to bring to market will primarily be available only with a physician’s prescription – either as an FDA-approved product or as a compounded drug under Section 503B of the FDCA. We may also bring to market consumer health products that can be obtained without a physician’s prescription. As discussed in more detail below, we are taking action to utilize 503B compounding to bring our 114

proprietary Sildenafil Cream formulation to market, and we are targeting to make it available in the fourth quarter of 2025. See “—Recent Events—Bringing Sildenafil Cream to Market under Section 503B.” The first FDA-approved product to emerge from our portfolio is XACIATO. We achieved FDA approval of XACIATO three years after acquiring rights to the program. In 2022, we entered into an agreement with Organon, whereby Organon licensed exclusive worldwide rights to develop, manufacture and commercialize XACIATO. Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023 and, in January 2024, Organon announced that XACIATO was available nationwide. As discussed below, to provide funding for the development of the product candidates in our pipeline, in April 2024, we entered into an agreement with XOMA whereby we sold our rights to all royalty and potential milestone payments based on net sales of XACIATO under our agreement with Organon, net of our obligations to certain third parties, until XOMA receives a specified return on its investment, after which we will share equally in the royalty and milestone payments earned on net sales of XACIATO from Organon. Our product pipeline includes diverse programs that target unmet needs in women's health in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause, and aim to expand treatment options, enhance outcomes and improve ease of use for women. We are primarily focused on progressing