Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 8

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 8
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. Our product candidates are in various stages of development, from pre-clinical through a pivotal Phase 3 clinical study. The most advanced product candidates we are developing are: Ovaprene®, an investigational, hormone-free, monthly intravaginal contraceptive currently being evaluated in a pivotal Phase 3 clinical study, whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, for the treatment of female sexual arousal disorder (FSAD); and DARE- HRT1, an intravaginal ring designed to deliver combination menopausal hormone therapy, bio-identical 17β-estradiol and progesterone together, continuously over a 28-day period for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes. As discussed in more detail below, because we believe women should not have to wait for needed medical treatment solutions, we are expanding our business strategy to include 503B compounding as a dual-path approach to bring some of our proprietary formulations to market as soon as practicable while we continue to pursue FDA approval of our product candidates. 503B compounding refers to the production and supply of compounded drugs by 503B-registered outsourcing facilities without patient-specific prescriptions in accordance with Section 503B of the FDCA. We are taking action to utilize 503B compounding to bring our proprietary Sildenafil Cream formulation to market, and we are targeting to make it available in the fourth quarter of 2025. In parallel, we will continue to pursue FDA approval of Sildenafil Cream as a treatment for FSAD. Bringing our proprietary Sildenafil Cream formulation to market via 503B compounding will not impact the regulatory process or commercial opportunity for an FDA-approved Sildenafil Cream product. Rather, if successful, 503B compounding will be a source of revenue from existing assets that is non-dilutive to our stockholders. 4

Our Strategy Our business strategy is to in-license or otherwise acquire the rights to intellectual property and know how that enables us to develop and bring to market differentiated evidence-based solutions that we believe can address unmet needs in women’s health and enhance outcomes and convenience, and that represent compelling and meaningful market opportunities. Certain assets we have in-licensed have existing clinical proof-of-concept data or an established safety profile for the active pharmaceutical ingredient that we seek to leverage. We may pursue regulatory approval of a product candidate through clinical development