Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 64

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 64
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, IUDs, implantable rods and injectables. In addition, multiple new methods of pregnancy prevention are in development, including hormone-free options, and some may be marketed in the U.S. before Ovaprene, potentially adding to the level of market competition Ovaprene will face, if approved. Currently, there are no FDA-approved therapies for FSAD. Sildenafil Cream has the potential to be the first FDA-approved product for the treatment of FSAD. However, Sildenafil Cream, if approved, may compete directly with compounded drugs available in the market, including those from outsourcing facilities that compound topical cream formulations of sildenafil citrate, the active ingredient in Sildenafil Cream. In addition, some compounding entities have partnered with telemedicine providers, enabling them to expand the potential market for their compounded drugs. The availability of other sildenafil products, could potentially make it more challenging for Sildenafil Cream to build and maintain market share. If we are successful in bringing our proprietary Sildenafil Cream formulation to market under Section 503B of the FDCA, it would compete directly with other topical cream formulations of sildenafil citrate provided by compounding entities described above. However, our proprietary Sildenafil Cream formulation, as of the filing date of this report, to our knowledge, would be the only compounded form of sildenafil citrate that has completed toxicology studies and Phase 1, and Phase 2 human clinical studies. DARE-HRT1, if approved as a treatment for moderate to severe VMS due to menopause, will compete with the many products on the market targeted to or FDA-approved for the treatment of menopausal symptoms, including VMS. Such products include hormone therapies in the form of pills, patches and creams, some of which are FDA- approved products and others which are supplied by compounding entities, as well as non-hormonal products, including an FDA-approved medication (Veozah® (fezolinetant)) and dietary supplements. Both the supplement and the compounded hormone therapy markets are very significant. A considerable segment of the compounded hormone therapy market is comprised of compounded hormones in pellet form that are implanted under the skin as a non-daily alternative, which could be directly competitive with DARE-HRT. In addition, we are aware of non-hormonal drug products in development for the treatment of VMS, including elinzanetant, a dual neurokinin-1 and 3 (NK-1 and NK-3) receptor antagonist, for which Bayer submitted an NDA in August