Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 170

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 170
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 not an affordable option for a significant segment of potential users, the ability to build a commercial market for Sildenafil Cream will be significantly impaired. In addition, FSAD is a condition that impacts women of many ages, including older and elderly populations. We have not yet thoroughly studied the topical or clinical pharmacology of Sildenafil Cream in different patient 85

populations, and sildenafil, the active ingredient in our drug candidate, has not been tested over long periods of time in older or elderly women. Older or elderly women may react differently and adversely to Sildenafil Cream than younger populations. We expect our pivotal Phase 3 clinical trials of Sildenafil Cream will be conducted in a premenopausal population. Therefore, we expect initial FDA approval of Sildenafil Cream, if received, to be limited to premenopausal women. Should Sildenafil Cream not be studied in older or elderly women, or, if studied in those populations, should it show increased risk of adverse reactions, or signs thereof, in older or elderly women during clinical development, the potential market for Sildenafil Cream could be significantly limited, which could have a material adverse impact on the value of this program. The commercial success of DARE-HRT1, if approved for commercial sale, will depend on the availability of alternative products for managing menopause symptoms, concerns about the safety of hormone therapy, and women's preferences, among other factors. DARE-HRT1, if approved as a treatment for moderate to severe VMS due to menopause, will compete with the many options on the market targeted to or FDA-approved for the treatment of menopausal symptoms, including VMS. Such options 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 options, including an FDA-approved product (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 2024,