Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 227

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 227
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 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, and is anticipated to launch in the second half of 2025. We expect the options for hormone therapy to continue to expand with time.  DARE-HRT1 is designed to offer a convenient vaginal ring that continuously delivers a combination of bioidentical estradiol and progesterone over 28 days. Bioidentical hormones refer to compounds that are chemically identical to those produced naturally in the human body. Studies have not demonstrated that bioidentical hormones are safer than synthetic hormones, so DARE-HRT1 will need to compete with many types of hormone therapy options in terms of convenience, safety and efficacy in managing symptoms of menopause.

Risks related to market acceptance of DARE-HRT1 include:

•women's preference for vaginal ring delivery of hormone therapy over pills, patches and creams;

•women's preference for a monthly product format over products to be taken or applied daily;

•data regarding symptom relief of DARE-HRT1 compared with other treatments and products for VMS;

•preference for bioidentical hormones by women and health care providers;

•positive or negative news and research regarding hormone therapy in general and bioidentical hormone therapy in particular;

•preference for an FDA-approved product by women