Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 171

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 171
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 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 and health care providers over treatments prepared in compounding entities; • the success or failure of other FDA-approved bioidentical hormone products and FDA-approved non- hormonal products for VMS; • new information supportive or against the use of hormones in menopause; and • availability and extent of third-party payor coverage and reimbursement for DARE-HRT1 and out-of- pocket cost for patients. Depending upon the direction of the factors above, a commercial market for DARE-HRT1 may develop more slowly than expected, or not at all, and our business, financial condition, results of operation and prospects could be hurt as a result. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses for prescription medical products. If we or any commercial collaborator is found or alleged to have improperly promoted any of our products for off-label uses, we may become subject to significant liability, including fines, penalties or injunctions, and reputational harm. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription medical products. In particular, a product may not be promoted for uses that are not approved by the FDA (i.e., off-label uses), as reflected in the product’s approved or cleared labeling. Promotional labeling and advertising for