Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 121

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 121
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 to address a preference due to personal or medical reasons among some women and healthcare providers to avoid estrogen and/or treatments with active ingredients that are estrogen-like or can metabolize into estrogen.

Currently, there are no FDA-approved therapies for HPV-related cervical disease. DARE-HPV has the potential to be the first FDA-approved product for the treatment of genital HPV infection in women and/or CIN (also known as cervical dysplasia). Persistent HPV infections can progress to cervical cancer through a series of cervical 

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lesions. Currently, there are no FDA-approved therapeutic treatments for HPV infections and no non-surgical pharmaceutical intervention to treat CIN2+. Surgical procedures are performed to remove late-stage cervical lesions to prevent the development of cervical cancer. We are aware of other product candidates in development to treat HPV-related cervical diseases, including an investigational vaginal insert being developed by Antiva Biosciences as a topical treatment for high-grade cervical intraepithelial neoplasia (HSIL, CIN2+) and for high-risk HPV infection, which currently is being evaluated in two Phase 1/2 clinical trials. These candidates may complete development, achieve FDA approval and be marketed in the U.S. before DARE-HPV, potentially creating direct market competition for DARE-HPV, if approved.  

Over the longer term, our ability, independently or otherwise, to successfully develop, manufacture, market, distribute and sell any approved products, expand their usage, or bring additional new products or compounded drugs to the marketplace will depend on many factors, including, but not limited to, FDA and foreign regulatory agency approval of new products and of new indications for existing products, changes in 503B compounding regulations, whether the drug substances in our proprietary formulations appear and remain on the FDA’s list of bulk drug substances that may be used in 503B compounding, the actual and perceived efficacy and safety of our products or our proprietary formulations made available via 503B compounding (alone and relative to other treatment options), the degree of patent or other protection afforded to particular products, and coverage and reimbursement by third-party payors.

Many other organizations are developing drug products and other therapies intended to treat the same diseases and conditions for which our product candidates are in development, and the success of others may render potential application of our product candidates obsolete or noncompetitive, even prior to completion of its development.

Government Regulation  

Governmental authorities in the U.S., at the federal, state and local level, and other countries extensively regulate the research, development