Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 9

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 9
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 or, if the active pharmaceutical ingredient is on the FDA’s list of bulk drug substances for which there is a clinical need, we may seek to bring it to market under Section 503B of the FDCA. In certain circumstances, as discussed in more detail below with respect to our proprietary Sildenafil Cream formulation, we may pursue both pathways. We believe having alternative pathways allows us to bring solutions to market as soon as practicable and optimizes access for women in a fiscally responsible manner. We are primarily focused on progressing the development and achieving commercialization of our existing portfolio of product candidates. However, we also explore opportunities to expand our portfolio through both business development activities that may result in acquiring, or acquiring access to, new intellectual property rights and know how through in-licensing or other collaborative arrangements, and leveraging platform technology assets we previously acquired or in-licensed from third parties that can be modified with different active pharmaceutical ingredients to address multiple indications. As with our current portfolio, we seek innovations in women’s health that have (a) attractive market opportunities with the potential to address an unmet need, including through new formulations, manners of application or delivery methods of well-known drug substances that result in novel product candidates customized for women, (b) human proof-of-concept clinical data previously generated by third parties, (c) potential to utilize the FDA's 505(b)(2) pathway, and/or (d) potential to become a first-in-category or first-line product. We consider a candidate to have potential to become a “first-in-category” product when we believe that, if the candidate were to successfully complete clinical development and receive marketing approval for the use for which it is being developed, or for which we anticipate developing it, the product would address a need in women’s health that is not being met by existing FDA-approved products. Key elements of our business strategy are as follows: • Accelerate innovation in women’s health and bring our proprietary formulations and other assets to market as soon as practicable utilizing all available pathways for the asset, including as a compounded drug under Section 503B of the FDCA, as an FDA-approved product, or as a consumer health product that does not require a physician’s prescription. • Advance clinical development of the product candidates in our portfolio through mid- to late-stage clinical development or regulatory approval. In 2024, we continued to make important progress in the clinical development of our product candidates, including with ongoing enrollment in the pivotal Phase 3 study of Ovaprene. • Explore opportunities