Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 65

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 65
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 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 to expand our portfolio, with evidence-based solutions for women’s health as our sole focus. While simultaneously advancing our current portfolio, we intend to continue to identify other important areas of unmet need in women’s health and to explore opportunities to build our portfolio by acquiring or in-licensing new programs or leveraging assets we previously acquired or in-licensed to create new programs that meet our selection criteria.

•Pursue strategic collaborations to fund our business, enhance our development and commercialization capabilities, and/or commercial offerings, optimizing for access in a fiscally responsible manner. With respect to our product candidates, we intend to develop and maintain strategic relationships with commercial-stage companies that are leaders or emerging leaders in women’s health, as well as with other entities, where we believe such collaborations will help fund our business or accelerate or otherwise improve upon our clinical development and regulatory strengths and/or product manufacturing, and commercialization capabilities. With respect to 503B compounding, we intend to develop and maintain relationships with Section 503B-registered outsourcing facilities to help bring our proprietary formulations to market. Examples of strategic collaborations to date include our license agreement with Organon to commercialize XACIATO, and our license agreement with Bayer to commercialize Ovaprene, if approved and the license becomes effective.

•Seek non-dilutive sources of funding to support product development. We intend to advance development of our product candidates through a variety of means, including through non-dilutive funding and potential revenue from 503B compounding. To date, we have received non-dilutive 

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funding from federal government agencies and/or a private foundation to support various aspects of our research and development activities, from preclinical discovery to a Phase 3 clinical study, for eight of our programs. We intend to continue to explore grants and other forms of non-dilutive funding to support development of our product candidates.

XACIATO™

XACIATO (clindamycin phosphate) vaginal gel, a linc