Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 146

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 146
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V, DARE-PTB1, DARE-LARC1, DARE-LBT, and activities to aid in the identification and development a novel non-hormonal intravaginal contraceptive candidate, should not provide any assurance that pre- clinical or clinical development supported by that funding will be successful, or, even if we are successful with all specified development activities, that we will be able or will choose to fund the additional development work that will be required to continue to advance the product candidates toward commercialization. Further, the grant agreements or other non-dilutive funding award agreements supporting these development programs generally feature milestone- based payments or, in the case of NIH grants, payments are received in reimbursement of specified activities, and there is no assurance that we will be able to achieve or otherwise demonstrate satisfaction of the specified development and reporting milestones required to receive future payments under the agreements. Additionally, the counterparties to these agreements may modify, suspend, discontinue payment of funds or terminate the agreements in certain circumstances largely in their discretion. Accordingly, we may never receive future payments under these agreements or realize the full potential amount of the grant or other funding award. Risks Related to Our Dependence on Third Parties Our existing product development and commercialization collaborations are important to our business, and future collaborations may also be important to us. If we are unable to maintain any of these collaborations, if these collaborations are not successful, or if we are unable to establish additional strategic collaborations, our business and prospects may be materially harmed. We have limited resources and no internal sales, marketing or distribution capabilities. A key aspect of our strategy is to establish collaborations with third parties, such as large and mid-size pharmaceutical companies and other third parties with the relevant R&D and/or commercial expertise and infrastructure, to help bring our product candidates to market. We currently do not expect to directly market, sell or distribute any of our products that receive regulatory approval, and instead intend to enter into agreements with third parties to market, sell and distribute and provide related support services for those products. For example, we have entered into out-license agreements with third parties for the commercialization of XACIATO and, if approved for commercial sale, Ovaprene. We intend to seek additional strategic collaborations. However, such strategic collaboration opportunities may not be available to us for a variety of reasons. For example, certain potential pharmaceutical company collaborators have announced discontinuation or significant reduction in their research and development efforts in women's health therapeutics. To the extent we do enter into strategic collaborations similar to