Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 72

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 72
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 date, these developments have not materially impacted the study, however, if NICHD is unable to enter into new contracts or contract modifications with CCTN sites for a prolonged period, or terminates its contracts with CCTN sites in our study before the study follow-up visits with existing participants are completed or before the study is completed, we may determine to contract directly with those sites to enable them to restart recruitment and enrollment of new participants and/or ensure they remain active sites to continue follow-up with existing participants, which could increase the time and cost to us to complete the study. There is a high level of uncertainty relating to U.S. government contracts and funding and regulation of research and development, as well as the functioning and funding of many federal government departments and agencies in general, and future developments may significantly delay or jeopardize the completion of the Phase 3 study and significantly increase the cost of the study to us. Further, depending on the duration of the enrollment period and number of subjects enrolled in the Phase 3 study, there may be future costs associated with the study that are not reflected in the current budget under the CRADA for the CCTN sites. We and NICHD have been in discussions regarding the CRADA, which are continuing and which may include discussing a mechanism to potentially provide for additional future payments by us in support of the Phase 3 study for the CCTN sites to complete subjects already enrolled, in the event that the currently budgeted CRADA funds are insufficient. As discussed above, we have contracted directly with five new study sites, which began recruiting in the 

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first quarter of 2025, with the support of grant funding we received from the Foundation. At this time, due to the uncertainty regarding the CCTN sites and because the five new study sites only recently began participant recruitment, we cannot reasonably predict the enrollment rate for the remainder of the study or an estimated time for completion of enrollment. 

We are collaborating with ADVA-Tec, Inc., or ADVA-Tec, and Bayer HealthCare LLC, or Bayer, for the development and commercialization of Ovaprene as part of two strategic collaborations announced in March 2017 and January 2020, respectively.  See "Strategic Agreements for Pipeline Development" and "Strategic Agreements for Product Commercialization" below for discussion of the terms of each collaboration. 

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