Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 207

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 207
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 to assist in the conduct of the study. Twenty clinical research sites from within the CCTN were initiated to enroll participants in the study. Currently, there are 15 active CCTN sites following enrolled participants in the study, but none are recruiting new participants. Enrollment is currently proceeding at five study sites outside of the CCTN that were initiated in 2025, funded by a grant we received in 2024 from the Foundation. Under the CRADA, NICHD, together with its selected CRO, is responsible for overseeing the clinical investigators in the conduct of the study at the CCTN sites, providing clinical site monitoring and quality assurance and performing data analysis, which are key factors to the successful completion of a clinical trial. We do not control those third parties and they may not perform as expected. For example, in 2024 there was slower than expected participant recruitment and enrollment at a number of the CCTN sites, leading to a decision by us and NICHD to proceed with recruitment at a subset of ten of the CCTN sites that had been initiated.

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In the first quarter of 2025, executive orders and other actions taken by the new U.S. presidential administration have negatively impacted the Phase 3 study and NICHD’s ability to carry out its responsibilities under the CRADA. In particular, the NICHD process to enter into contract modifications with the CCTN sites participating in the study in the same manner as it would ordinarily do to provide additional funding to those sites within the current budget under the CRADA has been impacted and remains uncertain. As a result, to help ensure CCTN sites remain active for continued follow-up with existing study participants, we and NICHD agreed to pause recruitment of new participants at all CCTN sites. Depending on its duration, this pause in recruitment at the CCTN sites could adversely impact the overall enrollment rate for the study and increase the time and cost to us to complete the study. In addition, most of the CCTN sites participating in the study are part of colleges or universities, and the federal government recently has terminated or threatened to terminate grants and contracts with colleges and universities, including clinical study contracts with at least one university that is a CCTN site in our study. 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