Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 151

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 151
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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 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. 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. In addition, if CCTN sites are closed, some participants may drop out of the study, which could adversely affect completion or results of the study. Though the CRADA has a five-year term ending in 2026, either party may terminate it for any reason or for no reason upon 30 days’ prior written notice to