Company: DARE
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001401914-25-000022
Chunk: 55

Company: Dare Bioscience, Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 1
Chunk 55
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 with Organon and our royalty purchase agreement with XOMA, respectively.

28

Recent Events

Product Candidate Updates

Ovaprene® 

Enrollment is ongoing in our pivotal Phase 3 multi-center, single arm, non-comparative clinical study of Ovaprene to evaluate its effectiveness as a contraceptive along with its safety and acceptability (ClinicalTrials.gov ID: NCT06127199). The Phase 3 study is being conducted, in part, under our Cooperative Research and Development Agreement, or CRADA, with the U.S. Department of Health and Human Services (HHS), as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD), part of the U.S. National Institutes of Health (NIH), and within the Contraceptive Clinical Trials Network (CCTN). Recent initiatives of the current U.S. presidential administration have negatively impacted the Phase 3 study and NICHD’s ability to carry out its responsibilities under the CRADA, and the future NICHD budget for the CRADA remains uncertain. 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 has been impacted. As a result, to help ensure the CCTN sites remain active for continued follow-up with existing study participants, we and NICHD agreed to pause recruitment of new participants at the CCTN sites, and we do not anticipate that they will resume enrolling new participants. Currently, there are nine CCTN sites following enrolled participants in the study. However, recruitment is proceeding at the five study sites outside of the CCTN that we contracted directly with and initiated in the first quarter of 2025 with grant funding we received in November 2024, and to date, we have been pleased with the pace of enrollment at those sites. We are evaluating whether to contract directly with up to three additional study sites or aim to complete enrollment in the study with the five new study sites. At this time, due to the foregoing, we cannot reasonably predict the enrollment rate for the remainder of the study or an estimated time for completion of enrollment. However, we continue to anticipate there will be sufficient data on Ovaprene use in the study by the end of the second quarter of 2025 to reach the designated check point for review of interim data by the study’s data safety monitoring board, or DSMB, an independent group of experts which evaluates the safety and