Company: DARE
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001401914-25-000044
Chunk: 65

Company: Dare Bioscience, Inc.
Filing Date: 2025-08-14
Form: 10-Q
Item: Part I, Item 1
Chunk 65
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 net of our obligations to certain third parties, to XOMA (US) LLC, or XOMA, until XOMA receives a specified return on its investment, after which we will share equally in the royalty and milestone payments earned on net sales of XACIATO from Organon. See Note 3 “Strategic Agreements” and Note 8 “Royalty Purchase Agreements” to the accompanying condensed consolidated financial statements for information regarding our exclusive license agreement with Organon and our royalty purchase agreement with XOMA, respectively.

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) across the five study sites we initiated in the first quarter of 2025 with grant funding we received in November 2024, and to date, we continue to be pleased with the pace of enrollment at those sites. We are evaluating whether to contract directly with additional study sites or aim to complete enrollment in the study with the five currently recruiting 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. We do not expect enrollment will be completed in 2025.

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). In the first quarter of 2025, due to uncertainty regarding the future NICHD budget for the CRADA following U.S. federal policy changes and executive orders, we and NICHD agreed to pause recruitment of new participants at all 15 of the CCTN study sites then following enrolled participants to help ensure the CCTN sites would remain active for continued follow-up with those participants. CCTN sites continue to follow previously enrolled participants who have not completed the study; we do not anticipate they will resume enrolling new participants.

In July 2025, the study’s data safety monitoring board (DSMB), an independent group of experts which evaluates the safety