Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 150

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 150
---
 of first negotiation for specified potential future products of ours, which may increase the complexity and time required, or otherwise inhibit our ability to transfer, license, sublicense, assign, grant or otherwise dispose of any rights in those potential future products to a third party, and lead to delays in their development and commercialization. If we are not successful in attracting collaborators, entering into collaborations on acceptable terms and maintaining our collaborations for the products we develop, we may not complete development of or obtain regulatory approval for such products and product candidates, or if we obtain regulatory approval, commercial launch may be delayed and market penetration could be limited. In such event, our ability to generate revenues from such products and achieve or sustain profitability would be significantly hindered which would materially harm our business and financial condition. Prolonged failure to carry out its responsibilities or underperformance of NICHD under the CRADA, lack of additional federal government funding allocated to the CRADA budget, or termination of the CRADA, may significantly delay or jeopardize the conduct and completion of the ongoing Phase 3 clinical study of Ovaprene and significantly increase the overall development timeline and costs for Ovaprene. The Phase 3 study of Ovaprene is being conducted, in part, under our CRADA with HHS, as represented by NICHD. As a result of the CRADA, the conduct and completion of the study is dependent, in part, on performance of NICHD and the third parties it engages 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. 75