Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 133

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 133
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 it to compete effectively in the contraceptive market. As another example, while data from our exploratory Phase 2b RESPOND study of Sildenafil Cream allows us to advance Sildenafil Cream into Phase 3 development, the co-primary efficacy endpoints of the Phase 2b study were not met and there is no guarantee that our planned Phase 3 clinical studies, which will have the same co- primary efficacy endpoints used in the Phase 2b study, will be successful. The fact that the active pharmaceutical ingredients in certain of our product candidates, including Sildenafil Cream, received regulatory approval in other formulations and/or for other indications does not guarantee successful development of our product candidates for their proposed intended uses. Clinical trials may never demonstrate sufficient safety and effectiveness to obtain the requisite regulatory approvals for our product candidates. Outcomes of our clinical trials, particularly later-stage clinical trials, including our ongoing Phase 3 study of Ovaprene, may significantly impact our stock price and our business prospects. If interim, preliminary or final results from our clinical studies are not positive, or are perceived by third parties, including the medical community, current and potential collaborators, and the investment community, as not positive, our stock price could decline significantly, our reputation may suffer, and our ability to raise additional capital to continue to operate as a going concern and execute our business strategy could be adversely impacted. If a product candidate fails to demonstrate adequate 66

safety or effectiveness in a clinical study, we may determine to delay, scale back or terminate the program, and we may not realize any return on our investment in the program. Even if we conduct and complete clinical trials for our product candidates, we may not obtain regulatory approval to market and sell any of them on the timelines we anticipate, or at all, which would have a material adverse effect on our business and operations. Delays in the commencement or completion of clinical testing of our product candidates may occur due to any of a number of factors and could result in significantly increased costs and longer timelines and could impact our ability to ever become profitable. Clinical trials of our product candidates may not commence, progress or be completed as expected. Delays could significantly impact our product development costs and timelines, as well as a product candidate’s market potential, if ultimately approved. The timing of initiation, conduct and completion of clinical trials and other development activities for our product candidates may vary dramatically due to factors within and outside of our control and is difficult to predict accurately. We may make statements regarding anticipated timing of clinical development milestones, such as commencement,