Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 189

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 189
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 testing and early clinical trials may not be predictive of success of later clinical trials, and interim results of a particular clinical trial do not necessarily predict final results of that trial. Accordingly, while some of our product candidates have undergone clinical trials and demonstrated positive results, including Ovaprene and Sildenafil Cream, there is no guarantee of successful outcomes in current or future clinical studies of these product candidates or of obtaining marketing approval for any of them. For example, while PCT clinical trials have been used as a surrogate marker for contraceptive effectiveness and our PCT clinical trial of Ovaprene met its primary endpoint, there is no guarantee Ovaprene will demonstrate contraceptive effectiveness in its ongoing pivotal Phase 3 clinical study or demonstrate a level of contraceptive effectiveness that will enable 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 

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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