Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 230

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 230
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Furthermore, the discovery of significant problems with another intravaginally administered or clindamycin-containing product perceived as comparable to XACIATO, could have an adverse impact on commercialization of XACIATO, including as a result of occurrence of the events described above. For example, XACIATO has not been studied in pregnant or breastfeeding women. Should increased risk of miscarriage or other adverse effects on maternal or fetal outcomes or breastfed infants be observed in future data from market surveillance or clinical trials of XACIATO or other clindamycin products, XACIATO’s commercial potential may be limited and we could become subject to product liability claims and lawsuits.

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The occurrence of any of the circumstances described above could reduce XACIATO’s market acceptance and adversely affect sales of XACIATO in the U.S. and inhibit or delay its development, approval or commercialization outside of the U.S., which could, in turn, have a significant negative impact on potential payments to us under the traditional royalty purchase agreement we entered into with XOMA, as well as our stock price.

If we suffer negative publicity concerning the safety or efficacy of XACIATO or the product candidates we develop, our reputation could be harmed, product sales could be adversely affected or we may be forced to cease or curtail product development efforts.

If concerns should arise about the actual or anticipated clinical outcomes regarding the safety of any of our product candidates, or about adverse event reports on XACIATO, including as a result of safety concerns related to third-party products containing the same or similar active or excipient substances, such concerns could adversely affect the market’s perception of XACIATO and our product candidates. Negative publicity could be time consuming and expensive to address and could  adversely affect potential opportunities with strategic partners or collaborators, lead to a decline in product sales, and negatively impact investor sentiment toward a product or product candidate or our company as a whole, which could lead to a decline in our stock price.

We are and will remain subject to ongoing regulatory requirements even after obtaining regulatory approval for a product candidate.

Even if any of the product candidates we develop are approved by the FDA or a comparable regulatory authority outside of the U.S., as long as we are the holder of the product approval or manufacturer of record with the FDA or other regulatory authority, we will be subject to ongoing regulatory requirements with respect to manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing clinical