Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 173

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 173
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 consequences, including: • modification to the product’s prescribing information, such as the addition of boxed or other warnings, contraindications, or limitations of use; • restrictions on the promotion or marketing of the product; • issuance of “Dear Doctor Letters” or similar communications to health care professionals or the public regarding safety or efficacy concerns; • imposition of post-marketing clinical trial requirements or other post-marketing studies; • product distribution restrictions or other risk management measures, such as a risk evaluation and mitigation strategy, or REMS, which could include elements to assure safe use; • warning or untitled letters; • suspension or withdrawal of marketing approvals; • suspension or termination of ongoing clinical trials, if any; • refusal by regulators to approve pending marketing applications or supplements to approved applications that we submit; • suspension of, or imposition of restrictions on, the operations of our commercial collaborator or any CMO producing commercial supplies of XACIATO, including costly new manufacturing requirements; • costly and time-consuming corrective actions; • voluntary or mandatory product recalls or withdrawals from the market; • significant reputational harm; and • product liability claims and lawsuits. 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. 87

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