Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 202

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 202
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 to supply chain disruptions or resource constraints or reallocation on the part of our CMOs and raw materials suppliers; • interruptions in U.S. or global shipping that may affect the transport and delivery of raw materials, clinical study materials and commercial product; • imposition of new or increased tariffs, sanctions, import/export controls or other trade policies that significantly increase the costs of the components and raw materials used in the production of XACIATO or our product candidates; • changes in local regulations in response to a public health emergency or other emergency situation that may require changes in the ways our clinical studies are conducted, require us to discontinue a clinical study, or make it more difficult for commercial and medical affairs field teams to call on or otherwise access healthcare providers; • patient delays in seeking or receiving treatment, either due to fear of infection or inaccessibility of healthcare providers; • delays in interactions with the FDA or a foreign regulatory authority necessary to advance clinical development of our product candidates, or delays in their review process and timing of potential approval of our product candidates, including delays in pre-approval manufacturing or clinical study site inspections; • difficulties and delays in establishing or maintaining strategic commercial or development collaborations due to the reallocation of resources or shifting business strategies of collaborators or potential collaborators away from the women’s health market in general or our areas of focus within women’s health in particular; or • disruption and volatility in the financial markets which negatively impacts our access to additional capital or stock price. For example, in March 2020, the COVID-19 pandemic began to impact the global economy. The COVID-19 pandemic disrupted our product development activities and the business activities of third parties on which we rely. The COVID-19 pandemic contributed to a slower than anticipated pace of enrollment of participants in our exploratory Phase 2b RESPOND clinical study of Sildenafil Cream as a result of operational restrictions or closure of certain study sites due to their adherence to governmental guidelines intended to reduce the spread of COVID-19. The COVID-19 pandemic also caused us to prioritize advancement of certain of our development programs over others, or certain development activities within a program over others, due to anticipated or actual difficulties and delays in recruiting clinical study sites and participants and obtaining clinical trial materials and supplies. 102

The strategies we implement designed to mitigate the effects or potential effects on our business of a public health emergency such as the COVID-19 pandemic, a natural or manmade disaster, act of terrorism, war or telecommunications or electrical failure that impacts our facilities or employees or those of third parties