Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 257

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 257
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 mass layoffs and large-scale voluntary departures, in particular at the FDA, NIH, ARPA-H and SEC, could adversely impact our company. For example, if it experiences significant workforce reduction or turnover, the FDA in the future may be unlikely to meet its application review goals or be available for timely interactions regarding our product development plans, which could delay our ability to advance clinical development of our product candidates or obtain marketing approvals. The ability of the FDA to review and approve new product applications or take action with respect to other regulatory matters can be affected by a variety of factors, including funding levels, ability to accept the payment of user fees, ability to hire and retain key personnel, and statutory, regulatory and policy changes. Disruptions at the FDA may delay meetings and other communications with or on-site inspections by agency staff necessary to progress development of our product candidates and may slow the time necessary for acceptance, review and approval of applications to commence clinical studies or to market a new product in the U.S. By way of further example, disruptions at the NIH, including its various institutes and centers, such as NICHD, could delay or prevent providing or processing new grant awards to fund research and development activities and disrupt staff’s work and other activities or funding under active grant/cooperative agreements. As discussed elsewhere in this report, including in this Risk Factors section, changes and disruptions at HHS agencies could result in delays or disruptions to our Phase 3 clinical study of Ovaprene and advancement of our DARE-HPV program. Moreover, reduced funding levels or leadership and policy changes at HHS agencies could negatively impact our ability to obtain additional grant awards or other non-dilutive federal funding opportunities. 

Disruptions at the SEC could prevent or delay SEC staff from performing key functions, including, for example, granting acceleration requests for registration statements, declaring registration statements or amendments thereto effective and providing interpretive guidance or no-action letters. For example, if a federal government shutdown halts non-essential SEC operations for an extended period during which we do not have an effective shelf registration statement, it may negatively impact our ability to raise additional capital through registered offerings of our securities. 

If a prolonged U.S. government shutdown or other event or condition occurs that prevents or significantly delays the FDA, NIH, SEC or other regulatory agencies from hiring and retaining personnel and conducting their regular activities, or if an agency is restructured or experiences a significant reduction in funding, leadership changes, 

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workforce reduction or employee turnover, it could significantly impact the ability of these