Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 200

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 200
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 A federal government shutdown could prevent or delay staff at federal agencies from performing key functions that may adversely affect our business. In addition, considerable uncertainty exists regarding how federal government policy changes and budget decisions will unfold, including the regulatory and spending priorities of the new U.S. presidential administration and Congress, and what challenges potential policy changes and budget reductions will present for us and our industry generally. Measures being implemented by the new U.S. presidential administration are expected to significantly impact federal regulatory agencies, such as by reducing funding to or restructuring such agencies. For example, in the first quarter of 2025, the new U.S. presidential administration began terminating federal government employees and federal agencies were directed to develop plans for large-scale reductions in force and reorganization. As a result, agencies throughout the federal government may experience mass layoffs, as well as a significant number of voluntary departures. The impact of these changes at federal government agencies with which we interact is uncertain at this time, however, 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