Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 233

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 233
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 be significant future effects on the women's health sector and the pharmaceutical and biopharmaceutical industries as a result of federal policy and regulatory changes under the new U.S. presidential administration, including in areas relating to regulatory framework and oversight, research and development funding, drug pricing reform, global trade policy and tariffs, and others. We continue to monitor these developments, which could result in new opportunities as well as challenges. The potential effects of these changes on our business could be significant. Our business strategy has included seeking non-dilutive sources of funding and collaborations to support product development, and we have received federal government grants and awards in support of several of our development programs. Our pivotal Phase 3 study of Ovaprene and our DARE-HPV program are being significantly supported by federal government funding. Our pivotal Phase 3 study of Ovaprene is being conducted, in part, under our CRADA with NICHD, and advancement of our DARE-HPV program is being supported by federal government funding under our October 2024 subaward agreement with VentureWell and a December 2024 grant award from NIAID. Our subaward agreement will automatically terminate if the prime agreement from which the federal government funding flows is terminated and may be terminated for convenience by VentureWell if the prime agreement is materially changed in a way that would materially adversely affect VentureWell financially and, if so terminated, we would be paid only for milestones achieved up to the date of termination. As discussed in ITEM 1. "BUSINESS– Our Pipeline: Clinical-Stage Programs– Ovaprene®– Pivotal Phase 3 Clinical Study" in Part I of this report, executive orders and other actions taken by the U.S. presidential administration in the first quarter of 2025 have negatively impacted the Phase 3 study and NICHD's ability to carry out its responsibilities under the CRADA, and future developments, including relating to executive orders issued in January 2025, could have a material adverse impact on the study. Given the high level of uncertainty regarding federal policy and enforcement and regulatory changes under the new U.S. presidential administration and that circumstances are rapidly evolving, including as a result of legal challenges to federal government actions, we are not able to reasonably predict the potential impact on our business at this time. Reverse Stock Split On July 1, 2024, we effected a 1-for-12 reverse split of our issued common stock. At the effective time of the reverse stock split, every 12 shares of our common