Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 5

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 5
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)(2) pathway; • Unfavorable differences between preliminary, interim or topline clinical study data reported by us and final study results; • Communication from the FDA or another regulatory authority, including a complete response letter, that such agency does not accept or agree with our assumptions, estimates, calculations, conclusions or analyses of clinical or nonclinical study data regarding a product candidate, or that such agency interprets or weighs the importance of study data differently than we have in a manner that negatively impacts the candidate's prospects for regulatory approval in a timely manner, or at all; • Failure to select product candidates that capitalize on the most scientifically, clinically or commercially promising or profitable indications or therapeutic areas within women's health including due to our limited financial resources; • Loss or impairment of our in-licensed rights to develop and commercialize XACIATO and our product candidates; • The timing and amount of our payment and other obligations under our in-license and acquisition agreements for XACIATO and our product candidates; • Developments by our competitors that make XACIATO, or any potential product we develop, less competitive or obsolete; • Unfavorable or unanticipated macroeconomic factors, geopolitical events or conflicts, public health emergencies, or natural disasters; • Weak interest in women's health relative to other healthcare sectors from the investment community or from pharmaceutical companies and other potential development and commercialization collaborators; • Cyber-attacks, security breaches or similar events compromising our technology systems and data, our financial resources and other assets, or the technology systems and data of third parties on which we rely; • Difficulty in introducing branded products in a market made up of generic products; • Inability to adequately protect or enforce our, or our licensor’s, intellectual property rights; • Lack of patent protection for the active ingredients in XACIATO and certain of our product candidates that expose them to competition from other formulations using the same active ingredients; • Higher risk of failure associated with product candidates in preclinical stages of development that may lead investors to assign them little to no value and make these assets difficult to fund; 2

• Dependence on grants and other financial awards from governmental entities and private foundations to advance the development of several of our product candidates; • Disputes or other developments concerning our intellectual property rights; • Actual and anticipated fluctuations in our quarterly or annual operating results or results that differ from investors' expectations for such results; • Price and volume fluctuations in the stock market, and in our stock in particular, which could cause investors to experience losses and subject