Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 134

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 134
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 completion of enrollment, and/or availability of results from our clinical studies, but those statements are predictions based on significant assumptions and the actual timing of achievement of development milestones may differ materially from our predictions for a variety of reasons. The commencement of clinical trials of our product candidates can be delayed for many reasons, including: • lack of adequate capital and the need to obtain additional funding; • delays in obtaining guidance or authorizations from the FDA or foreign regulatory authorities; • delays in obtaining approval from the institutional review boards, or IRBs, of prospective clinical study sites; • delays in finalizing the trial design as a result of discussions with the FDA, foreign regulatory authorities, prospective clinical trial investigators or IRBs; • delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites; or • inability to obtain sufficient quantities of clinical product supplies from our contract manufacturers and suppliers. Once a clinical trial has begun, it may be delayed, suspended or terminated by us, an IRB, the FDA or other regulatory authorities as a result of the occurrence of any of a number of events or circumstances, including: • lack of adequate capital and the need to obtain additional funding; • failure to conduct the clinical trial in accordance with its protocol or regulatory or IRB requirements; • slower than expected rates of participant recruitment and enrollment; • higher than anticipated participant drop-out rates; • failure of participants to use the investigational product as directed or to report data as per trial protocols; • inspection of the clinical trial operations or clinical trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold; • failure to achieve certain efficacy and/or safety standards; • participants experiencing severe undesirable side effects or other unexpected adverse events; • disruptions in or insufficient supply of clinical trial material or inadequate quality of such materials; • failure of our CROs or other third-party service providers to meet their contractual obligations to us in a timely manner, or at all; or • delays in quality control/quality assurance procedures necessary for study database lock and analysis of unblinded data. Unexpected SAEs or other undesirable side effects could arise during clinical development and interrupt, delay, or cause the termination of clinical trials, and require us to conduct additional clinical and nonclinical studies that were not part of our development plan, which could significantly increase the development costs and timeline for a program and adversely impact its value and our ability to continue product development. These events may also cause our reputation to suffer and subject us to lawsuits. As discussed elsewhere in this Risk Factors section,