Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 190

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 190
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 would have a material adverse effect on our business and operations.

Delays in the commencement or completion of clinical testing of our product candidates may occur due to any of a number of factors and could result in significantly increased costs and longer timelines and could impact our ability to ever become profitable.

Clinical trials of our product candidates may not commence, progress or be completed as expected. Delays could significantly impact our product development costs and timelines, as well as a product candidate’s market potential, if ultimately approved. The timing of initiation, conduct and completion of clinical trials and other development activities for our product candidates may vary dramatically due to factors within and outside of our control and is difficult to predict accurately. We may make statements regarding anticipated timing of clinical development milestones, such as commencement, 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;