Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 191

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 191
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•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, macroeconomic factors and events also have the potential to cause or contribute to significant delays in commencement and completion of our clinical trials. Global supply chain disruptions and the subsequent effects thereof may adversely affect the ability of contract manufacturers to manufacture and supply our clinical trial material. Our prospective or contracted clinical trial sites may experience 

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resource constraints, including staffing shortages, stemming from global or regional issues, such as a public health emergency, natural disaster, or worker strike, and become unable to allocate adequate resources to reach agreements necessary to commence our clinical trials at their facilities or, even if agreements are in place, to conduct our clinical trials. For ongoing clinical trials, macroeconomic factors or events, such as a global pandemic, may result in lower than anticipated subject enrollment and completion rates, including because clinical trial sites may temporarily close or reallocate resources away from clinical research, or study participants may withdraw prior to receiving study treatment or discontinue their treatment or follow up visits to avoid medical settings or because they become sick or must care for a sick family member.

Significant clinical trial delays could have a material adverse impact on our financial condition and results of operations by substantially increasing the costs of our development programs. Significant clinical trial delays also could jeopardize our ability to meet obligations under agreements under which we license our rights to our product candidates, allow other companies to bring competitive products to market before we do, shorten any period of market exclusivity we may otherwise have under our patent rights, and weaken our negotiating position in discussions with potential collaborators, any of which could impair our ability to successfully complete development of or commercialize our product candidates, if ultimately approved. Any significant delays in commencement or completion of clinical trials of our product candidates, or the