Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 187

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 187
---
 be exposed to significant liability and reputational harm. The success of our proprietary Sildenafil Cream formulation produced and distributed under Section 503B will depend to a significant extent upon perceptions of product quality. We could be adversely affected if the formulation is 94

subject to negative publicity. We could also be adversely affected if it or similar products sold by other companies, or any products sold by outsourcing facilities that produce our proprietary Sildenafil Cream formulation, prove to be, or are alleged or asserted to be, harmful to patients. There are a number of factors that could result in the injury or death of a patient who takes a compounded drug, including quality issues, manufacturing or labeling flaws, improper packaging or unanticipated or improper distribution or other uses of the compounded drug, any of which could result from human or other error. Any of these situations could lead to a recall of, or safety alert relating to, the compounded drug. Similarly, to the extent any of the ingredients used to produce a compounded drug have quality or other problems that adversely affect the finished compounded drug, its sales could be adversely affected. Because of our dependence upon perceptions of prescribing physicians and their patients, any adverse publicity associated with illness or other adverse effects resulting from the use or misuse of our proprietary Sildenafil Cream formulation produced and distributed under Section 503B, any similar product sold by other companies, or related to compounded formulations generally, could have a material adverse impact on our reputation, business, and financial condition. Risks Related to Employee Matters and Managing Our Growth We have a relatively small number of employees to manage and operate our business. As of March 28, 2025, we had 23 employees, of which 21 were full-time and two were part-time. Our focus on controlling our cash utilization requires us to manage and operate our business in a highly efficient manner, relying on consultants and other third-party service providers for product development and operational expertise we require, and to limit full-time personnel resources. With a small number of employees, our ability to supervise the service providers we engage, including our CMOs and CROs, may be constrained, which may impact the timing and quality of services we receive. No assurance can be given that we will be able to run our operations or accomplish all of the objectives we otherwise would seek to accomplish with the limited personnel resources we currently have. In addition, due to our small workforce, if multiple employees were to become unable to work for a protracted period for any reason, or if they were to resign at roughly the same time