Company: DARE
Filing Date: 2025-12-01
Form Type: 8-K
Source: 0001493152-25-025491
Chunk: 3

Company: Dare Bioscience, Inc.
Filing Date: 2025-12-01
Form: 8-K
Item: Item 7.01
Chunk 3
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 to conduct clinical and nonclinical studies and manufacture and supply clinical trial material and commercial product; the
risks that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in
subsequent clinical and/or nonclinical studies of that candidate and that interim data or results from a particular clinical study do
not necessarily predict the final results for that study; the risk that the FDA, other regulatory
authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation
of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires
more clinical or nonclinical studies than Daré anticipates, or that the duration of a study or number of study subjects must be
significantly greater than anticipated; Daré’s ability to raise additional capital when and as needed to execute its business
strategy and continue as a going concern; Daré’s dependence on grants and other financial awards from governmental entities
and the Gates Foundation, or the foundation; the foundation’s ability to modify, suspend, discontinue payment of grant funds or
terminate a grant agreement in certain circumstances largely in the foundation’s discretion; limitations on Daré’s
ability to raise additional capital through sales of its common stock or other equity securities due to restrictions under SEC and Nasdaq
rules and regulations or contractual limitation; Daré’s expanded business strategy to bring to market prescription compounded
drug products and non-prescription consumer health products; Daré’s inexperience, as a company, in and lack of infrastructure
for commercializing products; the degree of market demand and acceptance for the products Daré brings to market; competitive product
launches; Daré’s ability to identify, develop, obtain FDA or foreign regulatory approval for, and commercialize product
candidates and to do so on communicated timelines; failure or delay in starting, conducting or completing clinical trials and the inherent
uncertainty of outcomes of clinical trials; the loss of, or inability to attract, key personnel; Daré’s ability to retain
its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary
obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related
intellectual property related to its products and product candidates; Daré’s ability to adequately protect or enforce its,
or its licensor’s, intellectual property rights; disputes or other developments concerning Daré’s intellectual property
rights;