Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 177

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 177
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, results, costs, and timing of clinical trials and preclinical studies of our product candidates that we are pursuing or may choose to pursue in the future; 

•the cost and timing of manufacturing for clinical supplies of product candidates and, if applicable, commercial product at sufficient scale;

•the cost and timing of regulatory submissions to and the timing and outcome of decisions by the FDA and other regulatory authorities on our applications to commence and advance clinical development of and to market our product candidates; 

•the amount and timing of payments to third parties required under acquisition, in-license and other agreements relating our rights to develop and commercialize our product and product candidates; 

•the cost and timing of commercialization activities we undertake or engage third parties to undertake for any product;

•the amount and timing of future royalty, milestone or other payments, if any, we receive under our licensing agreement with Bayer, any future out-licensing agreement, or the Royalty Purchase Agreements;

•our ability to maintain, and establish new, strategic collaborations relating to the development and/or commercialization of our product and product candidates, and the terms and timing of such arrangements;

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•the extent to which we acquire, in-license, or otherwise invest in new product candidates or technologies and the terms of any such transaction; and 

•the cost and timing of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property rights, and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights. 

Should we add product candidates to our portfolio, should our existing product candidates require testing or other capital-intensive development activities that we do not anticipate, should the duration of our clinical trials be longer than anticipated, should manufacturing and supply be disrupted, or should regulatory approvals be delayed, our cash resources will be further strained. Should our product development efforts succeed, we will need to develop and implement a commercialization plan for each product, which may also require significant resources to create and implement. In addition, the terms of any collaboration agreements for development and/or commercialization of our product and product candidates may significantly impact our need for additional capital. Because of these uncertainties and the other risks and uncertainties discussed in this Risk Factors section, we cannot reasonably estimate the amount funding necessary to successfully complete development of and seek regulatory approval for our product candidates or to commercialize any approved products. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our planned operations.