Company: DAWN
Filing Date: 2025-11-04
Form Type: 10-Q
Source: 0001193125-25-264649
Chunk: 11

Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-11-04
Form: 10-Q
Item: Item 3
Chunk 11
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 many factors, including: •the progress, timing and results of preclinical studies and clinical trials for our current or any future product candidates; •the extent to which we develop, in-license or acquire other pipeline product candidates or technologies; •the number and development requirements of current or future product candidates that we may pursue, and other indications for our current product candidates that we may pursue; •the costs, timing and outcome of obtaining marketing authorization for our current or future product candidates or the modification of ongoing or planned clinical trials;•the successful development of and marketing authorization for any complementary or companion diagnostics that may be useful to or necessary for the commercialization of OJEMDA and our product candidates;•the scope and costs of making arrangements with third-party manufacturers, or establishing manufacturing capabilities, for both clinical and commercial supplies of our current or future product candidates; •the costs involved in growing our organization to the size needed to allow for the research, development and potential commercialization of our current or future product candidates; •to the extent we pursue strategic collaborations, including collaborations to commercialize OJEMDA, DAY301 or any of our future pipeline products and product candidates, if any, our ability to establish and maintain collaborations on favorable terms, if at all, as well as the timing and amount of any milestone or royalty payments we are required to make or are eligible to receive under such collaborations or our current licenses; •the cost associated with commercializing any approved products and product candidates, including establishing sales, marketing, market access and distribution capabilities; •the cost associated with completing any post-marketing studies or trials requested or required by the FDA or other regulatory authorities, including for OJEMDA; •the revenue, if any, received from commercial sales of OJEMDA, DAY301 or any of our future product candidates, if approved, or any other future pipeline product candidates that receive marketing authorization; •the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims that we may become subject to, including any litigation costs and the outcome of such litigation; and •the costs associated with potential product liability claims, including the costs associated with obtaining insurance against such claims and with defending against such claims. We may require additional capital to complete our planned clinical development programs for our current product candidates to obtain marketing authorization, and we anticipate needing to raise additional capital to complete the development of our product candidates. 

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Our ability to raise additional funds will depend on financial, economic and market conditions and