Company: DAWN
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0000950170-25-026654
Chunk: 136

Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1A
Chunk 136
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 result of, clinical trials that could delay or prevent receipt of marketing authorization or our ability to successfully commercialize OJEMDA or our product candidates, including: 

•the FDA or other regulators refusing to permit our clinical studies to proceed or placing studies on hold before or after the studies begin;

•a failure to demonstrate that the dose for a product candidate has been optimized;

•failure of our product candidates in clinical trials to demonstrate important functional, quality, or patient-reported outcomes;

•changes in the competitive landscape causing clinical trial enrollment challenges or preventing or delaying marketing authorization in one or several subsets studied in our programs, including in relapsed or front-line pLGG;

•receipt of feedback from regulatory authorities that requires us to modify the design of our clinical trials; 

•negative or inconclusive clinical trial results that may require us to conduct additional clinical trials or abandon certain research and/or drug development programs; 

•the number of patients required for clinical trials being larger than anticipated, enrollment in these clinical trials being slower than anticipated or participants dropping out of these clinical trials at a higher rate than anticipated;

•unanticipated delays in our preclinical studies or clinical trials;

•third-party contractors failing to comply with regulatory requirements, including Good Clinical Practice, or GCP, regulations, or meet their contractual obligations to us in a timely manner, or at all; 

•the suspension or termination of our clinical trials for various reasons, including non-compliance with regulatory requirements or a finding that our product candidates have undesirable side effects or other unexpected characteristics or risks; 

•the cost of clinical trials of our product candidates being greater than anticipated; 

•the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate;

•failure of our clinical trials to demonstrate the safety or effectiveness of our product candidates;

•regulators revising the requirements for approving our product candidates; and 

•receipt of feedback from regulatory authorities that would require us to include data from additional patients or longer term efficacy and safety data.

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We may also face unanticipated regulatory hurdles in our drug development program that may require additional data generation or delay our existing or planned trials and the timing of applications for marketing authorization. For instance, we may make formulation or manufacturing changes to our product candidates, in which case we may need to conduct additional preclinical studies to bridge our modified product candidates to earlier versions. Additionally, the FDA may determine that it has questions or concerns about our trials and may not permit our proposed clinical studies to move forward by imposing