Company: DAWN
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0000950170-25-026654
Chunk: 128

Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1A
Chunk 128
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 obtain foreign marketing authorization for OJEMDA as a treatment for patients with pLGGs; 

•initiate and complete additional, successful late-stage clinical trials that meet their clinical endpoints; 

•obtain favorable results from our clinical trials and apply for and obtain marketing authorizations for DAY301 and VRK1 from applicable regulatory authorities, including NDAs from the FDA, and maintaining such approvals; 

•establish licenses, collaborations or strategic partnerships that allow for the commercialization of OJEMDA and our product candidates and/or may increase the value of our programs; 

•successfully commercialize OJEMDA, DAY301, VRK1 and any future product candidates we may develop, if approved, by building and maintaining a sales force and/or entering into collaborations with third parties; 

•satisfy any post-marketing requirements imposed by, or post-marketing commitments made to, applicable regulatory authorities; 

•demonstrate an acceptable safety profile of our product and our product candidates, including DAY301 and VRK1, and continue to maintain a continued acceptable safety profile following marketing authorization, if any;

•identify, assess and develop new product candidates; 

•establish and maintain patent and trade secret protection, statutory exclusivities and other intellectual property protections for our products;

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•obtain, maintain, protect and defend our intellectual property portfolio, including any necessary licenses from third parties;

•address any competing therapies and technological and market developments; 

•achieve market acceptance of our product candidates, including DAY301 and VRK1, if approved, with patients, the medical community and third-party payors, both in the United States and internationally; and 

•attract, hire and retain qualified personnel and management. 

To become and remain profitable, we must succeed in developing and commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing clinical trials for OJEMDA and our product candidates, acquiring additional product candidates, establishing arrangements with third parties for the manufacture of clinical supplies of our product candidates, obtaining marketing authorization for our product candidates, obtaining and retaining patents, trade secrets, statutory exclusivities, and other intellectual property protections and marketing and selling products for which we may obtain marketing authorization, if any. We are in the early stages of most of these activities. We may never succeed in these activities and, even if we do, may never generate revenues that are significant enough to achieve profitability. 

In cases where we are successful in obtaining marketing authorizations to market