Company: DAWN
Filing Date: 2025-11-04
Form Type: 10-Q
Source: 0001193125-25-264649
Chunk: 8

Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-11-04
Form: 10-Q
Item: Item 3
Chunk 8
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 product candidates, which would materially harm our business.Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the development and commercialization of OJEMDA and our product candidates. Our business depends entirely on the successful commercialization of OJEMDA and development of our product candidates. We are early in our development efforts for other indications, and our product tovorafenib is currently in a pivotal Phase 3 clinical trial as a potential front-line therapy in pLGG. Our product candidate, DAY301, is in the earlier stages of development and is not approved for sale in any jurisdiction. There can be no assurance that tovorafenib and DAY301 or any future product candidates we develop, if any, will achieve success in their ongoing clinical trials or obtain marketing authorization.

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Our ability to generate future revenue at the levels or timing we expect and achieve profitability depends on several factors, including, but not limited to, our ability to:•successfully market and sell OJEMDA while maintaining full compliance with applicable federal and state laws, rules and regulations;•complete a successful pivotal Phase 3 FIREFLY-2 trial with tovorafenib that achieves a competitive, clinically meaningful and generally well-tolerated target product profile for the front-line treatment of pLGG;•complete a successful Phase 1a/b trial of DAY301;•initiate and successfully complete all safety, pharmacokinetic and other studies required to support Ipsen to 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 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, 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 candidate, DAY301, and continue to maintain a continued acceptable safety profile following marketing authorization, if any;•identify,