Company: DAWN
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0000950170-25-064436
Chunk: 1

Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-05-06
Form: 10-Q
Item: Item 1A
Chunk 1
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 involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials. OJEMDA and our product candidates may not have favorable results in later clinical trials, if any, or receive marketing authorization. If we fail to demonstrate the safety and effectiveness of our product candidates, our reputation may be harmed and our business will suffer.

•We may rely on data from investigator-initiated studies, as we did for the Phase 1 clinical trial, and we do not control the trial operations or reporting of the results of such trials. 

•The development and commercialization of pharmaceutical products are subject to extensive regulation, and we may not obtain marketing authorizations for DAY301, the VRK1 inhibitor program or any future product candidates, on a timely basis or at all. 

•The manufacture of pharmaceutical products, including OJEMDA and our product candidates, including DAY301 and the VRK1 inhibitor program, is complex. Our third-party manufacturers may encounter difficulties in production, which could delay or entirely halt their ability to supply our product candidates for clinical trials or, if approved, our products for commercial sale. 

•Our future success depends on our ability to retain our executive officers and key employees and to attract, retain and motivate qualified personnel and manage our human capital.