Company: DAWN
Filing Date: 2025-11-04
Form Type: 10-Q
Source: 0001193125-25-264649
Chunk: 19

Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-11-04
Form: 10-Q
Item: Item 3
Chunk 19
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 or (iii) whether each specific BRAF mutation targeted will be included in the approved drug labeling. If our strategies for patient identification and enrollment prove unsuccessful, we may have difficulty enrolling or maintaining patients appropriate for our product candidates. Patient enrollment is also affected by other factors, including: •severity of the disease under investigation; •our ability to recruit clinical trial investigators of appropriate competencies and experience; •the incidence and prevalence of our target indications; •clinicians’ and patients’ awareness of, and perceptions as to, the potential advantages and risks of our product candidates in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating;•the availability and capacity of clinical researchers to conduct our clinical trials;•the availability, expertise and selection of contract research organizations, or CROs, to manage operations related to clinical trial enrollment;•competing studies or trials with similar eligibility criteria; •any invasive procedures that may be required to enroll patients and to obtain evidence of the product candidate’s performance during the clinical trial; •availability and efficacy of approved medications for the disease under investigation;

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•ongoing shortages of chemotherapy standard of care, which may be used in the control arm of certain of our clinical trials, including FIREFLY-2; •eligibility criteria defined in the protocol for the trial in question; •the size and nature of the patient population required for analysis of the trial’s primary endpoints; •efforts to facilitate timely enrollment in clinical trials; •whether we are subject to a partial or full clinical hold on any of our clinical trials; •reluctance of physicians or patient advocacy organizations to encourage patient participation in clinical trials; •the ability to monitor patients adequately during and after treatment; •our ability to obtain and maintain patient consents; and •proximity and availability of clinical trial sites for prospective patients. In addition, the conditions for which we currently plan to evaluate our product candidates are orphan or rare diseases with limited patient pools from which to draw for clinical trials. The eligibility criteria of our clinical trials, once established, will further limit the pool of available trial participants. Further, some of our competitors currently have ongoing clinical trials for product candidates that would treat the same patients as our clinical product candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates. Moreover, if any of our competitors receive FDA approval for a product, it may limit our ability to enroll patients in our clinical trials if they decide to seek