Company: DAWN
Filing Date: 2025-08-05
Form Type: 10-Q
Source: 0000950170-25-103012
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Company: Day One Biopharmaceuticals, Inc.
Filing Date: 2025-08-05
Form: 10-Q
Item: Item 1A
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Investing in our common stock involves a high degree of risk. Before making your decision to invest in shares of our common stock, you should carefully consider the risks and uncertainties described below, together with the other information contained in this quarterly report, including our financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. We cannot assure you that any of the events discussed below will not occur. These events could have a material and adverse impact on our business, financial condition, results of operations and prospects. If that were to happen, the trading price of our common stock could decline, and you could lose all or part of your investment. 

Summary of Risk Factors 

Our business is subject to several risks and uncertainties, including those immediately following this summary. Some of these risks are: 

•We are a commercial stage biopharmaceutical company with a limited operating history in the initial stages of the commercialization of our product, OJEMDA, which may make it difficult for investors to evaluate our current business and likelihood of success and viability. 

•We have incurred significant net losses since our inception. We expect to incur continued losses for the foreseeable future and may never achieve or maintain profitability.

•Our near-term revenues are highly dependent on the successful commercialization of OJEMDA, which received marketing approval in April 2024 from the FDA for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. To the extent that OJEMDA is not commercially successful, our business, financial condition and results of operations would be materially and adversely affected and the price of our common stock would decline. 

•Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery or identification, development and commercialization of OJEMDA and our product candidates. 

•We may require additional capital to finance our operations and achieve our goals. If we are unable to raise capital when needed or on terms acceptable to us, we may be forced to delay, reduce or eliminate our research or product development programs, any future commercialization efforts or other operations. 

•Clinical trials are very expensive, time-consuming and difficult to design and implement, and