Company: BOLT
Filing Date: 2025-03-24
Form Type: 10-K
Source: 0000950170-25-043873
Chunk: 49

Company: Bolt Biotherapeutics, Inc.
Filing Date: 2025-03-24
Form: 10-K
Item: Item 1A
Chunk 49
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 may not be as accurate as they could be if we had a history of successfully developing and commercializing biopharmaceutical products. 

Since inception in 2015, we have not generated any product revenue and have incurred significant operating losses. Our net losses were $63.1 million and $69.2 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an accumulated deficit of $427.4 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. It could be at least several years, if ever, before we have product revenue from a commercialized drug. The net losses we incur may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially if, and as, we: 

•continue to advance our research and preclinical and clinical development of our product candidates; 

•expand and initiate further clinical trials for our product candidates; 

•seek to identify additional product candidates; 

•seek marketing approvals for our product candidates that successfully complete clinical trials, if any; 

•establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; 

•maintain, expand, protect and enforce our intellectual property portfolio and obtain licenses to third-party intellectual property; 

•attract, hire and retain additional administrative, clinical, regulatory and scientific personnel; 

•enter into third-party relationships for clinical trials, manufacturing and supply; and 

•incur additional legal, accounting and other expenses in operating our business, including the additional costs associated with operating as a public company. 

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In addition, because of the numerous risks and uncertainties associated with pharmaceutical products and development, we are unable to accurately predict the timing or amount of increased expenses and when, or if, we will be able to achieve profitability. Our expenses could increase and profitability could be further delayed if we decide to or are required by the FDA or other regulatory authorities such as the European Medicines Agency, or EMA, or the U.K. Medicines & Healthcare Products Regulatory Agency, or MHRA, to perform studies or trials in addition to those currently expected, or if there are any delays in the development or completion of any planned or future preclinical studies or clinical trials of our current and future product candidates. Even if we complete the development and regulatory processes described above, we anticipate incurring significant costs associated with launching and commercializing our current