Company: BOLT
Filing Date: 2025-03-24
Form Type: 10-K
Source: 0000950170-25-043873
Chunk: 69

Company: Bolt Biotherapeutics, Inc.
Filing Date: 2025-03-24
Form: 10-K
Item: Item 1A
Chunk 69
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 for any of our product candidates, we may not achieve market acceptance, which would limit the revenue that we can generate from sales of any of our approved product candidates. 

Even if the FDA approves the marketing of any product candidates that we develop, physicians, patients, third-party payors or the medical community may not accept or use them. Efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may not be successful. Market acceptance of our product candidates, if any are approved, will depend on a number of factors, including, among others: 

•the ability of our product candidates to treat cancer, as compared with other available drugs, treatments or therapies; 

•the prevalence and severity of any adverse side effects associated with our product candidates; 

•limitations or warnings contained in the labeling approved for our product candidates by the FDA; 

•availability of alternative treatments; 

•the size of the target patient population, and the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; 

•the strength of marketing and distribution support and timing of market introduction of competitive products; 

•publicity for our product candidates and competing products and treatments; 

•pricing and cost effectiveness; 

•the effectiveness of our sales and marketing strategies; 

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•our ability to increase awareness of our product candidates through marketing efforts; 

•our ability to obtain sufficient third-party coverage and adequate reimbursement; and 

•the likelihood that the FDA may impose additional requirements that limit the promotion, advertising, distribution or sales of our product candidates. 

The market acceptance of our product candidates also will depend in part on the market acceptance of other immunotherapies for the treatment of cancer. While a number of other cancer immunotherapies have received regulatory approval and are being commercialized, our approach to harnessing ISACs is novel. Adverse events in clinical trials for our product candidates or in clinical trials of others developing similar products and the resulting publicity, as well as any other adverse events in the field of immuno-oncology that may occur in the future, could result in a decrease in demand for any of the product candidates that we may develop. If public perception is influenced by claims that the use of cancer immunotherapies is unsafe, whether related to our therapies or those of our competitors, our products may not be accepted by the general public or the medical community. Future adverse events in immuno-oncology or the biopharmaceutical industry generally