Company: BOLT
Filing Date: 2025-03-24
Form Type: 10-K
Source: 0000950170-25-043873
Chunk: 54

Company: Bolt Biotherapeutics, Inc.
Filing Date: 2025-03-24
Form: 10-K
Item: Item 1A
Chunk 54
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 the development of BDC-3042, BDC-4182, and our collaborations. We cannot be certain that any of our other product candidates will receive regulatory approval or will be successfully commercialized even if they receive regulatory approval. The research, testing, manufacturing, safety, efficacy, labeling, approval, sale, marketing and distribution of our product candidates are, and will remain, subject to comprehensive regulation by the FDA and similar foreign regulatory authorities. Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate through preclinical studies and clinical trials that the product candidate is safe and effective for use in each target indication. Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. Failure to obtain regulatory approval for our product candidates will prevent us from commercializing and marketing our product candidates, or receiving royalty payments from our collaborators. The success of our product candidates will depend on several additional factors, including:

•completing clinical trials that demonstrate their safety and efficacy; 

•successful initiation of clinical trials; 

•successful patient enrollment in, and completion, of clinical trials; 

•the ability to successfully develop, in-license or otherwise acquire additional targeting agents for our Boltbody ISACs; 

•receiving marketing approvals from applicable regulatory authorities; 

•obtaining, maintaining, protecting and enforcing patent, trade secret and other intellectual property rights and regulatory exclusivity for our product candidates; 

•completing any post-marketing studies required by applicable regulatory authorities; 

•making and maintaining arrangements with third-party manufacturers, or establishing manufacturing capabilities, for both clinical and commercial supplies of our product candidates; 

•establishing sales, marketing and distribution capabilities and successfully launching commercial sales of our products, if and when approved, whether alone or in collaboration with others; 

•the prevalence and severity of adverse events experienced with our product candidates; 

•acceptance of our product candidates by patients, the medical community and third-party payors; 

•a continued acceptable safety profile following approval; 

•obtaining and maintaining healthcare coverage and adequate reimbursement for our product candidates; 

•competing effectively with other cancer therapies, including with respect to the sales and marketing of our product candidates, if approved; and 

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•obtaining licenses to any third-party intellectual property we deem necessary or desirable. 

Many of these factors are beyond our control, including the time needed to adequately complete clinical testing, the regulatory submission process, potential threats to our intellectual