Company: BOLT
Filing Date: 2025-03-24
Form Type: 10-K
Source: 0000950170-25-043873
Chunk: 62

Company: Bolt Biotherapeutics, Inc.
Filing Date: 2025-03-24
Form: 10-K
Item: Item 1A
Chunk 62
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 side effects. If one or more of our product candidates receives regulatory approval, and we, or others, later discover that they are less effective than previously believed, or cause undesirable side effects, a number of potentially significant negative consequences could result, including: 

•withdrawal or limitation by regulatory authorities of approvals of such product; 

•seizure of the product by regulatory authorities; 

•recall of the product; 

•restrictions on the marketing of the product or the manufacturing process for any component thereof; 

•requirement by regulatory authorities of additional warnings on the label, such as a “black box” warning or contraindication; 

•requirement that we implement a REMS or create a medication guide outlining the risks of such side effects for distribution to patients; 

•commitment to expensive additional safety studies prior to approval or post-marketing studies required by regulatory authorities of such product; 

•the product may become less competitive; 

•initiation of regulatory investigations and government enforcement actions; 

•initiation of legal action against us to hold us liable for harm caused to patients; and 

•harm to our reputation and resulting harm to physician or patient acceptance of our products. 

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, financial condition, results of operations and prospects. 

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. 

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The enrollment of patients depends on many factors, including: 

•the patient eligibility criteria defined in the protocol; 

•the size and health of the patient population required for analysis of the trial’s primary endpoints; 

•the proximity of patients to study sites; 

•the design of the trial; 

•our ability to recruit clinical trial investigators with the appropriate competencies and experience; 

•clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; 

•our ability to obtain and maintain patient consents; and 

•