Company: BOLT
Filing Date: 2025-03-24
Form Type: 10-K
Source: 0000950170-25-043873
Chunk: 74

Company: Bolt Biotherapeutics, Inc.
Filing Date: 2025-03-24
Form: 10-K
Item: Item 1A
Chunk 74
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 or operate facilities for drug manufacturing, storage, distribution or testing. Our current third-party contract development and manufacturing organizations, or CDMOs, may be unable or unwilling to supply us with sufficient clinical and commercial grade quantities of our clinical materials due to production shortages or other supply interruptions resulting from pandemics or otherwise, because they are purchased by one of our competitors or another company that decides not to continue supplying us with these materials, or for other reasons. If one or more of these events occur and we are unable to timely establish an alternate supply from one or more third-party CDMOs, we could experience delays in our development efforts as we locate and qualify new manufacturers. Under such circumstances, we may be required to receive drug substance for use on a purchase order basis, and as such, there can be no assurance that we actually receive sufficient quantities. See also the risk factor titled “Our business, operations and clinical development plans and timelines and supply chain could be adversely affected by the effects of health epidemics, including pandemics, on the manufacturing, clinical trial and other business activities performed by us or by third parties with whom we conduct business, including our CDMOs, CROs, shippers and others.” 

Further, our reliance on third-party manufacturers exposes us to risks beyond our control, including the risk of: 

•inability to meet our product specifications and quality requirements consistently; 

•delay or inability to procure or expand sufficient manufacturing capacity; 

•manufacturing and quality issues, including related to scale-up of manufacturing; 

•costs and validation of new equipment and facilities required for additional scale-up; 

•failure of the manufacturer to comply with cGMP and similar foreign standards; 

•inability to negotiate manufacturing agreements with third parties on commercially reasonable terms; 

•termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us; 

•reliance on a limited number of sources, and in some cases, single sources for components, such that if we are unable to secure a sufficient supply of these drug components, we will be unable to manufacture and sell our product candidates in a timely fashion, in sufficient quantities or under acceptable terms; 

•lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier; 

•operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier or the issuance of a FDA Form 483