Company: HCWB
Filing Date: 2025-04-28
Form Type: DRS
Source: 0000950123-25-003769
Chunk: 12

Company: HCW Biologics Inc.
Filing Date: 2025-04-28
Form: DRS
Chunk 12
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 of regulatory approval and commercialization. |

| • |     | Preliminary, topline or interim data from our clinical trials that we announce or publish from time to time may                                             
 change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data. |

| • |     | The development and commercialization of biopharmaceutical products is subject to extensive regulation, and the                                                                                                                                           
 regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates on a timely basis, if at all, 
 our business will be substantially harmed.                                                                                                                                                                                                                |

| • |     | Clinical drug development is a lengthy and expensive process with uncertain timelines and uncertain outcomes. If                                                                                                                                  
 clinical trials of our product candidates are prolonged or delayed, we or any collaborators may be unable to obtain required regulatory approvals, and, therefore, be unable to commercialize our product candidates on a timely basis or at all. |

| • |     | Even if our product candidates obtain regulatory approval, we will be subject to ongoing obligations and                                                                                                                                               
 continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we 
 fail to comply with regulatory requirements or experience unanticipated problems with our products.                                                                                                                                                    |

| • |     | We expect to rely on patents and other intellectual property rights to protect our technology, including product                                                                                                                                  
 candidates and our immunotherapy platform technology, the prosecution, enforcement, defense, and maintenance of which may be challenging, time-consuming and costly. Failure to defend, protect or enforce these rights adequately, and costs and 
 expenses associated with the same, could impact our financial condition and results of operations or otherwise harm our ability to compete and impair our business.                                                                               |

| • |     | We rely on third parties to manufacture our product candidates. Any failure by a third-party manufacturer to                                                                                                                                             
 produce acceptable drug substance for us or to obtain authorization from the FDA or comparable regulatory authorities may delay or impair our ability to initiate or complete our clinical trials, obtain regulatory approvals or commercialize approved 
 products.                                                                                                                                                                                                                                                |

| • |     | Our information technology systems, or those used by our third-party contractors or consultants, may fail or 
 suffer security breaches, which could adversely affect our business.                                         |

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