Company: HCWB
Filing Date: 2025-04-07
Form Type: S-1
Source: 0001193125-25-073723
Chunk: 41

Company: HCW Biologics Inc.
Filing Date: 2025-04-07
Form: S-1
Chunk 41
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 labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates. If we decide to pursue accelerated approval for any of our product candidates, it may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that it will receive marketing approval. If we are unable to obtain approval under an accelerated pathway, we may be required to conduct additional clinical trials beyond those that we contemplate, which could increase the expense of obtaining, reduce the likelihood of obtaining and/or delay the timing of obtaining, necessary marketing approvals. In the future, we may decide to pursue accelerated approval for one or more of our product candidates. Under the FDA’s accelerated approval program, the FDA may approve a drug or biologic for a serious or life-threatening illness that provides meaningful therapeutic benefit to patients over existing treatments based upon a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. Many cancer therapies rely on accelerated approval, and the treatment landscape can change quickly as the FDA converts accelerated approvals to full approvals on the basis of successful confirmatory trials. For drugs or biologics granted accelerated approval, post-marketing confirmatory trials are required to describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. These confirmatory trials must be completed with due diligence, and, in some cases, the FDA may require that the trial be designed, initiated and/or fully enrolled prior to approval. Moreover, the FDA may withdraw approval of any product candidate approved under the accelerated approval pathway if, for example:

| • |     | the trial or trials required to verify the predicted clinical benefit of our product candidate fail to verify     
 such benefit or do not demonstrate sufficient clinical benefit to justify the risks associated with such product; |

| • |     | other evidence demonstrates that our product candidate is not shown to be safe or effective under the conditions 
 of use;                                                                                                          |

| • |     | we fail to conduct any required post-approval trial of our product candidate with due diligence; or |

| • |     | we disseminate false or misleading promotional materials relating to the relevant product candidate. |

In addition, the FDA may terminate the accelerated approval program or change the standards under which accelerated