Company: HCWB
Filing Date: 2025-05-09
Form Type: S-1
Source: 0001193125-25-116745
Chunk: 44

Company: HCW Biologics Inc.
Filing Date: 2025-05-09
Form: S-1
Chunk 44
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 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. |

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In addition, the FDA may terminate the accelerated approval program or change the standards
under which accelerated approvals are considered and granted in response to public pressure or other concerns regarding the accelerated approval program. Changes to or termination of the accelerated approval program could prevent or limit our
ability to obtain accelerated approval of any of our clinical development programs. Recently, the accelerated approval pathway has come under scrutiny within the FDA and by Congress. The FDA has put increased focus on ensuring that confirmatory
studies are conducted with diligence and, ultimately, that such studies confirm the benefit.