Company: HCWB
Filing Date: 2025-04-16
Form Type: 424B3
Source: 0001193125-25-082835
Chunk: 41

Company: HCW Biologics Inc.
Filing Date: 2025-04-16
Form: 424B3
Chunk 41
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 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 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 26

increased focus on ensuring that confirmatory studies are conducted with diligence and, ultimately, that such studies confirm the benefit. For example, the FDA has convened its Oncologic
Drugs Advisory Committee to review what the FDA has called dangling or delinquent accelerated approvals where confirmatory studies have not been completed or where results did not confirm benefit. In addition, the Oncology Center of Excellence has
announced Project Confirm, which is an initiative to promote the transparency of outcomes related to accelerated approvals for oncology indications and provide a framework to foster discussion, research and innovation in approval and post-marketing
processes, with the goal to enhance the balance of access and verification of benefit for therapies available to patients with cancer and hematologic malignancies.

The recent enactment of FDORA included provisions related to the accelerated approval pathway. Pursuant to FDORA, the FDA is authorized to
require a post-approval study to be underway prior to approval or within a specified time period following approval. FDORA also requires the FDA to specify conditions of any required post-approval study and requires sponsors to submit progress
reports for required post-approval studies and any conditions required by the FDA. FDORA enables the FDA to initiate enforcement action for the failure to conduct with due diligence a required post-approval study, including a failure to meet any
required conditions specified by the FDA or to submit timely reports.

There is substantial uncertainty regarding the new Administration’s initiatives