Company: HCWB
Filing Date: 2025-04-07
Form Type: S-1
Source: 0001193125-25-073723
Chunk: 9

Company: HCW Biologics Inc.
Filing Date: 2025-04-07
Form: S-1
Chunk 9
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 indications. The Company is prepared to progress HCW9218 in Phase 2 clinical trials for nononcology indications; however, we must secure supply of clinical materials to do so. As a condition of the       
 Settlement Agreement, the Company transferred the master cell line for HCW9218 to ImmunityBio, who in turn agreed to enter a supply agreement with the Company by January 2025. As of the date of this prospectus, there is no supply agreement in place. 
 As a result of the delay in securing supply, there is no assurance that the Company will be able to continue the clinical development of HCW9218 in nononcology indications.                                                                              |

| • |     | The Company has been out of compliance with three applicable rules with respect to its continued listing on The                                                                                                                            
 Nasdaq Stock Market LLC (“Nasdaq”), namely, Nasdaq Listing Rule 5450(b)(2)(A) (the “MVLS Rule”), Nasdaq Listing Rule 5450(a)(1) (the “Bid Price Rule”) and Nasdaq Listing Rule 5450(b)(2&3)(C) (the “MVPHS                                 
 Rule”). As a result, the Listing Staff of Nasdaq delivered notices of its determination that the Company’s Common Stock was subject to delisting from The Nasdaq Global Market tier of Nasdaq. Nasdaq granted the Company a hearing before 
 the Nasdaq Hearings Panel (the “Panel”) to appeal the delisting determination of the Nasdaq Listing Staff, which hearing was held on February 13, 2025, at which we presented our plan to regain compliance with all listing               
 requirements. On March 3, 2025, the Panel granted our request to continue our listing on Nasdaq, subject to our demonstrating compliance with the Bid Price Rule on or before April 25, 2025, which date has been extended to              
 April 28, 2025, and to our demonstrating compliance with all other Nasdaq Listing Rules on or before June 15, 2025. While the Company is exercising diligent efforts to maintain the listing of our Common Stock on Nasdaq, there can be   
 no assurance that the Company will be able to regain or maintain compliance with the applicable Nasdaq Listing Rules. If the Company’s Common Stock were to be delisted from Nasdaq, it could have a material adverse effect on us and our 
 stockholders.                                                                                                                                                                                                                              |

| • |     | Our clinical trials may fail to demonstrate the