Company: HCWB
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046724
Chunk: 9

Company: HCW Biologics Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 9
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otech License Agreement.  The Company has now completed extensive preclinical studies that further support our belief in the potential for HCW11-006 for both an in vivo and ex vivo therapy.  The in vivo therapy is licensed by WY Biotech, however, the Company retained all rights to the ex vivo therapy and applications as a reagent in cell-based therapy treatments, including cell-based therapies, such as CAR-T therapies.  The Company considers WY Biotech License provisions for the Opt-In Right to take over the development of HCW11-006 for the Americas markets to be an important feature of the WY Biotech License.  We believe our right to recapture this market is a potentially high value opportunity.  Further, we will be able to base our decision to opt-in on the human-data read-out from a Phase 1 clinical trial, which will mitigate our development risks and provide valuable clinical information about the potential for the indications we will use for Phase 2 clinical studies.    

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HCW Biologics Clinical Development Pipeline

The clinical development progress of our lead immunotherapeutic programs is summarized in the table below:  

HCW Biologics Pipeline

1.As a result of the Settlement Agreement and Release HCWB entered into with ImmunityBio on July 13, 2024, the Company retains perpetual, exclusive worldwide rights to develop immunotherapeutic treatments based on HCW9218 for aging-related diseases other than cancer.  Our ability to continue development of HCW9218 depends on a supply agreement with ImmunityBio, who controls the master cell bank.  ImmunityBio is obligated under the terms of the Settlement Agreement to enter into a supply agreement with the Company not later than January 2025.  As of the reporting date, we have not received a draft of the supply agreement.  

2.WY Biotech holds the exclusive worldwide license rights to HCW11-006 for in vivo applications.  

3.Wugen holds an exclusive worldwide license for the ex vivo rights for two of our molecules, HCW9201 and HCW9206, with rights limited to the development of cell-based therapy treatments for cancer using the licensed molecules. Wugen’s lead clinical program, WU-NK-101, is based on molecules licensed from our Company.  We have retained all other rights to HCW9201 and HCW9206, including, but not limited to, manufacturing rights and treatment based on subcutaneous injection.  

HCW9302:  Novel Immunotherapeutic