Company: HCWB
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046724
Chunk: 13

Company: HCW Biologics Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 13
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 age-related diseases. At HCW Biologics, our proprietary immunotherapy platforms rejuvenate the immune system, allowing it to reduce accumulated senescent cells and silence activated inflammasomes. This disrupts the link between aging and chronic diseases.

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Persistently Activated Immune Cells:  Inflammatory Factors They Secreted Trigger Chronic Inflammatory Responses

Immune cells defend against infection or tissue injury. These activated immune cells persist as we age, even in the absence of infection, and regulate the release of pro-inflammatory factors. As inflammatory factor levels increase, this fuels a feedback cycle of inflammasome activation and leads to the persistent, low-grade body-wide inflammation associated with many age-related diseases.

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Our Strategy

Our strategy includes the following key components:

Focus on diseases with no known FDA-approved treatments.

•Diseases to be targeted include cancer indications, neurodegenerative diseases as well as quality-of-life indications.

•Indications that will be included in our clinical development are promoted by chronic inflammation, especially inflammaging. 

Focus on an autoimmune indication for the initial indication for clinical development for our lead product candidate, HCW9302.

•The Company received clearance of its IND from the FDA to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA-approved treatments.   

•The Company intends to include up to five clinical sites in this study.  Negotiations with clinical sites are currently underway, and the Company estimates the lead site may open and initiate late in the second quarter of 2025 or early in the third quarter of 2025.  

Once RP2D and safety is established in a successful Phase 1 study, expand to other carefully selected indications in Phase 2.

•The Company will refine potential expanded indications for Phase 2 clinical studies during Phase 1, conducting further preclinical research with support from Phase 1 clinical data from ancillary studies as well as human data read-outs.   

•For HCW9302, we are focused on autoimmune diseases, including alopecia areata, and inflammatory conditions, such as other dermatological conditions, graft rejection, and neurodegenerative diseases.

Continue to build our relationships with leading clinical research centers.  

•We believe we can reduce risks related to low patient recruitment and enrollment by continuing to build our relationships with clinical sites who specialize