Company: HCWB
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0000950170-25-046724
Chunk: 17

Company: HCW Biologics Inc.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1
Chunk 17
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, or, in some cases, the whole body. It occurs when the immune system mistakenly attacks hair follicles, leading to hair loss without causing permanent damage to the follicles. Patients often experience recurring episodes of hair loss throughout their lives.  While not life threatening, alopecia areata can have a significant negative impact on patients’ quality of life and psychological health.  Existing approved treatments may provide some relief of symptoms, but there are often dangerous side effects.  

Alopecia is one of the most prevalent autoimmune diseases in the world, affecting approximately 1 in 1,000 people, with a lifetime incidence of 2% worldwide, or 160 million people. According to the National Alopecia Areata Foundation, about 7 million  people in the United States have alopecia areata. The condition primarily affects individuals under the age of 30, occurring at similar rates in both males and females.

Many insurance plans may not fully cover alopecia areata treatments, leading to significant out-of-pocket expenses.  More extensive hair loss usually requires more intensive treatment, leading to higher costs.  Hair transplants are considered among the most expensive treatment options, with costs ranging from $7,400 to $25,000 depending on the procedure and the clinic.  Patients report even higher costs due to the need for medications like Janus kinase (“JAK”) inhibitors which can reach upwards of $50,000 annually.  JAK inhibitors have boxed warnings in their labeling due to an increased risk of serious heart-related events, cancer, blood clots, and death. 

(See StatsPearls, National Library of Medicine of National Institutes of Health, National Alopecia Areata Foundation.)

Potential Phase 2 Expanded Indications

The goals of the Phase 1 clinical trial are to assess whether the safety profile is acceptable to conduct further studies and establish a RP2D that can increase Treg cells activity in patients participating in the study.  If we achieve the Phase 1 study objectives, the Company plans to progress the clinical development of HCW9302 in patients with alopecia areata as well as other autoimmune diseases and inflammatory conditions, including other dermatologic diseases, organ transplant rejection and neurodegenerative diseases.  

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Organ Transplant Rejection

Through collaborative research, the Company has performed some preclinical research using HCW9302 in organ transplant rejection.  According to the United Network for Organ Sharing, in 2023, there were a record-breaking 46,632 organ transplants performed in the United