HCW Biologics Inc. (NASDAQ: HCWB) reported that it has administered the first dose of its lead autoimmune candidate, HCW9302, in a company‑sponsored, multi‑center Phase 1 trial for alopecia areata. The trial, registered as NCT07049328, began at the Ohio State University Wexner Medical Center on November 18, 2025 and is designed to enroll up to 30 patients to evaluate safety and establish a recommended Phase 2 dose.
HCW9302 is an interleukin‑2 fusion protein engineered to expand regulatory T cells (Tregs) and reduce inflammation without broad immunosuppression. The milestone marks the first human exposure of the drug and is a critical step toward validating the company’s TOBI™ platform, which underpins its broader autoimmune pipeline, including candidates for vitiligo and atopic dermatitis.
In its most recent quarterly report, HCW Biologics disclosed a sharp decline in revenue for Q3 2025, falling to $15,606 from $426,423 in the same quarter of 2024. The drop is largely attributable to a one‑year suspension of the Wugen License Agreement, which had previously contributed a significant portion of the company’s sales. The company also posted a net loss of $4.55 million, a swing from a $3.9 million loss in Q3 2024, reflecting higher research and development and general‑administrative expenses as the company ramps up clinical development.
CEO Dr. Hing C. Wong emphasized the clinical significance of the first‑in‑human dosing, noting that establishing a safe and tolerable dose is essential for progressing HCW9302 toward regulatory approval. He also acknowledged the company’s financial challenges, stating that the revenue decline is a temporary effect of the license suspension and that the company remains focused on long‑term growth through its pipeline and platform expansion.
Analyst coverage of HCW Biologics is divided. Some analysts maintain a “Strong Buy” stance with a price target of $35, citing the potential of the Treg‑based approach and the company’s platform advantages. Others issue “Underperform” or “Sell” ratings with lower targets, reflecting concerns about the company’s current financial performance, high operating costs, and the uncertainty surrounding the suspension of the Wugen agreement.
The announcement of the first patient dose is expected to reinforce investor confidence in HCW Biologics’ clinical strategy, while the financial context underscores the company’s ongoing need to manage cash burn and secure additional funding to sustain its development pipeline.
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