On November 14, 2025 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and diseases, reported financial results and recent business highlights for its three months ended September 30, 2025.
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The Company anticipates dosing the first patient in a Phase 1 clinical study (NCT07049328) to evaluate HCW9302 in patients with an autoimmune disease in the fourth quarter of 2025. HCW9302 is the Company’s lead product candidate for its clinical program to develop treatments for autoimmune diseases and inflammatory conditions. HCW9302 is a subcutaneously injectable, first-in-kind interleukin 2 ("IL-2") fusion molecule constructed using the Company’s legacy TOBITM platform technology. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of regulatory T ("Treg") cells in the body. Treg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases. The breakthrough discovery of the critical function of Treg cells by Drs. Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi was recently acknowledged with the 2025 Nobel Prize in Physiology or Medicine for their groundbreaking work concerning Treg cells, which discovery was that these cells are the immune system’s security guards which prevent immune cells from attacking our own body.
Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer said, "The goal of our Phase 1 clinical study for HCW9302 is to establish the safe dose that effectively increases Treg cell activity in patients with an autoimmune disease. Once we achieve this objective, we hope to rapidly expand clinical development of HCW9302 in Phase 2 studies in patients with alopecia areata as well as other autoimmune diseases and inflammatory conditions."
Business Highlights
Business Development Transactions
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The Company has launched its search for a strong commercial partner for the clinical development of its T-cell engager ("TCE") compounds. These compounds are designed to address shortfalls in the first generation products. The Company has created TCE compounds that can target cancer antigens and CD3 activation of effector T cells while simultaneously reducing the immunosuppression in tumor microenvironment. Such immunosuppression could play a pivotal role in reducing effector T-cell infiltration and anti-tumor efficacy in solid tumors.
Financing Transactions
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During the three months ended September 30, 2025, the Company issued 475,000 shares of Common Stock for gross proceeds of $2.2 million utilizing the Company’s Standby Equity Purchase Agreement.
Preclinical and Clinical Development Results
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The Company has successfully opened two clinical sites that are actively screening patients to participate in a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with alopecia areata. The Company expects to dose the first patient in this clinical trial in the fourth quarter of 2025. Alopecia areata is a common autoimmune disease in humans that currently has no curative FDA approved treatments. It causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. The National Alopecia Areata Foundation estimates approximately 160 million people worldwide and 7 million people in the United States have alopecia areata. The condition affects about 2% of the global population at some point in their lifetime.
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HCW Biologics showcased data for its lead engager HCW11-018b highlighting the uniqueness and advantages of the Company’s second-generation TCE program over the first-generation products at SITC (Free SITC Whitepaper). HCW11-018b is a tetra-valent construct that activates tumor-infiltrated exhausted T cells while addressing the immunosuppressive tumor microenvironment. It has broad coverage for human solid tumor indications by targeting tissue factor, with high potency and precision, shown in xenograft models including the Patient-Derived Xenograft (PDX) tumor model.
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HCW Biologics also presented data for its lead product candidate in the Company’s second-generation immune checkpoint inhibitor program at SITC (Free SITC Whitepaper). HCW11-040 is a proprietary TRBC-pembrolizumab-based immune checkpoint inhibitor, which the Company considers as its franchise immunotherapeutic compound for internal clinical development. It is a unique combination of cytokines in multi-functional fusion protein molecule that exhibits the ability to expand progenitor exhausted T cells, or TPEX cells, without inducing a cytokine storm in preclinical studies. TPEX cells, located in the draining lymph nodes and tumors of the patients, have been implicated as the primary responders to ICI therapy. HCW11-040 in undergoing IND-enabling studies to prepare for clinical trials for evaluation in the treatment of solid tumors.
Third Quarter 2025 Financial Results
Revenues: Revenues for the three months ended September 30, 2024 and 2025 were $426,423 and $15,606, respectively. Revenues for the nine months ended September 30, 2024 and 2025 were $2.2 million and $27,222, respectively. Historically, revenues have been derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the nine months ended September 30, 2025, the Company agreed to a one-year suspension of the Wugen License Agreement.
Research and development (R&D) expenses: R&D expenses for the three months ended September 30, 2024 and 2025 were $1.2 million and $1.4 million, respectively, an increase of $271,334, or 18%. R&D expenses for the nine months ended September 30, 2024 and 2025 were $5.3 million and $4.1 million, respectively, a decrease of $1.2 million, or 23%. R&D expenses in the nine months ended September 30, 2024 were comparatively higher than the same period in 2025 due to expenses incurred for the manufacture of a high-expressing line of HCW9101, an element needed in the manufacture of HCW9302, the Company’s clinical-stage molecule. Such activities were completed in 2024.
General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2024 and 2025 were $1.6 million and $1.9 million, respectively, an increase of $251,537, or 15%. G&A expenses for the nine months ended September 30, 2024 and 2025 were $4.8 million and $6.2 million, respectively, an increase of $1.4 million, or 29%. The increase in G&A expenses in 2025 was primarily due to salaries and benefits and professional fees related to audit services, tax and other advisory services, as well as required activities to remain in compliance with SEC regulations and Nasdaq listing rules.
Legal expenses (recoveries), net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration which held its hearing in May 2024, was settled on July 13, 2024, and was dismissed on December 24, 2024. Legal expenses (recoveries), net for the three months ended September 30, 2024 and 2025 were $1.0 million and $6,006, respectively. Legal expenses (recoveries), net for the nine months ended September 30,2024 and 2025 were $15.8 million and a contra expense of ($1.6) million, respectively. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to $12.1 million legal fees which remain unpaid.
Net loss: Net loss for the three months ended September 30, 2024 and 2025 was $3.9 million and $4.6 million, respectively. Net loss for the nine months ended September 30, 2024 and 2025 was $26.7 million and $8.7 million, respectively.
(Press release, HCW Biologics, NOV 14, 2025, View Source [SID1234659970])