HCW Biologics Strengthens U.S. Patent Estate for Its Lead Clinical-Stage Immunotherapeutic HCW9302 as Alopecia Areata Treatment

HCW9302 is a best-in-class IL-2-based immunotherapeutic for treatment of autoimmune diseases through expanding and activating regulatory T cells

Patent allowance received for use of HCW9302 as treatment for alopecia areata

Phase 1 dose-escalating clinical study evaluating HCW9302 as monotherapy in patients with alopecia areata on track for completion in Q4 2026, continues to be well tolerated with no dose-limiting toxicities

Preliminary readout of first two dose cohorts is encouraging -- patients diagnosed with alopecia areata show positive response after single dose of monotherapy at 3 micrograms/kg dose level

MIRAMAR, Fla., Sept. 02, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on developing novel fusion immunotherapeutics to treat autoimmune diseases, cancer, and senescence-associated dysplasia, announced receipt of a Notice of Allowance from the U.S. Patent and Trademark Office (“USPTO”) for claims directed to use of HCW9302 to treat alopecia areata (U.S. Patent Application Publication No. US2026/0139043).

Together with four other recently issued patents (U.S. Patent No. 11,401,326, U.S. Patent No. 11,987,619, U.S. Patent No.12,018,071, U.S. Patent No. 12,516,112) with claims for broad compositions, nucleic acids encoding for HCW9302 and the vectors comprising these, and method of treating other autoimmune diseases, the underlying U.S. patent estate has been further strengthened for the protection of the Company’s intellectual property related to further development and potential commercialization of HCW9302, a best-in-class IL-2-based immunotherapeutic for the treatment of autoimmune diseases. The Company continues to extend protection of its broad rights for treatments for all indications with respect to HCW9302 built on the foundation of its worldwide, perpetual, fully paid-up, royalty-free, exclusive license rights for this compound.

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “Our lead clinical product candidate HCW9302 exhibits a strong IL-2Rα bias, a unique and novel mechanism of action, while preferentially expanding and stimulating T reg cells to reduce pro-inflammatory and autoimmune responses in relevant animal models, including alopecia areata, atherosclerosis, and atopic dermatitis. This strong IL-2Rα bias differentiates HCW9302 from native recombinant IL-2 and other IL-2-based muteins and PEG conjugates, which typically exhibit reduced binding activity to IL-2Rα components. In addition, HCW9302 is comprised of all human-derived components and can be produced with a cost-effective, streamlined process similar to therapeutic monoclonal antibodies. Ongoing clinical activity for alopecia areata patients continues to be encouraging. With exceptionally strong intellectual property protection in place, we are vigorously pursuing alopecia areata as our lead indication of HCW9302. We are on track to provide the full Phase 1 readout of the current trial in Q4 2026 ( ClinicalTrials.gov ID: NCT07049328 ).”

About HCW Biologics:

HCW Biologics Inc. (the “Company”) (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat diseases promoted by chronic inflammation, including autoimmune diseases, cancer, and senescence-associated dysplasia. HCW Biologics is the leader in creation of multi-valent immunotherapeutics with a unique protein-based scaffold, without the antibody Fc domain. The Company’s immunotherapeutics represent a new class of drugs that it believes have the potential to fundamentally change the treatment of proinflammatory and senescence-associated diseases and conditions that are promoted by chronic inflammation —and in doing so, improve patients’ quality of life and possibly extend longevity. A key aspect of the Company’s clinical development and financing strategy is to focus on its business development programs, including its commercial-ready reagents to be used in the production of immunotherapeutics for cancer and infectious diseases. To date, the Company has entered into two licensing agreements in which it has licensed exclusive, worldwide rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/

Forward Looking Statements:

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, that a patent and/or specific alopecia treatment allowed claims will issue from U.S. Patent Application Publication No. US2026/0139043; the safety, ability and efficacy of HCW9302 to treat autoimmune diseases and other inflammatory diseases, including the efficacy of HCW9302 in the treatment of alopecia areata from preliminary clinical safety data; the ability of HCW9302 to advance to Phase 2 clinical trials; the ability of HCW9302 to treat other autoimmune or neurodegenerative conditions; the ability of HCW9302 to expand and stimulate T reg cells to reduce pro-inflammatory and autoimmune responses in relevant animal models; the completion of the full Phase 1 readout of the trial in Q4 2026. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 31, 2026, the quarterly report on Form 10-Q filed with the SEC on August 14, 2026, and in other filings filed from time to time with the SEC.

Company Contact: Dr. Peter Rhode Chief Scientific Officer and Vice President of Clinical Operations HCW Biologics Inc. PeterRhode@HCWBiologics.com

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