HCWB

MIRAMAR, Fla., May 14, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on developing transformative fusion immunotherapeutics to treat autoimmune disease, cancer and senescence-associated dysplasia, today reported financial results and recent business highlights for the three months ended March 31, 2026. The Company remains on track to provide preliminary clinical data readout from the first two dose levels of the Phase 1 clinical study evaluating HCW9302 in alopecia areata in the first half of 2026. There are two clinical sites actively enrolling patients, and enrollment has been on schedule. HCW9302 is an injectable, first-in-kind interleukin 2 (“IL-2”) fusion protein complex designed to suppress the hair-follicle killing activities of the auto-reactive immune cells typically found in patients suffering with alopecia areata by activating and expanding regulatory T (“Treg”) cells. The Company has not reported any dose limiting toxicities in the patients treated to date. With continued patient enrollment, the full Phase 1 human data readout is expected in the fourth quarter of 2026. Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “HCW9302 was selected as the lead product candidate for the Company’s autoimmune program because it has demonstrated relatively high IL-2Rα affinity and sustains serum exposure, which implies it has a strong profile for the treatment of autoimmune disorders. The Company’s preclinical studies in nonhuman primates show that HCW9302 achieves significantly longer serum half-life and exhibits strong biological activity in relatively low doses, which could appear in the human data readout as support for enhanced receptor selectivity, better tolerability and reduced off-target effects.” Business Highlights Transaction Closed for Exclusive Worldwide License for HCW11-006 On March 16, 2026, the closing for the licensing arrangement with Beijing Trimmune Biotech Co., Ltd (“Trimmune”) occurred upon receipt of the full nonrefundable upfront license fee. The Trimmune upfront license fee consisted of $3.5 million in gross cash proceeds, or $2.9 million net of taxes, and an in-kind payment of a transferable minority equity interest in Trimmune with a fair value of $3.5 million. For the three months ended March 31, 2026, th...

MIRAMAR, Fla., March 31, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation, today reported financial results and recent business highlights for its three months ended December 31, 2025. On November 17, 2025, the Company initiated its first-in-human clinical trial to evaluate HCW9302, the lead product candidate for the Company’s program to develop treatments for autoimmune disorders and proinflammatory diseases, in patients with areata alopecia. HCW9302 is a subcutaneously injectable, first-in-kind interleukin-2 (“IL-2”) fusion immunotherapeutic. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of Treg cells in the body. Treg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases. The Company believes that HCW9302 can suppress the hair-follicle killing activities of the auto-reactive immune cells by activating and expanding regulatory T cells (“Treg”) cells. There are no curative FDA approved treatments of this indication. Alopecia areata 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. The Phase 1 multi-center dose-escalation study of HCW9302 is designed to treat up to 30 patients. The primary objectives of the study are to evaluate the safety of HCW9302, injected under the skin (subcutaneously), and to determine the recommended dose level to advance to later phase clinical studies. A preliminary human data read out is expected in the first half of 2026. Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer said, “We are excited to be the sponsor of this clinical study to evaluate this promising new treatment for alopecia areata. We will be conducting additional ancillary studies to provide further insights into disease responses and the effects of HCW9302 on proliferation and fun...

Commercialization ready compound supports a new method of generating highly functional human CAR-T cells for treating infectious diseases and cancer In experimental models, human CAR-T cells manufactured using HCW9206 showed strong anti-tumor activity in leukemia and enhanced antiviral potency in HIV suggesting potential for curative outcomes Employing HCW9206 as a manufacturing reagent may lower the cost of CAR-T manufacturing MIRAMAR, Fla., March 16, 2026 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), is a U.S.-based commercial- and clinical-stage biopharmaceutical company focused on supporting or developing novel immunotherapies to treat autoimmune diseases, cancer, and senescence-associated dysplasia, announced today results of groundbreaking research studies, published in the peer-reviewed, high-impact journal, Science Advances (Cole et al., “IL-7/IL-15/IL-21 cytokine-fusion scaffold generates highly functional CAR-T cells enriched in long-lived T memory stem cells” Science Advances, 13 Mar 2026, Vol 12, Issue 11). These studies were led by Harris Goldstein, M.D., professor of pediatrics and of microbiology & immunology and director of the Einstein-Rockefeller-CUNY-Mount Sinai Center for AIDS Research and his team of Albert Einstein College of Medicine scientists, most notably Erin Cole, M.S., a graduate student in the Goldstein laboratory. The study results demonstrated that HCW9206, the Company’s proprietary and commercial-stage multi-cytokine fusion protein reagent, provides a revolutionary approach to generate chimeric T-cell receptor - T cells (“CAR-Ts”) for immunotherapy with increased function in a cost-effective manner. HCW9206, a first-in-class cytokine-scaffold-based platform, enables production of more potent CAR-T-based immunotherapies by generating a CAR-T population which is highly functional and markedly enriched for long-live T-memory stem cells (Tscm). Utilizing HCW9206 as a manufacturing strategy may be broadly applicable to increase persistence and functionality of CAR-Ts. Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “HCW9206 is a novel compound that enables a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. It is versatile and has shown activity in the creation of memory-like NK-cells for cell-based therapy against cance...

MIRAMAR, Fla., Nov. 14, 2025 (GLOBE NEWSWIRE) -- 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, today reported financial results and recent business highlights for its third quarter ended September 30, 2025. 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 TOBI™ 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 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...

HCW Biologics conducted investigative study to show safe dose levels of its lead drug candidate in non-human primates that were well tolerated at a level significantly higher than the identified efficacious dose level Program has addressed key challenges for first generation T-cell engagers related to manufacturability, preclinical safety profile, and ability to treat a wide spectrum of solid tumors Program is positioned for a potential high value corporate partnership MIRAMAR, Fla., Sept. 09, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, announced today that its scientists have successfully developed second-generation, tissue factor-targeting T-cell engagers against solid tumors, particularly for pancreatic cancer and glioblastoma, constructed with its novel proprietary TRBC product discovery and development platform technology. T-cell engagers (“TCEs”) revolutionized the immunotherapeutic approach against cancer since the first indication was approved for Amgen’s BLINCYTO® (blinatumomab) in 2014. Currently, the U.S. Food and Drug Administration (“FDA”) and other regulatory agencies have approved eight TCEs to be used to treat 11 indications. Even with a very limited number of approved indications, approved TCEs are currently generating multi-billion-dollar annual sales. As the current FDA-approved T cell engagers reshape the landscape of cancer therapy, numerous high-value partnership deals between major pharmaceutical companies and biotech companies have been reported in the past two years. These partnerships have likely been driven by TCE’s potential in both oncology and autoimmune diseases and the majority of these deals were based on preclinical TCE programs. Although there has been success in the development of TCE therapy, first generation TCEs continue to face a number of significant challenges such as antigen selection, efficacy for solid tumors, tolerability, safety, and complex manufacturing processes. HCW Biologics believes its second-generation TCEs could alleviate such shortfalls. The Company has constructed TCEs that have shown in preclinical studies to not only target cancer antigens and C...

MIRAMAR, Fla., Aug. 18, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its second quarter ended June 30, 2025. On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, “We are pleased to have completed a successful $5.0 million equity offering in a challenging market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder.” Dr. Wong continued, “Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our novel TRBC drug discovery and development platform.” Business Highlights Business Development Transactions On May 30, 2025, WY Biotech ended its due diligence period and formally accepted the technical report delivered by the Company on May 13, 2025. In order to accommodate WY Biotech’s timing in finalizing legally binding agreements with its CDMO and lead investor, the Company and WY Biotech agreed to extend the latest date for payment of the $7.0 million license fee to September 30, 2025. On May 29, 2025, after recognizing over $16.0 million in revenue from the Wugen License Agreement signed in 2020, the Company agreed to a one-year suspension of the Wugen License Agreement, during which time the Company may seek alternative licensing programs for HCW9206. The Company is actively negotiating with several major biologics manufacturing companies interested in licensing the molecule as a reagent to use in the manufacture of CAR-T products. HCW9206 represents a novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a stem cell-like memory T cell phenotype, which is expected to enhance the persistence of CAR-Ts in patients. The Company has launched a search for a strong commercial...

Explore HCW Biologics's Fair Values from the Community and select yours Net loss: US$1.93m (loss narrowed by 87% from 2Q 2024). US$0.90 loss per share (improved from US$16.16 loss in 2Q 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is expected to decline by 64% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 20%. Performance of the American Biotechs industry. The company's shares are down 11% from a week ago. Before you take the next step you should know about the 7 warning signs for HCW Biologics (6 don't sit too well with us!) that we have uncovered. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

MIRAMAR, Fla., May 15, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its first quarter ended March 31, 2025. On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, “We are pleased to have completed a successful $5.0 million equity offering in a difficult market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder.” Dr. Wong continued, “Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our TRBC drug discovery and development platform.” Dr. Wong explained the Company’s financing strategy, stating, “We have over 50 compounds that we have created and own. We are continually assessing our portfolio of molecules to identify strong candidates to develop and commercialize through licensing or other business development transactions. We plan to ramp up our business development efforts in the second half of 2025. One of our compounds that is ready to commercialize is HCW9206, a clinical-stage molecule. It is a promising revolutionary reagent to replace anti-CD3/anti-CD28/IL-2-based approaches to streamline and lower the costs of CAR-T manufacturing. Equally important, we believe that HCW9206 can improve the functional activities and persistence of CAR-Ts following adoptive transfer, a goal that has not been achieved for the last decade.” Business Highlights Business Development Transactions On May 13, 2025, the Company delivered its technology report to WY Biotech in accordance with the terms of the WY Biotech exclusive worldwide licensing agreement to use and apply HCW11-006 for in vivo applications. HCW11-006 is a preclinical drug built with our second-generation discovery and development platform -- the TRBC platform. WY Bi...

Addresses key challenges for CAR-T therapies Potential to significantly reduce costs and improve clinical efficacy of engineered effector T cells Data Shared at 2025 Annual Meeting of American Association of Immunologists MIRAMAR, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend healthspan by targeting the link between chronic inflammation and disease, announced today presentation of studies showing that its proprietary fusion protein, HCW9206, provides a new pathway for generating chimeric T-cell receptor - T cells (CAR-Ts) for immunotherapy with increased function. HCW9206 is a novel class of immunotherapeutic that enables a single molecule to deliver synergistic signals from three different immune-stimulatory cytokines. The activity of HCW9206 was significantly superior compared to standard methods employing anti-CD3/anti-CD28 and IL-2 reagents for CAR lentiviral transduction and subsequent expansion and persistence of human CAR-Ts. CAR-Ts represent a revolutionary technology with several CD19-specific CAR-T therapies approved by the FDA for the treatment of B-cell malignancies, and CAR-Ts continue to play an increasingly pivotal and expanding role in the treatment of cancer and has significant potential to treat autoimmune diseases and age-related diseases. The Company’s research collaborator Dr. Harris Goldstein’s laboratory at the Albert Einstein College of Medicine, Bronx, New York, recently presented findings of these studies at the 2025 Annual Meeting of American Association of Immunologists (AAI 2025), Honolulu, HI. The poster presentation reported that HCW9206 is not only a better reagent than the current anti-CD3/anti-CD28/IL-2 method for CAR-T viral transduction, it also effectively expanded stem cell-like memory T cells (Tscm) carrying the CAR constructs. It is well established that the Tscm subset of T cells exhibits more in vivo persistence and targeted cell killing than other subsets of T cells, including memory T cells, following adoptive transfer into patients. In experimental humanized models in mice, adoptively transferred HCW9206-generated HIV- and CD19-specific CAR-Ts displayed more potency in suppressing HIV-1 and leukemic cells with enhanced persistence, re...

MIRAMAR, Fla., March 28, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its fourth quarter and fiscal year ended December 31, 2024. Dr. Hing Wong, Founder and CEO, stated, “We are more passionate than ever about our desire to create breakthrough immunotherapeutic treatments for diseases with no known cures, especially pancreatic, ovarian cancer and other age-related diseases. We have received clearance to begin clinical trials in alopecia areata, our first-quality-of-life indication, with one of our lead molecules, HCW9302. In non-human primate studies, HCW9302 is well tolerated at the dose level of effectively expanding regulatory T (“Treg”) cells. Our surrogate efficacious marker for HCW9302 in treated patients is the expansion of Treg cells after subcutaneous administration.” Further, Dr. Wong provided insights to the Company’s preclinical programs, adding, “Our preclinical programs are also promising. In the fourth quarter of 2024, the Company revealed its new drug discovery and development platform, with a novel scaffolding or “backbone” of proteins called T-cell Receptor β Chain constant region (“TRBC”). The TRBC drug discovery and development platform leverages the Company’s in-depth knowledge of T cell and natural killer (“NK”) cell immunology. The Company has constructed 50 proprietary compounds with the TRBC platform for the treatment of hematologic and solid tumors, virally infected cells, and cellular senescence diseases associated with aging.” Dr. Wong explained, “Our expanded portfolio now includes constructs with immune-cell engagers targeting cell-surface antigens associated with diseased cells and multifunctional immunotherapeutic fusions which improve the performance of immune checkpoint inhibitors. They exhibit remarkably target-specific anti-tumor activity and tolerability in relevant animal models.” He continued, “We believe that some of our TRBC-based molecules could be a game-changer for Cell and Gene Based Therapies (“CGTs”) by significantly reducing cost and improving the clinical efficacy of engineered effector cells for CGT....