HCW Biologics Reports Second Quarter 2026 Business and Clinical Development Highlights and Financial Results

About this update from Hcw Biologics Inc.

MIRAMAR - HCW Biologics Inc. (the 'Company' or ' HCW Biologics' ) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on developing transformative fusion immunotherapeutics to treat autoimmune diseases, cancer and senescence-associated dysplasia, reported financial results and recent business highlights for the three and six months ended June 30, 2026 . On June 16, 2026 , the Company announced its preliminary human data readout for the first two cohorts in a dose-escalating Phase 1 clinical study to evaluate HCW9302 as a monotherapy in patients with alopecia areata. HCW9302 is a fusion immunotherapeutic which is potentially a best-in-class IL-2-based treatment for autoimmune diseases. These preliminary findings support the Company's belief that HCW9302 has the potential to activate and expand regulatory T (Treg) cells in patients, reducing inflammation, while minimizing the risk of broad immunosuppression or unwanted side effects caused by the activation of immune effector cells. The Company remains on track for a full Phase 1 clinical data readout in the fourth quarter of 2026. Treatment of patients in the third dose cohort (i.e., eight (8) micrograms/kg body weight) is underway and evaluation of correlative study endpoints is ongoing. The Company has not reported any dose-limiting toxicities. In the second dose cohort, comprised of patients who received a single subcutaneous dose of HCW9302 monotherapy of three (3) micrograms/kg body weight, all three participants showed preliminary indications of improvement in Severity of Alopecia Tool ('SALT') scores. These three participants, all with mild alopecia, showed a =25% reduction in SALT scores compared to baseline at four and/or nine weeks after dosing. In addition, there were no reported incidences of capillary leak or cytokine release syndromes associated with high dose intravenous IL-2 therapy. HCW9302 treatment did not increase blood eosinophil count, another serious side effect commonly associated with IL-2 therapy. Dr. Hing C. Wong , the Company's Founder and Chief Executive Officer, stated, 'HCW9302 was selected as our lead product candidate for our autoimmune program because it has several unique features that differentiate it from other immunotherapeutic treatments for autoimmune disorders. Because our clinical study was designed to administer HCW9302 as a monotherapy, we feel confident of our findings and clear signals that indicate this drug has great potential. So far, our in-human clinical experience with HCW9302 is consistent with our preclinical results showing HCW9302's effectiveness in alopecia areata and atopic dermatitis in relevant animal models.' Dr. Wong continued, 'HCW9302 targets CD25 directly, which we believe demonstrates activation and expansion of regulatory T cells. It has preliminarily demonstrated it has an effect on alopecia areata, even when administered as monotherapy at a low dose. Our design does not use pegylation, so we avoid anti-PEG immune responses, which account for efficacy loss and can possibly cause severe allergic symptoms. With an eye toward the future commercialization of HCW9302 for the treatment of alopecia areata and other autoimmune disorders, we developed a manufacturing process for this drug that is a simple process capable of producing large quantities with consistent quality at a relatively low cost.' Business and Clinical Development Highlights Commercial-Ready Molecules Used as Reagents Since the second quarter of 2025, the AlloTera Therapeutics License (formerly the Wugen License) was in a one-year suspension period, which the Company agreed to at the request of AlloTera Therapeutics, Inc. ('AlloTera Therapeutics'). On May 21, 2026 , the Company re-acquired the ex vivo rights to two commercial-ready molecules that had previously been licensed to AlloTera Therapeutics by exercising its right to terminate the AlloTera Therapeutics License Agreement according to the terms of the suspension letter agreement. The Company is actively pursuing a corporate partner to commercialize HCW9206 and like molecules as reagents to support the production of cell-based immunotherapeutics, particularly CAR-T therapies. In collaboration with researchers at the Albert Einstein College of Medicine , the Company demonstrated and published in a scientific paper in Science Advances that replacing standard activation with HCW9206 during CAR-T cell manufacturing significantly increased the long-term persistence, functionality, and proportion of T memory stem cells in immunotherapies for cancer and HIV and potentially significantly lowers the production costs. The market for reagents used in CAR-T therapy production is experiencing rapid expansion, driven by a projected increase in the global CAR-T cell therapy market, which is expected to grow from $4.0 billion in 2025 to over $15.0 billion by 2032. One of the impediments to growth is the manufacturing process, which is subject to delays and has difficult meeting target doses for commercial production. Milestone for Company's T-Cell Engager Program The Company requested a Type B (pre-IND application) meeting with the U.S. Food and Drug Administration ('FDA') to discuss the development and regulatory strategy for its investigational lead product candidate, HCW11-018b, a tetravalent T-cell engager ('TCE') constructed with the Company's proprietary TRBC drug development platform. The Company would like to reach agreement with the FDA on requirements for a clinical study before we submit an IND application to evaluate HCW11-018b in cancer. This clinical trial is on track to initiate in the first half of 2027, provided we secured FDA authorization. HCW11-018b is intended to treat solid tumors and is administered by subcutaneous injection. In preclinical studies, it has shown the ability to target tissue factor-expressing cancer cells and activate CD3-positive effector T cells, while simultaneously reducing immunosuppression in the tumor microenvironment. Immunosuppression in the tumor microenvironment can limit effector T-cell infiltration and antitumor activity in solid tumors, particularly in gynecologic and pancreatic cancers. The Company believes that our robust, streamlined, and cost-efficient manufacturing process will produce high-quality cGMP material to support clinical development. Our manufacturing process for HCW11-018b is based on high-producing recombinant CHO cell lines and a proprietary monoclonal antibody needed for the affinity purification process. This monoclonal antibody will be manufactured under GMP standards using a top-tier CDMO. TCEs have emerged as a potent therapeutic modality to treat cancer. First-generation TCEs represented a breakthrough in immunotherapy but they continue to face significant challenges, including limited antigen selection, poor efficacy in solid tumors, tolerability and safety concerns, and complex manufacturing processes. Extensive preclinical studies of HCW11-018b -including assessments of in vitro and in vivo potency, antigen specificity, pharmacokinetics, toxicity in nonhuman primates, and its therapeutic window - suggest that HCW11-018b may be able to overcome the limitations of earlier-generation TCEs. $5.6 Million in Equity Financings Pursuant to a May 2026 securities purchase agreement, in a private placement, the Company issued and sold an aggregate of 71,174 shares of Common Stock, 403,322 Pre-Funded Warrants, and Common Warrants to purchase an aggregate of up to 474,496 shares of Common Stock for aggregate gross proceeds of approximately $4.0 million at the closing, before deducting fees payable to the placement agent and other offering expenses payable by the Company. The Investors included officers, directors and significant stockholders. Scott Garrett , Chairman of the Company's Board of Directors, purchased $250,000 of securities, Hing C. Wong , the Company's Founder and Chief Executive Officer, purchased $160,000 of securities, and Rebecca Byam , the Company's Chief Financial Officer, purchased $20,000 of securities. Such purchases were made on the same terms and conditions as those offered to other investors. On June 18, 2026 , the SEC declared effective a resale registration statement on Form S-1 (File No. 333-296577) covering the resale of shares of Common Stock and warrants issued in this private placement. Pursuant to a July 2026 securities purchase agreement, in a private placement, the Company issued and sold an aggregate of 218,862 shares of Common Stock, 400,000 Pre-Funded Warrants and Common Warrants to purchase an aggregate of 618,682 shares of Common Stock for aggregate proceeds of approximately $1.6 million at closing, before deducting offering fees. The Investors included officers and directors. Scott Garrett purchased $20,000 of securities, Hing C. Wong purchased $60,000 of securities, and Lee Flowers , the Company's SVP Business Development, purchased $20,000 of securities. Under a Registration Rights Agreement, the Company is obligated to file a registration statement to register the securities sold in this offering within 15 business days from closing. 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. 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. 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. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including timing and efficacy in human clinical trial data for HCW9302, ability of HCW11-018b to treat solid tumors, ability to obtain U.S. Food and Drug Administration clearance to advance Phase 2 clinical trials for HCW9302, success in obtaining FDA clearance to initiate clinical trials for HCW11-018b, and effectiveness of commercial-ready reagents for production of immunotherapeutics and the Company's ability to license or sell reagents. 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 June 30, 2026, the Form 10-Q filed with the SEC on August 14, 2026, and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Contact: Rebecca Byam Email: [email protected] (C) 2026 Electronic News Publishing, source ENP Newswire

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