MIRAMAR, Fla., Nov. 19, 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 health span by targeting the link between chronic inflammation and disease, today announced it has entered into a warrant inducement agreement with an investor (“Investor”) for the immediate exercise of certain outstanding warrants that the Company issued on November 20, 2 ...

Core Viewpoint - HCW Biologics Inc. has initiated a first-in-human clinical trial for HCW9302, an innovative immunotherapeutic targeting alopecia areata, marking a significant milestone in the company's development of treatments for autoimmune diseases [1][4]. Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing immunotherapies aimed at chronic inflammation and age-related diseases [7]. - The company's lead product candidate, HCW9302, is a subcutaneously injectable interleukin-2 fusion molecule developed using the TOBI™ platform technology [2][7]. Product Details - HCW9302 is designed to activate and expand regulatory T cells (Treg cells), which play a crucial role in controlling excessive inflammation associated with autoimmune diseases [2][3]. - The active component, interleukin-2, is essential for maintaining Treg cell functions, which are critical in preventing immune cells from attacking the body [2]. Clinical Trial Information - The Phase 1 multi-center trial aims to treat up to 30 patients with alopecia areata, focusing on establishing the safety and recommended dose of HCW9302 [4][5]. - The trial's primary objectives include evaluating the safety of HCW9302 and determining the appropriate dose for subsequent studies, while secondary objectives will assess disease responses and Treg cell activity [4]. Market Potential - Alopecia areata affects approximately 160 million people globally, with around 7 million in the United States, representing a significant market opportunity for effective treatments [3][6]. - Current treatments for alopecia areata primarily manage symptoms rather than providing a cure, highlighting the need for innovative solutions like HCW9302 [6]. Future Development Plans - The company plans to expand clinical development of HCW9302 into Phase 2 studies for alopecia areata and other autoimmune diseases, including vitiligo and atopic dermatitis [4][5]. - Additionally, HCW9302 may be explored for its potential benefits in various inflammatory conditions and neurodegenerative diseases, such as Alzheimer's [4].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40591 HCW Biologics Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-5024477 (State or other jurisdiction of incorporation or organization) 2929 N. Commerce Parkway Identification No.) Miramar, Florida 33025 (Address of principal executive offi ...

EXHIBIT 99.1 HCW Biologics Reports Third Quarter 2025 Business Highlights and Financial Results Miramar, FL – 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, today reported financial results and recent business highlights for its three months ended September 30, 2025. The Company antic ...

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 eva ...

Core Insights - HCW Biologics Inc. announced the latest data for its first-in-class immune checkpoint inhibitor, HCW11-040, at the SITC2025 conference, highlighting its potential in treating cancer and age-related diseases [1][3] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies aimed at extending healthspan by addressing chronic inflammation and age-related diseases [4][6] - The company has developed a new drug discovery technology, the TRBC platform, which allows for the creation of various classes of immunotherapeutic compounds [6] Product Candidate Details - HCW11-040 is a multi-functional fusion protein that combines IL-15 and IL-7 domains with a TGF-β trap, demonstrating PD-1/PD-L1 blocking activity comparable to pembrolizumab in preclinical studies [2][5] - Preclinical data indicates that HCW11-040 significantly expands and activates TPEX cells and enhances anti-tumor activity of human peripheral blood mononuclear cells against cancer cells without causing excessive inflammatory responses [3][5] Development Plans - The company plans to advance additional IND-enabling studies for HCW11-040, including the establishment of a high-expression manufacturing cell bank and preclinical toxicology studies [3]

Core Insights - HCW Biologics has presented data on its tetra-valent, second-generation T-Cell Engager (TCE) Program at the SITC 40 Annual Meeting, showcasing advancements over first-generation products [1][2] - The lead TCE product candidate, HCW11-018b, demonstrated significant efficacy in preclinical studies, achieving 100% survival in tumor-bearing mice, particularly in models of pancreatic cancer and glioblastoma [2] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies aimed at treating diseases linked to chronic inflammation, including various cancers and autoimmune diseases [4] - The company utilizes its proprietary TRBC platform technology to create immunotherapeutics that activate immune responses and target cancerous cells [6] Product Development - The second-generation TCE program is designed to address limitations of bi-specific T-cell engagers, including manufacturability and safety, while expanding treatment options for solid tumors and potentially autoimmune diseases [1][2] - HCW Biologics has constructed over 50 molecules using the TRBC platform, with ongoing preclinical evaluations for selected candidates [6] Clinical and Preclinical Findings - The tetra-valent TCE construct has shown broad coverage for human solid tumor indications, with high potency and precision in xenograft models, including Patient-Derived Xenograft (PDX) models [5] - The product candidate HCW11-018b has a favorable tolerability profile and long serum half-life, with a streamlined GMP manufacturing process similar to therapeutic monoclonal antibodies [5] Presentation and Availability - A poster detailing the TCE program will be presented at the SITC meeting, with the ePoster available on the company's website following the presentation [2][3]

Core Insights - HCW Biologics Inc. presented data on its tetra-valent, second-generation T-Cell Engager (TCE) Program at the SITC 40th Annual Meeting, showcasing advancements in immunotherapy aimed at extending healthspan by addressing inflammation-related diseases [1][2] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies to treat diseases associated with chronic inflammation, particularly age-related conditions [4] - The company has developed a new drug discovery technology, the TRBC platform, which allows for the creation of various classes of immunotherapeutic compounds targeting cancer and autoimmune diseases [4] Product Development - The lead T-cell engager product candidate, HCW11-018b, demonstrated significant efficacy in preclinical studies, achieving 100% survival in tumor-bearing mice, while untreated mice showed no survival [2] - The second-generation TCE program is designed to enhance treatment options for a range of solid tumors, including pancreatic cancer and glioblastoma, and may also address autoimmune diseases [2][4] Research Findings - The preclinical evaluation highlighted the unique features of HCW11-018b, including its ability to shrink established tumors in xenograft models and its favorable tolerability profile in non-human primates [2][5] - The tetra-valent construct is designed to overcome immunosuppressive tumor microenvironments and activate exhausted T cells, showing long serum half-life and favorable pharmacokinetics [5] Future Directions - The company is conducting ongoing preclinical evaluation studies for selected molecules based on promising data and has established licensing programs for some proprietary molecules [6]

Core Insights - HCW Biologics Inc. is focused on developing novel immunotherapies aimed at extending healthspan by addressing inflammation and age-related diseases [1][4] - The company's lead product candidate, HCW11-040, is a second-generation immune checkpoint inhibitor that combines pembrolizumab with interleukin-7, interleukin-15, and TGF-β receptor components [2][4] - HCW Biologics will present data on HCW11-040 at the upcoming SITC annual meeting on November 8, 2025 [3] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company that aims to treat diseases associated with chronic inflammation, particularly those related to aging [4] - The company has developed a new drug discovery platform called TRBC, which allows for the creation of various classes of immunotherapeutics [4] - HCW Biologics has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-006, HCW11-018, and HCW11-040, with ongoing preclinical evaluations [4]

Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and associated diseases [5] - The company's lead product candidate, HCW9302, was developed using the TOBI™ platform, and it has also created the TRBC platform for constructing immunotherapeutics [5] - The TRBC platform enables the development of multiple classes of immunotherapeutic compounds, including multi-functional immune cell stimulators and second-generation immune checkpoint inhibitors [5] Upcoming Event - HCW Biologics will participate in the 2025 Maxim Growth Summit on October 22nd to 23rd at The Hard Rock Hotel NYC, which gathers industry leaders and innovators [1] - Dr. Hing C. Wong, the CEO, will meet with institutional investors and senior analysts during the event [2] - Keynote speakers at the summit include Larry Kudlow and Christopher Ruddy, with discussions covering various sectors including biotechnology and artificial intelligence [3] Company Pipeline - The company has constructed over 50 molecules using the TRBC platform, with ongoing preclinical evaluation studies based on promising data [5] - HCW Biologics has two licensing programs for exclusive rights to some proprietary molecules [5] Maxim Group Overview - Maxim Group LLC is a full-service investment banking and wealth management firm providing a range of financial services [6] - The firm is registered with the U.S. Securities and Exchange Commission and is a member of FINRA, SIPC, and NASDAQ [6]