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].

Core Viewpoint - HCW Biologics Inc. reported its financial results for Q3 2025, highlighting advancements in its clinical programs, particularly the upcoming Phase 1 study for HCW9302 targeting autoimmune diseases, and the need for additional funding to ensure continued operations [1][12]. Business Highlights - The company plans to dose the first patient in a Phase 1 clinical study for HCW9302 in Q4 2025, which is aimed at treating autoimmune diseases and inflammatory conditions [2]. - HCW9302 is a novel IL-2 fusion molecule designed to enhance Treg cell activity, which is crucial for controlling inflammation in autoimmune diseases [2]. - The company is actively seeking a commercial partner for its T-cell engager (TCE) compounds, which aim to improve cancer treatment by targeting tumor antigens while reducing immunosuppression in the tumor microenvironment [3]. Financial Results - Revenues for Q3 2025 were $15,606, a significant decrease from $426,423 in Q3 2024. For the nine months ended September 30, 2025, revenues totaled $27,222 compared to $2.2 million in the same period of 2024 [7]. - R&D expenses increased by 18% in Q3 2025 to $1.4 million, while for the nine months, they decreased by 23% to $4.1 million due to prior year manufacturing costs [8]. - G&A expenses rose by 15% in Q3 2025 to $1.9 million, and for the nine months, they increased by 29% to $6.2 million, primarily due to higher salaries and professional fees [9]. - The net loss for Q3 2025 was $4.6 million, compared to $3.9 million in Q3 2024. For the nine months, the net loss was $8.7 million, significantly lower than $26.7 million in the same period of 2024 [11]. Financial Guidance - The company expressed substantial doubt regarding its ability to continue as a going concern for at least 12 months without additional funding [12]. - As of September 30, 2025, the company is not in compliance with Nasdaq's Equity Rule, which requires a minimum stockholders' equity of $2.5 million [13]. - A Nasdaq Hearings Panel granted the company continued listing on the exchange, contingent upon compliance with the Equity Rule by December 31, 2025 [14].

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]

Core Insights - HCW Biologics Inc. will present research data on three lead drug candidates utilizing its TRBC platform technology at the 40th Annual Meeting of the Society for Immunotherapy of Cancer from November 5 to 9, 2025 [1][2] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases, aiming to improve healthspan and quality of life [3] - The company's lead product candidate, HCW9302, was developed using the legacy TOBI platform, while the new TRBC platform allows for the creation of various classes of immunotherapeutic compounds [3] TRBC Platform Details - The TRBC platform enables the development of multiple classes of immunotherapeutic compounds: - Class I: Multi-Functional Immune Cell Stimulators - Class II: Second-Generation Immune Checkpoint Inhibitors - Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers [2][3] - Over 50 molecules have been constructed using the TRBC platform, with ongoing preclinical evaluations based on promising data [3] Upcoming Presentations - The company will showcase three posters at the conference: - **Poster 1**: A novel multi-functional bispecific T-cell engager molecule for cancer therapy (Class III TRBC Compound) on November 7, 2025 [2] - **Poster 2**: A novel tetra-specific pembrolizumab-based immunotherapeutic (Class II TRBC Compound) on November 8, 2025 [2] - **Poster 3**: Enhancing immune cell expansion and checkpoint inhibitor synergy using HCW11-006 (Class I TRBC Compound) on November 8, 2025 [2]

Core Insights - HCW Biologics has announced advancements in its second-generation T-Cell Engager (TCE) program, which aims to improve manufacturability, safety, and efficacy in treating solid tumors compared to first-generation TCEs [2][3] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies to combat age-related diseases linked to chronic inflammation [5] - The company’s lead product candidate, HCW9302, was developed using the legacy TOBI platform, while the new TRBC platform allows for the creation of various immunotherapeutic compounds [5] T-Cell Engager Program - The second-generation TCE program is based on TRBC technology and has shown a positive safety profile in recent non-human primate studies [3] - The new TCEs are designed to address challenges faced by first-generation TCEs, including complex manufacturing, tolerability, and efficacy in solid tumors [3] Research and Development - HCW Biologics has developed over 50 molecules using the TRBC platform, with ongoing preclinical evaluations for selected candidates based on promising data [5] - The TRBC platform enables the development of multiple classes of immunotherapeutics, targeting various diseases including cancer and autoimmune conditions [5]