Core Insights - HCW Biologics has entered into an exclusive worldwide license agreement with WY Biotech for the development and commercialization of the proprietary molecule HCW11-006, valued at $7 million [1][2] - The Phase 1 clinical study for HCW11-006 is expected to begin in the first half of 2027, targeting solid tumors [3][4] - HCW Biologics retains a royalty-free option to reclaim rights for the Americas territory after the Phase 1 trial [4] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases [6] - The company has developed over 50 molecules using its TRBC drug development platform, which aims to create immunotherapeutics for various diseases, including cancer and autoimmune disorders [6][7] Partnership and Financials - A new entity, Beijing Trimmune Biotech Co., Ltd., has been established to manage the development and commercialization of HCW11-006, backed by CITIC Medical Fund and TigerYeah Capital Fund [2][3] - Trimmune has initiated payment of $1.75 million as part of a $3.5 million upfront cash license fee to HCW Biologics, with additional milestone payments and royalties expected from future sales [3][4] Development Strategy - Trimmune plans to leverage the expertise of HCW Biologics and its own management team to advance the clinical development of HCW11-006, aiming to address significant unmet medical needs in the Chinese market [2][5] - The collaboration is expected to facilitate the exploration of business development opportunities with multinational corporations once key clinical data is generated [4][5]

Table of Contents As filed with the Securities and Exchange Commission on February 11, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 HCW BIOLOGICS INC. (Exact name of Registrant as specified in its charter) Delaware 2834 82-5024477 (State or Other Jurisdiction of Incorporation or Organization) Primary Standard Industrial Classification Code Number 2929 N Commerce Parkway Miramar, FL 33025 (9 ...

FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 HCW BIOLOGICS INC. Table of Contents As filed with the Securities and Exchange Commission on January 9, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 (Exact name of Registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 82-5024477 Primary Standard Industrial Classification Code Number 2929 N Commerce Parkway Miramar, FL 33025 (954 ...

Core Viewpoint - HCW Biologics Inc. has entered into a warrant inducement agreement with an investor for the immediate exercise of certain outstanding warrants, which is expected to generate approximately $4.0 million in gross proceeds [1][3]. Group 1: Warrant Inducement Agreement - The investor has agreed to a reduced exercise price of $2.66 for the November 2024 and May 2025 Warrants, allowing the purchase of 167,925 and 1,342,280 shares of common stock, respectively [1]. - In exchange for the immediate exercise of existing warrants, the company will issue unregistered warrants to purchase an aggregate of 3,020,410 shares at an exercise price of $2.41 per share [3]. - The closing of the warrant exercise transactions is anticipated to occur on or about November 20, 2025, subject to customary closing conditions [4]. Group 2: Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases [7]. - The company's lead product candidate, HCW9302, is being evaluated in a Phase 1 clinical trial for autoimmune diseases, with additional TRBC-based molecules in the IND-enabling process for cancer and age-related diseases [8]. - HCW Biologics has developed over 50 molecules using its TRBC platform, which aims to create a new class of immunotherapeutics for various disease indications [7][8].

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]