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].

Company Overview - HCW Biologics Inc. is focused on developing proprietary immunotherapies targeting chronic inflammation and age-related diseases, with a particular emphasis on cancer and conditions that impact quality of life [149]. - The company has a clinical development pipeline that includes lead product candidates targeting life-threatening diseases such as pancreatic and ovarian cancer, as well as quality-of-life conditions like alopecia areata [154]. - The company’s TRBC platform is designed to create novel immunotherapeutics, including multi-specific cytokines and immune checkpoint inhibitors, aimed at treating cancer and age-related diseases [157]. - The company is focused on diseases with no curative FDA-approved treatments, particularly those driven by chronic inflammation and senescence [154]. - HCW Biologics aims to establish control over its clinical supply of materials and licensed molecules, responding to industry trends favoring domestic manufacturing [164]. Financial Performance - The Company recognized revenues of $426,423 and $15,606 for the three months ended September 30, 2024 and 2025, respectively, with revenues derived exclusively from the sale of licensed molecules to Wugen and related ancillary services [210]. - The Company has recognized $16.2 million of revenues derived from the Wugen License since inception, including upfront license fees and payments for materials [190]. - Revenues increased from $2.2 million for the nine months ended September 30, 2024, to $27,222 for the nine months ended September 30, 2025, primarily from the sale of licensed molecules to Wugen [231]. - The Company reported a net loss of $26,650,541 for the nine months ended September 30, 2025, compared to a net loss of $8,678,941 for the same period in 2024 [209]. - The company reported a net loss of $8.7 million for the nine months ended September 30, 2025, compared to a net loss of $26.7 million for the same period in 2024 [275]. Research and Development - Research and development expenses increased by $217,334, or 18%, from $1.2 million for the three months ended September 30, 2024 to $1.4 million for the three months ended September 30, 2025 [212]. - The Company expects research and development expenses to increase substantially for the foreseeable future as it continues the development of its product candidates [195]. - The Company has identified over 50 proprietary compounds for clinical development, with a focus on a select few for internal programs and clinical trials [168]. - HCW9302, the lead product candidate for autoimmune disorders, is expected to begin a Phase 1 clinical trial in Q4 2025, targeting alopecia areata [169]. - The Company presented a novel multi-functional bispecific T-cell engager molecule at the SITC meeting, highlighting its broad coverage and favorable pharmacokinetics [174]. Expenses and Cost Management - Total operating expenses for the nine months ended September 30, 2025, were $27,189,472, compared to $8,706,133 for the same period in 2024 [209]. - Salaries, benefits, and related expenses within research and development rose by 23% from $652,867 in Q3 2024 to $801,504 in Q3 2025 [211]. - General and administrative expenses increased by $251,537, or 15%, from $1.6 million for the three months ended September 30, 2024, to $1.9 million for the three months ended September 30, 2025 [219]. - Manufacturing and materials expense increased by $2,511, or 5%, from $47,748 for the three months ended September 30, 2024, to $50,259 for the three months ended September 30, 2025 [214]. - Clinical activities expenses decreased by $83,781, or 51%, from $164,139 for the three months ended September 30, 2024, to $80,358 for the three months ended September 30, 2025 [216]. Financing and Capital Structure - The company has raised $2.2 million through the issuance of 475,000 shares of Common Stock under its Standby Equity Purchase Agreement as of September 30, 2025 [160]. - The Company raised $7.0 million in the nine months ended September 30, 2025 through issuance of equity securities [254]. - The Company closed on a $5.0 million follow-on public offering with an offering priced at the market under Nasdaq rules in the nine months ended September 30, 2025 [257]. - The company is actively seeking financing to complete the renovation of a biologics manufacturing facility [266]. - The company believes there is substantial doubt regarding its ability to continue as a going concern for at least 12 months from the date of the financial statements without additional funding [269]. Legal and Compliance Issues - The Company entered a forbearance agreement with BE&K Building Group due to unpaid invoices related to construction, which terminated on March 31, 2025, leading to legal proceedings [165]. - The Company has a loan agreement with Cogent Bank for $6.5 million, which is currently in default due to mechanics liens, and negotiations for a forbearance agreement are ongoing [166]. - The Company reported a balance of $12.1 million for legal fees incurred in connection to the Arbitration but not yet paid as of September 30, 2025 [247]. - The company is negotiating terms for a forbearance agreement with Cogent Bank to address mechanics liens related to construction [268]. - The company was granted an extension until December 31, 2025 to regain compliance with the Nasdaq Listing Rules related to the minimum requirements to maintain a $2.5 million balance in stockholders' equity [258]. Market and Investment Risks - The company has a primary exposure to market risk related to interest rate sensitivity, affected by changes in U.S. interest rates [295]. - The fair value of the Wugen investment declined from $3.3 million as of June 30, 2025, to $1.3 million as of September 30, 2025 [287]. - The fair value of the related contingent liability for rights to proceeds from the sale or liquidation of Wugen shares decreased from $1.7 million to $692,531 during the same period [287]. - The company recognized an unrealized loss of $966,284 in the three months ended September 30, 2025, and an unrealized net gain of $782,404 in the nine months ended September 30, 2025 [287]. - The company has limited access to liquidity for Wugen common stock until these shares become publicly traded [295].

Financial Performance - Revenues for Q3 2025 were $15,606, a significant decrease from $426,423 in Q3 2024, while revenues for the nine months ended September 30, 2025, were $27,222 compared to $2.2 million in the same period of 2024[8]. - The net loss for Q3 2025 was $4.6 million, compared to a net loss of $3.9 million in Q3 2024, while the net loss for the nine months ended September 30, 2025, was $8.7 million compared to $26.7 million in the same period of 2024[12]. - Revenues for the three months ended September 30, 2024, were $426.4 million, a significant increase from $15.6 million in the same period of 2025[19]. - Net loss attributable to common stockholders for the three months ended September 30, 2024, was $3.9 million, compared to a loss of $4.6 million in the same period of 2025[19]. - Total operating expenses for the nine months ended September 30, 2024, were $27.19 million, compared to $8.71 million in the same period of 2025[19]. Research and Development - R&D expenses increased by 18% to $1.4 million in Q3 2025 from $1.2 million in Q3 2024, while R&D expenses for the nine months ended September 30, 2025, decreased by 23% to $4.1 million from $5.3 million in the same period of 2024[9]. - Research and development expenses for the nine months ended September 30, 2024, totaled $5.34 billion, up from $4.11 billion in the same period of 2025[19]. - The company plans to dose the first patient in a Phase 1 clinical study for HCW9302 in autoimmune disease patients in Q4 2025[3]. - HCW Biologics has opened two clinical sites for a Phase 1 trial evaluating HCW9302 in patients with alopecia areata, a condition affecting approximately 160 million people globally[7]. General and Administrative Expenses - G&A expenses rose by 15% to $1.9 million in Q3 2025 from $1.6 million in Q3 2024, with a 29% increase in the nine-month period to $6.2 million from $4.8 million[10]. Financial Position and Concerns - As of September 30, 2025, the company expressed substantial doubt about its ability to continue as a going concern without additional funding[13]. - Total current assets decreased to $5.70 million as of December 31, 2024, from $1.59 million as of September 30, 2025[21]. - Total liabilities increased to $37.01 million as of December 31, 2024, compared to $27.55 million as of September 30, 2025[21]. - Cash and cash equivalents were $4.67 million as of December 31, 2024, down from $1.10 million as of September 30, 2025[21]. - Accounts payable increased to $22.33 million as of December 31, 2024, from $18.97 million as of September 30, 2025[21]. - The accumulated deficit grew to $100.56 million as of December 31, 2024, compared to $109.24 million as of September 30, 2025[21]. Legal and Compliance - The company received a $2.0 million insurance reimbursement related to legal fees in January 2025, contributing to a net legal recovery of ($1.6) million for the nine months ended September 30, 2025[11]. - The Nasdaq Hearings Panel granted the company continued listing on the Exchange, contingent upon compliance with the Equity Rule by December 31, 2025[14]. Commercial Strategy - The company is seeking a commercial partner for its T-cell engager compounds to enhance cancer treatment efficacy[5].

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]