As filed with the Securities and Exchange Commission on February 13, 2026 Registration No. 333-293396 Amendment No. 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 HCW BIOLOGICS INC. (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 3 ...

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].

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]