Core Viewpoint - HCW Biologics Inc. has received FDA clearance to initiate a first-in-human Phase 1 clinical trial for its lead drug candidate HCW9302, aimed at treating moderate-to-severe alopecia areata, an autoimmune disease with no current FDA-approved cure [1][3]. Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases, with a goal to improve healthspan and quality of life [5][6]. - The company's lead product candidate, HCW9302, is developed using the proprietary TOBI platform and is designed to activate and expand regulatory T cells to reduce inflammation without broad immunosuppression [1][5]. Drug Candidate Details - HCW9302 is an injectable interleukin 2 fusion protein complex that targets IL-2αβγ receptors on regulatory T cells, promoting their activation and expansion [1][2]. - Preclinical studies have shown that HCW9302 can effectively treat autoimmune diseases at well-tolerated doses through subcutaneous injections [2]. Clinical Trial Information - The Phase 1 trial aims to establish a safe dosage of HCW9302 that effectively increases Treg cell activity in patients with alopecia areata [3]. - Following the initial trial, the company plans to expand clinical development into Phase 2 studies for other autoimmune diseases and inflammatory conditions [3]. Alopecia Areata Overview - Alopecia areata affects approximately 1 in 1,000 people globally, with a lifetime incidence of 2%, translating to around 160 million individuals [4]. - The condition primarily impacts individuals under 30 and is characterized by sudden hair loss due to the immune system attacking hair follicles [4]. Future Development Plans - The company is exploring the potential of HCW9302 in treating other conditions associated with chronic inflammation, including dermatological issues, graft rejection, arthrosclerosis, diabetes, and neurodegenerative diseases [3][5].

Core Insights - HCW Biologics Inc. has received FDA clearance to initiate a first-in-human Phase 1 clinical trial for HCW9302, targeting moderate to severe alopecia areata, an autoimmune disease with no current FDA-approved cure [1][3] - HCW9302 is an innovative interleukin 2 fusion protein designed to activate and expand regulatory T cells, potentially reducing inflammation without broad immunosuppression [1][2] - Alopecia areata affects approximately 1 in 1,000 people globally, with a lifetime incidence of 2%, impacting around 160 million individuals worldwide [4] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing immunotherapies for diseases associated with chronic inflammation, aiming to improve quality of life and extend healthspan [5][6] - The company's lead product candidate, HCW9302, was developed using the proprietary TOBI platform, which allows for the creation of immunotherapeutics targeting various diseases [6] - HCW Biologics has also developed the TRBC platform, enabling the construction of multiple classes of immunotherapeutic compounds for treating a wide range of conditions, including cancer and autoimmune diseases [6] Clinical Development - The initial goal of the Phase 1 trial for HCW9302 is to establish a safe dosage that effectively increases Treg cell activity in patients [3] - Following the Phase 1 trial, the company plans to expand clinical development into Phase 2 studies for other autoimmune diseases and inflammatory conditions [3] - Existing treatments for alopecia areata primarily manage symptoms rather than providing a cure, highlighting the potential significance of HCW9302 in addressing this unmet medical need [4]

Core Insights - HCW Biologics Inc. is participating in the 2025 GenScript Biotech Global Forum, focusing on challenges in cell and gene therapy (CGT) biomanufacturing and supply chain management [1][5] - Dr. Hing C. Wong, the Founder and CEO of HCW Biologics, will discuss how proprietary molecules developed by the company can reduce costs and enhance clinical efficacy in CGT [3][4] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company dedicated to developing novel immunotherapies aimed at extending healthspan by addressing chronic inflammation linked to various diseases [4] - The company has two drug discovery platforms, including the TOBI™ platform, which generates multi-functional fusion molecules with immunotherapeutic properties [4] Drug Development Focus - HCW Biologics categorizes its drug candidates into three classes: - Class I: Multi-Functional Immune Cell Stimulators - Class II: Second-Generation Immune Checkpoint Inhibitors and Multi-Specific Targeting Fusions - Class III: Enhanced Immune-Cell Engagers [2][4] - The company is targeting treatments for hematologic and solid tumors, virally infected cells, and age-related diseases [2][4] Industry Context - The GenScript Biotech Global Forum aims to address the rapid advancements and commercialization challenges in gene and cell therapy, highlighting the importance of collaboration among scientists, industry leaders, and regulatory bodies [5][6]

Core Insights - HCW Biologics Inc. is participating in the 2025 GenScript Biotech Global Forum, focusing on challenges in cell and gene therapy (CGT) [1][5] - Dr. Hing C. Wong, the CEO, will discuss how proprietary molecules can reduce manufacturing costs and enhance clinical efficacy in CGT [3][4] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company dedicated to developing novel immunotherapies aimed at extending healthspan by addressing chronic inflammation linked to various diseases [4] - The company has developed two drug discovery platforms, including the TOBI™ platform, which generates multi-functional fusion molecules for treating hematologic and solid tumors, viral infections, and age-related diseases [4] Event Details - The 2025 GenScript Biotech Global Forum will take place on January 15, 2025, in San Francisco, concurrently with the J.P. Morgan Healthcare Conference [2][6] - The panel discussion featuring Dr. Wong is scheduled from 4:05 PM to 5:00 PM PT [2] Industry Context - The gene and cell therapy sector is experiencing significant growth, driven by innovations in life sciences and substantial funding from global capital markets [5][6] - The forum aims to address recent advancements, commercialization challenges, and regulatory trends in the CGT field [6]

Core Viewpoint - HCW Biologics Inc. has received a notice from Nasdaq regarding its failure to meet the market value listing requirements, which may lead to delisting unless the company successfully appeals [1][5]. Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies aimed at extending healthspan by addressing chronic inflammation linked to age-related diseases, including cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, autoimmune diseases, and long-haul COVID-19 [6]. Compliance and Delisting Notice - On June 20, 2024, HCW Biologics was notified that its market value of listed securities fell below the $50 million threshold for 30 consecutive business days, leading to a compliance period of 180 days, which ended on December 16, 2024 [1]. - The company did not regain compliance by the deadline, resulting in a notice of potential delisting from Nasdaq unless a hearing is requested [1][5]. Appeal Process - HCW Biologics intends to request a hearing before the Nasdaq Hearing Panel, which will pause any delisting actions while the appeal is considered [5]. - The Panel can grant an extension of up to 180 days for the company to demonstrate compliance with the listing criteria [5].

Core Viewpoint - HCW Biologics Inc. has entered into a securities purchase agreement to raise approximately $6.9 million through a registered direct offering and a concurrent private placement, aimed at advancing its immunotherapy development efforts [1][2]. Group 1: Offering Details - The company will sell 6,717,000 shares of common stock or pre-funded warrants at an effective offering price of $1.03 per share [1]. - In addition, unregistered warrants to purchase up to 6,717,000 shares of common stock will be issued in the private placement [1]. - The offering is expected to close on or about November 20, 2024, pending customary closing conditions [2]. Group 2: Financial Aspects - Gross proceeds from the offering are estimated to be approximately $6.9 million before deducting fees and expenses [2]. - Maxim Group LLC is acting as the sole placement agent for the offering [3]. Group 3: Regulatory Information - The shares are being offered under a shelf registration statement declared effective by the SEC on August 26, 2022 [4]. - The warrants issued in the private placement are not registered under the Securities Act of 1933 and will be offered under Section 4(a)(2) and Regulation D [4]. Group 4: Company Overview - HCW Biologics is focused on developing novel immunotherapies to address age-related diseases linked to chronic inflammation [6]. - The company utilizes two drug discovery platforms, including the TOBI™ platform, to create multifunctional fusion molecules with immunotherapeutic properties [6]. - HCW9218 is set to be included in a Phase 2 clinical trial for advanced ovarian cancer in combination with chemotherapy [6].

HCW Biologics entered into License, Research and Co-Development Agreement with WY Biotech for one of its new proprietary preclinical molecules HCW Biologics to receive upfront payment of $7 million and is eligible to receive additional milestone payments and double-digit royalties on future product sales MIRAMAR, Fla., Nov. 18, 2024 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing n ...

F UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Securities registered pursuant to Section 12(b) of the Act: Title of each classTrading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share HCWB The Nasdaq Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE S ...

Exhibit 99.1 HCW Biologics Reports Third Quarter 2024 Financial Results and Business Highlights Miramar, FL– November 14, 2024 – 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 age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2024. Dr. H ...

MIRAMAR, Fla., Nov. 14, 2024 (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 age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2024.  Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “In the third quarter 20 ...