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) [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 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 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].

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 ...

Drug Development and Clinical Trials - HCW Biologics reported a focus on developing novel immunotherapies targeting age-related diseases linked to chronic inflammation, with a significant emphasis on the TOBI™ drug discovery platform[61]. - The company has manufactured quantities of four TOBI-based molecules in a cGMP manufacturing setting, indicating readiness for clinical applications[65]. - HCW9218 is a clinical-stage bifunctional molecule aimed at reducing senescent cells and their proinflammatory factors, with a Phase 2 study planned for ovarian cancer[66]. - The company has exclusive rights to develop HCW9218 for age-related diseases other than cancer, leveraging findings from Phase 1 studies completed in early 2024[67]. - HCW9302 is under FDA review for an IND application, targeting autoimmune indications, with plans to explore its utility in neurodegenerative diseases[71][72]. - The company has initiated IND-enabling activities for HCW9206, which is designed to stimulate T cell proliferation and enhance immune responses against tumors[73]. - HCW9201 is currently being evaluated in a Phase 1 clinical trial for Acute Myeloid Leukemia, with potential for further indications[74]. - A new drug discovery platform utilizing a novel protein scaffold has been developed, expanding treatment possibilities beyond the TOBI™ platform[75]. Financial Performance and Revenue - Revenues for the three months ended September 30, 2024, were $426,423, a decrease of 50% from $853,102 in the same period of 2023[101]. - Revenues for the nine months ended September 30, 2024, were $2,171,988, an increase from $1,517,792 for the same period in 2023[100]. - The principal source of revenue has been from the Wugen License and Master Services Agreement, which includes nonrefundable upfront payments and royalties[86]. - The company has not generated any revenue from commercial product sales of its internally-developed immunotherapeutic products as of September 30, 2024[133]. Expenses and Losses - Operating expenses are primarily composed of research and development expenses and general and administrative expenses[88]. - Research and development expenses are expected to increase substantially as the Company continues to develop its product candidates[90]. - General and administrative expenses increased by $129,216, or 9%, from $1,509,936 for the three months ended September 30, 2023, to $1,639,152 for the same period in 2024[109]. - Net loss for the three months ended September 30, 2024, was $3,902,288, compared to a net loss of $14,313,746 for the same period in 2023[100]. - Total operating expenses for the three months ended September 30, 2024, were $3,775,520, compared to $15,256,684 for the same period in 2023[100]. - Legal expenses increased from $4.6 million for the nine months ended September 30, 2023, to $15.8 million for the nine months ended September 30, 2024[129]. Funding and Financial Strategy - The company signed an out-license agreement with Wugen, Inc., receiving a 5.6% ownership interest, which supports its financing strategy for clinical development[78]. - The Company has launched a new financing plan, issuing $6.9 million in Secured Notes and is authorized to issue up to $10.0 million[81]. - The Company raised $9.4 million in financing in 2024, including a $2.5 million private placement of common stock and $6.5 million from the issuance of Secured Notes[134]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $8.9 million, significantly higher than the previous year's $716[144]. - The Company continues to seek financing to complete the construction of its new headquarters, which is currently facing mechanics liens from subcontractors[134]. Operational Challenges - As of September 30, 2024, substantial doubt exists regarding the Company's ability to continue as a going concern for at least 12 months without additional funding[82]. - The Company is facing headwinds from inflation, rising interest rates, and supply chain disruptions impacting operations and costs[83]. - The Company anticipates further cost reductions or restructuring after reassessing its clinical development strategy[134]. - As of September 30, 2024, the company had $1.0 million in cash and cash equivalents, raising substantial doubt about its ability to operate for the next 12 months[133].

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 ...

This release has made a correction to a release issued under the same headline on August 14, 2024, by HCW Biologics, Inc. (NASDAQ: HCWB), to show the amount included in the condensed interim balance sheet for Cash and cash equivalents as of December 31, 2023 as $3,595,101, not $95,101 as previously stated. The full text of the corrected release is as follows: MIRAMAR, Fla., Aug. 23, 2024 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceuti ...

Exhibit 99.1 HCW Biologics Reports Second Quarter 2024 Financial Results and Business Highlights Miramar, FL– August 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 second quarter ended June 30, 2024. Dr. Hing C ...