Financial Performance - Revenues for Q4 2024 were $394,804, a decrease of 70.5% compared to $1.3 million in Q4 2023; total revenues for the fiscal year 2024 were $2.6 million, down from $2.8 million in 2023[11] - Net loss for Q4 2024 was $3.4 million, compared to a net loss of $10.7 million in Q4 2023; total net loss for 2024 was $30.0 million, up from $25.0 million in 2023[11] - Revenues for the three months ended December 31, 2023, were $1,324,003, compared to $394,804 for the same period in 2024, representing a significant increase[18] - Net loss for the three months ended December 31, 2023, was $(10,680,530), compared to $(3,373,273) for the same period in 2024, indicating a worsening financial position[18] - Total operating expenses for the three months ended December 31, 2023, were $11,020,836, up from $3,238,720 in 2024, reflecting increased costs[18] - The accumulated deficit as of December 31, 2023, was $(70,532,323), which increased to $(100,556,137) in 2024, highlighting ongoing financial challenges[20] - The company reported a net loss per share of $(0.30) for the three months ended December 31, 2023, compared to $(0.08) for the same period in 2024[18] - Weighted average shares outstanding increased from 35,996,415 in 2023 to 42,301,694 in 2024, reflecting potential dilution of shares[18] Research and Development - R&D expenses for Q4 2024 were $1.0 million, a decrease of 51% from $2.1 million in Q4 2023; total R&D expenses for 2024 were $6.4 million, down 17% from $7.7 million in 2023[11] - Research and development expenses for the year ended December 31, 2023, were $7,676,316, compared to $6,388,994 in 2024, showing a year-over-year increase[18] - The company constructed 50 proprietary compounds using the TRBC platform for treating hematologic and solid tumors, virally infected cells, and age-related diseases[3] - The company is focusing on developing Immune-Cell Engagers, including T-Cell Engagers, through corporate partnerships and out-licensing arrangements[6] - The company received clearance from the FDA to initiate a Phase 1 clinical trial for HCW9302 in patients with moderate-to-severe alopecia areata[9] Financial Position and Funding - The company raised $16.3 million in 2024 through various financing transactions, including a $6.9 million securities purchase agreement with an institutional investor[6] - The company expects to receive $7.0 million from WY Biotech in June 2025 under an exclusive licensing agreement for the preclinical drug HCW11-006[6] - Legal expenses for 2024 increased by 142% to $15.9 million, primarily due to costs associated with arbitration proceedings[11] - The company has substantial doubt regarding its ability to continue as a going concern for at least 12 months without additional funding[12] Assets and Liabilities - Cash and cash equivalents as of December 31, 2023, were $3,595,101, compared to $4,674,572 in 2024, indicating a decrease in liquidity[20] - Total assets as of December 31, 2023, were $28,513,660, compared to $30,236,578 in 2024, showing a growth in total assets[20] - Total liabilities increased significantly from $15,051,943 in 2023 to $37,006,750 in 2024, indicating a rise in financial obligations[20]

Core Insights - HCW Biologics Inc. is focused on developing novel immunotherapies to address age-related diseases and has reported its financial results for the fourth quarter and fiscal year ended December 31, 2024 [1] Business Highlights - The company has received clearance to begin clinical trials for HCW9302, targeting alopecia areata, and has developed a new drug discovery platform utilizing T-cell Receptor β Chain constant region (TRBC) [2] - HCW Biologics has constructed 50 proprietary compounds using the TRBC platform aimed at treating various cancers and age-related diseases [2] - The company entered an exclusive licensing agreement with WY Biotech, expecting to receive $7 million in June 2025, and has opt-in rights for the Americas market after a Phase 1 clinical trial [5] Financial Results - Revenues for Q4 2024 were $394,000, down from $1.3 million in Q4 2023, while total revenues for the year decreased from $2.8 million in 2023 to $2.6 million in 2024 [9] - Research and development expenses decreased by 51% in Q4 2024 to $1 million, and for the year, R&D expenses fell by 17% to $6.4 million [9] - General and administrative expenses increased by 22% in Q4 2024 to $2 million, while remaining stable at $6.8 million for the year [9][10] Legal and Compliance - The company faced three deficiency notices from Nasdaq regarding stock price and market value but received an extension to regain compliance [9] - A special meeting of stockholders is scheduled for March 31, 2025, to approve critical proposals for compliance, including a reverse stock split [9] Future Outlook - The company has launched a multi-step financing plan and plans additional capital-raising activities in the first half of 2025 [11] - There is substantial doubt regarding the company's ability to continue as a going concern without additional funding [11]

Core Viewpoint - HCW Biologics Inc. has received an extension from the Nasdaq Hearings Panel to regain compliance with listing rules, allowing the company to continue its operations on the Nasdaq Capital Market [1][2]. Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies aimed at extending healthspan by addressing inflammation-related age diseases [1][3]. - The company’s lead product candidate, HCW9302, is developed using the TOBI™ platform, while another drug discovery technology, the TRBC platform, allows for the creation of various immunotherapeutic compounds [3]. Compliance and Listing Status - The Nasdaq Panel granted the company an extension to demonstrate compliance with the Bid Price Rule by April 25, 2025, and all other continued listing rules by June 15, 2025 [2]. - The extension follows a hearing where the company's compliance plan was evaluated [2]. Product Development and Pipeline - HCW Biologics is developing immunotherapeutics that target chronic inflammation, with applications in oncology and other diseases associated with aging [3]. - The TRBC platform has enabled the creation of over 50 molecules, with ongoing preclinical evaluations for several promising candidates [3].

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 ...