MIRAMAR, Fla., May 15, 2025 (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 health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its first quarter ended March 31, 2025. On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 milli ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 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 March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40591 HCW Biologics Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-5024477 (State or other jurisdictio ...

Exhibit 99.1 HCW Biologics Reports First Quarter 2025 Business Highlights and Financial Results Miramar, FL – May 15, 2025 – HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its first quarter ended March 31, 2025. On May 15, 2 ...

Core Viewpoint - HCW Biologics Inc. has announced a follow-on offering of 671,140 units at a price of $7.45 per unit, aiming to raise approximately $5.0 million for various developmental and corporate purposes [1][3]. Group 1: Offering Details - The offering consists of units that include one share of common stock (or pre-funded warrant) and two warrants, each with an exercise price of $7.45, exercisable immediately and expiring five years from the issuance date [1]. - The closing of the offering is expected around May 15, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to funding preclinical and clinical development, including trials for HCW9302, business development, out-licensing, collaborations, patent portfolio expansion, research and development, and general corporate purposes [3]. Group 3: Existing Warrants Adjustment - The company has negotiated to reduce the exercise price of certain existing warrants from $41.20 to $7.45 per share [4]. Group 4: Company Overview - HCW Biologics Inc. is focused on developing novel immunotherapies targeting chronic inflammation and age-related diseases, with a lead product candidate, HCW9302, developed using the TOBI™ platform [7]. - The company has also created the TRBC platform for constructing immunotherapeutics that target immune responses and cancerous cells, with over 50 molecules developed [7][8].

Addresses key challenges for CAR-T therapies Potential to significantly reduce costs and improve clinical efficacy of engineered effector T cells Data Shared at 2025 Annual Meeting of American Association of Immunologists MIRAMAR, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend healthspan by targeting the link between chronic inf ...

MIRAMAR, Fla., April 01, 2025 (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 health span by disrupting the link between inflammation and age-related diseases, today announced that its Board of Directors has approved a 1-for-40 reverse stock split of the Company's common stock, par value $0.0001 ("Common Stock"), which will be effective at 12:01 a.m. Ea ...

Drug Development and Clinical Trials - HCW Biologics Inc. is developing proprietary immunotherapies targeting chronic inflammation and age-related diseases, aiming to improve quality of life and potentially extend longevity[16]. - The company has two drug discovery platforms: the TOBI™ platform for multi-functional fusion proteins and the TRBC platform for novel immunotherapeutics[19][20]. - HCW9302, a first-in-kind IL-2 fusion protein, has received FDA clearance to initiate a Phase 1 clinical study for alopecia areata, with plans to expand to other indications[23]. - HCW9218, a bifunctional immunotherapeutic, is designed to reduce senescent cells and their proinflammatory factors, with clinical studies planned pending a supply agreement with ImmunityBio[27][30]. - The company has constructed over 50 compounds using the TRBC platform, focusing on selecting lead compounds for further development[34]. - The company aims to develop second-generation immune checkpoint inhibitors and multi-specific targeting fusions, with a focus on collaborations with larger pharmaceutical companies for Class III molecules[36]. - The Phase 1 trial for HCW9302 is a significant milestone, with potential expansion into other autoimmune diseases and serious inflammatory conditions if successful[50]. - The Company received FDA clearance for a Phase 1 clinical trial of HCW9302 in patients with moderate-to-severe alopecia areata, with the lead site expected to open in late Q2 or early Q3 2025[66]. - The Company plans to seek a partner for the development of T-Cell Engager and other Immune Cell Engagers in Q2 2025[66]. - The Company intends to refine potential expanded indications for Phase 2 clinical studies during Phase 1, focusing on autoimmune diseases and inflammatory conditions[66]. - The Company anticipates completing efficacy assessments in mice and safety profiling in non-human primates for HCW11-006 by the end of 2025[98]. - The Company has completed cGMP production of five molecules as of December 31, 2024, sufficient for planned Phase 1/2 clinical trials in 2025 and 2026[113]. - The Company purchased a 36,000 square foot building in Florida for cGMP clinical drug manufacturing, with validation expected in the first half of 2026[115]. Market and Competitive Landscape - The global population aged 60 years and older was estimated at 1.4 billion in 2020, expected to double to 2.1 billion by 2050, highlighting the growing need for treatments addressing age-related diseases[58]. - The company faces competition from major pharmaceutical and biotechnology companies, academic institutions, and research organizations, emphasizing the need for a strong competitive strategy[147]. - The company faces significant competition from larger pharmaceutical and biotechnology firms with greater financial resources and expertise in R&D, manufacturing, and clinical trials[148]. - The market for immune checkpoint inhibitors is dominated by Merck & Co. and Bristol Myers Squibb, with key products like Pembrolizumab (Keytruda®) and Nivolumab (Opdivo) facing patent expirations in 2028[157]. - The company recognizes the risk of competitors developing safer and more effective products that could capture market share before its own products are approved[155]. - There is a growing interest in targeting aging-related diseases, with major pharmaceutical companies investing heavily in this area due to its enormous market potential[151]. - The company is competing in the oncology segment against established players like Amgen and Pfizer, focusing on innovative therapies[150]. Intellectual Property and Licensing - As of December 31, 2024, the Company holds ten issued U.S. patents and 124 pending patent applications worldwide[120]. - The Company has created over 50 immunotherapeutic molecules and expects out-licensing to provide non-dilutive financing for core markets and programs[107]. - The Company entered into a license agreement with Wugen for two fusion protein molecules, retaining manufacturing rights and receiving milestone payments and royalties[108][109]. - The exclusive worldwide license agreement with Wugen grants rights to develop, manufacture, and commercialize cellular therapy products, with HCW Biologics retaining a 5.6% ownership interest in Wugen as of December 31, 2024[140]. - The WY Biotech License Agreement includes milestone payments as the licensed molecule advances through clinical trials, with double-digit royalties upon commercialization[145]. - The company has established expertise in preclinical research, manufacturing, quality control, regulatory affairs, and clinical trial design, which supports its product development efforts[138]. Regulatory Environment - The FDA requires a Biologics License Application (BLA) to include results from all preclinical and clinical testing, along with data on pharmacology, chemistry, and manufacturing[168]. - Most BLAs are classified as Standard Review, which typically takes ten months, while Priority Review applications are reviewed within six months[170]. - The FDA may require a risk evaluation and mitigation strategy (REMS) as a condition of BLA approval to ensure the benefits outweigh potential risks[171]. - Accelerated approval may be granted for products that provide a meaningful therapeutic advantage, based on surrogate endpoints or earlier clinical endpoints[179]. - The FDA's Food and Drug Omnibus Reform Act (FDORA) allows for post-approval studies to be required prior to or shortly after approval, with progress reports due every 180 days[180]. - Adverse event reporting and periodic reports are mandatory after BLA approval, with the FDA able to impose post-marketing testing and surveillance[187]. - Manufacturers must maintain compliance with current Good Manufacturing Practices (cGMP) after approval, subject to periodic inspections by the FDA[187]. - The FDA has the authority to withdraw product approvals if regulatory standards are not met or if new safety issues arise post-marketing[186]. Financial and Market Access Challenges - Coverage and reimbursement for pharmaceutical products depend on third-party payors, with no uniform policy existing in the U.S.[204]. - Obtaining coverage and adequate reimbursement for products administered under physician supervision may be particularly challenging due to higher prices[205]. - The U.S. government and foreign governments are implementing cost-containment programs, including price controls and restrictions on coverage[206]. - The Inflation Reduction Act (IRA) allows HHS to negotiate prices for 10 high-cost Medicare Part D products starting in 2026, with 15 additional drugs selected for negotiation in 2027[207]. - The IRA imposes rebates on Medicare Part B and Part D drugs whose prices increase faster than inflation, with finalized regulations announced in November 2024[207]. Research and Development Focus - The company is involved in the development of treatments for bronchopulmonary dysplasia (BPD), addressing unmet needs in premature infants[156]. - The complexity of clinical development for Class III TRBC Molecules is more suited for well-capitalized pharmaceutical companies, presenting challenges for smaller firms[105]. - The company is exploring the potential of HCW9302 in targeting neurodegenerative diseases, with ongoing collaborations to understand its biology[153]. - The methods of promoting NK cell activation and proliferation are covered by U.S. Patent Nos. 11,730,762 and 11,738,052, along with 16 pending patent applications across various jurisdictions[128].

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].