Tobramycin

MIRAMAR, Fla., Aug. 18, 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 second quarter ended June 30, 2025. On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, “We are pleased to have completed a successful $5.0 million equity offering in a challenging market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder.” Dr. Wong continued, “Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our novel TRBC drug discovery and development platform.” Business Highlights Business Development Transactions On May 30, 2025, WY Biotech ended its due diligence period and formally accepted the technical report delivered by the Company on May 13, 2025. In order to accommodate WY Biotech’s timing in finalizing legally binding agreements with its CDMO and lead investor, the Company and WY Biotech agreed to extend the latest date for payment of the $7.0 million license fee to September 30, 2025. On May 29, 2025, after recognizing over $16.0 million in revenue from the Wugen License Agreement signed in 2020, the Company agreed to a one-year suspension of the Wugen License Agreement, during which time the Company may seek alternative licensing programs for HCW9206. The Company is actively negotiating with several major biologics manufacturing companies interested in licensing the molecule as a reagent to use in the manufacture of CAR-T products. HCW9206 represents a novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a stem cell-like memory T cell phenotype, which is expected to enhance the persistence of CAR-Ts in patients. The Company has launched a search for a strong commercial partner for the clinical development of its T-cell engager compounds. The Company believes that its T-cell engagers target cancer antigens and CD3 activation of effector T cells while simultaneously reducing the immunosuppression in tumor microenvironment. Such immunosuppression could play a pivotal role in reducing effector T-cell infiltration and anti-tumor efficacy in solid tumors. Financing Transactions On May 15, 2025, the Company completed a $5.0 million offering with a single institutional investor for an aggregate of 671,140 units at a purchase price of $7.45 per unit priced at-the-market under Nasdaq rules. Each unit includes two warrants, which may be exercised to purchase common stock at $7.45 per share. On May 7, 2025, the Company extinguished $7.7 million of debt through restructuring or conversion to equity. As a result, the Company strengthened its balance sheet and completed an important element of its compliance plan with all Nasdaq Listing Rules. Clinical Development and Preclinical Results The Company remains on track to initiate the HCW9302 clinical trial in the third quarter of 2025. This trial is a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. The Company identified compounds created with the Company’s novel TRBC platform for clinical development: Second-Generation T-Cell Engagers and Second-Generation Immune Checkpoint Inhibitors. The Company’s T-cell engager compounds target tissue factor, which is a proven solid tumor antigen. The second-generation immune checkpoint inhibitors are the Company’s candidates as a potential gateway to the multi-billion-dollar immune checkpoint inhibitors product market. The Company has identified its pembrolizumab-based fusion molecule as its lead candidate because in preclinical IND-enabling studies this compound exhibits potent anti-pancreatic cancer activities. Second Quarter 2025 Financial Results Revenues: Revenues for the second quarters ended June 30, 2024 and 2025 were $618,854 and $6,550, respectively. Revenues for the six months ended June 30, 2024 and 2025 were $1.7 million and $11,615, respectively. Revenues were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the second quarter of 2025, the Company agreed to a one-year suspension of the Wugen License Agreement, during which time, the Company plans to identify a new corporate partner who wishes to license HCW9206. Research and development (R&D) expenses: R&D expenses for the second quarters ended June 30, 2024 and 2025 were $2.0 million and $1.2 million, respectively, a decrease of $802,362, or 40%. R&D expenses for the six months ended June 30, 2024 and 2025 were $4.2 million and $2.7 million, respectively, a decrease of $1.5 million, or 35%. R&D expenses were comparatively lower in 2025 primarily due to a decline in manufacturing and material and preclinical expenses. General and administrative (G&A) expenses: G&A expenses for the second quarters ended June 30, 2024 and 2025 were $1.6 million and $2.1 million, respectively, an increase of $501,828, or 31%. G&A expenses for the six months ended June 30, 2024 and 2025 were $3.2 million and $4.3 million, respectively, an increase of $1.1 million, or 36%. The increase in G&A expenses in 2025 was primarily related to an increase in fees for professional services, accretion of a fixed bonus payable upon Maturity Date to Secured Noteholders and insurance costs. Professional services include legal fees in the ordinary course of business, accounting advisors, auditing and tax services, facilities administrative costs, expenses related to maintaining our listing on Nasdaq and remaining in compliance with SEC filings, and other expenses. Legal expenses and recoveries, net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration. On July 13, 2024, the parties entered into a Settlement Agreement and General Release, and the Arbitration and related Complaint were dismissed on December 24, 2024. For the three and six months ended June 30, 2024, preparations for the hearing and the hearing took place, along with subsequent negotiations for settlement, and the Company incurred legal fees of $10.4 million and $14.8 million, respectively. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to $12.3 million legal fees which remain unpaid. Net loss: Net loss for the second quarters ended June 30, 2024 and 2025 were $15.3 million and $1.9 million, respectively. Net loss earnings for the six months ended June 30, 2024 and 2025 were $22.7 million and $4.1 million, respectively. Financial Guidance As of June 30, 2025, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the audited financial statements, without additional funding or financial support. We considered future elements of our financing plan, especially business development programs, that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in our going concern analysis. We have had early success in completing key elements of our multi-step financing plan, however, we cannot be assured that we will continue to have success with remaining elements of our plan. On June 24, 2025, HCWB received formal notice from Nasdaq confirming that the Company has satisfied the requirements of Listing Rule 5550(b)(1) (the “Equity Rule”). On May 13, 2025, the Company received formal notice from Nasdaq that it regained compliance with the bid price requirement in Listing Rule 5550(a)(2), the public float requirement in Listing Rule 5550(a)(4), and the market value of publicly held shares requirement in Listing Rule 5550(a)(5). Therefore, the Company now meets all Nasdaq Capital Market listing requirements for continued listing, and these matters are closed. The Company was also notified that it will remain subject to a “Panel Monitor,” as that term is defined in Nasdaq Listing Rule 5815(d)(4)(B), for a period of one year from the date of the Nasdaq notice, through June 23, 2026. If, during the term of the Panel Monitor, the Company does not continue to remain in compliance with the Equity Rule, the Company will not be provided with the opportunity to submit a compliance plan for review by the Listing Qualifications Staff and must instead request a hearing before the Panel to address the deficiency, with such request staying any further action with respect to the Company’s listing on Nasdaq pending completion of the hearing process. About HCW Biologics HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause for senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is such a versatile scaffold that it enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform, including HCW11-002, HCW11-018 and HCW11-040. Further preclinical evaluation studies are currently being conducted for these three molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/ Forward Looking Statements Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include: the Company’s ability to develop new immunotherapeutic treatments for non-oncology or oncology indications; timing of initiation of studies for age-related diseases; the Company’s ability to continue as a going concern and that after considering the elements of the Company’s financing plan that were probable to occur within a year of the date of issuance, the Company concluded that substantial doubt was not alleviated in its going concern analysis; the Company’s cash runway; the Company’s expectations regarding future purchases of licensed molecules by Wugen; the Company’s ability to license its preclinical molecules; the initiation of patient enrollment for a clinical trial to evaluate HCW9302; whether the Company’s second-generation, pembrolizumab-based immunotherapeutics is effective against solid tumors, particularly for pancreatic and ovarian cancer; whether the Company’s two lead T-cell engagers target tissue factor and mesothelin are effective in reducing immunosuppression in tumor microenvironment; the Company’s future capital-raising including business development plans and ability to continue with clinical development efforts until they are achieved, if at all; and Company’s ability to pay legal fees incurred in connection with the arbitration with ImmunityBio and its affiliates. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2025 and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Company Contact: Rebecca Byam CFO HCW Biologics Inc. rebeccabyam@hcwbiologics.com

每周药品注册获批数据，分门别类呈现，一目了然。(7.14-7.20）新药上市申请药品名称企业注册分类受理号玛赛洛沙韦片南京征祥医药有限公司1CXHS2400011植物源重组人血清白蛋白注射液武汉禾元生物科技股份有限公司1CXSS2400098舒西利单抗注射液海南赛乐敏生物科技有限公司1CXSS2300072新药临床申请药品名称企业注册分类受理号YKYY029注射液北京悦康科创医药科技股份有限公司1CXHL2500569Safusidenib胶囊葆元生物医药科技(杭州)有限公司1CXHL2500473WJ47DZ片南京逸境生物医药科技有限公司1CXHL2500472WJ47DZ片南京逸境生物医药科技有限公司1CXHL2500471HRS-5041片江苏恒瑞医药股份有限公司1CXHL2500470HRS-5041片江苏恒瑞医药股份有限公司1CXHL2500469HRS-5041片江苏恒瑞医药股份有限公司1CXHL2500468HRS-5041片江苏恒瑞医药股份有限公司1CXHL2500466KW-040注射液北京凯因科技股份有限公司1CXHL2500463马来酸苏特替尼胶囊江苏迈度药物研发有限公司1CXHL2500452炔丙基半胱氨酸胶囊依诺医药(广东)有限公司1CXHL2500447炔丙基半胱氨酸胶囊依诺医药(广东)有限公司1CXHL2500446DEG6498胶囊杭州达歌生物医药科技有限公司1CXHL2500456DEG6498胶囊杭州达歌生物医药科技有限公司1CXHL2500455DEG6498胶囊杭州达歌生物医药科技有限公司1CXHL2500454NTS071片上海宇道生物技术有限公司1CXHL2500451CMS-D001片海南德镁医药科技有限责任公司1CXHL2500440纳米氧化铁注射液苏州欣影生物医药技术有限公司1CXHL2500439HRS-1893片山东盛迪医药有限公司1CXHL2500431SBK017口服溶液成都施贝康生物医药科技有限公司2.2CXHL2500477YH2201干混悬剂浙江益汉制药有限公司2.2CXHL2500438YH2201干混悬剂浙江益汉制药有限公司2.2CXHL2500437WS-019湖北午时药业股份有限公司2.2CXHL2500415GBI268注射液苏州智耀生物科技有限公司2.2CXHL2500414舒沃替尼片迪哲(江苏)医药股份有限公司2.4CXHL2500462舒沃替尼片迪哲(江苏)医药股份有限公司2.4CXHL2500461二价重组呼吸道合胞病毒疫苗(CHO 细胞)浙江三叶草生物制药有限公司1.2CXSL2500331重组三价脊髓灰质炎疫苗(Sf-RVN细胞)康希诺生物股份公司1.2CXSL2500324注射用HDM2012杭州中美华东制药有限公司1CXSL2500483注射用HS-20093上海翰森生物医药科技有限公司1CXSL2500380SIBP-A16 注射液上海生物制品研究所有限责任公司1CXSL2500379注射用GB268嘉和生物药业有限公司1CXSL2500372IBI3011信达生物制药(苏州)有限公司1CXSL2500369注射用RC278荣昌生物制药(烟台)股份有限公司1CXSL2500368注射用VDJ006北京伟德杰生物科技有限公司1CXSL2500363注射用DB-1305映恩生物制药(苏州)有限公司1CXSL2500362注射用DB-1311映恩生物制药(苏州)有限公司1CXSL2500361BAT4406F注射液百奥泰生物制药股份有限公司1CXSL2500349注射用重组病毒巨噬细胞炎性蛋白广州弘润生物科技有限公司1CXSL2500346HCL001细胞注射液上海慧存医疗科技有限公司1CXSL2500323仿制药申请药品名称企业注册分类受理号注射用盐酸头孢替安/氯化钠注射液湖南科伦制药有限公司3CYHS2501904复合磷酸氢钾注射液济南康桥医药科技有限公司3CYHS2501851盐酸溴己新口服溶液合肥远志医药科技开发有限公司3CYHS2501814复方聚乙二醇电解质散(II)湖南普道医药技术有限公司3CYHS2404347盐酸普罗帕酮注射液江苏神龙药业有限公司3CYHS2402489腺苷钴胺胶囊杭州沐源生物医药科技有限公司3CYHS2401029硫酸沙丁胺醇口服溶液浙江恒研医药科技有限公司3CYHS2400946葡萄糖酸钙注射液石家庄四药有限公司3CYHS2400869异烟肼注射液沈阳红旗制药有限公司3CYHS2400870盐酸麻黄碱注射液成都苑东生物制药股份有限公司3CYHS2400825法莫替丁注射液湖南柏齐鹤药物研发有限公司3CYHS2400817腺苷钴胺胶囊湖南千金湘江药业股份有限公司3CYHS2400793美索巴莫注射液西洲医药科技(浙江)有限公司3CYHS2400686盐酸曲唑酮片河北龙海药业有限公司3CYHS2400436米诺地尔搽剂乐福思健康产业股份公司3CYHS2400413米诺地尔搽剂乐福思健康产业股份公司3CYHS2400411盐酸去氧肾上腺素注射液珠海前列药业有限公司3CYHS2400406盐酸去氧肾上腺素注射液珠海前列药业有限公司3CYHS2400404盐酸丙卡特罗口服溶液江苏广承药业有限公司3CYHS2400259腺苷钴胺胶囊浙江美迪深生物医药有限公司3CYHS2400254盐酸丙卡特罗口服溶液岳阳新华达制药有限公司3CYHS2400185复合磷酸氢钾注射液浙江高跖医药科技股份有限公司3CYHS2400139异烟肼注射液辽宁海神联盛制药有限公司3CYHS2400095己酮可可碱缓释片浙江赛默制药有限公司3CYHS2400115盐酸溴己新口服溶液河南上恒医药科技有限公司3CYHS2400065盐酸溴己新口服溶液河南上恒医药科技有限公司3CYHS2400066磷酸奥司他韦颗粒海南涛生医药科技研究院有限公司3CYHS2400033碳酸司维拉姆干混悬剂昆明贝克诺顿制药有限公司3CYHS2400037卡络磺钠注射液河北欣瑞未来科技有限公司3CYHS2303552注射用赖氨匹林海南天盛保和生物科技有限公司3CYHS2303496膦甲酸钠注射液华夏生生药业(北京)有限公司3CYHS2303384富马酸酮替芬滴眼液石家庄四药有限公司3CYHS2303334硫辛酸片福安药业集团烟台只楚药业有限公司3CYHS2303304硫辛酸片福安药业集团烟台只楚药业有限公司3CYHS2303302聚乙烯醇滴眼液浙江视方极医药科技有限公司3CYHS2303155盐酸纳洛酮注射液重庆中创科医药有限公司3CYHS2303080盐酸纳洛酮注射液重庆中创科医药有限公司3CYHS2303079盐酸拉贝洛尔氯化钠注射液北京柏雅联合药物研究所有限公司3CYHS2302925法莫替丁注射液中山万汉制药有限公司3CYHS2302780葡萄糖酸钙氯化钠注射液安徽丰原药业股份有限公司淮海药厂3CYHS2302661葡萄糖酸钙氯化钠注射液安徽丰原药业股份有限公司淮海药厂3CYHS2302660吲哚布芬片北京伟林恒昌医药科技有限公司3CYHS2302426依帕司他片广州仁恒医药科技股份有限公司3CYHS2302333盐酸伐地那非片山东华铂凯盛生物科技有限公司4CYHS2402999乳果糖口服溶液河南合智医药科技有限公司4CYHS2402771妥布霉素滴眼液扬州中宝药业股份有限公司4CYHS2402292氧(液态)浙江中龙气体科技有限公司4CYHS2402148沙库巴曲缬沙坦钠片湖南千金协力药业有限公司4CYHS2401748聚乙烯醇滴眼液浙江百代医药科技有限公司4CYHS2401649注射用阿糖胞苷仁合熙德隆药业有限公司4CYHS2401365注射用阿糖胞苷仁合熙德隆药业有限公司4CYHS2401363阿仑膦酸钠片山东华铂凯盛生物科技有限公司4CYHS2401153枸橼酸西地那非片河南中帅医药科技股份有限公司4CYHS2400864枸橼酸西地那非口腔崩解片济南高华制药有限公司4CYHS2400859精氨酸布洛芬颗粒中山万汉制药有限公司4CYHS2400765精氨酸布洛芬颗粒中山万汉制药有限公司4CYHS2400764替米沙坦氨氯地平片(II)湖南慧泽生物医药科技有限公司4CYHS2400459利奥西呱片江苏华阳制药有限公司4CYHS2400370利奥西呱片江苏华阳制药有限公司4CYHS2400369利奥西呱片江苏华阳制药有限公司4CYHS2400368醋酸加尼瑞克注射液成都圣诺生物制药有限公司4CYHS2400298盐酸曲美他嗪缓释片广州白云山医药集团股份有限公司白云山制药总厂4CYHS2400195甲磺酸雷沙吉兰片苏中药业集团股份有限公司4CYHS2400180硫酸阿巴卡韦片上海迪赛诺医药集团股份有限公司4CYHS2303477ω-3脂肪酸乙酯90软胶囊浙江医药股份有限公司新昌制药厂4CYHS2303154硫糖铝混悬凝胶云南积大生物科技有限公司4CYHS2302301二十碳五烯酸乙酯软胶囊四川科伦药业股份有限公司4CYHS2301645盐酸帕罗西汀肠溶缓释片北京世桥生物制药有限公司4CYHS2301313利斯的明透皮贴剂宜昌人福药业有限责任公司4CYHS2300811利斯的明透皮贴剂宜昌人福药业有限责任公司4CYHS2300810盐酸达泊西汀片植恩生物技术股份有限公司4CYHS2201518国;CYHS2201518舒更葡糖钠注射液江苏万高药业股份有限公司4CYHS2101401国;CYHS2101401舒更葡糖钠注射液江苏万高药业股份有限公司4CYHS2101402国;CYHS2101402瑞卢戈利片江苏联环药业股份有限公司3CYHL2500092布立西坦口服溶液山东达因海洋生物制药股份有限公司3CYHL2500091克霉唑阴道片浙江高跖医药科技股份有限公司4CYHL2500090倍氯米松福莫特罗吸入气雾剂合肥力成药业有限公司4CYHL2500088艾美赛珠单抗注射液南京正大天晴制药有限公司3.3CXSL2500357艾美赛珠单抗注射液南京正大天晴制药有限公司3.3CXSL2500356HWS111注射液湖北生物医药产业技术研究院有限公司3.3CXSL2500351进口申请药品名称企业注册分类受理号司美格鲁肽注射液Novo Nordisk Pharma AG2.2JXSS2400069司美格鲁肽注射液Novo Nordisk Pharma AG2.2JXSS2400068Rilzabrutinib片Sanofi-Aventis Recherche & Developpement1JXHL2500112AZD9833片ASTRAZENECA AB1JXHL2500107TQJ230注射液Novartis Pharma AG1JXHL2500103注射用KSP-1007-05Sumitomo Pharma Co., Ltd.1JXHL2500087AZD9793AstraZeneca AB1JXSL2500075Mezagitamab注射剂Takeda Development Center Americas, Inc.1JXSL2500067VHB937注射用浓溶液Novartis Pharma AG1JXSL2500065RisankizumabAbbVie Inc.2.1JXSL2500072RisankizumabAbbVie Inc.3.1JXSL2500073中药相关申请药品名称企业注册分类受理号化瘀解热颗粒四川省中医药转化医学中心1.1CXZL2500025枇杷清肺颗粒神威药业集团有限公司3.1CXZS2400032枇杷清肺饮颗粒天士力医药集团股份有限公司3.1CXZS2400002注：橙色字体部分结论为不批准或收到通知件；