Meropenem

导语：我国多重耐药菌感染现况严峻，以革兰阴性菌的疾病负担最为突出。近期，新β内酰胺酶抑制剂复方制剂头孢洛生-他唑巴坦正式上市，为治疗带来全新选择。时逢中华医学会第五次真菌细菌感染学术会议（BISC大会）（2025年8月7日~9日）举行，医脉通邀约来自复旦大学附属华山医院的杨帆教授、四川省医学科学院·四川省人民医院的喻华教授、天津市第一中心医院的杨文杰教授（按照专家姓名拼音首字母排序），共同探讨当前的诊疗策略及未来优化方向，为临床提供重要参考。 从耐药监测数据洞察 中国多重耐药菌感染现况 作为长期致力于微生物耐药监测领域的资深专家，喻华教授为我们分享了我国当前的耐药现状。结合全国细菌耐药监测网（CRASS）和中国细菌耐药监测网（CHINET）的数据，目前医院环境中主要分离的病原菌仍以革兰阴性杆菌为主，占70%。阴性杆菌中排名靠前的是大肠埃希菌、肺炎克雷伯菌、铜绿假单胞菌（PA）、鲍曼不动杆菌等1。 肠杆菌三代头孢耐药的情况较为突出，且不同肠杆菌目对于三代头孢的耐药性存在差异，CARSS最新数据显示，大肠埃希菌与肺炎克雷伯菌对三代头孢菌素的耐药率分别为48.7%和26.6%，整体呈现缓慢下降的趋势。产超广谱β内酰胺酶的大肠埃希菌检出率持续达到50%以上，构成重要的临床威胁2。WHO在2024年发布的重点病原体目录中，把产超广谱β内酰胺酶的肠杆菌（ESBL-E）列为了关键优先组的病原体3。本次BISC 2025大会上也有多个议题涉及ESBL-E，颁布了ESBL-E最新专家共识，引起临床高度关注4。大部分ESBL-E均携带超广谱β内酰胺酶，同时也会因为质粒介导、基因突变或整合呈现出多重耐药表型，临床治疗选择压力转移至碳青霉烯类，同时也加剧了对碳青霉烯类的耐药4。数据显示肺炎克雷伯菌对亚胺培南和美罗培南的耐药率分别达到22.6%和23.4%1。 除了ESBL-E，PA的耐药现状也不容忽视。中国多中心监测抗菌药物耐药性趋势研究（SMART）的结果显示，多重耐药铜绿假单胞菌（MDR-PA）、广泛耐药铜绿假单胞菌（XDR-PA）和难治性铜绿假单胞菌（DTR-PA）的检出率分别达到57.3%、43.5%、16.8%5。目前，PA对亚胺培南和美罗培南的耐药率分别达到21.3%和17.3%1，2024年整体耐药率与前几年相比略有下降趋势，但DTR-PA的治疗仍然属于临床难题。 临床治疗方案优化策略 聚焦PA、ESBL-E PA感染篇 杨帆教授对PA的临床治疗做了相关分享。PA是一类经典且历史悠久的耐药菌种，长期治疗选择比较有限。很多医生认为碳青霉烯治疗PA很强，但事实上它与临床常用的其他药物如三四代头孢菌素、β内酰胺酶抑制剂复方制剂、喹诺酮类等相比并无明显优势。目前针对DTR-PA的新药有头孢洛生-他唑巴坦、亚胺培南-西司他丁-瑞来巴坦等，除了常规的药物，也希望微生物实验室能增加这些新药物的药敏检测，给临床提供更多选择。 喻华教授指出，国内外多项研究及报道均表明，头孢洛生对DTR-PA在体外呈现出高敏感性，这与其独特的结构优势密不可分。其核心作用机制在于，头孢洛生对细菌细胞壁合成的关键物质——青霉素结合蛋白具有高度亲和力，通过与之结合可有效抑制细菌的生长与繁殖6。 头孢洛生-他唑巴坦的这种结构优势在临床数据中也得到了证实。发表在《Lancet Infect Dis》上的研究显示，对于多重耐药PA导致的肺炎或菌血症，头孢洛生-他唑巴坦的疗效显著优于头孢他啶-阿维巴坦（治疗成功率61%vs52%）7。多项指南推荐在PA、CRPA、DTR-PA感染中将头孢洛生-他唑巴坦作为治疗首选8-10。 ESBL-E感染篇 对于ESBL-E感染的诊治，抗菌药物的合理应用和分层管理非常重要。杨文杰教授指出，目前临床对于ESBL-E感染应基于感染部位、感染严重程度、是否存在ESBL感染的高风险以及免疫功能状态综合评估，再予以适当的治疗4。若存在ESBL高风险的重症或免疫功能低下患者感染，首选碳青霉烯类药物，当重症患者感染稳定后，可考虑降级为酶抑制剂复方制剂；轻中度感染患者，也可以基于药敏结果直接选择酶抑制剂复方制剂类，减轻碳青霉烯类的用药压力4。同时，应根据有无鲍曼不动杆菌或铜绿假单胞菌感染的风险差异性选择是否覆盖上述非发酵菌的碳青霉烯类抗菌药物。 相关临床研究比较了头孢洛生-他唑巴坦与碳青霉烯在ESBL-E感染中的疗效。发表在《Lancet Infect Dis》上的ASPECT-NP研究评估了两者治疗G-菌HABP/VABP的疗效与安全性，结果显示：头孢洛生-他唑巴坦在28天全因死亡率和临床痊愈率方面均不劣于美罗培南11。此外，ASPECT-cIAI研究（vs美罗培南）、ASPECT-cUTI研究（vs左氧氟沙星）证明其疗效与目前主流疗法相当，可作为临床新的治疗选择12,13。《53版热病》明确指出，对于ESBL大肠埃希菌、ESBL克雷伯菌属，头孢洛生-他唑巴坦可作为备选药物8。 杨帆教授特别强调，美国感染病学会的指引可能对哌拉西林-他唑巴坦对于ESBL-E的疗效存在顾虑，因为其在血流感染中的病死率高于碳青霉烯类。但需要注意，其依据来自于血流感染，不能推广至所有的ESBL-E感染。头孢洛生-他唑巴坦对于ESBL-E的抗菌活性强于哌拉西林-他唑巴坦，相关临床研究也证实其在ESBL-E所致肺部感染、腹腔感染中的疗效不劣于美罗培南，它在ESBL-E中的治疗潜力值得期待。 此外，酶抑制剂复方制剂的PK/PD也一直受到临床医生们的关注。杨帆教授指出，任何两种酶抑制剂的复方制剂，两者的药代动力学特点不应相差太大，包括半衰期、表观分布、排泄途径、蛋白结合率等，才能在感染部位发挥预期的疗效。头孢洛生-他唑巴坦在肺部、腹腔感染中都有较高的药效学达标率，支持其用于多系统的感染6,14,15。此外，它也有安全性方面的优势，此前在国外已经应用十余年，积累了丰富的临床数据，此次获批的适应症中有两个可用于新生儿（cIAI和cUTI）6，填补此领域的治疗空白。 防控优化策略 全程管理·合理应用 基于当前多重耐药菌感染的严峻现况，如何优化院感防控策略？杨文杰教授分享了她的关键见解，首先临床需要重视“关口前移”这一防控理念4。对于多重耐药菌感染，碳青霉烯有着不可替代的作用，但其使用也受到严格的管控和限制，在此背景下，加强ESBL-E的防控，使碳青霉烯耐药菌（CRO）防控“关口前移”，可对两大耐药难题（指产ESBL酶和碳青霉烯酶）同时带来获益4。 此外，还要重视院感防控的全程管理。杨文杰教授认为：抗菌药物合理利用、医院感染的防控缺一不可。医疗机构需要制定合理、能够满足临床需要的抗菌药物目录，并借助信息化的手段完善事前分级管理和提醒拦截、事后审核及监管，形成完整的PDCA（P：plan计划；D：do执行；C：check检查；A：action处理）循环。对于医务人员、患者和家属，都需要强化抗菌药物和卫生护理常识相关培训，实现从社区到医院全链条的耐药菌防控。 在抗菌药物的选择上，一些新型的药物对AMS有重要价值，应在满足临床疗效的前提下降低抗菌药物的使用强度，并优先选择诱导耐药率更低的药物。杨文杰教授指出，在轻中度的ESBL-E感染中考虑使用头孢洛生-他唑巴坦在内的β内酰胺酶抑制剂复方制剂等抗菌药，减少碳青霉烯的使用强度4。在PA感染中，头孢洛生-他唑巴坦的诱导耐药率远低于美罗培南和头孢他啶-阿维巴坦16,17，可作为优选。另外，减少联合用药是当前的大趋势，如果单药治疗已经表现出预期的临床疗效，联合治疗并没有额外的获益，只会增加抗菌药物相关不良事件的风险18。对于DTR-PA，尽管之前的多项专家共识和指南都建议联合治疗，但2024 IDSA耐药革兰阴性菌感染治疗指南指出，对于危重患者或感染控制不佳的患者，可考虑使用新型β-内酰胺类抗菌药物应对PA感染，首选头孢洛生-他唑巴坦、头孢他啶-阿维巴坦、亚胺培南-西司他丁-瑞来巴坦等10。有条件的医疗机构，宜积极检测耐药基因，根据耐药机制灵活选用酶抑制剂复方制剂，必要时早期合理用药，提高治疗成功率。 总  结 BISC 2025大会已经圆满落幕，但抗感染领域的多学科学术交流不会停息。本次多学科专家访谈聚焦革兰阴性菌耐药现状和趋势，就PA和ESBL-E的临床诊疗策略、院感防控策略优化做了深度交流和分享。核心要点如下： 目前革兰阴性菌仍是多重耐药的主要菌种，CRO、ESBL-E、PA的耐药趋势较为严峻，临床应重视“关口前移”，加强ESBL-E防控，规范各类抗生素的使用； 新β内酰胺酶抑制剂复方制剂为临床提供新选择，对于PA感染，头孢洛生-他唑巴坦可作为首选；对于ESBL-E感染，头孢洛生-他唑巴坦可作为碳青霉烯备选； 新β内酰胺酶抑制剂复方制剂对AMS有临床获益，头孢洛生-他唑巴坦在降低抗生素使用强度、降低耐药风险、减少联合用药方面有临床获益。 专家简介 杨帆 教授 主任医师，医学博士 复旦大学附属华山医院院感科主任，抗生素研究所临床应用室主任 中华医学会细菌感染与耐药防治分会常委兼秘书长 中华预防医学会感染控制专业委员会常委 中国医药教育协会感染疾病专业委员会常委 中国细菌耐药监测网专家委员会委员 全国抗菌药物临床应用监测网专家委员会委员 全国真菌病监测网专家委员会委员 上海市医学会感染与化疗分会主任委员 上海市医院协会医院感染管理专委会副主任委员 上海市医师协会临床合理用药分会副会长 上海市抗菌药物合理应用与管理专委会办公室主任 培元、培英、培微项目专家委员会委员 喻华 教授 教授、主任技师 四川省医学科学院，四川省人民医院 四川省卫生健康委学术技术带头人 四川省细菌耐药监测中心主任 四川省临床检验中心微生物室间质评负责人 全国细菌耐药监测学术委员会委员，数据处理组副组长 中华医学会细菌感染与耐药防治分会常委 中国医药教育协会临床微生物专业委员会副主任委员 中国医药教育协会感染疾病专业委员会常委 中国医促会临床微生物与感染分会常委 中国合格评定国家认可委员会ISO15189技术评审专家 四川省医学会细菌感染与耐药防治委员会候任主任委员 四川省抗菌药物合理使用专家委员会副主任委员 主要从事感染性疾病的实验室诊断、细菌耐药性监测、耐药机制研究 杨文杰 教授 主任医师，教授，硕士研究生导师 天津市第一中心医院感染科主任 国家卫健委抗菌药物临床应用与细菌耐药评价专委会感染工作组委员 国家感染性疾病专业医疗质量控制中心专委会委员 国家卫健委医院感染控制标准专业委员会委员 国家卫健委医疗机构感染防控专家委员会委员 中国研究型医院学会感染性疾病循证与转化专委会副主任委员 中华医学会细菌感染与耐药防治分会常委、天津市主委 中国医师协会感染科医师分会委员、天津市感染科医师协会会长 天津市抗微生物药物应用管理专家委员会办公室主任 天津市卫生健康委感染性疾病质控中心主任 中国老年医学会医院感染管理质量控制分会常委 中国医院协会抗菌药物合理应用工作委员会常委  中国医院协会医院感染管理专业委员会委员 中华医学会感染性疾病分会委员、天津市副主委           天津市预防医学会医院感染控制分会副主任委员 《新发传染病杂志电子版》《临床肝胆病杂志》常务编委、《中华临床感染病杂志》、《中华医院感染学杂志》、《药物不良反应杂志》等编委，《中华传染病学杂志》、《Infectious Diseases & Immunity》、《中国药物警戒》等杂志审稿专家 参考文献 1.CHINET中国细菌耐药监测网. CHINET 2024年细菌耐药监测结果（2024年1-12月） 2.王山梅, 等.2015—2021年CHINET临床分离大肠埃希菌耐药性变迁[J].中国感染与化疗杂志,2025,25(1):39-47. 3.WHO Bacterial Priority Pathogens List, 2024 4.卓超，徐英春，俞云松．临床产超广谱β-内酰胺酶肠杆菌目细菌感染应对策略专家共识（2025）[J/OL]．协和医学杂志.https://link.cnki.net/urlid/11.5882.r.20250702.1432.004 5.Yu W, et al. In-vitro activity of ceftolozane/tazobactam against Pseudomonas aeruginosa collected in the Study for Monitoring Antimicrobial Resistance Trends (SMART) between 2016 and 2019 in China. Int J Antimicrob Agents. 2023 Apr;61(4):106741. 6.注射用头孢洛生他唑巴坦钠说明书 7.Shields RK, et al. Effectiveness of ceftazidime-avibactam versus ceftolozane-tazobactam for multidrug-resistant Pseudomonas aeruginosa infections in the USA (CACTUS): a multicentre, retrospective, observational study. Lancet Infect Dis. 2025 May;25(5):574-584.  8.热病桑福德抗微生物诊疗指南（53版） 9.中华医学会呼吸病学分会感染学组,瞿介明,施毅,沈宁,卓超,徐金富,周华,苏欣,范红,张静,余丹阳,黄怡,田欣伦.中国铜绿假单胞菌下呼吸道感染诊治专家共识(2022年版)[J].中华结核和呼吸杂志,2022,45(8):739-752. 10.Tamma PD, et al. Infectious Diseases Society of America 2024 Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections. Clin Infect Dis. 2024 Aug 7:ciae403.  11.Kollef MH, et al. Ceftolozane-tazobactam versus meropenem for treatment of nosocomial pneumonia (ASPECT-NP): a randomised, controlled, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis. 2019 Dec;19(12):1299-1311. 12.Solomkin J, et al. Ceftolozane/Tazobactam Plus Metronidazole for Complicated Intra-abdominal Infections in an Era of Multidrug Resistance: Results From a Randomized, Double-Blind, Phase 3 Trial (ASPECT-cIAI). Clin Infect Dis. 2015;60(10):1462-1471.  13.Wagenlehner FM, et al. Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated urinary-tract infections, including pyelonephritis: a randomised, double-blind, phase 3 trial (ASPECT-cUTI). Lancet. 2015;385(9981):1949-1956.  14.Caro L, et al. Lung penetration, bronchopulmonary pharmacokinetic/pharmacodynamic profile and safety of 3 g of ceftolozane/tazobactam administered to ventilated, critically ill patients with pneumonia. J Antimicrob Chemother. 2020 Jun 1;75(6):1546-1553.  15.Yoshimura K, et al. Ceftolozane-Tazobactam Pharmacokinetics in the Abdominal Tissue of Patients Undergoing Lower Gastrointestinal Surgery: Dosing Considerations Based on Site-Specific Pharmacodynamic Target Attainment. Infect Dis Ther. 2023 Jan;12(1):193-207. 16.Johnson MG,et al. Evaluating the emergence of nonsusceptibility among Pseudomonas aeruginosa respiratory isolates from a phase-3 clinical trial for treatment of nosocomial pneumonia (ASPECT-NP). Int J Antimicrob Agents. 2021 Mar;57(3):106278.  17.Shah S, et al. Clin Infect Dis. 2024 Jun 21:ciae332. 18.袁瑾懿(编译),林东昉(审校).美国感染病学会对产超广谱β内酰胺酶肠杆菌目细菌、碳青霉烯类耐药肠杆菌目细菌和难治性耐药铜绿假单胞菌的治疗指导原则[J].中国感染与化疗杂志,2021,21(5):633-638. 撰写：Bela 审校：Bela 排版：Zelda 执行：Atai 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

– Transformational deal for CorMedix that expands and diversifies company’s commercial product portfolio, with seven innovative drug products and a pipeline expansion indication with near–term revenue growth potential – – Revised guidance of pro forma 2025 combined revenues, now estimated to be in the range of $325 to $350 million – – Transaction expected to be near-term accretive to EPS with double-digit accretion expected in 2026; annual run-rate synergies expected to be ~$35 to $45 million – Berkeley Heights, NJ – September 2, 2025 – CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that it has successfully completed its previously announced acquisition of Melinta Therapeutics LLC (“Melinta”), a private commercial-stage company providing innovative therapies for acute and life-threatening illnesses. “This acquisition is a transformational step in the evolution of CorMedix, providing an attractive revenue base of highly synergistic assets, as well as multiple opportunities to drive future growth. We are excited to complete the acquisition of Melinta, which enables us to expand our product portfolio in the hospital space while delivering therapies to patients with high unmet need,” said Joseph Todisco, CEO of CorMedix Inc. “The combination with Melinta creates a formidable and diversified specialty platform with a deep and experienced team in the hospital acute care and infectious disease arena.” Strategic and Financial Benefits Strengthens portfolio with multiple growth-driving assets – Seven marketed products (MINOCIN®, REZZAYO™, VABOMERE®, ORBACTIV™, BAXDELA®, KIMYRSA®, and TOPROL-XL®) will add revenue and expanded reach in infectious disease. Diversifies and increases portfolio and revenue base and cash flow – Melinta’s portfolio generated total revenues of $120 million in 2024 and is expected to deliver $125 million to $135 million of revenue for FY 2025. Growth asset in REZZAYO™ for prophylaxis – Ongoing Phase III study of REZZAYO™, if successful, is expected to support a supplemental New Drug Application (sNDA) for expanded use for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplant. If approved, peak annual sales for REZZAYO™ in this indication could exceed $200 million. Strong fit with existing CorMedix infrastructure and future deployment needs – With the potential to achieve annual run-rate synergies of $35 million to $45 million in the near-term, the combination sets the stage for the future potential expansion of DefenCath® into total parenteral nutrition (TPN), for which inpatient utilization is expected to account for a significant portion of the addressable market. CorMedix expects that if approved, peak annual sales of DefenCath® in the TPN indication will be in the range of $150 to $200 million. Acquisition is expected to be highly accretive in 2026 Revised Full Year Financial Guidance Pro forma 2025 Revenue: $325 million – $350 million Pro forma 2025 Synergized Adjusted EBITDA: $165 million – $185 million DefenCath® 2025 Revenue: $200 million – $215 million Planned Senior Leadership The following executives will form the core of the senior leadership team of the newly merged company serving in roles that are the same or essentially similar to the one each executive currently holds, unless otherwise stated: Susan Blum, CFO of Melinta Therapeutics LLC, will assume the role of EVP & Chief Financial Officer; Matt David, EVP & CFO of CorMedix Inc., will assume the newly created role of EVP & Chief Business Officer; Liz Hurlburt, EVP & Chief Clinical Strategy and Operations Officer of CorMedix Inc., will assume the newly created role of EVP & Chief Operating Officer, and will serve as Chief Integration Officer; Beth Steinbrenner, SVP and Chief Human Resource Officer of CorMedix Inc., will continue in her role for the newly merged company; and Beth Zelnick Kaufman, EVP & Chief Legal and Compliance Officer and Corporate Secretary of CorMedix Inc., will continue in her role for the newly merged company. Post closing, both Melinta Therapeutics LLC and CorMedix Inc. commercial leaders will retain oversight of their respective commercial teams on an interim basis, reporting directly to the CEO individually. The Company expects to finalize a permanent commercial organization structure by the end of the year. “This combination with Melinta has allowed us to significantly bolster all levels of our organization as well as create a dynamic leadership team that harnesses the best of both organizations,” said Joseph Todisco, CEO of CorMedix Inc. “I am proud of what both organizations have achieved independently and I am excited about the potential for the newly merged organization to achieve success.” Acquisition Terms and Financing Under the terms of the agreement, CorMedix paid $300 million in upfront consideration, comprised of $260 million in cash and $40 million in CorMedix equity issued to affiliates of Deerfield Management Company, L.P. (“Deerfield”) as Melinta’s sole owners. The cash consideration was funded by a combination of CorMedix’s existing cash on hand and the proceeds of a $150 million convertible debt financing with high quality healthcare focused institutional investors, including Deerfield, the terms of which are described in a Current Report on Form 8-K filed by CorMedix on August 7, 2025. The agreement contains an additional regulatory milestone payment of up to $25 million (payable in cash or shares at CorMedix’s election) for the FDA approval of the expanded indication of REZZAYO™ for prophylaxis of invasive fungal infections in adults undergoing allogeneic blood and marrow transplantation, if this milestone event is achieved by June 30, 2029. Furthermore, the agreement includes tiered royalties on REZZAYO™ U.S. net sales and low-single-digit royalties on MINOCIN® U.S. net sales. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter related bloodstream infections in patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products including MINOCIN® (minocycline), REZZAYO™ (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate). CorMedix has ongoing clinical studies for DefenCath® in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath® as a catheter lock solution for use in other patient populations. REZZAYO™ is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation. The completion of the Phase III study for REZZAYO™ is expected in 1H 2026. For more information visit: www.cormedix.com or www.melinta.com Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements, including, but not limited to statements regarding Melinta providing an attractive revenue base of highly synergistic assets with multiple opportunities to drive future growth; financial guidance, peak annual sales estimates, synergy estimates and timing, accretion estimates, and EBITDA or Adjusted EBITDA estimates. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Forward-looking statements involve estimates, expectations, projections, goals, forecasts, assumptions, risks and uncertainties. Actual outcomes or results may differ from anticipated results, sometimes materially. Factors that could cause actual results to differ include, but are not limited to: the ability to integrate the Melinta business into CorMedix and realize the anticipated strategic benefits of the transaction within the expected time-frames or at all; that such integration may be more difficult, time-consuming or costly than expected; the ability of the combined company to achieve the identified synergies; that operating costs, customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers or suppliers) may be greater than expected following the transaction; the retention of certain key employees; the expected benefits and success of Melinta’s products and product candidates; potential litigation relating to the transaction that could be instituted against CorMedix or its directors; rating agency actions and CorMedix’s ability to access short- and long-term debt markets on a timely and affordable basis; general economic conditions that are less favorable than expected; geopolitical developments and additional changes in international trade policies and relations, including tariffs; and the ability of our products and product candidates to compete effectively against current and future competitors. Non-GAAP Financial Measures This release includes certain non-GAAP financial measures, including Adjusted EBITDA, which are intended as supplemental measures of CorMedix’s performance that are not required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage CorMedix’s operations and to better understand its business because they facilitate a comparative assessment of CorMedix’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect CorMedix’s operations and underlying operational performance. CorMedix believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to CorMedix’s financial condition and operating results and facilitate an evaluation of the financial performance of CorMedix and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of CorMedix’s financial performance, results of operations and trends while viewing the information through the eyes of management. These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in CorMedix’s financial statements; do not reflect changes in, or cash requirements for, working capital needs. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with CorMedix’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate CorMedix’s business. Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as stock based compensation and certain non-recurring items. See CorMedix’s earnings release dated August 7, 2025 for further information. Pro forma 2025 Synergized Adjusted EBITDA and Pro Forma 2025 Revenue were prepared by combining the estimated financial results and guidance for CorMedix and Melinta for the full fiscal year ended December 31, 2025, without further adjustment, and taking into account 100% realization of expected synergies and full year run-rate of estimated synergies (as if the transaction had closed on January 1, 2025). As a result, we believe this pro forma financial information includes non-GAAP financial measures. CorMedix has not provided a reconciliation to the most directly comparable GAAP measures because certain items needed to make a reasonable forward-looking estimate of the comparable GAAP measures cannot be reasonably calculated or predicted at this time. Accordingly, a reconciliation is not available without unreasonable effort. Pro forma financial information does not necessarily reflect the actual results that we would have achieved had the pro forma transaction been consummated as of the date indicated nor does it reflect the potential future results of the combined company. Our forward-looking estimates of both GAAP and non-GAAP measures of our financial performance may differ materially from our actual results and should not be relied upon as statements of fact. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576