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– 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

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 PART 01 周报概述 随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵医药数据统计，新药申请与审批获批频繁，显示出医药创新领域的活跃态势。 本文将深入分析2025年8月11日至2025年8月17日期间，国内外新药申请、临床试验批准、仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。 PART 02 国内22款新药IND获批 根据摩熵医药数据库统计，2025年8月11日至8月17日期间共有76个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号52个，进口药品受理号24个。 本周共计22款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药8款，生物药13款，中药1款。 本周获批临床创新药/改良型新药部分信息速览（不含补充申请） 注：完整数据可识别“文末”二维码下载查看 PART 03 本周全球TOP10创新药研发进展 在全球创新药研发领域，8月12日，恒瑞医药宣布其自主研发的1类新药海曲泊帕乙醇胺片的药品上市许可申请获中国国家药监局（NMPA）受理，适应症为：适用于既往对糖皮质激素、免疫球蛋白等治疗反应不佳的原发免疫性血小板减少症（ITP）成人及≥6岁的儿童患者。 海曲泊帕乙醇胺片是一种口服非肽类血小板生成素受体激动剂，通过激活血小板生成素受体介导的STAT和MAPK信号转导通路，促进血小板生成。该产品已在原发免疫性血小板减少症、再生障碍性贫血、化疗所致血小板减少症、有创性操作或手术的慢性肝病伴血小板减少症患者中开展临床研究，以评估在不同血液系统疾病中的作用。 截图来源：摩熵医药全球药物研发数据库 海曲泊帕乙醇胺片已获批上市两个适应症，分别为：2021年6月获得NMPA批准用于既往对糖皮质激素、免疫球蛋白等治疗反应不佳的慢性原发免疫性血小板减少症成人患者的治疗，以及用于对免疫抑制治疗疗效不佳的重型再生障碍性贫血成人患者的治疗。此外，该产品用于恶性肿瘤化疗所致血小板减少症适应症（CIT）已获美国FDA授予孤儿药资格。 8月15日，国家药品监督管理局（NMPA）药品审评中心（CDE）官网显示，礼来的塞普替尼新适应症上市申请已获受理。根据其注册性临床研究进展，推测此次申报的适应症为治疗RET基因融合的局部晚期或转移性实体瘤儿童患者。 截图来源：摩熵医药全球药物研发数据库 塞普替尼是一种强效、高选择性、口服RET酪氨酸激酶抑制剂，该药于2020年5月首次获FDA批准上市，成为全球首个获批的高选择性RET抑制剂。一项评估塞普替尼治疗携带RET基因改变的晚期实体瘤或神经系统原发性肿瘤儿科患者的疗效和安全性的I/II期研究（LIBRETTO-121研究）最新结果显示，中位随访30个月，在可评估患者（n=36）中，ORR为36%，24个月的DOR率为100%，24个月的PFS率为86%。其中，在15例RET突变型甲状腺髓样癌患者中，ORR为40%；在15例RET融合阳性甲状腺状癌患者中，ORR为33.3%。 同样在8月15日，据CDE官网公示，神济昌华申报的1类新药SNUG01获批临床，拟开发治疗肌萎缩侧索硬化（ALS，俗称“渐冻症”），这是神济昌华自主研发的以TRIM72为靶点的基因治疗药物。（相关扩展阅读：全球首创渐冻症基因治疗药获批临床！中国创新药迈入国际赛道） 本周全球TOP10创新药研发进展 截图来源：摩熵咨询周报 PART 04 本周全球TOP10临床试验结果 本周全球TOP10临床结果中，8月12日，默沙东宣布帕博利珠单抗（Keytruda）联合维恩妥尤单抗（Padcev）围手术期治疗肌层浸润性膀胱癌（MIBC）的III期KEYNOTE-905（EV-303）研究取得了积极结果。 KEYNOTE-905（EV-303）研究是一项开放标签、随机、多臂、对照临床试验（n=595），评估了帕博利珠单抗联合或不联合维恩妥尤单抗对比与仅手术治疗在不适合或拒绝基于顺铂的化疗方案的MIBC患者中的有效性和安全性。结果显示，与仅手术治疗组相比，帕博利珠单抗联合维恩妥尤单抗组患者的无事件生存期（EFS）显著延长，数据具有统计学意义和临床意义。此外，帕博利珠单抗联合维恩妥尤单抗组在关键次要终点总生存期（OS）和病理完全缓解（pCR）率方面也表现出具有统计学意义和临床意义的改善。在该研究中，帕博利珠单抗联合维恩妥尤单抗的安全性与每种药物的已知安全性一致。该联用方案未发现新的安全性信号。 8月13日，2025年世界肺癌大会（WCLC 2025）常规摘要正文发布。正大天晴在大会上首次公布了HER2双抗ADC产品TQB2102治疗非小细胞肺癌（NSCLC）的 II 期临床研究数据。 截图来源：摩熵医药全球药物研发数据库 TQB2102是一款HER2双抗ADC，采用双表位设计，通过同时结合HER2阳性肿瘤细胞表面的ECD2、ECD4，增强药物内化效率，提升对肿瘤细胞的杀伤作用。此次在大会上公布的II期研究旨在评估 TQB2102在至少接受过一线治疗的局部晚期或转移性HER2基因异常 NSCLC 患者中的疗效。结果显示，在51例可评估疗效的患者中，32例（62.7%）达到部分缓解。队列1（22/36）的ORR为61.1%、队列 2（4/9）的ORR为44.4%、队列3（6/6）的ORR为100%。在32名应答的受试者中，有23名早在第一次肿瘤评估时就观察到了应答。 本周全球TOP10积极/失败临床结果 截图来源：摩熵咨询周报 PART 05 10款品种过评！涉及丽珠、方明药业等 根据摩熵医药数据库统计，2025年8月11日至8月17日期间共有127项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号111项（包括化药3类，4类），新注册分类临床申请受理号8项（包括化药3类，4类），一致性评价申请8项。本周10个品种通过一致性评价（按受理号计16项），本周无品种视同通过一致性评价。本周有3项生物类似物注册申报动态，分别是惠升生物制药的司美格鲁肽注射液（按受理号计2项）、齐鲁制药的QL-2302注射液。 本周过评/视同过评品种主要为系统用抗感染药物；过评/视同过评产品剂型主要为注射剂。 截图来源：摩熵咨询周报 本周注射用头孢噻肟钠品种过评/视同过评数量最多达5个，本周各品种过评/视同过评企业均为1家；各企业过评/视同过评品种数均为1种，本周过评/视同过评企业共包括湘北威尔曼制药股份有限公司、海南广升誉制药有限公司和武汉久安药业有限公司等10家企业。 截图来源：摩熵咨询周报 本周仅有盐酸米诺环素片1个品种为首次过评/视同过评。 截图来源：摩熵咨询周报 本周仅氟哌啶醇注射液1个品种的过评/视同过评达7家企业。 截图来源：摩熵咨询周报 摩熵咨询本期完整周报 识别二维码领取下载 END 本文为原创文章，转载请留言获取授权 近期热门资源获取 中国临床试验趋势与国际多中心临床展望-202505 2024年医药企业综合实力排行榜-202505 中国带状疱疹疫苗行业分析报告-202505 2023H2-2024H1中国药品分析报告-202504 数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-202503 2024年中国1类新药靶点白皮书-202503 中国AI医疗健康企业创新发展百强榜单-202502 解码护肤抗衰：消费偏好洞察与市场格局分析-202502 2024年FDA批准上市的新药分析报告-202501 小分子化药白皮书（上）-202501 2024年中国医疗健康投融资全景洞察报告-202501 2024年医保谈判及市场分析报告-202501 近期更多摩熵咨询热门报告，识别下方二维码领取 联系我们，体验摩熵医药更多专业服务 会议 合作 园区 服务 数据库 咨询 定制 服务 媒体 合作 点击上方图片，即可开启摩熵化学数据查询 点击阅读原文，申请摩熵医药企业版免费试用！