RegulationPriority Review (United States), Orphan Drug (United States), Qualified Infectious Disease Product (United States), Orphan Drug (European Union), Priority Review (European Union), Fast Track (United States)

Structure/Sequence

Molecular FormulaC65H88N8O19

InChIKeyMXMWJAPNUIKPGF-YOFVRWEXSA-N

CAS Registry1631754-41-0

Sequence Code 14003067

Clinical Trials associated with Rezafungin acetate

NCT06774144

/ Enrolling by invitationPhase 3IIT

Rezafungin Prophylaxis in Liver Transplant at High Risk for Invasive Fungal Infection

This is an interventional study to evaluate the efficacy of rezafungin, a new echinocandin, for the prevention of invasive fungal infections (IFIs) after liver transplantation. Patients who receive rezafungin will be compared to a similar group of patients who underwent liver transplantation in the preceding two years for the incidence of IFIs.

Start Date15 Oct 2025

Sponsor / Collaborator

University of Pittsburgh

[+1]

NCT06985758

/ Not yet recruitingPhase 4IIT

Phase IV, Open-label, Single Arm, Multicenter Trial to Evaluate Pharmacokinetic Parameters of Peritoneal Diffusion and Peritoneal Diffusion Activity.

Intra-abdominal candidiasis is the most frequent candidiasis infection after candidemia. The studies that have positioned echinocandins as the first therapeutic option in candidiasis have been carried out mainly in patients with candidemia. Peritoneal concentrations of caspofungin, micafungin and anidulafungin are clearly above the MICs of most Candida spp but are below the threshold for selection of resistant mutants, which has been argued by some researchers as a risk for the control of intra-abdominal infections with poor control of the focus and selection of resistant mutants, observed in Candida spp isolates at the peritoneal level in relation to isolates at the blood culture level.
Rezafungin, with its special pharmacokinetics, achieves higher tissue concentrations, including hepato-splenic and other abdominal organs, than the other echinocandins. Experimental studies have confirmed that the concentration of rezafungin at the level of the inflammatory focus in abdominal infections is higher than in the surrounding healthy tissue and higher than those achieved by micafungin. Finally, the biofilm activity of rezafungin is very high, clearly superior to fluconazole and possibly higher than that of other echinocandins.

Start Date01 Sep 2025

Sponsor / Collaborator

Hospital Universitario Ramón y Cajal

NCT06794554

/ RecruitingPhase 2

A Phase 2, Multicentre, Open-label, Single Arm Study to Evaluate the Effectiveness and Safety of Rezafungin (as Acetate) in the Treatment of Chronic Pulmonary Aspergillosis (CPA) in Patients With Limited Treatment Options

The goal of this clinical trial is to to evaluate the drug rezafungin in the treatment of Chronic Pulmonary Aspergillosis (CPA) in male and female patients aged 18 years and over with limited treatment options.
The study aims to answer whether 6 months of rezafungin treatment is effective and safe in patients with chronic pulmonary aspergillosis with limited treatment options according to clinical and radiological response as measured by the St George's Respiratory Questionnaire, weight, and CT imaging.
Participants will:
* Be given the drug rezafungin every week for 6 months.
* Visit the clinic once a month for checkups and tests.
* Complete questionnaires on thier health and wellbeing.

Start Date30 Jun 2025

Sponsor / Collaborator

Mundipharma Research Ltd.

100 Clinical Results associated with Rezafungin acetate

100 Translational Medicine associated with Rezafungin acetate

100 Patents (Medical) associated with Rezafungin acetate

146

Literatures (Medical) associated with Rezafungin acetate

04 Mar 2026·JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Rezafungin exhibits anti-biofilm properties against fungal biofilms in vitro

Article

Author: Ramage, Gordon ; Kean, Ryan ; Abduljalil, Hafsa ; Bal, Abhijit M ; Williams, Craig ; Rautemaa-Richardson, Riina ; Bartie, Kerry

Abstract:

Objectives:

We sought to evaluate the comparative activity of rezafungin compared with caspofungin and other antifungal classes against biofilms from a large clinical panel of Candida strains (n = 167).

Methods:

Biofilm killing and inhibition were assessed using standard XTT [2,3-bis(2-methoxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide salt] metabolic assessment. Biofilm time–kill kinetics were also evaluated using metabolic and viable cell counts. Microscopy was performed to visually assess biofilm inhibition.

Results:

Rezafungin was shown to outperform caspofungin and other antifungals against C. albicans, C. parapsilosis, C. tropicalis and Nakaseomyces glabratus (previously called C. glabrata) strains with a heterogeneous biofilm phenotype. Assessment of high biofilm-forming strains at 0.03 mg/L concentrations showed that rezafungin killed biofilms to an equal or greater extent than caspofungin. Time–kill studies showed a rapid reduction in metabolism and viable cfus by both rezafungin and caspofungin, but with little difference between both compounds. Evaluation of biofilm inhibition characteristics of both compounds showed that rezafungin was marginally more effective than caspofungin, which was corroborated by microscopical analyses.

Conclusions:

Together, these data show that rezafungin is non-inferior to caspofungin in terms of anti-biofilm activity and displays characteristics that suggest it can control biofilms more effectively than caspofungin. Further evaluation is required to establish whether these in vitro effects translate clinically, but the data indicate an opportunity for rezafungin to be used for the clinical management of biofilm-related diseases.

01 Mar 2026·CLINICAL MICROBIOLOGY AND INFECTION

Optimizing antifungal therapies for Candida infections: evidence, resistance, and emerging approaches

Review

Author: Alguacil-Cuéllar, Laura ; Alastruey-Izquierdo, Ana ; Chen, Sharon C-A ; Halliday, Catriona

BACKGROUND:

Invasive Candida infections are among the most common fungal diseases worldwide, with significant morbidity and mortality in immunocompromised individuals. The increasing prevalence of antifungal resistance in Candida species, particularly non-albicans Candida, complicates clinical management and necessitates novel treatment approaches. The emergence of resistance mechanisms has reduced the efficacy of available antifungal therapies, prompting the need for alternative strategies.

OBJECTIVES:

This manuscript aims to review the primary mechanisms underlying antifungal resistance in Candida species and explore emerging therapeutic strategies, including combination therapies and novel antifungal agents.

SOURCES:

Peer-reviewed literature, clinical guidelines, and recent studies were reviewed to provide a comprehensive overview of antifungal resistance mechanisms, as well as current evidence on novel antifungal agents and combination therapy strategies for the treatment of Candida infections.

CONTENT:

Antifungal resistance in Candida species arises through multiple mechanisms including the overexpression of efflux pumps, reducing intracellular drug concentrations; target site mutations, altering drug binding and efficacy; biofilm formation, providing a physical barrier against antifungals; phenotypic switching and adaptive stress responses; and genomic plasticity, promoting heteroresistance. Emerging therapies include novel antifungals such as rezafungin, ibrexafungerp, and fosmanogepix, as well as combination therapies targeting resistance pathways.

IMPLICATIONS:

The increasing burden of antifungal resistance highlights the need for optimized therapeutic strategies and improved diagnostic tools. Combination therapies and novel antifungals offer promising alternatives, but further research is essential to evaluate their clinical efficacy. Strengthening antifungal stewardship programmes and enhancing surveillance for resistance patterns are critical to managing Candida infections effectively and mitigating the public health threat posed by resistant strains.

01 Mar 2026·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Successful treatment with rezafungin after micafungin for relapsing Rasamsonia argillacea species complex pneumonia in a patient with bronchiectasis: A case report

Article

Author: Lortholary, Olivier ; Mortier, Coline ; Bermudez, Julien ; Bes-Berlandier, Hugo ; Manni, Sabrina ; Parize, Perrine ; Bouchara, Jean Philippe ; Coiffard, Benjamin ; Barrera, Coralie ; Cassir, Nadim ; Coron, Noémie ; Bellanger-Clerget, Anne-Pauline ; Pottier, Heloise ; Lanternier, Fanny ; Millon, Laurence

Rasamsonia argillacea species complex are emerging opportunistic molds increasingly reported in patients with chronic lung disease. We describe a 69-year-old woman with bronchiectasis who developed relapsing R. aegroticola pneumonia. After transient improvement with micafungin, relapse occurred, and antifungal therapy was switched to rezafungin, a novel echinocandin with a prolonged half-life and front-loaded pharmacokinetics. A total of 3 months of treatment led to clinical and radiological improvement, with sustained stability 6 months after therapy completion. This case illustrates the pathogenic role of R. argillacea species complex in non-immunocompromised hosts and suggests rezafungin as a promising therapeutic option for echinocandin-susceptible, azole-resistant Rasamsonia infections.

163

News (Medical) associated with Rezafungin acetate

05 Mar 2026

·cormedix.com

CORMEDIX INC. REPORTS FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

Careers Contact Us Healthcare Professionals ‒ Q4 2025 Net Revenue of $128.6 million ‒ ‒ Pro Forma Full Year 2025 Net Revenue of $401.3 million ‒ ‒ Q4 2025 Net Income of $14.0 million; Adjusted EBITDA of $77.2 million ‒ ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒ Parsippany, NJ – March 5, 2026 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on its business. Recent Corporate Highlights: CorMedix announces $128.6 million of net revenue for the fourth quarter of 2025, largely driven by continued utilization of DefenCath by its outpatient dialysis customers. DefenCath sales contributed $91.2 million of net revenue in the quarter. For the full-year 2025, CorMedix achieved total revenue of $311.7 million and pro forma total revenue of $401.3 million.(1) In the fourth quarter of 2025, the Company recognized Net Income of $14.0 million and adjusted EBITDA of $77.2 million.(2) Basic and Fully Diluted EPS were $0.18 and $0.16 per share, respectively. CorMedix reiterates previously established guidance for 2026, including net revenue of between $300 and $320 million and adjusted EBITDA of between $100 and $125 million. CorMedix announced in early February that its Board of Directors approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company’s outstanding common stock. As highlighted during the Company’s recent Analyst Day, CorMedix expects clinical data from the Phase 3 ReSPECT study of REZZAYO® (rezafungin for injection) in the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplant in Q2 2026. In addition, the ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients with targeted completion in the first half of 2027. Cash and short-term investments, excluding restricted cash, at December 31, 2025 amounted to $148.5 million. Joe Todisco, CorMedix Chairman and CEO, commented, “I am proud of the Company’s progress over the past year as we have accelerated the expansion of patient access for DefenCath, completed our acquisition and integration of Melinta, and saw progress in our two ongoing Phase 3 clinical programs for Rezzayo prophylaxis and DefenCath in TPN. With the announcement of our share repurchase program and multiple near-term milestones on the horizon, most notably the Rezzayo ReSPECT phase III data, CorMedix is focused on driving business growth and shareholder value over the year ahead.” Fourth Quarter and Full Year 2025 Financial Highlights For the fourth quarter of 2025, CorMedix recorded $128.6 million in net revenue, comprised of $91.2 million in sales of DefenCath and $37.4 million in revenue associated with the Melinta portfolio, an increase from $31.2 million in net revenue in the comparable period of 2024. The fourth quarter of 2025 was the first full quarter of Melinta portfolio revenue after the closing of the acquisition in August 2025. Total operating expenses in the fourth quarter of 2025 were $48.2 million, compared with $17.1 million in the fourth quarter of 2024, an increase of approximately 182%. The increase of $31.1 million over the prior period was driven primarily by the contribution of operating expenses from the Melinta acquisition for the full quarter. Fourth quarter 2025 operating expenses also included $4.1 million of non-recurring costs, including severance and other integration-related costs associated with the Melinta acquisition. Other drivers of increases year-over-year include stock-based compensation and investment in research and development programs associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI in TPN. For the fourth quarter of 2025, the Company recorded $14.0 million in net income, or $0.16 per diluted share, compared with net income of $13.5 million, or $0.20 per diluted share, in the fourth quarter of 2024. Net income for the fourth quarter of 2025 included tax expense, primarily associated with the utilization of the Company’s deferred tax assets, of $42.4 million. These deferred tax assets were established in the third quarter of 2025 and are associated with the anticipated future use of CorMedix Net Operating Loss (NOL) carryforwards due to projected future sustained profitability of the Company. Also for the fourth quarter of 2025, CorMedix reported Adjusted EBITDA of $77.2 million, compared to adjusted EBITDA of $15.3 million in the fourth quarter of 2024. For the year ended December 31, 2025, CorMedix recorded $311.7 million in total revenue, including $258.8 million in net sales of DefenCath and $52.9 million in net revenue from the legacy Melinta portfolio. Pro forma 2025 revenue, which reflects full-year revenue from the Melinta portfolio in addition to full-year net sales of DefenCath, was $401.3 million. The Company reported net income of $163.0 million, or $2.04 per diluted share, compared with a net loss of $17.9 million, or ($0.30) per share, in 2024. Net income was driven primarily by an increase in sales of DefenCath, and, to a lesser extent, net revenue from the acquisition of Melinta, partially offset by higher operating expenses. Operating expenses during the year ended December 31, 2025 totaled $125.6 million compared with $62.6 million for 2024, an increase of $63.0 million, or 101%. The increase over the prior year was driven primarily by the acquisition of Melinta, including the contribution of operating expenses from Melinta’s business for the period from August 29, 2025 through the end of the year as well as transaction, integration and severance costs. Other drivers of the year-over-year increase include stock-based compensation and investment in research and development programs associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI in TPN. The Company reported cash, cash equivalents and short-term investments of $148.5 million at December 31, 2025, excluding restricted cash. (1) Pro Forma Total Revenue was prepared by combining the financial results and for CorMedix and Melinta for the full fiscal year ended December 31, 2025, without further adjustment, as if the transaction had closed on January 1, 2025. (2) Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expense, taxes and certain non-recurring items. See “Non-GAAP Financial Measures” on the following pages for additional information regarding the use of EBITDA and Adjusted EBITDA and a reconciliation to the most comparable GAAP measure. Conference Call Information The management team of CorMedix will host a conference call and webcast today, March 5, 2026, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: March 5, 2026 @ 8:30am ET Domestic: 1-844-676-2922 International: 1-412-634-6840 Webcast: Webcast Link 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 adult 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) for Injection, 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 IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.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 of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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,” “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 financial and business guidance; sales, revenue and operating expense estimates; synergy estimates and timing; accretion estimates; expectations regarding product utilization and product reimbursement rates; Adjusted EBITDA estimates; expectations and timing regarding clinical studies and real world studies and development; and expectations of CorMedix’s product pipeline. 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. 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. In addition, 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. 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. Non-GAAP Financial Measures This release includes certain non-GAAP financial measures, including EBITDA and adjusted EBITDA, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’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 the Company’s operations and underlying operational performance. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results, which facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’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 the Company’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 the Company’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 the Company’s business. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

Phase 3Financial StatementDrug ApprovalAcquisition

05 Mar 2026

·www.biospace.com

CorMedix Inc. Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

‒ Q4 2025 Net Revenue of $128.6 million ‒ ‒ Pro Forma Full Year 2025 Net Revenue of $401.3 million ‒ ‒ Q4 2025 Net Income of $14.0 million; Adjusted EBITDA of $77.2 million ‒ ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒ PARSIPPANY, N.J., March 05, 2026 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the fourth quarter and full-year ended December 31, 2025 and provided an update on its business. Recent Corporate Highlights: CorMedix announces $128.6 million of net revenue for the fourth quarter of 2025, largely driven by continued utilization of DefenCath by its outpatient dialysis customers. DefenCath sales contributed $91.2 million of net revenue in the quarter. For the full-year 2025, CorMedix achieved total revenue of $311.7 million and pro forma total revenue of $401.3 million. (1) In the fourth quarter of 2025, the Company recognized Net Income of $14.0 million and adjusted EBITDA of $77.2 million. (2) Basic and Fully Diluted EPS were $0.18 and $0.16 per share, respectively. CorMedix reiterates previously established guidance for 2026, including net revenue of between $300 and $320 million and adjusted EBITDA of between $100 and $125 million. CorMedix announced in early February that its Board of Directors approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company’s outstanding common stock. As highlighted during the Company’s recent Analyst Day, CorMedix expects clinical data from the Phase 3 ReSPECT study of REZZAYO® (rezafungin for injection) in the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplant in Q2 2026. In addition, the ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients with targeted completion in the first half of 2027. Cash and short-term investments, excluding restricted cash, at December 31, 2025 amounted to $148.5 million. Joe Todisco, CorMedix Chairman and CEO, commented, “I am proud of the Company’s progress over the past year as we have accelerated the expansion of patient access for DefenCath, completed our acquisition and integration of Melinta, and saw progress in our two ongoing Phase 3 clinical programs for Rezzayo prophylaxis and DefenCath in TPN. With the announcement of our share repurchase program and multiple near-term milestones on the horizon, most notably the Rezzayo ReSPECT phase III data, CorMedix is focused on driving business growth and shareholder value over the year ahead.” Fourth Quarter and Full Year 2025 Financial Highlights For the fourth quarter of 2025, CorMedix recorded $128.6 million in net revenue, comprised of $91.2 million in sales of DefenCath and $37.4 million in revenue associated with the Melinta portfolio, an increase from $31.2 million in net revenue in the comparable period of 2024. The fourth quarter of 2025 was the first full quarter of Melinta portfolio revenue after the closing of the acquisition in August 2025. Total operating expenses in the fourth quarter of 2025 were $48.2 million, compared with $17.1 million in the fourth quarter of 2024, an increase of approximately 182%. The increase of $31.1 million over the prior period was driven primarily by the contribution of operating expenses from the Melinta acquisition for the full quarter. Fourth quarter 2025 operating expenses also included $4.1 million of non-recurring costs, including severance and other integration-related costs associated with the Melinta acquisition. Other drivers of increases year-over-year include stock-based compensation and investment in research and development programs associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI in TPN. For the fourth quarter of 2025, the Company recorded $14.0 million in net income, or $0.16 per diluted share, compared with net income of $13.5 million, or $0.20 per diluted share, in the fourth quarter of 2024. Net income for the fourth quarter of 2025 included tax expense, primarily associated with the utilization of the Company’s deferred tax assets, of $42.4 million. These deferred tax assets were established in the third quarter of 2025 and are associated with the anticipated future use of CorMedix Net Operating Loss (NOL) carryforwards due to projected future sustained profitability of the Company. Also for the fourth quarter of 2025, CorMedix reported Adjusted EBITDA of $77.2 million, compared to adjusted EBITDA of $15.3 million in the fourth quarter of 2024. For the year ended December 31, 2025, CorMedix recorded $311.7 million in total revenue, including $258.8 million in net sales of DefenCath and $52.9 million in net revenue from the legacy Melinta portfolio. Pro forma 2025 revenue, which reflects full-year revenue from the Melinta portfolio in addition to full-year net sales of DefenCath, was $401.3 million. The Company reported net income of $163.0 million, or $2.04 per diluted share, compared with a net loss of $17.9 million, or ($0.30) per share, in 2024. Net income was driven primarily by an increase in sales of DefenCath, and, to a lesser extent, net revenue from the acquisition of Melinta, partially offset by higher operating expenses. Operating expenses during the year ended December 31, 2025 totaled $125.6 million compared with $62.6 million for 2024, an increase of $63.0 million, or 101%. The increase over the prior year was driven primarily by the acquisition of Melinta, including the contribution of operating expenses from Melinta’s business for the period from August 29, 2025 through the end of the year as well as transaction, integration and severance costs. Other drivers of the year-over-year increase include stock-based compensation and investment in research and development programs associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI in TPN. The Company reported cash, cash equivalents and short-term investments of $148.5 million at December 31, 2025, excluding restricted cash. (1) Pro Forma Total Revenue was prepared by combining the financial results and for CorMedix and Melinta for the full fiscal year ended December 31, 2025, without further adjustment, as if the transaction had closed on January 1, 2025. (2) Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization, stock-based compensation, interest and other income and expense, taxes and certain non-recurring items. See “Non-GAAP Financial Measures” on the following pages for additional information regarding the use of EBITDA and Adjusted EBITDA and a reconciliation to the most comparable GAAP measure. Conference Call Information The management team of CorMedix will host a conference call and webcast today, March 5, 2026, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: March 5, 2026 @ 8:30am ET Domestic: 1-844-676-2922 International: 1-412-634-6840 Webcast: Webcast Link 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 adult 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) for Injection, 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 IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: . 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 of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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,” “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 financial and business guidance; sales, revenue and operating expense estimates; synergy estimates and timing; accretion estimates; expectations regarding product utilization and product reimbursement rates; Adjusted EBITDA estimates; expectations and timing regarding clinical studies and real world studies and development; and expectations of CorMedix’s product pipeline. 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 or upon request from CorMedix. 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. In addition, 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. 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. Non-GAAP Financial Measures This release includes certain non-GAAP financial measures, including EBITDA and adjusted EBITDA, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’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 the Company’s operations and underlying operational performance. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results, which facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’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 the Company’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 the Company’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 the Company’s business. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576 CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (In Thousands, Except Per Share Data) For the Three Months Ended December 31, For the Year Ended December 31, 2025 (Unaudited) 2024 (Unaudited) 2025 (Audited) 2024 (Audited) Revenue Product Sales, net $ 123,979 $ 31,210 $ 304,344 $ 43,472 Contract revenue 4,636 - 7,365 - Total revenue 128,615 31,210 311,709 43,472 Cost of revenues (11,167 ) (1,123 ) (22,088 ) (3,034 ) Amortization of intangible assets (10,140 ) (52 ) (13,872 ) (156 ) Gross profit (loss) 107,308 30,035 275,748 40,282 Operating Expenses Research and development (8,600 ) (1,727 ) (19,333 ) (3,942 ) Selling and marketing (16,010 ) (8,264 ) (38,054 ) (28,737 ) General and administrative (23,572 ) (7,108 ) (68,220 ) (29,959 ) Total operating expenses $ (48,182 ) $ (17,098 ) $ (125,607 ) $ (62,638 ) Income (Loss) from Operations 59,126 12,937 150,141 (22,356 ) Other Income (Expense) Total other income (expense) (2,680 ) 528 (125 ) 3,031 Net Income (Loss) Before Income Taxes 56,447 13,465 150,016 (19,325 ) Tax (expense) benefit (42,426 ) - 13,039 1,395 Net Income (Loss) $ 14,020 $ 13,465 $ 163,055 $ (17,930 ) Other Comprehensive Income (Loss) Total other comprehensive (loss) income (85 ) 2 (88 ) (3 ) Other Comprehensive (Loss) Income $ 13,935 $ 13,466 $ 162,967 $ (17,933 ) Net Income (Loss) Per Common Share – Basic $ 0.18 $ 0.22 $ 2.25 $ (0.30 ) Net Income (Loss) Per Common Share – Diluted $ 0.16 $ 0.20 $ 2.04 $ (0.30 ) Weighted Average Common Shares Outstanding – Basic 78,841 61,509 72,034 58,872 Weighted Average Common Shares Outstanding – Diluted 93,919 65,282 80,308 58,872 CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEET DATA (In Thousands) December 31, December 31, 2025 2024 (Audited) (Audited) ASSETS Cash, cash equivalents and restricted cash $ 145,825 $ 40,756 Short-term investments 3,694 11,037 Trade receivables, net 171,233 51,654 Inventories 29,716 7,600 Goodwill and intangible assets 409,074 1,844 Deferred tax assets 16,276 - Other current and long-term assets 50,324 5,955 Total Assets $ 826,142 $ 118,846 Total Liabilities $ 420,835 $ 34,189 Stockholders' Equity 405,307 84,657 Total Liabilities and Stockholders’ Equity $ 826,142 $ 118,846 CORMEDIX INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In Thousands) For the Year Ended December 31, 2025 (Audited) 2024 (Audited) Cash Flows from Operating Activities: Net income (loss) $ 163,055 $ (17,930 ) Net cash provided by (used in) operating activities 175,046 (50,615 ) Net cash (used in) provided by investing activities (308,430 ) 21,231 Net cash provided by financing activities 238,453 26,317 Net Increase (Decrease) in Cash and Cash Equivalents $ 105,069 $ (3,067 ) Cash and Cash Equivalents and Restricted Cash - Beginning of Period $ 40,756 $ 43,823 Cash and Cash Equivalents and Restricted Cash - End of Period $ 145,825 $ 40,756 CORMEDIX INC. AND SUBSIDIARIES Non-GAAP Reconciliations (In Thousands) (Unaudited) For the Three Months Ended December 31, 2025 2024 Net income (loss) $ 14,020 $ 13,464 Adjusted to add (deduct): Interest (income) expense, net 927 (500 ) Provision for (benefit from) income taxes 42,426 - Depreciation and amortization 10,434 134 EBITDA (Non-GAAP) $ 67,807 $ 13,098 Adjusted to add (deduct): Stock-based compensation expense 3,589 1,194 Merger-related and reorganization costs 4,085 1,055 Other (income) expense 1,753 (28 ) Adjusted EBITDA (Non-GAAP) $ 77,234 $ 15,319

Phase 3AcquisitionDrug ApprovalFinancial Statement

02 Feb 2026

·cormedix.com

CORMEDIX THERAPEUTICS ANNOUNCES SHARE REPURCHASE PROGRAM

Berkeley Heights, NJ – February 2, 2026 – CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced its Board of Directors has approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company’s outstanding common stock. The repurchase program is authorized through December 31, 2027. “With a strong balance sheet, solid operating performance, and expected ongoing cash flow generation, we believe we are well positioned to execute this share repurchase program while continuing to advance our growth strategy,” said Joseph Todisco, Chairman & CEO of CorMedix Therapeutics. “The program provides a disciplined way to return value to shareholders while preserving the financial flexibility to invest in our business, including potential inorganic opportunities. We remain confident in our long-term outlook and in the potential of our late-stage clinical programs to deliver meaningful benefits for patients.” CorMedix expects to begin repurchasing shares as early as Q1 2026 and had approximately $150 million in cash and cash equivalents, and 79.3 million common shares outstanding as of December 31, 2025. Repurchases may be made at management’s discretion from time to time in privately negotiated transactions, through block trades, pursuant to open market purchases or pursuant to trading plans as permitted under applicable securities laws. In addition, any repurchases under the authorization will be subject to prevailing market conditions, liquidity and cash flow considerations, applicable securities laws and regulations, and other factors. The share repurchase program does not require CorMedix Therapeutics to acquire any amount of shares, and may be suspended or discontinued at any time. About CorMedix CorMedix Therapeutics 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 adult 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) for Injection, REZZAYO® (rezafungin for injection), 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 (TPN) and Pediatric Hemodialysis 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 IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 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 of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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,” “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 financial and operating results, cash flow, shareholder return, outlook of the business, expectations regarding timing, execution and impact of the share repurchase program, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, expectations regarding implementation and perceived benefits of CorMedix’s products. 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. 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. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

Phase 3AcquisitionDrug Approval

100 Deals associated with Rezafungin acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D11198	-	-	DB16310

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Candidemia	United States	Mundipharma GmbH	22 Mar 2023
Candidiasis, Invasive	United States	Mundipharma GmbH	22 Mar 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumocystis Infections	Phase 3	Belgium	Cidara Therapeutics, Inc.	11 May 2020
Pneumocystis Infections	Phase 3	Canada	Cidara Therapeutics, Inc.	11 May 2020
Pneumocystis Infections	Phase 3	France	Cidara Therapeutics, Inc.	11 May 2020
Pneumocystis Infections	Phase 3	Germany	Cidara Therapeutics, Inc.	11 May 2020
Pneumocystis Infections	Phase 3	Italy	Cidara Therapeutics, Inc.	11 May 2020
Pneumocystis Infections	Phase 3	Spain	Cidara Therapeutics, Inc.	11 May 2020
Invasive Fungal Infections	Phase 3	Belgium	Cidara Therapeutics, Inc.	20 Feb 2020
Candidiasis, Oral	Phase 2	United States	Cidara Therapeutics, Inc.	08 Jun 2016
Candidiasis, Vulvovaginal	Phase 2	United States	Cidara Therapeutics, Inc.	08 Jun 2016
Yeast infection	Phase 2	United States	Cidara Therapeutics, Inc.	08 Jun 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03667690 (ReSTORE, Pubmed \| Mycoses)	Phase 3	Candidiasis, Invasive \| Candidemia	58	Rezafungin	mcvltvrbdy(fcpzcwhuwm) = isgfgnbtqi fnklejsuaq (jnftywmjzh ) View more	Positive	01 Nov 2025
				Caspofungin	mcvltvrbdy(fcpzcwhuwm) = hljiyrwuyj fnklejsuaq (jnftywmjzh ) View more
NCT02734862 \| NCT03667690 (ReSTORE;STRIVE, Pubmed \| Crit Care)	Phase 3	Candidemia \| Candidiasis, Invasive	294	Rezafungin	cejclpnlsq(geaewlimfm) = mlsgiwdcjz tuvggdqvlf (oyqfftvtkm ) View more	Positive	11 Nov 2024
				Caspofungin	cejclpnlsq(geaewlimfm) = xwmbkuxurq tuvggdqvlf (oyqfftvtkm ) View more
NCT02734862 \| NCT03667690 (ReSTORE, Pubmed \| Crit Care)	Phase 2/3	Candidemia \| Candidiasis, Invasive	113	Rezafungin	vozkggtiap(yurmlioaxy) = ojptjsszoy ifkhylzobv (vgswtddfsp ) View more	Positive	28 Oct 2024
				Caspofungin	vozkggtiap(yurmlioaxy) = ldwrnkmigr ifkhylzobv (vgswtddfsp ) View more
NCT03667690 (ReSTORE, Pubmed \| Clin Infect Dis)	Phase 3	Candidemia positive culture	-	Rezafungin	rkrouaghqu(jbbjfcrulr) = fylokppwhw vavfuwqstq (opisepregt ) View more	Positive	26 Sep 2024
				Caspofungin	rkrouaghqu(jbbjfcrulr) = cywcyvnmie vavfuwqstq (opisepregt ) View more
NCT02734862 \| NCT03667690 (ReSTORE, Biospace) Manual	Not Applicable	Candidemia \| Candidiasis, Invasive	-	REZZAYO	jipxiykhve(jmxjcdrjpg) = REZZAYO was generally well tolerated and had a similar safety profile to caspofungin mxwxikzyjl (orwqmscgck )	Positive	05 Dec 2023
NCT02734862 \| NCT03667690 (Pubmed 1 \| Pubmed 2 \| Lancet Infect Dis) Manual	Phase 2/3	Candidemia \| Candidiasis, Invasive	294	Rezafungin	ejvdxlbvii(pdxjoyumoi) = iiefrkyfhl ogwcvtspii (ncugzylkwm ) View more	Positive	23 Nov 2023
				Caspofungin	ejvdxlbvii(pdxjoyumoi) = xiqrnxhujg ogwcvtspii (ncugzylkwm ) View more
NCT03667690 (FDA) Manual	Phase 3	Candidemia \| Candidiasis, Invasive	187	REZZAYO 400 mg/200 mg	wknrpzidxx(xhajfptczo) = vntfoaavoq ywjpmsnazf (qouhsrdlgt ) View more	Superior	22 Mar 2023
				Caspofungin 70 mg/50 mg	wknrpzidxx(xhajfptczo) = hrtjcacyzj ywjpmsnazf (qouhsrdlgt ) View more
NCT03667690 (ReSTORE \| ReSTORE;STRIVE, CTgov)	Phase 3	Candidemia	199	oral placebo+Rezafungin (Group 1: Rezafungin for Injection)	uproxyuogc = ziizqlghni jfysvirirh (gseqnoyush, hahtexdthh - qkhpidjqjd) View more	-	06 Jan 2023
				intravenous placebo+Fluconazole+caspofungin (Group 2: Caspofungin)	uproxyuogc = tedtwbtken jfysvirirh (gseqnoyush, ejybercszj - bamsjbdwji) View more
NCT03667690 (ReSTORE, Pubmed \| Lancet)	Phase 3	Candidemia \| Candidiasis, Invasive	199	Rezafungin	opmmosavml(tkukwqgbpj) = zyifzngkor oujqmmdfch (dfgmgkvanp ) View more	Positive	25 Nov 2022
				Caspofungin	opmmosavml(tkukwqgbpj) = zpqlnwyeuz oujqmmdfch (dfgmgkvanp ) View more
NCT03667690 (ReSTORE, Corporate Publications) Manual	Phase 3	Candidemia \| Candidiasis, Invasive	187	Rezafungin acetate	illiafmccj(xxbezsasrv) = vrmkakrxoi xhrpisnhoq (liykdpyvmu ) View more	Positive	14 Dec 2021
				Caspofungin	illiafmccj(xxbezsasrv) = ttrxhzvdqq xhrpisnhoq (liykdpyvmu ) View more

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