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

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

111

Literatures (Medical) associated with Rezafungin acetate

01 Jan 2026·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Development of a rezafungin isolate verification panel and comparison of reference method to ThermoFisher Sensititre YeastOne panel MIC results

Article

Author: Koeth, Laura ; DiFranco-Fisher, Jeanna

Rezafungin is indicated for the treatment of adults with limited or no alternative treatment options for candidemia and invasive candidiasis. The development of a rezafungin isolate verification panel is described. A total of 35 Candida species isolates were chosen for initial testing and 30 isolates were selected for additional testing including C. albicans (n = 11), C. glabrata (n = 8), C. tropicalis (n = 7) and C. parapsilosis (n = 4). Modal MIC, range of results and categorical agreement results (based on an acceptable ±2 dilution from the modal MIC) were calculated. Both FDA STIC and CLSI breakpoints were applied to calculated categorical agreement. The replicate reference BMD (rBMD) MIC results spanned an average of 2.4-dilution range and were within ±1 dilution of the modal rBMD for 26/30 (86.7 %) isolates and within ±2 dilutions for all isolates (100 %). The final panel of isolates was used to compare rBMD MIC values with those generated using the Sensititre™ YeastOne™ panel. The correlation of YeastOne results to modal rBMD results was particularly good; 26 out of 30 isolates (86.7 %) were within ±1 dilution of the modal rBMD and 100 % were within ±2 dilutions. When categorical agreement was calculated using CLSI and FDA breakpoints, CLSI criteria performed better than FDA, albeit this was associated with a limited number of isolates with MIC results near the breakpoints. The availability of a curated verification panel with rezafungin modal MIC values will be a valuable resource for laboratories as they incorporate testing devices containing rezafungin into their yeast susceptibility testing paradigm.

01 Nov 2025·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Rezafungin vs caspofungin for the treatment of invasive candidiasis: A systematic review and meta-analysis

Review

Author: Eltayeb, Abdalla Osman ; Alhamed, Arina ; Abdat, Wejdan ; Alshahrani, Norah Nasser A ; Alhothali, Amjad Salman A ; Alsheikh, Razan Shukr ; Almajed, Hind Mohammed ; Alhamdi, Sultan Ibrahim S ; Al Diab Al Azzawi, Mohammad

BACKGROUND:

Severe fungal infection known as invasive candidiasis primarily impacts critically ill alongside immunocompromised patients with high mortality and long hospital stays and creates substantial healthcare expenses. Echinocandins constitute the current standard first-line treatment for invasive candidiasis, with caspofungin being among the most widely used agents, caspofungin is used to treat invasive candidiasis but requires daily intravenous administration, and its pharmacokinetics may vary between patients. A new generation echinocandin antifungal drug called Rezafungin demonstrates an extended half-life through which medical personnel can administer treatment only once per week to improve patient adherence and minimize healthcare costs. This review aimed to compare rezafungin and caspofungin to evaluate their efficacy and safety, and to explore whether rezafungin's pharmacokinetics offer clinical advantages.

METHODS:

We conducted a systematic review and meta-analysis of randomized controlled trials comparing rezafungin and caspofungin for invasive candidiasis in adults. Studies were selected based on predefined PICOS criteria and sourced from PubMed, Scopus, Embase, Web of Science, and Cochrane Library. After removing duplicates using Rayyan, four eligible trials involving adult patients were included. Data on efficacy and safety outcomes were extracted. Risk of bias was assessed using ROB 2, and meta-analysis was performed using RevMan 5.4 to calculate risk ratios with 95 % confidence intervals.

RESULTS:

Four RCT with 677 patients included in our systematic review and meta-analysis. The pooled analysis revealed no statistically significant differences between rezafungin and caspofungin in key outcomes. Global cure at day 14 was similar between the two groups (RR = 1.04, 95 % CI: 0.90-1.20, p = 0.45), as were the rates subgroup anaylsis of blood culture negativity at 24 and 48 h and mycological eradication, and safety outcomes such as, Patients with ≥1 treatment-emergent adverse event, abdominal pain, hypokalemia, acute kidney injury, septic shock, and all-cause mortality at day 30.

CONCLUSION:

Rezafungin is noninferior to caspofungin in the treatment of invasive candidiasis, offering equivalent efficacy and safety outcomes. Its once-weekly dosing regimen presents potential advantages in terms of improved patient adherence and reduced healthcare resource utilization. Future research should focus on larger, more diverse populations and longer follow-up durations to further elucidate the long-term benefits and cost-effectiveness of rezafungin.

01 Oct 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Design, synthesis and biological evaluation of natural product echinocandin derivatives

Article

Author: Zheng, Yan ; Chu, Shaojie ; Wu, Xuesong ; Wang, Hongbo ; Wang, Guoping ; Su, Shuangshuang ; Chen, Shaoxin

Fungal pathogen infections impose a great challenge for global public health, causing approximately 1.6 million deaths annually. Echinocandin-class drugs, with unique mechanism and favorable safety profile, have become the first-line anti-fungal therapeutic option for candidemia and invasive candidiasis. The present study successfully designed and synthesized a series of novel echinocandin derivatives, among which SIPI-18333 and SIPI-18334 exhibited a minimum inhibitory concentration (MIC) of 0.03125 μg/mL against Candida krusei in vitro, significantly surpassing existing echinocandin drugs. Furthermore, these optimized compounds demonstrated minimal dependence on CYP450 metabolism in liver microsomes, resulting in significantly reduced risk of drug-drug interactions. Meanwhile, plasma stability experiments indicated that the optimized compounds exhibited better stability in plasma compared with Micafungin. Subsequent pharmacokinetic studies in rats showed significantly higher plasma exposure levels [Cmax, AUC(0-t)] of the optimized compounds than those of Rezafungin. To sum up, SIPI-18333 and SIPI-18334 exhibit superior anti-fungal activity and enhanced bioavailability, which are promising candidates for the next-generation anti-fungal agents and warrant further development.

152

News (Medical) associated with Rezafungin acetate

24 Nov 2025

·www.fiercebiotech.com

Versant\'s Dayra dawns with $50M Biogen pact, oral macrocyclic peptide mission

It\'s a new Day(ra), and a new biotech has risen from Versant Ventures\' research labs.\n VC Versant Ventures is unveiling Dayra Therapeutics, a new biotech working on oral macrocyclic peptide drugs—a mission that has already reeled in a partnership with Biogen.The biopharma has paid $50 million upfront to enter a research pact with Toronto-based Dayra, according to a Nov. 24 release. Beyond Biogen’s cash payment, the new biotech has also locked in an equity commitment of $20 million from Versant.Together, Dayra and Biogen aim to discover and develop oral macrocyclic peptides for undisclosed targets in immunological diseases, according to a separate release. Macrocyclic peptides—such as the antifungal Rezzayo or multiple myeloma treatment Aphexda—are known for their target specificity and increased potency and durability. However, efforts to systematically develop macrocycles have run into challenges tied to pharmacokinetics, cell permeability and oral bioavailability.Dayra believes oral versions of the drug class could possibly boost specificity even more and access target protein binding sites that traditional small molecule drugs struggle to reach. And the biotech isn’t the only one who thinks that.Earlier this year, argenx penned a pact worth $1.5 billion in biobucks with Californian biotech Unnatural Products in hopes of generating orally available macrocyclic peptide action against a range of undisclosed “undruggable” targets.Big Pharma Merck & Co. has also hailed macrocyclic peptides as the “next wave of drug discovery,” supporting Unnatural Products and even inking its own deal with the biotech in 2024. In the newly announced partnership, Biogen will have the chance to acquire the development candidates for a potential additional payment per program. Preclinical and clinical development milestone payments are also on the table for each program.“With this collaboration, we are adding another potential best-in-class approach to our early-stage portfolio to target multiple high-value immunological conditions,” Jane Grogan, Ph.D., Biogen’s executive vice president and research head, said in the release.“Building on multiple technical advances in the field, we believe Dayra Therapeutics’ state-of-the-art macrocycle discovery platform could help realize the full potential of macrocycle-based treatments,” she added.In recent days, the company—known for its neuroscience efforts—has been doubling down on its immunology roots, Uptal Patel, M.D., head of Biogen’s West Coast hub, told Fierce Biotech. As for Dayra, the company emerges from Versant’s Frontier Discovery Engine—the firm’s state-of-the-art research labs—in Toronto and Montreal. The biotech says it is taking aim at creating oral macrocyclic peptides across a range of conditions.Dayra touts a macrocycle discovery platform that it combines with computational design and modeling to create novel drugs. “The field of macrocycles is at a new inflection point and is starting to deliver meaningful medicines,” Rami Hannoush, Ph.D., Dayra’s acting CEO and Versant venture partner, said in the release. “Dayra has brought together insights and enablement from Versant’s Frontier Discovery Engine, exceptional leadership with deep macrocycle drug development expertise, and this foundational collaboration with Biogen, putting the company in a very strong position.”Hannoush is joined by Roger Palframan, Ph.D., who serves as the biotech’s chief scientific officer. Before Dayra, Palframan spent more than 18 years at Belgium-based UCB.Dayra is one of the several biotechs coming from Versant this year, following autoimmune disease startup Granite Bio and obesity-focused Helicore Biopharma. Since Versant’s founding in 1999, more than 100 of the VC’s companies have been acquired or successfully debuted on the public market, according to the firm.

PDC

12 Nov 2025

·www.globenewswire.com

CorMedix Inc. Reports Third Quarter 2025 Financial Results and Updates FY 2025 Guidance

‒ Q3 2025 Net Revenue of $104.3 million; Pro Forma Net Revenue of $130.8 million ‒ ‒ Q3 2025 Net Income of $108.6 million; Adjusted EBITDA of $71.9 million ‒ ‒ FY 2025 Pro Forma Net Revenue Guidance Raised to a Range of $390 to $410 million ‒ ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒ BERKELEY HEIGHTS, N.J., Nov. 12, 2025 (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 third quarter ended September 30, 2025 and provided an update on its business. Recent Corporate Highlights: CorMedix announces $104.3 million of net revenue and $130.8 million of pro forma net revenue(1) for the third quarter of 2025, largely driven by higher than expected utilization of DefenCath by its outpatient dialysis customers. DefenCath sales contributed $88.8 million of net revenue in the quarter.In the third quarter of 2025, the Company recognized Net Income of $108.6 million and adjusted EBITDA of $71.9 million(2). Basic and Fully Diluted EPS were $1.42 and $1.26 per share, respectively.CorMedix again raises its full-year 2025 pro forma net revenue guidance to a range of $390 to $410 million, and fourth quarter net revenue guidance to a range of $115 to $135 million. In addition, the Company is increasing its guidance for fully synergized pro forma adjusted EBITDA for 2025 to a range of $220 – $240 million(3).The Company’s acquisition of Melinta Therapeutics closed on August 29, 2025. Ongoing integration efforts are proceeding more quickly than projected and CorMedix estimates synergy capture of approximately $30 million, of the total estimated $35 – $45 million, on an annual run-rate basis before the end of 2025.CorMedix announced today that the Company is re-branding as CorMedix Therapeutics, with all employees operating under the new company name.In October, the Company announced the completion of enrollment in the ongoing Phase III ReSPECT study of Rezzayo in the prophylaxis of invasive fungal infections in adult patients undergoing blood and marrow transplantation. CorMedix continues to expect top-line data from this study in 2Q of 2026.In September, the Company completed a strategic minority investment in Talphera, Inc. The strategic investment includes a Board seat and an exclusive right of first negotiation for an acquisition of Talphera following the company’s announcement of Phase 3 clinical data for Niyad, a hospital anticoagulant with a potential indication in patients undergoing Continuous Renal Replacement Therapy.Cash and short-term investments, excluding restricted cash, at September 30, 2025 amounted to $55.7 million, and the company projects year-end cash of approximately $100 million. Third Quarter 2025 Financial Results For the third quarter of 2025, CorMedix recorded $104.3 million in net revenue from sales of DefenCath and partial quarter sales of the Melinta portfolio, and recorded $108.6 million in net income, or $1.26 per diluted share, compared with a net loss of $2.8 million, or $0.05 per diluted share, in the third quarter of 2024. Net income for the third quarter of 2025 was driven primarily by net product sales in the period as well as a one-time tax benefit of $59.7 million. The tax benefit was derived from the realization of deferred tax assets primarily associated with the anticipated future use of 100% of CorMedix, Inc. Net Operating Loss (NOL) carryforwards due to projected sustained profitability of the Company. Total operating expenses in the third quarter of 2025 were $41.7 million, compared with $14.1 million in the third quarter of 2024, an increase of approximately 197%. The increase of $28.5 million over the prior period was driven primarily by $12.7 million of non-recurring costs, including transaction, integration and severance costs associated with the Melinta acquisition, as well as by the contribution of operating expenses from Melinta’s business for the month of September. 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. The Company reported cash, cash equivalents and short-term investments of $55.7 million at September 30, 2025, excluding restricted cash. (1) Q3 2025 unaudited pro forma net revenue was prepared by combining the estimated financial results for CorMedix and Melinta for the full fiscal quarter ended September 30, 2025, as if the transaction had closed as of the first day of the fiscal quarter. Pro Forma 2025 Net Revenue guidance was 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, 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 stock-based compensation 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. (3) Pro forma Adjusted EBITDA was prepared by combining the estimated financial results for CorMedix and Melinta for the full year ended December 31, 2025 and adding estimated synergies to be captured in 2025, as if the transaction had closed on January 1, 2025. Such reconciliation is not included in this release because certain items excluded from GAAP cannot be 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 Company. Conference Call Information The management team of CorMedix will host a conference call and webcast today, November 12, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: Wednesday, November 12th @ 8:30am ETDomestic:International:Webcast:1-844-676-2922 1-412-634-6840Webcast 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 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 financial guidance, sales estimates, synergy estimates and timing, accretion estimates, Adjusted EBITDA estimates, expectations and timing regarding clinical 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, adjusted EBITDA, and fully synergized 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 believe 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 and 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 FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com(617) 430-7576 CORMEDIX INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSAND COMPREHENSIVE INCOME(Unaudited) For the Three Months EndedSeptember 30, For the Nine Months EndedSeptember 30, 2025 2024 2025 2024Revenue Product Sales, net $101,546,423 $11,456,115 $180,364,870 $12,262,234 Contract revenue 2,728,866 - 2,728,866 - Total revenue 104,275,289 11,456,115 183,093,736 12,262,234 Cost of revenues (7,566,067) (634,650) (10,921,333) (1,911,079) Amortization of intangible assets (3,628,549) (51,948) (3,732,445) (103,896) Gross profit (loss) 93,080,673 10,769,517 168,439,958 10,247,259 Operating Expenses Research and development (5,097,644) (727,119) (10,732,793) (2,215,551) Selling and marketing (11,186,046) (6,748,900) (22,043,959) (20,472,961) General and administrative (25,451,017) (6,580,834) (44,648,454) (22,851,144) Total operating expenses (41,734,707) (14,056,853) (77,425,206) (45,539,656) Income (Loss) from Operations 51,345,966 (3,287,336) 91,014,752 (35,292,397) Other Income (Expense) Total other income 1,230,212 510,524 2,554,812 2,503,203 Net Income (Loss) Before Income Taxes 52,576,178 (2,776,812) 93,569,564 (32,789,194) Tax (expense) benefit 55,986,802 - 55,465,295 1,394,770 Net Income (Loss) 108,562,980 (2,776,812) 149,034,859 (31,394,424) Other Comprehensive Income (Loss) Total other comprehensive (loss) income 8,205 3,389 (3,006) (4,988) Other Comprehensive (Loss) Income $108,571,185 $(2,773,423) $149,031,853 $(31,399,412) Net Income (Loss) Per Common Share – Basic $1.42 $(0.05) $2.12 $(0.54) Net Income (Loss) Per Common Share – Diluted $1.26 $(0.05) $1.97 $(0.54) Weighted Average Common Shares Outstanding – Basic 75,930,243 58,825,221 69,739,907 57,986,190 Weighted Average Common Shares Outstanding – Diluted 86,214,170 58,825,221 75,676,776 57,986,190 CORMEDIX INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEET DATA September 30, December 31, 2025 2024 (Unaudited) (Audited) ASSETS Cash, cash equivalents and restricted cash $49,481,309 $40,756,138 Short-term investments 7,223,735 11,036,857 Trade receivables, net 158,574,116 51,653,583 Goodwill and intangible assets 407,526,976 - Deferred tax assets 52,500,000 - Other current and long-term assets 75,555,342 15,399,095 Total Assets $750,861,478 $118,845,673 Total Liabilities $376,732,072 $34,188,723 Stockholders' Equity 374,129,406 84,656,950 Total Liabilities and Stockholders’ Equity $750,861,478 $118,845,673 CORMEDIX INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited) For the Nine Months EndedSeptember 30, 2025 2024 Cash Flows from Operating Activities: Net income (loss) $149,034,859 $(31,394,424) Net cash provided by (used in) operating activities $80,584,819 $(45,000,117) Net cash (used in) provided by investing activities (311,727,039) 21,534,874 Net cash provided by financing activities 239,867,391 15,033,273 Net Increase (Decrease) in Cash and Cash Equivalents $8,725,171 $(8,431,970) Cash and Cash Equivalents and Restricted Cash - Beginning of Period $40,756,138 $43,823,192 Cash and Cash Equivalents and Restricted Cash - End of Period $49,481,309 $35,391,222 CORMEDIX INC. AND SUBSIDIARIESNon-GAAP Reconciliations(Unaudited) For the Three Months EndedSeptember 30, 2025 2024Net income (loss) $108,562,980 $(2,776,812) Adjusted to add (deduct): Interest income (expense), net (612,030) (543,849) Provision for (benefit from) income taxes (55,986,802) - Depreciation and amortization 3,790,466 77,408 EBITDA (Non-GAAP) $55,754,614 $(3,243,253) Adjusted to add (deduct): Stock-based compensation expense 4,065,541 1,227,476 Merger-related costs 12,655,620 - Other income (expense) (618,182) 33,325 Adjusted EBITDA (Non-GAAP) $71,857,593 $(1,982,452)

Phase 3AcquisitionFinancial StatementDrug ApprovalClinical Result

12 Nov 2025

·cormedix.com

CORMEDIX INC. REPORTS THIRD QUARTER 2025 FINANCIAL RESULTS AND UPDATES FY 2025 GUIDANCE

‒ Q3 2025 Net Revenue of $104.3 million; Pro Forma Net Revenue of $130.8 million ‒ ‒ Q3 2025 Net Income of $108.6 million; Adjusted EBITDA of $71.9 million ‒ ‒ FY 2025 Pro Forma Net Revenue Guidance Raised to a Range of $390 to $410 million ‒ ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒ Berkeley Heights, NJ – November 12, 2025 – 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 third quarter ended September 30, 2025 and provided an update on its business. Recent Corporate Highlights: CorMedix announces $104.3 million of net revenue and $130.8 million of pro forma net revenue(1) for the third quarter of 2025, largely driven by higher than expected utilization of DefenCath by its outpatient dialysis customers. DefenCath sales contributed $88.8 million of net revenue in the quarter. In the third quarter of 2025, the Company recognized Net Income of $108.6 million and adjusted EBITDA of $71.9 million(2). Basic and Fully Diluted EPS were $1.42 and $1.26 per share, respectively. CorMedix again raises its full-year 2025 pro forma net revenue guidance to a range of $390 to $410 million, and fourth quarter net revenue guidance to a range of $115 to $135 million. In addition, the Company is increasing its guidance for fully synergized pro forma adjusted EBITDA for 2025 to a range of $220 – $240 million(3). The Company’s acquisition of Melinta Therapeutics closed on August 29, 2025. Ongoing integration efforts are proceeding more quickly than projected and CorMedix estimates synergy capture of approximately $30 million, of the total estimated $35 – $45 million, on an annual run-rate basis before the end of 2025. CorMedix announced today that the Company is re-branding as CorMedix Therapeutics, with all employees operating under the new company name. In October, the Company announced the completion of enrollment in the ongoing Phase III ReSPECT study of Rezzayo in the prophylaxis of invasive fungal infections in adult patients undergoing blood and marrow transplantation. CorMedix continues to expect top-line data from this study in 2Q of 2026. In September, the Company completed a strategic minority investment in Talphera, Inc. The strategic investment includes a Board seat and an exclusive right of first negotiation for an acquisition of Talphera following the company’s announcement of Phase 3 clinical data for Niyad, a hospital anticoagulant with a potential indication in patients undergoing Continuous Renal Replacement Therapy. Cash and short-term investments, excluding restricted cash, at September 30, 2025 amounted to $55.7 million, and the company projects year-end cash of approximately $100 million. Third Quarter 2025 Financial Results For the third quarter of 2025, CorMedix recorded $104.3 million in net revenue from sales of DefenCath and partial quarter sales of the Melinta portfolio, and recorded $108.6 million in net income, or $1.26 per diluted share, compared with a net loss of $2.8 million, or $0.05 per diluted share, in the third quarter of 2024. Net income for the third quarter of 2025 was driven primarily by net product sales in the period as well as a one-time tax benefit of $59.7 million. The tax benefit was derived from the realization of deferred tax assets primarily associated with the anticipated future use of 100% of CorMedix, Inc. Net Operating Loss (NOL) carryforwards due to projected sustained profitability of the Company. Total operating expenses in the third quarter of 2025 were $41.7 million, compared with $14.1 million in the third quarter of 2024, an increase of approximately 197%. The increase of $28.5 million over the prior period was driven primarily by $12.7 million of non-recurring costs, including transaction, integration and severance costs associated with the Melinta acquisition, as well as by the contribution of operating expenses from Melinta’s business for the month of September. 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. The Company reported cash, cash equivalents and short-term investments of $55.7 million at September 30, 2025, excluding restricted cash. (1) Q3 2025 unaudited pro forma net revenue was prepared by combining the estimated financial results for CorMedix and Melinta for the full fiscal quarter ended September 30, 2025, as if the transaction had closed as of the first day of the fiscal quarter. Pro Forma 2025 Net Revenue guidance was 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, 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 stock-based compensation 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. (3) Pro forma Adjusted EBITDA was prepared by combining the estimated financial results for CorMedix and Melinta for the full year ended December 31, 2025 and adding estimated synergies to be captured in 2025, as if the transaction had closed on January 1, 2025. Such reconciliation is not included in this release because certain items excluded from GAAP cannot be 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 Company. Conference Call Information The management team of CorMedix will host a conference call and webcast today, November 12, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: Wednesday, November 12th @ 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 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 financial guidance, sales estimates, synergy estimates and timing, accretion estimates, Adjusted EBITDA estimates, expectations and timing regarding clinical 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, adjusted EBITDA, and fully synergized 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 and 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 3AcquisitionFinancial StatementDrug ApprovalClinical Result

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
Invasive Fungal Infections	Phase 3	United States	Melinta Therapeutics, Inc.	15 Oct 2025
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
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	jglnhuaizf(nspyzfznic) = zjiecbwedj mlfkgjjktg (sxrcipptkv ) View more	Positive	01 Nov 2025
				Caspofungin	jglnhuaizf(nspyzfznic) = knjalerdde mlfkgjjktg (sxrcipptkv ) View more
NCT02734862 \| NCT03667690 (ReSTORE;STRIVE, Pubmed \| Crit Care)	Phase 3	Candidemia \| Candidiasis, Invasive	294	Rezafungin	obukjaqbog(dziniwjpju) = vvunjssrva mozacgicpx (xgedzylsmk ) View more	Positive	11 Nov 2024
				Caspofungin	obukjaqbog(dziniwjpju) = oqnkdbujjd mozacgicpx (xgedzylsmk ) View more
NCT02734862 \| NCT03667690 (ReSTORE, Pubmed \| Crit Care)	Phase 2/3	Candidemia \| Candidiasis, Invasive	113	Rezafungin	zltdrfmigb(mtvyvpnzao) = schrlwcsqm nretddfywv (gnozquhuou ) View more	Positive	28 Oct 2024
				Caspofungin	zltdrfmigb(mtvyvpnzao) = iwshdfnrve nretddfywv (gnozquhuou ) View more
NCT03667690 (ReSTORE, Pubmed \| Clin Infect Dis)	Phase 3	Candidemia positive culture	-	Rezafungin	hzlfdysddk(iviyalogmi) = xrogdhskgz ulfowlotpi (zibgdstypz ) View more	Positive	26 Sep 2024
				Caspofungin	hzlfdysddk(iviyalogmi) = eexrikdnyi ulfowlotpi (zibgdstypz ) View more
NCT02734862 \| NCT03667690 (ReSTORE, Biospace) Manual	Not Applicable	Candidemia \| Candidiasis, Invasive	-	REZZAYO	yjxmkddodf(nregjxhdww) = REZZAYO was generally well tolerated and had a similar safety profile to caspofungin zbhnzjkmjt (uvjdyyokny )	Positive	05 Dec 2023
NCT02734862 \| NCT03667690 (Pubmed 1 \| Pubmed 2 \| Lancet Infect Dis) Manual	Phase 2/3	Candidemia \| Candidiasis, Invasive	294	Rezafungin	xnzkmmnipl(mzbnckdtbt) = mtpigxwqst jxbrfcopju (otyxdhkbbr ) View more	Positive	23 Nov 2023
				Caspofungin	xnzkmmnipl(mzbnckdtbt) = fsmfcjrtkk jxbrfcopju (otyxdhkbbr ) View more
NCT03667690 (FDA) Manual	Phase 3	Candidemia \| Candidiasis, Invasive	187	REZZAYO 400 mg/200 mg	tqpppyiniy(wxnbkhvbcl) = zfujkpmobi egbblyuwkz (vtdwgkrbgk ) View more	Superior	22 Mar 2023
				Caspofungin 70 mg/50 mg	tqpppyiniy(wxnbkhvbcl) = nckgtmpiir egbblyuwkz (vtdwgkrbgk ) View more
NCT03667690 (ReSTORE \| ReSTORE;STRIVE, CTgov)	Phase 3	Candidemia	199	oral placebo+Rezafungin (Group 1: Rezafungin for Injection)	tcekelbfrb = syudfjeafv yatjdebizi (ntevjiclsg, lswhiparwd - leyjmrxqkd) View more	-	06 Jan 2023
				intravenous placebo+Fluconazole+caspofungin (Group 2: Caspofungin)	tcekelbfrb = osstbsfggt yatjdebizi (ntevjiclsg, zwgrmkiqnx - ogjavdxeal) View more
NCT03667690 (ReSTORE, Pubmed \| Lancet)	Phase 3	Candidemia \| Candidiasis, Invasive	199	Rezafungin	baxxozydse(deanadwimc) = ucyjwimrau cphxwnymeh (ghvzhtmzeu ) View more	Positive	25 Nov 2022
				Caspofungin	baxxozydse(deanadwimc) = jsxrbrbeev cphxwnymeh (ghvzhtmzeu ) View more
NCT03667690 (ReSTORE, Corporate Publications) Manual	Phase 3	Candidemia \| Candidiasis, Invasive	187	Rezafungin acetate	ndssoyiqoz(nayuecmplz) = bamwnkjdrj pcsliskpsl (nijtjerjnq ) View more	Positive	14 Dec 2021
				Caspofungin	ndssoyiqoz(nayuecmplz) = ogtojfjkmb pcsliskpsl (nijtjerjnq ) View more

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