Oritavancin Diphosphate

‒ Q3 2025 Unaudited Pro Forma Net Revenue of more than $125 million ‒ ‒ Q3 2025 Unaudited DefenCath Net Revenue of more than $85 million ‒ ‒ Raising FY 2025 Pro Forma Net Revenue Guidance to at least $375 million ‒ ‒ ~$30mm of operating synergy on a go-forward run-rate basis before year end 2025 ‒ Berkeley Heights, NJ – October 20, 2025 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced selected preliminary unaudited third quarter results and provided an update on its business. These include the following key updates: Preliminary Q3 2025 unaudited net revenue of more than $100 million, including at least $85 million for DefenCath, and preliminary pro forma Q3 2025 unaudited Company net revenue of more than $125 million(1). DefenCath revenue growth has been driven by stronger than projected utilization by the Company’s LDO customer as well as continued utilization growth with other customers. Based on the current sales trend for DefenCath as well as the performance of the recently acquired Melinta portfolio, CorMedix is increasing its full-year 2025 pro forma net revenue guidance from the previously announced range of $325-$350 million to at least $375 million(1). Company expects Q3 2025 adjusted EBITDA(2) of at least $70 million. The Company has made significant progress on the integration of Melinta and management now forecasts cost synergy capture of at least $30 million on a go-forward run-rate basis before the end of the fourth quarter 2025, with the remaining targeted synergies of $5 – $15 million expected to be captured in CY 2026. CorMedix recently announced the completion of enrollment in the ongoing Phase III ReSPECT study of Rezzayo in prophylaxis of fungal infection in adult patients undergoing allogeneic blood and marrow transplant. The Company expects to be able to share clinical data in 2Q 2026 and believes that the total addressable market for prophylaxis is more than $2 billion. Cash, cash equivalents and short-term investments as of September 30, 2025 accounted for approximately $56 million, and the Company is guiding to a projected year end cash and cash equivalent balance of approximately $100 million. The Company’s Q3 cash balance was impacted by cash payments made for the acquisition of Melinta and associated closing costs, the Company’s strategic investment in Talphera, as well as increased working capital requirements necessary to support revenue growth. The preliminary financial information presented in this press release is based on CorMedix’s current expectations and may be adjusted as a result of, among other things, the completion of the quarterly review procedures of CorMedix’s third quarter 2025 financial statements. 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. Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as stock-based compensation and certain non-recurring items. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the third quarter 2025 financial results. Such reconciliation is not included in this release because the Company is currently finalizing certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation. 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), 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, peak annual sales estimates, synergy estimates and timing, accretion estimates and Adjusted EBITDA estimates. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. 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. Investor Contact: Dan Ferry Managing Director LifeSci Advisors daniel@lifesciadvisors.com (617) 430-7576

- Enrollment Completed in Ongoing Phase III ReSPECT Study in Prophylaxis of Fungal Infections in Adult Patients Undergoing Allogeneic Blood and Marrow Transplant - - Topline Results from ReSPECT Study Expected in 2Q 2026 - BERKELEY HEIGHTS, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced completion of enrollment for the ongoing, global Phase III ReSPECT trial evaluating the efficacy of REZZAYO® (rezafungin), a single-agent echinocandin in the prevention of Candida, Aspergillus, and Pneumocystis infection in patients undergoing allogeneic blood and marrow transplantation (BMT). This clinical trial has been sponsored by Mundipharma, located in the United Kingdom. The US distribution rights for REZZAYO were licensed under a strategic collaboration agreement with Melinta Therapeutics, LLC, a wholly owned subsidiary of CorMedix. “Completing enrollment for the Phase III ReSPECT study represents an important step toward our goal of seeking FDA approval for REZZAYO in the prophylaxis of invasive fungal disease in adult patients receiving BMT,” said Joseph Todisco, CEO of CorMedix. Mr. Todisco continued, “While we have just recently closed our acquisition of Melinta Therapeutics, we believe that a prophylaxis indication for REZZAYO represents a significant growth opportunity for CorMedix, given the critical unmet need in this high-risk patient population. We look forward to sharing topline results from this study next year.” The ReSPECT clinical trial is a Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of once-weekly rezafungin (REZZAYO) versus a standard antimicrobial regimen (SAR) for the prevention of invasive fungal diseases (IFDs) in adults undergoing allogeneic BMT. Participants in the experimental arm receive a 400 mg loading dose of rezafungin in week one, followed by 200 mg weekly for 13 weeks, along with oral placebos matching the SAR components. The primary endpoint is fungal-free survival at day 90, with secondary objectives including incidence of IFD, discontinuation due to toxicity, and mortality adjusted for comorbidities. About REZZAYO® REZZAYO (rezafungin for injection) is a next generation echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. There are an estimated 50,000 cases of candidemia and invasive candidiasis each year in the U.S. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic BMT. CorMedix estimates that there are an approximately 130,000 patients that could constitute the addressable market for antifungal prophylaxis in the U.S. and estimates an implied total addressable market (“TAM”) of over $2B in this market segment. REZZAYO has orphan drug exclusivity through 2035 and patent coverage through 2038 in the U.S. 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), 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. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Most common adverse reactions (incidence ≥5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at www.rezzayo.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. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com (617) 430-7576