Rezafungin acetate

Enrolment completed in Phase III ReSPECT study in prophylaxis of fungal infections in adult patients undergoing allogeneic blood and marrow transplant Topline results from ReSPECT study expected by mid-2026 CAMBRIDGE, England--(BUSINESS WIRE)--Mundipharma today announced completion of patient enrolment for the ongoing, global Phase III ReSPECT trial evaluating REZZAYO® (rezafungin). The ReSPECT trial is a global, randomised, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic blood and marrow transplantation. “Completing patient enrolment for the Phase III ReSPECT study marks a key milestone in addressing the unmet need for antifungal prevention in immunosuppressed patients,” said Dr Yuri Martina, Chief Development and Medical Officer at Mundipharma. “Patients have enrolled in this global study from more than 50 clinical trial centres across seven countries. We look forward to the clinical evidence that this study will produce.” *ENDS* About invasive candidiasis Invasive candidiasis (IC) continues to be an area of significant unmet need, especially for critically ill patients in hospitals and patients with compromised immune systems.1,2 Despite a number of available treatments, the mortality rate for patients with invasive candidiasis is as high as 40%.2,3 IC is characterised as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidemia and deep-seated tissue candidiasis.4 About rezafungin Rezafungin is indicated for the treatment of invasive candidiasis in adults.5 REZZAYO® is a registered trademark of NAPP Pharmaceutical Group Limited a member of the Mundipharma network. About Mundipharma Mundipharma is a global healthcare company with a presence in Africa, Asia Pacific, Canada, Europe, Latin America and the Middle East. In line with its mission, United for Patients, Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease, ophthalmology, oncology, respiratory and central nervous system. For more information visit www.mundipharma.com. Commercialisation rights to rezafungin in the United States are licensed to CorMedix Inc. References: Cortegiani A, et al. Cochrane Database Syst Rev 2016;1:CD004920 Kullberg BJ, Arendrup MC. N Engl J Med 2015;373:1445–56 Bassetti M, et al. Crit Care 2019;23(1):219 Cortes JA, Corrales IF. Invasive candidiasis: Epidemiology and Risk Factors. November 2018. Available at https://www.intechopen.com/chapters/64365 (last accessed October 2025) REZZAYO ® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/15479/smpc#gref (last accessed October 2025) Job code: GBL-S-RZF-2500016 Date of preparation: October 2025

- 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