CorMedix to pay Melinta $300 million in upfront consideration, comprised of $260 million in cash and $40 million in CorMedix equity issued to Melinta shareholders

The agreement also includes a regulatory milestone payment of up to $25 million and royalties

Transformational deal that strengthens and diversifies commercial product portfolio for CorMedix

Parsippany, NJ, August 7, 2025 — Melinta Therapeutics, LLC (“Melinta”), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announces that it has entered into a definitive agreement to be acquired by CorMedix Inc. (“CorMedix”) (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions. The acquisition is a testament to the exceptional value Melinta has created through its strong portfolio, culture, capabilities, and experienced team within the hospital ecosystem for acute care.

“This acquisition represents a milestone achievement for Melinta and validates our position as a recognized leader in acute care,” said Christine Ann Miller, CEO of Melinta Therapeutics. “I’m incredibly proud of our accomplishments. Through our talented team’s dedication, we have undergone an extraordinary transformation to build a highly sought-after commercialization platform with sustainable growth and profitability. By joining forces with CorMedix, we’re creating a stronger organization that will accelerate both our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses and our vision that all patients who need our therapies receive them.”

Since becoming privately owned by affiliates of healthcare investment firm Deerfield Management Company, L.P. in 2020, Melinta has demonstrated exceptional organizational evolution across operations, culture, and strategic positioning to achieve 85% revenue growth, positive cash flow, and sustainable profitability, while increasing employee satisfaction and building a highly talented team. Melinta has strengthened its position with global presence through ex-US partnerships and seven business development deals, including strategic partnership with BARDA to advance two FDA-approved antibiotics for use in pediatric patients, as well as the development of one product for use against biothreat pathogens.ⁱ This comprehensive evolution has established Melinta as a preferred partner who is fully integrated within the hospital ecosystem.

This acquisition will expand CorMedix’s commercial portfolio with six marketed, highly differentiated, hospital- and clinic-focused infectious disease products, including REZZAYO^® (rezafungin for injection), MINOCIN^® (minocycline) for Injection, VABOMERE^® (meropenem and vaborbactam), KIMYRSA^® (oritavancin), ORBACTIV^® (oritavancin), BAXDELA^® (delafloxacin), and an additional well-established cardiovascular product, TOPROL-XL^® (metoprolol succinate)ⁱⁱ. The portfolio’s flagship product, REZZAYO^® is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation (BMT), which is expected to be completed in 1H2026. The addition of Melinta’s high-performing team, innovative assets, and a pipeline expansion indication positions CorMedix to deliver on its ambition of becoming a leader in the specialty pharmaceutical business.

“The combination of CorMedix and Melinta represents a compelling opportunity to create a specialty pharmaceutical leader with enhanced capabilities to serve patients,” said Joseph Todisco, Chief Executive Officer of CorMedix Inc. “Melinta’s proven commercial platform and portfolio perfectly complement our own, and once combined we will have the scale, resources, and expertise to accelerate innovation while creating significant value for our stakeholders. We are thrilled to welcome the talented Melinta team and look forward to building on our shared commitment to excellence in this space.”

“Under Christine’s leadership, the transformation of Melinta has been remarkable,” said Jonathan Leff, Board Member of Melinta and Partner at Deerfield Management Company. “Through focused execution and strategic investment in its commercial capabilities, the Melinta team has built a high-performing organization that has consistently exceeded expectations. The combination with CorMedix reflects the strategic value of Melinta’s infrastructure and positions the combined company for continued growth under Joe’s leadership. We look forward to this next chapter.”

Under the terms of the agreement, which has been approved by the CorMedix and Melinta Board of Directors respectively, CorMedix will pay Melinta $300 million in upfront consideration (subject to customary adjustments), comprised of $260 million in cash and $40 million in CorMedix equity (in the form of pre-funded warrants) issued to Melinta shareholders. The agreement also contains an additional regulatory milestone of up to $25 million (payable in cash or shares at CorMedix’s election) for the FDA approval of REZZAYO^® for prophylaxis of invasive fungal infections in adults undergoing allogenic BMT, if the milestone event is achieved by June 30, 2029.  Furthermore, the agreement includes tiered royalties on REZZAYO U.S. net sales and low-single-digit royalties on MINOCIN^® for injection U.S. net sales. The merger is subject to customary closing conditions and U.S. regulatory approval and is expected to close in September.

Advisors

Evercore is acting as exclusive financial advisor and Fenwick & West LLP is acting as legal advisor to Melinta. Katten Muchin Rosenman LLP is acting as legal advisors for Deerfield Management Company, L.P.

About Melinta Therapeutics

Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA^® (delafloxacin), KIMYRSA^® (oritavancin), MINOCIN^® (minocycline) for Injection, ORBACTIV^® (oritavancin), REZZAYO^® (rezafungin for injection), TOPROL-XL^® (metoprolol succinate) and VABOMERE^® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, including their important safety information, visit Melinta.com.

About REZZAYO^® (rezafungin for injection)

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.

ⁱ These projects have been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00022.

ⁱⁱ TOPROL-XL^® is a registered trademark of the AstraZeneca group of companies.

Publication reaffirms the efficacy of rezafungin for treatment of candidemia and invasive candidiasis (IC) in adult patients across Candida species

PARSIPPANY, NJ—May 23, 2024— Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO^® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults. The data analyses in the article, “Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species. Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups.

The article additionally highlights the approval of the Clinical and Laboratory Standards Institute (CLSI) susceptibility breakpoints for rezafungin against several Candida species including Candida glabrata, a species increasingly associated with reduced susceptibility to treatment with echinocandins, and Candida auris, a highly resistant pathogen that is associated with life-threating infections.  Rezafungin is the only antifungal, based on in vitro data, that has a defined susceptibility breakpoint for C. auris approved by CLSI; the efficacy of rezafungin in treating candidemia or invasive candidiasis caused by this pathogen has not been established in adequate and well-controlled clinical trials. 

Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, said, “We are delighted with the release of this analysis of data from the ReSTORE Phase 3 trial, which supports the effectiveness and safety of REZZAYO in comparison to caspofungin and are also pleased to see that CLSI approved the REZZAYO susceptibility breakpoints for Candida pathogens, including C. auris, which has been identified as a potential global threat by the CDC and WHO.”

She added, “Melinta has been leveraging our expertise in hospital and acute care environments to commercialize REZZAYO, making it available to healthcare providers and their patients affected by candidemia and invasive candidiasis. This effort supports our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses.”

Melinta holds the exclusive rights to commercialize rezafungin in the U.S. from Mundipharma.  

 About REZZAYO^® (rezafungin for injection)

REZZAYO (rezafungin for injection) is a novel once weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation.

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

Contraindications

REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

Warnings and Precautions

• Infusion-related Reactions: 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.
• Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
• Hepatic Adverse Reactions: 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.

Adverse Reactions

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.

About Melinta Therapeutics, LLC
Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit www.melinta.com.