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CorMedix Inc. develops and commercializes therapeutic products for life-threatening conditions, with a U.S. commercial focus in institutional settings of care. Its recurring news centers on DefenCath, a taurolidine and heparin product used to prevent catheter-related bloodstream infections in adult hemodialysis patients with central venous catheters, and on the specialty pharmaceutical portfolio added through the completed Melinta Therapeutics acquisition.
Company updates also cover anti-infective and hospital-focused products such as MINOCIN for Injection, REZZAYO, VABOMERE, ORBACTIV, BAXDELA and KIMYRSA, as well as TOPROL-XL. News themes include operating and financial results, commercial execution, clinical and regulatory disclosures for expanded product uses, shareholder voting matters, governance updates, investor conference activity and capital actions such as share repurchase authorization.
CorMedix Inc. (NYSE American: CRMD) announced the pricing of its underwritten public offering, selling 4,444,444 shares at $4.50 per share, aiming for $20 million in gross proceeds. The offering is set to close on July 30, 2020, pending customary conditions. The proceeds will be utilized for general corporate purposes, including the regulatory approval and commercialization of Defencath™, research and development, and working capital. Underwriters have a 30-day option for an additional 666,666 shares.
CorMedix Inc. (NYSE American: CRMD) reported a Q1 2020 net loss of $5.6 million ($0.21/share), higher than the $5.2 million loss the previous year. Operating expenses rose 14% to $5.6 million, primarily due to increased SG&A expenses in preparation for a New Drug Application (NDA) for its lead product, Defencath™, which aims to prevent bloodstream infections in hemodialysis patients. The FDA conditionally accepted the proprietary name. The company has cash and short-term investments of $23.2 million, which, along with recent tax benefit sales, gives a pro forma cash total of $31.3 million, sustaining operations into Q2 2021.
CorMedix Inc. (CRMD) announced the appointment of Matt David, M.D. as Executive Vice President and Chief Financial Officer. Dr. David brings extensive experience in healthcare capital markets and strategy, essential for the company as it approaches regulatory approval for Neutrolin, its lead product aimed at preventing bloodstream infections in hemodialysis patients. Neutrolin has demonstrated a 71% reduction in related infections compared to traditional treatments, and it holds FDA Fast Track status. The company has commenced the NDA submission process for the product.
CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company, announced it will report its first-quarter financial results on May 11, 2020, after market close. The company has a focus on developing Neutrolin®, an innovative antimicrobial solution aimed at preventing bloodstream infections related to central venous catheters. The Phase 3 clinical trial for Neutrolin showed a significant 71% reduction in infections compared to heparin controls. Neutrolin holds FDA Fast Track status, and the NDA submission process has commenced. Neutrolin is already CE Marked in Europe.