GlobeNewswire Inc | Aug 3, 2020 04:05PM EDT

August 03, 2020

BERKELEY HEIGHTS, N.J., Aug. 03, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it will report its financial results for the second quarter ended June 30, 2020, after the market close on Monday, August 10, and will host a corporate update conference call at 4:30pm Eastern Time.

Monday, August 10^th @ 4:30pm ETDomestic: 877-423-9813International: 201-698-8573Conference ID: 13707638Webcast: Webcast Link

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Defencath, a novel antibacterial and antifungal solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Defencath contains taurolidine, which has been shown in laboratory testing to kill both gram-negative and gram-positive bacteria, as well as fungi that have been associated with CRBSIs. Development of resistance to taurolidine has not been demonstrated in laboratory studies. The Company completed a Phase 3 clinical trial of Defencath in patients undergoing hemodialysis for end-stage renal disease, which showed a 71% reduction in catheter-related bloodstream infections (CRBSIs) relative to the heparin control arm (p=0.0006) with a good safety profile.

Defencath has Fast Track designation from FDA, which provides the potential for priority review of a marketing application, and Qualified Infectious Disease Product designation, which allows for 5 additional years of marketing exclusivity when approved for commercial distribution by FDA. FDA granted rolling submission of the new drug application (NDA) and CorMedix has submitted the NDA. Priority review was requested and the FDA has 60 days to evaluate the request and make a filing decision for the NDA. If priority review is granted, FDA will have a goal of a 6 month review period, compared to 10 months for a standard review. FDA has conditionally approved the name Defencath and the name Neutrolin will continue to be used where the product is CE Marked and commercially distributed as a medical device in Europe and other territories.

CorMedix intends to pursue additional significant market indications for Defencath, such as use in central venous catheters in oncology and total parenteral nutrition patients, and aims to explore regulatory pathways forward in these areas following an initial NDA approval. A deferral of a study in pediatric hemodialysis patients was granted by FDA and will be conducted after the approval of the NDA for Defencaths use in adult hemodialysis patients. An additional 6 months of marketing exclusivity can be received for conducting the pediatric study. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information, visit: www.cormedix.com.

Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com(617) 430-7576