Business
CorMedix Inc. Reports Third Quarter 2020 Financial Results and Provides Business Update
Conference Call Scheduled for Today at 4:30 p.m. Eastern Time BERKELEY HEIGHTS, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a
About this update from Cormedix Inc.
[{"type":"text","content":"Conference Call Scheduled for Today at 4:30 p.m. Eastern Time\nBERKELEY HEIGHTS, N.J., Nov. 05, 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 financial results for the third quarter and nine months ended September 30, 2020 and provided an update on recent developments.\n Recent Corporate and Regulatory Highlights: CorMedix continues its interactions with the FDA regarding the New Drug Application, or NDA, for Defencath™ for the prevention of catheter related blood stream infections, or CRBSIs, in patients undergoing hemodialysis via central venous catheter. The FDA has tentatively scheduled the previously announced meeting of the Antimicrobial Drugs Advisory Committee for January 14, 2021 to discuss the Defencath NDA.Recent changes to the CorMedix Board of Directors include the addition of Paulo Costa and Greg Duncan. These individuals further augment the expertise at the Board level on commercial leadership as well as corporate strategy. Each of Paulo and Greg has had successful careers and leadership roles in the biopharma industry.CorMedix has continued to expand its efforts to prepare for the commercial launch of Defencath. This includes ongoing dialogue with key payors and dialysis providers and ongoing market research. The interactions have been positive and clearly position CorMedix to ensure that, once Defencath is approved by the FDA, it will be in the best possible position to successfully launch in the US market.Cash and short-term investments, excluding restricted cash, at September 30, 2020 amounted to $37.0 million. Pro forma cash, including cash on the balance sheet at September 30, 2020 and the net proceeds from recent ATM issuance, is approximately $41.8 million. Khoso Baluch, CorMedix CEO, commented, “We have continued to make progress on our goal of bringing Defencath to the U.S. market as a catheter lock solution for hemodialysis. We look forward to discussing Defencath with the Antimicrobial Drugs Advisory Committee in January, ahead of the February 28, 2021 PDUFA date for the product. We also are making necessary preparations for the launch of Defencath in the U.S. hemodialysis market, following FDA approval. We be...