Business
CorMedix Inc. Reports Third Quarter and Nine Month 2023 Financial Results and Provides Business Update
Conference Call Scheduled for Today at 4:30 p.m. Eastern Time BERKELEY HEIGHTS, N.J., Nov. 14, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: 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. 14, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced financial results for the third quarter and nine months ended September 30, 2023 and provided an update on recent business events. Recent Corporate Highlights: The FDA completed a preapproval inspection for CorMedix’s primary finished dosage CMO site in September and the Company is pleased with the outcome. In addition, the FDA has also conducted preapproval inspections for DefenCath at suppliers of active pharmaceutical ingredients, contract laboratories involved in testing of product specifications and packaging facilities, and CorMedix is not aware of any outstanding deficiencies or review issues at this time.CorMedix has intensified preparations for commercial launch with a number of new hires in market access, sales training, pricing and contracting, commercial operations, field medical, and drug safety and pharmacovigilance.In the event CorMedix receives final FDA approval over the coming days, the Company is targeting a commercial launch before the end of the first quarter of 2024.The United States Patent and Trademark Office (USPTO) issued a patent with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This Patent reflects the unique and proprietary nature of DefenCath®, and will extend the Company’s intellectual property protection with an expiration date of April 15, 2042.Cash and short-term investments, excluding restricted cash, at September 30, 2023 amounted to $86.6 million. Joe Todisco, CorMedix CEO, commented, “I am very pleased with the Company’s progress on all fronts, most notably the outcomes of the preapproval inspections at our primary CMO facility and other key vendors, as well as our preparations toward commercial readiness. We have accelerated multiple work streams aimed at commercial launch, and made a number of key hires over the past quarter that are essential to ensuring a successful commercial launch following a potential FDA approval of DefenCath. We look forward to providing addi...