Business
CorMedix Inc. Reports Third Quarter 2022 Financial Results and Provides Business Update
Conference Call Scheduled for Today at 8:30 a.m. Eastern Time BERKELEY HEIGHTS, N.J., Nov. 10, 2022 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a
About this update from Cormedix Inc.
[{"type":"text","content":"Conference Call Scheduled for Today at 8:30 a.m. Eastern Time\nBERKELEY HEIGHTS, N.J., Nov. 10, 2022 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced financial results for the third quarter and nine months ended September 30, 2022 and provided an update on recent business events. Recent Corporate Highlights: Earlier this week, CorMedix announced that the Center for Medicare & Medicaid Services (CMS) has published in the Federal Register a correction to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals New Technology Add on Payment (NTAP) reimbursement of DefenCath, increasing the maximum reimbursement per average hospital visit from $4,387.50 to $14,259.38. CorMedix also announced the recent submission of a duplicate NTAP application to CMS, intended to take effect should the potential final approval of the DefenCath New Drug Application (NDA) by FDA occur after July 1st of 2023. The Contract Manufacturing Organization (CMO) for the manufacture of DefenCath has informed the Company that it has implemented more than 95% of the corrective actions that resulted from a June FDA inspection, and that the CMO believes it is on track to close out remaining items during December. As CorMedix executes on its plan to create alternative supply chain options for resubmission of the NDA for DefenCath, the Company is in the process of validating manufacturing at the CMO with heparin sourced from an alternative API supplier, as well as validating manufacturing at Alcami, an additional CMO, with heparin sourced from an alternative API supplier. The Company’s target is to resubmit the DefenCath NDA by the end of the first quarter of 2023. Cash and short-term investments, excluding restricted cash, at September 30, 2022 amounted to $59.0 million. Joe Todisco, CorMedix CEO, commented, “the CorMedix team has made excellent progress on all fronts, working diligently in support of the CMO as it implements corrective actions to address deficiencies the CMO received from FDA during a June inspection of the manufacturing facility, as well as undertaking multiple steps to build out the team, processes and systems to be ready for commercialization ...