CorMedix receives second FDA CRL for DefenCath; Q2 net loss $7.6M

CorMedix Inc.

Second CRL from FDA for DefenCath NDA due to unresolved deficiencies at CMO and heparin supplier.
Entered agreement with Alcami as alternative manufacturer; expects to submit NDA supplement around Q1 2023.
CMS granted conditional NTAP reimbursement, conditioned on FDA approval before July 1, 2023.
Net loss Q2 2022: $7.6M ($0.19/share) vs $4.6M ($0.12/share) in Q2 2021; OpEx $8.3M, up 41%.
Cash and short-term investments $64.6M at June 30, 2022; funding through at least Q3 2023.

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