secwatch.observer — SEC 8-K summary
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Issuer:     CorMedix Inc. (CRMD)
CIK:        0001410098
Form:       8-K
Filed at:   2022-08-11T23:59:59+00:00
Accession:  0001213900-22-046610
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1410098/000121390022046610/0001213900-22-046610-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1410098/000121390022046610/ea164139-8k_cormedixinc.htm
  HTML page:      https://secwatch.observer/filing/0001213900-22-046610

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer