secwatch.observer — SEC 8-K summary
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Issuer:     DELCATH SYSTEMS, INC. (DCTH)
CIK:        0000872912
Form:       8-K
Filed at:   2023-08-09T23:59:59+00:00
Accession:  0001628280-23-028674
Event type: regulatory
Sentiment:  neutral
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Delcath reports Q2 results; PDUFA for HEPZATO KIT on Aug 14
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- PDUFA date August 14, 2023 for HEPZATO KIT NDA resubmission; FDA review ongoing.
- Financing: $25M closed; up to $35M additional upon NDA approval; up to $25M on $10M quarterly revenue.
- Q2 revenue $0.5M (down from $0.8M); R&D $3.6M (down from $5.6M); SG&A $4.8M (up from $4.5M).
- Hired new CMO, SVP Finance, Director of Sales; treating patients at 3 Expanded Access sites.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/872912/000162828023028674/0001628280-23-028674-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/872912/000162828023028674/dcth-20230809.htm
  HTML page:      https://secwatch.observer/filing/0001628280-23-028674

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