Delcath reports Q3 results; FDA approved HEPZATO KIT, launch planned Jan 2024

DELCATH SYSTEMS, INC.

2023-Q3 EPS reported -$2.61 revenue$1,526,000

FDA approved HEPZATO KIT for metastatic uveal melanoma with hepatic metastases; commercial launch planned for January 2024.
Raised ~$35M from Tranche A warrant exercise; up to $25M more upon achieving $10M quarterly revenue.
Q3 revenue $0.4M vs $0.9M YoY; R&D $4.7M, SG&A $6.2M.
Retrospective study showed median overall survival 516 days for PHP vs 301 days for SIRT in metastatic uveal melanoma.
CHOPIN trial enrolled 55 of 76 patients; interim futility analysis recommended continuing; full enrollment expected mid-2024.

item 2.02 item 9.01

Key facts

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Earnings Releases SEC 8-K Item 2.02 confidence 0.95

DELCATH SYSTEMS, INC. reported third quarter ended September 30, 2023 results: revenue approximately $0.4 million.

Period: third quarter ended September 30, 2023
Revenue: approximately $0.4 million
Result: reported results

Exact text from the filing

Total revenue for the three months ended September 30, 2023, was approximately $0.4 million, compared to $0.9 million for the prior year period

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Source: SEC EDGAR

accession 0001628280-23-038607

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