Highest-materiality recent filing
Delcath Q2 revenue $29.1M, up 20% YoY; raises FY 2026 revenue guidance to $104-108M
Total revenue $29.1M (Q2 2026) vs $24.2M (Q2 2025); HEPZATO KIT $27.1M, CHEMOSAT $2.0M.
Delcath Q1 2026 revenue $25M (+26% YoY); net loss $1.1M; guides FY rev at least $100M
Total revenue $25.0M, up 26% YoY; HEPZATO KIT revenue $23.3M (+29% YoY); CHEMOSAT $1.7M (flat).
Delcath's CHOPIN trial published: PHP+immunotherapy shows 54.7% vs 15.8% 1-year PFS
1-year PFS 54.7% vs 15.8% (adjusted HR 0.34; p=0.0002); median PFS 12.8 vs 8.3 months.
Delcath reports FY2025 revenue $85.2M, net income $2.7M; guides FY2026 revenue ≥$100M
FY2025 total revenue $85.2M, up 129% YoY ($37.2M); HEPZATO revenue $78.8M, CHEMOSAT $6.4M.
Delcath prelim FY2025 revenue $85.2M, HEPZATO $78.8M, cash $91M
Total Q4 revenue ~$20.7M, FY revenue ~$85.2M; HEPZATO KIT Q4 ~$19.0M, FY ~$78.8M.
Delcath Systems board authorizes $25 million share repurchase program
Board authorized repurchase of up to $25M of common stock on November 19, 2025.
Delcath Q3 2025 revenue $20.6M (+84% YoY); net income $0.8M; FY revenue guidance $83-85M
Q3 total revenue $20.6M (+84% YoY); HEPZATO revenue $19.3M, CHEMOSAT $1.3M.
Delcath: Q3 prelim rev $20.5M, net income $0.8M; CHOPIN trial meets endpoint
Prelim Q3 rev $20.5M ($19.2M HEPZATO, $1.3M CHEMOSAT); net income $0.8M; adj EBITDA $5.3M; cash $88.9M, no debt.
Delcath Q2 revenue jumps 210% to $24.2M; net income $2.7M vs loss; FY25 guidance raised
Total revenue $24.2M (+210% YoY); HEPZATO KIT revenue $22.5M, CHEMOSAT $1.7M.
Delcath issues 2025 revenue guidance of $94-98M, plans to enter Medicaid drug rebate agreement
Revenue guidance $94-98M, >150% YoY growth.
Delcath Q1 revenue surges to $19.8M, posts net income of $1.1M vs loss a year ago
Total revenue $19.8M (vs $3.1M Q1 2024); HEPZATO KIT sales $18.0M, CHEMOSAT $1.8M.
Delcath Q4 revenue $15.1M, positive adjusted EBITDA; FY revenue $37.2M, no debt
Q4 total revenue $15.1M ($13.7M HEPZATO US, $1.4M CHEMOSAT Europe); FY total $37.2M.
Delcath announces preliminary Q4/FY2024 revenue of $15.1M/$37.2M; cash $53.2M, no debt
Q4 revenue ~$15.1M; FY2024 total revenue ~$37.2M.
Delcath Systems receives $16.3M from Series E and E1 warrant exercises
1,746,424 warrants exercised; 1,045,157 shares of common stock and 603,954 pre-funded warrants issued.
Delcath Q3 revenue $11.2M (+44% QoQ); HEPZATO adoption grows; debt-free after warrant exercise
Q3 total revenue $11.2M (vs $0.4M prior year); HEPZATO $10.0M, CHEMOSAT $1.2M.
Delcath reports preliminary Q3 revenue $11.2M; HEPZATO KIT sales trigger $25M warrant exercise
Preliminary Q3 2024 revenue of $11.2M, including $10M U.S. sales from HEPZATO KIT.
Study of 167 patients showed median melanoma-specific survival of 28 months with first-line liver-directed therapy vs 10 months with systemic therapy.
CHEMOSAT study: 91% disease control rate, 18.2% complete response in liver tumors; median hepatic PFS 52 weeks overall.
Delcath Q2 revenue $7.8M vs $0.5M YoY; HEPZATO KIT generates $6.6M
Revenue $7.8M ($6.6M HEPZATO US, $1.2M CHEMOSAT Europe) vs $0.5M prior year.
Delcath Systems Q1 2024 revenue jumps to $3.1M; raises center activation target to 20 by year-end
Revenue $3.1M, up from $0.6M YoY, driven by HEPZATO KIT sales of $2.0M and CHEMOSAT of $1.1M.
Delcath Systems extends melphalan supply agreement through Dec 2028; modifies pricing terms
Term extended to December 31, 2028; effective May 1, 2024.
Delcath Systems reports Q4/FY2023 results; first HEPZATO KIT use, site guidance raised to 20
First commercial HEPZATO KIT treatment for metastatic uveal melanoma performed at Moffitt Cancer Center.
Delcath appoints Martha Rook as COO effective March 18, 2024
Martha Rook appointed COO; succeeds John Purpura who is retiring after consulting transition.
Delcath Systems raises $7M via private placement of common stock and pre-funded warrants
Private placement of 876,627 shares at $3.72/share and 1,008,102 pre-funded warrants at $3.71 each.
CMS grants permanent J-code J9248 for Delcath's HEPZATO, effective April 1, 2024
CMS established permanent product-specific J-code (J9248) for HEPZATO (melphalan/Hepatic Delivery System).
Delcath reports Q3 results; FDA approved HEPZATO KIT, launch planned Jan 2024
FDA approved HEPZATO KIT for metastatic uveal melanoma with hepatic metastases; commercial launch planned for January 2024.
Delcath Systems receives FDA approval for HEPZATO KIT for metastatic uveal melanoma
FDA approved HEPZATO KIT (melphalan/HDS) for unresectable hepatic-dominant metastatic uveal melanoma patients.
Delcath reports Q2 results; PDUFA for HEPZATO KIT on Aug 14
PDUFA date August 14, 2023 for HEPZATO KIT NDA resubmission; FDA review ongoing.
Delcath provides Q1 preliminary results; PDUFA date Aug 14, closes $25M financing
FDA set PDUFA goal date of August 14, 2023 for Hepzato Kit NDA resubmission.
Delcath Systems raises up to $85M in private placement led by Vivo Capital
$25M upfront from Series F Convertible Preferred Stock and warrants; up to $60M additional tied to FDA approval and revenue milestones.
Delcath Systems secures up to $85M financing led by Vivo Capital, $25M upfront
Financing includes $24.9M in Series F Convertible Preferred and two warrant tranches totaling $59.8M.
Delcath resubmits NDA to FDA for HEPZATO Kit in metastatic ocular melanoma
NDA resubmission for HEPZATO Kit (melphalan/HDS) to FDA for unresectable hepatic-dominant metastatic ocular melanoma.
on May 23, 2024, the Company appointed Bridget Martell, M.A. M.D., as a Class III Director on the Company's Board, commencing on May 23, 2024
Following the voting on Proposal 1 (as listed below in Item 5.07) at the Annual Meeting on May 23, 2024, Roger Stoll's previously announced retirement from the Board took effect.
Effective as of March 18, 2024, Delcath Systems, Inc. (the “Company”) appointed Martha S. Rook, Ph.D., as Chief Operating Officer of the Company.
As previously reported on February 12, 2024, John Purpura notified the Company of his intent to retire as the Company’s Chief Operating Officer
on February 9, 2024, Roger Stoll notified the Company of his intent to retire from the board of directors of the Company (the “Board”) and not stand for re-election at the Company’s 2024 Annual Meeting of Stockholders (the “2024 Annual Meeting”).
On February 12, 2024, John Purpura notified Delcath Systems, Inc. (the “Company”) of his intent to retire as the Company’s Chief Operating Officer.
On June 1, 2023, and effective as of the date thereof, Delcath Systems, Inc. (the “Company”) appointed Sandra Pennell as Senior Vice President of Finance and principal financial and accounting officer of the Company.
On October 20, 2021, Christine Padula informed Delcath Systems, Inc. (the “Company”) of her intention to resign as interim principal accounting officer of the Company, effective November 15, 2021, to pursue a new opportunity.
Max materiality 1.00 · Median 0.70 · Most common event other_material