DCTH on Nasdaq

Delcath Systems, Inc.

Logo: delcath.com5

Delcath Systems, Inc. (NASDAQ: DCTH) is a publicly traded specialty pharmaceutical and medical device company, that develops percutaneous perfusion technologies for the targeted administration of high-dose chemotherapeutic agents to specific organs or regions of the body. Based in Queensbury, New York, the company has an intellectual property portfolio consisting of 28 patents worldwide. Delcath's Percutaneous Hepatic Perfusion (PHP) is currently undergoing Phase II and Phase III trials against tumors in the liver.3 It was founded in 1988.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

1988Founded1

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  • TickerDCTH on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersNew York City1
  • Websitewww.delcath.com
  • Legal formDelaware corporation1
  • Incorporated inDE6
  • Business address566 Queensbury Avenue, Queensbury, Ny 128046
  • Filer categoryNon-accelerated filer, Smaller reporting company6
  • LEI549300NVPLITUM6URT024
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressC/O Corporation Service Company, 19808 Wilmington, United States4
  • Registered withDivision of Corporations, Department of State, 21687134

Delcath Systems, Inc. (NASDAQ: DCTH) is a publicly traded specialty pharmaceutical and medical device company, that develops percutaneous perfusion technologies for the targeted administration of high-dose chemotherapeutic agents to specific organs or regions of the body. Based in Queensbury, New York, the company has an intellectual property portfolio consisting of 28 patents worldwide. Delcath's Percutaneous Hepatic Perfusion (PHP) is currently undergoing Phase II and Phase III trials against tumors in the liver. Delcath has a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute and has received Fast Track and a Special Protocol Assessment from the Food and Drug Administration for its use of melphalan in treating unresectable liver tumors. PHP, also known as the Delcath System, is tested for the treatment of metastatic melanoma in the liver and for primary liver cancer and metastatic hepatic malignancies from neuroendocrine cancers and adenocarcinomas, as well as patients with melanoma who previously received isolated perfusion. Chemotherapy is usually delivered intravenously, although a number of agents can be administered orally (e.g. specialty drugs, melphalan (trade name Alkeran), busulfan, capecitabine).3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

86.2%Gross margin8
0.8%Operating margin8
3.2%Net margin8
129.1%Revenue growth, 20258
2.4%Return on equity8
$21.0MFree cash flow8

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Hepzato Kit brought in 92% of the revenue Delcath Systems, Inc. broke down this way in fiscal 2025.

  1. Hepzato Kit$78.8M892%up 144% from 2024
  2. Chemosat$6.4M88%up 30% from 2024
Products and services by year
Products and services20242025
Hepzato Kit$32.3M$78.8M
Chemosat$4.9M$6.4M

Regions

United States brought in 92% of the revenue Delcath Systems, Inc. broke down this way in fiscal 2025.

  1. United States$78.8M892%up 144% from 2024
  2. Outside the United States$6.4M88%up 30% from 2024
Regions by year
Regions20242025
United States$32.3M$78.8M
Outside the United States$4.9M$6.4M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue13¢$11.8M
  • Research and development33¢$29.2M
  • Selling, general and admin49¢$43.5M
  • Income tax1¢$810.0K
  • Profit3¢$2.7M

Out of $85.2M in revenue.8

Where each dollar of operating cash went, fiscal 2025

  • Capital spending7¢$1.5M
  • Share buybacks27¢$6.0M
  • Kept or used elsewhere66¢$15.0M

Out of $22.5M of cash from operations.8

Financial statements

Revenue910118$85.2M in 2025+2297% since 2021
0$25.0M$50.0M$75.0M$100.0M2021: $3.6M$3.6M20212022: $2.7M$2.7M2022−24%2023: $2.1M$2.1M2023−24%2024: $37.2M$37.2M2024+1702%2025: $85.2M$85.2M2025+129%
Gross profit1213910118$73.4M in 2025+8429% since 2019
0$20.0M$40.0M$60.0M$80.0M2019: $861.0K$861.0K20192020: $1.0M$1.0M2020+17%2021: $2.9M$2.9M2021+187%2022: $2.0M$2.0M2022−30%2023: $1.4M$1.4M2023−30%2024: $31.0M$31.0M2024+2069%2025: $73.4M$73.4M2025+137%
Operating income1213910118$660.0K in 2025
-$40.0M-$30.0M-$20.0M-$10.0M0$10.0M2019: -$19.9M-$19.9M20192020: -$21.3M-$21.3M2020+7%2021: -$24.5M-$24.5M2021+15%2022: -$33.9M-$33.9M2022+38%2023: -$38.2M-$38.2M2023+13%2024: -$12.4M-$12.4M2024−67%2025: $660.0K$660.0K2025
Net income1213910118$2.7M in 2025
-$60.0M-$40.0M-$20.0M0$20.0M2019: -$8.9M-$8.9M20192020: -$24.2M-$24.2M2020+172%2021: -$25.6M-$25.6M2021+6%2022: -$36.5M-$36.5M2022+42%2023: -$47.7M-$47.7M2023+31%2024: -$26.4M-$26.4M2024−45%2025: $2.7M$2.7M2025

Every line of the income statement as filed: the last 2 fiscal years, latest first.8

Period ending2025-12-312024-12-31
Total revenue$85.2M$37.2M
Cost of goods sold-$11.8M-$6.2M
Gross profit$73.4M$31.0M
Research and development expenses$29.2M$13.9M
Selling, general and administrative expenses$43.5M$29.6M
Total operating expenses$72.8M$43.4M
Operating income (loss)$660.0K-$12.4M
Change in fair value of warrant liability$0-$14.1M
Interest income, net$2.9M$125.0K
Other expense-$70.0K-$30.0K
Income before taxes$3.5M-$26.4M
Income tax expense$810.0K$0
Net income (loss)$2.7M-$26.4M
Unrealized gain on investment adjustments$394.0K-$22.0K
Foreign currency translation adjustments$99.0K-$31.0K
Total comprehensive income (loss)$3.2M-$26.4M
Basic income (loss) per common share (in dollars per share)$0.08-$0.93
Weighted average number of basic shares outstanding (in shares)35.8M shares28.5M shares
Diluted income (loss) per common share (in dollars per share)$0.07-$0.93
Weighted average number of diluted shares outstanding (in shares)39.9M shares28.5M shares

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Corporate structure

Delcath Systems, Inc. sits at the top of its group. 6 entities, 6 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Delcath Systems, Inc.

  • BlackRock Filed SCHEDULE 13G on Delcath Systems, Inc., latest Jul 28, 2026 (3 filings since Oct 17, 2025)
  • Daniel Louis Kaufman Filed SCHEDULE 13G on Delcath Systems, Inc., latest Mar 20, 2026
  • Rosalind Advisors, Inc. Filed SCHEDULE 13D/A on Delcath Systems, Inc., latest Feb 10, 2026 (10 filings since Feb 14, 2022)
  • Vivo Opportunity Fund Holdings, L.P. Filed SCHEDULE 13G/A on Delcath Systems, Inc., latest May 15, 2025 (4 filings since Jun 22, 2023)
  • BIOTECHNOLOGY VALUE FUND L P Filed SC 13G/A on Delcath Systems, Inc., latest Nov 14, 2024 (3 filings since Jun 22, 2023)
  • Orin Hirschman Filed SC 13G/A on Delcath Systems, Inc., latest Nov 8, 2024 (2 filings since Jan 9, 2024)
  • Stonepine Capital Management, LLC Filed SC 13G/A on Delcath Systems, Inc., latest Feb 13, 2024 (2 filings since Jun 26, 2023)
  • Soleus Capital Master Fund, L.P. Filed SC 13G/A on Delcath Systems, Inc., latest Feb 2, 2024 (2 filings since Aug 16, 2023)
  • James E. Flynn Filed SC 13G/A on Delcath Systems, Inc., latest Dec 29, 2022
  • Gerard J. Michel Filed SC 13D/A on Delcath Systems, Inc., latest Dec 16, 2022 (2 filings since Jul 27, 2022)
  • SILVERARC CAPITAL MANAGEMENT, LLC Filed SC 13G/A on Delcath Systems, Inc., latest Feb 8, 2022
  • Delcath Systems, Inc. New York, New York, United States
    • 1. Delcath Systems Limited, organized under the laws of Subsidiary · Ireland
    • 2. Delcath UK Systems Limited, organized under the laws of Subsidiary · United Kingdom
    • 3. Delcath Systems GmbH, organized under the laws of Subsidiary · Germany
    • 4. Delcath Systems B.V., organized under the laws of Subsidiary · Netherlands
    • 5. Delcath Systems S.R.L., organized under the laws of Subsidiary · Italy

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Delcath Systems, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$8.4M8 Dec 31, 2025$6.7M8 Dec 31, 2024+24.8%
Accumulated depreciation$5.2M8 Dec 31, 2025$5.0M8 Dec 31, 2024+5.9%
Property and equipment, net$3.2M8 Dec 31, 2025$1.8M8 Dec 31, 2024+76.9%
Operating-lease assets (leased space)$936.0K8 Dec 31, 2025$1.0M8 Dec 31, 2024−9.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$43.5M8 Dec 31, 2025$32.4M8 Dec 31, 2024+34.1%
Marketable securities, current$47.6M8 Dec 31, 2025$20.8M8 Dec 31, 2024+128.5%
Debt securities available for sale$47.6M8 Dec 31, 2025$20.8M8 Dec 31, 2024+128.5%

Inventory

ItemLatestA year beforeChange
Inventory, total$10.3M8 Dec 31, 2025$6.9M8 Dec 31, 2024+47.9%
Raw materials$6.5M8 Dec 31, 2025$3.8M8 Dec 31, 2024+68.3%
Work in process$2.8M8 Dec 31, 2025$2.3M8 Dec 31, 2024+24.3%
Finished goods$966.0K8 Dec 31, 2025$824.0K8 Dec 31, 2024+17.2%

Properties, in its own words

Our corporate offices occupy 10,320 square feet at 566 Queensbury Avenue in Queensbury, New York. The corporate office is owned by the Company. We also own a building comprised of approximately 6,000 square feet at 95-97 Park Road in Queensbury, New York. We lease approximately 18,000 square feet of space at 2 Country Club Road in Queensbury, New York. These Queensbury facilities house manufacturing, quality assurance and quality control, research and development, and office space functions. We also own approximately four acres of land at 12 and 14 Park Road in Queensbury, New York. In addition, we sub-lease a facility for office and manufacturing comprised of approximately 2,409 square feet at 19 Mervue, Industrial Park in Galway, Ireland under a lease agreement that expires in August 2026. We believe substantially all of our property and equipment is in good condition and that we have sufficient capacity to meet current operational needs.

Item 2 of the 10-K filed Feb 26, 2026.16

Leadership

Who has led Delcath Systems, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (44)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerJohnny G. John named Jul 22, 2022 to Mar 31, 202372

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • 1. Delcath Systems Limited, organized under the laws of Ireland.7
  • 2. Delcath UK Systems Limited, organized under the laws of England.7
  • 3. Delcath Systems GmbH, organized under the laws of Germany.7
  • 4. Delcath Systems B.V., organized under the laws of the Netherlands.7
  • 5. Delcath Systems S.R.L., organized under the laws of Italy.7

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • DELCATH SYSTEMS INCJun 16, 2000 to Apr 22, 20136

Timeline

  1. Aug 14, 20268-K Bylaws or fiscal year changed73
  2. Aug 6, 20268-K Results of operations74
  3. May 14, 20268-K Executive or director change; Shareholder vote75
  4. May 7, 20268-K Results of operations76
  5. Mar 3, 20268-K Other events77
  6. Feb 26, 20268-K Results of operations78
  7. Jan 12, 20268-K Results of operations; Regulation FD disclosure; Other events79
  8. Nov 20, 20258-K Other events80
  9. Nov 4, 20258-K Results of operations81
  10. Oct 20, 20258-K Results of operations; Regulation FD disclosure; Other events82
  11. Aug 15, 20258-K Bylaws or fiscal year changed83
  12. Aug 6, 20258-K Results of operations84
  13. Oct 5, 2020New chief executive Gerard J. Michel becomes CEO17
  14. Nov 18, 2013New chief executive Jennifer K. Simpson becomes CEO19
  15. Nov 18, 2013New chief executive Graham G. Miao becomes CEO18
  16. Nov 20, 2009New chief executive Eamonn P. Hobbs becomes CEO20
  17. Jan 5, 2007New chief executive Richard Taney becomes CEO21
  18. Aug 3, 2006New chief executive M. S. /fa/ Koly becomes CEO22
  19. 1988Founded Founded1

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.02 a share, on Nov 4, 2025.85

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results74
  2. May 7, 2026Reported quarterly or annual results76
  3. Feb 26, 2026Reported quarterly or annual results78
  4. Jan 12, 2026Reported quarterly or annual results79
  5. Nov 4, 2025Reported quarterly or annual results81
  6. Oct 20, 2025Reported quarterly or annual results82
  7. Aug 6, 2025Reported quarterly or annual results84
  8. May 8, 2025Reported quarterly or annual results86

Drug trials and FDA: coming up

  1. Dec 2026Phase 2 trial readout expected Phase 2 trial of Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-tipiracil plus Bevacizumab and Trifluridine-tipiracil plus Bevacizumab Alone in Refractory Metastatic Colorectal Cancer: primary completion expected Dec 2026 (ClinicalTrials.gov NCT06607458).87

Drug trials and FDA: recently

  1. May 18, 2023Phase 3 trial completed Phase 3 trial of Melphalan/HDS in Ocular Melanoma: primary completion May 18, 2023, results posted Sep 10, 2026 (ClinicalTrials.gov NCT02678572).88

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

325 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 65 major events, 143 insider forms, 31 large holders, 4 private raises, 62 other. The latest 20:

  1. Oct 14, 20264 PRIMARY DOCUMENT EDGAR
  2. Aug 14, 2026S-8 EDGAR
  3. Aug 14, 20268-K EDGAR
  4. Aug 6, 202610-Q EDGAR
  5. Aug 6, 20268-K EDGAR
  6. Jul 28, 2026SCHEDULE 13G EDGAR
  7. May 14, 20264 EDGAR
  8. May 14, 20264 EDGAR
  9. May 14, 20264 EDGAR
  10. May 14, 20264 EDGAR
  11. May 14, 20264 EDGAR
  12. May 14, 20268-K EDGAR
  13. May 7, 202610-Q EDGAR
  14. May 7, 20268-K EDGAR
  15. Apr 27, 2026SCHEDULE 13G/A EDGAR
  16. Apr 2, 2026ARS EDGAR
  17. Apr 2, 2026DEFA14A EDGAR
  18. Apr 2, 2026DEF 14A EDGAR
  19. Mar 20, 2026SCHEDULE 13G EDGAR
  20. Mar 6, 20264 EDGAR

The 325 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

42 open-market trades by officers, directors and large owners since October 2021: 42 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Mar 6, 2026Pennell SandraChief Financial OfficerBuy5,533$9.04$50.0KForm 4
Mar 2, 2026MICHEL GERARD JCHIEF EXECUTIVE OFFICERBuy11,200$8.96$100.4KForm 4
Nov 21, 2025Sylvester John RichardDirectorBuy4,386$8.89$39.0KForm 4
Nov 11, 2025MICHEL GERARD JCHIEF EXECUTIVE OFFICERBuy11,500$8.53$98.1KForm 4
Mar 19, 2024Aharon GilDirectorBuy26,882$3.72$100.0KForm 4
Mar 19, 2024SALAMON STEVEN A JDirectorBuy26,882$3.72$100.0KForm 4
Dec 12, 2023Vukovic VojoCHIEF MEDICAL OFFICERBuy40,000$3.00$120.0KForm 4
Dec 8, 2023MICHEL GERARD JCHIEF EXECUTIVE OFFICERBuy34,000$2.94$100.0KForm 4
Nov 17, 2023Rosalind Advisors, Inc.DirectorBuy100,000$2.40$240.0KForm 4
Nov 17, 2023Pennell SandraChief Financial OfficerBuy30,000$2.43$72.9KForm 4
Nov 16, 2023Vukovic VojoCHIEF MEDICAL OFFICERBuy60,000$2.48$148.8KForm 4
Nov 16, 2023Hoffman David L.GEN'L COUNSEL, CCO & SECYBuy40,000$2.48$99.2KForm 4
Oct 13, 2023Purpura JohnCHIEF OPERATING OFFICERBuy14,505$3.44$49.9KForm 4
Aug 21, 2023Sylvester John RichardDirectorBuy10,550$4.80$50.6KForm 4
Mar 29, 2023MICHEL GERARD JCHIEF EXECUTIVE OFFICERBuy19,646$4.84$95.1KForm 4
Dec 14, 2022Rosalind Advisors, Inc.DirectorBuy15,215$3.62$55.1KForm 4
Dec 14, 2022SALAMON STEVEN A JDirectorBuy15,215$3.62$55.1KForm 4
Dec 13, 2022MICHEL GERARD JCHIEF EXECUTIVE OFFICERBuy51,725$2.90$150.0KForm 4
Jul 20, 2022MICHEL GERARD JCHIEF EXECUTIVE OFFICERBuy62,814$3.98$250.0KForm 4
May 16, 2022Purpura JohnCHIEF OPERATING OFFICERBuy3,300$4.61$15.2KForm 4

All 42 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Gerard Michel62$635.7K$5.8M100
2025Vojislav Vukovic59$488.0K$2.1M100
2025Martha Rook55$460.8K$2.0M100
2024Chief Executive Officer$560.6K$2.2M100
2024Chief Medical Officer$465.0K$1.1M100
2024Chief Operating Officer$336.5K$933.1K100

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$40.8M 2022–2024
Money received by yearMoney received by year, 2022–2024: $40.8M in all. Private raises (Form D) $40.8M.$0$10M$20M$30M2022 · Private raises (Form D): $8.8M20222023 · Private raises (Form D): $25.0M20232024 · Private raises (Form D): $7.0M2024
Figures by year
YearPrivate raises (Form D)Total
2024$7.0M$7.0M
2023$25.0M$25.0M
2022$8.8M$8.8M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Mar 19, 2024Raised $7 million in a private offering of equity101 Form D: 17 investors so far Form D
  2. Mar 29, 2023Raised $25 million in a private offering of equity72 Form D: 17 investors so far Form D
  3. Dec 12, 2022Raised $3.8 million in a private offering of equity102 Form D: 7 investors so far Form D
  4. Jul 20, 2022Raised $5 million in a private offering of equity103 Form D: 6 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Rosalind Advisors, Inc.3,300,389$41.6M15.6%No change
BlackRock, Inc.2,706,802$34.1M0.0%+922,336
Vanguard Capital Management LLC1,221,247$15.4M0.0%−108,041
Propel Bio Management, LLC871,460$11.0M5.7%−108,238
Geode Capital Management, LLC733,115$9.2M0.0%+41,084
State Street Corp679,280$8.6M0.0%+14,852
Algert Global LLC580,708$7.3M0.1%+434,975
Millennium Management LLC566,371$7.1M0.0%−21,684
Divisadero Street Capital Management, LP499,796$6.3M0.1%No change
Morgan Stanley407,983$5.1M0.0%+22,459
ExodusPoint Capital Management, LP359,884$4.5M0.0%+323,916
Private Wealth Advisors, LLC310,863$3.9M1.2%−280,661
Simplify Asset Management Inc.264,770$3.3M0.0%+3,644
Northern Trust Corp252,108$3.2M0.0%+245
Goldman Sachs Group Inc250,312$3.2M0.0%−38,819
ADAR1 Capital Management, LLC224,385$2.8M0.1%No change
Marshall Wace, Llp218,963$2.8M0.0%+27,333
Dimensional Fund Advisors LP210,298$2.6M0.0%New
Kennedy Capital Management LLC204,143$2.6M0.0%−3,780
Vanguard Portfolio Management LLC193,448$2.4M0.0%+15,412
Ikarian Capital, LLC185,667$2.3M0.4%−245,584
Vanguard Fiduciary Trust Co181,903$2.3M0.0%−19,921
Nuveen, LLC181,595$2.3M0.0%+77,821
Aqr Capital Management LLC172,993$2.2M0.0%+140,897
Cibc World Market Inc.163,208$2.1M0.0%−26,529

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Delcath Systems, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARDELCATH SYSTEMS, INC.2
  • CIK0000872912
  • Employer ID (EIN)06-124588116
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company16
  • Incorporated inDelaware16
  • Fiscal year endsDecember 312
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address566 Queensbury Avenue, Queensbury, NY 128042
  • Phone(518) 743-88922
  • Shares outstanding34,698,795 as of Jul 31, 202615
  • Public float$419.7M as of Jun 30, 202516
  • AuditorCBIZ CPAs P.C., New York, NY PCAOB ID 688; no auditor attestation of internal control over financial reporting16
  • On EDGAR sinceJun 16, 20002
  • Filings1,643 in all: 4 (499), 8-K (416), 10-Q (60), 3 (55), CORRESP (43), DEFA14A (41), SC 13G/A (34), UPLOAD (31)2
    All 72 form types

    SC 13G (30), DEF 14A (29), EFFECT (26), 424B3 (25), 424B5 (25), SC 13D/A (25), 4/A (23), 10-K (20), DFAN14A (20), S-1/A (20), S-3 (19), 10QSB (18), S-8 (12), PRE 14A (11), S-3/A (11), 5 (10), ARS (10), S-1 (9), 8-K/A (8), SB-2/A (8), 3/A (7), 424B4 (7), D (7), 10KSB (5), 25 (4), POS AM (4), PREC14A (4), SC 13D (4), 10-K/A (3), 10QSB/A (3), 8-A12B (3), CT ORDER (3), NT 10-Q (3), PRE 14C (3), REGDEX (3), SC TO-I/A (3), SCHEDULE 13D/A (3), SCHEDULE 13G (3), 10-Q/A (2), DEFC14A (2), FWP (2), PRER14A (2), SB-2 (2), SC TO-I (2), SCHEDULE 13G/A (2), 10KSB/A (1), 10KSB40 (1), 10SB12G (1), 144 (1), 25-NSE (1), 424A (1), 424B1 (1), 424B2 (1), 8-A12B/A (1), 8-A12G (1), AW (1), CERT (1), DEF 14C (1), DEFN14A (1), PREN14A (1), PRRN14A (1), RW (1), S-3MEF (1), SC TO-T/A (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 2, 2026
    Latest 8-K (8-K) Aug 14, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.01 par value per shareDCTHNasdaq

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).16

Risk factors and legal proceedings

The risks Delcath Systems, Inc. names in Item 1A of its 10-K filed Feb 26, 2026: 61 risks under these headings, as written.16

  • Risks Related to Our Business and Financial Condition
  • We have incurred significant losses since inception and continuing losses may exhaust our capital resources.
  • We may need additional capital to maintain our operations. If we cannot raise additional capital, our potential to generate future revenues may be significantly limited if such capital is then necessary in order to further commercialize CHEMOSAT and HEPZATO, or conduct future product development, including clinical trials, if any.
  • We have in the past, and may in the future, become subject to litigation or claims arising in or outside the ordinary course of business that could negatively affect our business operations and financial condition.
  • We may be the subject of product liability claims or product recalls, and we may be unable to maintain insurance adequate to cover potential liabilities.
  • Risks Related to Manufacturing, Commercialization and Market Acceptance of CHEMOSAT and HEPZATO
  • We have limited experience as a commercial company and generating revenue from product sales. If the continued commercialization of HEPZATO is unsuccessful or any future approved products are unsuccessful, we may never be profitable.
  • We must maintain or enter into acceptable arrangements for the supply of melphalan and other critical components of HEPZATO and CHEMOSAT and we may not be able to ensure adequate supply impacting our ability to successfully commercialize HEPZATO in the United States and CHEMOSAT in the European Union or complete any future clinical trials.
  • If we cannot successfully manufacture CHEMOSAT and HEPZATO, our ability to develop and commercialize the system would be impaired.
  • We do not have written contracts with all of our suppliers for the manufacture of components for CHEMOSAT and HEPZATO.
  • We may be unsuccessful in commercializing CHEMOSAT and HEPZATO because of inadequate infrastructure or an ineffective commercialization strategy.
  • If we are unable to maintain and, if necessary, expand sales and marketing capabilities and/or enter into agreements with third parties to utilize HEPZATO in the United States or other product candidates, we may not be successful in commercializing HEPZATO in the United States or any other of our product candidates if they are approved.
The other 50 risks
  • We may need to enter into collaborative arrangements with third parties to help market and sell CHEMOSAT and HEPZATO, but it may not be successful.
  • If we fail to overcome the challenges inherent in international operations, our business and results of operations may be materially adversely affected.
  • Rapid technological developments in treatment methods for liver cancer and competition with other forms of liver cancer treatments could affect our ability to achieve meaningful revenues or profit.
  • We may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for the commercial success of CHEMOSAT or HEPZATO, in which case we may not generate significant revenue for the foreseeable future.
  • The sizes of the market opportunities for our product or product candidates, particularly HEPZATO for the treatment of mUM and CHEMOSAT for the treatment of cancers of the liver, have not been established with precision and may be smaller than we estimate, possibly materially. If our estimates of the sizes overestimate these markets, our sales growth may be adversely affected. We may also not be able to grow the markets for our product candidates as intended or at all.
  • Risks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
  • The development and approval process in the United States and abroad could take many years, require substantial resources and may never lead to the approval of our product candidates by the FDA for use in the United States or by foreign regulators in their respective jurisdictions.
  • Our ability to market HEPZATO is limited to those uses that are approved.
  • If we fail to comply with reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • Changes in healthcare law and implementing regulations, including government restrictions on pricing and reimbursement, as well as healthcare policy and other healthcare payor cost-containment initiatives, may have a material adverse effect on us
  • If future clinical trials are unsuccessful, significantly delayed or not completed, we may not be able to market HEPZATO for other indications.
  • We have obtained the right to affix the CE Mark for the CHEMOSAT Hepatic Delivery System as a medical device for the delivery of melphalan in the European Union. Since we may only promote the device within this specific indication, if physicians are unable or unwilling to obtain melphalan separately for use with CHEMOSAT, our ability to commercialize CHEMOSAT in the European Union will be significantly limited.
  • We are subject to significant ongoing regulatory obligations and oversight in the European Union and the United States and will be in any other country where we receive marketing authorization or approval.
  • We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
  • We continue to rely on third parties to conduct certain elements of clinical trials for CHEMOSAT and HEPZATO, should we seek to obtain regulatory approval for use of these products to treat additional indications for which we do not currently have regulatory approval, or for any future product candidates, if any, and if these third parties do not
  • perform their obligations to us, we may not be able to obtain the necessary regulatory approvals for our products or product candidates, as applicable.
  • Purchasers of CHEMOSAT in Europe may not receive third-party reimbursement or such reimbursement may be inadequate. Without adequate reimbursement, commercialization of CHEMOSAT in Europe may not be successful.
  • The success of our products may be harmed if the government, private health insurers or other third-party payors do not provide sufficient coverage or reimbursement.
  • CHEMOSAT and HEPZATO may not achieve sufficient acceptance by the medical community to sustain our business.
  • We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Consolidation in the healthcare industry could lead to demands for price concessions.
  • Risks Related to our Intellectual Property
  • Intellectual property rights may not provide adequate protection, which may permit third parties to compete against us more effectively.
  • We have not and may not be able to adequately protect our intellectual property rights throughout the world.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Our success depends in part on our ability to obtain patents, which can be an expensive, time consuming, and uncertain process, and the value of the patents is dependent in part on the breadth of coverage and the relationship between the coverage and the commercial product.
  • Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
  • We may in the future become involved in lawsuits to protect or enforce our intellectual property, or to defend our products against assertion of intellectual property rights by a third party, which could be expensive, time consuming and unsuccessful.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product and our technologies.
  • If we breach our license agreements, it could have a material adverse effect on our commercialization efforts for our product candidates.
  • Our trademarks may be infringed or successfully challenged, resulting in harm to our business.
  • We may rely primarily on trade secret protection for important proprietary technologies.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of confidentiality, non-competition or non-solicitation agreements with our competitors.
  • Risks Related to Tax Matters
  • Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
  • Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income or taxes may be limited.
  • Tax authorities could reallocate our taxable income among our subsidiaries, which could increase our overall tax liability.
  • Risks Related to Our Common Stock
  • The market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in substantial losses for investors.
  • Because of volatility in our trading price and trading volume, we may incur significant costs from class action securities litigation.
  • Sales of a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, could adversely affect the market price of our common stock and could impair our ability to raise additional equity capital.
  • There can be no assurance that any share repurchase will enhance long-term stockholder value.
  • Anti-takeover provisions in our Amended and Restated Certificate of Incorporation and By-laws may reduce the likelihood of a potential change of control or make it more difficult for our stockholders to replace management.
  • We have never declared or paid any dividends to the holders of our common stock and we do not expect to pay cash dividends in the foreseeable future.
  • If we engage in acquisitions, reorganizations or business combinations, we will incur a variety of risks that could adversely affect our business operations or our stockholders.
  • If securities or industry analysts do not publish or cease publishing research or reports about us, our business, or our market, or if they change their recommendations regarding our securities adversely, the price and trading volume of our securities could decline.
  • General Risk Factors
  • The loss of key personnel could adversely affect our business.
  • We and the third parties with whom we work rely on the proper function, availability and security of information technology systems to operate our business and a cyber-attack or other breach of these systems, or our data, could have a material adverse effect on our business, including by not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
  • We will continue to incur significant costs as a result of operating as a public company, and our management will continue to devote substantial time to compliance initiatives.
  • We are a “smaller reporting company” and have elected to comply with reduced public company reporting requirements, which could make our common stock less attractive to investors.
  • Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, political crises, global geopolitical conflicts, trade wars, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance.
  • Further downgrades of the United States credit rating, automatic spending cuts, or a government shutdown could negatively impact our liquidity, financial condition and earnings.
  • Environmental, social and governance matters and any related reporting obligations may impact our business.

Legal proceedings

From time to time, claims are made against the Company in the ordinary course of business, which could result in litigation. Claims and associated litigation are subject to inherent uncertainties and unfavorable outcomes could occur, such as monetary damages, fines, penalties, or injunctions prohibiting us from selling our products or engaging in other activities.

medac Matter

See Note 13 - “Commitment and Contingencies - Litigation, Claims and Assessments - medac Matter” in the accompanying notes to our consolidated financial statements for more information.

The opening of Item 3, Legal Proceedings.16

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