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Delcath Systems (Nasdaq: DCTH) boosts 2026 outlook after Q2 gains

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Delcath Systems, Inc. reported second quarter 2026 results, with total revenue of $29.1 million, up from $24.2 million a year earlier, driven by HEPZATO KIT revenue of $27.1 million and CHEMOSAT revenue of $2.0 million. Gross margin rose to 90% from 86%, while net income was $2.7 million in both periods.

Non-GAAP adjusted EBITDA was $7.6 million, compared with $9.8 million in the prior-year quarter, and operating cash flow was $5.7 million. Cash and investments totaled $95.9 million as of June 30, 2026, with no debt, supporting expansion to 31 active treatment centers and ongoing clinical trials.

For full-year 2026, Delcath increased its revenue guidance for HEPZATO KIT and CHEMOSAT to $104–$108 million, targeting gross margins of 86–89% and positive adjusted EBITDA, and highlighted approximately 30% growth in HEPZATO volume and new data and trials across uveal melanoma and metastatic breast cancer.

Positive

  • Raises 2026 revenue guidance to $104–$108 million with targeted 86–89% gross margin and positive adjusted EBITDA, reflecting expectations for continued HEPZATO KIT and CHEMOSAT growth.

Negative

  • None.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Q2 2026 total revenue $29.1 million Quarter ended June 30, 2026; up from $24.2 million in Q2 2025
Q2 2026 gross margin 90% Compared with 86% in the second quarter of 2025
Q2 2026 net income $2.7 million Net income for the quarter; same as Q2 2025
Q2 2026 adjusted EBITDA $7.6 million Non-GAAP adjusted EBITDA; compared with $9.8 million in Q2 2025
Q2 2026 operating cash flow $5.7 million Cash provided by operations during the quarter
Cash and investments $95.9 million Balance as of June 30, 2026; company reports no debt
2026 revenue guidance $104–$108 million Full-year HEPZATO KIT and CHEMOSAT revenue outlook
2026 gross margin guidance 86–89% Targeted full-year gross margin range for 2026
adjusted EBITDA financial
"Non-GAAP adjusted EBITDA for the quarter ended June 30, 2026 was $7.6 million"
Adjusted EBITDA is a way companies measure how much money they make from their core operations, like running a business, by removing certain costs or income that aren’t part of regular business activities. It helps investors see how well a company is doing without distractions from unusual expenses or gains, making it easier to compare companies or track performance over time.
percutaneous hepatic perfusion medical
"CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP)"
Percutaneous hepatic perfusion is a medical procedure that delivers high doses of cancer-fighting medicine directly to the liver through a small tube inserted into a blood vessel. It matters because it targets liver tumors more precisely, often with fewer side effects, helping to control cancer that has spread to the liver.
Risk Evaluation and Mitigation Strategy regulatory
"implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy"
A risk evaluation and mitigation strategy is the process a company uses to identify potential problems that could hurt its finances or operations, estimate how likely and severe those problems are, and put practical steps in place to reduce their chance or impact. For investors, it matters because a clear, credible plan is like good insurance and brakes on a car — it lowers the chance of sudden losses, improves predictability, and can make a business a safer, more attractive investment.
interventional oncology medical
"an interventional oncology company focused on the treatment of primary and metastatic liver cancers"
Interventional oncology is a branch of medicine that uses image-guided, minimally invasive procedures to treat cancer by targeting tumors directly—through techniques such as precise heat, cold, chemical delivery, or blocking a tumor's blood supply. Investors care because it drives demand for specialized devices, hospital services and repeatable outpatient procedures, and can change treatment costs and patient outcomes much like a targeted tool that removes a weed without digging up the whole garden.
hepatic partial response rate medical
"showing a 60% hepatic partial response rate with percutaneous hepatic perfusion"
The hepatic partial response rate is the percentage of patients in a clinical trial whose liver tumors shrink by a predefined amount but are not completely gone, according to the study’s measurement rules. For investors, it signals how well a liver-directed therapy is working in reducing tumor size—like measuring how many trees in an orchard have visibly trimmed canopies after treatment—and helps gauge potential clinical value and market impact.
Total revenue $29.1 million up from $24.2 million in the second quarter of 2025
Gross margin 90% up from 86% in the second quarter of 2025
Net income $2.7 million in line with $2.7 million in the second quarter of 2025
Adjusted EBITDA (non-GAAP) $7.6 million down from $9.8 million in the second quarter of 2025
Guidance

For 2026, Delcath forecasts HEPZATO KIT and CHEMOSAT revenue of $104–$108 million, full-year gross margins of 86–89%, at least 28% HEPZATO KIT volume growth over 2025, and positive adjusted EBITDA.

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FAQ

What were Delcath Systems (DCTH) Q2 2026 revenues and year-over-year growth?

Delcath reported Q2 2026 revenue of $29.1 million, up from $24.2 million in Q2 2025. HEPZATO KIT contributed $27.1 million versus $22.5 million, and CHEMOSAT contributed $2.0 million versus $1.7 million a year earlier.

How profitable was Delcath Systems (DCTH) in the second quarter of 2026?

Delcath generated net income of $2.7 million in Q2 2026, matching the prior-year quarter. Basic and diluted EPS were $0.07, and non-GAAP adjusted EBITDA was $7.6 million compared with $9.8 million in Q2 2025.

What 2026 financial guidance did Delcath Systems (DCTH) provide?

Delcath now expects 2026 HEPZATO KIT and CHEMOSAT revenue of $104–$108 million. The outlook includes at least 28% HEPZATO KIT volume growth over 2025, full-year gross margins of 86–89%, and positive adjusted EBITDA for the year.

What is Delcath Systems (DCTH) cash and debt position as of June 30, 2026?

As of June 30, 2026, Delcath held $95.9 million in cash and investments and reported no debt. This balance sheet position supports continued commercial expansion and clinical trial activity across its interventional oncology programs.

What operational and clinical highlights did Delcath Systems (DCTH) report for Q2 2026?

Delcath reported 31 active treatment centers and about 30% HEPZATO volume growth versus Q2 2025. Investigators showed a 60% hepatic partial response rate in metastatic breast cancer and initiated a global Phase 2 HEPZATO combination trial in liver-dominant HER2-negative metastatic breast cancer.

How did Delcath Systems (DCTH) operating expenses change in Q2 2026?

In Q2 2026, R&D expenses were $10.4 million versus $6.9 million a year earlier, mainly from added clinical headcount and trial activity. Selling, general and administrative expenses rose to $13.4 million from $11.4 million, reflecting ongoing commercial expansion.
FALSE000087291200008729122026-08-062026-08-06

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
_____________________
FORM 8-K
_____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 6, 2026
_____________________

DELCATH SYSTEMS, INC.
(Exact Name of Registrant as Specified in its Charter)
_____________________
Delaware001-1613306-1245881
(State or other jurisdiction of incorporation or organization)(Commission File Number)(IRS Employer Identification No.)
566 Queensbury Avenue
Queensbury, NY 12804
(Address of principal executive offices) (Zip Code)
(518) 743-8892
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
_____________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Name of each exchange
symbol(s)
on which registered
Common Stock, $.01 par value
DCTH
The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.




Item 2.02    
Results of Operations and Financial Condition.

On August 6, 2026, Delcath Systems, Inc. (“Delcath”) issued a press release announcing financial results and business highlights for the quarter ended June 30, 2026 (the “Press Release”). A copy of the press release is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto and is incorporated herein by reference.

The information contained in this Current Report on Form 8-K, including the Press Release, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the Press Release shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission by Delcath whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01    
Financial Statements and Exhibits.

(d) Exhibits
Exhibit No.Description
99.1
Press Release, dated August 6, 2026
104Cover Page Interactive Data File (embedded within the Inline XBRL document)








SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
DELCATH SYSTEMS, INC.
Date: August 6, 2026
By:
/s/ Sandra Pennell
Name: Sandra Pennell
Title: Chief Financial Officer

Exhibit 99.1

Delcath Systems Reports Second Quarter 2026
Results and Business Highlights

Increases 2026 Revenue Guidance to a Range of $104M to $108M
Conference Call Today at 8:30 a.m. Eastern Time

QUEENSBURY, NY – August 6, 2026, Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced financial results and business highlights for the second quarter ended June 30, 2026.

Second Quarter 2026 Financial Results
Total revenue of $29.1 million, compared with $24.2 million in the second quarter of 2025
HEPZATO KIT™ revenue of $27.1 million, compared to $22.5 million in the second quarter of 2025
CHEMOSAT® revenue of $2.0 million, compared to $1.7 million in the second quarter of 2025
Gross margins of 90%, compared to 86% in the second quarter of 2025
Net income of $2.7 million for both second quarters in 2026 and 2025
Non-GAAP adjusted EBITDA of $7.6 million, compared to $9.8 million in the second quarter of 2025
Cash provided by operations of $5.7 million in the quarter; compared to $7.3 million in the second quarter of 2025
Cash and investments of $95.9 million as of June 30, 2026

Business Highlights
Currently 31 active treatment centers
Approximately 30% growth in HEPZATO volume in the second quarter 2026 compared to the second quarter 2025
Independent investigators presented retrospective data at ESMO Breast Cancer 2026 showing a 60% hepatic partial response rate with percutaneous hepatic perfusion in heavily pretreated patients with liver-dominant metastatic breast cancer
Independent investigators presented two investigator-initiated Trials-in-Progress abstracts at ASCO 2026: one evaluating sequential HEPZATO followed by tebentafusp in metastatic uveal melanoma, and one evaluating HEPZATO in combination with nivolumab/relatlimab in metastatic cutaneous melanoma with liver metastases
Dosed the first patient in the global Phase 2 trial of HEPZATO in combination with standard of care in patients with liver-dominant HER2-negative metastatic breast cancer

“Our strong second quarter, including total revenue of $29.1 million and quarterly operating cash flow of $5.7 million, reflects continued momentum in HEPZATO procedures,” said Gerard Michel, Chief Executive Officer of Delcath Systems. “As we grow our active treatment center network and drive physician adoption, we are seeing increased usage of HEPZATO in combination with systemic therapies to treat metastatic uveal melanoma. The growing clinical experience with this treatment strategy is strengthening physician confidence in HEPZATO and supporting its development as a multi-indication, liver-directed therapy platform, including colorectal and breast cancer.”

1

Exhibit 99.1
2026 Full Year Financial Guidance
The Company’s financial outlook for fiscal year 2026:
Total HEPZATO KIT and CHEMOSAT revenue to range from $104 million to $108 million, reflecting an increase in HEPZATO KIT volume of at least 28% over 2025
Full year gross margins in the range of 86% to 89%
Positive adjusted EBITDA
Second Quarter 2026 Results
Total revenue for the quarter ending June 30, 2026 was $29.1 million compared to $24.2 million for the same period in the prior year. Revenue in the quarter includes sales of $27.1 million of HEPZATO in the U.S. and $2.0 million of CHEMOSAT in Europe.
Research and development expenses for the quarter ending June 30, 2026, were $10.4 million compared to $6.9 million for the same period in the prior year. The increase is primarily due to increased clinical headcount and increased clinical trial activity.

Selling, general and administrative expenses for the quarter ended June 30, 2026, were $13.4 million compared to $11.4 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities.
Net income was $2.7 million for both the quarters ended June 30, 2026 and June 30, 2025.
Non-GAAP adjusted EBITDA for the quarter ended June 30, 2026 was $7.6 million compared to adjusted EBITDA of $9.8 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.
As of June 30, 2026, the Company had $95.9 million in cash and investments, and no debt.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Thursday, August 6, 2026
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-800-717-1738
International: 1-646-307-1865
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1767384&tp_key=cbc23b55c8

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website https://investors.delcath.com/news-events/events-and-presentations.

GAAP v. Non-GAAP Measures
Delcath’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Delcath has provided in this release certain financial information that has not been prepared in accordance with GAAP. Delcath’s management believes that the non-GAAP adjusted EBITDA described in this release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Delcath’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Delcath’s industry. However, the non-GAAP financial measures that Delcath uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.
2

Exhibit 99.1

About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System (HDS) for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.

In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcaths proprietary HDS. The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT.

In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.

Safe Harbor / Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, including the Company’s statements regarding the possible synergy seen in the successful Phase 2 CHOPIN Trial being transferable to clinical practice; Company’s 2026 financial outlook, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company’s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; contributions to adjusted EBITDA; the Company’s successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company’s successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company’s ability to obtain reimbursement for the HEPZATO KIT; and the Company’s ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company’s filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

Investor Relations Contact:
ICR Healthcare
investorrelations@delcath.com
3

Exhibit 99.1

DELCATH SYSTEMS, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share data)
June 30,
2026
December 31,
2025
Assets
Current assets
Cash and cash equivalents$47,521 $43,454 
Short-term investments48,381 47,582 
Accounts receivable15,942 11,744 
Inventories11,713 10,252 
Prepaid expenses and other current assets6,979 6,498 
Total current assets130,536 119,530 
Property, plant and equipment, net4,019 3,166 
Right-of-use assets2,463 936 
Total assets$137,018 $123,632 
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable$4,011 $2,658 
Accrued expenses9,072 8,191 
Lease liabilities, current196 101 
Total current liabilities13,279 10,950 
Lease liabilities, non-current2,267 835 
Other liabilities, non-current327 628 
Total liabilities$15,873 $12,413 
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.01 par value; 10,000,000 shares authorized; 14,192 and 14,192 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively
— — 
Common stock, $0.01 par value; 80,000,000 shares authorized; 34,636,252 shares and 34,691,671 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively
346 347 
Additional paid-in capital647,791 639,145 
Accumulated deficit(527,250)(528,848)
Accumulated other comprehensive income258 575 
Total stockholders’ equity121,145 111,219 
Total liabilities and stockholders’ equity$137,018 $123,632 

4

Exhibit 99.1
DELCATH SYSTEMS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Income
(Unaudited)
(in thousands, except share and per share data)

Three months ended June 30,Six months ended June 30,
2026202520262025
Product revenue$29,133 $24,156 $54,127 $43,940 
Cost of goods sold(2,985)(3,318)(6,721)(6,163)
Gross profit26,148 20,838 47,40637,777
Operating expenses:
Research and development expenses10,380 6,882 20,20411,889
Selling, general and administrative expenses13,373 11,366 26,44422,656
Total operating expenses23,753 18,248 46,64834,545
Operating income
2,395 2,590 758 3,232 
Interest income
781 649 1,568 1,267 
Other expense
(17)(34)(75)$(30)
Income before income taxes
3,159 3,205 2,251 4,469 
Income tax expense
491 508 653 703 
Net income
2,668 2,697 1,598 3,766 
Other comprehensive income:
Unrealized gain on investments adjustments(295)57 (250)296 
Foreign currency translation adjustments(18)154 (67)214 
Total comprehensive income
$2,355 $2,908 $1,281 $4,276 
Common share data:
Basic income per common share
$0.07 $0.08 $0.04 $0.11 
Weighted average number of basic shares outstanding35,891,91535,786,81335,956,20535,217,887
Diluted income per common share
$0.07 $0.07 $0.04 $0.09 
Weighted average number of dilutive shares outstanding39,761,48040,262,76439,584,32939,890,102
DELCATH SYSTEMS, INC.
Reconciliation of Reported Net Income (GAAP) to Adjusted EBITDA (NON-GAAP Measure)
(Unaudited)
(in thousands)
Three months ended June 30,Six months ended June 30,
2026202520262025
Net income$2,668 $2,697 $1,598 $3,766 
Stock-based compensation expense5,118 7,209 10,064 14,072 
Depreciation 113 51 215 94 
Interest income(781)(649)(1,568)(1,267)
Income tax expense491 508 653 703 
Adjusted EBITDA (Non-GAAP)$7,609 $9,816 $10,962 $17,368 
5

Filing Exhibits & Attachments

4 documents