DCTH

EX-99.1

2 dcth-q22026erex991.htm

EX-99.1

Document

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 earnin

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dcth-20260226FALSE000087291200008729122026-02-262026-02-26

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): February 26, 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 February 26, 2026, Delcath Systems, Inc. (“Delcath”) issued a press release announcing financial results and business highlights for the year and quarter ended December 31, 2025 (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 99.1Press Release, dated February 26, 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: February 26, 2026 By: /s/ Gerard Michel Name: Gerard Michel

Title: Chief Executive Officer