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Form 8-K

sec.gov

8-K — DELCATH SYSTEMS, INC.

Accession: 0001628280-26-053902

Filed: 2026-08-06

Period: 2026-08-06

CIK: 0000872912

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — dcth-20260806.htm (Primary)

EX-99.1 (dcth-q22026erex991.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: dcth-20260806.htm · Sequence: 1

dcth-20260806

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)

_____________________

Delaware 001-16133 06-1245881

(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

104 Cover 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

EX-99.1

EX-99.1

Filename: dcth-q22026erex991.htm · Sequence: 2

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 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 Delcath’s 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 investments 48,381  47,582

Accounts receivable 15,942  11,744

Inventories 11,713  10,252

Prepaid expenses and other current assets 6,979  6,498

Total current assets 130,536  119,530

Property, plant and equipment, net 4,019  3,166

Right-of-use assets 2,463  936

Total assets $ 137,018  $ 123,632

Liabilities and Stockholders’ Equity

Current liabilities

Accounts payable $ 4,011  $ 2,658

Accrued expenses 9,072  8,191

Lease liabilities, current 196  101

Total current liabilities 13,279  10,950

Lease liabilities, non-current 2,267  835

Other liabilities, non-current 327  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 capital 647,791  639,145

Accumulated deficit (527,250) (528,848)

Accumulated other comprehensive income 258  575

Total stockholders’ equity 121,145  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,

2026 2025 2026 2025

Product revenue $ 29,133  $ 24,156  $ 54,127  $ 43,940

Cost of goods sold (2,985) (3,318) (6,721) (6,163)

Gross profit 26,148  20,838  47,406 37,777

Operating expenses:

Research and development expenses 10,380  6,882  20,204 11,889

Selling, general and administrative expenses 13,373  11,366  26,444 22,656

Total operating expenses 23,753  18,248  46,648 34,545

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 outstanding 35,891,915 35,786,813 35,956,205 35,217,887

Diluted income per common share

$ 0.07  $ 0.07  $ 0.04  $ 0.09

Weighted average number of dilutive shares outstanding 39,761,480 40,262,764 39,584,329 39,890,102

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,

2026 2025 2026 2025

Net income $ 2,668  $ 2,697  $ 1,598  $ 3,766

Stock-based compensation expense 5,118  7,209  10,064  14,072

Depreciation 113  51  215  94

Interest income (781) (649) (1,568) (1,267)

Income tax expense 491  508  653  703

Adjusted EBITDA (Non-GAAP) $ 7,609  $ 9,816  $ 10,962  $ 17,368

5

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