Form 8-K

8-K — DELCATH SYSTEMS, INC.

Accession: 0001628280-26-031725

Filed: 2026-05-07

Period: 2026-05-07

CIK: 0000872912

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — dcth-20260507.htm (Primary)

EX-99.1 (dcth-q126erex991.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: dcth-20260507.htm · Sequence: 1

dcth-20260507

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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): May 7, 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 May 7, 2026, Delcath Systems, Inc. (“Delcath”) issued a press release announcing financial results and business highlights for the quarter ended March 31, 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 May 7, 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: May 7, 2026

By:

/s/ Sandra Pennell

Name: Sandra Pennell

Title: Chief Financial Officer

EX-99.1

Filename: dcth-q126erex991.htm · Sequence: 2

Document

Exhibit 99.1

Delcath Systems Reports First Quarter 2026

Results and Business Highlights

2026 Revenue Guidance of at least $100M

Conference Call Today at 8:30 a.m. Eastern Time

QUEENSBURY, NY – May 7, 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 first quarter ended March 31, 2026.

First Quarter 2026 Financial Results

•Total revenue of $25.0 million, compared with $19.8 million in the first quarter of 2025

◦HEPZATO KIT™ revenue of $23.3 million, compared to $18.0 million in the first quarter of 2025

◦CHEMOSAT® revenue of $1.7 million, compared to $1.8 million in the first quarter of 2025

•Gross margins of 85%, compared to 86% in the first quarter of 2025

•Net loss of $1.1 million, compared to a net income of $1.1 million in the first quarter of 2025

•Non-GAAP adjusted EBITDA of $3.4 million, compared to $7.6 million in the first quarter of 2025

•Cash provided by operations of $0.9 million in the quarter; compared to $2.2 million provided by operations in the first quarter of 2025

•Repurchased 316,023 common shares for proceeds of approximately $3.0 million in the first quarter of 2026 under the approved $25 million Share Buyback Program

•Cash and investments of $89.3 million as of March 31, 2026

Business Highlights

•Currently 29 active centers

•Approximately 36% growth in HEPZATO volume in the first quarter 2026 compared to the first quarter 2025

•Announced the publication of full results from the investigator-initiated CHOPIN randomized Phase 2 trial in The Lancet Oncology, demonstrating that adding ipilimumab and nivolumab to percutaneous hepatic perfusion significantly improved progression-free survival in metastatic uveal melanoma.

•Announced that CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M-PHP) has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up (April 2026)

“We delivered a strong first quarter, marked by 20% volume growth over the prior quarter and a strong increase in new patient starts.” said Gerard Michel, Chief Executive Officer. “The recent publication of the full CHOPIN results in The Lancet Oncology is already having a meaningful impact on prescribing patterns, further validating HEPZATO KIT and positioning us for continued momentum and long-term value for patients and shareholders alike.”

2026 Full Year Financial Guidance

The Company’s financial outlook for fiscal year 2026:

Exhibit 99.1

•Total CHEMOSAT and HEPZATO KIT revenue to be at least $100 million, reflecting an increase in HEPZATO KIT volume of at least 20% over 2025

•Gross margins in the range of 84% to 87%

•Positive adjusted EBITDA

First Quarter 2026 Results

Total revenue for the quarter ending March 31, 2026 was $25.0 million compared to $19.8 million for the same period in the prior year. Revenue in the quarter includes sales of $23.3 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ending March 31, 2026, were $9.8 million compared to $5.0 million for the same period in the prior year. The increase is primarily due to the continued costs associated with expanding the clinical team, including the share-based compensation expense related to an increase in headcount, and continuation of the Phase 2 clinical trials evaluating HEPZATO.

Selling, general and administrative expenses for the quarter ended March 31, 2026, were $13.1 million compared to $11.3 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses, additional personnel in the commercial team and share-based compensation expenses.

Net loss for the quarter ended March 31, 2026 was $1.1 million compared to net income of $1.1 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended March 31, 2026 was $3.4 million compared to adjusted EBITDA of $7.6 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 March 31, 2026, the Company had $89.3 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, May 7, 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=1757946&tp_key=463dd4d428

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.

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

Exhibit 99.1

DELCATH SYSTEMS, INC.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share data)

March 31,

2026 December 31,

2025

Assets

Current assets

Cash and cash equivalents $ 41,313 $ 43,454

Short-term investments 47,986 47,582

Accounts receivable 14,159 11,744

Inventories 9,808 10,252

Prepaid expenses and other current assets 7,003 6,498

Total current assets 120,269 119,530

Property, plant and equipment, net 3,662 3,166

Right-of-use assets 907 936

Total assets $ 124,838 $ 123,632

Liabilities and Stockholders’ Equity

Current liabilities

Accounts payable $ 3,463 $ 2,658

Accrued expenses 7,143 8,191

Lease liabilities, current 92 101

Total current liabilities 10,698 10,950

Lease liabilities, non-current 815 835

Other liabilities, non-current 615 628

Total liabilities $ 12,128 $ 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 March 31, 2026 and December 31, 2025, respectively

— —

Common stock, $0.01 par value; 80,000,000 shares authorized; 34,465,087 shares and 34,691,671 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

344 347

Additional paid-in capital 641,713 639,145

Accumulated deficit (529,918) (528,848)

Accumulated other comprehensive income 571 575

Total stockholders’ equity 112,710 111,219

Total liabilities and stockholders’ equity $ 124,838 $ 123,632

Exhibit 99.1

DELCATH SYSTEMS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share data)

Three months ended March 31,

2026 2025

Product revenue $ 24,994 $ 19,784

Cost of goods sold (3,736) (2,845)

Gross profit 21,258 16,939

Operating expenses:

Research and development expenses 9,824 5,007

Selling, general and administrative expenses 13,071 11,290

Total operating expenses 22,895 16,297

Operating (loss) income

(1,637) 642

Interest income

787 618

Other (expense) income

(58) 4

(Loss) income before income taxes

(908) 1,264

Income tax expense

162 195

Net (loss) income

(1,070) 1,069

Other comprehensive income (loss):

Unrealized gain on investments adjustments 45 239

Foreign currency translation adjustments (49) 60

Total comprehensive (loss) income

$ (1,074) $ 1,368

Common share data:

Basic (loss) income per common share

$ (0.03) $ 0.03

Weighted average number of basic shares outstanding 36,021,210 34,642,641

Diluted (loss) income per common share

$ (0.03) $ 0.03

Weighted average number of dilutive shares outstanding 36,021,210 39,511,120

DELCATH SYSTEMS, INC.

Reconciliation of Reported Net Income (Loss) (GAAP) to Adjusted EBITDA (NON-GAAP Measure)

(Unaudited)

(in thousands)

Three months ended March 31,

2026 2025

Net (loss) income $ (1,070) $ 1,069

Stock-based compensation expense 4,946 6,863

Depreciation 102 43

Interest income (787) (618)

Income tax expense 162 195

Adjusted EBITDA (Non-GAAP) $ 3,353 $ 7,552

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