# EDGAR Filing Document

**Accession Number:** 0000872912
**File Stem:** 0001193125-25-242909
**Filing Date:** 2025-10
**Character Count:** 41737
**Document Hash:** 1e4af1120cd64bfbdda16333d6b1b471
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-242909.hdr.sgml**: 20251020

**ACCESSION NUMBER**: 0001193125-25-242909

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20251018

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251020

**DATE AS OF CHANGE**: 20251020

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** DELCATH SYSTEMS, INC.
- **CENTRAL INDEX KEY:** 0000872912
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 061245881
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-16133
- **FILM NUMBER:** 251402222

**BUSINESS ADDRESS:**
- **STREET 1:** 566 QUEENSBURY AVENUE
- **CITY:** QUEENSBURY
- **STATE:** NY
- **ZIP:** 12804
- **BUSINESS PHONE:** (518) 743-8892

**MAIL ADDRESS:**
- **STREET 1:** 566 QUEENSBURY AVENUE
- **CITY:** QUEENSBURY
- **STATE:** NY
- **ZIP:** 12804

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** DELCATH SYSTEMS INC
- **DATE OF NAME CHANGE:** 19990607

?xml version='1.0' encoding='ASCII'? 8-K

### 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): October 18, 2025

## DELCATH SYSTEMS, INC.

#### (Exact Name of Registrant as Specified in its Charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-16133** | **06-1245881** |
| **(State or other jurisdiction<br>of incorporation or organization)** | **(Commission**<br> **File Number)** | **(IRS Employer<br>Identification No.)** |

---

#### 566 Queensbury Avenue

#### Queensbury, NY 12804

#### (Address of principal executive offices) (Zip Code)
(212) 489-2100

#### (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**<br> **symbol(s)** | **Name of each exchange<br>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 October 18, 2025, Delcath Systems, Inc. ("Delcath") issued a press release announcing preliminary financial results for the quarter ended September 30, 2025. 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 Item 2.02, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended ("Exchange Act"), or otherwise subject to the liabilities of that section nor shall it be incorporated by reference into any other filing by Delcath with the U.S. Securities and Exchange Commission (the "Commission") whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.* 

---

| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.**  |

---

On October 18, 2025, Delcath issued a press release announcing, among other things, updated 2025 full year revenue guidance. A copy of the press release is furnished as Exhibit 99.1 and incorporated by reference in this Item 7.01.

*The information contained in this Item 7.01, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section nor shall it be incorporated by reference into any other filing by Delcath with the Commission whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.* 

---

| | |
|:---|:---|
| **Item 8.01** | **Other Events.**  |

---

#### CHOPIN Trial
On October 18, 2025, Delcath issued a press release announcing the results of the CHOPIN Trial. A copy of the press release is furnished as Exhibit 99.2. The CHOPIN Trial was designed to compare the safety, tolerability and efficacy of Delcath's CHEMOSAT<sup>®</sup> Hepatic Delivery System ("HDS") with melphalan for percutaneous hepatic perfusion ("PHP") when used alone versus when combined with the systemic immune checkpoint inhibitors ("ICI") ipilimumab and nivolumab.

The CHOPIN Trial randomized 1:1 76 patients with metastatic uveal melanoma ("mUM") to receive PHP alone at weeks one and seven (the "PHP group") or four cycles of ipilimumab (1 mg/kg) and nivolumab (3 mg/kg) every three weeks over approximately nine weeks with two PHP treatments at weeks one and seven (the "combination group"). Once the nine-week treatment period was completed patients were monitored until progression. Key eligibility criteria included unresectable hepatic metastases with 50% or less unresectable disease and limited extrahepatic disease. The primary endpoint was one-year progression-free survival; secondary endpoints included safety, best overall response rate, overall survival, and hepatic progression-free survival.

The key results from the CHOPIN Trial were as follows:

**•** **Progression-Free Survival (95% CI):** 

• One Year % (95% CI)

• Combination group: 54.7% (36.8 - 69.5)

• PHP group: 15.8% (5.8 - 30.1)

• Median months (95% CI)

• Combination group: 12.8 (9.2 - 15.4)

• PHP group: 8.3 (6.0 - 9.6)

• Hazard Ratio 0.34 (0.19 - 0.60)

• P<0.001

**•** **Overall Survival - (95% CI):** 

• One Year % (95% CI)

------

• Combination group: 82.8% (65.6 - 91.9)

• PHP group: 82.2% (64.5 - 91.6)

• Two Year % (95% CI)

• Combination group: 49.6% (29.3 - 67.0)

• PHP group: 22.1% (7.9 - 40.6)

• Median: months (95% CI)

• Combination group: 23.1 (20.2 - 38.5)

• PHP group: 19.6 (15.2 - 21.8)

• Hazard Ratio: 0.39 (0.20 - 0.77)

• P = 0.006

**•** **Best Overall Response Rate (95% CI):** 

• Combination group: 76.3 (59.4 - 88.0)

• PHP group: 39.5 (24.5 - 56.5)

• P < 0.001

#### Preliminary Third Quarter Financial Results (unaudited)
On October 18, 2025, Delcath also announced the following preliminary unaudited third quarter ended September 30, 2025, financial and operational results:

• Total CHEMOSAT and HEPZATO KIT revenue of approximately $20.5 million

• HEPZATO KIT<sup>™</sup> revenue of $19.2 million

• CHEMOSAT<sup>®</sup> revenue of $1.3 million

• Gross margins expected to be 87%

• Net income of $0.8 million

• Positive adjusted EBITDA of $5.3 million

• Positive operating cash flow of approximately $4.8 million

As of September 30, 2025, Delcath had approximately $88.9 million of cash, cash equivalents and short-term investments and no debt.

*Preliminary and Unaudited Nature of Preliminary Third Quarter Financial Results* 

The preliminary estimated financial results for the quarter ended September 30, 2025, included in this Current Report on Form 8-K are preliminary, unaudited and have not been reviewed by Delcath's independent auditors and are subject to completion of quarter-end financial and accounting procedures and may change as a result of management's continued review. The preliminary financial results represent management estimates that constitute forward-looking statements subject to risks and uncertainties. As a result, the preliminary financial results may materially differ from the actual results when they are completed and publicly disclosed. The preliminary financial results are not a comprehensive statement of all financial results for the quarter ended September 30, 2025. Subsequent information or events may lead to material differences between the foregoing preliminary financial results and those reported in Delcath's subsequent filings with the Commission. Accordingly, investors should not place undue reliance on these preliminary financial results.

*GAAP v. Non-GAAP Measures* 

In addition to the financial information presented in this Current Report on Form 8-K in accordance with accounting principles generally accepted in the United States of America (GAAP), Delcath also presents adjusted non-GAAP financial measures. Delcath's management believes that the non-GAAP adjusted EBITDA described in this Current Report on Form 8-K, 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.

Delcath does not provide guidance for net loss, the most directly comparable GAAP measure to Adjusted EBITDA, and similarly cannot provide a reconciliation between its forecasted Adjusted EBITDA and net loss without unreasonable effort due to the unavailability of reliable estimates for certain components of net income and the respective reconciliations. These forecasted items are not within Delcath's control, may vary greatly between periods, and could significantly impact future financial results.

*Forward-Looking Statements* 

*The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by Delcath or on its behalf. This Current Report on Form 8-K contains forward-looking statements, including statements regarding Delcath's 2025 full-year revenue guidance, 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: Delcath's commercialization plans and its ability to successfully commercialize the HEPZATO KIT; contributions to adjusted EBITDA; Delcath'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 Delcath and those of its third-party suppliers/manufacturers; Delcath'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; Delcath's ability to obtain reimbursement for the HEPZATO KIT; and Delcath'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 Delcath, please see Delcath'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.* 

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.**  |

---

(d) Exhibits

---

| | |
|:---|:---|
| **Exhibit<br>No.** | **Description** |
| 99.1 | [Press Release (Preliminary Financial Results), dated October 18, 2025.](d51469dex991.htm) |
| 99.2 | [Press Release (CHOPIN Trial results), dated October 18, 2025.](d51469dex992.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

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#### 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. | DELCATH SYSTEMS, INC. |
| Date: October 20, 2025 | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;By: | /s/ Gerard Michel |
|  | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Name: | Gerard Michel |
|  | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Title: | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**![LOGO](g51469g41r30.jpg)

**Delcath Systems Announces Preliminary Third Quarter 2025 Financial Results** 

October 18, 2025

***Conference Call October 20, 8:45am EST*** 

QUEENSBURY, N.Y.—(BUSINESS WIRE)—Oct. 18, 2025— Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today provided preliminary revenue and financial results for the quarter ended September 30, 2025, and updated 2025 full-year revenue guidance.

**Preliminary Third Quarter Financial Results (unaudited)** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Total CHEMOSAT and HEPZATO KIT revenue of approximately $20.5 million

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• HEPZATO KIT revenue of $19.2 million

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• CHEMOSAT revenue of $1.3 million

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Gross margins expected to be 87%

Net income of $0.8 million

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Positive adjusted EBITDA of $5.3 million

Positive operating cashflow of approximately $4.8 million

As of September 30, 2025, the Company had approximately $88.9 million of cash, cash equivalents and short-term investments and no debt.

**2025 Full Year Financial Guidance** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Total CHEMOSAT and HEPZATO KIT revenue of $83 million to $85 million, reflecting an approximate 150%
increase in treatment volume over 2024

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Quarterly gross margins between 85% to 87%

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Positive adjusted EBITDA and operating cashflow in each quarter of 2025

"Although our third quarter revenue was modestly lower than the second quarter, this decline was primarily due to the NDRA discounts and unexpected summer seasonality which impacted the scheduling of new patient starts," said Gerard Michel, Chief Executive Officer of Delcath Systems. "We are confident that we will achieve strong growth in 2026 and beyond. This expectation is based on our ongoing expansion of active treatment centers and the positive influence of the CHOPIN trial results, which have demonstrated impressive efficacy and offer practical advantages for initiating patients on systemic therapy, while preparing for PHP therapy."

**Conference Call Information** 

Delcath Systems, Inc. will host a conference call and webcast on October 20, 2025, at 8:45 a.m. Eastern Time to discuss the Phase 2 CHOPIN Trial results and provide a brief overview of the financial results announced in this release. Joining Delcath management on the call with pre-recorded remarks will be Dr. Vincent T. Ma, Assistant Professor and Medical Oncologist at the University of Wisconsin Department of Medicine, a current user of HEPZATO KIT for the treatment of metastatic uveal melanoma patients, an expert in treating cutaneous melanoma, and a co-author on the seminal Nature Medicine paper exploring liver immune tolerance mechanisms in cancer.

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

Event Date: Monday, October 20

Time: 8:45 AM Eastern Time

------

Participant Numbers:

Toll Free: 1-877-407-3982

International: 1-201-493-6780

Webcast: <u>https://viavid.webcasts.com/starthere.jsp?ei=1738867&tp_key=6f3953dd75</u>

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

**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 <u>Prescribing Information</u>, 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.

**Preliminary Nature of Third Quarter Financial Results** 

The preliminary estimated financial results for the quarter ended September 30, 2025 included in this press release are preliminary, unaudited and have not been reviewed by Delcath's independent auditors and are subject to completion of quarter-end financial and accounting procedures and may change as a result of management's continued review. The preliminary financial results represent management estimates that constitute forward-looking statements subject to risks and uncertainties. The preliminary financial results are not a comprehensive statement of all financial results for the quarter ended September 30, 2025. Subsequent information or events may lead to material differences between the foregoing preliminary financial results and those reported in Delcath's subsequent SEC filings. Accordingly, investors should not place undue reliance on these preliminary financial results.

**GAAP v. Non-GAAP Measures** 

In addition to the financial information presented in this release in accordance with accounting principles generally accepted in the United States of America (GAAP), Delcath also presents adjusted non-GAAP financial measures. 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.

Delcath does not provide guidance for net loss, the most directly comparable GAAP measure to Adjusted EBITDA, and similarly cannot provide a reconciliation between its forecasted Adjusted EBITDA and net loss without unreasonable effort due to the unavailability of reliable estimates for certain components of net income and the respective reconciliations. These forecasted items are not within Delcath's control, may vary greatly between periods, and could significantly impact future financial results.

**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; statements regarding the potential of CHEMOSAT Hepatic Delivery System and HEPZATO KIT to improve outcomes for patients with metastatic uveal melanoma; statements regarding the potential to drive increased adoption of HEPZATO KIT; statements regarding the CHOPIN Phase 2 Trial results supporting the opening of new treatment sites, and accelerating the referral of mUM patients to treatment sites; statements regarding Delcath's continued growth and leadership in liver-directed oncology; and statements regarding Delcath's 2025 full-year revenue guidance, , 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-*

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*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.* 

This release contains forward-looking statements, including statements regarding the expected release of clinical trial results, which are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, delays in the presentation of the data, or other unforeseen issues relating to the release of the clinical trial results. For a detailed discussion of these and other risks, please refer to Delcath's filings with the SEC.

View source version on <u>businesswire.com</u>: <u>https://www.businesswire.com/news/home/20251018070634/en/</u>

**Investor Relations Contact:** 

ICR Healthcare

<u>investorrelations@delcath.com</u>

Source: Delcath Systems, Inc.

## Exhibit 99.2

**Exhibit 99.2**![LOGO](g51469g41r30.jpg)

**Delcath Systems Announces Investigator-Initiated CHOPIN Clinical Trial Meets Primary Endpoint** 

October 18, 2025

***Conference Call October 20, 8:45am EST***

QUEENSBURY, N.Y.—(BUSINESS WIRE)—Oct. 18, 2025— Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the results of the CHOPIN randomized Phase 2 clinical trial (CHOPIN Trial) presented by Principal Investigator and Lead Author Professor Ellen Kapiteijn, MD, from Leiden University Medical Center's Department of Medical Oncology at the 2025 European Society of Medical Oncology (ESMO) Annual Congress.

**CHOPIN Trial Design** 

The investigator-initiated, prospective, randomized Phase 2 CHOPIN Trial was designed to compare the safety, tolerability, and efficacy of Delcath's CHEMOSAT <sup>®</sup> Hepatic Delivery System (HDS) with melphalan for percutaneous hepatic perfusion (PHP) when used alone versus when combined with the systemic immune checkpoint inhibitors (ICI) ipilimumab and nivolumab. Patients with metastatic uveal melanoma (mUM) were randomized 1:1 to receive PHP alone or in combination with ipilimumab and nivolumab. CHEMOSAT is the device component of the U.S. Food and Drug Administration (FDA) approved combination drug and device product HEPZATO KIT<sup>™</sup> (HEPZATO (melphalan) for Injection/Hepatic Delivery System). HEPZATO KIT is approved for the liver-directed treatment of adult patients with uveal melanoma with unresectable hepatic metastases with less than 50% liver involvement and is administered every six to eight weeks for up to six melphalan/HDS treatments.

Ipilimumab and nivolumab are approved by the FDA and European Union for the treatment of unresectable metastatic melanoma, typically administered intravenously every three weeks for four doses, followed by maintenance nivolumab monotherapy every two to four weeks until disease progression.

The CHOPIN Trial randomized 76 patients 1:1 to receive PHP alone at weeks one and seven (PHP group) or four cycles of ipilimumab (1 mg/kg) and nivolumab (3 mg/kg) every three weeks over approximately nine weeks with two PHP treatments at weeks one and seven (combination group). The CHOPIN Trial design did not include additional PHP treatments beyond two treatments or nivolumab maintenance monotherapy. Once the nine-week treatment period was completed patients were monitored until progression. Key eligibility criteria included unresectable hepatic metastases with 50% or less unresectable disease and limited extrahepatic disease. The primary endpoint was one-year progression-free survival; secondary endpoints included safety, best overall response rate, overall survival, and hepatic progression-free survival.

**CHOPIN Trial Results** 

**Key Results from the CHOPIN Phase 2 Trial:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**•** **Progression-Free Survival (95% CI):** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• One Year % (95% CI)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Combination group: 54.7% (36.8 - 69.5)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• PHP group: 15.8% (5.8 - 30.1)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Median months (95% CI)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Combination group: 12.8 (9.2 - 15.4)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• PHP group: 8.3 (6.0 - 9.6)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Hazard Ratio 0.34 (0.19 - 0.60)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• P<0.001

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**•** **Overall Survival - (95% CI):** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• One Year % (95% CI)

------

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Combination grosaup:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• PHP group: 82.2% (64.5 - 91.6)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Two Year % (95% CI)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Combination group: 49.6% (29.3 - 67.0)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• PHP group: 22.1% (7.9 - 40.6)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Median: months (95% CI)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Combination group: 23.1 (20.2 - 38.5)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• PHP group: 19.6 (15.2 - 21.8)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Hazard Ratio: 0.39 (0.20 - 0.77)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• P = 0.006

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Best Overall Response Rate (95% CI):** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Combination group: 76.3 (59.4 - 88.0)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• PHP group: 39.5 (24.5 - 56.5)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• P < 0.001

Grade 3 or higher treatment-related adverse events were more frequent in the combination group (81.6% vs. 40.5%, P<0.001), but most were manageable with standard care. Overall, the combination treatment was well tolerated, with types, rates and frequencies of adverse events consistent with individual use of PHP and checkpoint inhibitors. No new safety signals were identified.

The abstract is available at <u>ESMO Congress 2025—Mini Oral Session LBA59</u>.

"The CHOPIN trial clearly demonstrates that adding ipilimumab and nivolumab to PHP is both effective and tolerable. The efficacy results are impressive, especially when considering the treatment regime included only two PHP treatments and did not include nivolumab maintenance. Since many oncologists start systemic therapy first, this approach provides valuable lead time for patient assessment and scheduling PHP, helping to overcome logistical barriers and support broader adoption and near- to medium-term uptake," said Gerard Michel, Chief Executive Officer of Delcath Systems.

A number of large, randomized clinical trials shows that patients with liver metastases typically have poorer outcomes than those with metastases elsewhere when treated with ICIs across multiple tumor types, including melanoma, non-small-cell lung cancer (NSCLC), urothelial carcinoma, and renal cell carcinoma<sup>1</sup><sup>,</sup> <sup>2</sup>. This diminished efficacy of ICIs has been attributed to the well-documented immunosuppressive nature of the liver microenvironment, with underlying mechanisms increasingly understood through preclinical and clinical research<sup>3</sup>.

"In addition to the potential immediate benefit to patients with metastatic uveal melanoma, the possible synergy of PHP and ICI therapy seen in the successful Phase 2 CHOPIN trial may be transferable to other cancers with liver-dominant disease, and Delcath looks forward to investigating that potential," said Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems.

**Conference Call Information** 

Delcath Systems, Inc. will host a conference call and webcast on October 20, 2025, at 8:45 a.m. Eastern Time to discuss the Phase 2 CHOPIN Trial results and provide a brief overview of the financial results and guidance announced in this release. Joining Delcath management on the call with pre-recorded remarks will be Dr. Vincent T. Ma, Assistant Professor and Medical Oncologist at the University of Wisconsin Department of Medicine, a current user of HEPZATO KIT for the treatment of metastatic uveal melanoma patients, an expert in treating cutaneous melanoma, and a co-author on the seminal Nature Medicine paper exploring liver immune tolerance mechanisms in cancer.

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

Event Date: Monday, October 20

Time: 8:45 AM Eastern Time

Participant Numbers:

Toll Free: 1-877-407-3982

International: 1-201-493-6780

Webcast: <u>https://viavid.webcasts.com/starthere.jsp?ei=1738867&tp_key=6f3953dd75</u>

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

**About Delcath Systems, Inc., HEPZATO KIT, and CHEMOSAT** 

De lcath 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.

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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 <u>Prescribing Information</u>, 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.

**Forward-Looking Statements**

*The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by Delcath or on its behalf. This press release contains forward-looking statements, including statements regarding the possible synergy seen in the successful Phase 2 CHOPIN Trial being transferable to other cancers with liver-dominant disease; statements regarding the potential of CHEMOSAT Hepatic Delivery System and HEPZATO KIT to improve outcomes for patients with metastatic uveal melanoma and other cancers with liver-dominant disease; statements regarding the potential to drive increased adoption of HEPZATO KIT; statements regarding Delcath's commitment to raising awareness of the innovative approach taken in the CHOPIN Trial, and accelerating the referral of patients to treatment sites; and statements regarding Delcath's continued growth and leadership in liver-directed oncology, 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.* 

This release contains forward-looking statements, including statements regarding the expected release of clinical trial results, which are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, delays in the presentation of the data, or other unforeseen issues relating to the release of the clinical trial results. For a detailed discussion of these and other risks, please refer to Delcath's filings with the SEC.

Citations for footnotes:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1. Yu, J. et al. Liver metastasis restrains immunotherapy efficacy via macrophage-mediated T cell elimination. Nat
Med 27, 152–164 (2021)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. Wang, F. et al. Pan-Cancer Analysis Identifies Liver Metastases as Negative Predictive Biomarker for Immune
Checkpoint Inhibitors Treatment Outcome. Front Oncol 11:691853 (2021). doi:10.3389/fonc.2021.691853

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. Li, L. et al. Liver metastases and the efficacy of immune checkpoint inhibitors in patients with advanced lung
cancer: A retrospective study. Front Oncol 12:978069 (2022). doi:10.3389/fonc.2022.978069

View source version on <u>businesswire.com</u>: <u>https://www.businesswire.com/news/home/20251018759712/en/</u>

**Investor Relations Contact:**

ICR Healthcare

<u>investorrelations@delcath.com</u>

Source: Delcath Systems, Inc.