Delcath Systems Board of Directors Authorizes $25 Million Share Repurchase Program

Delcath Systems, Inc. (NASDAQ:DCTH), ("Delcath") an interventional oncology company focused on the treatment of primary and metastatic cancers to the liver, today announced that its Board of Directors has authorized a share repurchase program under which Delcath may repurchase up to $25 million of its outstanding shares of common stock from time to time, subject to market conditions. The repurchase program does not have an expiration date.

"The share repurchase program reflects our confidence in Delcath's long-term growth prospects and our commitment to creating shareholder value," said Gerard Michel, Chief Executive Officer of Delcath Systems. "We believe the current share price does not fully reflect our commercial progress, future development potential and strong balance sheet. This program underscores our positive outlook as we continue to advance our mission in interventional oncology."

Under the program, repurchases may be made from time to time at management's discretion through a variety of methods, such as open-market transactions including pre-set trading plans, privately negotiated transactions, accelerated share repurchases, and other transactions in accordance with applicable securities laws.

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 Ill 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, but not limited to, statements related to potential share repurchases and the future performance of Delcath. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements, include but are not limited to the following: whether we will be able to consummate the contemplated share repurchases in the amount authorized or at all; constraints, volatility, or disruptions in the capital markets or other factors affecting our ability to enter into or complete share repurchases; risks and uncertainties associated with Delcath's business and finances in general; risks and uncertainties associated with the commercialization of HEPZATO KIT and CHEMOSAT. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. Factors that may cause such differences include, but are not limited to, those discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Delcath undertakes no obligation to publicly update or revise these forward-looking statements except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251120794521/en/

Investor Relations Contact:

ICR Healthcare

[email protected]