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December 13, 2022

Delcath Systems, an Interventional Oncology Company, Closes Private Placement for Funding

December 13, 2022—Delcath Systems, Inc., an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced the closing of a previously announced private placement with certain accredited investors.

Delcath Systems’ percutaneous hepatic perfusion (PHP) system is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In the United States, the PHP system is being developed under the tradename Hepzato Kit (a melphalan hydrochloride for injection/hepatic delivery system) for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (also known as metastatic uveal melanoma) and is considered a combination drug and device product regulated by the FDA.

In Europe, the PHP system is now regulated as a class lll medical device and is approved for sale under the trade name Chemosat hepatic delivery system for melphalan. It is used in Europe at major medical centers to treat a wide range of cancers of the liver.

In August 2022, the company announced the publication of a retrospective analysis of the Chemosat device at three European centers between February 2014 and December 2019. The study was composed of 101 patients who completed a minimum of one PHP procedure to treat unresectable uveal melanoma liver metastases. The study was published by T. M. L. Tong, MD, et al, in CardioVascular and Interventional Radiology (2022;45:1304-1313).

According to the company, gross proceeds from the private placement were approximately $6.2 million before deducting offering expenses payable by Delcath. Delcath issued and sold 1,448,889 shares of its common stock at a price per share of $2.90, or—in lieu of shares of common stock—692,042 prefunded warrants to purchase common stock at a price per prefunded warrant of $2.89. The prefunded warrants will have an exercise price of $0.01 per share of common stock, be immediately exercisable, and remain exercisable until exercised in full.

The company intends to use the net proceeds from the private placement for working capital purposes and other general corporate purposes.

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