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Saturday, December 3, 2022

The Exciting Rise of Delcath Systems, Inc. (OTCMKTS: DCTH)

Delcath Systems, Inc. (OTCMKTS: DCTH) is making an explosive move up after the Company announced it is entered into a definitive licensing agreement for CHEMOSAT [(R)] commercialization in Europe with medac Gesellschaft fur klinische Spezialpraparate mbH (medac), a privately held, multi-national pharmaceutical company based in Hamburg area, Germany. Founded in 1970, medac specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases. The company has offices globally, worldwide partner agreements in over 90 countries, and approximately 1,200 employees.

Under the terms of the seven-year agreement, Delcath’s European subsidiary, Delcath Systems, Ltd. exclusively licenses medac to sell and market CHEMOSAT in all member states of the European Union, Norway, Liechtenstein, Switzerland, and the United Kingdom. medac will pay Delcath EUR6,000,000 in a combination of upfront and success-based milestone payments. Additionally, Delcath will receive a fixed transfer price per unit of CHEMOSAT as well as royalties. The agreement has a projected value of up to $45 million over the first seven-year term and includes an optional five-year extension.

DCTH used to traded on the NASDAQ stock exchange but was de-listed last year after the Company’s board failed to approve a reverse stock split. DCTH began trading on the OTCBB on Friday, September 15.

Delcath Systems, Inc. (OTCMKTS: DCTH) is an interventional oncology Company focused on the treatment of primary and metastatic liver cancers. DCTH investigational product – Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) – is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects.

The Company has commenced a global registration trial (The FOCUS Trial) for Patients with Hepatic Dominant Ocular Melanoma (OM) and have initiated a global Phase 3 trial (The ALIGN Trial) for patients with intrahepatic cholangiocarcinoma (ICC). Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S.

In Europe, Melphalan/HDS has been commercially available since 2012 under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT), where it has been used at major medical centers to treat a wide range of cancers of the liver.

Earlier this year DCTH announced the initiation of their registration trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with intrahepatic cholangiocarcinoma (ICC). Called The ALIGN Trial, this trial will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The trial is being conducted under a Special Protocol Assessment (SPA) agreement reached with the U.S. Food and Drug Administration (FDA) in March 2017. The ALIGN Trial is based on a strong efficacy signal observed in the ICC tumor type through our commercial experience with CHEMOSAT in Europe. We are leveraging our existing network of trial sites from our FOCUS Phase 3 trial to rollout the trial protocol as efficiently as possible and have 3 centers open for patient enrollment to date. In this orphan population where there exists a huge unmet need, this trial provides us with a second pathway to commercial drug approval in the United States, and if successful we believe will be an important value driver for the Company.

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Last month DCTH announced the first patient has been enrolled under the amended protocol for its registration trial in ocular melanoma liver metastases. Stanford University Medical Center is the first trial site to enroll a patient under the amended protocol. The trial, A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma (The FOCUS Trial), will enroll a minimum of 80 patients with ocular melanoma metastatic to the liver. Patients previously enrolled in the Melphalan/HDS arm of the trial under the prior randomized protocol will continue to be treated and evaluated as part of the amended trial.

Earlier this year DCTH raised $8.1 million from a sharehlders rights offering. The rights offering was made pursuant to a Registration Statement on Form S-1 that was made effective on August 3, 2018. At the end of the subscription period on September 26, 2018, Delcath had received 4,249,604 basic subscriptions and 418,207 oversubscriptions for a total of 4,667,811 subscriptions, each subscription for one share of its Common Stock.

In October DCTH began patient treatments in the Company’s second global US registration trial investigating Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) in the treatment of patients with intrahepatic cholangiocarcinoma (ICC). The trial, entitled A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma, (the ALIGN Trial) will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe.

on the CHEMOSAT agrreement Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath stated: “With offices throughout Europe and a well-established network among oncology key opinion leaders, medac is a well-suited partner to help advance CHEMOSAT commercialization in the European Union and neighboring countries. medac provides the organizational scale, expertise and market reach necessary to help us strive to firmly establish CHEMOSAT in the European treatment landscape for cancers of the liver. Additionally, through this agreement, we obtain immediate resources to support our efforts to advance our clinical development program. This is a highly significant development for Delcath, and we are pleased to be working with a market leader like medac to help this therapy fully realize its potential.”

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Currently trading at a $2.5 million market valuation DCTH has $1.2 million in the treasury and $4.2 million in current assets and carries a very significant debt load of $18 million in current liabilities. DCTH is an interventional oncology company focused on the treatment of primary and metastatic liver cancers and has small but growing revenues reporting $858,000 in sales for the 3 months ended June 30, 2018 up from $584,000 for the same period last year. We will be updating on DCTH when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with DCTH.

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Disclosure: we hold no position in DCTH either long or short and we have not been compensated for this article.

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