About Delcath Systems (OTCQB:DCTH) Delcath Systems was formed in 1988 as a Pharmaceutical and Medical Device company focused on Interventional Oncology. The company is registered in Delaware with offices in New York, New York and Manufacturing , Distribution, Research and Development facilities located in Quensbury, New York. The company currently has 10 patents in their U.S. Intellectual Property portfolio according to the U.S. Patent Office.
Delcath Systems subsidiaries include Delcath Holdings Limited (Ireland), Delcath Systems Limited (Ireland), Delcath Systems B.V. (Netherlands), Delcath Systems Gmbh (Germany) and Delcath Systems UK (United Kingdom). About CHEMOSAT® and Melphalan/HDS The Delcath system administers concentrated regional chemotherapy directly to the liver. This “whole organ” therapy is performed by 1) isolating the circulatory system of the liver, 2) infusing the liver with a chemotherapeutic agent, and then 3) filtering the blood prior to returning it to the patient’s circulatory system.
During the procedure, known as percutaneous hepatic perfusion, PHP ®, or PHP therapy, three catheters are placed percutaneously through standard interventional radiology techniques. The catheters temporarily isolate the liver from the body’s circulatory system, allow administration of the chemotherapeutic agent melphalan hydrochloride directly to the liver, and collect blood exiting the liver for filtration by our proprietary filters. The filters absorb the chemotherapeutic agent in the blood, thereby reducing systemic exposure to the drug and related toxic side effects, before the filtered blood is returned to the patient’s circulatory system.
PHP therapy is performed in an interventional radiology suite in approximately two to three hours. Patients remain in an intensive care or step-down unit overnight for observation following the procedure. Treatment with CHEMOSAT® and Melphalan/HDS is repeatable, and a new disposable system is used for each treatment. Patients treated in clinical settings are permitted up to six treatments. In commercial treatment settings, patients have received up to eight treatments. In the United States, melphalan hydrochloride for injection will be included as part of the system, if approved. In Europe, the system is sold separately and used in conjunction with melphalan hydrochloride commercially available from a third party. In our clinical trials, melphalan hydrochloride for injection is provided to both European and United States clinical trial sites.
In the United States, the Melphalan/HDS system is considered a combination drug and device product and is regulated as a drug by the United States Food and Drug Administration (FDA). The Melphalan/HDS system has not been approved for sale in the United States.
In Europe, their proprietary system to deliver and and filter melphalan hydrochloride is marketed under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan. In April 2012, they obtained authorization to affix a CE Mark for the Generation 2 CHEMOSAT® system. The right to affix the CE mark allows the company to market and sell the CHEMOSAT® system in Europe.
In December 2018, Delcath entered into a License Agreement with medac GmbH for the commercialization of the CHEMOSAT® system in Europe. Under the terms of the medac License, medac has the exclusive right to sell and market CHEMOSAT® in all member states of the EU, Norway, Liechtenstein, Switzerland, and the United Kingdom. Since launching CHEMOSAT® in Europe, over 750 commercial treatments have been performed at over 25 European cancer centers. Physicians in Europe have used CHEMOSAT® to treat patients with a variety of cancers in the liver, primarily ocular melanoma liver metastases, and other tumor types including cutaneous melanoma, hepatocellular carcinoma, cholangiocarcinoma, and liver metastases from colorectal cancer, breast, pancreatic and neuroendocrine.
Declcath Systems currently has two clinical trials underway. The first is the FOCUS Trial and the second is the ALIGN Trial.
The FOCUS Trial is designed to evaluate patients who have melanoma that has spread from the eye to the liver. All patients in the study will be treated with Melphalan/HDS for up to 6 treatments. This study will evaluate the safety and effects of the treatment on how long patients live and how long it takes for the cancer to advance or respond to the treatment.
Study Type: Interventional (Clinical Trial)
Enrollment: 80 participants
Intervention Model: Single Group Assignment
Study Start Date: February 1, 2016
Enrollment in the FOCUS Trial was completed in January 2020. Top line data for the study is expected mid-2020 and an NDA (New Drug Application) filing is expected in Q1 2021.
For more info click here
The ALIGN Trial will evaluate two groups of patients who have intrahepatic cholangiocarcinoma. Each group will receive induction treatment with Cisplatin and Gemcitabine per SOC for 4 treatment cycles. Following induction treatment patients will be randomize (1:1), to 2 arms of treatment. One group (50%) will receive high dose chemotherapy delivered specifically to the liver, while the other group (50%) will continue treatment with Cisplatin and Gemcitabine. Patient in each group will get repeating cycles of treatment until the cancer advances. All patients will be followed until death. This study will compare the overall survival (OS) in patients with intrahepatic cholangiocarcinoma. The ALIGN Trial has an estimated completion date of January 2023. Study Type:
Interventional (Clinical Trial) Estimated Enrollment:
295 participants Intervention Model:
Parallel Assignment Study Start Date:
April 10, 2018 The Primary Completion date for this study is estimated to be January 2023.. For more info click here Delcath Systems securities originally came on the market on June 16, 2000 with an IPO offering of 1.2m shares priced at $6.00 per share. Securities were listed on both the NASDAQ and Boston Stock Exchange. The stock moved from the NASDAQ to the OTCQB on September 15, 2017 after the company Voluntarily Delisted it from NASDAQ and requested an Accelerated listing in the OTC marketplace.
Stock Split History
Since their initial public offering in 2000, Delcath have affected five reverse stock splits for a cumulative ratio since their IPO of 1:31,360,000,000. Each such reverse split has resulted in an effective decline in the price of their common stock.
|Split # || Date ||Ratio |
|1 || April 9, 2014 ||1:16 |
|2 || July 21, 2016 ||1:16 |
|3 || November 6, 2017 ||1:350 |
|4 || May 2, 2018 ||1:500 |
|5 || December 24, 2019 ||1:700 |
Delcath Share Structure as of 23 January 2020
Delcath Warrants and Options as of 23 January 2020
|Common Shares Authorized: ||1,000,000,000 |
|Common Shares Outstanding: ||70,056 |
|Preferred Shares Authorized: ||10,000,000 |
|Preferred Shares Outstanding: ||41,447 |
Shares Reserved for Conversion as of 23 January 2020
|Warrants: ||29 ||($42; exp 2/2020 - 10/2021) |
|2019 Warrants: ||1,826,579 ||($23.04; exp 12/2024) |
|Options: ||1,640 || |
|Preferred Stock: ||1,799,093 |
|Convertible Notes: ||63,493 |
Total shares issued and reserved as of 23 January 2020
Delcath Shareholder Information
Management and BOD (Common Stock)
Investment Funds (Common Stock)
|Jennifer K. Simpson, Ph.D. ||: 2,965 |
|John Purpura, M.S. ||: 2,830 |
|William D. Rueckert ||: 2,619 |
|Roger G. Stoll, Ph.D. ||: 4,047 |
|Marco Taglietti, M.D. ||: 2,606 |
|Altium Capital Management L.P. ||: 7,204 |
|Rosalind Master Fund L.P. ||: 7,024 |
|Hudson Bay Master Fund Ltd. ||: 7,024 |
Retail Shareholders (Common Stock)
|45 Shareholders (est.) ||: 26,985 |
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