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Delcath Systems Inc. (DCTH)

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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

 
Common Shares Authorized: 1,000,000,000
Common Shares Outstanding: 70,056
Preferred Shares Authorized: 10,000,000
Preferred Shares Outstanding: 41,447

Delcath Warrants and Options 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  

Total Warrants/Options:

1,828,248
 

Shares Reserved for Conversion as of 23 January 2020
 
Preferred Stock:  1,799,093
Convertible Notes: 63,493

Total Reserved:

1,862,586
 
Total shares issued and reserved as of 23 January 2020
3,760,890

 
Delcath Shareholder Information
 
Management and BOD (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

Total Shares  

: 21,459

Investment Funds (Common Stock)
Altium Capital Management L.P. : 7,204
Rosalind Master Fund L.P. : 7,024
Hudson Bay Master Fund Ltd. : 7,024

Total Shares  

: 21,612
 
Retail Shareholders (Common Stock)
45 Shareholders (est.) : 26,985

 --- Daily Chart ---

       

Company Website: Delcath Systems, Inc. Stock and Financial Website: OTC Marketplace
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News News Alert: Statement of Changes in Beneficial Ownership (4) 05/16/2022 08:06:19 AM
PostSubject
#50108   just waiting.................................................................... nealhugh 05/02/22 04:17:39 AM
#50107   yup--- good chat with GA... TY. Neal nealhugh 03/30/22 04:43:38 AM
#50106   FDA submission Summer/Fall 2022 nealhugh 03/10/22 10:40:38 AM
#50105   https://ih.advfn.com/p.php?pid=nmona&article=87441339 nealhugh 03/07/22 08:39:10 PM
#50104   Yeah--- I had Covid so I have been nealhugh 03/07/22 08:38:14 PM
#50103   Yeah--- I had Covid so I have been nealhugh 03/07/22 08:38:09 PM
#50102   Better call Toronto!! Lol highstreettrader 03/07/22 04:59:00 PM
#50101   6.12-------------crazy!!! porque??? nealhugh 03/07/22 03:17:55 PM
#50100   I have COVID--- 2nd month... and a ton nealhugh 02/25/22 06:09:06 PM
#50099   DCTH stock price--- OY OY OY... nealhugh 02/19/22 08:21:24 PM
#50098   Bought a bunch today. Got way too cheap. highstreettrader 01/26/22 01:37:17 PM
#50097   ???????????????????? wtf nealhugh 01/15/22 05:05:45 AM
#50096   Gotta call Gil in TO. nealhugh 01/11/22 08:59:39 AM
#50095   Thanks! We are loaded--- ! nealhugh 01/01/22 07:43:49 AM
#50094   Free money Neal. Snacked hard on the Filterthenoise 12/31/21 05:53:05 PM
#50093   7.50!--- why??? PT is $25... wtf. nealhugh 12/31/21 03:07:32 AM
#50092   wtf... gotta call Toronto. :( nealhugh 12/29/21 12:43:52 AM
#50091   PT $25 and more if all goes as planned nealhugh 12/26/21 03:08:39 AM
#50090   Holding a lot, hoping, waiting... nealhugh 12/21/21 02:39:07 AM
#50089   BUY--- PT $25 nealhugh 12/11/21 12:59:58 PM
#50088   Yeah, seems like data is still good. SweatpantKing 12/02/21 10:12:46 AM
#50087   coming back now lousy market shurtha2000 12/02/21 09:56:04 AM
#50086   Lol, what’s going on here??? SweatpantKing 12/02/21 09:51:43 AM
#50085   hits $16 now red this is crazy shurtha2000 12/02/21 08:45:19 AM
#50084   Bizarro world shurtha2000 12/02/21 08:44:54 AM
#50083   10.5 now support. Lets GO !! Filterthenoise 11/03/21 04:08:36 PM
#50082   Another crack at that 10.5 wall coming up. Filterthenoise 10/19/21 10:44:10 PM
#50081   Making another attempt to get loose... Filterthenoise 09/27/21 03:11:48 PM
#50080   Lets GO Filterthenoise 09/09/21 02:33:50 PM
#50079   up today... $10 now. nealhugh 08/31/21 06:57:19 PM
#50078   should rise now into Fall presentation in Europe... nealhugh 08/23/21 08:27:31 PM
#50077   Excellent. I think it was a waste of SAMNOTSAMUEL 08/23/21 12:51:45 PM
#50076   they say all is OK... nealhugh 08/23/21 11:40:39 AM
#50075   need info... nealhugh 08/20/21 08:05:24 AM
#50074   BUY nealhugh 08/13/21 03:10:56 AM
#50073   Getting excited for the coming weeks Filterthenoise 07/30/21 10:46:05 AM
#50072   $10... Beast mode about to be activated Filterthenoise 07/28/21 02:47:36 PM
#50071   BUYING here. nealhugh 07/28/21 03:19:00 AM
#50070   correct nealhugh 07/27/21 08:38:13 AM
#50069   No reason to my knowledge to discount all SAMNOTSAMUEL 07/26/21 08:15:56 PM
#50068   All OK it seems and Sept conf in nealhugh 07/24/21 01:18:23 AM
#50067   Just BUY nealhugh 07/23/21 04:56:37 PM
#50066   You'd be kicking yourself for a long time Filterthenoise 07/23/21 03:34:44 PM
#50065   I am buying DCTH!!!!!!!!!!! nealhugh 07/23/21 03:32:48 PM
#50064   Looking interesting again here highstreettrader 07/12/21 11:28:14 PM
#50063   Creeping up... Lets GO! Filterthenoise 06/30/21 10:40:54 AM
#50062   Looks nice heading into next week Filterthenoise 06/25/21 06:20:52 PM
#50061   Bought again. Lets GO! Filterthenoise 06/23/21 07:50:27 PM
#50060   Looks like show time... Filterthenoise 06/11/21 04:12:49 PM
#50059   Set to join the russell microcap index!!! dj1216 06/08/21 01:08:19 PM
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