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Delcath Systems Inc. (DCTH)

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Last Post: 9/22/2020 8:33:16 AM - Followers: 512 - Board type: Free - Posts Today: 0

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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DCTH News: Current Report Filing (8-k) 06/05/2020 04:03:45 PM
DCTH News: Current Report Filing (8-k) 05/22/2020 04:06:25 PM
DCTH News: Quarterly Report (10-q) 05/14/2020 05:24:47 PM
DCTH News: Current Report Filing (8-k) 05/12/2020 04:14:38 PM
DCTH News: Statement of Changes in Beneficial Ownership (4) 05/08/2020 07:26:58 PM
PostSubject
#49874   The company also has an atm type financing SAMNOTSAMUEL 09/22/20 08:33:16 AM
#49873   Looks like a headfake today Filterthenoise 09/21/20 11:38:38 PM
#49872   Today is either a headfake before a run Filterthenoise 09/21/20 03:24:55 PM
#49871   8's are likely a super buy even if SAMNOTSAMUEL 09/21/20 01:53:13 PM
#49870   Ya im good, been loading under and around Filterthenoise 09/21/20 01:10:34 PM
#49869   As I see below $10, it could take SAMNOTSAMUEL 09/21/20 11:22:07 AM
#49868   Added a bit more this week. Filterthenoise 09/18/20 06:13:27 PM
#49867   We may see this stock 3X higher if Apophis 08/26/20 07:11:10 AM
#49866   OK. nealhugh 08/26/20 12:21:30 AM
#49865   I see no reason for excitement until new SAMNOTSAMUEL 08/25/20 04:01:32 PM
#49864   yawn for now... nealhugh 08/24/20 06:22:52 PM
#49863   On this slow afternoon looking back, majority of SAMNOTSAMUEL 08/15/20 04:13:26 PM
#49862   I watched the 2 live calls and got SAMNOTSAMUEL 08/15/20 03:49:03 PM
#49861   I am also waiting on the new CEO... nealhugh 08/15/20 07:57:30 AM
#49860   first live quarterly call in years today. Lot SAMNOTSAMUEL 08/13/20 07:07:46 PM
#49859   Looks like sellers are perking up around $12.90, SAMNOTSAMUEL 08/11/20 01:32:21 PM
#49858   looking good so far... nealhugh 08/11/20 01:01:29 PM
#49857   When is the last time people with big SAMNOTSAMUEL 08/11/20 10:40:24 AM
#49856   we shall see Sam... :) nealhugh 08/07/20 03:28:15 AM
#49855   This board is one of the perfect examples SAMNOTSAMUEL 08/06/20 06:32:48 PM
#49854   Every reason for optimism except for exceptions, more SAMNOTSAMUEL 07/22/20 09:30:52 AM
#49853   Moving nice. Anything back around $10 in the Filterthenoise 07/21/20 05:57:54 PM
#49852   an analyst according to yahoo is predicting $14 SAMNOTSAMUEL 07/20/20 11:09:59 AM
#49851   nice up to 11.30 now... nealhugh 07/19/20 02:39:07 PM
#49850   looks good for now nealhugh 07/17/20 10:05:49 PM
#49849   Surprising for recent volume this was good but SAMNOTSAMUEL 07/17/20 04:57:00 PM
#49848   Getting interesting. I'll keep loading for another Filterthenoise 07/17/20 04:00:50 PM
#49847   Hmmmm... the submariner 07/17/20 03:33:28 PM
#49846   Let's see who they pick for new CEO! nealhugh 07/17/20 01:42:21 AM
#49845   Dunno--- I am just holding now. nealhugh 07/17/20 01:09:14 AM
#49844   Funny thing..the ask showed 9.50 so I thru the submariner 07/15/20 01:38:27 PM
#49843   Well, I believe Rosalind has treated shareholders more SAMNOTSAMUEL 07/15/20 01:16:33 PM
#49842   I got back in today...been a few years the submariner 07/15/20 01:11:44 PM
#49841   So Neal, the trading today is another head SAMNOTSAMUEL 07/15/20 11:50:31 AM
#49840   Desert Eagle--- call me pls re Rosalind 212-666-6217. nealhugh 07/02/20 04:32:29 PM
#49839   1st key is who they hire plus down SAMNOTSAMUEL 07/02/20 07:46:24 AM
#49838   My conversation with Rosalind was reassuring... They seem nealhugh 07/02/20 06:52:55 AM
#49837   Part way there. Yesterday surge above $10 on SAMNOTSAMUEL 07/01/20 10:25:05 AM
#49836   Chatted with Rosalind. nealhugh 06/29/20 01:52:46 PM
#49835   2 gone, 3 new in 2020 of bod. SAMNOTSAMUEL 06/29/20 10:49:40 AM
#49834   I am in this at over $3000/share. thanks BOD Apophis 06/29/20 09:58:26 AM
#49833   You should concede that crossover lived 100 days SAMNOTSAMUEL 06/29/20 09:14:23 AM
#49832   Hobbs and the BOD sorta destroyed DCTH with nealhugh 06/29/20 08:25:29 AM
#49831   The next key is probably who replaces Simpson. SAMNOTSAMUEL 06/28/20 01:51:13 PM
#49830   Yes... and watch Rosalind. nealhugh 06/28/20 01:11:01 PM
#49829   GL. Filterthenoise 06/28/20 10:55:28 AM
#49828   My last recent purchase was $8.03, at this SAMNOTSAMUEL 06/28/20 09:59:45 AM
#49827   Still loading Filterthenoise 06/27/20 11:05:56 PM
#49826   bueno, I guess... we put in $10 million nealhugh 06/26/20 05:18:13 AM
#49825   And what I see as spelled out in SAMNOTSAMUEL 06/25/20 04:57:22 PM
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