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Monday, November 30, 2020

The Squeeze is on in Delcath Systems, Inc. (OTCMKTS:DCTHD)

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While it has been decimated through a vicious funding spiral over recent years, it still piques our interest from time to time to check in on Delcath Systems, Inc. (OTCMKTS:DCTHD). And this is a particularly interesting time for such a task given the massive rip higher in shares to close the action last week – the stock blasted off for as much as 335% on the day on Friday.

While it is difficult to nail down the precise catalyst for the move, we would pin it down to a combination of the company’s announcement Friday morning that Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of the company, will present at the RHK Capital 2018 Disruptive Growth and Healthcare Conference next week as well as the company’s announcement a day earlier that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma has completed another review of safety data for treated patients in the trial. According to this earlier release, “the DSMB has again recommended that the study continue without modification.”

Delcath Systems, Inc. (OTCMKTS:DCTHD) frames itself as a specialty pharmaceutical and medical device company focused on oncology.

DCTH focuses on the treatment of primary and metastatic liver cancers. The company is developing melphalan hydrochloride for Injection for use with the Delcath hepatic delivery system to administer high-dose chemotherapy to the liver. It offers melphalan hydrochloride under the Delcath Hepatic CHEMOSAT Delivery System for Melphalan name in Europe.

The company was founded in 1988 and is headquartered in New York, New York.

According to company materials, “Delcath Systems, Inc. is an interventional oncology Company focused on the treatment of primary and metastatic liver cancers. Our 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. We have commenced a global Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma (OM), and plans to initiate a Registration trial for intrahepatic cholangiocarcinoma (ICC) by the end of 2017 contingent on effecting the reverse stock split as outlined in the Company’s consent proposal. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S.  In Europe, our system 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.”

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“The DSMB’s continued recommendation to proceed without modification with the FOCUS Trial as planned confirms once again our own observations of the safety profile of PHP therapy based on prior research and our commercial experience with CHEMOSAT in Europe,” said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. “Given that safety concerns with the previous generation product and procedure were the primary issue in the FDA’s previous assessment, we are pleased with the safety profile demonstrated by our therapy in the trial thus far.”

Interestingly, as noted above, the company also just announced that Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer, will present at the RHK Capital 2018 Disruptive Growth and Healthcare Conference being held May 8-9, 2018 at Reed Smith, LLP in New York. Dr. Simpson’s presentation details are as follows.

This could augment the recent action if the company has something important to disclose. It’s not a bad idea to keep an eye on this one at this point.

At this time, carrying a capital value in the market of $2.24M, DCTHD has a significant war chest ($5.3M) of cash on the books, which is balanced by virtually no total current liabilities. DCTHD is pulling in trailing 12-month revenues of $2.7M. In addition, the company is seeing major top-line growth, with y/y quarterly revenues growing at 4.1%. We will update the story again soon as developments transpire. Sign-up for continuing coverage on shares of $DCTHD stock, as well as other hot stock picks, get our free newsletter today and get our next breakout pick!

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

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