Monday, June 27, 2022

Here’s Why Delcath Systems, Inc. (NASDAQ:DCTH) is Soaring

Delcath Systems, Inc. (NASDAQ:DCTH) is a hard one to figure out as shares bounced +100% this morning. It’s critical to note that shares traded down from $1.00 to .02 cents so far this year, which puts the bounce today back to .19 cents in perspective after a 98% sell off. Take a look at the chart below to see the precipitous sell off and subsequent bounce. This puts the value of the company at $59.24 million with the 167.88 million shares outstanding carrying this .17 cent price tag. This stock was worth much, much more starting 2017, so we need to break down what is happening here.
DCTH is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. It seems the metric for Decalth is the SPA agreement, which indicates if the pivotal trial design will adequately address objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS by the FDA. It is hard to tell what information is out there, and if this price spike is pure speculation.  Or if this is just value buyers jumping in driving shares higher for their own benefit, hard to tell for me.
Delcath Systems, Inc. (NASDAQ:DCTH) has pivotal trial titled “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.”  Under the SPA, the study will enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe.  The primary endpoint is overall survival (OS) and secondary and exploratory endpoints include safety, progression-free survival (PFS), overall response rate (ORR) and quality-of-life measures. The Company expects to initiate the study in the Fall of 2017.
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“We look forward to initiating this important study in ICC under a SPA with the FDA,” said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. “The promising outcomes and observations in this tumor type identified by European investigators at our global Key Opinion Leader Forum last year were discussed at length with the agency, and provide us with considerable confidence in the potential of our therapy as a treatment for ICC. A manuscript of the European investigator data will be submitted to a peer-reviewed journal for publication.”
“This pivotal study in ICC is designed to be cost effective and pursued in a financially prudent manner.  Given the sequential nature of the trial design, Delcath’s investment in this study will be modest in 2017 as the Melphalan/HDS segment of the study will not occur until late in the year,” added Dr. Simpson.
Intrahepatic cholangiocarcinoma is the second most common primary liver tumor and represents approximately 10-20% of new hepatocellular carcinoma (primary liver cancer or HCC) cases diagnosed annually, or approximately 3,100 new cases every year in the U.S.1 Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.
Delcath Systems, Inc. (NASDAQ:DCTH) seems to be receiciving volatility around a trial which will begin soon, while traders and portfolio managers are looking at the price bouncing off a .02 cent low after a 98% decline. Stocks cannot go below zero, so this becomes a viable bet for a stock setting up for Phase 3. This was an interesting play under a nickel, but is it a value in the teens? It is hard to tell, but worth checking back here as we follow and update these small movers on our radar. For continuing coverage on shares of $DCTH stock, as well as our other breakout stock picks, sign up for our free newsletter now and get our next hot stock pick!

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