Wednesday, June 29, 2022

Delcath Systems, Inc. (NASDAQ:DCTH) Stock Looks Rejuvenated

Delcath Systems, Inc. (NASDAQ:DCTH) loves the month of June. Shares have rallied off the lows of just less than $.02 sitting comfortably at $.05 cents trading excellent volume during this turnaround news. Although the overall trend is not a pretty one. Shares are down 90% overall in 2017, so a bounce was inevitable once traders found a low. The .$02 penny price seems as logical a place as any for them to find support. The chart below shows the harsh decline, followed by the June bounce.
DCTH is an interventional oncology company focused on the treatment of primary and metastatic liver cancers, and they recently announced that Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer, issued a Letter to Stockholders providing a business update.
Delcath Systems, Inc. (NASDAQ:DCTH) provided a comprehensive update for all shareholders about the direction of the company saying, the development of oncology therapeutics is a long and sometimes difficult path, but one great reward is being able to bring new therapies to patients in need.

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An important portion of DCTH’s shareholder letter is below:
“I am writing you to affirm Delcath’s unwavering commitment to advancing our innovative percutaneous hepatic perfusion (PHP®) therapy and to highlight the important role this therapy can play in treating patients with cancers of the liver.  Oftentimes these patients face limited treatment options.  Toward that end, I’d like to update you on our progress and plans for the future, as well as to review some of the challenges we faced last year.
 Our clinical development programs now provide us with two viable paths to U.S. market approvals. We believe that it is through these trials that shareholder value will ultimately be realized.  As such, our focus in 2017 remains on advancing the programs for our innovative Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS), as well as on our commercialization efforts for CHEMOSAT® in Europe. The year began with a number of significant developments toward these twin goals, and we are positioned for further advancement of these programs throughout the balance of the year.
Our priority for the year is expanding the number of clinical sites and enrolling patients into our global FOCUS Phase 3 clinical trial in hepatic dominant ocular melanoma (the FOCUS Trial). We initiated the FOCUS Trial in January 2016 under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA)which indicates that the design of this trial adequately addresses objectives that, if met, will support regulatory requirements for approval of Melphalan/HDS in this indication. Throughout 2016 we established a network of participating clinical trial sites that now includes 20 prestigious cancer research centers across the U.S. and Europe that are open for patient enrollment. We are continuing to expand this network and expect to have up to 40 clinical centers participating globally in this pivotal study by the end of the summer of 2017.
I’d also like to highlight that the clinical potential of Melphalan/HDS in the treatment of ocular melanoma liver metastases was repeatedly supported by compelling clinical data presented and published throughout the past year. Most recently, a single-center retrospective review was published in the American Journal of Clinical Oncology in which the authors found that investigational PHP with Melphalan/HDS offered promising results with a doubling of overall survival (OS) and significantly longer progression-free survival (PFS) and hepatic PFS than other targeted therapies. In addition, an oral presentation at the Regional Cancer Therapies 12th International Symposium reported data from a retrospective, multicenter study demonstrating that 45.7% of patients with ocular melanoma that metastasized to the liver who underwent PHP using investigational Melphalan/HDS experienced a complete or a partial response. That same study further showed that among those who responded to treatment, OS was projected to be more than three years.  The projected 657-day median OS and 1,207-day median OS in patients with a partial or a complete response is very impressive, and we believe speaks to the potential of our system to provide a meaningful and durable response in a disease that has an average survival of only six to eight months.
We continue to be encouraged that results such as these have been presented or published on several occasions over the last two years, as they provide us with considerable confidence in the potential of the FOCUS Trial to support FDA approval in the U.S. We believe the FOCUS trial represents our fastest path to U.S market approval, and that PHP with Melphalan has the potential to treat up to 2,000 patients with ocular melanoma liver metastases in the U.S. and Europe annually.” 
The bottom line: DCTH and CEO Simpson are bound and determined to turn things around here for shareholders. We will be paying close attention here to determine if they have put in a bottom during June. We will be back to see how management’s plan is translating to a solid share price. 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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