Delcath Systems Inc (DCTH)

[Rapture2020]

RES IPSA LOQUITUR

1. DCTH FY 2017 EARNINGS HIGHLIGHTS

• Revenue from European sales for 2017 increased 35%

• Satisfaction of all obligations under the privately placed senior secured convertible notes issued to two institutional investors in June 2016 – DCTH IS DEBT FREE;

• Completed a $5.0 million capital raise in February 2018;

• Modified the Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration (FDA) for the Company’s Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma (OM);

• Announced that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 FOCUS clinical trial recommended that the study continue without modification; Reported the 500th CHEMOSAT treatment in Europe;

• Announced results from a multi-center analysis of Delcath’s Percutaneous Hepatic Perfusion (PHP) therapy in the peer-reviewed Journal of Surgical Oncology; largest data set outside of clinical trial showed manageable toxicity and overall median overall survival of 15.3 months, and;

• Secured a commercial supply of melphalan through an agreement with Tillomed Laboratories for use with the company’s CHEMOSAT® Delivery System for Melphalan, where it is marketed in Europe for the treatment of a wide range of cancers of the liver.

https://finance.yahoo.com/news/delcath-announces-2017-financial-results-130000468.html

2. DCTH IS TELEGRAPHING

Delcath Announces Commercial Supply Agreement for Melphalan Hydrochloride for Injection with Tillomed Laboratories
“We are particularly pleased to be working with a supplier of Tillomed’s caliber and experience as it establishes firm control over our melphalan supply chain in Europe and, over time, will provide economies of scale", noted Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath.

ECONOMIES OF SCALE: A proportionate saving in costs gained by an increased level of production.

Read: Additional supply is needed to match the increased demand for the CHEMSAT therapy.

10K CONFIRMATION:

During 2017, Delcath added 7 employees to support clinical trial implementations in the EU and United States and to meet the demands of commercial sales

http://delcath.com/investors-news/

3. OTHER 10K HIGHLIGHTS

With the establishment of a ZE code for CHEMOSAT, the procedure is now permanently represented in the DRG catalog in Germany.

In the Netherlands CHEMOSAT has been performed at the Netherlands Cancer Institute in 2013 and at Leiden University Medical Centre since 2014. In June 2017 the Medical Oncology National Treatment Guidelines for Uveal Melanoma were updated and now include recommendations to consider CHEMOSAT in the treatment of liver metastases.

4. ICC. In March 2017 we announced another SPA agreement with the FDA for the design of a new pivotal trial of Melphalan/HDS to treat patients with intrahepatic cholangiocarcinoma (ICC). Under the SPA, the Pivotal ICC Trial will enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The SPA agreement for this trial indicates that the pivotal trial design adequately addresses objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS in ICC.

5. DARK HORSE. U.S. Right to Try Legislation. Passed Senate. Failed House 3/12/18 (259-140). House leadership will re-submit bill for vote requiring only simple majority. Republicans have simple majority in House. This will pass in time before mid-term elections, IMO.

So what does this mean?

Ocular Melanoma and Intrahepatic cholangiocarcinoma (ICC) are among the most prevalent and lethal forms of cancer. Approval of RIGHT TO TRY would put Ocular Melanoma (FOCUS trial) and Intrahepatic Cholangiocarcinoma (ICC) in play this year.

DCTH believes their Ocular Melanoma therapy and Intrahepatic cholangiocarcinoma therapy, combined, tap into a potential market opportunity is between $452 MILLION - $1.3 BILLION annually.