Delcath (NSDQ:DCTH) said today it inked a securities purchase agreement with an investor for $35 million in senior convertible notes and stock purchase warrants, expecting to bring in $32.2 million to support operations and ongoing clinical trials.
Of the $32.2 million in proceeds, Delcath said $3 million will be immediately available, with the remaining $29.2 million subject to a cash covenant restricting it and requiring it be held by control accounts of the company.
“This committed financing provides us with the resources to advance our clinical development plan through the end of 2017 while also supporting our commercialization programs in Europe. We are positioned to achieve important clinical inflection points in our Focus trial and our global phase 2 program in HCC and ICC, which we believe represent the fastest path to U.S. FDA approval and ultimately the generation of shareholder value. This financing will be valuable to our efforts to expand global access to our Melphalan/HDS for the benefit of patients suffering with primary and metastatic liver cancers,” CEO Jennifer Simpson said in prepared remarks.
Funds from the round will support corporate activities, as well as the company’s global phase III trial of its Hepatic Delivery System and Melphalan Hydrochloride designed for the treatment of hepatic dominant ocular melanoma and a phase II trial of the system for treating hepatocellualr carcinoma and intrahepatic cholangiocarcinoma.
The Queensbury, N.Y.-based company will issue notes at an 8% original issue discount, and notes issued will be convertible at the option of the holder at 110% of the market price into a fixed number of common shares.
Roth Capital Partners acted as sole placement agent for the offering, Delcath said.
In January, Delcath said it launched a Phase III trial of its Delcath Hepatic Delivery System and Melphalan Hydrochloride designed for the treatment of hepatic dominant ocular melanoma.
The Focus trial will examine the safety, efficacy and pharmocokinetic profile of its Melphalan and HDS system when compared with the standard of care, the New York City-based company said.
The trial is slated to enroll 240 patients, with a primary endpoint comparing overall survival between 2 arms of the trial and secondary endpoints including progression-free survival, overall response rate and quality of life measures.
The company is conducting the trial under a Special Protocol Assessment it received from the FDA, and will be the only Phase III trial required for the company to submit a New Drug Application, Delcath said.
