- Appoints John Purpura as interim Chief Executive Officer.
- Reiterates intention to announce top-line data from Phase 3 FOCUS trial by year-end
- Accelerates shift to commercialization planning
NEW YORK, May 26, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on liver-directed treatment of rare primary and metastatic cancers, today announced that the Board of Directors appointed John Purpura as interim Chief Executive Officer. Dr. Roger Stoll, Chairman of Delcath commented: “The Company is very fortunate to have John Purpura’s strong leadership. John’s tenure with Delcath and thirty-five years of relevant healthcare experience make him the right choice to guide us through a seamless transition.”
Mr. Purpura stated, “I am excited to guide the Company through a transformative period as we prepare to release top line data from the Phase 3 FOCUS trial in metastatic ocular melanoma by year-end 2020 and resubmit our NDA next year.”
Earlier this month, Dr. Gil Aharon and Steven Salamon of Rosalind Advisors, a healthcare-focused investment advisor founded in 2006, joined the Board. Rosalind led Delcath’s $51.5 million recapitalization over the last 12-months, culminating in the Company’s recent uplisting to NASDAQ. Dr. Aharon commented, “Melphalan/HDS has significant clinical and commercial value. As scientists and investors, we are compelled by the opportunity to bring to market a novel treatment paradigm for patients, who have no clinically satisfactory treatments available. Steven and I are pleased to join the Board and strengthen our commitment to Delcath.”
Jennifer Simpson, President & CEO and Barbra Keck, CFO resigned from the Company effective June 1, 2020. The Board of Directors has launched an executive search process to identify a permanent CEO and CFO to strategically lead the company through FDA approval and commercialization.
About Delcath Systems, Inc.
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 minimizing systemic exposure and associated side effects. In addition to the Phase 3 FOCUS Trial, we have initiated a global Phase 3 clinical trial for intrahepatic cholangiocarcinoma (ICC) called The ALIGN Trial. We currently are also evaluating other forms of metastatic liver cancers. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT) and has been CE Marked and used at major medical centers to treat a wide range of cancers of the liver. CHEMOSAT is being marketed under an exclusive licensing agreement with medac GmbH, a privately held multi-national pharmaceutical company headquartered in Germany that specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases.
Safe Harbor / Forward-Looking Statements
Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to the timing and results of the Company’s clinical trials, including without limitation the OM and ICC clinical trial programs, and timely enrollment and treatment of patients in the global Phase 3 OM and ICC clinical trials and the impact of the COVID-19 pandemic on the enrollment and completion of our clinical trials; IRB or ethics committee clearance of the Phase 3 OM and ICC Registration trial protocols from participating sites and the timing of site activation and subject enrollment in each trial; the impact of the presentations at major medical conferences and future clinical results consistent with the data presented; approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure; the impact, if any of ZE reimbursement on potential CHEMOSAT product use and sales in Germany; clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK; the Company’s ability to successfully commercialize the Melphalan HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver; our ability to obtain reimbursement for the CHEMOSAT system in various markets; approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the U.S. and/or in foreign markets; actions by the FDA or other foreign regulatory agencies; the Company’s ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same; uncertainties relating to the timing and results of research and development projects; and uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.