Delcath Announces Leadership Transition
May 26 2020 - 8:30AM
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.
Contact:
Hayden IR James Carbonara (646)-755-7412
james@haydenir.com
Brett Maas (646) 536-7331
brett@haydenir.com
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