Delcath Strengthens Executive Team with Appointment of Gerard Michel as Chief Executive Officer
October 01 2020 - 4:07PM
Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the Board
of Directors appointed Gerard Michel as Chief Executive Officer,
effective October 1, 2020. Mr. Michel will also serve as a member
of the Delcath Systems Board of Directors. In his most recent role,
Mr. Michel was the Chief Financial Officer and Vice President of
Corporate Development at Vericel Corporation. Mr. Michel was a key
member of the executive team that successfully restructured Vericel
enabling it to become a commercial leader in the fields of advanced
Cell Therapy and specialty Biologics.
In addition to Mr. Michel’s appointment as CEO, John Purpura,
was appointed as Chief Operating Officer. Mr. Purpura’s leadership
and operational excellence in areas of regulatory affairs,
manufacturing and distribution have been a critical component of
preparing Delcath for its planned New Drug Application (NDA)
resubmission to the FDA in mid-2021.
“Following an intensive process, the Board determined that
Gerard is the right leader for Delcath at this critical juncture,”
said Dr. Roger Stoll, Chairman, Delcath Systems. “He is uniquely
qualified to take on this role given his track record of success
and experience across therapeutics classes. Gerard’s extensive
experience in strategy, operations, commercialization, business
development and capital markets will be a tremendous asset.” Dr.
Stoll added, “We thank John for successfully guiding Delcath as
interim CEO over recent months. On behalf of the Board, I
congratulate him on his appointment to COO.”
Mr. Michel commented, “I am excited to join the talented Delcath
team ahead of a transformational year as we prepare to report phase
3 FOCUS trial data in metastatic ocular melanoma (mOM) in early
2021. I am committed to leading the organization towards its goal
of making Melphalan/HDS the first product specifically labeled for
metastatic ocular melanoma patients, a population which currently
has limited therapeutic options.”
Mr. Michel added, “Interventional oncology is a rapidly growing
segment of comprehensive oncology care. Within that segment
Melphalan/HDS is a clinically differentiated, high-value platform
with the potential to address multiple cancer indications of
high-unmet medical need. I look forward to building value both
through the successful commercialization of Melphalan/HDS in mOM
and initiating additional targeted clinical programs to expand the
market opportunity of this platform technology.”
Mr. Michel joins Delcath Systems with over 30 years of
experience in the pharmaceutical and medical technology industries
across multiple functional areas. Prior to Delcath, he was Chief
Financial Officer of Vericel since June 2014 where he was a key
member of the management team which integrated a transformative
acquisition and revised the company’s business model from a
research focused company to a fully integrated, profitable
commercial business. Mr. Michel also served as Chief Financial
Officer and Vice President, Corporate Development of Biodel from
November 2007 to May 2014, and Chief Financial Officer and Vice
President of Corporate Development of NPS Pharmaceuticals Inc. from
August 2002 to November 2007. Prior to that, Mr. Michel was a
Principal at Booz Allen and held a variety of commercial roles at
both Lederle Labs and Wyeth Labs. Mr. Michel holds a M.S in
Microbiology from the University of Rochester School of Medicine,
an M.B.A. from the Simon School of Business, and a B.S. in both
Biology and Geology from the University of Rochester.
Inducement Grant Under NASDAQ Listing Rule
5635(c)(4)
The Company also announced the grant of an option award to Mr.
Michel, which was approved by the Board on August 31, 2020 as an
inducement material to his entering employment with the Company in
accordance with NASDAQ Listing Rule 5635(c)(4). The inducement
award was approved subject to his commencement of employment with
the Company on October 1, 2020 and consists of an option to
purchase up to 498,000 shares of the Company’s common stock. The
option will be exercisable at a price of (i) $11.67 per share (the
closing price on October 1, 2020) as to the first 396,000 shares to
vest, (ii) 1.5 times the closing trading price per share of the
Company’s common stock on October 1, 2020 as to the next 51,000
shares to vest and (iii) 2.0 times the closing trading price per
share of the Company’s common stock on October 1, 2020 as to the
remaining 51,000 shares to vest and will vest ratably over
thirty-six months, provided that he remains employed by Delcath on
each vesting date.
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. The phase
3 FOCUS trial in metastatic Ocular Melanoma (mOM) is approaching
completion. We are also currently evaluating other forms of primary
and 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 CHEMOSAT® Hepatic 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
mOM clinical trial program, timely enrollment and treatment of
patients in the global Phase 3 mOM clinical trial and the impact of
the COVID-19 pandemic on the enrollment and completion of our
clinical trial; subject enrollment in the Phase 3 mOM 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 IRJames
Carbonara(646)-755-7412james@haydenir.com
Brett Maas(646) 536-7331brett@haydenir.com
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