Delcath Systems Secures Up to a $20.0 Million Debt Facility with Avenue Venture Opportunities Fund, L.P.
August 09 2021 - 6:30AM
Delcath Systems, Inc. (Nasdaq:
DCTH), an
interventional oncology company focused on the treatment of rare
primary and metastatic cancers of the liver, announced today that
it has entered into a debt facility with Avenue Venture
Opportunities Fund, L.P. ("Avenue Venture Fund") providing up to
$20 million with an initial $15 million funded at close. Additional
details concerning the debt facility will be contained in the
company's Current Report on Form 8-K to be filed shortly with the
Securities and Exchange Commission.
"We are pleased to partner with Avenue Venture Fund ahead of
major upcoming milestones,” said Gerard Michel, CEO of Delcath.
“These loan facilities provide, at a low cost of capital, funding
to support the planned filing of our NDA in early 2022 for the use
of HEPZATO™ in the treatment of hepatic-dominant metastatic ocular
melanoma as well as expanding the development of HEPZATO into
additional areas of high unmet need.”
Chad Norman, Senior Portfolio Manager with Avenue Venture Fund,
commented, “We are pleased to partner with Delcath and support its
efforts to bring a highly innovative and unique modality of cancer
treatment to patients suffering from liver dominant cancers.”
Reedland Capital Partners, acting through Weild & Co.,
member FINRA|SIPC, served as financial advisor to Delcath in
connection with this transaction. For more information, please
visit www.reedland.com.
About Avenue Venture Opportunities
The Avenue Venture Opportunities Fund seeks to provide creative
financing solutions to high-growth, venture capital-backed
technology and life science companies. The Avenue Venture
Opportunities Fund focuses generally on companies within the
underserved segment of the market created by the widening financing
gap between commercial banks and larger debt funds. For additional
information on Avenue Capital Group, which is a global investment
firm with assets estimated to be approximately $11.6 billion as of
June 30, 2021, please visit www.avenuecapital.com.
About Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional oncology company
focused on the treatment of primary and metastatic liver cancers.
The company’s proprietary percutaneous hepatic perfusion (PHP)
system is designed to administer high-dose chemotherapy to the
liver while controlling systemic exposure and associated side
effects. In the United States, the PHP system is being developed
under the tradename HEPZATO™ KIT (melphalan hydrochloride for
injection/hepatic delivery system), or HEPZATO, and is considered a
combination drug and device product regulated by the United States
Food and Drug Administration (FDA).
In Europe, the PHP system is regulated as a Class IIb medical
device and is approved for sale under the trade name CHEMOSAT®
Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has
been 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
The 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 and ICC clinical trial programs, as well as the
receipt of additional data and the performance of additional
analyses with respect to the mOM clinical trial, our determination
whether to continue the ICC clinical trial program or to focus on
other alternative indications, and timely monitoring and treatment
of patients in the global Phase 3 mOM clinical trial and the impact
of the COVID-19 pandemic on the completion of our clinical trials;
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 HEPZATO KIT/CHEMOSAT
system and the potential of the HEPZATO KIT/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 HEPZATO
KIT/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
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:
Delcath Investor Relations
Email: investorrelations@delcath.com
Hayden IR
James
Carbonara(646)-755-7412james@haydenir.com
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