Amendment with Avenue Venture Opportunities Fund, L.P.
provides for an interest-only period from March 31, 2023 to September 30, 2023 and defers $4.3 million in principal payments
NEW
YORK, April 3, 2023 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), an interventional oncology company
focused on the treatment of primary and metastatic cancers of the
liver, today announced it reached an agreement to amend its
existing loan agreement with Avenue Venture Opportunities Fund,
L.P. ("Avenue").
Avenue agreed to provide an interest-only ("I/O") period from
March 31, 2023 to September 30, 2023. The I/O period defers
approximately $4.3 million in
principal payments to beyond September 30,
2023. The I/O period may be extended at Delcath's option to
December 31, 2023 if, by September 30, 2023, Delcath has (a) received FDA
approval for the HEPZATO Kit and (b) received net proceeds of at
least $10 million from the sale and
issuance of equity securities or exercise of existing warrants. In
exchange for this extension, Delcath has agreed to provide Avenue
34,025 warrants to purchase shares of common stock. The
exercise price of the warrants is $0.01.
"We appreciate the ongoing support of Avenue in resuming the
interest-only period to help us preserve near-term cash," said
Gerard Michel, Chief Executive
Officer of Delcath. "This amendment in combination with the recent
equity financing, extends our cash runway well beyond our
August 14th PDUFA date for HEPZATO
Kit."
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 products, HEPZATO Kit (melphalan
hydrochloride for Injection/Hepatic Delivery System) and
CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous
hepatic perfusion (PHP) are designed to administer high-dose
chemotherapy to the liver while controlling systemic exposure and
associated side effects during a PHP procedure.
In the United States,
HEPZATO Kit is considered an investigational drug/device
combination product regulated as a drug by the United States
Food and Drug Administration (FDA). HEPZATO Kit is comprised
of the chemotherapeutic drug melphalan and Delcath's proprietary
Hepatic Delivery System (HDS). The HDS is used to surgically
isolate the liver while simultaneously filtrating hepatic venous
blood during melphalan infusion and washout. The use of the HDS
results in loco-regional delivery of a relatively high melphalan
dose, which can potentially induce a clinically meaningful tumor
response with minimal hepatotoxicity and reduce systemic exposure.
In the US, HEPZATO Kit was the subject of a February 14,
2023 new drug application resubmission to FDA for the
treatment of patients with unresectable hepatic-dominant metastatic
ocular melanoma (mOM), also known as metastatic uveal melanoma
(mUM). FDA has established an August 14,
2023 PDUFA date for the resubmission. In Europe, the device-only configuration of the
HDS is regulated as a Class III medical device and is approved for
sale under the trade name CHEMOSAT Hepatic Delivery System for
Melphalan, or CHEMOSAT, where it has been used in the conduct of
percutaneous hepatic perfusion procedures at major medical centers
to treat a wide range of cancers of the liver.
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 in particular, the statements regarding our private
placement and expected gross proceeds and the expected uses of the
proceeds from the private placement. Factors that may cause such
differences include, but are not limited to, uncertainties relating
to: anticipated use of proceeds from the private placement,
achievement of milestones, the likelihood and timing of the
potential approval of HEPZATO by the FDA by the PDUFA date of
August 14, 2023, the Company's
ability to commercialize HEPZATO, the receipt of stockholder
approval to allow for the conversion of the Series F Preferred
Stock into shares of the Company's common stock and the
exercisability of the warrants; the sufficiency of the aggregate
proceeds from the financing to fund commercialization of HEPZATO in
the U.S., the Company's ability to generate revenue from HEPZATO,
clinical adoption, use and resulting sales, if any, for the
CHEMOSAT system to deliver and filter melphalan in; 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; 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; 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 SEC. 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.
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
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SOURCE Delcath Systems, Inc.