Led by Vivo Capital with participation from Logos Capital,
BVF Partners LP, Stonepine Capital Management, LLC, Serrado Capital
LLC and supported by existing investor, Rosalind Advisors
$25 million financing upfront
with up to an additional $60 million
tied to satisfaction of milestones
Aggregate financing expected to be sufficient to fund Company
through potential approval of HEPZATO and commercialization
NEW
YORK, March 27, 2023 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an
interventional oncology company focused on the treatment of primary
and metastatic cancers of the liver, today announced that the
Company has signed securities purchase agreements with certain
healthcare-focused institutional investors that will provide up to
$85 million in gross proceeds to
Delcath through a private placement that includes initial upfront
funding of $25 million.
The financing is being led by Vivo Capital with participation
from Logos Capital, BVF Partners LP, Stonepine Capital Management,
LLC, Serrado Capital LLC and supported by existing investor,
Rosalind Advisors.
This financing is expected to enable the Company to have
sufficient cash past its anticipated PDUFA date of August 14, 2023, and fund the commercialization
of HEPZATO, if approved.
About the Private
Placement
Pursuant to the securities purchase agreements, the Company will
issue to purchasers (i) an aggregate $24.9
million in shares of the Company's Series F Convertible
Preferred Stock and (ii) two tranches of warrants that are
exercisable for shares of the Company's Series F Convertible
Preferred Stock as follows:
- Tranche A warrants for an aggregate exercise price of
approximately $34.9 million are
exercisable until the earlier of 3/31/2026 or 21 days following the Company's
announcement of receipt of FDA approval for HEPZATO; and
- Tranche B warrants for an aggregate exercise price of
approximately $24.9 million are
exercisable until the earlier of 3/31/2026 or 21 days following disclosure of the
Company's public announcement of recording at least $10 million in quarterly U.S. revenue from the
commercialization of HEPZATO.
Shares of Series F Convertible Preferred Stock will be issued at
a price of $1,000.00 per share.
Conversion of the Series F Convertible Preferred Stock into shares
of common stock of the Company, and the exercisability of the
warrants, is subject to approval by the Company's stockholders.
Pursuant to a separate securities purchase agreement, the Company
will issue to a certain purchaser (i) an aggregate of $0.1 million in shares of the Company's common
stock and (ii) the Tranche A and Tranche B warrants to purchase
shares of common stock. All of the securities in this private
placement are being offered by Delcath.
Canaccord Genuity acted as the placement agent for the private
placement.
The securities to be issued in connection with the private
placement described above are being offered in a private placement
under Section 4(a)(2) of the Securities Act of 1933, as amended,
and Regulation D promulgated thereunder and have not been
registered under the Act or applicable state securities laws.
Accordingly, such securities may not be offered or sold in
the United States except pursuant
to an effective registration statement or an applicable exemption
from the registration requirements of the Act and such applicable
state securities laws. The Company has agreed to file a resale
registration statement with the U.S. Securities and Exchange
Commission (SEC), for purposes of registering the resale of the
common stock issued or issuable in connection with the private
placement.
This press release shall not constitute an offer to sell or a
solicitation of an offer to buy any of the securities described
herein, nor shall there be any sale of these securities in any
state or other jurisdiction in which such offer, solicitation or
sale would be unlawful prior to the registration or qualification
under the securities laws of any such state or other
jurisdiction.
For further information, please see the Company's current report
on Form 8-K to be filed with the SEC.
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.
Contact:
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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SOURCE Delcath Systems, Inc.