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 29, 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 announces that it has
closed its previously announced private placement (the "Private
Placement"), for gross proceeds of approximately $25.0 million from the issuance and sale of
shares of the Company's common stock and shares of its Series F
Convertible Preferred Stock and warrants, before deducting the fees
paid to the placement agent and the financial advisors of the
Private Placement and other financing expenses payable by the
Company.
The Company intends to use the net proceeds from the Private
Placement for working capital purposes and other general corporate
purposes.
The Private Placement was 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.
The Private Placement 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 a securities purchase agreement, the Company has
issued to purchasers an aggregate $24.9
million in shares, consisting of 24,900 shares of the
Company's Series F-1 Convertible Preferred Stock, par value
$0.01 per share, that are convertible
into approximately 7.6 million shares of common stock at a
conversion price of $3.30 per share,
and two tranches of warrants that are exercisable as follows:
- Tranche A warrants for an aggregate exercise price of
approximately $34.9 million are
exercisable for an aggregate of up to 34,860 shares of Series F-3
Convertible Preferred Stock, par value $0.01 per share, at an exercise price of
$1,000 per share (and convertible
into an aggregate of up to approximately 7.8 million shares of
common stock at a conversion price of $4.50 per share) 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
$24.9 million are exercisable for an
aggregate of up to 24,900 shares of Series F-4 Convertible
Preferred Stock, par value $0.01 per
share, at an exercise price of $1,000
per share, (and convertible into an aggregate of up to
approximately 4.2 million shares of common stock at a conversion
price of $6.00 per share) 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.
The shares of Series F-1 Convertible Preferred Stock, and
accompanying warrants, were issued at a price of $1,000.00 per share. Conversion of the Series F-1
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 has issued to the Company's Chief Executive Officer 19,646
shares of the Company's common stock and Tranche A and Tranche B
warrants to purchase shares of common stock for an aggregate of
$0.1 million, exercisable into an
aggregate of up to approximately 48,000 shares of common stock
across both tranches.
All of the securities in this Private Placement were offered by
the Company.
Canaccord Genuity acted as the placement agent for the Private
Placement. BTIG and Roth Capital Partners acted as financial
advisors.
The securities sold and issued in connection with the Private
Placement described above were offered in a private placement under
Section 4(a)(2) of the Securities Act of 1933, as amended (the
"Act"), 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 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.