NEW
YORK, Nov. 13, 2023 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an
interventional oncology company focused on the treatment of primary
and metastatic cancers of the liver, today reported business
highlights and financial results for the third quarter ended
September 30, 2023.
Recent Business Highlights
- Received approval from the US Food and Drug Administration
(FDA) for HEPZATO KIT™ (melphalan)/Hepatic Delivery System) as a
liver-directed treatment for adult patients with metastatic uveal
melanoma (mUM) with unresectable hepatic metastases affecting less
than 50% of the liver and no extrahepatic disease, or extrahepatic
disease limited to the bone, lymph nodes, subcutaneous tissues, or
lung that is amenable to resection or radiation;
- Raised approximately $35 million
through the exercise of all the Tranche A warrants issued as part
the previously announced March 29,
2023, financing with up to an additional $25 million available upon the achievement of
$10 million in quarterly
revenue;
- Announced publication by independent investigators of a
retrospective comparative study of CHEMOSAT® Hepatic
Delivery System for Melphalan percutaneous hepatic perfusion (PHP)
and Selective Internal Radiation Therapy (SIRT) citing a
statistically significant difference in median overall survival
with 301 days for SIRT and 516 days for PHP;
- Announced that independent investigators at Leiden University
recruited 55 of 76 planned patients in the CHOPIN trial studying
the impact of CHEMOSAT and immune checkpoint inhibitor combination
therapy in the treatment of metastatic uveal melanoma and expect
the trial to be fully enrolled mid-2024. An interim futility
analysis conducted in September resulted in the independent data
monitoring committee recommending continuing the study without
modification; and
- Partnered with seven clinical treatment sites to satisfy the
initial training requirements to be able to treat their first
commercial patient, subject to proctor availability and the sites'
value analysis committee approvals, upon the planned launch in
January.
"The Company has been preparing for a January launch of HEPZATO
KIT by building our commercial team and engaging with potential
treating centers," said Gerard
Michel, Chief Executive Officer of Delcath. Mr. Michel
added, "We have been encouraged by the reception that HEPZATO KIT
has received from the medical oncologist community and are
confident that by the end of 2024 at least 15 centers will be
actively treating metastatic uveal melanoma patients with
HEPZATO KIT."
Third Quarter 2023 Results
Total revenue for the three months ended September 30, 2023, was approximately
$0.4 million, compared to
$0.9 million for the prior year
period, from our sales of CHEMOSAT in Europe.
Research and development expenses for the quarter were
$4.7 million, compared to
$4.1 million in the prior year
quarter. The increase in R&D expense is primarily due to
completing clinical trial activities and expenses related to the
FDA inspection and other requests in advance of the approval
received for HEPZATO.
Selling, general and administrative expenses for the quarter
increased to $6.2 million, compared
to $4.8 million in the prior year
quarter primarily relating to activities to prepare for a
commercial launch. The increase in fair value warrant liability
adjustment during the quarter ended September 20, 20223 was a result of our final
valuation for the Tranche A warrants exercised and outstanding
Tranche B warrants.
About Delcath Systems, Inc., CHEMOSAT and HEPZATO
KIT
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 (Hepzato
(melphalan) 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 a combination drug and device product and is
regulated and approved for sale as a drug by the 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. HEPZATO KIT is approved in the United States as a liver-directed
treatment for adult patients with metastatic uveal melanoma (mUM)
with unresectable hepatic metastases affecting less than 50% of the
liver and no extrahepatic disease, or extrahepatic disease limited
to the bone, lymph nodes, subcutaneous tissues, or lung that is
amenable to resection or radiation. Please see the full Prescribing
Information, including BOXED WARNING for the HEPZATO KIT.
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 Company's ability to commercialize
HEPZATO, necessary 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 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 related to the continued supply of
melphalan, necessary materials and other critical components for
the HEPZATO KIT/CHEMOSAT; uncertainties relating to manufacturing
delays or difficulties; the Company's ability to mitigate risks
from single-source suppliers; 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
shamsian@lythampartners.com
DELCATH SYSTEMS,
INC.
Condensed
Consolidated Balance Sheets
(Unaudited)
(in thousands,
except share and per share data)
|
|
|
September
30,
2023
|
|
December 31,
2022
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
40,462
|
|
$
7,671
|
Restricted
cash
|
50
|
|
4,151
|
Accounts receivable,
net
|
205
|
|
366
|
Inventory
|
2,667
|
|
1,998
|
Prepaid expenses and
other current assets
|
2,712
|
|
1,969
|
Total current
assets
|
46,096
|
|
16,155
|
Property, plant and
equipment, net
|
1,374
|
|
1,422
|
Right-of-use
assets
|
107
|
|
285
|
Total
assets
|
$
47,577
|
|
$
17,862
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities
|
|
|
|
Accounts
payable
|
$
753
|
|
$
2,018
|
Accrued
expenses
|
5,230
|
|
4,685
|
Lease liabilities,
current
|
35
|
|
186
|
Loan payable,
current
|
5,080
|
|
7,846
|
Convertible notes
payable, current
|
2,876
|
|
—
|
Total current
liabilities
|
13,974
|
|
14,735
|
Warrant
liability
|
5,773
|
|
—
|
Other liabilities,
non-current
|
1,111
|
|
1,144
|
Loan payable,
non-current
|
—
|
|
3,070
|
Convertible notes
payable, non-current
|
2,000
|
|
4,772
|
Total
liabilities
|
22,858
|
|
23,721
|
Commitments and
contingencies
|
|
|
|
Stockholders' equity
(deficit)
|
|
|
|
Preferred stock, $0.01
par value; 10,000,000 shares authorized; 37,787 and
11,357
shares issued
and outstanding at September 30, 2023 and December 31, 2022,
respectively
|
—
|
|
—
|
Common stock, $.01 par
value; 80,000,000 shares authorized; 19,688,991 shares
and
10,046,571
shares issued and outstanding at September 30, 2023 and December
31, 2022,
respectively
|
197
|
|
100
|
Additional paid-in
capital
|
518,607
|
|
451,608
|
Accumulated
deficit
|
(494,026)
|
|
(457,484)
|
Accumulated other
comprehensive loss
|
(59)
|
|
(83)
|
Total stockholders'
equity (deficit)
|
24,719
|
|
(5,859)
|
Total liabilities and
stockholders' equity
|
$
47,577
|
|
$
17,862
|
DELCATH SYSTEMS,
INC.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(Unaudited)
(in thousands,
except share and per share data)
|
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Product
revenue
|
$
434
|
|
$
906
|
|
$
1,526
|
|
$
1,909
|
Other
revenue
|
—
|
|
—
|
|
—
|
|
171
|
Total
revenues
|
434
|
|
906
|
|
1,526
|
|
2,080
|
Cost of goods
sold
|
(133)
|
|
(235)
|
|
(464)
|
|
(449)
|
Gross
profit
|
301
|
|
671
|
|
1,062
|
|
1,631
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development expenses
|
4,662
|
|
4,065
|
|
12,793
|
|
14,152
|
Selling, general and
administrative expenses
|
6,195
|
|
4,779
|
|
15,147
|
|
13,477
|
Total operating
expenses
|
10,857
|
|
8,844
|
|
27,940
|
|
27,629
|
Operating
loss
|
(10,556)
|
|
(8,173)
|
|
(26,878)
|
|
(25,998)
|
Change in fair value of
warrant liability
|
(9,384)
|
|
—
|
|
(8,224)
|
|
—
|
Interest expense,
net
|
(395)
|
|
(730)
|
|
(1,454)
|
|
(2,040)
|
Other income
(expense)
|
(5)
|
|
26
|
|
14
|
|
2
|
Net loss
|
(20,340)
|
|
(8,877)
|
|
(36,542)
|
|
(28,036)
|
Other comprehensive
income:
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
5
|
|
(46)
|
|
24
|
|
(82)
|
Total other
comprehensive loss
|
$
(20,335)
|
|
$
(8,923)
|
|
$
(36,518)
|
|
$
(28,118)
|
Common share
data:
|
|
|
|
|
|
|
|
Basic and diluted loss
per common share
|
$
(1.14)
|
|
$
(0.96)
|
|
$
(2.61)
|
|
$
(3.29)
|
Weighted average
number of basic and diluted shares outstanding
|
17,863,078
|
|
9,215,786
|
|
13,985,248
|
|
8,536,006
|
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SOURCE Delcath Systems, Inc.