NEW
YORK, Aug. 9, 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 second quarter ended
June 30, 2023.
Recent Business Highlights
During and since the second quarter, Delcath:
- Has continued to communicate with the United States Food and
Drug Administration (FDA) as the agency continues its review of the
HEPZATO KIT™ New Drug Application (NDA) resubmission with an
anticipated PDUFA date of August 14,
2023;
- Received stockholders approval for the potential issuance in
excess of 19.99% of Delcath's outstanding common stock upon the
conversion of the preferred stock issued pursuant to a private
placement that closed on March 29,
2023 and generated $25 million
on closing with up to an additional $35
million expected upon the exercise of warrants into
additional series of preferred stock upon the approval of the
HEPZATO KIT NDA and up to an additional $25
million upon the achievement of $10
million in quarterly revenue;
- Hired Vojislav Vukovic, MD, PhD
as Chief Medical Officer; Sandra
Pennell as Senior Vice President of Finance; and
Zac MacLean as Director of Sales and
Strategy; and
- Continued to treat patients at 3 Expanded Access Program
sites.
"As we approach the August 14 PDUFA date, the Company has
been preparing for the commercialization of HEPZATO KIT, if
approved," said Gerard Michel, Chief
Executive Officer of Delcath. Mr. Michel added, "As part of this
preparation, we continue to add experienced personnel across the
key functional areas involved in commercialization."
Delcath will schedule an update call shortly after the FDA's
action on the HEPZATO KIT NDA resubmission, which the Company
expects to occur on or around the anticipated PDUFA date of
August 14, 2023.
Second Quarter 2023 Results
Financial Highlights.
Total revenue for the three months ended June 30, 2023, was approximately $0.5 million, compared to $0.8 million for the prior year period, from our
sales of CHEMOSAT in Europe. This
decrease in product revenue is primarily due to potential
commercial patients in the
Netherlands being treated in the CHOPIN trial and reduced
demand in Germany, possibly due to
tebentefusp usage.
Research and development expenses for the quarter were
$3.6 million, compared to
$5.6 million in the prior year
quarter. The decrease in R&D expense is primarily due to
completing clinical trial activities. The prior year quarter
included expenses for the preparation of the pre-NDA meeting with
the FDA. Selling, general and administrative expenses for the
quarter increased to $4.8 million,
compared to $4.5 million in the prior
year quarter primarily relating to activities to prepare for a
commercial launch if the HEPZATO KIT is approved.
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 (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 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.
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, or any
delays, of the potential approval of HEPZATO by the FDA by the
PDUFA date of August 14, 2023, 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
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 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, including in
connection with current good manufacturing practices compliance,
that may delay the potential approval of HEPZATO by the FDA by the
PDUFA date of August 14, 2023; 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)
|
|
|
June 30,
2023
|
|
December 31,
2022
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
14,540
|
|
$
7,671
|
Restricted
cash
|
50
|
|
4,151
|
Accounts receivable,
net
|
127
|
|
366
|
Inventory
|
2,480
|
|
1,998
|
Prepaid expenses and
other current assets
|
2,275
|
|
1,969
|
Total current
assets
|
19,472
|
|
16,155
|
Property, plant and
equipment, net
|
1,403
|
|
1,422
|
Right-of-use
assets
|
175
|
|
285
|
Total
assets
|
$
21,050
|
|
$
17,862
|
Liabilities and
Stockholders' Equity
|
|
|
|
Current
liabilities
|
|
|
|
Accounts
payable
|
$
966
|
|
$
2,018
|
Accrued
expenses
|
5,546
|
|
4,685
|
Lease liabilities,
current
|
92
|
|
186
|
Loan payable,
current
|
4,510
|
|
7,846
|
Total current
liabilities
|
11,114
|
|
14,735
|
Warrant
liability
|
3,780
|
|
—
|
Other liabilities,
non-current
|
1,146
|
|
1,144
|
Loan payable,
non-current
|
411
|
|
3,070
|
Convertible notes
payable, non-current
|
4,841
|
|
4,772
|
Total
liabilities
|
21,292
|
|
23,721
|
Commitments and
contingencies
|
|
|
|
Stockholders' equity
(deficit)
|
|
|
|
Preferred stock, $0.01
par value; 10,000,000 shares authorized; 20,981 and 11,357
shares issued and outstanding at June 30, 2023 and
December 31, 2022,
respectively
|
—
|
|
—
|
Common stock, $.01 par
value; 80,000,000 shares authorized; 15,250,469 shares and
10,046,571 shares issued and outstanding at June 30, 2023 and
December 31, 2022,
respectively
|
153
|
|
100
|
Additional paid-in
capital
|
473,355
|
|
451,608
|
Accumulated
deficit
|
(473,686)
|
|
(457,484)
|
Accumulated other
comprehensive loss
|
(64)
|
|
(83)
|
Total stockholders'
equity (deficit)
|
(242)
|
|
(5,859)
|
Total liabilities and
stockholders' equity
|
$
21,050
|
|
$
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
June 30,
|
|
Six months ended
June 30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Product
revenue
|
$
495
|
|
$
797
|
|
$
1,092
|
|
$
1,003
|
Other
revenue
|
—
|
|
—
|
|
—
|
|
171
|
Total
revenues
|
495
|
|
797
|
|
1,092
|
|
1,174
|
Cost of goods
sold
|
(150)
|
|
(180)
|
|
(331)
|
|
(214)
|
Gross
profit
|
345
|
|
617
|
|
761
|
|
960
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development expenses
|
3,555
|
|
5,606
|
|
8,131
|
|
10,087
|
Selling, general and
administrative expenses
|
4,787
|
|
4,497
|
|
8,952
|
|
8,699
|
Total operating
expenses
|
8,342
|
|
10,103
|
|
17,083
|
|
18,786
|
Operating
loss
|
(7,997)
|
|
(9,486)
|
|
(16,322)
|
|
(17,826)
|
Change in fair value of
warrant liability
|
1,160
|
|
—
|
|
1,160
|
|
—
|
Interest expense,
net
|
(371)
|
|
(665)
|
|
(1,059)
|
|
(1,309)
|
Other income
(expense)
|
6
|
|
(8)
|
|
19
|
|
(24)
|
Net loss
|
(7,202)
|
|
(10,159)
|
|
(16,202)
|
|
(19,159)
|
Other comprehensive
income:
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
—
|
|
(31)
|
|
19
|
|
(29)
|
Total other
comprehensive loss
|
$
(7,202)
|
|
$
(10,190)
|
|
$
(16,183)
|
|
$
(19,188)
|
Common share
data:
|
|
|
|
|
|
|
|
Basic and diluted loss
per common share
|
$
(0.58)
|
|
$
(1.24)
|
|
$
(1.35)
|
|
$
(2.34)
|
Weighted average
number of basic and
diluted shares outstanding
|
12,463,665
|
|
8,190,483
|
|
12,035,738
|
|
8,190,483
|
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SOURCE Delcath Systems, Inc.