Conference Call Today at 8:30 am Eastern Time
QUEENSBURY, N.Y., May 14, 2024
/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 financial results and business highlights for the first
quarter ended March 31, 2024.
Recent Business Highlights
During and since the
first quarter, Delcath:
- Recognized over $2.0 million of
revenue from sales of HEPZATO KIT (melphalan/Hepatic Delivery
System) and $1.1 million in CHEMOSAT
sales through March 31, 2024;
- Updated U.S. center activation guidance from 15 active centers
to a total of 20 active centers by the end of 2024;
- Activated four treating centers during the first quarter with
an additional two centers in April. A further five centers are
accepting patient referrals in anticipation of activation;
- Raised $7.0 million in a private
placement transaction with certain accredited investors comprised
of existing investors, Delcath senior executives, and members of
its Board of Directors;
- Appointed Martha S. Rook, Ph.D,
an experienced industry leader with more than 25 years of academic
and industry experience, as Chief Operating Officer;
- Received a permanent, product-specific J-code (J9248) and
transitional pass-through payment status for HEPZATO KIT from the
Centers for Medicare & Medicaid Services (CMS) which became
effective on April 1, 2024;
- Executed an amendment with Synerx Pharma, LLC and Mylan
Teoranta for Delcath's supply of melphalan hydrochloride which
extends the term of the original agreement to December 31, 2028; and
- Announced the publication of results from the pivotal Phase 3
FOCUS study of HEPZATO KIT in patients with unresectable metastatic
Uveal Melanoma on May 4, 2024, in the
journal Annals of Surgical Oncology.
"We continue to make steady progress in the training and
activation of new treatment centers which is a testament to both
the emerging role of HEPZATO in the treatment of patients with
metastatic uveal melanoma and the capability and dedication of our
field force," said Gerard Michel,
Delcath's Chief Executive Officer. "We are committed to expanding
the availability of HEPZATO to patients in need and I am confident
that we will reach our goal of 20 treating centers by the end of
2024."
First Quarter 2024 Results
Cash, cash equivalents and
investment totaled $27.2 million as
of March 31, 2024, which includes a
$7.0 million private placement
financing which closed on March 19,
2024.
Total revenue for the quarter ended March
31, 2024 was $3.1 million
compared to $0.6 million for the same
period in the prior year from our sales of HEPZATO in the U.S. and
CHEMOSAT in Europe.
Research and development expenses for the quarter ended
March 31, 2024, were $3.7 million compared to $4.6 million for the same period in the prior
year. The change in research and development expenses is primarily
due to a decrease in clinical trial activities and expenses related
to the FDA inspection offset by an increase in personnel related
expenses.
Selling, general and administrative expenses for the quarter
ended March 31, 2024, were
$8.8 million compared to $4.2 million for the same period in the prior
year. The increase primarily relates to commercial launch
activities including marketing-related expenses and additional
personnel in the commercial team.
Conference Call Information
To participate in this
event, dial in approximately 5 to 10 minutes before the beginning
of the call.
Event
Date:
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Tuesday, May 14,
2024
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Time:
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8:30 AM Eastern
Time
|
|
|
Participant
Numbers
|
Toll Free:
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1-833-630-1960
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International:
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1-412-317-1841
|
Webcast:
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https://app.webinar.net/PKDyZ5PV2aB
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|
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Conference
Replay
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US Toll
Free:
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1-877-344-7529
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International
Toll:
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1-412-317-0088
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Replay Access
Code:
|
9490444
|
End Date:
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May 21,
2024
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About Delcath Systems, Inc., HEPZATO KIT and
CHEMOSAT
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 press release contains forward-looking statements,
which are subject to certain risks and uncertainties, that can
cause actual results to differ materially from those described. The
words "anticipate," "believe," "continue," "could," "estimate,"
"expect," "intend," "may," "plan," "potential," "predict,"
"project," "should," "target," "will," "would" and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Factors that may cause such differences include,
but are not limited to, uncertainties relating to: the Company's
commercialization plans and its ability to successfully
commercialize the HEPZATO KIT; the Company's successful management
of the HEPZATO KIT supply chain, including securing adequate supply
of critical components necessary to manufacture and assemble the
HEPZATO KIT; successful FDA inspections of the facilities of the
Company and those of its third-party suppliers/manufacturers; the
Company's successful implementation and management of the HEPZATO
KIT Risk Evaluation and Mitigation Strategy; the potential benefits
of the HEPZATO KIT as a treatment for patients with primary and
metastatic disease in the liver; the Company's ability to obtain
reimbursement for the HEPZATO KIT; and the Company's ability to
successfully enter into any necessary purchase and sale agreements
with users of the HEPZATO KIT. For additional information about
these factors, and others that may impact the Company, please see
the Company's filings with the Securities and Exchange Commission,
including those on Forms 10-K, 10-Q, and 8-K. However, new risk
factors and uncertainties may emerge from time to time, and it is
not possible to predict all risk factors and uncertainties.
Accordingly, 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:
Westwicke Partners
investorrelations@delcath.com
DELCATH SYSTEMS, INC.
|
Condensed Consolidated Balance
Sheets
|
(Unaudited)
|
(in thousands, except
share and per share data)
|
|
|
March 31,
2024
|
|
December 31,
2023
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
11,760
|
|
$
12,646
|
Restricted
cash
|
50
|
|
50
|
Short-term
investments
|
15,360
|
|
19,808
|
Accounts receivable,
net
|
1,564
|
|
241
|
Inventory
|
3,634
|
|
3,322
|
Prepaid expenses and
other current assets
|
1,278
|
|
1,091
|
Total current
assets
|
33,646
|
|
37,158
|
Property, plant and
equipment, net
|
1,336
|
|
1,352
|
Right-of-use
assets
|
1,117
|
|
103
|
Total
assets
|
$
36,099
|
|
$
38,613
|
Liabilities and Stockholders'
Equity
|
|
|
|
Current
liabilities
|
|
|
|
Accounts
payable
|
$
1,487
|
|
$
1,012
|
Accrued
expenses
|
4,395
|
|
5,249
|
Lease liabilities,
current
|
102
|
|
37
|
Loan
payable
|
2,408
|
|
5,239
|
Convertible notes
payable
|
4,949
|
|
4,911
|
Total current
liabilities
|
13,341
|
|
16,448
|
Warrant
liability
|
6,160
|
|
5,548
|
Lease Liabilities,
non-current
|
1,016
|
|
—
|
Other liabilities,
non-current
|
962
|
|
840
|
Total
liabilities
|
21,479
|
|
22,836
|
Commitments and
contingencies
|
|
|
|
Stockholders'
equity
|
|
|
|
Preferred stock, $0.01
par value; 10,000,000 shares authorized; 16,809 and 24,819
shares issued and outstanding at March 31, 2024 and
December 31, 2023,
respectively
|
—
|
|
—
|
Common stock, $0.01
par value; 80,000,000 shares authorized; 25,439,319 shares and
22,761,554 shares issued and outstanding at March 31, 2024 and
December 31,
2023, respectively
|
254
|
|
228
|
Additional paid-in
capital
|
530,482
|
|
520,576
|
Accumulated
deficit
|
(516,273)
|
|
(505,162)
|
Accumulated other
comprehensive loss
|
157
|
|
135
|
Total stockholders'
equity
|
14,620
|
|
15,777
|
Total liabilities and
stockholders' equity
|
$
36,099
|
|
$
38,613
|
DELCATH SYSTEMS, INC.
|
Condensed Consolidated Statements of Operations and
Comprehensive Loss
|
(Unaudited)
|
(in thousands, except share and per share
data)
|
|
|
Three months ended March 31,
|
|
2024
|
|
2023
|
Product
revenue
|
$
3,139
|
|
$
597
|
Other
revenue
|
—
|
|
—
|
Total
revenues
|
3,139
|
|
597
|
Cost of goods
sold
|
(903)
|
|
(181)
|
Gross
profit
|
2,236
|
|
416
|
Operating
expenses:
|
|
|
|
Research and
development expenses
|
3,700
|
|
4,576
|
Selling, general and
administrative expenses
|
8,814
|
|
4,165
|
Total operating
expenses
|
12,514
|
|
8,741
|
Operating
loss
|
(10,278)
|
|
(8,325)
|
Change in fair value of
warrant liability
|
(612)
|
|
—
|
Interest expense,
net
|
(199)
|
|
(688)
|
Other (expense)
income
|
(22)
|
|
13
|
Net loss
|
(11,111)
|
|
(9,000)
|
Other comprehensive
(loss) income:
|
|
|
|
Unrealized gain on
investments
|
8
|
|
—
|
Foreign currency
translation adjustments
|
14
|
|
19
|
Total comprehensive
loss
|
$
(11,089)
|
|
$
(8,981)
|
Common share
data:
|
|
|
|
Basic and diluted loss
per common share
|
$
(0.45)
|
|
$
(0.77)
|
Weighted average
number of basic and diluted shares outstanding
|
24,887,180
|
|
11,622,384
|
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SOURCE Delcath Systems, Inc.