Increases 2024 Treatment Site Activation
Guidance to 20 Sites
QUEENSBURY, N.Y., March 26,
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 recent business highlights and
financial results for the fourth quarter and full year ended
December 31, 2023.
Recent Business Highlights
During and since the
fourth quarter, Delcath:
- Announced the first commercial use of HEPZATO KIT™ for the
treatment of metastatic uveal melanoma (mUM) at Moffitt Cancer
Center;
- Activated three treating sites which are fully trained to treat
commercial patients with a fourth expected to be active before the
end of the first quarter and an additional three sites expected to
become active in the first few weeks of the second quarter of
2024;
- Updated site activation guidance from 15 active sites to a
total of 20 active sites by the end of 2024;
- Received notification that a permanent, product-specific J-code
(J9248) and transitional pass-through payment status for HEPZATO,
was established by the Centers for Medicare & Medicaid Services
(CMS) and will become effective on April 1,
2024;
- Finalized its patient access program and launched websites
relating to the HEPZATO KIT, including HEPZATOKIT.com,
HEPZATOKITREMS.com, and HEPZATOKITACCESS.com, to support the
commercial launch;
- 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
as Chief Operating Officer on March 18,
2024. Ms. Rook is an experienced industry leader who brings
more than 25 years of academic and industry experience in molecular
biology, diagnostics development, biologics process development and
combination products manufacturing; and
- 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; and
- A clinical study entitled "Quality of Life After Melphalan
Hepatic Perfusion for Uveal Melanoma" in which the authors
concluded utilizing Delcath's CHEMOSAT to administer high-dose
melphalan to the liver is well tolerated by patients and does not
negatively affect their quality of life.
"We have made tremendous progress since the January launch of
HEPZATO KIT in the US," said Gerard
Michel, Delcath's Chief Executive Officer. "We have
successfully secured a product specific J-Code and, with over 90
preceptorships completed by healthcare professionals across
approximately 20 institutions in the US, are on track to train and
activate 20 sites by year end. Furthermore, we have strengthened
our balance sheet with additional investment from senior management
and existing investors. I am proud of the team's success in
providing access to a new treatment for patients suffering from
metastatic uveal melanoma."
Fourth Quarter and Full Year 2023 Results
Cash, cash
equivalents and investment totaled $32.5
million as of December 31,
2023. Subsequent to year-end, on March 19, 2024, the company closed a $7.0 million private placement
financing.
Total revenue for the quarter and year-ended December 31, 2023, was approximately $0.5 million and $2.1
million, respectively, compared to $0.6 million and $2.7
million for the same periods in the prior year,
respectively, from our sales of CHEMOSAT in Europe.
Research and development expenses for the quarter and year-ended
December 31, 2023, were $4.7 million and $17.5
million, respectively, compared to $4.4 and $18.6
million, respectively, for the same periods 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 and
year-ended December 31, 2023,
increased to $7.0 million and
$22.1 million, respectively, compared
to $3.8 million and $17.3 million, respectively for the same periods
in the prior year. The increase primarily relates to activities to
prepare for a commercial launch including marketing-related
expenses and additional personnel in the commercial team.
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:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
DELCATH SYSTEMS,
INC.
Consolidated Balance
Sheets
(Unaudited)
(in thousands,
except share and per share data)
|
|
|
December 31,
2023
|
|
December 31,
2022
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
12,646
|
|
$
7,671
|
Restricted
cash
|
50
|
|
4,151
|
Short-term
investments
|
19,808
|
|
—
|
Accounts receivable,
net
|
241
|
|
366
|
Inventories
|
3,322
|
|
1,998
|
Prepaid expenses and
other current assets
|
1,091
|
|
1,969
|
Total current
assets
|
37,158
|
|
16,155
|
Property, plant and
equipment, net
|
1,352
|
|
1,422
|
Right-of-use
assets
|
103
|
|
285
|
Total
assets
|
$
38,613
|
|
$
17,862
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
Current
liabilities
|
|
|
|
Accounts
payable
|
$
1,012
|
|
$
2,018
|
Accrued
expenses
|
5,249
|
|
4,685
|
Lease liabilities,
current
|
37
|
|
186
|
Loan payable,
current
|
5,239
|
|
7,846
|
Convertible notes
payable, current
|
4,911
|
|
—
|
Total current
liabilities
|
16,448
|
|
14,735
|
Warrant
Liability
|
5,548
|
|
—
|
Other liabilities,
non-current
|
840
|
|
1,144
|
Loan payable,
non-current
|
—
|
|
3,070
|
Convertible notes
payable, non-current
|
—
|
|
4,772
|
Total
liabilities
|
22,836
|
|
23,721
|
Commitments and
contingencies
|
|
|
|
Stockholders' equity
(deficit)
|
|
|
|
Preferred stock, $.01
par value; 10,000,000 shares authorized; 24,819 and 11,357 shares
issued and outstanding at December 31, 2023 and 2022,
respectively
|
—
|
|
—
|
Common stock, $.01 par
value; 80,000,000 shares authorized; 22,761,554 shares and
10,046,571 shares issued and outstanding at December 31, 2023 and
2022, respectively
|
228
|
|
100
|
Additional paid-in
capital
|
520,576
|
|
451,608
|
Accumulated
deficit
|
(505,162)
|
|
(457,484)
|
Accumulated other
comprehensive income (loss)
|
135
|
|
(83)
|
Total stockholders'
equity (deficit)
|
15,777
|
|
(5,859)
|
Total liabilities and
stockholders' equity
|
$
38,613
|
|
$
17,862
|
DELCATH SYSTEMS,
INC.
Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands,
except share and per share data)
|
|
|
Three months
ended December 31,
|
|
Year
ended December 31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Product
revenue
|
$
539
|
|
$
639
|
|
$
2,065
|
|
$
2,548
|
Other
revenue
|
—
|
|
—
|
|
—
|
|
171
|
Total
revenues
|
539
|
|
639
|
|
2,065
|
|
2,719
|
Cost of goods
sold
|
(171)
|
|
(237)
|
|
(635)
|
|
(686)
|
Gross
profit
|
368
|
|
402
|
|
1,430
|
|
2,033
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development expenses
|
4,709
|
|
4,431
|
|
17,502
|
|
18,583
|
Selling, general and
administrative expenses
|
6,963
|
|
3,826
|
|
22,110
|
|
17,303
|
Total operating
expenses
|
11,672
|
|
8,257
|
|
39,612
|
|
35,886
|
Operating
loss
|
(11,304)
|
|
(7,855)
|
|
(38,182)
|
|
(33,853)
|
Change in fair value of
warrant liability
|
226
|
|
—
|
|
(7,998)
|
|
—
|
Interest income
(expense), net
|
15
|
|
(645)
|
|
(1,439)
|
|
(2,685)
|
Other income
(expense)
|
(73)
|
|
28
|
|
(59)
|
|
30
|
Net loss
|
(11,136)
|
|
(8,472)
|
|
(47,678)
|
|
(36,508)
|
Other comprehensive
income:
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on investments
|
157
|
|
—
|
|
157
|
|
—
|
Foreign currency
translation adjustments
|
37
|
|
(19)
|
|
61
|
|
101
|
Total other
comprehensive loss
|
$
(10,942)
|
|
$
(8,491)
|
|
$
(47,460)
|
|
$
(36,407)
|
Common share
data:
|
|
|
|
|
|
|
|
Basic and diluted loss
per common share
|
$
(0.48)
|
|
$
(0.86)
|
|
$
(2.94)
|
|
$
(4.12)
|
Weighted average
number of basic and diluted shares outstanding
|
23,088,685
|
|
9,871,669
|
|
16,229,931
|
|
8,864,615
|
|
|
|
|
|
|
|
|
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SOURCE Delcath Systems, Inc.