NEW
YORK, Nov. 8, 2022 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), 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,
2022.
Recent Business Highlights
During and since the third quarter, Delcath:
- Confirmed the pending resubmission of the NDA for the Hepzato
Kit® (melphalan hydrochloride for injection/Hepatic
Delivery System) to the FDA by the end of the year,
- Attracted a growing number of sites to our Expanded Access
Program (EAP),
- Strengthened its balance sheet by raising $5 million in a private placement priced at
market,
- Reached terms of settlement to end its dispute with medac, its
former distributor in Europe,
and
- Announced that independent investigators published
Predictive Parameters in Patients Undergoing Percutaneous
Hepatic Perfusion with Melphalan for Unresectable Liver Metastases
from Uveal Melanoma: A Retrospective Pooled Analysis in the
journal Cardiovascular and Interventional Radiology
"We are excited by the level of clinician interest in Hepzato
and have enrolled three EAP sites with an additional four sites in
process" said Gerard Michel, Chief
Executive Officer of Delcath. Mr. Michel added, "We continue to
make progress toward the resubmission of the Hepzato Kit NDA by the
end of this year, and assuming a six-month review, we consequently
would expect a PDUFA date by the end of June
2023."
Third Quarter 2022 Results
Income Statement Highlights.
Total revenue for the three months ended September 30, 2022, was approximately
$0.9 million, compared to $0.5
million for the prior year period, from our sales of CHEMOSAT
in Europe. This increase in product revenue is primarily due
to direct product sales for the third quarter of 2022 compared to
the revenue share arrangement with our distribution partner in
Europe during the third quarter of
2021.
Research and development expenses for the quarter were
$4.0 million, compared to
$3.0 million in the prior year
quarter. The growth in R&D expense is primarily due to
increased activity related to the expenses incurred in preparation
for our NDA filing by the end of the year. Selling, general and
administrative expenses for the quarter were approximately
$4.5 million, compared to
$4.0 million in the prior year
quarter. The increase in general and administrative expenses was
primarily due to the settlement of the medac litigation offset by
lower share-based compensation expense.
The Company recorded a net loss for the three months ended
September 30, 2022 of $8.5 million, $0.92
per share (basic and diluted), compared to a net loss of
$7.1 million, $0.94 per share (basic and diluted), for the same
period in 2021.
Balance Sheet Highlights
On September 30, 2022, the Company
had cash, cash equivalents and restricted cash totaling
$14.0 million, as compared to cash,
cash equivalents and restricted cash totaling $27.0 million on December
31, 2021. During the three months ended September 30, 2022, and September 30, 2021, we used $5.2 million and $4.9
million, respectively, of cash in our operating
activities.
On July 20, 2022, we closed a
private placement for the issuance and sale of 690,954 shares of
common stock and 566,751 pre-funded warrants to purchase Common
Stock (the "Pre-Funded Warrants") to certain investors. Each share
of common stock was sold at a price per share of $3.98 and the Pre-Funded Warrants were sold at a
price of $3.97 per Pre-Funded
Warrant. The Pre-Funded Warrants have an exercise price of
$0.01 per share of common stock and
are immediately exercisable. We received gross proceeds from
the Private Placement of approximately $5.0
million before deducting offering expenses.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes
before the beginning of the call.
Event Date: Tuesday November 8,
2022
Time: 8:30 AM Eastern Time
Participant Numbers: Toll Free: 1-844-836-8745
International: 1-412-317-6797
Webcast: https://app.webinar.net/X9na2DKgekK
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 percutaneous hepatic perfusion (PHP)
system is designed to administer high-dose chemotherapy to the
liver while controlling systemic exposure and associated side
effects. In the United States, the
PHP system is being developed under the tradename HEPZATO KIT
(melphalan hydrochloride for injection/Hepatic Delivery System), or
HEPZATO, for the treatment of patients with unresectable
hepatic-dominant metastatic ocular melanoma (mOM), also known as
metastatic uveal melanoma (mUM), and is considered a combination
drug and device product regulated by the United States Food and
Drug Administration (FDA).
In Europe, the PHP system is
now regulated as a Class lll medical device and is approved for
sale under the trade name CHEMOSAT Hepatic Delivery System for
Melphalan, or CHEMOSAT, where it has been used 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. Factors that may cause such differences include, but are
not limited to, uncertainties relating to: the timing and results
of the Company's clinical trials, including without limitation the
mOM and ICC clinical trial programs, as well as the receipt of
additional data and the performance of additional analyses with
respect to the mOM clinical trial, our determination whether to
continue the ICC clinical trial program or to focus on other
alternative indications, and timely monitoring and treatment of
patients in the global Phase 3 mOM clinical trial and the impact of
the COVID-19 pandemic on the completion of our clinical trials; the
impact of the presentations at major medical conferences and future
clinical results consistent with the data presented; approval of
Individual Funding Requests for reimbursement of the CHEMOSAT
procedure; the impact, if any, of ZE reimbursement on potential
CHEMOSAT product use and sales in Germany; clinical adoption,
use and resulting sales, if any, for the CHEMOSAT system to deliver
and filter melphalan in Europe including the key markets
of Germany and the UK; 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; our
ability to obtain reimbursement for the CHEMOSAT system in various
markets; 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; the Company's ability to successfully
enter into strategic partnership and distribution arrangements in
foreign markets and the timing and revenue, if any, of the same;
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 Securities and Exchange Commission. 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)
|
(Unaudited,in
thousands, except share and per share data)
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
2022
|
|
2021
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$
9,831
|
|
$
22,802
|
Restricted
cash
|
|
4,151
|
|
4,151
|
Accounts receivable,
net
|
|
537
|
|
44
|
Inventories
|
|
1,926
|
|
1,412
|
Prepaid expenses and
other current assets
|
|
2,035
|
|
2,743
|
Total current
assets
|
|
18,480
|
|
31,152
|
Property, plant and
equipment, net
|
|
1,452
|
|
1,348
|
Right-of-use
assets
|
|
294
|
|
624
|
Total assets
|
|
$
20,226
|
|
$
33,124
|
|
|
|
|
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts
payable
|
|
$
2,632
|
|
$
638
|
Accrued
expenses
|
|
5,137
|
|
4,109
|
Deferred
revenue
|
|
—
|
|
170
|
Lease liabilities,
current
|
|
196
|
|
416
|
Loan payable,
current
|
|
6,481
|
|
621
|
Total current
liabilities
|
|
14,446
|
|
5,954
|
Other liabilities,
non-current
|
|
1,299
|
|
207
|
Loan payable,
non-current
|
|
4,990
|
|
10,372
|
Convertible notes
payable, non-current
|
|
4,737
|
|
4,639
|
Total
liabilities
|
|
25,472
|
|
21,172
|
|
|
|
|
|
Commitments and
contingencies
|
|
—
|
|
—
|
|
|
|
|
|
Stockholders' equity
(deficit)
|
|
|
|
|
Preferred stock, $.01
par value; 10,000,000 shares authorized; 11,357 shares
issued and outstanding at September 30, 2022 and
December 31, 2021
|
|
—
|
|
—
|
Common stock, $.01 par
value; 40,000,000 shares authorized; 8,597,682 shares and 7,906,728
shares
issued and outstanding at September 30, 2022 and December 31, 2021,
respectively
|
|
86
|
|
79
|
Additional paid-in
capital
|
|
442,066
|
|
432,831
|
Accumulated
deficit
|
|
(447,341)
|
|
(420,976)
|
Accumulated other
comprehensive (loss) income
|
|
(57)
|
|
18
|
Total stockholders'
equity (deficit)
|
|
(5,246)
|
|
11,952
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
20,226
|
|
$
33,124
|
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(Unaudited)
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Product
revenue
|
$
906
|
|
$
395
|
|
$
1,909
|
|
$
1,054
|
Other
revenue
|
—
|
|
127
|
|
171
|
|
393
|
Cost of goods
sold
|
(235)
|
|
(227)
|
|
(449)
|
|
(541)
|
Gross profit
|
671
|
|
295
|
|
1,631
|
|
906
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development expenses
|
3,953
|
|
2,955
|
|
13,649
|
|
10,159
|
Selling, general and
administrative expenses
|
4,519
|
|
4,036
|
|
12,309
|
|
10,621
|
Total operating
expenses
|
8,472
|
|
6,991
|
|
25,958
|
|
20,780
|
Operating
loss
|
(7,801)
|
|
(6,696)
|
|
(24,327)
|
|
(19,874)
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
(730)
|
|
(420)
|
|
(2,040)
|
|
(501)
|
Other income
(expense)
|
26
|
|
(9)
|
|
2
|
|
73
|
Net loss
|
(8,505)
|
|
(7,125)
|
|
(26,365)
|
|
(20,302)
|
|
|
|
|
|
|
|
|
Other comprehensive
(loss) income:
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
(46)
|
|
51
|
|
(82)
|
|
84
|
Total other
comprehensive loss
|
$
(8,551)
|
|
$
(7,074)
|
|
$
(26,447)
|
|
$
(20,218)
|
|
|
|
|
|
|
|
|
Common share
data:
|
|
|
|
|
|
|
|
Basic and diluted loss
per common share
|
$
(0.92)
|
|
$
(0.94)
|
|
$
(3.09)
|
|
$
(2.93)
|
|
|
|
|
|
|
|
|
Weighted average number
of basic and diluted shares
outstanding
|
9,215,786
|
|
7,587,643
|
|
8,536,006
|
|
6,923,541
|
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SOURCE Delcath Systems, Inc.