NEW
YORK, Aug. 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 second quarter ended June 30,
2022.
Recent Business Highlights
During and since the second quarter, Delcath:
- Held a pre-NDA meeting with FDA and locked the phase 3 FOCUS
Trial database for the purpose of resubmitting the NDA for the
Hepzato Kit® (melphalan hydrochloride for
injection/hepatic delivery system) in the third quarter of
2022,
- Presented a poster updating the results from the FOCUS Trial at
the American Society of Clinical Oncology (ASCO) 2022 Annual
Meeting,
- Opened two Expanded Access Program (NCT05022901) sites,
and
- Raised $5 million in a private
placement priced at market.
In addition, during and since the fourth quarter, 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,
- Presented two abstracts on the use of Chemosat®
Hepatic Delivery System with Melphalan in the treatment of
metastatic uveal melanoma at the American Society of Clinical
Oncology (ASCO) 2022 Annual Meeting, including:
-
- Safety and efficacy of combined melphalan percutaneous
hepatic perfusion (M-PHP) and ipilimumab plus nivolumab (IPI+NIVO)
in metastasized uveal melanoma: First results of the phase Ib part
of the CHOPIN trial, and
- Temporal evolution in quality-of-life following melphalan
percutaneous hepatic perfusion for patients with metastatic uveal
melanoma.
"As we prepare to resubmit the Hepzato Kit NDA by the end of the
third quarter, Chemosat usage in Europe continues to result in publications
supportive of both Chemosat and by extension the Hepzato Kit," said
Gerard Michel, Chief Executive
Officer of Delcath. Mr. Michel continued, "We would expect that
within 30 days of the resubmission, the FDA will confirm receipt of
the submission and, if they agree the resubmission is sufficiently
complete to warrant review, establish a PDUFA date sometime late in
the first quarter of 2023."
First Quarter 2022 Results
Income Statement Highlights.
Total revenue for the three months ended June 30, 2022, was approximately $0.8 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 a full quarter of direct product sales by Delcath compared to
the revenue share arrangement with our distribution partner in
Europe in 2021.
Research and development expenses for the quarter were
$5.5 million, compared to
$3.5 million in the prior year
quarter. The growth in R&D expense is primarily due to
increased activity related to the NDA preparation. Selling, general
and administrative expenses for the quarter were approximately
$4.1 million, compared to
$3.3 million in the prior year
quarter. Total operating expenses for the quarter were $9.6 million, compared with $6.8 million in the prior year quarter.
The Company recorded a net loss for the three months ended
June 30, 2022, of $9.7 million, compared to a net loss of
$6.4 million for the same period in
2021.
Balance Sheet Highlights
On June 30, 2022, the Company had
cash, cash equivalents and restricted cash totaling $14.4 million, as compared to cash, cash
equivalents and restricted cash totaling $27.0 million on December
31, 2021. During the three months ended June 30, 2022, and June
30, 2021, we used $6.1 million
and $7.1 million, respectively, of
cash in our operating activities.
On July 20, 2022, Delcath closed a
private placement for the issuance and sale of 690,954 shares of
common stock (the "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. Delcath received gross proceeds
from the Private Placement of approximately $5.0 million before deducting offering expenses
payable by Delcath. Delcath intends to use the net proceeds from
the Private Placement for working capital purposes and other
general corporate purposes.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes
before the beginning of the call.
Event Date: Monday August 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/leg9qEP2vWK
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, in particular, 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: 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.
|
|
|
|
|
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
June
30,
|
|
December 31,
|
|
|
2022
|
|
2021
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$
10,203
|
|
$
22,802
|
Restricted
cash
|
|
4,151
|
|
4,151
|
Accounts receivable,
net
|
|
438
|
|
44
|
Inventories
|
|
2,040
|
|
1,412
|
Prepaid expenses and
other current assets
|
|
2,370
|
|
2,743
|
Total current
assets
|
|
19,202
|
|
31,152
|
Property, plant and
equipment, net
|
|
1,457
|
|
1,348
|
Right-of-use
assets
|
|
407
|
|
624
|
Total assets
|
|
$
21,066
|
|
$
33,124
|
|
|
|
|
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts
payable
|
|
$
2,067
|
|
$
638
|
Accrued
expenses
|
|
5,417
|
|
4,109
|
Deferred
revenue
|
|
—
|
|
170
|
Lease
liabilities
|
|
294
|
|
416
|
Loan payable,
current
|
|
4,474
|
|
621
|
Total current
liabilities
|
|
12,252
|
|
5,954
|
Lease liabilities,
non-current
|
|
113
|
|
207
|
Loan payable,
non-current
|
|
6,838
|
|
10,372
|
Convertible notes
payable, non-current
|
|
4,709
|
|
4,639
|
Total
liabilities
|
|
23,912
|
|
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 June 30, 2022 and December
31, 2021
|
|
—
|
|
—
|
Common stock, $.01 par
value; 40,000,000 shares authorized; 7,906,728 shares
issued and outstanding at June 30, 2022 and December 31,
2021
|
|
79
|
|
79
|
Additional paid-in
capital
|
|
435,922
|
|
432,831
|
Accumulated
deficit
|
|
(438,836)
|
|
(420,976)
|
Accumulated other
comprehensive (loss) income
|
|
(11)
|
|
18
|
Total stockholders'
equity (deficit)
|
|
(2,846)
|
|
11,952
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
21,066
|
|
$
33,124
|
|
|
|
|
|
|
|
|
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,
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Product
revenue
|
$
797
|
|
$
398
|
|
$
1,003
|
|
$
659
|
Other
revenue
|
—
|
|
138
|
|
171
|
|
265
|
Cost of goods
sold
|
(180)
|
|
(202)
|
|
(214)
|
|
(314)
|
Gross profit
|
617
|
|
334
|
|
960
|
|
610
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development expenses
|
5,456
|
|
3,497
|
|
9,696
|
|
7,204
|
Selling, general and
administrative expenses
|
4,145
|
|
3,288
|
|
7,791
|
|
6,584
|
Total operating
expenses
|
9,601
|
|
6,785
|
|
17,487
|
|
13,788
|
Operating
loss
|
(8,984)
|
|
(6,451)
|
|
(16,527)
|
|
(13,178)
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
(665)
|
|
(40)
|
|
(1,309)
|
|
(81)
|
Other (loss)
income
|
(8)
|
|
61
|
|
(24)
|
|
82
|
Net loss
|
(9,657)
|
|
(6,430)
|
|
(17,860)
|
|
(13,177)
|
|
|
|
|
|
|
|
|
Other comprehensive
income:
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
(31)
|
|
(61)
|
|
(29)
|
|
33
|
Total other
comprehensive loss
|
$
(9,688)
|
|
$
(6,491)
|
|
$
(17,889)
|
|
$
(13,144)
|
|
|
|
|
|
|
|
|
Common share
data:
|
|
|
|
|
|
|
|
Basic and diluted loss
per common share
|
$
(1.18)
|
|
$
(0.96)
|
|
$
(2.18)
|
|
$
(2.00)
|
|
|
|
|
|
|
|
|
Weighted average number
of basic and diluted shares outstanding
|
8,190,483
|
|
6,681,369
|
|
8,190,483
|
|
6,589,655
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/delcath-systems-reports-second-quarter-2022-results-and-provides-business-update-301601223.html
SOURCE Delcath Systems, Inc.