NEW YORK, Nov. 11, 2016 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH), an interventional oncology company
focused on the treatment of primary and metastatic liver cancers,
announces financial results for the three and nine months ended
September 30, 2016.
Highlights for the third quarter of 2016 and recent weeks
include:
- Raised $1,275,000 through an
underwritten public offering of common stock and warrants;
- Expanded the FOCUS Phase 3 Trial in hepatic dominant ocular
melanoma to include 10 new research centers in the U.S. and
Europe;
- Presented data from two single-institution studies conducted in
Germany on the use of the Delcath
Hepatic CHEMOSAT® Delivery System to treat patients with
liver metastases in scientific posters at the Cardiovascular and
Interventional Radiology Society of Europe (CIRSE) annual
meeting;
- Announced acceptance for publication of a retrospective review
study, "Chemosaturation Percutaneous Hepatic Perfusion: A
Systemic Review," by Dr. Arndt
Vogel, et al, in the prestigious journal Advances in
Therapy; and
- Sponsored the Ocular Melanoma Foundation Eye Am Not
Alone patient education retreat.
"Throughout the third quarter we continued to make steady
progress in our clinical development program for Melphalan/HDS and
in our efforts to advance CHEMOSAT as a commercially viable
treatment option for primary and metastatic liver cancers in
Europe," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President
and Chief Executive Officer of Delcath. "We also recently secured
an additional $1.275 million in
financing via a small fundraise in October, which will bridge us to
receipt of the first cash release from the committed financing we
announced in June 2016. Assuming all
conditions are satisfied, we expect the anticipated quarterly
releases throughout 2017 will fund our clinical development plan
through the end of 2017, while also supporting our commercial
activities in Europe.
"The presentation and publication of data supportive of CHEMOSAT
continued during our third quarter. This includes a retrospective
review study conducted by a team led by Dr. Arndt Vogel of the University of Hanover in Germany, which was accepted for publication by
the prestigious peer-reviewed journal, Advances in Therapy.
This study originated as a white paper produced by our
Experts Panel in 2015, and we are pleased that the potential for
CHEMOSAT to treat primary and metastatic liver cancers as
identified by our experts will now reach a wider audience. Also
during the quarter investigators from Asklepios Barmbek Clinic and
Hanover Medical School in Germany,
and Southampton University Hospital in the United Kingdom, presented compelling data from
their single-institution investigations. These data provide
us with considerable confidence that similar results may be
formally validated by the trials that comprise our Clinical
Development Plan, and we look forward to additional presentations
and publications of data in support of CHEMOSAT throughout the
remainder of the year and beyond.
"Negotiations by hospitals in Germany to determine reimbursement levels for
CHEMOSAT under the ZE national system are expected to conclude
during our fourth quarter. We believe that favorable
reimbursement levels defined through this process will support
growth in procedure volumes in Germany and provide important validation for
reimbursement appeals in other markets in Europe.
"The advances we made in 2016 have positioned us to achieve
important clinical inflection points in our FOCUS trial and our
global Phase 2 program in HCC and ICC, as we work to expand global
access to CHEMOSAT for the benefit of patients suffering with
primary and metastatic liver cancers," concluded Dr.
Simpson.
Third Quarter Financial Results
Total revenues for the third quarter of 2016 and 2015 were
$0.4 million. Selling, general and
administrative expenses for the third quarter of 2016 were
$2.4 million, compared with
$2.3 million for the same period in
2015, primarily attributable to a slight increase in facility and
professional expenses. Research and development expenses increased
to $2.7 million for the 2016 third
quarter from $1.7 million for the
same period in 2015, primarily due to increased investment in
clinical development initiatives, specifically the global Phase 3
FOCUS clinical trial.
Total operating expenses for the third quarter of 2016 increased
to $5.0 million from $4.0 million for the same period in 2015. This
reflects an increase in clinical development initiatives.
The Company recorded a net loss for the three months ended
September 30, 2016 of $1.0 million, or $0.66 per share, a decrease of $1.4 million from a net loss of $2.4 million, or $1.96 per share, for the same period in 2015.
This was primarily driven by amortization of debt discounts related
to the convertible note issued in June
2016 and a change in the fair value of the warrant
liability, a non-cash item.
Nine Month Financial Results
Total revenues for the first nine months of 2016 and 2015 were
$1.3 million. Selling, general and
administrative expenses for the first nine months of 2016 were
$7.0 million, an improvement of
$0.8 million or 11% from $7.8 million reported for the same period in
2015, primarily attributable to a reduction in facility expenses
related to the lease restructurings. Research and development
expenses during the first nine months of 2016 increased to
$6.0 million compared with
$4.1 million for the same period in
2015, primarily due to increased investment in clinical development
initiatives.
Total operating expenses for the first nine months of 2016 were
$13.0 million compared with
$12.0 million for the same period in
2015.
The Company recorded a net loss for the nine months ended
September 30, 2016 of $9.5 million, or $6.39 per share, a decrease of $0.1 million from a net loss of $9.6 million, or $10.75 per share, for the nine months ended
September 30, 2015. This was
primarily driven by amortization of debt discounts related to the
convertible note issued in June 2016
and a change in the fair value of the warrant liability, a non-cash
item.
Balance Sheet Highlights
As of September 30, 2016, Delcath
had cash and cash equivalents of $3.7
million, compared with $12.6
million as of December 31,
2015. During the first nine months of 2016, the Company used
$10.6 million in cash to fund its
operating activities. In June 2016,
Delcath issued $35.0 million of
senior convertible notes and related common stock purchase warrants
and in October 2016, the Company
raised $1,275,000 through an
underwritten public offering of common stock and warrants. As a
result, Delcath believes it has sufficient capital to fund its
operating activities through the end of 2017.
About Delcath Systems
Delcath Systems, Inc. is an interventional oncology Company
focused on the treatment of primary and metastatic liver cancers.
Our investigational product—Melphalan Hydrochloride for Injection
for use with the Delcath Hepatic Delivery System (Melphalan/HDS)
—is designed to administer high-dose chemotherapy to the liver
while controlling systemic exposure and associated side effects. We
have commenced a global Phase 3 FOCUS clinical trial for Patients
with Hepatic Dominant Ocular Melanoma (OM) and a global Phase 2
clinical trial in Europe and the U.S. to investigate the
Melphalan/HDS system for the treatment of primary liver cancer
(HCC) and intrahepatic cholangiocarcinoma (ICC). Melphalan/HDS has
not been approved by the U.S. Food & Drug Administration (FDA)
for sale in the U.S. In Europe, our system has been
commercially available since 2012 under the trade name Delcath
Hepatic CHEMOSAT® Delivery System for Melphalan
(CHEMOSAT), where it has been used at major medical centers to
treat a wide range of cancers of the liver.
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: our ability to repay and
comply with the obligations under our senior secured convertible
notes, the timing and results of the Company's clinical
trials including without limitation the OM, HCC ,and ICC
clinical trial programs, timely enrollment and treatment of
patients in the global Phase 3 FOCUS Clinical Trial for Patients
with Hepatic Dominant Ocular Melanoma and the global Phase 2 HCC
and ICC clinical trials, IRB or ethics committee clearance of the
Phase 2 HCC/ICC and/or Phase 3 OM protocols from
participating sites and the timing of site activation and subject
enrollment in each trial, the impact, if any, of publication of the
Phase 3 trial manuscript to support the Company's efforts, the
impact of the presentations at major medical conferences and future
clinical results consistent with the data presented, 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, the Company's ability to successfully
commercialize the CHEMOSAT/Melphalan HDS system and the potential
of the CHEMOSAT/Melphalan HDS 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,
the Company's ability to satisfy the remaining requirements of the
FDA's Complete Response Letter and provide the same in a timely
manner, approval of the current or future Melphalan HDS/CHEMOSAT
system for delivery and filtration of melphalan for various
indications in the U.S. and/or in foreign markets, actions by the
FDA or other 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, our ability to maintain NASDAQ
listing, 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 Contact:
Anne Marie
Fields
LHA
212-838-3777
afields@lhai.com
-Tables to Follow-
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(Unaudited)
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenue
|
|
$
435
|
|
$
399
|
|
$
1,316
|
|
$
1,308
|
Cost of goods
sold
|
|
112
|
|
90
|
|
373
|
|
360
|
Gross
profit
|
|
323
|
|
309
|
|
943
|
|
948
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
2,361
|
|
2,276
|
|
7,025
|
|
7,818
|
Research and
development
|
|
2,686
|
|
1,683
|
|
5,975
|
|
4,112
|
Total operating
expenses
|
|
5,047
|
|
3,959
|
|
13,000
|
|
11,930
|
Operating
loss
|
|
(4,724)
|
|
(3,650)
|
|
(12,057)
|
|
(10,982)
|
Change in fair value
of the warrant liability, net
|
|
8,680
|
|
1,253
|
|
9,171
|
|
1,414
|
Interest income
(expense)
|
|
(4,963)
|
|
(14)
|
|
(6,584)
|
|
(39)
|
Other income
(expense)
|
|
2
|
|
(11)
|
|
(15)
|
|
(4)
|
Net loss
|
|
$
(1,005)
|
|
$
(2,422)
|
|
$
(9,485)
|
|
$ (9,611)
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
|
(2)
|
|
(4)
|
|
(12)
|
|
(12)
|
Comprehensive
loss
|
|
$
(1,007)
|
|
$
(2,426)
|
|
$
(9,497)
|
|
$ (9,623)
|
|
|
|
|
|
|
|
|
|
Common share
data:
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per common share*
|
|
$
(0.66)
|
|
$
(1.96)
|
|
$
(6.38)
|
|
$ (10.75)
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted common shares outstanding*
|
|
1,521,927
|
|
1,233,086
|
|
1,486,986
|
|
893,819
|
|
*reflects a
one-for-sixteen (1:16) reverse stock split effected on July 21,
2016
|
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Balance Sheets
|
(in thousands,
except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$
3,689
|
|
$
12,607
|
Restricted
cash
|
|
23,737
|
|
—
|
Accounts receivables,
net
|
|
342
|
|
277
|
Inventories
|
|
600
|
|
757
|
Prepaid expenses and
other current assets
|
|
310
|
|
960
|
Deferred financing
costs
|
|
489
|
|
—
|
Total current
assets
|
|
29,167
|
|
14,601
|
Restricted cash, net
of current portion
|
|
6,550
|
|
—
|
Deferred financing
costs, net of current portion
|
|
122
|
|
—
|
Property, plant and
equipment, net
|
|
1,141
|
|
1,132
|
Total
assets
|
|
$
36,980
|
|
$
15,733
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts
payable
|
|
$
182
|
|
$
284
|
Accrued
expenses
|
|
2,701
|
|
2,243
|
Warrant
liability
|
|
22,502
|
|
3,785
|
Total current
liabilities
|
|
25,385
|
|
6,312
|
Convertible notes
payable, net of debt discount
|
|
6,413
|
|
—
|
Deferred
Revenue
|
|
31
|
|
—
|
Other non-current
liabilities
|
|
665
|
|
820
|
Total
liabilities
|
|
32,494
|
|
7,132
|
|
|
|
|
|
Commitments and
Contingencies
|
|
—
|
|
—
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
Preferred stock, $.01
par value; 10,000,000 shares authorized; no shares issued and
outstanding at September 30, 2016 and December 31, 2015,
respectively
|
|
—
|
|
—
|
Common stock,
$.01 par value; 500,000,000 shares authorized; 1,541,043 and
1,396,348 shares issued and 1,521,933 and 1,360,239 shares
outstanding at September 30, 2016 and December 31, 2015,
respectively*
|
|
15
|
|
14
|
Additional paid-in
capital
|
|
275,245
|
|
269,863
|
Accumulated
deficit
|
|
(270,703)
|
|
(261,217)
|
Treasury stock,
at cost; 110 shares at September 30, 2016 and December 31, 2015,
respectively*
|
|
(51)
|
|
(51)
|
Accumulated other
comprehensive income
|
|
(20)
|
|
(8)
|
Total
stockholders' equity
|
|
4,486
|
|
8,601
|
Total
liabilities and stockholders' equity
|
|
$
36,980
|
|
$
15,733
|
*reflects a
one-for-sixteen (1:16) reverse stock split effected on July 21,
2016
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/delcath-announces-third-quarter-financial-results-300361112.html
SOURCE Delcath Systems, Inc.