NEW YORK, Aug. 16, 2016 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and
medical device company focused on oncology with an emphasis on the
treatment of primary and metastatic liver cancers, announces
financial results for the three and six months ended June 30, 2016.
Highlights for the second quarter of 2016 and recent weeks
include:
- Issuance of $35 million in senior
convertible notes to support Melphalan/HDS Phase 3 Focus Trial
enrollment and CHEMOSAT European commercialization through the end
of 2017;
- Presentation of data from a large single hospital experience
conducted at Southampton University Hospital in the United Kingdom at the 6th European
Post-Chicago Melanoma/Skin Cancer Meeting, which demonstrated
overall survival benefit using Delcath's CHEMOSAT to treat
metastatic uveal melanoma;
- Acceptance of abstracts from two studies conducted in
Germany using Delcath's
CHEMOSAT® to treat patients with liver metastases for
presentation as posters at the Cardiovascular and Interventional
Radiology Society of Europe
(CIRSE) Annual Meeting in September
2016;
- Acceptance of a review of clinical research treatment outcomes
using Melphalan Hydrochloride for Injection with the Delcath
Hepatic Delivery System (Melphalan/HDS) in patients with hepatic
metastases for publication in the prestigious journal, Cancer
Control;
- Promotion of John Purpura to
Executive Vice President, Global Head of Operations from Executive
Vice President-Regulatory Affairs and Quality Assurance; and
- Launch of CHEMOSAT at the HM Sanchinarro University Hospital in
Madrid.
"Throughout the second quarter we made considerable clinical and
commercial progress advancing CHEMOSAT as an innovative new
treatment option for primary and metastatic liver cancers," noted
Jennifer K. Simpson, Ph.D., MSN,
CRNP, President and Chief Executive Officer of Delcath.
"Importantly, we secured $35 million
in committed financing that provides us with the resources to
advance our clinical development plan through to key inflection
points while also supporting our commercialization programs in
Europe.
"We were particularly pleased to have real-world data from
Southampton University Hospital's experience presented at the
Melanoma/Skin Cancer meeting as the progression free and overall
survival benefits observed in this study are dramatic, especially
given the limited treatment options for patients suffering with
these life-threatening cancers. These supportive data provide
us with considerable confidence that similar results may be
formally validated by our FOCUS Phase 3 Trial in hepatic dominant
ocular melanoma that is currently underway in the U.S. and
Europe. We look forward to additional presentations and
publication of data in support of CHEMOSAT in the treatment of
cancers of the liver during the second of half of the year.
"The addition of CHEMOSAT to centers in Spain and Turkey highlight our continued progress
commercializing the system in Europe. We continue with negotiations to
determine reimbursement levels for CHEMOSAT under the ZE national
system in Germany and expect
coverage levels to be defined later this year. We believe
that favorable reimbursement levels will enhance growth in
procedure volumes in Germany and
provide important validation for reimbursement appeals in other
markets in Europe.
"The advances we made during the first half of 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 our CHEMOSAT for the benefit of
patients suffering with primary and metastatic liver cancers,"
concluded Dr. Simpson.
Second Quarter Financial Results
Total revenues for the second quarter of 2016 and 2015 were
$0.5 million. Selling, general and
administrative expenses for the second quarter of 2016 were
$2.3 million, compared with
$2.5 million for the same period in
2016, primarily attributable to a reduction in depreciation and
corporate expenses. Research and development expenses increased to
$1.9 million for the 2016 second
quarter from $1.5 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 second quarter of 2016
increased to $4.2 million from
$4.0 million for the same period in
2015. This reflects an increase in clinical development
initiatives, partially offset by reductions in depreciation and
corporate expenses.
The Company recorded a net loss for the three months ended
June 30, 2016 of $6.7 million, an increase of $3.0 million from a net loss of $3.7 million 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.
First Half Financial Results
Total revenues for the first half of 2016 and 2015 were
$0.9 million. Selling, general and
administrative expenses for the first six months of 2016 were
$4.7 million, an improvement of
$0.8 million or 15% from $5.5 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 half of 2016 increased to $3.3 million compared with $2.4 million for the same period in 2015,
primarily due to increased investment in clinical development
initiatives.
Total operating expenses for the first half of 2016 were
$8.0 million compared with
$8.0 million for the same period in
2015.
The Company recorded a net loss for the six months ended
June 30, 2016 of $8.5 million, an increase of $1.3 million from a net loss of $7.2 million for the six months ended
June 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 June 30, 2016, Delcath had
cash and cash equivalents of $7.5
million, compared with $12.6
million as of December 31,
2015. During the first half of 2016, the Company used
$7.0 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. 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 a specialty pharmaceutical and
medical device company focused on oncology with a principal focus
on the treatment of primary and metastatic liver cancers. Our
proprietary 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. In April 2012 we obtained
authorization to affix a CE Mark to our second-generation system,
which is currently marketed in Europe as a device under
the trade name Delcath Hepatic CHEMOSAT® Delivery System for
Melphalan (CHEMOSAT). In the U.S. the Melphalan/HDS system is
considered a combination drug and device product, and is regulated
as a drug by the U.S. Food and Drug Administration (FDA).
Melphalan/HDS has not been approved for sale in the U.S. We have
commenced our 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).
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 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, 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, 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 or other
chemotherapeutic agents 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 Balance Sheets
|
(in thousands,
except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$
7,484
|
|
$
12,607
|
Restricted
cash
|
|
17,162
|
|
—
|
Accounts receivables,
net
|
|
363
|
|
277
|
Inventories
|
|
746
|
|
757
|
Prepaid expenses and
other current assets
|
|
1,245
|
|
960
|
Total current
assets
|
|
27,000
|
|
14,601
|
Restricted cash, net
of current portion
|
|
13,100
|
|
—
|
Deferred financing
costs, net of current portion
|
|
226
|
|
—
|
Property, plant and
equipment, net
|
|
1,062
|
|
1,132
|
Total
assets
|
|
$
41,388
|
|
$
15,733
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts
payable
|
|
$
439
|
|
$
284
|
Accrued
expenses
|
|
2,035
|
|
2,243
|
Current portion of
convertible notes payable, net of discount
|
|
—
|
|
—
|
Warrant
liability
|
|
31,181
|
|
3,785
|
Total current
liabilities
|
|
33,655
|
|
6,312
|
Convertible notes
payable, net of current portion and debt discount
|
|
1,568
|
|
—
|
Deferred
Revenue
|
|
19
|
|
—
|
Other non-current
liabilities
|
|
716
|
|
820
|
Total
liabilities
|
|
35,958
|
|
7,132
|
|
|
|
|
|
Commitments and
Contingencies
|
|
—
|
|
—
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
Preferred stock, $.01
par value; 10,000,000 shares authorized; no shares
issued and outstanding at June 30, 2016 and December
31, 2015,
respectively
|
|
—
|
|
—
|
Common stock,
$.01 par value; 500,000,000 shares authorized; 1,541,016 and
1,396,348 shares issued and 1,521,906 and 1,360,239 shares
outstanding
at June 30, 2016 and December 31, 2015,
respectively
|
|
15
|
|
14
|
Additional paid-in
capital
|
|
275,182
|
|
269,863
|
Accumulated
deficit
|
|
(269,698)
|
|
(261,217)
|
Treasury stock,
at cost; 110 shares at June 30, 2016 and December 31, 2015,
respectively
|
|
(51)
|
|
(51)
|
Accumulated other
comprehensive income
|
|
(18)
|
|
(8)
|
Total stockholders'
equity
|
|
5,430
|
|
8,601
|
Total liabilities and
stockholders' equity
|
|
$
41,388
|
|
$
15,733
|
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,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenue
|
|
$
511
|
|
$
466
|
|
$
880
|
|
$
910
|
Cost of goods
sold
|
|
150
|
|
137
|
|
261
|
|
270
|
Gross
profit
|
|
361
|
|
329
|
|
619
|
|
640
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
2,287
|
|
2,502
|
|
4,663
|
|
5,542
|
Research and
development
|
|
1,945
|
|
1,450
|
|
3,289
|
|
2,430
|
Total operating
expenses
|
|
4,232
|
|
3,952
|
|
7,952
|
|
7,972
|
Operating
loss
|
|
(3,871)
|
|
(3,623)
|
|
(7,333)
|
|
(7,332)
|
Change in fair value
of the warrant liability, net
|
|
(1,181)
|
|
(48)
|
|
491
|
|
161
|
Other income
(expense)
|
|
(1,615)
|
|
(28)
|
|
(1,638)
|
|
(18)
|
Net loss
|
|
$
(6,667)
|
|
$ (3,699)
|
|
$
(8,480)
|
|
$ (7,189)
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
|
(1)
|
|
7
|
|
(10)
|
|
(7)
|
Comprehensive
loss
|
|
$
(6,668)
|
|
$ (3,692)
|
|
$
(8,490)
|
|
$ (7,196)
|
|
|
|
|
|
|
|
|
|
Common share
data:
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per common share
|
|
$
(4.41)
|
|
$
(4.84)
|
|
$
(5.72)
|
|
$
(9.96)
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted common
shares outstanding
|
|
1,510,752
|
|
765,072
|
|
1,483,148
|
|
722,036
|
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visit:http://www.prnewswire.com/news-releases/delcath-announces-second-quarter-financial-results-300313615.html
SOURCE Delcath Systems, Inc.