LAWRENCEVILLE, N.J.,
March 30, 2016 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced financial results for the year
ended December 31, 2015 and provided
an update on its development programs for ThermoDox®, its
proprietary heat-activated liposomal encapsulation of doxorubicin
and GEN-1, an IL-12 DNA plasmid vector encased in a nanoparticle
delivery system, which enables cell transfection followed by
persistent, local secretion of the IL-12 protein. The
Company's lead program is ThermoDox® which is currently in Phase
III development for the treatment of primary liver cancer and in
Phase II development for the treatment of recurrent chest wall
breast cancer. The Company's immunotherapy program consists
of GEN-1 and is currently in Phase I development for the localized
treatment of ovarian cancer.
"Celsion had a very productive 2015. We entered 2016 with
a clear vision for leveraging two leading-edge technology platforms
designed to enhance clinically powerful therapies. These
approaches provide us with an opportunity to deliver cutting edge
therapeutics that address prevalent cancers with high unmet needs,
while at the same time driving growth for the Company and value for
our shareholders," said Michael H.
Tardugno, Celsion's chairman, president and CEO. "Over
the past year, we have demonstrated the potential of ThermoDox and
GEN-1, and we plan to build on this progress in 2016, as we focus
our efforts on the pivotal Phase III OPTIMA Study and the Phase II
Euro-DIGNITY Study for ThermoDox, and advancing GEN-1 in ovarian
cancer."
Recent Developments
ThermoDox®
Announced the launch of the OPTIMA Study in China. On March 5,
2016, the Company held an Investigators' Meeting for the
OPTIMA Study in Shanghai,
China. Professor Ronnie T.P.
Poon, MD, MBBS, MS, PhD, FRCS (Edin), FACS, Medical Director
at the Hong Kong Integrated Oncology Center, Honorary Professor of
Surgery at the University of Hong Kong
Queen Mary Hospital, and member of the International Liver Cancer
Association (ILCA) Governing Board provided the Keynote Address
entitled "Treatment Strategies for Early/Intermediate
HCC." Professor Poon discussed strategies for
treating different stages of primary liver cancer.
Investigators and their staff from 20 sites in mainland
China and Hong Kong were in attendance. With the
addition of these Chinese clinical sites, the Company expects to
complete enrollment in the OPTIMA Study by the end of 2017. Results
from the OPTIMA Study, if successful, will provide the basis for a
global registration filing and marketing approval.
Received CFDA approval to conduct the OPTIMA Study in
China. In December 2015,
Celsion announced that it has received Clinical Trial Application
(CTA) approval from the China Food and Drug Administration (CFDA)
to conduct the ongoing Phase III OPTIMA Study at clinical sites in
China. This approval by the CFDA represents another important
validation of the Company's development program for ThermoDox®,
which shows the potential for improvement in overall survival in
HCC patients. The Phase III OPTIMA Study is expected to enroll up
to 550 patients globally, and has been successfully enrolling
patients at 50 clinical sites in 12 different countries in
North America, Europe and Asia
Pacific. The CTA approval will now allow Celsion to enroll
patients at up to 20 additional clinical sites in China.
Presented DIGNITY Phase I/II ThermoDox® Data at the 2015 San
Antonio Breast Cancer Symposium. In December 2015, the Company presented results from
its ongoing Phase I/II US DIGNITY Study of ThermoDox® in
combination with mild hyperthermia in patients with recurrent chest
wall (RCW) breast cancer which demonstrated a combined local
response rate of 62% among evaluable patients treated with
ThermoDox®. In addition to a local response rate of 62%
among evaluable patients, a combined local response rate was
observed in 46% of the intent-to-treat population (13/28), notably
consisting of five patients demonstrating a durable local response
lasting greater than three months. The Company plans to
initiate a 70 patient Phase II study in Europe and Israel in less advanced, less heavily
pretreated patients as part of the Euro-DIGNITY Trial. The
Euro-DIGNITY Trial will evaluate ThermoDox® plus
radiation and hyperthermia in RCW breast cancer patients.
GEN-1 Immunotherapy
Reported translational data from its Phase Ib Study of GEN-1
Immunotherapy in recurrent ovarian cancer. In
January 2016, the Company announced
new translational data from its Phase Ib study of GEN-1 in patients
with platinum-resistant ovarian cancer. The new data indicated that
intraperitoneally-administered GEN-1 produces an immunologically
distinct IL-12 protein that is localized at the tumor site and
lasts for up to one week after a single treatment. In
addition, concomitant increases in IFN-γ and
TNF-α indicate that the IL-12 produced following treatment
with GEN-1 treatment is immunologically active. Celsion
intends to collect additional translational data, including
cellular responses in primary tumor tissue and peritoneal ascites,
in its ongoing OVATION Study, a Phase I dose escalation study in
newly diagnosed ovarian cancer patients in the neoadjuvant
setting.
Announced completion of enrollment of the first cohort of
patients in the Phase 1b OVATION Study. In February 2016, the Company reported that the
first two patients in the OVATION Study who completed treatment
have shown promising results. Both patients reported stable
disease with a dramatic drop in their CA-125 protein levels of 89%
and 98%. Cancer antigen 125 (CA-125) is used to monitor certain
cancers during and after treatment. A 50% reduction in CA-125
levels is considered meaningful. Both patients' CA-125 levels were
below the normal healthy level of 35 U/mL. In addition, both
patients experienced successful surgical resections of their tumors
with one patient reporting a R0 resection which indicates a
microscopically margin-negative resection in which no gross or
microscopic tumor remains in the tumor bed.
Announced presentation of preclinical data for GEN-1 IL-12
Immunotherapy in combination with Avastin® and Doxil® at the
American Association for Cancer Research (AACR) Annual Meeting
2016. In March 2016, the
Company announced that preclinical data for GEN-1 in combination
with Avastin® and Doxil® for the treatment of ovarian cancer will
be presented at the upcoming AACR Annual Meeting 2016. The
presentation will summarize results from preclinical studies
demonstrating significant synergistic anti-cancer effects when
GEN-1 is combined with Avastin® and Doxil®, a current Standard of
Care (SoC) for platinum resistant ovarian cancer patients.
The preclinical studies show that GEN-1 when combined with Avastin®
and Doxil® indicated a greater than 98% reduction in tumor burden
when compared to the untreated control group. The findings
represent a statistically significant reduction in tumor burden and
disease progression when compared to the combination of Avastin®
and Doxil®. These preclinical data will be used by the
Company to support a comprehensive IND protocol filing for a Phase
I/II clinical trial evaluating the combination in recurrent ovarian
cancer later this year.
TheraSilence
Announced the issuance of a key U.S. Patent covering its
novel TheraSilence™ RNA Program. In March 2016, the
Company announced that the U.S. Patent and Trademark Office issued
a key patent (U.S. Patent No. 9,254,334 B2) which provides broad
intellectual property protection covering the therapeutic use of
the Company's proprietary TheraSilence™ lung-specific delivery
system in a broad range of therapeutic entities, including the
delivery of synthetically-generated inhibitory RNA (RNAi) such as
small inhibitory RNAs (siRNAs), microRNAs, microRNA mimics,
anti-microRNAs and related molecules that can regulate protein
expression at the transcript level by exploiting endogenous cell
mechanisms.
Corporate Development
Appointment of two new members to Celsion's Board of
Directors. In December
2015, the Company announced the appointment of Donald P. Braun, Ph.D. and Andreas Voss, M.D., to the Company's Board of
Directors. Dr. Braun brings over 30 years of research expertise in
oncology, with a focus on immunotherapy and the effectiveness and
impact of chemotherapy protocols on various cancers and tumor
types, and currently serves as Vice President Translational
Research and Chief Science Officer at the Cancer Treatment Centers
of America. Dr. Voss currently serves as Vice President of Clinical
Affairs in Europe at Caris Life
Sciences, a biotechnology company focused on implementing
personalized medicine in oncology through its liquid biopsy
technology. Prior to joining Caris in 2010, he was responsible for
the global clinical development of Avastin® and a member of the
Corporate Drug Safety Board at F. Hoffmann-La Roche.
Financial Results
For the year ended December 31,
2015, Celsion reported a net loss of $22.5 million, or $1.03 per share, compared to a net loss of
$25.5 million, or $1.38 per share, in 2014. Operating expenses were
$21.3 million in 2015 compared to
$25.2 million in 2014. This
decrease was primarily due to lower general and administrative
expenses coupled with a $1.4 million
one-time charge in connection with the acquisition of the assets of
EGEN, Inc. in 2014.
Research and development costs were $14.7
million in 2015 compared to $15.0
million in the prior year as a result of the Company's
tighter clinical development focus around the pivotal Phase III
OPTIMA Study for the treatment of primary liver cancer and the
clinical development program for GEN-1 IL-12 immunotherapy for the
localized treatment of ovarian cancer. General and
administrative expenses were $6.7
million in 2015 compared to $8.9
million in the prior year. This $2.2 million decrease in general and
administrative expenses in 2015 is primarily the result of lower
insurance premiums, reductions in personnel costs and reduced
marketing expenses when compared to 2014.
Net cash used in operations was $20.8
million in 2015 compared to $21.4
million in the prior year. The Company ended 2015 with
$20.1 million of total cash,
investments and accrued interest on these investments.
Quarterly Conference Call
The Company is hosting a conference call to provide a business
update and discuss year-end 2015 financial results at 11:00 a.m. ET on Wednesday, March 30, 2016. To participate in the
call, interested parties may dial 1-800-505-9587
(Toll-Free/North America) or
1-416-204-9524 (International/Toll) and ask for the Celsion
Corporation Year-End 2015 Conference Call (Conference Code:
4103364) to register ten minutes before the call is scheduled to
begin. The call will also be broadcast live on the internet at
www.celsion.com.
The call will be archived for replay on March 30, 2016 and will remain available until
April 13, 2016. The replay can
be accessed at 1-888-203-1112 (Toll-Free/North America) or 1-719-457-0820
(International/Toll) using Conference ID: 4103364. An audio
replay of the call will also be available on the Company's website,
www.celsion.com, for 30 days after 2:00 p.m.
ET Wednesday, March 30, 2016.
About Celsion Corporation
Celsion is a fully-integrated oncology company focused on
developing a portfolio of innovative cancer treatments, including
directed chemotherapies, immunotherapies and RNA- or DNA-based
therapies. The Company's lead program is ThermoDox®, a proprietary
heat-activated liposomal encapsulation of doxorubicin, currently in
Phase III development for the treatment of primary liver cancer and
in Phase II development for the treatment of recurrent chest wall
breast cancer. The pipeline also includes GEN-1, a DNA-based
immunotherapy for the localized treatment of ovarian and brain
cancers. Celsion has two platform technologies for the
development of novel nucleic acid-based immunotherapies and other
anti-cancer DNA or RNA therapies, including TheraPlas™ and
TheraSilence™. For more information on Celsion, visit our
website: http://www.celsion.com (CLSN-FIN).
Celsion wishes to inform readers that forward-looking
statements in this release are made pursuant to the "safe harbor"
provisions of the Private Securities Litigation Reform Act of
1995. Readers are cautioned that such forward-looking
statements involve risks and uncertainties including, without
limitation, unforeseen changes in the course of research and
development activities and in clinical trials; the uncertainties of
and difficulties in analyzing interim clinical data, particularly
in small subgroups that are not statistically significant; FDA and
regulatory uncertainties and risks; the significant expense, time,
and risk of failure of conducting clinical trials; the need for
Celsion to evaluate its future development plans; possible
acquisitions or licenses of other technologies, assets or
businesses; possible actions by customers, suppliers, competitors,
regulatory authorities; and other risks detailed from time to time
in the Celsion's periodic reports and prospectuses filed with the
Securities and Exchange Commission. Celsion assumes no
obligation to update or supplement forward-looking statements that
become untrue because of subsequent events, new information or
otherwise.
Celsion Investor Contact
Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
jchurch@celsion.com
Celsion
Corporation
|
Condensed
Statements of Operations
|
(in thousands
except per share amounts)
|
|
|
|
|
|
Year
ended
December
31,
|
|
|
2015
|
|
2014
|
|
|
|
|
|
Licensing
revenue
|
$
|
500
|
$
|
500
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
14,660
|
|
14,969
|
General and
administrative
|
|
6,687
|
|
8,861
|
Acquisition
costs
|
|
–
|
|
1,385
|
Total operating
expenses
|
|
21,347
|
|
25,215
|
Loss from
operations
|
|
(20,847)
|
|
(24,715)
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
(Loss) gain from
valuation of earn-out milestone liability
|
|
(258)
|
|
214
|
(Loss) gain valuation
of common stock warrant liability
|
|
(61)
|
|
204
|
Interest expense,
investment income and other income (expense), net
|
|
(1,295)
|
|
(1,197)
|
Total other (expense) income, net
|
|
(1,614)
|
|
(779)
|
|
|
|
|
|
Net
loss
|
$
|
(22,461)
|
$
|
(25,494)
|
|
|
|
|
|
Net loss per
common share - basic and diluted
|
$
|
(1.03)
|
$
|
(1.38)
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
|
21,813
|
|
18,472
|
|
|
|
|
|
|
|
|
|
|
|
Celsion
Corporation
|
|
Selected Balance
Sheet Information
|
|
(in
thousands)
|
|
|
|
|
|
|
|
ASSETS
|
|
December
31,
2015
|
|
December
31,
2014
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
9,265
|
$
|
12,687
|
|
Investment securities
and interest receivable on investment securities
|
|
10,827
|
|
24,383
|
|
Prepaid expenses and
other current assets
|
|
189
|
|
436
|
|
Total current
assets
|
|
20,281
|
|
37,506
|
|
|
|
|
|
|
|
Property and
equipment
|
|
855
|
|
1,171
|
|
|
|
|
|
|
|
Other
assets
|
|
|
|
|
|
In-process research
and development
|
|
25,802
|
|
25,802
|
|
Goodwill
|
|
1,976
|
|
1,976
|
|
Deposits
|
|
100
|
|
150
|
|
Other
assets
|
|
41
|
|
90
|
|
Total other
assets
|
|
27,919
|
|
28,018
|
|
|
|
|
|
|
|
Total
assets
|
$
|
49,055
|
$
|
66,695
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
4,750
|
$
|
5,937
|
|
Deferred revenue -
current portion
|
|
500
|
|
500
|
|
Note payable - current
portion
|
|
4,100
|
|
3,654
|
|
Total current
liabilities
|
|
9,350
|
|
10,091
|
|
|
|
|
|
|
|
Earn-out milestone
liability
|
|
13,921
|
|
13,664
|
|
Common stock warrant
liability
|
|
–
|
|
275
|
|
Notes payable -
noncurrent portion
|
|
2,350
|
|
6,053
|
|
Other liabilities -
noncurrent portion
|
|
3,048
|
|
3,787
|
|
Total liabilities
|
|
28,669
|
|
33,870
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
Common
stock
|
|
234
|
|
201
|
|
Additional paid-in
capital
|
|
239,668
|
|
229,779
|
|
Accumulated other
comprehensive loss
|
|
(4)
|
|
(16)
|
|
Accumulated
deficit
|
|
(218,130)
|
|
(195,074)
|
|
|
|
21,768
|
|
34,890
|
|
Less: Treasury
stock
|
|
(1,382)
|
|
(2,065)
|
|
Total stockholders' equity
|
|
20,386
|
|
32,825
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
|
49,055
|
$
|
66,695
|
|
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SOURCE Celsion Corporation