LAWRENCEVILLE, N.J.,
March 12, 2015 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced financial results for the year
ended December 31, 2014 and provided
an update on its development programs for ThermoDox®, its
proprietary heat-activated liposomal encapsulation of doxorubicin,
and two newly acquired technology platforms, TheraPlas™ and
TheraSilence™, in immunotherapy and RNA delivery. 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, 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 and is currently
under development for the localized treatment of ovarian and brain
cancers.
"We enter 2015 well-positioned as we continue to make
significant progress in our ongoing clinical, regulatory and
business strategies. With the substantial and growing support
from the medical and scientific community, the encouragement of key
regulatory bodies in the United
States, Europe and
Asia, a strong balance sheet, and
impressive overall survival data from the HEAT Study, we are
especially encouraged by progress in our clinical development
program for ThermoDox in both primary liver cancer and RCW breast
cancer," said Michael H. Tardugno,
Celsion's president and CEO. "The immunotherapy and RNA
therapy platforms that we gained when we acquired EGEN provide
synergy, complementary assets and multiple opportunities to create
additional value for our shareholders, and we look forward to
advancing GEN-1 into a first-line ovarian cancer study mid-year and
to the prospect of a high potential GBM program shortly
thereafter."
Recent Pipeline Developments
ThermoDox®
Reported Convincing Updated Survival Data from Phase III HEAT
Study. As of January 15,
2015, the latest quarterly overall survival (OS) analysis
demonstrated that in a large, well bounded, subgroup of patients
(n=285, 41% of the study patients), the combination of ThermoDox®
and optimized RFA provided a 59% improvement in OS compared to
optimized RFA alone. The Hazard Ratio at this analysis is 0.628
(95% CI 0.420 - 0.939) with a p-value of 0.02. This data continues
to suggest that ThermoDox® may significantly improve OS compared to
a RFA control in patients whose lesions undergo optimized RFA
treatment for 45 minutes or more.
"These findings provide a strong rationale for the ongoing
OPTIMA Study and may also underscore the interest of clinical
investigators to evaluate the potential of ThermoDox plus optimized
RFA for curative intent among intermediate stage HCC patients,"
noted Riccardo Lencioni, MD, FSIR,
EBIR, professor and director of the diagnostic imaging and
intervention at the Pisa University School of Medicine in
Italy.
Partnered with myTomorrows to Introduce the ThermoDox®
Early Access Program (EAP) in Europe. In January 2015, Celsion announced a license and
distribution agreement with myTomorrows to implement an EAP for
ThermoDox® in all countries of the European Union territory plus
Switzerland for the treatment of
patients with recurrent chest wall (RCW) breast cancer. The Company
expects to have ThermoDox® available in the second quarter of 2015
for sales to physicians who are treating patients with limited
therapeutic options. The EAP provides physicians with access to
products in later stage development demonstrating evidence of
clinical benefit, with an acceptable safety profile and a quality
manufacturing process in place. Celsion will be allowed to
price ThermoDox at commercial rates.
Advancing Plans to Launch the DIGNITY Study in
Europe. Reflecting remarkable overall response rates in
prior studies of patients with refractory disease, Celsion
remains on track to initiate the Euro-DIGNITY Trial of ThermoDox®
plus hyperthermia in patients with RCW breast cancer in the first
half of 2015. The study will be conducted in five countries with
the eventual objective of an RCW breast cancer label for ThermoDox.
Celsion will conduct the trial with the support of key European
investigators and with assistance from MedLogics Corporation, an
Italian-based hyperthermia device company.
Expanded Pivotal OPTIMA Study in Europe. In
September 2014, Celsion announced
that the first patient had been enrolled in its pivotal Phase III
OPTIMA Study of ThermoDox® in combination with optimized
radiofrequency ablation (RFA) in patients with primary liver
cancer. In November 2014, the OPTIMA
Study was approved via Europe's
centralized Voluntary Harmonization Procedure, allowing the Company
to begin enrolling patients at 14 clinical sites in Germany, Italy, France
and Spain. The Company is
aggressively initiating sites in North
America, Europe and
Asia Pacific and expects to enroll
550 patients at up to 100 clinical sites in 13 countries.
GEN-1 Immunotherapy
Announced Plans for a Phase Ib Study for GEN-1 in First-Line
Ovarian Cancer. In February
2015, Celsion announced that the U.S. Food and Drug
Administration (FDA) has accepted, without comment, its planned
Phase Ib dose-escalation clinical trial of GEN-1 in combination
with the standard of care in neo-adjuvant ovarian cancer, which is
expected to commence in mid-2015 at five to six U.S. clinical
centers. The study will evaluate safety and efficacy and attempt to
define an optimal dose and an enhanced patient population to carry
forward into a Phase 2 trial.
Presented Phase Ib Data for GEN-1 in Platinum-Resistant
Ovarian Cancer. The Company presented preliminary data
from its recently completed study of GEN-1, its IL-12 coded DNA
plasmid nanoparticle, in combination with pegylated doxorubicin in
16 patients with platinum-resistant ovarian cancer at the Molecular
Medicine TRI-Conference in February
2015. The findings demonstrated that there were no
overlapping toxicities between GEN-1, its subsequent immune system
activation, and pegylated doxorubicin. An abstract for
this study detailing efficacy findings and clinical response
results has been submitted to ASCO for its upcoming annual
conference in the second quarter.
Ongoing Preclinical Studies in GBM to Support IND Filing in
Mid-2015. Celsion is conducting comprehensive preclinical
studies to support an Investigational New Drug (IND) application
for clinical studies of its immune system activator, GEN-1, in
glioblastoma multiforme (GBM). As currently conceived, the
Phase I study would provide GEN-1 for local administration,
recruiting the immune system to combination with temozolomide to
treat post-surgical patients. The study will recruit
chemotherapy naive patients, whose immune system is theorized, will
respond actively to IL-12 DNA-based immunotherapy.
TheraSilence
Presented Preclinical Data for TheraSilence™ Platform at the
miRNA World Conference Workshop on miRNA Delivery. In
October 2014, Celsion highlighted
formulation characteristics of its TheraSilence™ delivery platform,
preclinical proof-of-concept data and data supportive of GEN-2 at
the miRNA World Conference Workshop on miRNA Delivery.
Financial Results
For the year ended December 31,
2014, Celsion reported a net loss of $25.5 million, or $1.38 per share, compared to a net loss of
$12.9 million, or $0.95 per share, in 2013. Operating expenses were
$25.2 million in 2014 compared to
$15.9 million in 2013.
Operating expenses in 2014 included a $1.4 million one-time charge in connection with
the acquisition of the assets of EGEN, Inc. In 2013, Celsion
recorded an $8.1 million non-cash
gain related to the change in the common stock warrant liability
compared to a $0.2 million non-cash
gain in the current year.
Research and development costs were $15.0
million in 2014 compared to $9.3
million in the prior year. The increase in 2014 is
primarily due to costs associated with the startup of the Phase III
OPTIMA Study and the integration of the operations associated with
the acquisition of EGEN, Inc. in June 2014. General and
administrative expenses were $8.9
million in 2014 compared to $6.5
million in the prior year due to higher personnel-related
costs and professional fees. In 2014, Celsion recorded
$2.6 million in non-cash
stock-based compensation expense compared to $1.2 million in the same period of last year.
Net cash used in operations was $21.4
million in 2014 compared to $9.5
million in the prior year. The Company ended 2014 with
$37.1 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 2014 financial results at 11:00 a.m. ET on Thursday,
March 12, 2015. To participate in the call, interested
parties may dial 1-888-428-9480 (Toll-Free/North America) or 1-719-785-1765
(International/Toll) and ask for the Celsion Corporation Year-End
2014 Conference Call (Conference Code: 3652186) to register ten
minutes before the call is scheduled to begin. The call will also
be broadcast live on the internet at http://www.celsion.com.
The call will be archived for replay on March 12, 2015 and will remain available until
March 26, 2015. The replay can
be accessed at 1-888-203-1112 (Toll-Free/North America) or 1-719-457-0820
(International/Toll) using Conference ID: 3652186. An audio replay
of the call will also be available on the Company's website,
http://www.celsion.com, for 30 days after 2:00 p.m. ET Thursday, March 12, 2015.
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 three platform technologies for the
development of novel nucleic acid-based immunotherapies and other
anti-cancer DNA or RNA therapies, including TheraPlas™,
TheraSilence™ and RAST ™. For more information on Celsion,
visit our website: http://www.celsion.com.
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 or the possible failure to make such acquisitions or
licenses; 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
Senior 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,
|
|
|
2014
|
|
2013
|
|
|
|
|
|
Licensing
revenue
|
$
|
500
|
$
|
500
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
14,969
|
|
9,364
|
General and
administrative
|
|
8,861
|
|
6,547
|
Acquisition
costs
|
|
1,385
|
|
–
|
Total operating
expenses
|
|
25,215
|
|
15,911
|
Loss from
operations
|
|
(24,715)
|
|
(15,411)
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Gain from valuation of
common stock warrant liability
|
|
204
|
|
8,090
|
Gain from valuation of
earn-out milestone liability
|
|
214
|
|
–
|
Interest, dividends
and other income (expense), net
|
|
(1,197)
|
|
(930)
|
Total other income
(expense), net
|
|
(779)
|
|
7,160
|
Net Loss from
operations
|
|
(25,494)
|
|
(8,251)
|
Non-cash
deemed dividend from
beneficial conversion
feature on
convertible preferred stock
offering
|
|
–
|
|
(4,601)
|
Net loss
attributable to common shareholders
|
$
|
(25,494)
|
$
|
(12,852)
|
|
|
|
|
|
Net loss per
common share –
basic and
diluted
|
$
|
(1.38)
|
$
|
(0.95)
|
|
|
|
|
|
Weighted average
common shares outstanding – basic and diluted
|
|
18,472
|
|
13,541
|
|
|
|
|
|
Celsion
Corporation
|
|
Selected Balance
Sheet Information
|
|
(in
thousands)
|
|
|
|
|
|
|
|
ASSETS
|
|
December
31,
2014
|
|
December 31,
2013
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
12,687
|
$
|
5,719
|
|
Investment securities
and interest receivable on investment securities
|
|
24,383
|
|
37,368
|
|
Prepaid expenses and
other current assets
|
|
436
|
|
675
|
|
Total current
assets
|
|
37,506
|
|
43,762
|
|
|
|
|
|
|
|
Property and
equipment
|
|
1,171
|
|
833
|
|
|
|
|
|
|
|
Other
assets
|
|
|
|
|
|
In-process research
and development
|
|
25,802
|
|
–
|
|
Goodwill
|
|
1,976
|
|
–
|
|
Deposits
|
|
150
|
|
200
|
|
Other
assets
|
|
90
|
|
876
|
|
Total other
assets
|
|
28,018
|
|
1,076
|
|
|
|
|
|
|
|
Total
assets
|
$
|
66,695
|
$
|
45,671
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
5,937
|
$
|
4,160
|
|
Deferred revenue –
current portion
|
|
500
|
|
500
|
|
Note payable - current
portion
|
|
3,654
|
|
11
|
|
Total current
liabilities
|
|
10,091
|
|
4,671
|
|
|
|
|
|
|
|
Earn-out milestone
liability
|
|
13,664
|
|
–
|
|
Common stock warrant
liability
|
|
275
|
|
3
|
|
Notes payable –
noncurrent portion
|
|
6,053
|
|
5,000
|
|
Other liabilities –
noncurrent portion
|
|
3,787
|
|
4,473
|
|
Total
liabilities
|
|
33,870
|
|
14,147
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
Common
stock
|
|
201
|
|
137
|
|
Additional paid-in
capital
|
|
229,779
|
|
203,139
|
|
Accumulated other
comprehensive loss
|
|
(16)
|
|
(44)
|
|
Accumulated
deficit
|
|
(195,074)
|
|
(169,287)
|
|
|
|
34,890
|
|
33,945
|
|
Less: Treasury
stock
|
|
(2,065)
|
|
(2,421)
|
|
Total stockholders'
equity
|
|
32,825
|
|
31,524
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
$
|
66,695
|
$
|
45,671
|
|
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SOURCE Celsion Corporation