LAWRENCEVILLE, N.J.,
Nov. 11, 2014 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced financial results for the
third quarter ended September 30,
2014. The Company also 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.
"We have successfully completed our integration of EGEN's
operations and development programs. Our organization is now fully
positioned to execute our strategy for ThermoDox® and to build
momentum as we advance our multi-stage pipeline of high value
oncology programs," said Michael H.
Tardugno, Celsion's Chairman, President and Chief Executive
Officer. "Our pivotal Phase III OPTIMA Study for ThermoDox® in
primary liver cancer is progressing nicely, with sites actively
enrolling patients and tangible progress in our global regulatory
strategy. Enrollment in our Phase II DIGNITY Study for
recurrent chest wall (RCW) breast cancer is nearing completion.
Based on the extraordinary tumor response findings observed to date
in this trial, we are working with noted thought leaders to launch
a similar RCW breast cancer study in Europe. For EGEN-001, with guidance from
investigators from MD Anderson, Roswell Park, University of Chicago, and Washington University, among others, our clinical
plans in ovarian cancer and GBM remain on track to initiate studies
in both indications next year. We were also pleased to share
encouraging data from our TheraSilence™ program at the miRNA World
Conference in October, and look forward to reporting additional
data from all our development programs before year-end."
Recent Corporate Highlights
Successfully Integrated EGEN, Inc. Operations and Development
Programs. In June, Celsion completed its acquisition of EGEN,
Inc., a privately-held biopharmaceutical company focused on the
development of nucleic acid-based therapeutics for the treatment of
cancer and other difficult-to-treat diseases. The "investor
friendly" acquisition provides for milestone-based payments and
includes: EGEN's Phase Ib DNA-based immunotherapy product candidate
EGEN-001; GEN-2, an RNA interference (RNAi) therapeutic for
the treatment of lung cancer; the TheraPlas™ platform for delivery
of DNA and mRNA; and TheraSilence™ for the delivery of RNA.
Enrolled First Patient in the Phase III OPTIMA
Study. In early September, 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. The
trial is expected to enroll 550 patients at up to 100 sites in
North America, Europe, China
and Asia Pacific. The primary
endpoint for the trial is Overall Survival. The statistical plan
calls for two interim efficacy analyses by an independent Data
Monitoring Committee (iDMC).
Received Authorization for the OPTIMA Study in Europe through the rigorous Virtual
Harmonization Procedure (VHP). In October, Celsion
received approval for VHP request, which provided for the
assessment of multinational clinical trial applications across
several European countries. The approval allows Celsion to
broaden its footprint in Europe
and activate clinical sites in Spain, France, Germany and Italy. The Company is
aggressively initiating sites in North
America, Europe and
Asia Pacific for the OPTIMA
Study.
Presented HEAT Study Overall Survival Data at the 2014
International Liver Cancer Association (ILCA) Annual Conference.
In September, Celsion announced three presentations
highlighting ThermoDox® at the 2014 ILCA Annual Conference,
including results from a retrospective analysis of the 701-patient
HEAT Study of ThermoDox® in combination with RFA in
primary liver cancer, which strongly supports the rationale for an
optimized RFA regimen when using ThermoDox®. As of
June 30, 2014, 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 57% improvement in OS compared to optimized RFA alone. The Hazard
Ratio at this analysis is 0.639 (95% CI 0.419 - 0.974) with a
p-value of 0.037.
Reported Clinical Data on ThermoDox® in Recurrent Chest Wall
Breast Cancer. In September, Celsion published data from two
Phase I studies on ThermoDox® in recurrent chest wall breast cancer
in the International Journal of Hyperthermia. The
article describes the combined results of two similarly designed
Phase I trials with one study conducted at Duke
University and the second study conducted at other major
breast cancer centers in the U.S., in which eligible patients with
unresectable chest wall recurrences had progressed on the chest
wall after prior hormone therapy, chemotherapy, and
radiotherapy.
Announced Plans to Launch a Registration-Enabling DIGNITY
Study in Europe. Celsion today announced plans to
initiate the Euro-DIGNITY Trial of ThermoDox plus hyperthermia in
patients with recurrent chest wall breast cancer. The study will be
conducted in five countries, and has the potential to support a MAA
filing in Europe. The trial will be conducted by Celsion with
the support of key European investigators and with assistance from
MedLogics Corporation, an Italian based hyperthermia device
company. The trial is expected to launch in the first half of
2015.
Presented Preclinical Data for TheraSilence™ Platform at the
miRNA World Conference Workshop on miRNA Delivery. On
October 28, 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 quarter ended September 30,
2014, Celsion reported a net loss of $6.9 million net of acquisition costs compared to
a net loss of $4.1 million in the
same period of 2013. Net loss for the quarter ended
September 30, 2014 was impacted by
higher operating costs associated with the initiation of the OPTIMA
Study ($1.7 million), the inclusion
of operating costs of CLSN Labs ($0.7
million) and higher interest expense ($0.3 million). For the nine month period
ended September 30, 2014, Celsion
reported a net loss of $19.0 million
compared to a net loss of $4.3
million in the same prior year period. The nine month
period ended September 30, 2014
included $1.2 million of one-time
costs associated with the June 2014
acquisition of EGEN, Inc. The net loss for the nine months ended
September 30, 2014 included higher
operating costs associated with the initiation of the OPTIMA Study
($2.4 million) and operating costs of
CLSN Labs ($0.9 million)
whereasduring the nine month period ended September 30, 2013, net loss was favorably
impacted by lower operating costs ($4.9
million) coupled with the non-cash benefit of $8.1 million from the change in valuation of
common stock warrant liability associated with equity financings in
September 2009 and June 2013.
The Statement of Operations for the nine month period ended
September 30, 2013 was also impacted
by a non-cash deemed dividend from the beneficial conversion
feature of $4.6 million on the
preferred stock equity financing announced in February 2013, resulting in a net loss
attributable to common shareholders for the nine month period ended
September 30, 2013 of $8.9 million.
The Company ended the current quarter with $43.8 million in cash, investments and accrued
interest on short-term investments. Revenue from licensing
collaborations totaled $125,000 in
each of the first three quarters of 2014 and 2013. Net cash
used in operations was $14.8 million
for the nine months ended September 30,
2014 compared to $6.1 million
in the same prior year period. This $8.7 million increase in 2014 was due to higher
operating costs in 2014 related to the initiation of the Phase III
OPTIMA Study, the inclusion of post-acquisition operations for CLSN
Laboratories (EGEN, Inc.) and the one-time acquisition costs
associated with the EGEN acquisition. In addition, cash used
in operations during 2013 was favorably impacted by a $5 million cash payment from Celsion's Chinese
collaborator, Zhejiang Hisun Pharmaceutical Company, received in
January 2013 for a non-refundable
technology transfer fee. During the first nine months of
2014, the Company raised approximately $18.8
million in new capital, net of issuance costs, from the sale
of stock to certain institutional investors in January 2014 and a second draw of $5 million off its venture debt facility with
Hercules Technology Growth Capital, Inc.
Research and development (R&D) expenses increased by
$2.3 million from $2.3 million in the third quarter of 2013 to
$4.6 million in the third quarter of
2014. R&D expenses increased by $3.2 million from $7.5
million in the nine month period ended September 30, 2013 to $10.7 million in the same period of 2014.
The increase in R&D expenses was due primarily to start-up
costs associated with the Company's Phase III OPTIMA Study during
2014. General and administrative expenses were $2.0 million in the third quarter of 2014
compared to $1.4 million in the third
quarter of 2013. General and administrative expenses were
$6.8 million in the first nine months
of 2014 compared to $5.0 million in
the comparable prior year period. These increases were
primarily the result of higher insurance premiums and personnel
costs (which included an increase of $0.7
million in non-cash stock compensation expense). The
2014 expenses included one-time transaction costs of $1.2 million for legal and banking fees and due
diligence expenses associated with the June
2014 acquisition of EGEN, Inc.
Quarterly Conference Call
The Company is hosting a conference call to provide a business
update and discuss the third quarter 2014 financial results at
4:30 p.m. EST Tuesday, November 11,
2014. To participate in the call, interested parties may
dial 1-888-430-8709 (Toll-Free/North
America) or 1-719-457-1512 (International/Toll) and ask for
the Celsion Corporation Third Quarter 2014 Financial Results
Conference Call (Conference Code: 3981708) approximately 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 November 12, 2014 and will remain available until
November 26, 2014. The replay can be
accessed at 1-888-203-1112 (Toll-Free/North
America) or 1-719-457-0820 (International/Toll) using
Conference Code: 3981708. An audio replay of the call will also be
available on the Company's website, http://www.celsion.com, for 30
days after November 11, 2014.
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.
The pipeline also includes EGEN-001, 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™ and TheraSilence™. 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.
Investor Contact
Jeffrey W.
Church
Senior Vice President and
Chief Financial Officer
609-482-2455
jchurch@celsion.com
Celsion
Corporation
|
Condensed
Statements of Operations
|
(In thousands
except per share amounts)
|
(Unaudited)
|
|
|
|
|
|
|
|
Three Months
Ended September
30,
|
|
Nine Months
Ended September
30,
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
revenue
|
$
|
125
|
|
$
|
125
|
|
$
|
375
|
|
$
|
375
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
4,630
|
|
|
2,269
|
|
|
10,688
|
|
|
7,495
|
|
General and
administrative
|
|
2,044
|
|
|
1,390
|
|
|
6,783
|
|
|
5,029
|
|
Acquisition
costs
|
|
120
|
|
|
–
|
|
|
1,187
|
|
|
–
|
|
Total operating
expenses
|
|
6,794
|
|
|
3,659
|
|
|
18,658
|
|
|
12,524
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(6,669)
|
|
|
(3,534)
|
|
|
(18,283)
|
|
|
(12,149)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) from
change in valuation of common
stock warrant
liability
|
|
97
|
|
|
(519)
|
|
|
81
|
|
|
8,142
|
|
Investment income,
net
|
|
27
|
|
|
145
|
|
|
57
|
|
|
228
|
|
Interest
expense
|
|
(419)
|
|
|
(163)
|
|
|
(912)
|
|
|
(520)
|
|
Other
expense
|
|
22
|
|
|
(1)
|
|
|
19
|
|
|
(3)
|
|
Total other
(expense) income, net
|
|
(273)
|
|
|
(538)
|
|
|
(755)
|
|
|
7,847
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
|
(6,942)
|
|
|
(4,072)
|
|
|
(19,038)
|
|
|
(4,302)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash deemed
dividend from beneficial conversion feature on convertible
preferred stock
|
|
–
|
|
|
─
|
|
|
–
|
|
|
(4,601)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
attributable to common shareholders
|
$
|
(6,942)
|
|
$
|
(4,072)
|
|
$
|
(19,038)
|
|
$
|
(8,903)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
attributable to common shareholders per common share
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
$
|
(0.35)
|
|
$
|
(0.30)
|
|
$
|
(1.06)
|
|
$
|
(0.76)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
19,964
|
|
|
13,602
|
|
|
17,949
|
|
|
11,756
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celsion
Corporation
|
Selected Balance
Sheet Information
|
(In
thousands)
|
|
|
|
|
|
|
|
ASSETS
|
|
September
30,
2014
(Unaudited)
|
|
December 31,
2013
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
4,558
|
$
|
5,719
|
|
Short term investments
and accrued interest
|
|
39,254
|
|
37,368
|
|
Other current
assets
|
|
687
|
|
675
|
|
Total current
assets
|
|
44,499
|
|
43,762
|
|
|
|
|
|
|
|
Property and
equipment
|
|
1,044
|
|
833
|
|
|
|
|
|
|
|
Other
assets
|
|
|
|
|
|
In-process research
and development
|
|
25,802
|
|
–
|
|
Goodwill
|
|
1,976
|
|
–
|
|
Deposits, deferred
fees and other assets
|
|
236
|
|
1,055
|
|
Patent license fees,
net
|
|
15
|
|
21
|
|
Total other
assets
|
|
28,029
|
|
1,076
|
|
|
|
|
|
|
|
Total
assets
|
$
|
73,572
|
$
|
45,671
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
6,211
|
$
|
4,160
|
|
Notes payable –
current portion
|
|
2,701
|
|
11
|
|
Deferred revenue –
current portion
|
|
500
|
|
500
|
|
Total current
liabilities
|
|
9,412
|
|
4,671
|
|
|
|
|
|
|
|
Earn-out milestone
liability
|
|
13,878
|
|
–
|
|
Common stock warrant
liability
|
|
398
|
|
3
|
|
Notes payable, net of
discounts
|
|
6,888
|
|
5,000
|
|
Deferred
revenue
|
|
3,625
|
|
4,000
|
|
Other non-current
liabilities
|
|
454
|
|
473
|
|
Total
liabilities
|
|
34,655
|
|
14,147
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
Preferred
stock
|
|
–
|
|
–
|
|
Common
stock
|
|
201
|
|
137
|
|
Additional paid-in
capital
|
|
229,447
|
|
203,139
|
|
Accumulated other
comprehensive loss
|
|
(26)
|
|
(44)
|
|
Accumulated
deficit
|
|
(188,501)
|
|
(169,287)
|
|
Subtotal
|
|
41,121
|
|
33,945
|
|
Less: Treasury
stock
|
|
(2,204)
|
|
(2,421)
|
|
Total stockholders'
equity
|
|
38,917
|
|
31,524
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
|
73,572
|
$
|
45,671
|
|
SOURCE Celsion Corporation