LAWRENCEVILLE, N.J.,
May 12, 2015 /PRNewswire/ -- Celsion
Corporation (NASDAQ: CLSN), an oncology drug development company,
today announced financial results for the quarter ended
March 31, 2015 and provided an update
on its development programs, including ThermoDox®, its proprietary
heat-activated liposomal encapsulation of doxorubicin, and GEN-1,
an IL-12 DNA-based immunotherapy encased in a synthetic
nanoparticle delivery system, which is currently under development
for the localized treatment of ovarian and brain cancers.
"Over the past quarter, we have reported meaningful progress
with both ThermoDox® and GEN-1," said Michael H. Tardugno, Celsion's chairman,
president and CEO. "Positive data for GEN-1 in
platinum-resistant ovarian cancer provided important insights on
its potential clinical utility and safety. Based on these
impressive results, we are preparing to launch a Phase Ib trial in
first-line ovarian cancer mid-year. We have also seen synergistic
anti-cancer effects when combining GEN-1 with Avastin®in
preclinical studies, and we look forward to launching a clinical
study later this year to further explore this combination in
platinum-resistant ovarian cancer patients."
Mr. Tardugno continued, "Remarkable interim data from our Phase
II DIGNITY study reinforces our confidence in the potential of
ThermoDox®in recurrent chest wall breast cancer.
Consequently, we are accelerating our efforts in this indication
with our upcoming Euro-DIGNITY study and our Early Access Program
in Europe. In parallel, we
continue to advance our global Phase III OPTIMA Study evaluating
ThermoDox®in primary liver cancer. With enrollment well underway in
North America, Europe and Asia
Pacific, we are evaluating exciting strategic options for
the China market."
Recent Pipeline Developments
ThermoDox®
Reported Positive Interim Data from the Phase II US DIGNITY
Study in RCW Breast Cancer. In April 2015, Celsion announced positive interim
data from its Phase II DIGNITY trial of ThermoDox® in recurrent
chest wall (RCW) breast cancer. 12 of the original 16
patients enrolled and treated were eligible for evaluation.
Based on available data, 67% of patients experienced a clinical
benefit, with a local response rate of 58%, including 5 complete
responses, 2 partial responses, and 1 patient with stable
disease. These results are consistent with previous clinical
data from the Company's Phase I DIGNITY Study and a Duke University sponsored Phase I trial of
ThermoDox® in this same refractory patient population, and warrant
our accelerated clinical study plans for Europe.
Advancing Plans to Launch the Euro-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 mid-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. With hyperthermia as an
accepted adjuvant treatment for cancer in Europe, Celsion anticipates a very receptive
patient recruitment environment for the 100 patient study.
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
and myTomorrows launched the ThermoDox Early Access Program in late
April with ThermoDox® now available 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.
Updated Overall Survival Data from Phase III HEAT Study
Continues to Strongly Support the Clinical Protocol for the OPTIMA
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. These data continue
to support the protocol for the Phase III OPTIMA Study, which is
evaluating ThermoDox® in combination with optimized RFA, which will
be standardized to a minimum of 45 minutes across all investigators
and clinical sites for treating lesions 3 to 7 centimeters, versus
standardized RFA alone. The study is expected to enroll up to 550
patients globally in up to 80 clinical sites in the United States, Europe, China
and Asia Pacific.
GEN-1 IL-12 DNA-based Immunotherapy
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. Full data from
this study will be presented at the upcoming ASCO meeting on
May 29 to June 4, 2015.
On Track to Initiate a Phase Ib Study for GEN-1 in First-Line
Ovarian Cancer in Mid-2015. Celsion expects to commence a Phase
Ib dose-escalation clinical trial of GEN-1 in combination with the
standard of care in neo-adjuvant ovarian cancer 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 II trial.
Announced GEN-1 Plus Avastin® Clinical Strategy Based on the
Combination's Synergistic Anti-Cancer Effects. Celsion is
expanding its ovarian cancer development program to include a Phase
1 dose escalating trial evaluating GEN-1 in combination with
Avastin® and Doxil® in platinum-resistant ovarian cancer patients,
expected to begin enrollment in the first half of 2016. The new
trial is supported by preclinical studies demonstrating that the
combination of GEN-1 with Avastin® may result in significant
clinical benefit with a favorable safety profile.
IND Filings for GEN-1 in Platinum Resistant Ovarian Cancer
and GBM Brain Cancer Expected in Second Half of 2015.
Celsion is conducting comprehensive preclinical studies to
support an Investigational New Drug (IND) application for clinical
studies of its GEN-1 in platinum resistant ovarian cancer in
combination with Doxil® and Avastin® and in glioblastoma multiforme
(GBM). As currently conceived, the Phase I study for GBM may
provide GEN-1 for local administration, recruiting the immune
system to combination with standard of care to treat post-surgical
patients.
Financial Results
For the quarter ended March 31,
2015, Celsion reported a net loss of $7.0 million, or $0.35 per share, compared to a net loss of
$5.4 million, or $0.33 per share, in the same period of 2014.
Operating expenses were $6.5 million
in the first quarter of 2015 compared to $5.3 million in the same period of 2014.
Net cash used in operations was $5.9
million in the first quarter of 2015 compared to
$4.8 million in the same period last
year. The Company ended the first quarter of 2015 with
$30.0 million of total cash,
investments and accrued interest on these
investments.
Research and development costs were $4.5
million in the first quarter of 2015 compared to
$2.9 million the same period last
year. The increase in 2015 is primarily due to costs
associated with the operations of EGEN, Inc., which the Company
acquired in June 2014, and the costs
associated with the initiation of the Phase III OPTIMA Study in the
first quarter of 2014. General and administrative expenses
were $2.0 million in the first
quarter of 2015 compared to $2.4
million the same period of 2014. This decrease was
primarily the result of lower insurance premiums. In the first
quarter of 2015, Celsion recorded $0.8
million in non-cash stock-based compensation expense
compared to $0.6 million in the same
period of 2014.
Quarterly Conference Call
The Company is hosting a conference call to provide a business
update and discuss first quarter 2015 financial results at
11:00 a.m. EDT on Tuesday, May 12, 2015. To participate in the
call, interested parties may dial 1-888-427-9411
(Toll-Free/North America) or
1-719-457-2661 (International/Toll) and ask for the Celsion
Corporation First Quarter 2015 Conference Call (Conference Code:
5892530) 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 May 12, 2015 and will remain available until
May 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: 5892530. 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. EDT Thursday, May 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)
|
|
|
|
Three Months
Ended
March
31,
|
|
|
2015
|
|
2014
|
|
|
|
|
|
Licensing
revenue
|
$
|
125
|
$
|
125
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
4,506
|
|
2,893
|
General and
administrative
|
|
2,032
|
|
2,434
|
Total operating
expenses
|
|
6,538
|
|
5,327
|
Loss from
operations
|
|
(6,413)
|
|
(5,202)
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
(Loss) gain from
valuation of common stock warrant liability
|
|
(43)
|
|
3
|
(Loss) from valuation
of earn-out milestone liability
|
|
(172)
|
|
–
|
Interest, dividends
and other income (expense), net
|
|
(377)
|
|
(224)
|
Total other income
(expense), net
|
|
(592)
|
|
(221)
|
Net Loss from
operations
|
$
|
(7,005)
|
$
|
(5,423)
|
|
|
|
|
|
Net loss per
common share –
basic and
diluted
|
$
|
(0.35)
|
$
|
(0.33)
|
|
|
|
|
|
Weighted average
common shares outstanding – basic and diluted
|
|
19,990
|
|
16,371
|
|
|
|
|
|
Celsion
Corporation
Selected Balance
Sheet Information
(in
thousands)
|
|
ASSETS
|
|
March
31,
2015
|
|
December 31,
2014
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
$
|
7,614
|
$
|
12,687
|
Investment securities
and interest receivable
on investment securities
|
|
22,434
|
|
24,383
|
Prepaid expenses and
other current assets
|
|
625
|
|
436
|
Total current
assets
|
|
30,673
|
|
37,506
|
|
|
|
|
|
Property and
equipment
|
|
1,106
|
|
1,171
|
|
|
|
|
|
Other
assets
|
|
|
|
|
In-process research
and development
|
|
25,802
|
|
25,802
|
Goodwill
|
|
1,976
|
|
1,976
|
Deposits
|
|
150
|
|
150
|
Other
assets
|
|
77
|
|
90
|
Total other
assets
|
|
28,005
|
|
28,018
|
|
|
|
|
|
Total
assets
|
$
|
59,784
|
$
|
66,695
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
6,036
|
$
|
5,937
|
Deferred revenue –
current portion
|
|
500
|
|
500
|
Note payable - current
portion
|
|
3,756
|
|
3,654
|
Total current
liabilities
|
|
10,292
|
|
10,091
|
|
|
|
|
|
Earn-out milestone
liability
|
|
13,836
|
|
13,664
|
Common stock warrant
liability
|
|
318
|
|
275
|
Notes payable –
noncurrent portion
|
|
5,188
|
|
6,053
|
Other liabilities –
noncurrent portion
|
|
3,446
|
|
3,787
|
Total
liabilities
|
|
33,080
|
|
33,870
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
Common
stock
|
|
201
|
|
201
|
Additional paid-in
capital
|
|
230,628
|
|
229,779
|
Accumulated other
comprehensive loss
|
|
(8)
|
|
(16)
|
Accumulated
deficit
|
|
(202,253)
|
|
(195,074)
|
|
|
28,568
|
|
34,890
|
Less: Treasury
stock
|
|
(1,864)
|
|
(2,065)
|
Total stockholders'
equity
|
|
26,704
|
|
32,825
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
$
|
59,784
|
$
|
66,695
|
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SOURCE Celsion Corporation