LAWRENCEVILLE, N.J.,
March 13, 2014 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced financial results for the year
ended December 31, 2013, and provided
an update on its clinical trials of ThermoDox®, Celsion's
proprietary heat-activated liposomal encapsulation of
doxorubicin. ThermoDox is being evaluated in a Phase III
clinical trial for primary liver cancer and a Phase II clinical
trial for recurrent chest wall breast cancer.
The Company is on track to launch its planned pivotal,
double-blind, placebo-controlled Phase III trial of ThermoDox in
combination with RFA in primary liver cancer, also known as the
OPTIMA study, in the first half of 2014. The trial design is based
on a comprehensive analysis of data from the 701-patient clinical
trial (the HEAT study), which demonstrated that treatment with
ThermoDox resulted in a 55 percent improvement in overall survival
in a substantial number of patients that received an optimized RFA
treatment. In addition, the Company recently met with the China
State Food and Drug Administration (SFDA) to discuss the Phase III
trial, including minimum patient enrollment requirements supporting
ThermoDox's registration in China.
Based on those discussions, the Company is submitting an
application for accelerated approval of the study in China. The Company plans to expand its
clinical site footprint in Europe
for the OPTIMA study and meet with the European Medicines Agency
(EMA) in the first half of 2014.
"In 2013, we focused on defining our clinical strategy for
ThermoDox, a drug technology that has shown remarkable potential in
one of the most difficult and prevalent cancers, and positioning
the Company to deliver on the ThermoDox value proposition," said
Michael H. Tardugno, Celsion's
President and Chief Executive Officer. "We enter 2014
well-positioned to execute our clinical, regulatory and business
development strategies. With the growing support of the
medical and scientific community, the encouragement of key
regulatory bodies in the United
States and Asia, a strong
balance sheet, and impressive survival data we are confident in our
clinical development program for ThermoDox in HCC, and are
optimistic that we will identify additional pipeline opportunities
that provide synergy, complementary assets and improved valuation
potential for our shareholders."
Recent Business Developments
Reported FDA Allowance to Launch Pivotal OPTIMA
Study. In February 2014, we
announced that the U.S. Food and Drug Administration (FDA) has
reviewed and has allowed the Company's planned pivotal,
double-blind, placebo-controlled Phase III trial of ThermoDox®, its
proprietary heat-activated liposomal encapsulation of doxorubicin
in combination with RFA in primary liver cancer, also known as
hepatocellular carcinoma (HCC). The Phase III OPTIMA Study is
expected to enroll 550 patients globally, with up to 100 sites in
the United States, Europe, China
and Asia Pacific and will evaluate
ThermoDox in combination with RFA, which will be standardized to a
minimum of 45 minutes across all investigators and sites for
treating lesions 3 to 7 centimeters, versus standardized RFA alone.
The primary endpoint for the trial is overall survival (OS).
The statistical plan calls for two interim efficacy analyses by an
independent Data Monitoring Committee (iDMC).
Reported Compelling Updated Data from Phase III HEAT
Study. In January 2014,
Celsion reported updated data from its post-hoc data from the
Company's HEAT Study. As provided for in the HEAT Study's Special
Protocol Assessment (SPA) agreement with the FDA, the Company
continues to follow patients for overall survival, the secondary
endpoint of the study. Data from the updated HEAT Study
analysis suggests that ThermoDox may significantly improve overall
survival, compared to control, in patients whose lesions undergo
RFA treatment for 45 minutes or more. Specifically, the patient
subgroup in the ThermoDox arm whose RFA procedure lasted longer
than 45 minutes (285 patients or 63% of single lesion patients)
experienced a 55% improvement in overall survival, with a Hazard
Ratio of 0.64 (95% CI 0.41 - 1.00) and a P-value = 0.0495. Median
overall survival for this subgroup has not yet been reached.
Celsion will continue to follow patients in the HEAT Study on a
quarterly basis.
Reported Positive Interim Data Phase II DIGNITY Trial in
Breast Cancer. In February
2014, Celsion reported positive interim data from its
ongoing open-label Phase II DIGNITY Trial of ThermoDox in Recurrent
Chest Wall Breast Cancer (RCWBC). The trial will enroll 20
patients at 5 clinical sites in the
United States and is evaluating ThermoDox in combination
with mild hyperthermia. Based on data available to date, a local
response rate of 80% has been observed in the 5 evaluable patients
with refractory disease, notably 2 complete responses (CR), 2
partial responses (PR) and 1 patient with stable disease
(SD).
Reported Promising Phase 1 Data for ThermoDox in Breast
Cancer. In December 2013,
Celsion reported combined clinical data from two Phase I trials,
the Company's Phase I DIGNITY Study and the Duke University sponsored Phase I trial of
ThermoDox plus hyperthermia in BCRCW. There were 29 patients
treated in the two trials (11 patients in the Company's DIGNITY
study and 18 patients in the Duke
study). Of the 29 patients treated, 23 were eligible for
evaluation of efficacy. A local response rate of over 60% was
reported in 14 of the 23 evaluable patients with 5 complete
responses and 9 partial responses. These data were presented in
December at the San Antonio Breast Cancer Conference by the Study's
lead principal investigator, Hope
Rugo MD, of the UC San Francisco Medical Center.
Initiated Development for Glioblastoma Brain Tumors with
ThermoDox and HIFU. In January
2014, the Company announced plans to pursue the development
of ThermoDox to investigate applications for treating brain cancer
tumors, notably Glioblastoma Multiforme or GBM. In addition to
jointly submitting multiple grant applications, the company is also
pursuing preclinical studies in collaboration with Dr. Costas D.
Arvanitis at the Brigham and Women's Hospital and Harvard Medical
School. Experiments will study the use of ThermoDox in
combination with MR guided High Intensity Focused Ultrasound (HIFU)
to treat brain tumors, initially in animal models.
Strengthened Balance Sheet with Strategic Loan Facility and
Registered Direct Offering. In January
2014, Celsion raised approximately $15 million in an at-the-market registered direct
offering. In November 2013, Celsion
entered into a loan agreement with Hercules Technology Growth
Capital, Inc. that would permit up to $20
million in new capital distributable in multiple tranches
with agreement from Hercules. Celsion drew the first tranche
of $5 million upon closing of the
loan agreement on November 25,
2013.
Financial Results
For the year ended December 31,
2013, Celsion reported a net loss of $12.9 million, or $0.95 per share, compared to a net loss of
$26.6 million, or $3.44 per share, in 2012. Net cash used in
operations was $9.5 million in 2013
compared to $22.3 million in the
prior year. Operating expenses dropped to $15.9 million in 2013 compared to $22.1 million in 2012. In 2013, Celsion recorded
an $8.1 million non-cash gain related
to the change in the common stock warrant liability compared to a
$4.1 million non-cash charge in the
same period of last year. In 2013, the Company recognized
$0.5 million in licensing revenue
related to the technology development collaboration with Zhejiang
Hisun Pharmaceutical Company Ltd., compared to zero revenue in
2012.
Research and development costs were $6.4
million lower in 2013 compared to the prior year, primarily
due to the completion of patient enrollment in the HEAT Study in
the first half of 2012. General and administrative expenses
were relatively constant at $6.5
million in 2013 compared to prior year levels as a result of
the corporate restructuring program implemented in April 2013.
The Company ended 2013 with $43.8
million of total cash, investments and accrued interest on
these investments. Subsequent to year-end, the Company
strengthened its balance sheet by raising an additional
$13.8 million in aggregate net
proceeds through a common stock equity offering in January 2014.
Quarterly Conference Call
The Company is hosting a conference call to provide a business
update and discuss year-end 2013 financial results at 11:00 a.m. ET on Thursday,
March 13, 2014. To participate in the call, interested
parties may dial 1-888-572-7033 (Toll-Free/North America) or 1-719-325-2469
(International/Toll) and ask for the Celsion Corporation
4th Quarter 2013 Conference Call (Conference Code:
6632100) 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 13, 2014 and will remain available until
March 27, 2014. The replay can
be accessed at 1-888-203-1112 (Toll-Free/North America) or 1-719-457-0820
(International/Toll) using Conference ID: 6632100. 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 13, 2014.
About Celsion Corporation
Celsion is dedicated to the development and commercialization of
innovative cancer drugs, including tumor-targeting treatments using
focused heat energy in combination with heat-activated liposomal
drug technology. Celsion has research, license or
commercialization agreements with leading institutions, including
the National Institutes of Health, Duke
University Medical Center, University
of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the
Kyungpook National University Hospital,
the Beijing Cancer Hospital and the University of Oxford. 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; HEAT Study data
is subject to further verification and review by the HEAT Study
Data Management Committee; 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
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,
|
|
|
2013
|
|
2012
|
|
|
|
|
|
Licensing
revenue
|
$
|
500
|
$
|
-
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
9,364
|
|
15,770
|
General and
administrative
|
|
6,547
|
|
6,373
|
Total operating
expenses
|
|
15,911
|
|
22,143
|
Loss from
operations
|
|
(15,411)
|
|
(22,143)
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Gain (loss) from
valuation of common stock warrant liability
|
|
8,090
|
|
(4,118)
|
Interest, dividends
and other income (expense), net
|
|
(931)
|
|
(307)
|
Total other income
(expense), net
|
|
7,160
|
|
(4,425)
|
Net Loss from
operations
|
|
(8,251)
|
|
(26,568)
|
Non-cash
deemed dividend from
beneficial conversion
feature on
convertible preferred stock
offering
|
|
(4,601)
|
|
-
|
Net loss
attributable to common shareholders
|
$
|
(12,852)
|
$
|
(26,568)
|
|
|
|
|
|
Net loss per
common share –
basic and
diluted
|
$
|
(0.95)
|
$
|
(3.44)
|
|
|
|
|
|
Weighted average
common shares outstanding –
basic
and diluted
|
|
13,541
|
|
7,731
|
|
|
|
|
|
|
|
|
|
Celsion
Corporation
|
|
Selected Balance
Sheet Information
|
|
(in
thousands)
|
|
|
|
ASSETS
|
|
December
31,
2013
|
|
December
31,
2012
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
5,719
|
$
|
14,991
|
|
Investment securities
and interest receivable on
investment
securities
|
|
37,368
|
|
8,104
|
|
Prepaid expenses and
other current assets
|
|
675
|
|
554
|
|
Total current
assets
|
|
43,762
|
|
23,649
|
|
|
|
|
|
|
|
Property and
equipment
|
|
833
|
|
1,115
|
|
|
|
|
|
|
|
Other
assets
|
|
|
|
|
|
Deposits
|
|
200
|
|
250
|
|
Other
assets
|
|
876
|
|
345
|
|
Total other
assets
|
|
1,076
|
|
595
|
|
|
|
|
|
|
|
Total
assets
|
$
|
45,671
|
$
|
25,359
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
4,160
|
$
|
3,595
|
|
Deferred revenue –
current portion
|
|
500
|
|
-
|
|
Note payable -
current portion
|
|
11
|
|
1,410
|
|
Total current
liabilities
|
|
4,671
|
|
5,005
|
|
|
|
|
|
|
|
Common stock warrant
liability
|
|
3
|
|
4,284
|
|
Notes payable –
noncurrent portion
|
|
5,000
|
|
3,661
|
|
Other liabilities –
noncurrent portion
|
|
4,473
|
|
447
|
|
Total
liabilities
|
|
14,147
|
|
13,397
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
Common
stock
|
|
137
|
|
380
|
|
Additional paid-in
capital
|
|
203,139
|
|
165,276
|
|
Accumulated other
comprehensive loss
|
|
(44)
|
|
(127)
|
|
Accumulated
deficit
|
|
(169,287)
|
|
(150,877)
|
|
|
|
33,945
|
|
14,652
|
|
Less: Treasury
stock
|
|
(2,421)
|
|
(2,690)
|
|
Total stockholders'
equity
|
|
31,524
|
|
11,962
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
$
|
45,671
|
$
|
25,359
|
|
SOURCE Celsion Corporation