LAWRENCEVILLE, N.J.,
Aug. 10, 2015 /PRNewswire/
-- Celsion Corporation (NASDAQ: CLSN), an oncology drug
development company, today announced financial results for the
quarter ended June 30, 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 few months, we reported positive data
highlighting the multiple development opportunities for our
portfolio, launched our European Early Access Program for ThermoDox
in recurrent chest wall breast cancer and strengthened our balance
sheet, providing a strong foundation as we advance our pipeline,"
said Michael H. Tardugno, Celsion's
chairman, president and CEO. "We remain on track to initiate
key clinical studies this year, including the Euro-DIGNITY study
evaluating ThermoDox in breast cancer, a Phase 1b trial for GEN-1
in first-line ovarian cancer, and a trial evaluating GEN-1 with
Avastin® in platinum-resistant ovarian cancer patients. In
parallel, we continue enroll patients from North America, Europe and Asia
Pacific in our global Phase III OPTIMA Study evaluating
ThermoDox® in primary liver cancer. Finally, we continue to
evaluate ways to leverage our TheraSilence technology platform to
advance the development of RNAi therapeutics that can be delivered
directly to the lung."
Recent Developments
ThermoDox®
Reported Positive Interim Data from the Phase II US DIGNITY
Study in RCW Breast Cancer.
In July 2015, Celsion announced
continuing positive interim data from its Phase II DIGNITY trial of
ThermoDox® in recurrent chest wall (RCW) breast cancer. Of
the 17 patients enrolled and treated in the DIGNITY Study, 13 were
eligible for evaluation of efficacy. Based on available data,
every patient experienced a clinical benefit of their highly
refractory disease with a local response rate of 69% observed in
the 13 evaluable patients, notably 5 complete responses, 4 partial
responses and 4 patients with stable disease.
Announced Updated Overall Survival Data from Phase III HEAT
Study, Providing Strong Support for the Clinical Protocol for the
Phase III OPTIMA Study.
As of July 15, 2015, the latest
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 58%
improvement in OS compared to optimized RFA alone. The Hazard Ratio
at this analysis is 0.63 (95% CI 0.43 - 0.93) with a p-value of
0.0198. Median overall survival for the ThermoDox® group has been
reached which translates into a 25.4 month (2.1 year) survival
benefit over the optimized RFA only group (79 months for the
ThermoDox® plus optimized RFA group versus 53.6 months for the
optimized RFA only group). 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 75 clinical sites in the United States, Europe, China
and Asia Pacific.
Launched the ThermoDox® Early Access Program (EAP) in
Europe.
The Company and myTomorrows launched the ThermoDox Early Access
Program in the second quarter, making ThermoDox® 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.
GEN-1 IL-12 DNA-Based Immunotherapy
Presented Phase Ib Data for GEN-1 in Platinum-Resistant
Ovarian Cancer at ASCO.
In May 2015, Celsion presented
clinical results from the Phase Ib trial for GEN-1in combination
with pegylated doxorubicin in 16 patients with platinum-resistant
ovarian cancer in a poster session at the 2015 American Society of
Clinical Oncology (ASCO) Meeting in Chicago. The clinical findings
demonstrated an overall clinical benefit of 57% for all treatment
arms, with a partial response (PR) rate of 21% and a stable disease
(SD) rate of 36%. The overall clinical benefit observed at the
highest dose cohort in this difficult-to-treat patient population
was 100% (PR=33% and SD=67%) in all six evaluable patients. GEN-1
was well tolerated, with no dose limiting toxicities and no
overlapping toxicities between GEN-1 and pegylated
doxorubicin.
TheraSilence™
Demonstrated Potent, Durable Preclinical Lung Expression Data
for Its TheraSilence™.
In May 2015, Celsion reported data
from a preclinical study confirming that its TheraSilence™
technology platform can safely and effectively deliver RNA to the
lungs in non-human primates, enabling the development of RNA
therapeutics for lung diseases. In the study,
TheraSilence-formulated signaling RNA resulted in preferential
expression in the lungs, with expression in the liver at less than
15% of expression levels observed in the lungs, and expression
levels in tissues other than the lung, spleen and liver at very low
or background levels. A liver-directed delivery system, used
as a positive control for the study, yielded preferential
expression in liver and spleen, with only background expression
levels observed in the lung.
Published Preclinical Data Demonstrating Lung Specific
Delivery of microRNA-145 Inhibitor Using the TheraSilence™
Platform.
In May 2015, an abstract published in the Journal of
Controlled Release summarized findings from a preclinical study
confirming effective delivery of RNA to lung cells. In
the study, the Company's TheraSilence™ technology platform safely
and effectively delivered an inhibitor of microRNA-145 (miR-145) in
a well-established model of severe occlusive pulmonary arterial
hypertension (PAH). Treatment was associated with significant
delivery of miR-145 inhibitor in the lung, inhibition of miR-145
levels and reversal of the pulmonary hypertension associated with
the advanced stages of the disease leading to a normalization of
cardiovascular function.
Corporate Developments
Raised $8 Million Through
Registered Direct Equity Offering priced "at the market".
During the second quarter of 2015, the Company completed an
$8 million at-the-market registered
direct equity offering and a concurrent private placement of
warrants to purchase common stock with two institutional healthcare
investors.
Financial Results
For the quarter ended June 30,
2015, Celsion reported a net loss of $5.7 million, or $(0.27) per share, compared to a net loss of
$6.7 million, or $(0.38) per share, in the same period of 2014.
Operating expenses were $5.4 million
in the second quarter of 2015 compared to $6.5 million in the same period of 2014.
For the six month period ended June
30, 2015, the Company reported a net loss of $12.7 million, or $(0.62) per share, compared to $12.1 million, or $(0.71) per share, in the same period of
2014. Operating expenses were $11.9
million in the first half of 2015 compared to $11.9 million in the same period of 2014.
Net loss and operating expenses for the three-month and six-month
periods ended June 30, 2014 included
$1.1 million of one-time costs
associated with the acquisition of EGEN, Inc. Net cash
used in operations was $11.6 million
in the first half of 2015 compared to $9.0
million in the same period last year. The Company
ended the second quarter of 2015 with $30.8
million of total cash, investments and accrued interest on
these investments, which included the proceeds of an $8 million registered direct offering that was
completed during the quarter.
Research and development costs were $3.6
million in the second quarter of 2015 compared to
$3.2 million the same period last
year. Research and development costs were $8.1 million in the first half of 2015 compared
to $6.1 million the same period last
year. The increases 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
2014 and the production of clinical supplies in the first half of
2015 for the three GEN-1 Phase I studies. General and
administrative expenses were $1.8
million in the second quarter of 2015 compared to
$2.3 million the same period of
2014. General and administrative expenses were $3.8 million in the first half of 2015 compared
to $4.7 million the same period of
2014. These decreases were primarily the result of lower
insurance premiums and lower personnel costs.
Quarterly Conference Call
The Company is hosting a conference call to provide a business
update and discuss second quarter 2015 financial results at
11:00 a.m. EDT on Monday, August 10, 2015. To participate in the
call, interested parties may dial 1-800-768-6490 (Toll-Free/North
America) or 1-785-830-7987 (International/Toll) and ask for
the Celsion Corporation Second Quarter 2015 Conference Call
(Conference Code: 9366896) 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 August 10, 2015 and will remain available until
August 24, 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: 9366896. 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 Monday, August 10,
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; 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 June
30,
|
|
Six Months
Ended June
30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
revenue
|
$
|
125
|
|
$
|
125
|
|
$
|
250
|
|
$
|
250
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
3,568
|
|
|
3,165
|
|
|
8,074
|
|
|
6,059
|
|
General and
administrative
|
|
1,802
|
|
|
2,305
|
|
|
3,834
|
|
|
4,739
|
|
Acquisition
costs
|
|
–
|
|
|
1,067
|
|
|
–
|
|
|
1,067
|
|
Total operating
expenses
|
|
5,370
|
|
|
6,538
|
|
|
11,908
|
|
|
11,865
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(5,245)
|
|
|
(6,413)
|
|
|
(11,658)
|
|
|
(11,615)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from valuation
of common stock warrant liability
|
|
(69)
|
|
|
–
|
|
|
(242)
|
|
|
–
|
|
Loss from change in
valuation of common stock warrant liability
|
|
(18)
|
|
|
(18)
|
|
|
(61)
|
|
|
(16)
|
|
Investment income,
net
|
|
17
|
|
|
24
|
|
|
33
|
|
|
31
|
|
Interest
expense
|
|
(360)
|
|
|
(263)
|
|
|
(753)
|
|
|
(494)
|
|
Other
expense
|
|
–
|
|
|
(3)
|
|
|
1
|
|
|
(2)
|
|
Total other
(expense) income, net
|
|
(430)
|
|
|
(260)
|
|
|
(1,022)
|
|
|
(481)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
(5,675)
|
|
|
(6,673)
|
|
|
(12,680)
|
|
|
(12,096)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
$
|
(0.27)
|
|
$
|
(0.38)
|
|
$
|
(0.62)
|
|
$
|
(0.71)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
19,964
|
|
|
13,602
|
|
|
17,949
|
|
|
11,756
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Celsion
Corporation
|
Selected Balance
Sheet Information
|
(in
thousands)
|
|
ASSETS
|
|
June
30, 2015
|
|
December 31,
2014
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
11,951
|
$
|
12,687
|
|
Investment securities
and interest receivable
on investment
securities
|
|
18,830
|
|
24,383
|
|
Prepaid expenses and
other current assets
|
|
684
|
|
436
|
|
Total current
assets
|
|
31,465
|
|
37,506
|
|
|
|
|
|
|
|
Property and
equipment
|
|
1,009
|
|
1,171
|
|
|
|
|
|
|
|
Other
assets
|
|
|
|
|
|
In-process research
and development
|
|
25,802
|
|
25,802
|
|
Goodwill
|
|
1,976
|
|
1,976
|
|
Deposits and other
assets
|
|
162
|
|
240
|
|
Total other
assets
|
|
27,940
|
|
28,018
|
|
|
|
|
|
|
|
Total
assets
|
$
|
60,414
|
$
|
66,695
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
5,439
|
$
|
5,937
|
|
Deferred revenue –
current portion
|
|
500
|
|
500
|
|
Note payable - current
portion
|
|
3,865
|
|
3,654
|
|
Total current
liabilities
|
|
9,804
|
|
10,091
|
|
|
|
|
|
|
|
Earn-out milestone
liability
|
|
13,905
|
|
13,664
|
|
Common stock warrant
liability
|
|
–
|
|
275
|
|
Notes payable –
noncurrent portion
|
|
4,286
|
|
6,053
|
|
Other liabilities –
noncurrent portion
|
|
3,314
|
|
3,787
|
|
Total
liabilities
|
|
31,309
|
|
33,870
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
Common
stock
|
|
231
|
|
201
|
|
Additional paid-in
capital
|
|
238,645
|
|
229,779
|
|
Accumulated other
comprehensive loss
|
|
(4)
|
|
(16)
|
|
Accumulated
deficit
|
|
(208,075)
|
|
(195,074)
|
|
|
|
30,797
|
|
34,890
|
|
Less: Treasury
stock
|
|
(1,692)
|
|
(2,065)
|
|
Total stockholders'
equity
|
|
29,105
|
|
32,825
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
$
|
60,414
|
$
|
66,695
|
|
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SOURCE Celsion Corporation