Celsion Corporation (NASDAQ: CLSN), a leading oncology drug
development company, today announced financial results for the
third quarter ended September 30, 2012 and provided a business
update including development progress with ThermoDox®, Celsion's
proprietary heat-activated liposomal encapsulation of doxorubicin
for the treatment of hepatocellular carcinoma (HCC), commonly
referred to as primary liver cancer. ThermoDox® is currently being
evaluated under a Special Protocol Assessment with the U.S. Food
and Drug Administration (FDA) in a global, multi-center,
randomized, pivotal Phase III trial (the HEAT Study) in patients
with non-resectable primary liver cancer. The HEAT Study has been
designated as a Priority Trial for liver cancer by the National
Institutes of Health, has received Fast Track Designation from the
FDA and has received Orphan Drug Designation in both the U.S. and
Europe. ThermoDox® is also being evaluated in two Phase II trials
for patients with recurrent chest wall breast cancer and colorectal
liver metastases.
"Celsion stands focused on ThermoDox®'s transformative potential
for the largest unmet need remaining in oncology. With positive
results from the HEAT Study, we are preparing to introduce the
first and most important 1st line drug therapy ever for
non-resectable HCC. If successful, we will create substantial value
for all of our stakeholders, including the global oncology
community, our investors and most importantly HCC patients and
their families," said Michael H. Tardugno, Celsion's President and
Chief Executive Officer. "Preparedness leading up to this event is
paramount. We have worked to ensure that the HEAT Study is robust
and well conducted. We have maintained constant communication with
our study sites, our manufacturers and with regulators to ensure a
clean, consistent and high quality data package for review in
markets around the world. Further, we enter this period with a
strong balance sheet, including financial resources that will take
us well beyond data and into multiple indications where the promise
of ThermoDox® will significantly improve treatment outcomes."
Mr. Tardugno added, "The momentum behind ThermoDox® and our
technology platform is evident in the growing interest within
industry and the medical and academic communities to explore their
application in a broad range of cancers and indications. Following
the outcome of the HEAT Study, we intend to accelerate our on-going
development programs, an effect that will ultimately reveal the
significant potential and elegance of our targeted tumor
technology."
Recent Business Developments
In August 2012, the Company and Royal Philips Electronics
(Philips) announced FDA clearance to commence a Phase II Study of
ThermoDox® and Philip's Sonalleve MR-Guided HIFU technology for the
palliation of painful metastases to the bone caused by lung,
prostate or breast cancers.
In September 2012, the Company announced
- The independent Data Monitoring Committee (DMC) for the
Company's HEAT Study completed a regularly scheduled review of all
701 patients enrolled in the trial and has unanimously recommended
that the HEAT Study continue according to protocol to its final
data readout.
- Ronnie T.P. Poon, MD, MS, PhD, FRCS (Edin), FACS, Professor of
Surgery at the University of Hong Kong and Lead Asia Pacific
Principal Investigator for Celsion's HEAT Study, discussed
advancements in thermal-based treatments in cancer, including the
use of ThermoDox® in combination with radiofrequency ablation, at
the 2012 Annual Congress of the Cardiovascular and Interventional
Radiological Society of Europe in Lisbon, Portugal. Professor
Poon's presentation, "Combining Thermal Ablation with
Thermosensitive Liposomes," emphasized the need to consolidate
standards of care in non-resectable liver cancer to improve
outcomes. The presentation can be viewed on Celsion's website at
http://investor.celsion.com/events.cfm.
- The presentation of Phase I results from the Company's Phase
I/II DIGNITY study of ThermoDox® in Breast Cancer Recurrences at
the Chest Wall at the ESMO 2012 Congress, the annual conference for
the European Society of Medical Oncology held in Vienna, Austria.
The presentation, titled "Breast Cancer Recurrences at the Chest
Wall (BCRCW) When Standard Treatments (Tx) Have Failed:
Lyso-Thermosensitive Liposomal Doxorubicin (LTLD) + Mild Local
Hyperthermia (MLH)," was delivered by Professor Hope S. Rugo, MD,
from the UCSF School of Medicine, and provided a clinical update of
the Phase I/II DIGNITY trial studying ThermoDox® for breast cancer.
A copy of the poster presentation is available at
www.celsion.com/docs/pipeline_presentations.
In November 2012, the Company announced that a minimum of 380
events of progression have been realized in the HEAT Study.
According to protocol, 380 events of progression, subject to
confirmation by the Study's independent Data Monitoring Committee
(DMC), trigger the data collection process, unblinding and final
analysis of the results by the DMC. Progression Free Survival (PFS)
is the HEAT Study's primary end point which has been granted
Special Protocol Assessment by the FDA. Following DMC review, the
Company plans to disclose top line results, an announcement that is
expected to occur in January 2013.
Financial Results
For the quarter ended September 30, 2012, Celsion reported a net
loss of $6.0 million, or $0.18 per share, compared to a net loss of
$6.4 million, or $0.25 per share, in the same period of 2011. For
the nine months ended September 30, 2012, Celsion reported a net
loss of $18.3 million, or $0.55 per share, compared to a net loss
of $17.1 million, or $0.72 per share, in the same period of 2011.
For the first nine months of 2012, net cash used in operations was
$16.2 million compared to $18.3 million in the same period of 2011.
The Company reported $22.7 million in cash and investments
(including related accrued interest on these investments) as of
September 30, 2012. During the third quarter, the Company received
gross proceeds of approximately $4.0 million from the exercise of
warrants and options.
In the third quarter of 2012, the Company recorded an $881,000
non-cash charge related to the change in the common stock warrant
liability compared to a $375,000 non-cash benefit in the same
period of last year. In the first nine months of 2012, Celsion
recorded a $1.3 million non-cash charge related to the change in
the common stock warrant liability compared to a non-cash charge of
$42,000 in the same period last year. In the first nine months of
2011, the Company recognized $2 million in licensing revenue as a
result of its Development, Product Supply and Commercialization
Agreement for ThermoDox® with Yakult Honsha Co.
Research and development costs decreased by approximately $1.9
million to $3.5 million in the third quarter of 2012 compared to
$5.4 million in the same period of 2011. Research and development
costs decreased by approximately $2.4 million to $12.3 million in
the first nine months of 2012 compared to $14.7 million in the same
period of 2011. The decreased costs in each of these periods were
primarily due to lower investigator grants and related monitoring
activities associated with the HEAT Study. General and
administrative expenses remained relatively unchanged at $1.4
million in the third quarter of 2012 compared to the same period in
2011. General and administrative expenses increased by
approximately $0.7 million to $4.6 million in the first nine months
of 2012, from $3.9 million for the same period in 2011. This
increase is largely the result of an increase in professional fees
and personnel costs to support the Company's growth.
Quarterly Conference Call
The Company is hosting a conference call to provide a business
update and discuss the third quarter 2012 results at 11:00 a.m.
Eastern Time Monday, November 12, 2012. To participate in the call,
interested parties may dial 1-888-364-3108 (Toll-Free/North
America) or 1-719-457-2628 (International/Toll) and ask for the
Celsion Corporation Third Quarter 2012 Earnings Conference Call
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, 2012 at
2:00 p.m. ET and will remain available until November 26, 2012. The
replay can be accessed at 1-877-870-5176 (Toll-Free/North America)
or 1-858-384-5517 (International/Toll) using Conference ID:
8948347. 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 Monday, November 12, 2012.
About ThermoDox® and the Phase III HEAT
Study
ThermoDox® is a proprietary heat-activated liposomal
encapsulation of doxorubicin, an approved and frequently used
oncology drug for the treatment of a wide range of cancers. In the
HEAT Study, ThermoDox® is administered intravenously in combination
with Radio Frequency Ablation (RFA). Localized mild hyperthermia
(39.5 - 42 degrees Celsius) created by the RFA releases the
entrapped doxorubicin from the liposome. This delivery technology
enables high concentrations of doxorubicin to be deposited
preferentially in a targeted tumor.
For primary liver cancer, ThermoDox® is being evaluated in a
global, multi-center, randomized, pivotal Phase III HEAT Study at
79 clinical sites under an FDA Special Protocol Assessment. The
study is designed to evaluate the efficacy of ThermoDox® in
combination with RFA when compared to patients who receive RFA
alone as the control. The primary endpoint for the study is
progression-free survival with a secondary confirmatory endpoint of
overall survival.
Additional information on the Company's ThermoDox® clinical
studies may be found at www.clinicaltrials.gov.
About Celsion Corporation
Celsion is a leading oncology company 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 and the Beijing Cancer Hospital.
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; FDA and regulatory risks; the need to raise funds
for planned drug development; the Company's history of losses and
its expectation of continuing to incur such losses; possible
acquisitions of other technologies, assets or businesses; possible
actions by customers, suppliers, competitors, regulatory
authorities; and other risks detailed from time to time in the
Company's periodic reports filed with the Securities and Exchange
Commission.
Celsion Corporation
Condensed Statements of Operations
(in thousands except per share amounts)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
-------------------- --------------------
2012 2011 2012 2011
--------- --------- --------- ---------
Licensing revenue $ - $ - $ - $ 2,000
--------- --------- --------- ---------
Operating expenses:
Research and development 3,540 5,414 12,345 14,727
General and administrative 1,420 1,409 4,586 3,906
--------- --------- --------- ---------
Total operating expenses 4,960 6,823 16,931 18,633
--------- --------- --------- ---------
Loss from operations (4,960) (6,823) (16,931) (16,633)
--------- --------- --------- ---------
Other (expense) income:
(Loss) gain from valuation of
common stock warrant
liability (881) 375 (1,251) (42)
Other (expense)income, net (177) 55 (127) (426)
--------- --------- --------- ---------
Total other (expense)
income, net (1,058) 430 (1,378) (468)
--------- --------- --------- ---------
Net Loss $ (6,018) $ (6,393) $ (18,309) $ (17,101)
========= ========= ========= =========
Net loss per common share -
basic and diluted $ (0.18) $ (0.25) $ (0.55) $ (0.93)
========= ========= ========= =========
Weighted average shares
outstanding - basic and diluted 33,642 25,150 33,418 18,360
========= ========= ========= =========
Celsion Corporation
Selected Balance Sheet Information
(in thousands)
September 30,
2012 December 31,
(unaudited) 2011
------------- -------------
ASSETS
Current assets:
Cash and cash equivalents $ 8,318 $ 20,146
Short-term investments 14,229 10,157
Accrued interest on short term investments 134 244
Other current assets 1,085 961
------------- -------------
Total current assets 23,766 31,508
------------- -------------
Property and equipment 1,008 783
------------- -------------
Other assets:
Deposits, deferred fees and other assets 605 323
Patent licensing fees, net 30 35
------------- -------------
Total other assets 635 358
------------- -------------
Total assets $ 25,409 $ 32,649
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $ 5,661 $ 6,042
Notes payable - current portion 945 110
------------- -------------
Total current liabilities 6,606 6,152
Common stock warrant liability 1,417 166
Notes payable - non-current portion &
other 4,362 137
------------- -------------
Total liabilities 12,385 6,455
------------- -------------
Stockholders' equity:
Common stock 354 339
Additional paid-in capital 158,121 153,237
Accumulated other comprehensive loss (131) (276)
Accumulated deficit (142,620) (124,222)
------------- -------------
Subtotal 15,724 29,078
Treasury stock (2,700) (2,884)
------------- -------------
Total stockholders' equity 13,024 26,194
------------- -------------
Total liabilities and stockholders'
equity $ 25,409 $ 32,649
============= =============
Investor Contact David Pitts Argot Partners 212-600-1902
Email Contact
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