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Celsion Corporation Reports Third Quarter 2012 Financial

Celsion Corporation Reports Third Quarter 2012 Financial Results and
Business Update 
Company to Hold Conference Call on Monday, November 12, 2012 at 11:00
a.m. ET 
LAWRENCEVILLE, NJ -- (Marketwire) -- 11/12/12 --  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(R), Celsion's proprietary heat-activated liposomal
encapsulation of doxorubicin for the treatment of hepatocellular
carcinoma (HCC), commonly referred to as primary liver cancer.
ThermoDox(R) 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(R) 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(R)'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(R) will
significantly improve treatment outcomes." 
Mr. Tardugno added, "The momentum behind ThermoDox(R) 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(R)
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(R) 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(R) 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(R) 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(R) 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(R) and the Phase III HEAT Study 
ThermoDox(R) 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(R)
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(R) 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(R) 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(R) 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 
David@argotpartners.com 
 
 
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