Navigation Links
Celsion Corporation Reports First Quarter 2013 Financial Results and Provides Business Update

LAWRENCEVILLE, N.J., May 9, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced financial results for the first quarter ended March 31, 2013 and provided a business update on its clinical trials of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin.  ThermoDox® is being evaluated in a global, multi-center Phase III clinical trial (the HEAT Study) in patients with non-resectable hepatocellular carcinoma (HCC), also known as primary liver cancer.  ThermoDox® is also being evaluated in a Phase II trial for patients with recurrent chest wall breast cancer, The DIGNITY Study.

Following the announcement on January 31, 2013, that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet the HEAT Study's primary endpoint, the Company conducted a comprehensive analysis of the data from the Study which was reviewed by its key principal investigators as well as liver cancer and clinical data experts.  These emerging findings from the HEAT Study suggest that RFA dwell time had a positive impact on progression free survival (PFS) and overall survival (OS) in patients treated with ThermoDox® plus RFA when compared to the control group.  This analysis was conducted in a sizable patient subgroup.  These findings will be discussed by two of the HEAT Study's lead investigators at scientific sessions of the World Conference on Interventional Oncology on May 16, 2013. Celsion's lead investigators agree that these are interesting findings which should be further pursued.

"With the support of our medical advisors, we have been working diligently to better understand the clinical data and findings from the Phase III HEAT Study.  Concurrently, we have been taking appropriate measures to position Celsion for future success including reducing expenses and exploring acquisition opportunities," said Michael Tardugno , Celsion's President and Chief Executive Officer. "At this point, we have concluded that emerging findings from our post hoc analysis of the HEAT Study provide a basis for review with various regulatory agencies and an opportunity to discuss a path forward for our HCC development program.  Our recent expense reduction initiatives ensure a strong balance sheet as we explore opportunities to broaden our product pipeline and mitigate risk."

Recent Business DevelopmentsDuring the first quarter of 2013, the Company raised $27 million in gross proceeds from several financing transactions as well as a new research and development collaboration:

  • Celsion sold common stock through a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. and received gross proceeds of approximately $7 million.
  • Celsion entered into a Securities Purchase Agreement with certain institutional investors, pursuant to which the Company sold, in a registered offering, an aggregate of 15,000 shares of its Series A 0% convertible preferred stock and warrants to purchase approximately 6.0 million shares of its common stock at an exercise price of $1.18 per share, for gross proceeds of $15 million.
  • Celsion entered into a Technology Development Agreement with Zhejiang Hisun Pharmaceutical Co., Ltd. (Hisun) for ThermoDox® for the greater China territory.  Under the terms of the agreement, Hisun paid Celsion a $5 million payment in support of ThermoDox® technology development.
  • In April 2013, the Company provided a comprehensive business update which included the following:

  • Emerging findings from the HEAT Study post hoc analysis suggests that ThermoDox® markedly improved progression free survival (PFS) and overall survival (OS) in patients who had optimal RFA.
    The post hoc analysis indicated that if patients' lesions undergo RFA for 45 minutes or more, they clearly benefitted from ThermoDox®.  These findings apply to HCC lesions from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a sizable subgroup of patients.
  • The Company implemented a restructuring program to lower its operating costs to conserve capital.  The program included the elimination of approximately one-third of Celsion's workforce and the deferral of expenses associated with the Company's Phase II study of ThermoDox® in combination with RFA for the treatment of colorectal liver metastases (The ABLATE Study).
  • The Company engaged Cantor Fitzgerald & Co. to conduct a comprehensive review of merger and acquisition opportunities with the goal of identifying novel products with high potential, or companies, for Celsion to acquire.
  • Financial Results

    For the quarter ended March 31, 2013, Celsion reported a net loss of $651,000 compared to a net loss of $6.2 million in the same period of 2012. Net loss for the quarter ended March 31, 2013 was favorably impacted by lower operating costs coupled with the non-cash benefit of $4.3 million from the valuation of the common stock warrant liability associated with warrants issued in a registered direct equity offering in September 2009.  Also in the first quarter of 2013, the Company entered into a Technology Development Agreement with Hisun, which included a payment of $5 million from Hisun, to support technology development transfer of ThermoDox® in the China territory.  The first quarter income statement was also impacted by a one-time, non-cash deemed dividend from the beneficial conversion feature of $4.6 million on the preferred stock issued in February 2013, resulting in a net loss attributable to common shareholders of $5.3 million.

    For the quarter ended March 31, 2013, net cash provided by operations was $1.8 million.  During the first quarter of 2013, the Company raised $20.8 million in new capital, net of issuance costs, from the sale of preferred stock to certain institutional investors, the sale of common stock under a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., and the exercise of common stock warrants and options.  The Company ended the current quarter with $45.9 million in cash, investments and accrued interest on short-term investments.

    Research and development expenses decreased by $1.5 million (32%), from $4.7 million in the first quarter of 2012 to $3.2 million in the first quarter of 2013.  This decrease was primarily due to reduced clinical development costs associated with the Phase III HEAT Study and activities related to the development of commercial manufacturing capabilities for ThermoDox®. General and administrative expenses of $1.7 million in the first quarter of 2013 were relatively flat as compared to the same period of 2012.

    Quarterly Conference CallThe Company is hosting a conference call to provide a business update and discuss the first quarter 2013 results at 11:00 a.m. EDT Thursday, May 9, 2013. To participate in the call, interested parties may dial 1-888-329-8862 (Toll-Free/North America) or 1-719-325-2376 (International/Toll) and ask for The Celsion Corporation First Quarter 2013 Earnings Conference Call approximately ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at

    The call will be archived for replay on May 9, 2013 at 2:00 p.m. EDT and will remain available until May 23, 2013. The replay can be accessed at 1-877-870-5176 (Toll-Free/North America) or 1-858-384-5517 (International/Toll) using Conference ID: 2227568. An audio replay of the call will also be available on the Company's website,, for 30 days after 2:00 p.m. EDT Thursday, May 9, 2013.

    About ThermoDox® and the Phase III HEAT StudyThermoDox® 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.  ThermoDox® is being evaluated in a Phase III clinical trial for primary liver cancer (the HEAT study), a Phase II clinical trial for colorectal liver metastasis and a Phase II clinical trial for recurrent chest wall breast cancer.  Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by radiofrequency ablation (RFA) releases the entrapped doxorubicin from the liposome.  This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.  On January 31, 2013, Celsion announced that ThermoDox® in combination with RFA did not meet the primary endpoint of the HEAT study in patients with hepatocellular carcinoma, also known as primary liver cancer.  Celsion is conducting additional analyses of the data from the HEAT study to assess the future strategic value of ThermoDox®.

    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:

    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 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; termination of the Technology Development Contract or collaboration between Celsion and Hisun at any time; possible changes in cost and timing of development and testing, capital structure, financial condition, working capital needs and other financial items; 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 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.

    Investor Contact Jeffrey W. Church
    Senior Vice President – Corporate
    Strategy and Investor Relations
    609-482-2455  Celsion Corporation
    Condensed Statements of Operations
    (In thousands except per share amounts)
    (Unaudited)Three Months Ended March 31,20132012Licensing revenue$



    -Operating expenses: Research and development3,2034,693General and administrative 1,6891,570 Total operating expenses 4,8926,263 


    Loss from operations (4,767)(6,263)Other income (expense): Gain from valuation of common stock warrant liability4,28078Interest, dividends and other income (expense), net(164)(1)Total other income, net4,11677 


    Net loss(651)(6,186) 

    Non-cash deemed dividends from beneficialconversion feature on convertible preferred stock (4,601)– 


    Net loss attributable to common shareholders$




    Net loss attributable to common shareholders per
    common share – basic and diluted$



    (0.19)Weighted average common shares outstanding –basic and diluted42,99633,197 Celsion Corporation
    Selected Balance Sheet Information
    (In thousands)ASSETSMarch 31, 2013 (Unaudited)December 31,
    2012 Current assetsCash and cash equivalents




    14,991Short term investments and accrued interest25,4868,104Other current assets562554Total current assets46,41523,649Property and equipment 1,0401,115Other assetsDeposits and other assets477567Patent license fees, net 2628Total other assets503595Total assets$



    25,359LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilitiesAccounts payable and accrued liabilities




    3,595Deferred revenue – current portion500—Note payable - current portion1,8841,410Total current liabilities7,6625,005Common stock warrant liability44,284Note payable – non-current portion3,1733,661Deferred revenue – noncurrent portion4,375—Other liabilities – noncurrent portion443447Total liabilities15,65713,397Stockholders' equity Series A convertible preferred stock1–Common stock515380Additional paid-in capital190,743165,276Accumulated other comprehensive loss (159)(127)Accumulated deficit(156,119)(150,877)  Subtotal34,98114,652Less: Treasury stock (2,680)(2,690)Total stockholders' equity 32,30111,962Total liabilities and stockholders' equity$




    SOURCE Celsion Corporation
    Copyright©2012 PR Newswire.
    All rights reserved

    Related biology technology :

    1. Celsion Corporation to Hold First Quarter 2013 Financial Results Conference Call on Thursday, May 9, 2013
    2. Celsion Corporation Provides Business Update
    3. Todays Research on Celsion, Zogenix, Actavis, and Avanir Pharma
    4. Celsion Corporation Announces $15 Million Registered Direct Offering
    5. Celladon Corporation and SIRO Clinpharm Announce Presentation at "Statisticians in the Pharmaceutical Industry International Conference"
    6. ETEX Corporation announces extended Supply Agreement with Knee Creations, LLC
    7. Verenium Corporation to Announce First Quarter 2013 Financial Results
    8. EMCO High Voltage Corporation to Exhibit at 61st ASMS Conference on Mass Spectrometry and Allied Topics
    9. Intrexon Corporation Raises $150 Million for Synthetic Biology Initiatives
    10. Techne Corporation Releases Unaudited Third Quarter And Nine Month Fiscal Year 2013 Results
    11. Street Named After EMCO High Voltage Corporation
    Post Your Comments:
    (Date:10/8/2015)... , Oct. 8, 2015 Celemics, a global ... into the North American market with the establishment of ... and Europe , has secured ... Target Enrichment methodology and sample preparation for DNA sequencing ... both hereditary and somatic genetic testing more accurately, quickly, ...
    (Date:10/8/2015)...  The ALS Association, in partnership with Prize4Life, is ... revolutionize communication technology solutions for people living with ALS. ... (amyotrophic lateral sclerosis) is a progressive neurodegenerative disease that ... spinal cord. Eventually, people with ALS lose the ability ... to total paralysis and death within two to five ...
    (Date:10/8/2015)... ... October 08, 2015 , ... ... an exclusive license agreement to develop and commercialize intellectual property rights belonging to ... agreement from February 2009, and affords exclusive worldwide rights to intellectual property based ...
    (Date:10/7/2015)... Texas (PRWEB) , ... October 07, 2015 , ... ... Institute ( ) will present a public educational seminar on the latest ... Saturday, October 10th from 1:00 pm – 3:00 pm at the Hilton Dallas/Southlake ...
    Breaking Biology Technology:
    ... Merrimack Pharmaceuticals today announced that it will present at the Jefferies 2010 Global Life Sciences Conference ... provide a company overview at 11:00am EDT , Wednesday, June 9, 2010 at ... , , ... , , , ...
    ... June 1 Diplomat Specialty Pharmacy, the ... launch of Navigator Health Services, an independent division of ... pharmacy industry. The announcement was made by Diplomat Specialty ... who says that Navigator Health Services was formed in ...
    ... Calif. , June 1 Epeius Biotechnologies Corporation ( ... "Advanced Phase I/II Evaluation of Tumor-Targeted Gene Delivery: Intravenous Rexin-G as ... the ASCO Annual Meeting on June 8, 2010 . The ... Stanford University Medical Center, Palo Alto CA. ...
    Cached Biology Technology:
    (Date:9/10/2015)... , Sept. 10, 2015 Pursuant ... Clinic Wellness to create an interactive, image-based health ... health and wellness kiosk.  The unique assessment quantifies ... a number that suggests an individual,s biological age ... values as measured by the kiosk. ...
    (Date:9/8/2015)... , Sept. 8, 2015   TREW Marketing ... the new survey, Smart Marketing for Engineers TM ... 580 engineering professionals reveals insightful findings about engineers, preferences ... types of content engineers most value and trust, and ... Marketers targeting technical audiences grapple with how to ...
    (Date:9/2/2015)... YORK , Sept. 2, 2015 ... key concern for enterprises, banks, government organizations, telecommunications, ... and numeric keypads were previously being used to ... introduction of two-factor authentication, wherein individuals could gain ... two different components, such as hardware devices and ...
    Breaking Biology News(10 mins):
    ... "We can make you and we can break you." If ... oxide would start something like that. But this song wouldn,t ... of Rice chemist James Tour demonstrates an environmentally friendly way ... version of single-atom-thick graphene expected to find use in all ...
    ... A novel approach detects genetically abnormal cells in the blood ... in tumor cells and increase in number with the severity ... The University of Texas MD Anderson Cancer Center report in ... patients in the study also had many times the number ...
    ... A University of Minnesota Medical School research team led ... a novel approach to ease the chronic and acute ... a mouse model of SCD, Gupta and University of ... that exhibited both musculoskeletal pain and temperature sensitivity, symptoms ...
    Cached Biology News:
    ... The Rapid-Screen cDNA Library Panels were ... just three sets of PCRs to identify ... analysis is performed in a 96-well "Master ... from 5,000 clones. Having identified the positive ...
    Application: For use as a carrier in nucleic acid purification and precipitation. Physical form: Solution in 10 mM Tris HCl, pH 7.4, 1 mM EDTA Concentration: 9-11 mg/mL Physical Form: buffered aqu...
    ... Note: Prepared by a modification of ... al., Biotechnol. Bioeng., 11 ... unit will yield an A 260 ... of water (1 cm light path). ...
    ... Unique, compact measuring instrument for calibrating ... compact design and the robust carrying case, ... both in the laboratory and on-site at ... easy to use because the individual channels ...
    Biology Products: