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Celsion Corporation Reports Year End 2010 Financial Results and Provides Business Update
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Financial Results
For the year ended
For the year ended
- Committed Equity Financing Facility - The Company entered into a Committed Equity Financing Facility (CEFF) with
Small Cap Biotech Value, Ltd (SCBV) onJune 17, 2010 . The CEFF provides that SCBV is committed to purchase up to$15 million worth of the Company's shares of common stock over the 24-month term of the CEFF under certain specified conditions and limitations. As ofMarch 16, 2011 , the Company has completed four draws and sales to SCBV under the CEFF totaling 1,339,774 shares of common stock for gross proceeds of$3.2 million . Broker fees and other expenses associated with these draws totaled approximately$104,000 . The proceeds were used to fund expenses associated with acceleration of commercial manufacturing, related product development specifications and working capital needs. - Equity Offering - In
January 2011 , the Company completed a registered offering of$5.1 million of convertible preferred stock and common stock warrants. - Licensing Transaction - On
January 11, 2011 , the Company amended its Development, Product Supply and Commercialization Agreement for ThermoDox® withYakult Honsha Co. to provide for accelerated payment of up to$4 million in future milestone payments, including$2 million that was paid to the Company onJanuary 12, 2011 , in exchange for a reduction in product approval milestones that the Company may receive under the Yakult Agreement.
Recent Business Highlights
- Patient enrollment for the Phase III HEAT study is approaching 90% completion. Enrollment is ongoing at 66 sites in ten countries, with enrollment completion expected by mid-2011;
- In
February 2011 , the independent Data Monitoring Committee (DMC) reviewed clinical data on 482 patients enrolled in the Phase III HEAT study and unanimously recommended that the trial continue to enroll patients with the goal of reaching 600 patients required to complete the study; - In
March 2011 ,Celsion received Orphan Drug Designation inEurope for ThermoDox® to treat primary liver cancer. ThermoDox® will have 10 year marketing exclusivity following EMA approval. A Scientific Advisory Committee Meeting is planned for the second quarter of 2011 to outline registrational pathway; - Recent financings and accelerated milestone payments from our Japanese development partner aggregated
$7.7 million with the potential for an additional$2 million accelerated milestone payment after resumption of patient enrollment inJapan . At this time, the Company is unable to determine what, if any, effect the catastrophic events resulting from theMarch 2011 earthquake and tsunami inJapan will have on the conduct or timeframe of the Phase III HEAT study or the DMC's review of clinical data for the Japanese patient cohort. The Company foresees no material impact on the conduct or the outcome of the balance of the HEAT study; - In
March 2011 ,Celsion published and announced upcoming scientific conference presentations of data highlighting the preclinical efficacy for ThermoDox® withPhillips Healthcare's High Intensity Focused Ultrasound (HIFU) System to address certain difficult-to-treat cancers; Celsion and Philips have submitted their preclinical findings with a request to initiate a clinical program in metastatic bone cancer to theFDA ; clinical studies in bone cancer are planned for 2011 with a portion of clinical trial costs to study ThermoDox® and MRI-Guided HIFU covered by a$9 million grant from theCenter for Translational Molecular Medicine (CTMM); and- Work is continuing under the recently awarded
$200,000 SBIR grant from theNational Institutes of Health to expand the Company's technology platform.
The Company is holding a conference call to provide a business update and discuss fiscal year 2010 results at
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 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 600 patient global Phase III study at 75 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with Radio Frequency Ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT Study is complete and 190 PFS events are realized in the study population. Additional information on the Company's ThermoDox® clinical studies may be found at http://www.clinicaltrials.gov.
About
Celsion Corporation Condensed Statements of Operations (in thousands except for per share amounts) Year Ended December 31, ------------------- 2010 2009 --------- -------- Operating expenses: Research and development $ 14,714 $13,681 General and administrative 4,923 3,327 --------- -------- Total operating expenses 19,637 17,008 --------- -------- Loss from operations (19,637) (17,008) --------- -------- Other income: Gain from valuation of common stock warrants 574 732 Other income, net 245 274 --------- -------- Total other income, net 819 1,006 --------- -------- Loss before income taxes (18,818) (16,002) Income tax benefit - 806 --------- -------- Net Loss $ (18,818) $(15,196) ========= ======== Net loss per common share - basic and diluted $ (1.52) $(1.43) ========= ======== Weighted average common shares outstanding - basic and diluted 12,375 10,655 ========= ======== Celsion Corporation Balance Sheets (in thousands except for per share amounts) December 31, December 31, ASSETS 2010 2009 -------------- -------------- Current assets Cash and cash equivalents $ 1,139 $ 6,924 Short term investments 396 5,695 Refundable income taxes - 806 Prepaid expenses and other current assets 492 695 -------------- -------------- Total current assets 2,027 14,120 -------------- -------------- Property and equipment 378 537 -------------- -------------- Other assets Deposits and other assets 77 97 Patent license fees, net 43 51 -------------- -------------- Total other assets 120 148 -------------- -------------- Total assets $ 2,525 $ 14,805 ============== ============== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable and accrued liabilities $ 6,673 $ 3,643 Note payable - current portion 123 108 -------------- -------------- Total current liabilities 6,796 3,751 Common stock warrant liability 248 822 Other liabilities - noncurrent portion 57 197 -------------- -------------- Total liabilities 7,101 4,770 -------------- -------------- Stockholders' equity Common stock,$0.01 par value (75,000 shares authorized; 14,091 and 12,895 shares issued and 13,331 and 12,135 shares outstanding atDecember 31, 2010 and 2009, respectively) 141 129 Additional paid-in capital 99,317 95,035 Accumulated other comprehensive (loss) income (18) 68 Accumulated deficit (100,939) (82,120) -------------- -------------- Subtotal (1,499) 13,112 Less: Treasury stock - at cost (3,077) (3,077) -------------- -------------- Total stockholders' (deficit) equity (4,576) 10,035 -------------- -------------- Total liabilities and stockholders' (deficit) equity 2,525 14,805 ============== ==============
Investor ContactDavid Pitts Argot Partners 212-600-1902 Email Contact
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