Celsion Reports Second Quarter 2011 Financial Results and Provides Business Updates
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Financial Results
For the second quarter ended
Compared to the prior year, research and development costs were
For the second quarter ended
In June , a private placement of$8.6 million in common stock and warrants.In July , a registered direct offering of$6.6 million in common stock and warrants.In July , sales of an aggregate$18.4 million of the Company's securities, of which$13.0 million was from institutional investors in a registered direct offering and an additional$5.4 million was from other investors in a private placement.
Recent Business Highlights
In August ,Celsion announced that it had reached its pre-planned enrollment objective of 600 patients in the Company's pivotal, Phase III HEAT Study, a multinational, randomized, double-blind, placebo-controlled clinical study of ThermoDox® in combination with radio frequency ablation (RFA) for the treatment of primary liver cancer. The enrollment objective was established so that the study's primary end point, progression-free survival, can be achieved with adequate statistical power, and is one of two triggers for an interim efficacy analysis by the study's independent Data Monitoring Committee, the second being 190 progression-free survival events realized in the study population. The HEAT Study is being conducted under a FDA Special Protocol Assessment, has received FDA Fast Track Designation and has been designated as a Priority Trial for primary liver cancer by theNational Institutes of Health ;In April ,Celsion was granted an additional U.S. Patent in the "Needham Patent Family" covering Temperature-Sensitive Liposomal technologies, including the ThermoDox® formulation. The new patent provides coverage for a new method of loading active agents (such as doxorubicin or other active chemotherapy drugs) into liposomes which, with USPTO patent term adjustment, provides protection throughFebruary 13, 2021 ;In April ,Celsion was granted the Japanese counterpart of the "Needham" composition of matter patent, "Temperature-Sensitive Liposomal Formulation," which is issued in various regions around the world, including the U.S. and theEuropean Union ;In June , an independent Drug Safety Monitoring Board (DSMB) completed a review of safety data from the Phase I portion ofCelsion's DIGNITY Phase I/II study of ThermoDox® and hyperthermia in recurrent chest wall (RCW) breast cancer (the DIGNITY Study), and unanimously recommended advancing from Phase I to Phase II at 50 mg/m2 of ThermoDox®;In July ,Celsion announced the appointment ofGregory Weaver , a Director onCelsion's Board since 2005, to the role of Senior Vice President and Chief Financial Officer, the promotion ofJeffrey W. Church to the newly created role of Senior Vice President, Strategy and Investor Relations, and the appointment ofFrederick Fritz as a Director; andIn July ,Celsion announced plans to relocate its operation and corporate headquarters toLawrenceville, New Jersey , and in close proximity to top biopharmaceutical companies, research institutions, academic centers and investment sources.
Quarterly Conference Call
The Company is hosting a conference call to provide a business update and discuss the second quarter 2011 results at
The call will be archived for replay on
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer is approximately 20,000 cases per year in
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 76 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 www.clinicaltrials.gov.
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Celsion Corporation Condensed Statements of Operations (in thousands except for per share amounts) (Unaudited) Three Months Ended Six Months Ended June 30, June 30, ------------------ ------------------ 2011 2010 2011 2010 -------- -------- -------- -------- Licensing revenue $ - $ - $ 2,000 $ - -------- -------- -------- -------- Operating expenses: Research and development 4,964 3,439 9,313 6,715 General and administrative 1,282 1,026 2,497 2,324 -------- -------- -------- -------- Total operating expenses 6,246 4,465 11,810 9,039 -------- -------- -------- -------- Loss from operations (6,246) (4,465) (9,810) (9,039) -------- -------- -------- -------- Other (expense) income: (Loss) gain from valuation of common stock warrant liability (586) 1,829 (418) 259 Interest, dividends and other expense, net (112) 5 (480) 4 -------- -------- -------- -------- Total other (expense) income, net (698) 1,834 (898) 263 -------- -------- -------- -------- Net Loss $ (6,944) $ (2,631) $(10,708) $ (8,776) ======== ======== ======== ======== Net loss per common share - basic and diluted $ (0.42) $ (0.22) $ (0.72) $ (0.72) ======== ======== ======== ======== Weighted average common shares outstanding - basic and diluted 16,366 12,232 14,914 12,208 ======== ======== ======== ======== Celsion Corporation Selected Balance Sheet Information (in thousands) (Unaudited) June 30, December 31, ASSETS 2011 2010 ------------- ------------- Current assets Cash and cash equivalents $ 5,380 $ 1.139 Short term investments 134 396 Prepaid expenses and other current assets 694 492 ------------- ------------- Total current assets 6,208 2,027 ------------- ------------- Property and equipment 479 378 ------------- ------------- Other assets Deferred financing fees 86 - Deposits and other assets 77 77 Patent license fees, net 39 43 ------------- ------------- Total other assets 202 120 ------------- ------------- Total assets $ 6,889 $ 2,525 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable and accrued liabilities $ 5,016 $ 6,673 Note payable - current portion 120 123 ------------- ------------- Total current liabilities 5,136 6,796 Common stock warrant liability 666 248 Other liabilities - noncurrent portion - 57 8% Series A Redeemable Convertible Preferred Stock 597 - ------------- ------------- Total liabilities 6,399 7,101 ------------- ------------- Stockholders' equity (deficit) Common stock 205 141 Additional paid-in capital 114,958 99,317 Accumulated other comprehensive income (loss) 22 (18) Accumulated deficit (111,675) (100,939) ------------- ------------- Subtotal 3,510 (1,499) Less: Treasury stock (3,020) (3,077) ------------- ------------- Total stockholders' equity (deficit) 490 (4,576) ------------- ------------- Total liabilities and stockholders' equity (deficit) $ 6,889 $ 2,525 ============= =============
Investor ContactDavid Pitts Argot Partners 212-600-1902 Email Contact
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