Celsion Reports First Quarter 2011 Financial Results and Provides Business Update
"With enrollment in our HEAT study nearing completion, we look forward to
the key event in our clinical timeline, a pre-planned efficacy analysis
mid-year, followed by the top-line results in 2012," said
Financial Results
For the first quarter ended
Research and development costs were
For the quarter ended
Recent Business Highlights
-- Patient enrollment for the Phase III HEAT study is 93%. Enrollment is
ongoing at 66 sites in ten countries, with enrollment completion
expected mid-year;
-- In January , the Company completed a registered offering of $5.1 million
of convertible preferred stock and common stock warrants. Concurrent
with this effort, the Company amended its Development, Product Supply
and Commercialization Agreement for ThermoDox® with Yakult 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
on January 12, 2011 , in exchange for a reduction in product approval
milestones that the Company may receive under the Yakult Agreement;
-- In February, the independent Data Monitoring Committee (DMC) reviewed
clinical data on 482 randomized 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 , Celsion received Orphan Drug Designation in Europe 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 a registrational pathway for ThermoDox®;
-- In April , Celsion was granted an additional U.S. Patent in the "Needham
Patent Family" covering Temperature-Sensitive Liposomal technologies,
including the ThermoDox® formulation;
-- 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 European Union ;
-- Celsion presented preclinical data highlighting the efficacy for
ThermoDox® with High Intensity Focused Ultrasound (HIFU) System in
certain difficult-to-treat cancers at the Annual Meetings of the
Society of Thermal Medicine (STM) and International Society of
Therapeutic Ultrasound (ISTU). The data are supportive of the
Company's plan to initiate a clinical trial in metastatic bone
cancer later in 2011 with partner, Phillips Healthcare .
Quarterly Conference Call
The Company is hosting a conference call to provide a business update and
discuss the first quarter 2011 results at
The call will be archived for replay on
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 http://www.clinicaltrials.gov.
About
Celsion Corporation
Condensed Statements of Operations
(in thousands except for per share amounts)
(Unaudited)
Three Months Ended
March 31,
------------------------
2011 2010
----------- -----------
Licensing revenue $ 2,000 $ -
Operating expenses:
Research and development 4,349 3,275
General and administrative 1,215 1,299
----------- -----------
Total operating expenses 5,564 4,574
----------- -----------
Loss from operations (3,564) (4,574)
----------- -----------
Other income (expense):
Gain (loss) from valuation of common stock
warrants 168 (1,570)
Other expense, net (368) (1)
----------- -----------
Total other income (expense), net (200) (1,571)
----------- -----------
Net Loss $ (3,764) $ (6,145)
=========== ===========
Net loss per common share - basic and diluted $ (0.28) $ (0.50)
=========== ===========
Weighted average common shares outstanding -
basic and diluted 13,453 12,186
=========== ===========
Celsion Corporation
Selected Balance Sheet Information
(in thousands)
(Unaudited)
March 31, December
ASSETS 2011 31, 2010
----------- -----------
Current assets
Cash and cash equivalents $ 1,965 $ 1,139
Short term investments 131 396
Prepaid expenses and other current assets 1,651 492
----------- -----------
Total current assets 3,747 2,027
----------- -----------
Property and equipment 338 378
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Other assets
Deferred financing fees 605 -
Deposits and other assets 77 77
Patent license fees, net 41 43
----------- -----------
Total other assets 723 120
----------- -----------
Total assets $ 4,808 $ 2,525
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued liabilities $ 6,740 $ 6,673
Note payable - current portion 127 123
----------- -----------
Total current liabilities 6,867 6,796
Common stock warrant liability 80 248
Other liabilities - noncurrent portion 23 57
8% Series A Redeemable Convertible Preferred
Stock 2,878 -
----------- -----------
Total liabilities 9,848 7,101
----------- -----------
Stockholders' deficit
Common stock 146 141
Additional paid-in capital 102,560 99,317
Accumulated other comprehensive (loss) income 19 (18)
Accumulated deficit (104,716) (100,939)
----------- -----------
Subtotal (1,991) (1,499)
Less: Treasury stock (3,049) (3,077)
----------- -----------
Total stockholders' deficit (5,040) (4,576)
----------- -----------
Total liabilities and stockholders' deficit $ 4,808 $ 2,525
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Investor ContactDavid Pitts Argot Partners 212-600-1902 Email Contact
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