Celsion Reports First Quarter 2012 Financial Results
"With the HEAT Study moving toward final data readout later this year, we have spent this first quarter focused on the realization of global enrollment objectives and preparing for a successful clinical and regulatory process to follow," said
Recent Business Developments
- In May,
Celsion announced the signing of a long-term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. for theChina territory. The agreement provides for Hisun funding of costs necessary to complete the technology transfer of the Company's proprietary manufacturing process and the production of registration batches for the Chinese territory. - In May, following extensive evaluation of high intensity focused ultrasound (HIFU) in bone cancer patients,
Celsion announced the joint resubmission withPhilips Healthcare of a combined IND/IDE proposal for a Phase II Study in prostate metastases to the bone, and the Company's long term intent to pursue this important combination therapy through multiple programs. - In May, the Company and the
Focused Ultrasound Foundation announced their support for preclinical studies designed to explore the use of ThermoDox® in combination with MR-guided HIFU for the treatment of pancreatic cancer. The studies are being conducted at theUniversity of Washington School of Medicine byJoo Ha Hwang , M.D., Ph.D., Director,Endoscopic Research , Associate Professor of Medicine and Adjunct Professor of Bioengineering and Radiology. - In April,
Celsion announced that the HEAT Study achieved its 200 patient enrollment target inthe People's Republic of China (PRC), a key milestone for the Company's global regulatory strategy as it allows for regulatory filing inChina -- a market which accounts for over 50% of the 750,000 annual incidences of liver cancer. Concurrently,Celsion announced that the HEAT Study's independent Data Monitoring Committee (DMC) completed a safety review of 652 patients and unanimously recommended that the study continue according to protocol. - In February,
Celsion announced that the first patient was enrolled in a randomized Phase II study of ThermoDox® in combination with radiofrequency ablation (RFA) for the treatment of colorectal liver metastases (CRLM).
Financial Results
For the quarter ended
Research and development costs increased by approximately
The Company ended the quarter with
Quarterly Conference Call
The Company is hosting a conference call to provide a business update and discuss the first quarter 2012 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 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® 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® 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® clinical studies may be found at www.clinicaltrials.gov.
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Celsion Corporation Condensed Statements of Operations (in thousands except per share amounts) (unaudited) Three Months Ended March 31, ---------------------------- 2012 2011 ------------- ------------- Licensing revenue $ - $ 2,000 Operating expenses: Research and development 4,693 4,349 General and administrative 1,570 1,215 ------------- ------------- Total operating expenses 6,263 5,564 ------------- ------------- Loss from operations (6,263) (3,564) ------------- ------------- Other income (expense): Gain from valuation of common stock warrant liability 78 168 Interest, dividends and other income (expense), net (1) (368) ------------- ------------- Total other income (expense), net 77 (200) ------------- ------------- Net Loss $ (6,186) $ (3,764) ============= ============= Net loss per common share - basic and diluted $ (0.19) $ (0.28) ============= ============= Weighted average common shares outstanding - basic and diluted 33,197 13,453 ============= ============= Celsion Corporation Selected Balance Sheet Information (in thousands) March 31, December 31, 2012 2011 ASSETS (unaudited) ------------- ------------- Current assets Cash and cash equivalents $ 9,122 $ 20,146 Short term investments 15,472 10,401 Other current assets 1,179 961 ------------- ------------- Total current assets 25,773 31,508 ------------- ------------- Property and equipment 908 783 ------------- ------------- Other assets Deposits and other assets 323 323 Patent license fees, net 33 35 ------------- ------------- Total other assets 356 358 ------------- ------------- Total assets $ 27,037 $ 32,649 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable and accrued liabilities $ 6,320 $ 6,042 Note payable - current portion 78 110 ------------- ------------- Total current liabilities 6,398 6,152 Common stock warrant liability 89 166 Other liabilities - noncurrent portion 188 137 ------------- ------------- Total liabilities 6,675 6,455 ------------- ------------- Stockholders' equity Common stock 339 339 Additional paid-in capital 153,532 153,237 Accumulated other comprehensive loss (278) (276) Accumulated deficit (130,473) (124,222) ------------- ------------- Subtotal 23,120 29,078 Less: Treasury stock (2,758) (2,884) ------------- ------------- Total stockholders' equity 20,362 26,194 ------------- ------------- Total liabilities and stockholders' equity $ 27,037 $ 32,649 ============= =============
Investor ContactDavid Pitts Argot Partners 212-600-1902 Email Contact
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