UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 13, 2008
Celsion Corporation
(Exact Name of Registrant as Specified in Charter)
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Delaware |
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000-14242 |
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52-1256615 |
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(State or other jurisdiction |
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(Commission File Number) |
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(IRS Employer |
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10220-L Old Columbia Road, Columbia, Maryland |
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21046-2364 |
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(Address of principal executive office) |
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(Zip Code) |
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Registrant’s telephone number, including area code: (410) 290-5390
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.135-4(c))
Item 2.02 Results of Operations and Financial Condition.
On November 13, 2008, Celsion Corporation issued a press release reporting its financial results for the quarter and nine months ended September 30, 2008 (the “Earnings Release”). The Earnings Release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, and shall not be incorporated by reference into any registration statement pursuant to the Securities Act of 1933, as amended.
Item 9.01 Financial Statements and Exhibits.
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Exhibit Number |
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Description |
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99.1 |
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Earnings Release dated November 13, 2008, furnished pursuant to Item 2.02 of Form 8-K |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CELSION CORPORATION |
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Date: November 13, 2008 |
By: |
/s/ Paul B. Susie |
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Paul B. Susie |
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Chief Accounting Officer |
EXHIBIT INDEX
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Exhibit Number |
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Description |
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99.1 |
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Earnings Release dated November 13, 2008, furnished pursuant to Item 2.02 of Form 8-K |
Exhibit 99.1
For Further Information Contact:
Geoff Grande
FD
617-747-1721
geoff.grande@fd.com
CELSION CORPORATION REPORTS THIRD QUARTER
2008 FINANCIAL RESULTS
Focus continues on the Advancement of Primary Liver Cancer and Recurrent Chest Wall Clinical Trials
Columbia, MD., November 13, 2008: Celsion Corporation (NASDAQ: CLSN) today announced financial results for its third quarter ended September 30, 2008. The Company reported a net loss from continuing operations of $4.3 million, or $0.43 per diluted share, compared to a net loss from continuing operations of $3.7 million, or $0.34 per diluted share, for the third quarter of 2007. When factoring in discontinued operations in 2007, the Company reported a net loss of $3.6 million, or $.34 per diluted share, in the third quarter ended September 30, 2007.
Recent Celsion Milestones:
· Announced that site initiation is tracking well against Celsion’s most recent projections in its global Phase III Primary Liver Cancer trial. The Company anticipates that a Clinical Trial Agreement will be obtained in China by the end of 2008 in addition to the regulatory approval already received in Hong Kong, Taiwan, Korea, Canada, and Italy.
· Continued to make progress in accelerating Celsion’s Recurrent Chest Wall (RCW) cancer trial and anticipate initiating the pivotal Phase II study before the end of this year.
· Signed a joint research agreement with Philips to explore the potential for using investigational magnetic resonance imaging (MRI)-guided high intensity focused ultrasound (HIFU) system in combination with Celsion’s leading drug candidate, ThermoDox®, to treat a broad range of cancers.
· Announced that Yakult Honsha is proceeding with its plans to initiate a clinical program in Japan to study ThermoDox® for the treatment of primary liver cancer. Celsion and Yakult have executed a letter of intent relating to the commercialization of ThermoDox® for the Japanese markets subject to the execution of definitive agreements.
· Presented at the Rodman & Renshaw 10th Annual Healthcare Conference on November 11 in New York.
Mr. Michael H. Tardugno, Celsion’s President and Chief Executive Officer, commented, “We are excited about each of the recent milestones that we have met as we move forward with the Company’s current programs. Advancing our pivotal studies including our Phase II RCW and Phase III liver cancer trials remains our number one priority and we continue to see significant progress in their development. Each of the milestones we have reached speaks to the competency, credibility, and hard work of our management team and staff.”
“Celsion is delivering on its goals,” continued Mr. Tardugno. “Our cash position is strong, and we remain well-positioned to fund our Phase III primary liver cancer study to a point where we have sufficient results to determine if there is support for an NDA filing. That said, we will continue to be prudent in our spend management while fully supporting our development pipeline.”
For the nine months ended September 30, 2008, Celsion reported a net loss from continuing operations of $10.9 million, or $1.07 per share compared to a net loss from continuing operations of $11.5 million, or $1.07 per share, for the comparable period in 2007. Including income from discontinued operations in 2007, the Company recorded net income of $38.2 million, or $3.32 per diluted share.
Celsion is holding a conference call to discuss third quarter results on Thursday, November 13, 2008, at 11:00 a.m. Eastern Time. Interested parties may dial 877-604-2080 (U.S./Canada) or 706-902-1383 (International) for the teleconference and use Conference ID #72753429 to register ten minutes before the call is scheduled to begin. The call will also be broadcast live on the internet at http://www.celsion.com.
The call will be archived for replay on November 13, 2008 at 2:00 p.m. and will be made available until Thursday, November 20, 2008. The replay can be accessed at 800-642-1687 or 706-645-9291, Conference ID: # 72753429. The call will also be available on the Company’s website, http://www.celsion.com for 30 days after 2:00 p.m. on Thursday, November 13, 2008.
About Celsion: Celsion is dedicated to the development and commercialization of oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat activated drug delivery systems.
Celsion has research, license or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.
For more information on Celsion, visit our website: http://www.celsion.com.
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 by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission.
Celsion Corporation
Condensed Statements of Operations
(in thousands except for per share amounts)
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Revenues |
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$ |
— |
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$ |
— |
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$ |
— |
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$ |
— |
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Operating expenses: |
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Research and development |
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3,840 |
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1,959 |
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8,422 |
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6,079 |
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General and administrative |
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510 |
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1,860 |
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1,586 |
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4,826 |
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Total operating expenses |
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4,350 |
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3,819 |
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10,008 |
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10,905 |
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Loss from operations |
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(4,350 |
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(3,819 |
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(10,008 |
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(10,905 |
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Other income (expense): |
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Other expense |
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(57 |
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(24 |
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(896 |
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(439 |
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Interest income |
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81 |
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204 |
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185 |
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505 |
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Interest expense |
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(14 |
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(12 |
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(133 |
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(677 |
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Loss from continuing operations |
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(4,340 |
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(3,651 |
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(10,852 |
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(11,516 |
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Discontinued Operations |
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Income from discontinued operations |
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— |
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33 |
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— |
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49,755 |
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Net (loss) / income |
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$ |
(4,340 |
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$ |
(3,618 |
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$ |
(10,852 |
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$ |
38,239 |
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Net loss from continuing operations per common share - basic |
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$ |
(0.43 |
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$ |
(0.34 |
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$ |
(1.07 |
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$ |
(1.07 |
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Net loss from continuing operations per common share - diluted |
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$ |
(0.43 |
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$ |
(0.34 |
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$ |
(1.07 |
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$ |
(1.07 |
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Net income from discontinued operations per common share - basic |
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$ |
— |
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$ |
— |
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$ |
— |
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$ |
4.62 |
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Net income from discontinued operations per common share - diluted |
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$ |
— |
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$ |
— |
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$ |
— |
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$ |
4.32 |
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Net (loss) / income per common share - basic |
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$ |
(0.43 |
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$ |
(0.34 |
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$ |
(1.07 |
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$ |
3.55 |
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Net (loss) / income per common share - diluted |
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$ |
(0.43 |
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$ |
(0.34 |
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$ |
(1.07 |
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$ |
3.32 |
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Weighted average shares outstanding - basic |
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10,149,055 |
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10,774,497 |
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10,146,339 |
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10,764,878 |
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Weighted average shares outstanding - diluted |
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10,149,055 |
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10,774,497 |
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10,146,339 |
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11,526,717 |
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Celsion Corporation
Condensed Balance Sheets
(in thousands)
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September 30, |
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December 31, |
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2008 |
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2007 |
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(Unaudited) |
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Current assets |
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Cash and short term investments |
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$ |
8,969 |
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$ |
5,937 |
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Accounts receivable |
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68 |
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230 |
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Due from Boston Scientific Corporation |
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15,000 |
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15,000 |
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Prepaid expenses |
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141 |
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257 |
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Total current assets |
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24,178 |
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21,424 |
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Property and equipment, net |
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225 |
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268 |
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Notes and loans receivable |
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321 |
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1,382 |
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Due from Boston Scientific Corporation - Non Current |
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— |
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15,000 |
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Deposits with CROs and other assets |
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1,178 |
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965 |
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Total other assets |
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1,724 |
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17,615 |
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Total assets |
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$ |
25,902 |
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$ |
39,039 |
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Current liabilities |
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Accounts payable |
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$ |
2,237 |
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$ |
1,830 |
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Accrued expenses |
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2,755 |
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5,066 |
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Income taxes payable |
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— |
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546 |
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Note payable - current portion |
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408 |
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677 |
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Total current liabilities |
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5,400 |
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8,119 |
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Long-term liabilities |
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Note payable |
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— |
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235 |
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Other liabilities |
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30 |
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34 |
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Total long-term liabilities |
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30 |
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269 |
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Total liabilities |
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5,430 |
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8,388 |
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Stockholders’ equity |
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Common stock |
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108 |
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108 |
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Additional paid-in capital |
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89,014 |
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88,320 |
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Unrealized loss on available for sale securities |
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(21 |
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Accumulated deficit |
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(65,990 |
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(55,138 |
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Subtotal |
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23,111 |
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33,290 |
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Less: Treasury Stock - at cost |
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(2,639 |
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(2,639 |
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Total stockholders’ equity |
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20,472 |
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30,651 |
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Total liabilities and stockholders’ equity |
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$ |
25,902 |
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$ |
39,039 |
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