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): August 18, 2008
Celsion Corporation
(Exact Name of Registrant as Specified in Charter)
Delaware |
|
000-14242 |
|
52-1256615 |
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
|
|
|
|
10220-L Old Columbia Road, Columbia, Maryland |
|
21046-2364 |
||
(Address of principal executive office) |
|
(Zip Code) |
Registrants 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 August 18, 2008, Celsion Corporation issued a press release reporting its financial results for the quarter and six months ended June 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.
Exhibit Number |
|
Description |
99.1 |
|
Earnings Release dated August 18, 2008, furnished pursuant to Item 2.02 of Form 8-K |
2
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.
|
|
|
CELSION CORPORATION |
|
|
|
|
|
|
Date: August 18, 2008 |
|
|
By: |
/s/ Paul B. Susie |
|
|
|
|
Paul B. Susie |
|
|
|
|
Chief Accounting Officer |
3
EXHIBIT INDEX
Exhibit Number |
|
Description |
99.1 |
|
Earnings Release dated August 18, 2008, furnished pursuant to Item 2.02 of Form 8-K |
4
Exhibit 99.1
For Further Information Contact:
Geoff Grande
FD Ashton Partners
617-747-1721
geoff.grande@fdashtonpartners.com
CELSION CORPORATION REPORTS SECOND QUARTER
2008 FINANCIAL RESULTS
Focus continues on the Advancement of Primary Liver Cancer and Recurrent Chest Wall Clinical Trials
Columbia, MD., August 18, 2008: Celsion Corporation (NASDAQ: CLSN) today announced financial results for its second quarter ended June 30, 2008. The Company reported a net loss from continuing operations of $2.4 million, or $0.24 per diluted share, compared to a net loss from continuing operations of $4.6 million, or $0.43 per diluted share, for the second quarter of 2007. When factoring in discontinued operations in 2007, the Company reported net income of $44.2 million, or $3.80 per diluted share, in the second quarter ended June 30, 2007. Net income for 2007 included the gain on the Sale of the Prolieve assets of $48 million.
Recent Celsion Milestones:
· Presented well-received abstract presentations regarding Phase I and preclinical studies at two prestigious oncologic and drug delivery conferences
· Demonstrated biological activity of its formulation in a patient population in its Phase I study for RCW cancer
· Included in the Russell Microcap Index
Mr. Michael H. Tardugno, Celsions President and Chief Executive Officer, commented, Advancing our Phase III Liver Cancer Trial is our number one priority and we made significant progress on achieving our goals in this respect. Additionally, we have been and will continue carefully managing overhead costs while fully supporting our development pipeline. These actions reflect our commitment to advancing our research programs and thus driving shareholder value.
Celsion remains focused on advancing our current programs, continued Mr. Tardugno. We are in a strong position 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, as well as demonstrating feasibility for additional formulations. Additionally, we continue to make progress in accelerating our Recurrent Chest Wall (RCW) cancer trial and anticipate initiating our pivotal Phase II study before the end of this year.
For the six months ended June 30, 2008, Celsion reported a net loss from continuing operations of $6.5 million, or $0.64 per share compared to a net loss from continuing operations of $7.9 million, or $0.73 per share, for the comparable period in 2007. Including income from discontinued operations in 2007, the Company recorded net income of $41.9 million, or $3.64 per diluted share.
Celsion is holding a conference call to discuss second quarter results on Monday, August 18, 2008, at 11:00 a.m. Eastern Time. Interested participants may dial 877-604-2080 (U.S./Canada) or 706-902-1383 (International) for the teleconference and use Conference ID: #59454102 to register ten minutes before the call is scheduled to begin.
The call will be archived for replay on August 18, 2008 at 2:00 p.m. and will be made available until Monday, August 25, 2008. The replay can be accessed at 800-642-1687 or 706-645-9291, Conference ID: # 59454102. The call will also be available on the Companys website <www.celsion.com> for 30 days after 2:00 p.m. on Monday, August 18, 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 Companys periodic reports filed with the Securities and Exchange Commission.
Celsion Corporation
Condensed Statements of Operations
(in thousands except for per share amounts)
(Unaudited)
|
|
Three Months Ended |
|
Six Months Ended |
|
||||||||
|
|
June 30, |
|
June 30, |
|
||||||||
|
|
2008 |
|
2007 |
|
2008 |
|
2007 |
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Revenues |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
1,615 |
|
2,349 |
|
4,582 |
|
4,120 |
|
||||
General and administrative |
|
581 |
|
1,671 |
|
1,077 |
|
2,965 |
|
||||
Total operating expenses |
|
2,196 |
|
4,020 |
|
5,659 |
|
7,085 |
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
(2,196 |
) |
(4,020 |
) |
(5,659 |
) |
(7,085 |
) |
||||
|
|
|
|
|
|
|
|
|
|
||||
Other income (expense): |
|
|
|
|
|
|
|
|
|
||||
Other expense |
|
(159 |
) |
(416 |
) |
(839 |
) |
(416 |
) |
||||
Interest income |
|
29 |
|
120 |
|
104 |
|
301 |
|
||||
Interest expense |
|
(104 |
) |
(317 |
) |
(118 |
) |
(665 |
) |
||||
|
|
|
|
|
|
|
|
|
|
||||
Loss from continuing operations |
|
(2,430 |
) |
(4,633 |
) |
(6,512 |
) |
(7,865 |
) |
||||
|
|
|
|
|
|
|
|
|
|
||||
Discontinued Operations |
|
|
|
|
|
|
|
|
|
||||
Income from discontinued operations |
|
|
|
48,847 |
|
|
|
49,722 |
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Net (loss) / income |
|
$ |
(2,430 |
) |
$ |
44,214 |
|
$ |
(6,512 |
) |
$ |
41,857 |
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss from continuing operations per common share - basic |
|
$ |
(0.24 |
) |
$ |
(0.43 |
) |
$ |
(0.64 |
) |
$ |
(0.73 |
) |
|
|
|
|
|
|
|
|
|
|
||||
Net loss from continuing operations per common share - diluted |
|
$ |
(0.24 |
) |
$ |
(0.43 |
) |
$ |
(0.64 |
) |
$ |
(0.73 |
) |
|
|
|
|
|
|
|
|
|
|
||||
Net income from discontinued operations per common share - basic |
|
$ |
|
|
$ |
4.53 |
|
$ |
|
|
$ |
4.62 |
|
|
|
|
|
|
|
|
|
|
|
||||
Net income from discontinued operations per common share - diluted |
|
$ |
|
|
$ |
4.20 |
|
$ |
|
|
$ |
4.33 |
|
|
|
|
|
|
|
|
|
|
|
||||
Net (loss) / income per common share - basic |
|
$ |
(0.24 |
) |
$ |
4.10 |
|
$ |
(0.64 |
) |
$ |
3.89 |
|
|
|
|
|
|
|
|
|
|
|
||||
Net (loss) / income per common share - diluted |
|
$ |
(0.24 |
) |
$ |
3.80 |
|
$ |
(0.64 |
) |
$ |
3.64 |
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average shares outstanding - basic |
|
10,146,446 |
|
10,773,023 |
|
10,144,944 |
|
10,760,019 |
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Weighted average shares outstanding - diluted |
|
10,146,446 |
|
11,628,480 |
|
10,144,944 |
|
11,493,854 |
|
Celsion Corporation
Condensed Balance Sheets
(in thousands)
|
|
June 30, |
|
December 31, |
|
||
|
|
2008 |
|
2007 |
|
||
|
|
(Unaudited) |
|
|
|
||
Current assets |
|
|
|
|
|
||
Cash and short term investments |
|
$ |
12,642 |
|
$ |
5,937 |
|
Accounts receivable |
|
73 |
|
230 |
|
||
Due from Boston Scientific Corporation |
|
15,000 |
|
15,000 |
|
||
Prepaid expenses |
|
226 |
|
257 |
|
||
Total current assets |
|
27,941 |
|
21,424 |
|
||
|
|
|
|
|
|
||
Property and equipment, net |
|
212 |
|
268 |
|
||
Notes and loans receivable |
|
378 |
|
1,382 |
|
||
Due from Boston Scientific Corporation - Non Current |
|
|
|
15,000 |
|
||
Other assets |
|
1,460 |
|
965 |
|
||
Total other assets |
|
1,838 |
|
17,347 |
|
||
|
|
|
|
|
|
||
Total assets |
|
$ |
29,991 |
|
$ |
39,039 |
|
|
|
|
|
|
|
||
Current liabilities |
|
|
|
|
|
||
Accounts payable |
|
$ |
1,310 |
|
$ |
1,830 |
|
Accrued expenses |
|
3,394 |
|
5,066 |
|
||
Income taxes payable |
|
|
|
546 |
|
||
Note payable - current portion |
|
578 |
|
677 |
|
||
Total current liabilities |
|
5,282 |
|
8,119 |
|
||
|
|
|
|
|
|
||
Long-term liabilities |
|
|
|
|
|
||
Note payable |
|
|
|
235 |
|
||
Other liabilities |
|
31 |
|
34 |
|
||
Total long-term liabilities |
|
31 |
|
269 |
|
||
|
|
|
|
|
|
||
Total liabilities |
|
5,313 |
|
8,388 |
|
||
|
|
|
|
|
|
||
Stockholders equity |
|
|
|
|
|
||
Common stock |
|
108 |
|
108 |
|
||
Additional paid-in capital |
|
88,866 |
|
88,320 |
|
||
Unrealized loss on available for sale securities |
|
(7 |
) |
|
|
||
Accumulated deficit |
|
(61,650 |
) |
(55,138 |
) |
||
Subtotal |
|
27,317 |
|
33,290 |
|
||
Less: Treasury Stock - at cost |
|
(2,639 |
) |
(2,639 |
) |
||
Total stockholders equity |
|
24,678 |
|
30,651 |
|
||
|
|
|
|
|
|
||
Total liabilities and stockholders equity |
|
$ |
29,991 |
|
$ |
39,039 |
|