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): March 3, 2009

 

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)

 

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 March 3, 2009, Celsion Corporation issued a press release reporting its financial results for the quarter and year ended December 31, 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.

 

(d)     Exhibits

 

Exhibit Number

 

Description

99.1

 

Earnings Release, dated March 3, 2009, 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: March 3, 2009

By:

/s/ Sean F. Moran

 

 

Sean F. Moran

 

 

Senior Vice President and
Chief Financial Officer

 



 

EXHIBIT INDEX

 

Exhibit Number

 

Description

99.1

 

Earnings Release, dated March 3, 2009, furnished pursuant to Item 2.02 of Form 8-K.

 


 

Exhibit 99.1

 

GRAPHIC

 

Celsion Reports Fourth Quarter and Full Year 2008 Financial Results

 

Key Pivotal ThermoDox® Clinical Trials Underway for Primary Liver Cancer and Recurrent Chest Wall Breast Cancer

 

COLUMBIA, Md., March 3, 2009: Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company, today announced financial results for the fourth quarter and year ended December 31, 2008. For the fourth quarter ended December 31, 2008, Celsion reported a net loss of $.9 million, or $0.09 per diluted share, compared to a net loss of $2.9 million, or $0.27 per diluted share, for the fourth quarter of 2007. The Company recorded a loss from continuing operations of $.9 million, or $0.09 per diluted share, for the fourth quarter of 2008, compared to a loss of $2.5 million, or $0.24 per diluted share, for the fourth quarter of 2007. In the fourth quarter of 2008, the Company entered into a ThermoDox® licensing agreement with Yakult Honsha for the territory of Japan and received a non-refundable $2.5 million up-front payment that was recorded as licensing revenue.

 

For the year ended December 31, 2008, the Company reported a net loss of $11.8 million, or $1.16 per diluted share, compared to net income of $35.3 million, or $3.07 per diluted share, in 2007. The Company recorded a loss from continuing operations of $11.8 million, or $1.16 per diluted share, for the year 2008, compared to a loss of $14 million, or $1.31 per diluted share, for the year 2007. In 2007, the Company divested its medical device business and recorded net income from discontinuing operations of $49.4 million.

 

Mr. Michael H. Tardugno, Celsion’s president and chief executive officer, commented, “During 2008, we made substantial progress advancing our lead oncology drug ThermoDox® into pivotal clinical trials. Celsion obtained FDA agreement for its Global Phase III study through Special Protocol Assessment, and is enrolling and recruiting patients at 28 sites in 6 countries. A second trial was initiated for recurrent chest wall breast cancer following agreement with FDA that an open label Phase I/II study with complete local response end point may be sufficient for ThermoDox® approval dependent on the response rate. We expect to complete enrollment for both studies in early 2010 and are very fortunate to be able to self-fund these critical milestones within our existing financial resources.”

 

“We continue to be very encouraged by the medical and pharmaceutical community’s high level of interest level in ThermoDox®”, Mr. Tardugno added. In December 2008, we completed an exclusive ThermoDox® licensing agreement with Yakult Honsha for the Japanese market. The license agreement will provide Celsion with $20.5 million in up front licensing payments, $18 million of which will be made upon ThermoDox® approval in Japan. Additionally, Celsion will receive escalating double digit royalties from product sales. The terms require Yakult to conduct and fund all studies uniquely required for NDA submission in Japan. We view this partnership as a further validation of ThermoDox®’s therapeutic potential and its significant market opportunity.”

 

“Both primary liver cancer and recurrent breast cancer are diseases with limited treatment options and no chemotherapeutic standard-of-care. ThermoDox® is a potent heat-activated liposomal encapsulated formulation of Doxorubicin that delivers a significantly greater concentration of the drug directly to the tumor than other liposomal Doxorubicin formulations. The promise of

 



 

ThermoDox®’s approach is reflected in the remarkable evidence of clinical activity shown our in Phase I studies.”

 

The Company is holding a conference call to provide a business update and discuss the fiscal 2008 results at 11:00 a.m. Eastern Time on Tuesday, March 3, 2009. To participate in the call, interested parties may dial 877-604-2080 (U.S./Canada) or 706-902-1383 (International) and use Conference ID: #87627643 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 March 3, 2009 at 2:00 P.M. and will remain available until Monday, March 9, 2009. The replay can be accessed at 800-642-1687 or 706-645-9291 using Conference ID: #87627643. The call will also be available on the Company’s website, http://www.celsion.com, for 30 days after 2:00 p.m. on Tuesday, March 3, 2009.

 

About ThermoDox®

 

ThermoDox® in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. 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 including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) 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 3 study at 40 clinical sites under an FDA Special Protocol Assessment. The primary endpoint for the study is progression-free survival and enrollment  is expected to be completed in 2010. For recurrent chest wall breast cancer, ThermoDox® is being evaluated in a Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site. Celsion expects to enroll approximately 100 patients across the United States and to complete the study by the first half of 2010.  Additional information on these ThermoDox® clinical studies may be found at http://www.clinicaltrials.gov.

 

About Celsion

 

Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer 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 Investor Contacts:

 

Sean Moran, Chief Financial Officer

Tel: +1 410 290 5390

Email : smoran@celsion.com

 

Geoff Grande, CFA

FD

Tel: +1 617 747 1721

Email: geoff.grande@fd.com

 

Celsion Media Contact:

 

Irma Gomez-Dib

FD

Tel: +1 212 850 5761

Email: irma.gomez-dib@fd.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)

 

 

 

Three Months Ended

 

Year Ended

 

 

 

December 31,

 

December 31,

 

 

 

2008

 

2007

 

2008

 

2007

 

 

 

(Unaudited)

 

(Unaudited)

 

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

Licensing revenues

 

$

2,500

 

$

 

$

2,500

 

$

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

3,584

 

2,153

 

12,006

 

8,231

 

General and administrative

 

456

 

528

 

2,042

 

5,355

 

Total operating expenses

 

4,040

 

2,681

 

14,048

 

13,586

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(1,540

)

(2,681

)

(11,548

)

(13,586

)

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Other (expense) / income, net

 

579

 

(18

)

(317

)

(457

)

Interest income

 

36

 

163

 

221

 

669

 

Interest expense

 

(9

)

(17

)

(142

)

(695

)

 

 

 

 

 

 

 

 

 

 

Loss from continuing operations before income taxes

 

(934

)

(2,553

)

(11,786

)

(14,069

)

 

 

 

 

 

 

 

 

 

 

Income taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from continuing operations

 

$

(934

)

$

(2,553

)

$

(11,786

)

$

(14,069

)

 

 

 

 

 

 

 

 

 

 

Discontinued Operations

 

 

 

 

 

 

 

 

 

Income from discontinued operations (including gain on sale of $48,029,793)

 

 

209

 

 

50,237

 

Income tax expense

 

 

(544

)

 

(819

)

 

 

 

 

 

 

 

 

 

 

Income from discontinued operations

 

 

(335

)

 

49,418

 

 

 

 

 

 

 

 

 

 

 

Net (loss) / income

 

$

(934

)

$

(2,888

)

$

(11,786

)

$

35,349

 

 

 

 

 

 

 

 

 

 

 

Net loss from continuing operations per common share - basic

 

$

(0.09

)

$

(0.24

)

$

(1.16

)

$

(1.31

)

 

 

 

 

 

 

 

 

 

 

Net loss from continuing operations per common share - diluted

 

$

(0.09

)

$

(0.24

)

$

(1.16

)

$

(1.31

)

 

 

 

 

 

 

 

 

 

 

Net income from discontinued operations per common share - basic

 

$

 

$

(0.03

)

$

 

$

4.60

 

 

 

 

 

 

 

 

 

 

 

Net income from discontinued operations per common share - diluted

 

$

 

$

(0.03

)

$

 

$

4.29

 

 

 

 

 

 

 

 

 

 

 

Net (loss) / income per common share - basic

 

$

(0.09

)

$

(0.27

)

$

(1.16

)

$

3.29

 

 

 

 

 

 

 

 

 

 

 

Net (loss) / income per common share - diluted

 

$

(0.09

)

$

(0.27

)

$

(1.16

)

$

3.07

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding - basic

 

10,154

 

10,636

 

10,149

 

10,732

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding - diluted

 

10,154

 

11,433

 

10,149

 

11,514

 

 



 

Celsion Corporation

Condensed Balance Sheets

(in thousands)

 

 

 

 

December 31,

 

December 31,

 

 

 

2008

 

2007

 

 

 

(Unaudited)

 

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and short term investments

 

$

7,517

 

$

5,937

 

Accounts receivable

 

 

183

 

Due from Boston Scientific Corporation

 

15,000

 

15,000

 

Prepaid expenses

 

306

 

304

 

Escrow account - license fee

 

 

 

Total current assets

 

22,823

 

21,424

 

 

 

 

 

 

 

Property and equipment, net

 

223

 

268

 

Notes and loans receivable

 

221

 

1,382

 

Due from Boston Scientific Corporation - Non current

 

 

15,000

 

Other assets

 

421

 

965

 

Total other assets

 

642

 

17,347

 

 

 

 

 

 

 

Total assets

 

$

23,688

 

$

39,039

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

Accounts payable

 

$

1,186

 

$

1,831

 

Accrued expenses

 

2,514

 

5,065

 

Income taxes payable

 

 

546

 

Note payable - current portion

 

235

 

677

 

Current portion of deferred revenue

 

 

 

Total current liabilities

 

3,935

 

8,119

 

 

 

 

 

 

 

Long-term liabilities

 

 

 

 

 

Notes payable

 

 

235

 

Other liabilities

 

27

 

34

 

Total long-term liabilities

 

27

 

269

 

 

 

 

 

 

 

Total liabilities

 

3,962

 

8,388

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Common stock

 

108

 

108

 

Additional paid-in capital

 

86,542

 

85,681

 

Accumulated deficit

 

(66,924

)

(55,138

)

Total stockholders’ equity / (deficit)

 

19,726

 

30,651

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

23,688

 

$

39,039