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)

 

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 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, Celsion’s 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 Company’s 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 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)

 

 

 

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