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Celsion Corporation
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AstraZeneca names new head of MedImmune
www.bizjournals.com | Nov 13, 2008
Less than four months after MedImmune CEO David Mott stepped down, its parent company AstraZeneca PLC has named the interim chief executive officer to the permanent post. Tony Zook, who has been heading AstraZeneca’s largest markets, the U.S.
http://www.bizjournals.com/baltimore/stories/2008/11/10/daily52.html?ana=from_rss
Boston Scientific reports positive data from Taxus Olympia registry
www.pharmaceutical-business-review.com | Sep 4, 2008
Boston Scientific, a manufacturer and marketer of medical devices, has announced positive one-year results from the European and intercontinental launch Phases of its global Taxus Olympia registry, the worlds largest post-approval, prospective registry for a single drug-eluting stent.
Celsion Corporation Secures Special Protocol Assessment of its Pivotal Phase III Liver Cancer Trial from FDA
www.biospace.com | Jan 18, 2008
COLUMBIA, Md.--(BUSINESS WIRE)--CELSION CORPORATION (AMEX: CLN) today announced that its application for a Special Protocol Assessment (SPA) for its Pivotal Phase III Primary Liver Cancer trial has been agreed to by the US Food and Drug Administration.
http://www.biospace.com/news_story.aspx?StoryID=83169&full=1
December 21, 2007, issue
www.sec.gov | Dec 21, 2007
SEC NEWS DIGEST Issue 2007-245 December 21, 2007 COMMISSION ANNOUNCEMENTS STAFF ACCOUNTING BULLETIN 110 The U.S. Securities and Exchange Commission's Office of the Chief Accountant and Division of Corporation Finance announced today the release of Staff Accounting Bulletin (SAB) No. 110.
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CLSN: Joint Research Agreement w/Royal Philips for New Cancer Treatment - Zibb.com
www.zibb.com
By Fain Hughes, fhughes@knobias.com Royal Philips Electronics (PHG) and Celsion Corporation (CLSN) announced the signing of a joint research agreement focusing on a new cancer treatment that combines Philips' ultrasound technology with Celsion's drug delivery solution to target tumors with high
Celsion Corporation -
Celsion Corporation is an innovative oncology drug development company singularly focused on improving treatment for those suffering with highly difficult forms of cancer.
Fast Track Systems Inc.
The Grants Manager and CROCAS date bases, which are representative of clinical costs for the global pharmaceutical industry, will be a useful tool in planning, budgeting and controlling the costs of this study”.
TA: Article
An SDIO-funded adaptive phased-array (APA) microwave focusing technique, originally developed for missile radar applications, is being used in clinical trials for the treatment of breast cancer.
http://www.mdatechnology.net/printerpage_techsearch.asp?articleid=398
News from Zibb.com
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Celsion to Present at BIO-Europe 2008 in Mannheim Germany Tuesday, November 18, 2008 - Zibb.com
COLUMBIA, Md., Nov 17, 2008 (BUSINESS WIRE) --
Celsion Corporation (NASDAQ: CLSN), a biotechnology drug development company that is leveraging its Heat Sensitive Liposomal Technology platform to encapsulate and deliver high concentrations of proven chemotherapeutics, today announced that President and CEO Michael H. Tardugno will present at BIO-Europe 2008 in Mannheim, Germany on November 18, 2008. This year marks BIO-Europe's 14th Annual International Partnering Conference, with over 1,300 global companies represented. The presentation is scheduled to begin at 10:30 a.m. CET at the m:con Congress Center Rosengarten.
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, and North Shore Hospital.
For more information on Celsion, visit: http://www.celsion.com.
SOURCE: Celsion Corporation
FD Geoff Grande, +1-617-747-1721 geoff.grande@fd.com
Tags: biotechnology ceo conference congress drugs energy europe germany health hong kong hospital medical nasdaq president research technology university
Companies: Celsion Corp. (CLSN)
Celsion Corporation Reports Third Quarter 2008 Financial Results - Zibb.com
COLUMBIA, Md., Nov 13, 2008 (BUSINESS WIRE) --
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(R), 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(R) for the treatment of primary liver cancer. Celsion and Yakult have executed a letter of intent relating to the commercialization of ThermoDox(R) 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 Primary 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 or706-645-9291, 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)
Three Months Ended Nine Months Ended
September 30, September 30,
2008 2007 2008 2007
Revenues $ - $ - $ - $ -
Operating expenses:
Research and development 3,840 1,959 8,422 6,079
General and administrative 510 1,860 1,586 4,826
Total operating expenses 4,350 3,819 10,008 10,905
Loss from operations (4,350 ) (3,819 ) (10,008 ) (10,905 )
Other income (expense):
Other expense (57 ) (24 ) (896 ) (439 )
Interest income 81 204 185 505
Interest expense (14 ) (12 ) (133 ) (677 )
Loss from continuing operations (4,340 ) (3,651 ) (10,852 ) (11,516 )
Discontinued Operations
Income from discontinued operations - 33 - 49,755
Net (loss) / income $ (4,340 ) $ (3,618 ) $ (10,852 ) $ 38,239
Net loss from continuing operations per common share - basic $ (0.43 ) $ (0.34 ) $ (1.07 ) $ (1.07 )
Net loss from continuing operations per common share - diluted $ (0.43 ) $ (0.34 ) $ (1.07 ) $ (1.07 )
Net income from discontinued operations per common share - basic $ - $ - $ - $ 4.62
Net income from discontinued operations per common share - diluted $ - $ - $ - $ 4.32
Net (loss) / income per common share - basic $ (0.43 ) $ (0.34 ) $ (1.07 ) $ 3.55
Net (loss) / income per common share - diluted $ (0.43 ) $ (0.34 ) $ (1.07 ) $ 3.32
Weighted average shares outstanding - basic 10,149,055 10,774,497 10,146,339 10,764,878
Weighted average shares outstanding - diluted 10,149,055 10,774,497 10,146,339 11,526,717
Celsion Corporation
Condensed Balance Sheets
(in thousands)
September 30,
2008 December 31,
(Unaudited) 2007
Current assets
Cash and short term investments $ 8,969 $ 5,937
Accounts receivable 68 230
Due from Boston Scientific Corporation 15,000 15,000
Prepaid expenses 141 257
Total current assets 24,178 21,424
Property and equipment, net 225 268
Notes and loans receivable 321 1,382
Due from Boston Scientific Corporation - Non Current - 15,000
Deposits with CROs and other assets 1,178 965
Total other assets 1,724 17,615
Total assets $ 25,902 $ 39,039
Current liabilities
Accounts payable $ 2,237 $ 1,830
Accrued expenses 2,755 5,066
Income taxes payable - 546
Note payable - current portion 408 677
Total current liabilities 5,400 8,119
Long-term liabilities
Note payable - 235
Other liabilities 30 34
Total long-term liabilities 30 269
Total liabilities 5,430 8,388
Stockholders' equity
Common stock 108 108
Additional paid-in capital 89,014 88,320
Unrealized loss on available for sale securities (21 )
Accumulated deficit (65,990 ) (55,138 )
Subtotal 23,111 33,290
Less: Treasury Stock - at cost (2,639 ) (2,639 )
Total stockholders' equity 20,472 30,651
Total liabilities and stockholders' equity $ 25,902 $ 39,039
SOURCE: Celsion Corporation
FD Geoff Grande, 617-747-1721 geoff.grande@fd.com
Tags: acquisition canada cancer ceo china clinical conference deficit drugs energy equity financial results health hong kong italy japan jewish korea medical nasdaq new_york note pipeline president property research research and development securities taiwan taxes technology treasury trial university
Companies: Celsion Corp. (CLSN)
Celsion Corp. (CLSN) Corporate Event Announcement Notice - Zibb.com
Oct 30, 2008 (Wall Street Horizon via COMTEX) --
Celsion Corp. (CLSN)
Expected next earnings release: Announcement date: 11/6/2008 - Before Market Earnings Quarter: Q3 Announcement Status: Unconfirmed
Tags: corporate earnings market
Companies: Celsion Corp. (CLSN)
Celsion Corp. (CLSN) Corporate Event Announcement Notice - Zibb.com
Oct 21, 2008 (Wall Street Horizon via COMTEX) --
Celsion Corp. (CLSN)
Expected next earnings release: Announcement date: 11/6/2008 - Before Market Earnings Quarter: Q3 Announcement Status: Unconfirmed
Tags: corporate earnings market
Companies: Celsion Corp. (CLSN)
News from Zibb.com
- Celsion to Present at BIO-Europe 2008 in Mannheim Germany Tuesday, November 18, 2008 - Zibb.com
- Celsion Corporation Reports Third Quarter 2008 Financial Results - Zibb.com
- Celsion Corp. (CLSN) Corporate Event Announcement Notice - Zibb.com
- Celsion Corp. (CLSN) Corporate Event Announcement Notice - Zibb.com
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