EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

Cell Therapeutics, Inc.

Making cancer more treatable

 

LOGO   

501 Elliott Ave. W. #400

Seattle, WA 98119

   T  206.282.7100

F  206.272.4010

  

Cell Therapeutics Second Quarter Net Loss Decreases

54%; Pixantrone NDA Submitted to the FDA for

Approval

Total Net Operating Expenses Decrease Significantly in First Half 2009

Compared to First Half 2008

August 6, 2009 Seattle— Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today reported recent achievements and financial results for the second quarter and six months ended June 30, 2009.

“The second quarter of 2009 was a transforming quarter for the Company as we reported, in a peer reviewed setting, pixantrone phase III data at the American Society of Clinical Oncology Annual Meeting and completed the submission of the pixantrone New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA),” said James A. Bianco, M.D., CEO of Cell Therapeutics. “On the financial front, we continue to reduce and control our operating expenses, eliminated 44.5% of our outstanding debt through exchange offers completed in June 2009, and raised significant capital to continue to advance pixantrone to market.”

Recent Highlights

 

 

Completed the submission of the pixantrone NDA to the FDA to treat relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL). CTI requested priority review of the pixantrone NDA which, if granted, could lead to an approval decision from the FDA in the fourth quarter of 2009.

 

 

Reduced outstanding debt by $52.9 million, representing 44.5% of outstanding debt, through exchange offers completed in June 2009, resulting in an estimated savings in future annual interest expense of approximately $3.3 million.

 

 

Added to the Russell 3000®, Russell 2000® and Russell Global® Indexes.

 

 

Raised $43.8 million in gross proceeds in connection with financing transactions in the second quarter of 2009, and an additional $41.7 million in proceeds, net of underwriting discount, in connection with an underwritten offering of common stock and warrants in July 2009.

For the quarter ended June 30, 2009, total net operating expenses decreased approximately 24% to $21.7 million, compared to $28.7 million for the same period in 2008. The decrease is mainly a result of a 54% reduction in research and development

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expenses for the quarter ended June 30, 2009, compared to the same period in 2008. Total operating expenses included restructuring charges of $3.8 million related to the closing of CTI’s Bresso, Italy research facility. Net loss attributable to common shareholders decreased by 54% to $27.4 million ($0.06 per share), compared to a net loss attributable to common shareholders of $59.3 million ($5.18 per share) for the same period in 2008. The reduction in net loss per share is due to an increase in the number of shares outstanding and a reduction in research and development and financing expenses as described above.

For the six months ended June, 30 2009, total operating expenses decreased approximately 50% to $28.3 million, compared to $57.0 million for the same period in 2008. The decrease is mainly a result of a 52% decrease in research and development expenses and a $10.2 million gain on the sale of CTI’s remaining interest in a 50/50-owned joint venture with Spectrum Pharmaceuticals, Inc. in 2009. Net loss attributable to common shareholders decreased 64% to $40.6 million ($0.11 per share), compared to a net loss attributable to common shareholders of $113.9 million ($12.28 per share) for the same period in 2008. The reduction in net loss per share is due to an increase in the number of shares outstanding and a reduction in research and development and financing as described above.

CTI had approximately $12.0 million in cash and cash equivalents, securities available-for-sale, and interest receivable as of June 30, 2009. This does not include approximately $41.7 million, net of underwriting discount, the Company received in July 2009 in connection with an underwritten offering of common stock and warrants.

Conference Call Information

On Thursday, August 6, 2009, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific, members of CTI’s management team will host a quarterly conference call to discuss CTI’s 2009 second quarter achievements and financial results.

Conference Call Numbers

Thursday, August 6

8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time

1-877-941-9205 (US Participants)

1-480-629-9835 (International)

Call-back numbers for post-listening available at 11:30 a.m. Eastern:

1-800-406-7325 (US Participants)

1-303-590-3030 (International)

Passcode: 4130004#

Live audio webcast at www.celltherapeutics.com will be archived for post-call listening approximately two hours after call ends.

www.CellTherapeutics.com


About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the market price of our securities. Specifically, the risks and uncertainties include statements about our ability to continue to reduce our operating expenses, our ability to continue to raise capital as needed to fund our operations, the development of OPAXIO, pixantrone, and brostallicin, which include risks associated with preclinical and clinical developments in the biopharmaceutical industry, in general, and with OPAXIO, pixantrone, and brostallicin, in particular, including, without limitation, the potential failure of these product candidates to prove safe and effective for treatment of non-small cell lung cancer, ovarian cancer, non-Hodgkin’s lymphoma, and sarcoma or to achieve market acceptance for such treatments, the possibility that priority review will not be granted by the FDA for the pixantrone NDA and that a decision by the FDA is not rendered in late 2009, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling OPAXIO, pixantrone, and brostallicin, and the risk factors listed or described from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, we do not intend to update or alter our forward-looking statements whether as a result of new information, future events, or otherwise.

###

Media Contact:

Dan Eramian

T: 206.272.4343

C: 206.854.1200

F: 206.272.4434

E: deramian@ctiseattle.com

www.celltherapeutics.com/media.htm

Investors Contact:

Ed Bell

T: 206.282.7100

Lindsey Jesch Logan

T: 206.272.4347

F: 206.272.4434

E: invest@ctiseattle.com

www.celltherapeutics.com/investors.htm

www.CellTherapeutics.com


Cell Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except for per share amounts)

(unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2009     2008     2009     2008  

Revenues:

        

Product sales

   $ —        $ 2,870      $ —        $ 6,244   

License and contract revenue

     20        20        40        40   
                                

Total revenues

     20        2,890        40        6,284   
                                

Operating expenses, net:

        

Cost of product sold

     —          767        —          1,657   

Research and development

     7,320        15,857        15,276        31,712   

Selling, general and administrative

     10,580        11,518        19,330        22,728   

Amortization of purchased intangibles

     —          537        —          934   

Restructuring charges

     3,820        —          3,944        —     

Gain on sale of investment in joint venture

     —          —          (10,244     —     
                                

Total operating expenses, net

     21,720        28,679        28,306        57,031   
                                

Loss from operations

     (21,700     (25,789     (28,266     (50,747

Other income (expense):

        

Investment and other income, net

     37        93        71        353   

Interest expense

     (1,583     (2,395     (3,200     (4,380

Amortization of debt discount and issuance costs

     (497     (30,202     (5,348     (41,146

Foreign exchange gain (loss)

     54        76        95        (2,161

Make-whole interest expense

     —          (25,596     (6,345     (33,377

Gain on derivative liabilities, net

     1,596        31,433        7,218        43,177   

Gain (loss) on exchange of convertible notes

     7,201        (3,313     7,201        (5,608

Equity loss from investment in joint venture

     —          —          (1,204     —     

Settlement expense

     (3,198     —          (3,368     —     

Write-off of financing arrangement costs

     —          (2,361     —          (2,361
                                

Net loss before noncontrolling interest

     (18,090     (58,054     (33,146     (96,250

Noncontrolling interest

     63        31        152        63   
                                

Net loss attributable to CTI

     (18,027     (58,023     (32,994     (96,187

Gain on restructuring of preferred stock

     —          —          2,116        —     

Preferred stock dividends

     (1     (226     (24     (468

Deemed dividends on preferred stock

     (9,398     (1,067     (9,648     (17,265
                                

Net loss attributable to CTI common shareholders

   $ (27,426   $ (59,316   $ (40,550   $ (113,920
                                

Basic and diluted net loss per common share

   $ (0.06   $ (5.18   $ (0.11   $ (12.28
                                

Shares used in calculation of basic and diluted net loss per common share (1)

     446,174        11,447        366,293        9,277   
                                

Balance Sheet Data:

 

     (amounts in thousands)  
     June 30,
2009
    December 31,
2008
 
     (unaudited)        

Cash and cash equivalents and securities available-for-sale

   $ 11,980      $ 10,671   

Restricted cash

     —          6,640   

Working capital

     (15,134     (14,141

Total assets

     43,230        64,243   

Convertible debt

     66,391        142,373   

Accumulated deficit

     (1,352,870     (1,312,320

Total deficit

     (57,630     (132,061

 

(1) Amounts reflect a one-for-ten reverse stock split of our common stock effective August 31, 2008.