EX-99.1 2 dex991.htm ENGLISH TRANSLATION OF PRESS RELEASE English Translation of Press Release

Exhibit 99.1

 

   LOGO
LOGO   

501 Elliott Ave. W. #400

Seattle, WA 98119

  

T 206.282.7100

F 206.272.4010

Cell Therapeutics Provides Monthly Information

at Request of CONSOB

September 30, 2009 Seattle — Cell Therapeutics, Inc. (the “Company” or “CTI”) (NASDAQ and MTA: CTIC) is providing the information herein pursuant to a request from the Italian securities regulatory authority, CONSOB, pursuant to Article 114, Section 5 of the Unified Financial Act, that the Company issue at the end of each month a press release providing a monthly update of certain information relating to the Company’s management and financial situation. However, the Company also directs its Italian shareholders to the Italian language section of its website at www.celltherapeutics.com/italiano, where more complete information about the Company and its products and operations, including press releases issued by the Company, as well as the Company’s SEC filings and the Listing Prospectus authorized to be published by CONSOB, can be found. The information provided below is qualified in its entirety by reference to such information.

Please note that all the information disclosed in this press release primarily refers to the period August 1, 2009 through August 31, 2009.

Provisional financial information as of August 31, 2009 and EBITDA

The following information concerns the Company’s provisional (unaudited) results for the month ended August 31, 2009.

Such financial information represents estimates that are based on assumptions the occurrence of which depends on circumstances relating to the Company and the macroeconomic situation, and which assumptions might or might not occur.


The following table reports the Estimated Indication of a few relevant items referring to the statements of operations for the month ended August 31, 2009:

Estimated financial data of the company for the month ended August 31, 2009

The estimated and unaudited financial data of the Company as of August 31, 2009 compared with those for the previous month are shown below (amounts in thousands of U.S. dollars):

 

     July 31, 2009     August 31, 2009  

Net revenue

   $ 7      $ 7   

Operating income (expense)

   $ (15,519   $ (5,395

Profit /(Loss) from operations

   $ (15,512   $ (5,388
                

Other income (expenses), net

   $ 153      $ (5,162

Preferred Stock:

    

- Dividend

   $ —        $ —     

- Deemed Dividend

   $ —        $ (13,812

EBITDA

   $ (15,359   $ (24,362
                

Depreciation and amortization

   $ (146   $ (201

Amortization of debt discount and issuance costs

   $ (32   $ (39

Interest expense

   $ (277   $ (280
                

Net profit /(loss) attributable to common shareholders

   $ (15,814   $ (24,882

Estimated Research and Development expenses were $1.8 million and $2.4 million for the months of July and August 2009, respectively.

Net financial indebtedness

The following table reports the estimated and unaudited net debt financial indebtedness of the Company as of July 31, 2009 and August 31, 2009, including the separate indication of the total financial needs, regarding debts expiring less than 12 months ahead (current portion). The relevant financial data are compared with those for the previous month (amounts in thousands of U.S. dollars).

 

Net Financial Standing

   July 31, 2009     August 31, 2009  

Cash and cash equivalents

   $ 45,203      $ 60,962   

Long term obligations, current portion

   $ (1,653   $ (1,589

Senior Subordinated Notes

     (43,363   $ (43,363

Net Financial Standing, current portion

   $ 187      $ 16,010   

Long term obligations, less current portion

   $ (2,152   $ (2,124

Convertible senior notes

   $ (23,027   $ (23,027

Net Financial Standing, less current portion

   $ (25,179   $ (25,151

Net Financial Indebtedness

   $ (24,992   $ (9,141


The total estimated and unaudited net financial position of the Company as of August 31, 2009 is approximately a negative $9,141 (in thousands of U.S. dollars).

The Company’s 4% Convertible Senior Subordinated Notes Convertible with redemption date of July 1, 2010 come due within the next twelve months.

The Company had no debt that matured during the month of August 2009.

Outstanding notes and preferred shares

The following table discloses information on the Company’s convertible notes as of August 31, 2009, compared with the same information as of July 31, 2009:

Convertible Notes – August 31, 2009

 

Description

   Maturity/
Redemption
Date
   Principal/
Aggregated Stated
Value Outstanding
as of July 31, 2009
   Number of
Common Stock
Reserve as of
July 31, 2009
   Principal/
Aggregated Stated
Value Outstanding
as of August 31, 2009
   Number of
Common Stock
Reserve as of
August 31, 2009

4% Convertible Senior Subordinated Notes

   1-Jul-10    43,363,000    80,301    43,363,000    80,301

6.75% Convertible Senior Notes

   31-Oct-10    1,500,000    14,263    1,500,000    14,263

7.5% Convertible Senior Notes

   30-Apr-11    10,250,000    122,620    10,250,000    122,620

5.75% Convertible Senior Notes

   15-Dec-11    10,913,000    363,766    10,913,000    363,766
                      

Totals

      66,026,000    580,950    66,026,000    580,950
                      

The Company had no outstanding preferred shares as of July 31, 2009 and August 31, 2009.

Regulatory Matters and Products in Development

With respect to the period from August 1, 2009 through August 31, 2009, the Company announced on August 24, 2009 that the U.S. Food and Drug Administration (“FDA”) has accepted and has filed for review the Company’s New Drug Application (“NDA”) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL). Furthermore, on September 5, 2009, the Company announced that the FDA had notified the Company that a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010 under standard review has been established regarding the pixantrone NDA. Additionally, on September 21, 2009, the Company announced that it had notified the European Medicines Agency (EMEA) of its decision


to withdraw its Marketing Authorization Application (MAA) for a non-inferiority indication in non-small cell lung cancer (NSCLC) and will focus efforts on the approval of OPAXIO for a potential superiority indication in maintenance therapy for ovarian cancer. In addition, given the encouraging results of treatment of advanced esophageal cancer with OPAXIO to be reported at the upcoming International Society of Gastrointestinal Oncology Annual Meeting, the Company plans on meeting with the FDA to discuss an additional registration study utilizing OPAXIO as a radiation sensitizer in the treatment of advanced esophageal cancer.

Corporate Transactions and Assignment of Assets

With respect to the period from August 1, 2009 through August 31, 2009, the Company has no information to disclose to the market.

Exchange Listing Matters

The Company has no information to disclose related to exchange listing matters.

Update on Outstanding Shares

The number of shares of the Company’s common stock, no par value (the “Common Stock”), issued and outstanding as of July 31, 2009 and August 31, 2009 were 541,165,832 and 560,000,935, respectively.

During the month of August 2009, the following transactions contributed to the change in the number shares of the Company’s outstanding Common Stock:

 

   

Conversion of the Company’s Series 2 Preferred Stock, which resulted in the issuance of 18,853,103 shares.

 

   

The cancellation of 18,000 shares due to employee termination under the Company’s 2007 Equity Incentive Plan.

The Company is not aware of any agreement for the resale of its shares of Common Stock on the MTA nor of the modalities by means of which shares of Common Stock were or will be resold.

Debt Restructuring Program

With respect to the period from August 1, 2009 through August 31, 2009, the Company has no information to disclose to the market.

The Company, in August 2009, neither issued any new debt instruments nor bought any debt instruments already issued by the Company.


The Company believes it is in compliance with the covenants on each series of its outstanding convertible notes.

Information about the capacity of the Company to sustain its financial needs

As disclosed in the press release dated August 21, 2009, the Company announced the closing of the sale of $30 million of shares of its Series 2 Preferred Stock and warrants to purchase shares of its common stock in a registered offering to a single institutional investor. The Company received approximately $28.2 million in net proceeds from the offering, after deducting placement agent fees and estimated offering expenses.

About Cell Therapeutics, Inc.

Headquartered in Seattle, the Company 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 future results and the trading prices of the Company’s securities. Specifically, the risks and uncertainties include that the Company continues to have a substantial amount of debt outstanding and the quarterly interest expense associated with the debt is significant; the Company’s operating expenses continue to exceed its net revenues; that the Company may not be able to further reduce its operating expenses; that the Company will continue to need to raise capital to fund its operating expenses and may not be able to raise sufficient amounts to fund its continued operation; that the information presented herein with respect to the Company’s convertible notes and convertible preferred stock may differ materially from the information presented by the Company with respect to its convertible notes and convertible preferred stock prepared in accordance with U.S. GAAP in its periodic reports on Form 10-K and Form 10-Q; as well as other risks listed or described from time to time in the Company’s most recent filings with the SEC on Forms 10-K, 10-Q and 8-K. Except as required by law, the Company does not intend to update any of the statements in this press release upon further developments.

###

Media Contact:

Dan Eramian

T: 206.272.4343

C: 206.854.1200

E: deramian@ctiseattle.com

www.CellTherapeutics.com/media.htm

Investors Contact:

Ed Bell

T: 206.272.4345

Lindsey Jesch Logan

T: 206.272.4347

F: 206.272.4434

E: invest@ctiseattle.com

www.CellTherapeutics.com/investors