-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FsbSIE0+02hhtUHr8I0E5sqOJw5KNlVPw0pMDI2nmbRKlay/s+xFY4B/Ss8oLnFl WGQucbOPdgzcjfTXcjFo1g== 0001193125-09-102397.txt : 20090507 0001193125-09-102397.hdr.sgml : 20090507 20090507062149 ACCESSION NUMBER: 0001193125-09-102397 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20090507 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090507 DATE AS OF CHANGE: 20090507 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CELL THERAPEUTICS INC CENTRAL INDEX KEY: 0000891293 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 911533912 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12465 FILM NUMBER: 09803400 BUSINESS ADDRESS: STREET 1: 501 ELLIOTT AVE W STREET 2: STE 400 CITY: SEATTLE STATE: WA ZIP: 98119 BUSINESS PHONE: 2062707100 MAIL ADDRESS: STREET 1: 501 ELLIOTT AVE W STREET 2: STE 400 CITY: SEATTLE STATE: WA ZIP: 98119 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report:

May 7, 2009

(Date of earliest event reported)

CELL THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Washington   001-12465   91-1533912

(State or other jurisdiction

of incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

501 Elliott Avenue West, Suite 400

Seattle, Washington 98119

(206) 282-7100

(Address including zip code, and telephone number, including

area code, of Registrant’s principal executive offices)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02 Results of Operations and Financial Condition.

The information provided pursuant to this Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any filing or other document filed by the Company pursuant to the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing or document. The information furnished pursuant to this Item 2.02 shall instead be deemed “furnished.”

On May 7, 2009, Cell Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2009 and certain other information. The full text of the press release is set forth in Exhibit 99.1 hereto.

 

Item 9.01 Financial Statements and Exhibits.

 

  (d) Exhibits.

The following exhibit is furnished with this report on Form 8-K:

 

99.1    Press Release dated May 7, 2009.

 

-1-


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

    CELL THERAPEUTICS, INC.
Date: May 7, 2009     By:   /s/ Louis A. Bianco
     

Louis A. Bianco

Executive Vice President, Finance and Administration

 

-2-


EXHIBIT INDEX

 

Exhibit
Number

  

Description

99.1    Press Release dated May 7, 2009

 

-3-

EX-99.1 2 dex991.htm PRESS RELEASE DATED MAY 7, 2009 Press Release dated May 7, 2009

Exhibit 99.1

LOGO

 

LOGO   

501 Elliott Ave. W. #400

Seattle, WA 98119

  

T 206.282.7100

F 206.284.6206

Cell Therapeutics Reports 76% Decrease in First Quarter

2009 Net Loss Attributable to Common Shareholders;

Completion of Pixantrone NDA Submission

on Track for Second Quarter 2009

Pixantrone Named-Patient Program Initiated in Europe

May 7, 2009 Seattle—Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) reported recent accomplishments and financial results for the quarter ended March 31, 2009.

“Our focus for the first half of 2009 was to initiate and complete the NDA submission for pixantrone while we implemented final steps in our cost cutting efforts and raised much needed operating capital on the least dilutive terms possible—all while cleaning up the Company’s capital structure,” said James A. Bianco, M.D., CEO of CTI. “We are pleased with our results as reflected in our first quarter financials. We have cut our net operating losses attributable to common shareholders by 76%, raised gross proceeds of $44.3 million in 2009 and eliminated all of our outstanding preferred stock, while staying on track to complete the NDA submission for pixantrone in June 2009.”

Recent Highlights

 

   

Initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pixantrone and are targeting completing this NDA submission in June 2009, which if granted priority review could lead to an FDA approval decision as early as December 2009.

 

   

Pixantrone Phase III study results to be presented at the American Society of Clinical Oncology Conference on June 1, 2009.

 

   

Pixantrone is now available through a named-patient program in Europe.

 

   

Raised $23.8 million through the sale of Series 1 Preferred Stock to a single institutional investor and upon the exercise of the associated common stock warrants. The investor subsequently converted 100% of the Series 1 Preferred Stock to common stock. CTI has no remaining issued or outstanding preferred stock.

 

   

Received $20.5 million in gross proceeds in 2009 from Spectrum Pharmaceuticals, Inc. associated with the initial divestiture of Zevalin to the joint venture with Spectrum and the subsequent sale of CTI’s remaining interest in this joint venture (total $28.0 million received to date with up to an additional $3.5 million owed).

www.CellTherapeutics.com


Total net operating expenses decreased $21.8 million, or 77%, to $6.6 million for the quarter ended March 31, 2009 compared to $28.4 million for the same period in 2008 as a result of a $10.2 million one-time gain on the sale CTI’s investment in the Zevalin joint venture coupled with a decrease in research and development expenses. Excluding the one-time gain, total net operating expenses decreased 41% over the same period last year. Research and development expenses decreased 7.9 million, or 50%, to $8.0 million for the current quarter compared to $15.9 million for the same period in 2008 as the result of cost reduction initiatives and expenses related to our clinical trial programs. Net loss attributable to common shareholders decreased $41.5 million, or 76%, to $13.1 million ($0.05 per share) for the quarter ended March 31, 2009, compared to $54.6 million ($7.68 per share) for the comparable period in 2008. The reduction in net loss per share is primarily due to an increase in the number of shares outstanding, reduction of expenses and gain on sale of CTI’s investment in the Zevalin joint venture.

CTI had approximately $0.7 million in cash and cash equivalents, securities available-for-sale, and interest receivable as of March 31, 2009. In addition, on April 3, 2009, CTI received $6.5 million in gross proceeds from Spectrum associated with the sale of its interest in the Zevalin joint venture and expects to receive up to an additional $3.5 million upon the completion of Spectrum’s payment obligations to CTI. In April 2009 CTI received $20.0 million in gross proceeds upon the sale of its Series 1 Preferred Stock and an additional $3.8 million upon the exercise of the associated common stock warrants in May 2009.

Conference Call Information

On Thursday, May 7, 2009, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific members of Cell Therapeutics, Inc.’s (CTI) (NASDAQ and MTA: CTIC) management team will host a conference call to discuss CTI’s 2009 first quarter achievements and financial results.

Conference Call Numbers

Thursday, May 7

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

1-888-561-1799 (US Participants)

1-480-629-9867 (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: 4066143

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

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.

www.CellTherapeutics.com

 

Page 2 of 4


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. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the results of complete safety information, the failure to receive anticipated number of requests for pixantrone to treat specific patients, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the possibility that the NDA submission will not be completed in the second quarter of 2009, that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in late 2009, the possibility that we may not receive all of the additional amount owed to us by Spectrum, our ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, 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, 8-K, and 10-Q. 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: media@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.htm

www.CellTherapeutics.com

 

Page 3 of 4


Cell Therapeutics, Inc.

Condensed Consolidated Statements of Operations

(In thousands, except for per share amounts)

(unaudited)

 

     Three Months Ended
March 31,
 
     2009     2008  

Revenues:

    

Product sales

   $ —       $ 3,374  

License and contract revenue

     20       20  
                

Total revenues

     20       3,394  
                

Operating expenses, net:

    

Cost of product sold

     —         890  

Research and development

     7,956       15,855  

Selling, general and administrative

     8,874       11,210  

Amortization of purchased intangibles

     —         397  

Gain on sale of Zevalin

     (10,244 )     —    
                

Total operating expenses, net

     6,586       28,352  
                

Loss from operations

     (6,566 )     (24,958 )

Other income (expense):

    

Investment and other income, net

     34       260  

Interest expense

     (1,617 )     (1,985 )

Amortization of debt discount and issuance costs

     (4,851 )     (10,944 )

Foreign exchange gain (loss)

     41       (2,237 )

Make-whole interest expense

     (6,345 )     (7,781 )

Gain on derivative liabilities, net

     5,622       11,744  

Loss on exchange of convertible notes

     —         (2,295 )

Equity loss from investment in joint venture

     (1,204 )     —    

Settlement expense

     (170 )     —    
                

Net loss before noncontrolling interest

     (15,056 )     (38,196 )

Noncontrolling interest

     89       32  
                

Net loss attributable to CTI

     (14,967 )     (38,164 )

Gain on restructuring of preferred stock

     2,116       —    

Preferred stock dividends

     (23 )     (242 )

Deemed dividends on conversion of preferred stock

     (250 )     (16,198 )
                

Net loss attributable to CTI common shareholders

   $ (13,124 )   $ (54,604 )
                

Basic and diluted net loss per common share

   $ (0.05 )   $ (7.68 )
                

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

     285,525       7,107  
                

Balance Sheet Data:

    
     (amounts in thousands)  
     March 31,
2009
    December 31,
2008
 
     (unaudited)        

Cash and cash equivalents and securities available-for-sale

   $ 748     $ 10,671  

Restricted cash

     —         6,640  

Working capital

     (22,776 )     (14,141 )

Total assets

     42,933       64,243  

Convertible debt

     119,030       142,373  

Accumulated deficit

     (1,325,444 )     (1,312,320 )

Total deficit

     (115,984 )     (132,061 )

 

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