-----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, ODzFx1CDOXcd2ElPvTUeQXOEtX5K/ayXPpN6FcVY0dt4h9qQOJ3AypetPY95HcoT dyQmgUfqOI4pr32BeXWH3w== 0001193125-10-095620.txt : 20100428 0001193125-10-095620.hdr.sgml : 20100428 20100428060625 ACCESSION NUMBER: 0001193125-10-095620 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20100428 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100428 DATE AS OF CHANGE: 20100428 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: 10775063 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

 

 

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:

April 28, 2010

(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 April 28, 2010, Cell Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2010 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:

 

Exhibit
Number

 

Description

99.1   Press Release dated April 28, 2010.


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: April 28, 2010     By:  

/s/ Louis A. Bianco

      Louis A. Bianco
      Executive Vice President, Finance and Administration


EXHIBIT INDEX

 

Exhibit
Number

 

Description

99.1   Press Release dated April 28, 2010.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

 

LOGO   

501 Elliott Ave. W. #400

Seattle, WA 98119

    

T 206.282.7100

F 206.272.4010

  

CTI Focuses on Pixantrone Application

in Europe, U.S. Trial and

Expanded Access Program; Cuts Burn Rate

April 28, 2010 Seattle—Cell Therapeutics, Inc. (“CTI” or the “Company”) (NASDAQ and MTA: CTIC) today reported recent accomplishments and financial results for the first quarter ended March 31, 2010.

“It was encouraging to receive a positive reception from the European Medicinal Agency’s (EMEA) clinical experts regarding our plans to submit a Marketing Authorization Application (MAA) for pixantrone in the European Union. Concurrently, we are working with leading lymphoma treatment practices across the U.S. and look forward to working with the U.S. Food and Drug Administration (FDA) on the design of a follow-on pivotal clinical trial in an effort to fulfill the requirements for marketing approval of pixantrone in the U.S.,” said James A. Bianco, M.D., Chief Executive Officer of the Company. “We firmly believe that given the strength of evidence across clinically meaningful primary and secondary endpoints that pixantrone would fulfill a significant unmet medical need for patients who have no other approved options through establishing an expanded access program in the U.S. We remain committed to patients with non-Hodgkin’s lymphoma (NHL) and in bringing this important new therapeutic option to them in as expeditious manner as possible.”

Recent Highlights

 

 

In preparation for its submission of a MAA for pixantrone in Europe, the Company met with the EMEA’s Committee for Medicinal Products for Human Use (CHMP) clinical experts (rapporteurs) and the EMEA’s medical reviewers. Discussion and feedback from those meetings was supportive of filing the MAA on the basis of the PIX301 trial. The Company expects to submit the MAA in the second half of 2010.

 

 

The Company met with the EMEA’s Pediatric Committee (the “PDCO”) who recommended that the Company should submit an updated Pediatric Investigation Plan (“PIP”) for pixantrone following discussions about the preclinical and clinical pixantrone data, including PIX301, and the desire to explore the potential benefits pixantrone may offer to children with hematologic cancers. The Company expects to submit a revised PIP to the EMEA by the end of the second quarter of 2010.

www.CellTherapeutics.com


Page 2 of 4

 

 

The Company successfully raised gross proceeds of $30 million in January 2010 and additional gross proceeds of $20 million in April 2010 through financings with institutional investors.

 

 

The Company implemented a cost reduction plan in April 2010, aimed at reducing planned operating expenses that are expected to result in savings of approximately $16 million in 2010. The Company’s total projected operating expenses, excluding equity based compensation, are expected to be approximately $60 million in 2010, which is a 21% reduction from its previously projected estimates. As a result of reducing these expenses, the Company is targeting an average net operating burn rate of approximately $4.4 million per month starting in the second quarter of 2010.

For the quarter ended March 31, 2010, total net operating expenses were $25.8 million compared to $6.6 million for the same period in 2009. The increase in total net operating expenses is mainly a result of expenses related to preparation for the potential pixantrone regulatory approval in the U.S. and Europe, a $7.8 million non-cash equity-based compensation expense recognized in 2010, and a $10.2 million gain on the sale of the Company’s investment in the Zevalin joint venture that was recognized in 2009. Research and development expenses decreased to $7.4 million compared to $8.0 million for the same period in 2009. Net loss attributable to common shareholders was $44.2 million ($0.07 per share) for the quarter ended March 31, 2010 compared to a net loss attributable to common shareholders of $13.1 million ($0.05 per share) for the same period in 2009.

CTI had approximately $41.5 million in cash and cash equivalents as of March 31, 2010. This does not include approximately $18.5 million in net proceeds the Company received in April 2010 in connection with a registered offering of preferred stock and warrants.

Conference Call Information

On Wednesday, April 28, 2010, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time, members of CTI’s management team will host a quarterly conference call to discuss CTI’s 2010 first quarter achievements and financial results.

Conference Call Numbers

Wednesday, April 28, 2010

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

1-866-225-8754 (US Participants)

1-480-629-9692 (International)

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

1-800-406-7325 (US Participants)

1-303-590-3030 (International)

Passcode: 4288273#

 

www.CellTherapeutics.com


Page 3 of 4

 

Live audio webcast at www.celltherapeutics.com will be archived for post-call 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.

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 the Company’s securities. 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 potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory aggressive NHL and/or other tumors as determined by the FDA and/or the EMEA, that the FDA may not accept the Company’s proposed design for the protocol of the Company’s clinical trial and/or may request additional clinical trials, that if the Company conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that the Company cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that the FDA may not grant the Company a meeting to discuss the design of the follow-on clinical trial for pixantrone, that the Company may not submit the MAA during the second half of 2010, that the EMEA may not accept the MAA, that the Company may not submit the PIP by the end of the second quarter of 2010, that the EMEA may not accept the PIP and the Company’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone,. Further risks and uncertainties 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 Company may not obtain approval of its shareholders at the Special Meeting to amend to the Company’s Amended and Restated Articles of Incorporation, that the Company may not achieve the expected savings resulting from the reduction in force and there may be other costs associated with the reduction in force, that the Company might not achieve an average net operating burn rate per month of approximately $4.4 million per month starting in the second quarter of 2010, that the Company’s total projected operating expenses, excluding equity based compensation, will not be approximately $60 million in 2010 and that the information presented herein with respect to the Company’s convertible notes 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.

###

 

www.CellTherapeutics.com


Page 4 of 4

 

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
March 31,
 
     2010     2009  

Revenues:

    

License and contract revenue

   $ 20      $ 20   
                

Total revenues

     20        20   
                

Operating expenses, net:

    

Research and development

     7,360        7,956   

Selling, general and administrative

     18,417        8,874   

Gain on sale of investment in joint venture

     —          (10,244
                

Total operating expenses, net

     25,777        6,586   
                

Loss from operations

     (25,757     (6,566

Other income (expense):

    

Investment and other income, net

     262        34   

Interest expense

     (787     (1,617

Amortization of debt discount and issuance costs

     (215     (4,851

Foreign exchange gain (loss)

     (475     41   

Make-whole interest expense

     —          (6,345

Gain on derivative liabilities, net

     —          5,622   

Equity loss from investment in joint venture

     —          (1,204

Settlement expense, net

     —          (170
                

Net loss before noncontrolling interest

     (26,972     (15,056

Noncontrolling interest

     52        89   
                

Net loss attributable to CTI

     (26,920     (14,967

Gain on restructuring of preferred stock

     —          2,116   

Preferred stock dividends

     —          (23

Deemed dividends on preferred stock

     (17,277     (250
                

Net loss attributable to CTI common shareholders

   $ (44,197   $ (13,124
                

Basic and diluted net loss per common share

   $ (0.07   $ (0.05
                

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

     598,984        285,525   
                

Balance Sheet Data:

    
     (amounts in thousands)  
     March 31,
2010
    December 31,
2009
 
     (unaudited)        

Cash and cash equivalents

   $ 41,511      $ 37,811   

Working capital

     (14,892     (21,694

Total assets

     75,531        69,595   

Convertible debt

     62,271        62,142   

Accumulated deficit

     (1,473,280     (1,429,083

Total deficit

     (10,162     (18,769
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