-----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, DtePXT3qcM2TXmCOIHvq+Tm+Q7SQQe8ig5tjQ4cIJGhZUbnwG7V3x7T0CReRJ8a/ Q3HcZUvBO6ZENUr3dyrWUg== 0001193125-11-047542.txt : 20110225 0001193125-11-047542.hdr.sgml : 20110225 20110225165426 ACCESSION NUMBER: 0001193125-11-047542 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20110225 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110225 DATE AS OF CHANGE: 20110225 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: 11641810 BUSINESS ADDRESS: STREET 1: 501 ELLIOTT AVE W STREET 2: STE 400 CITY: SEATTLE STATE: WA ZIP: 98119 BUSINESS PHONE: 2062827100 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: (Date of earliest event reported): February 25, 2011

 

 

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

(Address of principal executive offices)

Registrant’s telephone number, including area code: (206) 282-7100

Not applicable

(Former name or former address, if changed since last report).

 

 

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 (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 (the “Securities Act”), except as shall be expressly set forth by specific reference in such filing or document. The information provided pursuant to this Item 2.02 shall instead be deemed “furnished.”

Pursuant to a request from CONSOB, the Italian securities regulatory authority, Cell Therapeutics, Inc. (the “Company”) issued a press release in Italy on February 25, 2011 (the “Press Release”), providing certain requested financial information for the month ended January 31, 2011 and other information. An English translation of the Press Release is attached as Exhibit 99.1 and incorporated by reference herein. The financial information contained in the Press Release was prepared at the instruction of CONSOB pursuant to Section 114, paragraph 5, of the Unified Financial Act. In communications with CONSOB about their request that certain estimated and unaudited financial information be disclosed by the Company, the Company advised CONSOB that the information is not otherwise required to be disclosed in the United States by public companies under the U.S. securities laws. The Company further advised CONSOB that any such financial information has not been reviewed or audited by the Company’s independent auditors as such reviews only occur on a quarterly basis in connection with the requirements of Quarterly Reports on Form 10-Q which are prepared for the first three quarters of the year, and in connection with the annual audit of the Company’s year-end financial statements which is included in the Company’s Annual Reports on Form 10-K. The Company further advised CONSOB that any such financial information could not be prepared in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”), as promulgated by the Financial Accounting Standards Board.

In addition, the financial information contained in the Press Release does not conform to U.S. GAAP because the Company has not concluded its consideration of authoritative literature and guidelines, including the guidelines established by FAS 133 “Accounting for Derivatives and other Hedging Activities,” in the preparation of the information. Accordingly, the data presented in the information does not reflect the Fair Market Value assessments of the Company’s convertible debt, convertible preferred stock and the underlying derivative instruments under U.S. GAAP as such instruments are presented in the Company’s quarterly and annual financial statements and therefore should not be relied on for investment purposes. Moreover, the information may deviate from values as reported in accordance with U.S. GAAP in the Company’s reviewed quarterly financial statements and audited year-end financial statements.

Further, the information contained in the Press Release may constitute non-GAAP financial measures within the meaning of Regulation G of U.S. securities law. These non-GAAP financial measures are being provided solely at the instruction of CONSOB and are not presented as or intended to be an alternative to U.S. GAAP financial information. The Company is unable to provide a reconciliation of these non-GAAP financial measures to the most directly comparable U.S. GAAP financial measures, because no such comparable U.S. GAAP financial measures exist or are available at the time, as the Company’s year-end review and audit process has not yet been completed.

Investors are urged to refer to the Company’s financial statements prepared in accordance with U.S. GAAP, including a more detailed description of the terms of the convertible debt and convertible preferred stock, and the risk factors listed or described from time to time in the Company’s filings with the U.S. Securities and Exchange Commission including, without limitation, the Company’s filings on Forms 10-K, 10-Q, and 8-K.

Item 7.01. Regulation FD Disclosure.

The information provided pursuant to this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of 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 except as shall be expressly set forth by specific reference in such filing or document. The information provided pursuant to this Item 7.01 shall instead be deemed “furnished.”


Pursuant to a request from CONSOB, the Company issued a press release in Italy on February 25, 2011 providing certain requested financial information about the Company’s financial condition and operations. Attached hereto as Exhibit 99.1 is an English translation of such press release.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

No.

  

Description

99.1    English Translation of Press Release of Cell Therapeutics, Inc. dated February 25, 2011.


SIGNATURE

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

 

    CELL THERAPEUTICS, INC.
Date: February 25, 2011     By:  

/S/    LOUIS A. BIANCO        

      Louis A. Bianco
      Executive Vice President, Finance and Administration


EXHIBIT INDEX

 

Exhibit

No.

  

Description

99.1    English Translation of Press Release of Cell Therapeutics, Inc. dated February 25, 2011.
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 Provides Monthly Information

at Request of CONSOB

February 25, 2011 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 U.S. Securities and Exchange (“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 January 1, 2011 through January 31, 2011 except as otherwise expressly noted.

Provisional financial information as of January 31, 2011 and EBITDA

The following information concerns the Company’s provisional (unaudited) results for the month ended January 31, 2011.

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 January 31, 2011:

 

www.CellTherapeutics.com


Estimated financial data of the Company for the month ended January 31, 2011

The estimated and unaudited financial data of the Company as of January 31, 2011 compared with those for the previous month are shown below (amounts in thousands of U.S. dollars):

 

     December 31, 2010     January 31, 2011  

Net revenue

   $ —        $ —     

Operating income (expense)

   $ (8,427   $ (4,032

Profit /(Loss) from operations

   $ (8,427   $ (4,032

Other income (expenses), net

   $ (2,937   $ 263   

Preferred Stock:

    

-Deemed Dividend

   $ (14,399   $ —     

EBITDA

   $ (25,763   $ (3,769

Depreciation and amortization

   $ (119   $ (146

Amortization of debt discount and issuance costs

   $ (147   $ (10

Interest expense

   $ 162      $ (117
                

Net profit /(loss) attributable to common shareholders

   $ (25,867   $ (4,042
                

Estimated Research and Development expenses were $4.4 million and $2.0 million for the months of December 2010 and

January 2011, respectively.

Net financial indebtedness

The following table reports the estimated and unaudited net financial indebtedness of the Company as of December 31, 2010 and January 31, 2011, 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).

 

www.CellTherapeutics.com


Net Financial Standing

   December 31, 2010     January 31, 2011  

Cash and cash equivalents

   $ 22,649      $ 39,148   

Long term obligations, current portion

   $ (1,717   $ (1,717

Convertible senior notes

   $ (22,308   $ (22,308

Net Financial Standing, current portion

   $ (1,376 )    $ 15,123   

Long term obligations, less current portion

   $ (4,206   $ (4,250

Net Financial Standing, less current portion

   $ (4,206   $ (4,250

Net Financial Indebtedness

   $ (5,582 )    $ 10,873   

The total estimated and unaudited net financial position of the Company as of January 31, 2011 was approximately positive $10,873 (in thousands of U.S. dollars).

The Company’s 7.5% Convertible Senior Notes with a maturity date of April 30, 2011 and 5.75% Convertible Senior Notes with a maturity date of December 15, 2011 come due within the next twelve months.

The Company had no debt that matured during the month of January 2011.

Outstanding notes and preferred shares

The following tables disclose information about the Company’s outstanding convertible senior notes as of January 31, 2011, compared with the same information as of December 31, 2010, and the Company’s outstanding non-convertible Series 8 preferred stock as of January 31, 2011, compared with the same information as of December 31, 2010:

Convertible Notes–January 31, 2011

 

Description

   Maturity/
Redemption
Date
     Principal/
Aggregated Stated
Value Outstanding
as of December  31,
2010
     Number of
Common Stock
Reserve as of
December 31,
2010
     Principal/
Aggregated Stated
Value Outstanding
as of January 31,
2011
     Number of Common
Stock Reserve as of
January 31, 2011
 

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

      $ 21,163,000         486,386       $ 21,163,000         486,386   
                                      

 

www.CellTherapeutics.com


Preferred Stock–January 31, 2011

 

Description

   Principal/Aggregated
Stated Value Outstanding
as of December 31, 2010
     Number of Preferred
Shares outstanding as of
December 31, 2010
     Principal/Aggregated
Stated  Value Outstanding
as of January 31, 2011
     Number of Preferred
Shares outstanding as of
January 31, 2011
 

Series 8 Non-Convertible Preferred Stock*

     —           —         $ 25,000,000         25,000   
                                   

Totals

     —           —         $ 25,000,000         25,000   
                                   

 

* The shares of Series 8 Preferred Stock will accrue annual dividends at the rate of 10% from the date of issuance, payable in additional shares of Series 8 Preferred Stock.

Debt Restructuring Program

In January 2011, the Company 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.

Regulatory Matters and Products in Development

Pixantrone

On November 18, 2010, the Company announced that the Marketing Authorization Application (“MAA”) seeking approval for pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin’s lymphoma (“NHL”) was validated and accepted for review by the European Medicines Agency (“EMA”). On December 3, 2010, the Company announced that it had submitted a formal appeal to the Office of New Drugs in the U.S. Food and Drug Administration’s (“FDA”) Center for Drug Evaluation and Research regarding FDA’s decision from earlier this year on the pixantrone New Drug Application (“NDA”) to treat relapsed/refractory aggressive NHL.

Corporate Transactions and Assignment of Assets

 

www.CellTherapeutics.com


With respect to the period from January 1, 2011 through January 31, 2011, the Company has no additional information to disclose to the market.

Exchange Listing Matters

With respect to the period from January 1, 2011 through January 31, 2011, the Company has no additional information to disclose to the market.

Update on Outstanding Shares of Common Stock

The number of shares of the Company’s common stock, no par value (the “Common Stock”), issued and outstanding as of December 31, 2010 and January 31, 2011 was 813,751,299 and 900,732,163, respectively.

During the month of January 2011, the following transactions contributed to the change in the number of shares of the Company’s outstanding Common Stock:

 

   

the issuance of 22,563,177 shares of Common Stock upon exercises of common stock purchase warrants;

 

   

conversion of the Company’s Series 9 preferred stock resulting in the issuance of 64,466,219 shares of Common Stock; and

 

   

the cancellation of 48,532 shares of Common Stock under the Company’s 2007 Equity Incentive Plan, as amended.

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

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

As disclosed in this press release, the Company had approximately $39.1 million in cash and cash equivalents as of January 31, 2011. This amount includes the proceeds from the registered offering announced by the Company on January 13, 2011 (the “January Offering”) of up to $25 million of shares of the Company’s Series 8 Non-Convertible Preferred Stock (the “Series 8 Preferred Stock”), warrants (“Warrants”) to purchase up to 22,563,177 shares of Common Stock and an additional investment right (the “January Investment Right”) to purchase up to $25 million of shares of the Company’s Series 9 Convertible Preferred Stock (the “Series 9 Preferred Stock”) to a single life sciences institutional investor (the “Investor”). Prior to the closing of the January Offering, the Investor elected to exercise all of the Warrants to purchase 22,563,177 shares of Common Stock and the entire January Investment Right to purchase 25,000 shares of Series 9 Preferred Stock (together, the “January Exercises”). The Investor also elected to convert the 25,000 shares of Series 9 Preferred Stock into 64,466,219 shares of Common Stock, for a total of 87,029,396 shares of Common Stock issued to the Investor as a result of the January Exercises. The exercise price for the January Exercises was paid through the issuance by the Investor to the Company of recourse notes fully secured with marketable securities. The January Offering closed

 

www.CellTherapeutics.com


on January 27, 2011 and the Company received $25 million in gross proceeds upon issuance of 25,000 shares of Series 8 Preferred Stock. As of February 25, 2011, 25,000 shares of the Series 8 Preferred Stock are issued and outstanding.

On February 18, 2011, the Company announced a registered offering (the “February Offering”) of up to approximately $25 million of shares of the Company’s Series 10 Non-Convertible Preferred Stock (the “Series 10 Preferred Stock”), Warrants to purchase up to approximately 25.9 million shares of Common Stock and an additional investment right (the “February Investment Right”) to purchase up to approximately $25 million of shares of the Company’s Series 11 Convertible Preferred Stock (the “Series 11 Preferred Stock”) to the Investor. As of February 24, 2011, the Investor had exercised Warrants to purchase 10,376,825 shares of Common Stock and the February Investment Right to purchase 9,991 shares of the Series 11 Preferred Stock (together, the “February Exercises”) and had elected to convert 9,991 shares of the Series 11 Preferred Stock into 29,646,884 shares of Common Stock, for a total of 40,023,709 shares of Common Stock issued to the Investor as a result of the February Exercises. The exercise price for the February Exercises was paid through the issuance by the Investor to the Company of recourse notes fully secured with marketable securities. The closing of the issuance and sale of the Series 10 Preferred Stock is expected to occur on March 4, 2011.

For further information about the January Offering and the February Offering please refer to the press releases disseminated on January 13, January 28 and February 18, 2011.

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 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 EMA, that the FDA may not accept the Company’s special protocol assessment and/or the proposed design for the protocol of the Company’s clinical trial and/or may request additional clinical trials, that the EMA may not approve the Company’s MAA after review, that the Company may not regain compliance with NASDAQ’s minimum bid price rule by May 2, 2011, that the Company cannot predict the outcome of the formal dispute resolution process, that the Company’s appeal may not be successful, and the Company’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, and costs of developing, producing and selling pixantrone. Further 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, and that the information presented herein with respect to the Company’s convertible notes and non-convertible preferred stock may

 

www.CellTherapeutics.com


differ materially from the information presented by the Company with respect to its convertible notes and non-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:

Cell Therapeutics, Inc.

Dan Eramian

T: 206.272.4343

C: 206.854.1200

Lindsey Jesch

T : 206.272.4347

F : 206.272.4434

E: deramian@ctiseattle.com

www.CellTherapeutics.com/press_room

Investors Contact:

Cell Therapeutics, Inc.

Ed Bell

T: 206.272.4345

F: 206.272.4434

E: invest@ctiseattle.com

www.CellTherapeutics.com/investors

 

www.CellTherapeutics.com

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