-----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, QT3+YUaFgWIr1IYZtKaKYYgp6C1oRRrq5QZ0J7MEnsfSB4cFotTWBkpi2yjfOm4H jr7F7tD7oNWDpIg+POYUFQ== 0000950124-04-003466.txt : 20040729 0000950124-04-003466.hdr.sgml : 20040729 20040729093108 ACCESSION NUMBER: 0000950124-04-003466 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040729 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040729 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TARGETED GENETICS CORP /WA/ CENTRAL INDEX KEY: 0000921114 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 911549568 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23930 FILM NUMBER: 04937538 BUSINESS ADDRESS: STREET 1: 1100 OLIVE WAY STREET 2: STE 100 CITY: SEATTLE STATE: WA ZIP: 98101 BUSINESS PHONE: 2066237612 MAIL ADDRESS: STREET 1: 1100 OLIVE WAY STREET 2: STE 100 CITY: SEATTLE STATE: WA ZIP: 98101 8-K 1 v00673e8vk.htm FORM 8-K e8vk
Table of Contents

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)
  July 29, 2004
 
 

Targeted Genetics Corporation


(Exact name of registrant as specified in charter)
         
Washington   0-23930   91-1549568

 
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)
         
1100 Olive Way, Suite 100, Seattle, Washington   98101

 
(Address of principal executive offices)   (Zip Code)
     
Registrant’s telephone number, including area code
  (206) 623-7612
 
 

Not Applicable


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

 


TABLE OF CONTENTS

Item 7. Exhibits.
Item 12. Results and Operations of Financial Condition.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1


Table of Contents

Item 7. Exhibits.

  (a)   Financial statements of business acquired.
 
      Not applicable.
 
  (b)   Pro forma financial information.
 
      Not applicable.

     (c) Exhibits.

     
Exhibit    
No.
  Description
99.1
  Press Release of Targeted Genetics Corporation dated July 29, 2004

Item 12. Results and Operations of Financial Condition.

     On July 29, 2004, Targeted Genetics Corporation issued a press release announcing its financial results for the quarter ended June 30, 2004. A copy of the press release is furnished as Exhibit 99.1 and is incorporated into this current report by reference.

SIGNATURES

     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.

         
  TARGETED   GENETICS CORPORATION
 
       
Date: July 29, 2004
  By:   /s/ Todd E. Simpson
     
 
      Todd E. Simpson
      Vice President, Finance and Administration and Chief Financial Officer, Secretary and Treasurer (Principal Financial and Accounting Officer)

 


Table of Contents

EXHIBIT INDEX

     
Exhibit    
No.
  Description
99.1
  Press Release of Targeted Genetics Corporation dated July 29, 2004

 

EX-99.1 2 v00673exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99. 1

(TARGETED GENETICS LOGO)©

Contact
Courtney Self
Targeted Genetics
206.521.7392

TARGETED GENETICS REPORTS SECOND QUARTER 2004
FINANCIAL RESULTS

- Clinical Progress Highlights Quarter -

Seattle, WA – July 29, 2004 – Targeted Genetics Corporation (NASDAQ: TGEN) today announced its financial results for the second quarter of 2004. As previously announced, the Company will hold a conference call with analysts at 10:30 AM EDT today. The call will be broadcast live over the Internet and can be accessed, along with replay information, at www.targetedgenetics.com.

For the second quarter of 2004, the Company reported a net loss of $4.5 million, or $0.05 per share, compared to $6.9 million, or $0.13 per share for the second quarter of 2003. For the six months ended June 30, 2004, the Company reported a net loss of $9.3 million, or $0.12 per share, compared to $7.7 million, or $0.15 per share for the same period in 2003.

Revenue for the three months ended June 30, 2004 increased to $2.8 million compared to $2.1 million for the second quarter of 2003, and was $4.1 million for the six months ended June 30, 2004, compared to $7.7 million for the same period in 2003. 2004 revenue reflects research and

 


 

development activities under Targeted Genetics’ AIDS vaccine collaboration with the International AIDS Vaccine Initiative (IAVI) and revenue from completing its contract manufacturing agreement with GenVec.

“Progress in our three clinical development programs continues to be a top priority for us, and we made significant progress during the quarter. The successful completion of an interim analysis for Targeted Genetics’ Phase IIb cystic fibrosis clinical trial was a key highlight for the Company,” said H. Stewart Parker, president and chief executive officer of Targeted Genetics. “This analysis, conducted by an independent data monitoring committee, led to their recommendation that we continue the trial as planned. We remain on target to complete enrollment in both our cystic fibrosis and AIDS vaccine clinical trials in 2004, while continuing to enroll patients in our rheumatoid arthritis clinical trial, which began during the first quarter of 2004. Our cash position remains healthy, providing us with the necessary resources to support plans for the next stages of product development.”

Operating expenses were $7.1 million for the second quarter of 2004, down from $8.7 million for the second quarter of 2003, and were $13.3 million for the six months ended June 30, 2004, down from $14.8 million for the same period in 2003. 2004 expenses reflect increased research and development expenses, primarily attributable to the Company’s AIDS vaccine and rheumatoid arthritis programs and higher general and administrative expenses, reflecting increases in patent issuances and regulatory compliance costs. 2003 expenses included restructuring charges of $2.9 million for the three months and $3.2 million for the six months ended June 30, 2003, compared to $.2 million and $.4 million for the same periods in 2004.

Second quarter highlights include:

    Successful interim analysis from the Company’s cystic fibrosis Phase IIb clinical trial; trial on track for completion by year-end;
 
    Targeted Genetics’ AAV technology highlighted in 12 presentations at the 7th Annual Meeting of the American Society of Gene Therapy;
 
    Presentation of positive preclinical data from the Company’s rheumatoid arthritis program at ASGT, demonstrating complete suppression of disease during study after intramuscular injection;
 
    Issuance of additional patent giving Targeted Genetics exclusive rights to AAV1, providing expanded potential for future product development and partnering opportunities;
 
    Announcement of merger agreement between CellExSys and Chromos Molecular Systems; and
 
    Issuance of an exclusive worldwide license agreement with the National Institutes of Health (NIH) for patents that cover ITR (inverted terminal repeat) sequences as a promoter for use with AAV in any product indication.

 


 

Targeted Genetics develops gene-based products for preventing and treating acquired and inherited diseases. The Company has three clinical product development programs, targeting cystic fibrosis, AIDS prophylaxis and rheumatoid arthritis. The Company also has a promising pipeline of product candidates focused on hemophilia and cancer and a broad platform of gene delivery technologies. For more information about the Company visit its website at www.targetedgenetics.com.

NOTE: This release contains forward-looking statements regarding our projected financial resources, intellectual property, clinical trials and regulatory filings and anticipated data from our clinical and preclinical programs. These statements, involve current expectations, forecasts of future events and other statements that are not historical facts. Inaccurate assumptions and known and unknown risks and uncertainties can affect the accuracy of forward-looking statements. Actual results could differ materially from expectations for a number of reasons, including failure of our partners to provide funding, our failure to make progress with our clinical trials, our failure to obtain positive results from our preclinical programs, our failure to obtain or maintain regulatory approvals, our failure to maintain or protect our intellectual property and the other risks described in the section entitled “Factors Affecting Our Operating Results, Our Business and Our Stock Price” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2004. You should not rely unduly on these forward-looking statements, which apply only as of the date of this release. We undertake no duty to publicly announce or report revisions to these statements as new information becomes available that may change our expectation.

 


 

TARGETED GENETICS CORPORATION
(in thousands, except per share information)
(unaudited)

                                 
    Three months ended   Six months ended
    June 30,
  June 30,
    2004
  2003
  2004
  2003
Statement of Operations Information:
                               
Collaborative agreements with affiliates
  $ 2,761     $ 2,053     $ 4,081     $ 7,692  
Operating expenses:
                               
Research & development
    4,828       4,327       9,065       8,869  
General & administrative
    2,066       1,438       3,816       2,774  
Restructure charges
    221       2,899       416       3,180  
 
   
 
     
 
     
 
     
 
 
Total operating expenses
    7,115       8,664       13,297       14,823  
 
   
 
     
 
     
 
     
 
 
Loss from operations
    (4,354 )     (6,611 )     (9,216 )     (7,131 )
Investment income
    21       56       145       108  
Interest expense
    (117 )     (360 )     (237 )     (722 )
 
   
 
     
 
     
 
     
 
 
Net loss
  $ 4,450     $ (6,915 )   $ (9,308 )   $ (7,745 )
 
   
 
     
 
     
 
     
 
 
Net loss per common share
  $ (0.05 )   $ (0.13 )   $ (0.12 )   $ (0.15 )
 
   
 
     
 
     
 
     
 
 
Shares used in computation of net loss per common share
    81,604       51,694       77,239       51,133  
 
   
 
     
 
     
 
     
 
 

 


 

TARGETED GENETICS CORPORATION
(in thousands)

                 
    June 30,   December 31,
    2004
  2003
    (unaudited)        
Balance Sheet Information:
               
Cash and cash equivalents
  $ 37,381     $ 21,057  
Other current assets
    554       575  
Property and equipment, net
    2,876       3,423  
Other assets
    32,462       32,617  
 
   
 
     
 
 
Total assets
  $ 73,273     $ 57,672  
 
   
 
     
 
 
Current liabilities
  $ 8,328     $ 6,709  
Long-term obligations and other liabilities
    16,231       16,734  
Preferred stock and minority interest
          750  
Shareholders’ equity
    48,714       33,479  
 
   
 
     
 
 
Total liabilities and shareholders’ equity
  $ 73,273     $ 57,672  
 
   
 
     
 
 

 

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