-----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, GVl4fkqTLqo6GrUHu/pefXLGF8Ev3/Ig3XS6kL0Z86PW0H0mmkivWHkJJ0PpraT7 //7gr6aY00EbKhWQwyRXcA== 0001193125-05-154000.txt : 20050802 0001193125-05-154000.hdr.sgml : 20050802 20050801191950 ACCESSION NUMBER: 0001193125-05-154000 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050728 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050802 DATE AS OF CHANGE: 20050801 FILER: COMPANY DATA: COMPANY CONFORMED NAME: KOSAN BIOSCIENCES INC CENTRAL INDEX KEY: 0001110206 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 943217016 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31633 FILM NUMBER: 05989717 BUSINESS ADDRESS: STREET 1: 3832 BAY CENTER PLACE CITY: HAYWARD STATE: CA ZIP: 94545 BUSINESS PHONE: 5107328400 MAIL ADDRESS: STREET 1: 3832 BAY CENTER PLACE CITY: HAYWARD STATE: CA ZIP: 94545 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):

JULY 28, 2005

 


 

KOSAN BIOSCIENCES INCORPORATED

(Exact name of registrant specified in its charter)

 


 

DELAWARE   000-31633   94-3217016

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

 

3832 BAY CENTER PLACE HAYWARD, CA   94545
(Address of principal executive offices)   (Zip Code)

 

REGISTRANT’S TELEPHONE, INCLUDING AREA CODE: (510) 732-8400

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under an 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.

 

On Thursday July 28, 2005, Kosan Biosciences Incorporated (the “Company”) announced via a press release its financial results for the three and six months ended June 30, 2005. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

The information in this Report on Form 8-K, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01. FINANCIAL STATEMENTS AND EXHIBITS

 

(c) Exhibits

 

Exhibit

  

Description


99.1    Press Release dated July 28, 2005, relating to the Company’s financial results for the three and six months ended June 30, 2005.


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.

 

KOSAN BIOSCIENCES INCORPORATED

(Registrant)

By

 

/s/ Daniel V. Santi


   

Daniel V. Santi, M.D., Ph.D.

   

Chairman and Chief Executive Officer

 

Dated: August 1, 2005


EXHIBIT INDEX

 

Exhibit

  

Description


99.1   

Press Release dated July 28, 2005, relating to the Company’s financial results for the three and six months ended

June 30, 2005.

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

Contact:

Kosan Biosciences Incorporated

Susan M. Kanaya

Chief Financial Officer

(510) 732-8400 ext. 5227

kanaya@kosan.com

 

FOR IMMEDIATE RELEASE

 

Kosan Reports Second Quarter and Six-Month Financial Results

 

Hayward, CA. July 28, 2005 – Kosan Biosciences Incorporated (Nasdaq: KOSN) today reported financial results for the quarter and six months ended June 30, 2005. Total operating expenses were $11.0 million and $22.2 million for the quarter and six months ended June 30, 2005, respectively, compared to $11.4 million and $22.1 million in the same periods last year. Kosan increased spending in its Hsp90 inhibitor program, which was partially offset by lower spending on its epothilone analog program given the selection of KOS-1584 as a follow-on epothilone compound and its advancement into Phase I clinical trials, as explained below. Kosan’s total operating expenses do not reflect costs incurred by partners Roche or the National Cancer Institute (NCI) in connection with clinical trials that Roche is conducting in connection with the Company’s epothilone program and the NCI is conducting in connection with the Company’s Hsp90 inhibitor program.

 

Revenues were $3.3 million and $6.2 million for the second quarter and six months ended June 30, 2005, respectively, compared to $5.9 million and $12.3 million in the same periods in 2004, substantially all of which was generated under the Roche-Kosan global development and commercialization agreement in both periods. Revenues in the 2004 period included research funding from Roche for the identification of an epothilone analog as a follow-on compound to KOS-862; this research funding concluded in the third quarter of 2004 as a result of the selection of KOS-1584 as a second-generation epothilone compound and its advancement into clinical testing. Clinical development of KOS-1584 is being funded by Roche. Advancing KOS-1584 into the clinic also resulted in a change in the estimated clinical development period with Roche, which extended the amortization period of up-front payments.

 

Net losses for the quarter and six months ended June 30, 2005 were $7.3 million and $15.3 million, or $0.25 and $0.53 per share, compared to $5.2 million and $9.3 million, or $0.18 and $0.32 per share, in the same periods for the prior year. At June 30, 2005, cash, cash equivalents and marketable securities totaled $69.3 million, compared to $83.4 million at December 31, 2004. In July 2005, Kosan secured a $35 million credit facility, which provides flexibility to its overall financing strategy as Kosan’s anticancer drug candidates advance further in the clinic.

 

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Q2 Earnings – Page 2

 

Clinical Highlights

 

During the quarter, Kosan reported continued clinical progress in its two oncology programs. In the Company’s epothilone program, KOS-862 (Epothilone D) successfully advanced to the second stage of a two-stage Simon design in a Phase II clinical trial in breast cancer. The compound is also being evaluated in an ongoing Phase II clinical trial in prostate cancer, as well as in several Phase Ib chemotherapy combination trials. A second-generation epothilone, KOS-1584, continues in Phase I testing. In Kosan’s Hsp90 inhibitor program, KOS-1022 (DMAG), a second-generation Kosan-proprietary compound, entered into Phase I clinical trials in hematologic cancers, supplementing the multiple ongoing NCI-sponsored Phase I clinical trials in solid tumors. KOS-953, a proprietary formulation of 17-AAG (the Company’s first generation Hsp90 inhibitor compound), continues in Phase I and Phase Ib combination clinical trials. Data from these programs were reported at the American Society of Clinical Oncology (ASCO) annual meeting in May 2005 and the European Hematology Association 10th Congress in June 2005, including the following highlights:

 

    Preliminary Phase II data on KOS-862 in patients with metastatic breast cancer demonstrated that two of ten evaluable patients had confirmed partial responses, suggesting encouraging anti-tumor activity.

 

    Preliminary Phase II data on KOS-862 in patients with non-small cell lung cancer demonstrated biologic activity and possible safety advantages over other epothilones.

 

    Preliminary data from two Phase Ib trials of KOS-862 administered in combination with carboplatin and gemcitabine suggested encouraging preliminary anti-tumor activity.

 

    Preliminary Phase I and Phase Ib results of KOS-953 as monotherapy and in combination with bortezomib, respectively, in patients with multiple myeloma showed early signs of activity and tolerability in an advanced and heavily pretreated patient population.

 

About Kosan

 

Kosan Biosciences has two first-in-class anticancer agents in Phase II and Phase Ib clinical trials: KOS-862 (Epothilone D) and 17-AAG, an Hsp90 (heat shock protein 90) inhibitor and geldanamycin analog. KOS-862, the Company’s lead drug candidate, has a mechanism of action similar to taxanes and is partnered with Roche in a global development and commercialization agreement, along with a follow-on compound, KOS-1584, currently in Phase I testing. 17-AAG targets multiple pathways required for tumor growth and is being developed in collaboration with the National Cancer Institute, in addition to a second-generation geldanamycin analog, KOS-1022 (DMAG), now in Phase I trials. Kosan also has a proprietary formulation of 17-AAG, called KOS-953, in Phase I and Phase Ib trials. Kosan has generated a pipeline of potentially significant product candidates for cancer, infectious disease and other therapeutic areas based on its proprietary technologies for discovering, developing and manufacturing polyketide analogs. Polyketides are an important class of natural products that have yielded numerous pharmaceuticals for the treatment of cancer, infectious diseases, high cholesterol, transplant rejection and other diseases. For additional information on Kosan Biosciences, please visit the Company’s website at www.kosan.com.

 

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Q2 Earnings – Page 3

 

This press release contains “forward-looking” statements, including statements related to ongoing and further development of, and the potential for, Kosan’s product candidates, including KOS-862, KOS-1584, 17-AAG, KOS-953 and KOS-1022, in the treatment of cancer. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. There are a number of important factors that could cause the results of Kosan to differ materially from those indicated by these forward-looking statements, including, among others, risks and uncertainties related to the clinical advancement of KOS-862, KOS-1584, 17-AAG, KOS-953 and KOS-1022 and the costs of conducting clinical studies for these product candidates; Kosan’s dependence on its collaborations with Roche and the NCI for development of its product candidates; Kosan’s dependence on its collaboration with Roche for most of its revenues; and other risks detailed from time to time in the Company’s SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, and other periodic filings with the SEC. Kosan does not undertake any obligation to update forward-looking statements.

 

FINANCIAL TABLE FOLLOWS

 

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Selected Financial Information

 

Condensed Statements of Operations

(in thousands, except per share amounts)

 

     Three Months Ended
June 30,


    Six Months Ended
June 30,


 
     2005

    2004

    2005

    2004

 
     (unaudited)     (unaudited)  

Revenues:

                                

Contract revenue

   $ 2,897     $ 5,111     $ 5,513     $ 11,234  

Grant revenue

     441       829       700       1,067  
    


 


 


 


Total revenues

     3,338       5,940       6,213       12,301  

Operating expenses:

                                

Research and development

     9,471       10,000       19,126       19,341  

General and administrative

     1,523       1,388       3,064       2,791  
    


 


 


 


Total operating expenses

     10,994       11,388       22,190       22,132  
    


 


 


 


Loss from operations

     (7,656 )     (5,448 )     (15,977 )     (9,831 )

Net interest income

     340       268       646       526  
    


 


 


 


Net loss

   $ (7,316 )   $ (5,180 )   $ (15,331 )   $ (9,305 )
    


 


 


 


Basic and diluted net loss per common share

   $ (0.25 )   $ (0.18 )   $ (0.53 )   $ (0.32 )
    


 


 


 


Shares used in computing basic and diluted net loss per common share

     29,194       28,899       29,146       28,827  

 

Condensed Balance Sheets

(in thousands)

 

    

June 30,

2005


   December 31,
2004


     (unaudited)     

Cash, cash equivalents and marketable securities

   $ 69,259    $ 83,393

Total assets

   $ 80,385    $ 96,613

Deferred revenue

   $ 13,791    $ 15,430

Total liabilities

   $ 25,897    $ 27,427

Total liabilities and stockholders’ equity

   $ 80,385    $ 96,613

Shares issued and outstanding

     29,206      29,096
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