-----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, Sc71oRLkHWwSr48N3GB6uj3YpEAKlAH5DfREH+BMW5ApimT0itCSx52HnpERy6cZ cKHrDmB9jU2oevLwQ5MjAw== 0001193125-03-032523.txt : 20030811 0001193125-03-032523.hdr.sgml : 20030811 20030811095216 ACCESSION NUMBER: 0001193125-03-032523 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030807 ITEM INFORMATION: FILED AS OF DATE: 20030811 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AUTOIMMUNE INC CENTRAL INDEX KEY: 0000879106 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 133489062 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-20948 FILM NUMBER: 03833360 BUSINESS ADDRESS: STREET 1: 1199 MADIA STREET CITY: PASADENA STATE: CA ZIP: 91103 BUSINESS PHONE: 6267921235 MAIL ADDRESS: STREET 1: 128 SPRING STREET CITY: LEXINGTON STATE: MA ZIP: 02173 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):

August 7, 2003

 


 

AUTOIMMUNE INC.

(Exact Name of Registrant as specified in its charter)

 

DELAWARE    0-20948    13-348-9062
(State or Other Jurisdiction    (Commission    (IRS Employer
of Incorporation)    File Number)    Identification No.)

 

1199 Main Street, Pasadena, CA    91103
(Address of Principal Executive Offices)    (Zip Code)

 

(626) 792-1235

Registrant’s telephone number, including area code:

 

Not Applicable

(Registrant’s name or former address, if change since last report)

 



Item 12.    Results of Operations and Financial Condition.

 

The information contained in this report on Form 8-K is being furnished pursuant to Item 12 “Results of Operations and Financial Condition”. The Company issued a press release on August 7, 2003 announcing its financial results for the quarter ended June 30, 2003, a copy of which is attached as Exhibit 99.1.

 

SIGNATURES

 

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.

 

Date: August 11, 2003

AUTOIMMUNE INC.

 

By:    /s/    Heather A. Ellerkamp                    

Name: Heather A. Ellerkamp

Title: Director of Finance and Treasurer

EX-99.1 3 dex991.htm PRESS RELEASE PRESS RELEASE

Exhibit 99.1

 

[AUTOIMMUNE LOGO]

 

AutoImmune Inc.

1199 Madia Street

Pasadena, CA 91103

Phone: 626-792-1235

Fax: 626-792-1236

 

 

Contact:

Robert C. Bishop, Ph.D.

Chairman and Chief Executive Officer

AutoImmune Inc.

626-792-1235

website: http://www.autoimmuneinc.com

 

FOR IMMEDIATE RELEASE

 

AUTOIMMUNE INC. REPORTS 2003 SECOND QUARTER FINANCIAL RESULTS

 

Pasadena, California, August 7, 2003—AutoImmune Inc. (Nasdaq: AIMM) today reported a net loss of $0.14 million, or $0.01 per share basic and diluted, for the three months ended June 30, 2003, compared with a net loss of $0.18 million, or $0.01 per share basic and diluted, for the three months ended June 30, 2002. For the six months ended June 30, 2003, net income was $0.89 million, or $0.05 per share basic and diluted, compared with a net loss of $0.39 million, or $0.02 per share basic and diluted, for the six months ended June 30, 2002. Results for the six months ended June 30, 2003 reflect receipt of the final payment in March 2003 from a subsidiary of Elan Corporation plc for its purchase of AutoImmune’s rights to certain patent applications. As of June 30, 2003, the Company reported $11.0 million in cash and marketable securities.

 

Robert C. Bishop, Ph.D., Chairman of the Board and Chief Executive Officer stated, “During the second quarter, Colloral LLC, AutoImmune’s joint venture with Deseret Laboratories International, reported small but increasing sales of Colloral®, a product for nutritional support of patients with rheumatoid arthritis. The joint venture is planning to expand marketing efforts over the next several quarters and, under the currently applicable accounting model, we will begin to recognize income when profits exceed cumulative start-up costs.”

 

BioMS recently confirmed in a press release that its advanced phase clinical trial of MBP8298 treatment for chronic progressive multiple sclerosis, which utilizes intellectual property rights exclusively licensed from AutoImmune, is scheduled to start before the end of this year. BioMS makes monthly diligence payments to AutoImmune and has a royalty obligation on sales of MBP8298 should it reach the market.

 

Teva Pharmaceutical Industries, Ltd., is considering various options for the next human clinical studies on an oral formulation of COPAXONE® (glatiramer acetate), a product for the treatment of multiple sclerosis, which utilizes intellectual property rights exclusively licensed from AutoImmune. If Teva is successful in bringing this product to market, AutoImmune will receive both a milestone payment and a royalty on sales.


Results from the oral insulin arm of the NIH sponsored diabetes prevention trial (DPT-1) were presented at the ADA meeting in New Orleans. Although there was a trend in favor of the treated group versus the placebo group, the data did not reach statistical significance. It is expected the results will be submitted for publication and there remains the possibility that sub-group analysis will suggest additional trials worth considering.

 

AutoImmune has agreed to help sponsor a New York Academy of Sciences meeting titled “Oral Tolerance: Mechanisms and Applications” to be held at Mt Sinai Medical Center in New York City, October 23-26, 2003.

 

AutoImmune is a biopharmaceutical company involved in the development of a new class of mucosally administered therapies for the treatment of autoimmune and cell-mediated inflammatory diseases and conditions.

 

This release contains forward-looking statements which involve risks and uncertainties. The Company’s actual results may differ significantly from results discussed in the forward-looking statements due to a number of important factors, including, but not limited to the uncertainties of clinical trial results, the Company’s dependence on third parties for licensing revenue, and the risks of technological change and competition. These factors are more fully discussed in the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission in the section “Business-Factors to be Considered.” The discussion in the Annual Report on Form 10-K is hereby referenced into this release.

 

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AUTOIMMUNE INC.

STATEMENT OF OPERATIONS

(Unaudited)

 

     Three months ended June 30,     Six months ended June 30,
     2002

    2003

    2002

    2003

Revenue

   $ 15,000     $ 23,000     $ 30,000     $ 1,390,000
    


 


 


 

Costs and expenses:

                              

Research and development

     55,000       33,000       118,000       171,000

General and administrative

     187,000       164,000       405,000       394,000
    


 


 


 

Total costs and expenses

     242,000       197,000       523,000       565,000
    


 


 


 

Interest income

     50,000       32,000       101,000       66,000
    


 


 


 

       50,000       32,000       101,000       66,000
    


 


 


 

Net income (loss)

   ($ 177,000 )   ($ 142,000 )   ($ 392,000 )   $ 891,000
    


 


 


 

Net income (loss) per share—basic

   ($ 0.01 )   ($ 0.01 )   ($ 0.02 )   $ 0.05
    


 


 


 

Net income (loss) per share—diluted

   ($ 0.01 )   ($ 0.01 )   ($ 0.02 )   $ 0.05
    


 


 


 

Weighted average common shares outstanding—basic

     16,919,623       16,919,623       16,919,623       16,919,623
    


 


 


 

Weighted average common shares outstanding—diluted

     16,919,623       16,919,623       16,919,623       17,183,205
    


 


 


 

CONDENSED BALANCE SHEET

(Unaudited)

     December 31,     June 30,            
     2002

    2003

           

Cash and marketable securities

   $ 10,018,000     $ 11,045,000                

Other current assets

     81,000       22,000                
    


 


             

Total assets

   $ 10,099,000     $ 11,067,000                
    


 


             

Current liabilities

   $ 187,000     $ 112,000                

Total stockholders’ equity

     9,912,000       10,955,000                
    


 


             

Total liabilities and equity

   $ 10,099,000     $ 11,067,000                
    


 


             
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