AUTOIMMUNE INC. PROVIDES PRODUCT UPDATE AND REPORTS THIRD QUARTER 1997 RESULTS
-- Company Announces Six U.S. and International Patent Issuances, Three Patent Allowances on Oral Tolerance --
Lexington, Massachusetts, November 4, 1997 --AutoImmune Inc. (Nasdaq: AIMM) today reported a net loss of $0.21 million, or $0.01 per share, for the third quarter ended September 30, 1997, compared with a net loss of $7.2 million, or $0.44 per share, for the same quarter one year earlier. The decrease is due to a favorable adjustment in the estimated restructuring costs and previously accrued expenses, as well as lower research and development activity levels following the completion of several clinical trials. Net loss for both the nine months ended September 30, 1996 and 1997 was $16.8 million, or $1.03 per share. As of September 30, 1997, the Company reported $32.6 million in cash and marketable securities.
In line with the Company's strategy of focusing on the development of Colloral(R) for rheumatoid arthritis, AutoImmune recently completed and submitted to the FDA an end of Phase II integrated safety and efficacy analysis on the more than 1200 patients who participated in Colloral trials. AutoImmune plans to meet with the FDA during the fourth quarter to determine the next steps in the approval process of Colloral. In other product development, AutoImmune's partner in diabetes, Eli Lilly and Company, is now supporting four different clinical trials involving a total of more than 900 patients. Additionally, the Company has an open label pilot trial underway in chronic transplant rejection.
Management also noted that four U.S. patents were recently issued to AutoImmune and an additional three of AutoImmune's U.S. patent applications were allowed. The patents are directed to a variety of methods for inducing tolerance, including administration of autoantigens by inhalation to treat various autoimmune diseases, and methods for treating or preventing Type I diabetes.
The allowed applications are directed to a method for suppressing allograft rejection, a treatment for uveoretinitis, and a treatment for rheumatoid arthritis. In addition, AutoImmune recently received two European patents directed to a method for enhancing oral tolerance and a method for treating uveoretinitis.
AutoImmune Inc. is a biopharmaceutical company developing a new class of drug therapy for the treatment of cell-mediated inflammatory conditions. With highly focused human and capital resources, the Company has advanced several product candidates, all based on the principle of oral tolerance, into human clinical testing.
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 developmental stage of the Company's products and uncertainties of clinical trial results; the Company's capital requirements, history of operating losses and lack of product revenue, its limited manufacturing and marketing experience, 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.