AUTOIMMUNE INC. REPORTS THIRD QUARTER 1998 RESULTS
-- Over 90% of Patients Admitted Into Colloral® Pivotal Trial --
Lexington, Massachusetts, November 3, 1998 -- AutoImmune Inc. (Nasdaq: AIMM) today reported a net loss of $3.6 million, or $0.22 per share, for the quarter ended September 30, 1998, compared with a net loss of $0.2 million, or $0.01 per share, for the same quarter one year earlier. Research and development expenses increased to $3.4 million for the quarter ended September 30, 1998, from $0.2 million in the comparable 1997 period, reflecting increased costs for clinical trial activity with Colloral® and prior year favorable adjustments in accrued expenses. Net loss for the nine months ended September 30, 1998 was $10.3 million, or $0.63 per share, versus a net loss of $16.8 million, or $1.03 per share, for the same period in 1997. As of September 30, 1998, the Company reported $20.0 million in cash and marketable securities.
"We have nearly completed enrollment in the Colloral double-blind pivotal trial for the treatment of rheumatoid arthritis, with more than 700 of the 800 rheumatoid arthritis patients already admitted at 44 participating U.S. centers," said Robert C. Bishop, Ph.D., President and Chief Executive Officer of AutoImmune. "We are pleased that we have been able to rapidly enroll patients without compromising entry criteria and we attribute this to a high level of interest among patients and physicians. We are on schedule to report the results of the study next summer." "
Dr. Bishop noted that the trial is being overseen by the AutoImmune clinical team with the assistance of a full-service contract research organization and Dr. Malcolm Fletcher, formerly Vice President of Clinical and Regulatory Affairs for AutoImmune. Dr. Fletcher, who resigned his full-time employment in October, will remain affiliated with the Company as a consultant Medical Director until the Phase III Colloral trial is completed.
Dr. Bishop noted that the trial is being overseen by the AutoImmune clinical team with the assistance of a full-service contract research organization and Dr. Malcolm Fletcher, formerly Vice President of Clinical and Regulatory Affairs for AutoImmune. Dr. Fletcher, who resigned his full-time employment in October, will remain affiliated with the Company as a consultant Medical Director until the Phase III Colloral trial is completed.
AutoImmune is a biopharmaceutical company developing a new class of orally administered pharmaceutical therapies for the treatment of autoimmune and cell-mediated inflammatory diseases and 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 in the section "Business-Factors to be Considered." The discussion in the Annual Report on Form 10-K is hereby referenced into this release.