Opexa Reports Year End 2006 Financial Results
THE WOODLANDS, Texas - Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, has reported financial results for the year ended December 31, 2006 and provided an update on its progress.
Recent highlights include:
More than 110 patients admitted into the Tovaxin™ IIb clinical trial; 100% enrollment of 150 patients expected in the first half of 2007
Publication of encouraging clinical data from novel T-cell vaccination therapy for rheumatoid arthritis in Arthritis & Rheumatism
David McWilliams, chief executive officer of Opexa, commented, “This has been an extraordinary year for Opexa, which culminated with the commencement at the end of November of our Phase IIb trial in multiple sclerosis with our lead drug candidate Tovaxin. We have 35 U.S. clinical sites actively recruiting patients and now have more than 110 patients admitted to the trial, which, I believe, speaks to the need for effective, patient-friendly therapies for this debilitating disease.”
McWilliams continued, “We are also pleased with the progress of our other preclinical programs:
The clinical data from a 15-patient trial, which demonstrated that a T-cell vaccination therapy for Rheumatoid Arthritis induces regulatory immune responses, was recently published in Arthritis & Rheumatism. This publication of this data is another step forward in our plan to file an IND with the U.S. Food and Drug Administration for this therapy.
The initiation of preclinical animal studies of Opexa’s monocyte-derived pancreatic islet cells being conducted at the University of Texas Medical Branch – Galveston. These studies, if successful, will form the foundation for the Company’s preclinical diabetes program.
“On the financial front, we have cash on hand to take us into 2008 while supporting these projects,” McWilliams added.
Year-to-Date Financial Results
Opexa reported no revenues in the 12 months ended December 31, 2006 or in the comparable prior-year period. General and administrative expenses for the 12 months of 2006 were $5,461,047, compared with $6,259,075 for the 12 months of 2005. The decrease in expenses was due to a combination of factors including a decrease in stock compensation expenses, professional service fees and overhead expenses in 2006.
Research and development expenses were $7,612,932 for the 12 months of 2006, compared with $4,183,356 million for the 12 months of 2005. The increase was primarily due to the costs of the clinical trials for Tovaxin and research and development in support of pre-clinical diabetes stem cell therapies.
Interest expense was $984 for the 12 months ended December 31, 2006, compared with $7,323,851 for the 12 months ended December 31, 2005. Interest expense in the 2005 period was due to notes payable that were then outstanding, which subsequently were converted into equity in June 2005, resulting in acceleration of the amortization of the discount related to the notes.
Interest income was $688,299 for the 12 months of 2006, compared with $81,930 for the 12 months of 2005. The increase was due to the investment of the cash proceeds from the April 2006 equity offering in short term and cash equivalent investments.
The Company recognized a gain on derivative instruments of $104,978 for the 12 months ended December 31, 2006, compared with $3,896,841 for the 12 months ended December 31, 2005. The decrease is a result of the net unrealized (non-cash) change in the fair value of Opexa’s derivative instrument liabilities.
Opexa reported a net loss for the year ended December 31, 2006 of $14,056,407, or ($2.61) per share, compared with a net loss for the year ended December 31, 2005 of $15,517,356, or ($9.90) per share.
Cash and cash equivalents and investments in marketable securities were $14,972,010 as of December 31, 2006. This compares with $2,560,666 as of December 31, 2005.
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