THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing Tcelna (imilecleucel-T), a novel T-cell immunotherapy for the treatment of Multiple Sclerosis (MS), today reported financial results for the first quarter ended March 31, 2014 and provided an overview of the Companys recent corporate developments.
Recent highlights include:
Reaching our clinical trial enrollment target of 180 patients in the Phase IIb Abili-T trial in Secondary Progressive Multiple Sclerosis represents an important milestone in the development of our personalized immunotherapy for this unmet medical need, said Neil K. Warma, Opexas President and Chief Executive Officer. MS patients are in dire need of a product to treat the progressive form of the disease. With so few treatment options for Secondary Progressive MS patients, we remain committed in our efforts to develop Tcelna for this patient group.
During the first quarter of 2014, Hans-Peter Hartung and Tim Barabe joined Opexas Board of Directors. They bring with them deep experience in the areas of clinical development, neurology, finance and operations.
As of March 31, 2014, Opexas cash and cash equivalents totaled approximately $19.7 million and our monthly burn rate for the three months ending March 2014 was approximately $1.3 million. Based on the cash position, the Company believes it has sufficient liquidity to support its current clinical activities for the Abili-T trial and general operations to sustain itself into the fourth quarter of 2015.
First Quarter Financial Results
Opexa reported revenue of $348,837 for the three months ended March 31, 2014, compared to $220,100 for the three months ended March 31, 2013. The revenue is related to the recognized portion of the $5 million upfront payment received from Merck Serono in conjunction with the Option and License Agreement entered into between Opexa and Merck Serono during February 2013.
Research and development expenses were $2,811,139 for the three months ended March 31, 2014, compared with $1,621,366 for the three months ended March 31, 2013. The increase in expenses is primarily due to increased costs in connection with the enrollment of patients for the ongoing clinical trial of Tcelna in Secondary Progressive Multiple Sclerosis, the procurement and use of supplies for product manufacturing and development, the number of employees to support the ongoing clinical trial and stock compensation expense.
General and administrative expenses for the three months ended March 31, 2014 were $1,102,880, compared with $1,102,435 for the three months ended March 31, 2013. The increase in expense is due to increases in employee compensation and stock compensation expenses, and was partially offset by decreases in legal and professional fees.
Depreciation and amortization expenses for the three months ended March 31, 2014 were $95,586, compared with $78,311 for the three months ended March 31, 2013. The increase in expense is due to increases in depreciation for laboratory, manufacturing and computer equipment acquired during 2013 and 2014 and leasehold improvements during 2013 and 2014 to support increased development activities.
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Opexa Therapeutics Reports First Quarter 2014 Financial Results and Provides Corporate Update
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