News Column

Opexa Therapeutics Posts First Quarter Results

May 20, 2014

Opexa Therapeutics, Inc., a biotechnology company developing Tcelna (imilecleucel-T), a novel T-cell immunotherapy for the treatment of Multiple Sclerosis (MS), reported financial results for the first quarter ended March 31, and provided an overview of the Company's recent corporate developments.

In a release on May 14, the company noted that recent highlights include:

-Clinical

-As of May 13, Opexa reached the targeted enrollment of 180 patients in the Phase IIb "Abili-T" clinical study of Tcelna (imilecleucel-T) in patients with Secondary Progressive Multiple Sclerosis. The Abili-T clinical trial is a randomized, double- blind, placebo-controlled study at approximately 35 leading clinical sites in the U.S. and Canada.

-The Company will also allow patients who are currently in the screening process to enroll in the Abili-T clinical study should they meet the trial's entry criteria. The Company expects to report the top-line results of the Abili-T clinical study in mid-2016.

-Operations

-In March, Opexa appointed two highly experienced individuals to join the Company's Board of Directors - Hans-Peter Hartung, M.D., Ph.D., FRCP, a world leading clinician and expert in the treatment of Multiple Sclerosis and other neurological diseases, and Timothy Barabe, a proven CFO with global operational and financial expertise.

-Financial

-Reported cash and cash equivalents of $19,659,525 as of March 31.

-Opexa believes it has sufficient liquidity to support its current clinical activities for the Abili-T trial and general operations to sustain the Company and support such trial into the fourth quarter of 2015.

"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, Opexa's 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 Opexa's Board of Directors. They bring with them deep experience in the areas of clinical development, neurology, finance and operations.

As of March 31, Opexa's 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, 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, 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, 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, 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.

Interest expense of $1,635,254 for the three months ended March 31, 2013 was primarily related to the amortized debt discount and interest on both the July 25, 2012 convertible secured promissory notes and the January 23, 2013 convertible promissory notes and the amortization of the financing fees over the life of the notes. No interest expense was recorded for the three months ended March 31.

Opexa reported a net loss for the three months ended March 31, of approximately $3.7 million, or $0.13 loss per share (basic and diluted), compared with a net loss of approximately $4.2 million or $0.58 loss per share (basic and diluted) for the three months ended March 31, 2013. The decrease in net loss is primarily due to a decrease in interest expense and an increase in revenue, and was partially offset by increases in research and development, general and administrative and depreciation costs.

Cash and cash equivalents were $19,659,525 as of March 31, compared to $23,644,542 as of December 31, 2013.

For additional information please see Opexa's Quarterly Report on Form 10-Q filed May 14 with the SEC.

Opexa conducted a conference call and webcast to provide a corporate update and discuss the financial results on May 14. A live webcast of the call can also be accessed via the webcast link on the Investor Relations page of Opexa's website (opexatherapeutics.com).

Opexa's mission is to lead the field of Precision Immunotherapy by aligning the interests of patients, employees and shareholders. The Company's leading therapy candidate, Tcelna, is a personalized T- cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive MS. Tcelna is derived from T-cells isolated from the patient's peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections.

More information:

www.opexatherapeutics.com.

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