2014 and early 2015 Operational Highlights:
We are pleased with the productive year we had last year, one that was highlighted by completing enrollment in our landmark Abili-T Phase 2b clinical trial of Tcelna in Secondary Progressive MS patients and expanding our pipeline into a second autoimmune disease, said Neil K. Warma, Opexas President and Chief Executive Officer. The Abili-T trial in progressive MS is one that we believe could be an important step in advancing a therapy that has the potential to be the treatment of choice in this patient population that currently has access to very limited treatment options. We continue to treat patients in the trial and expect to report top line results in the second half of 2016.
Additionally, with the initiation of preclinical development activities in our second indication, neuromyelitis optica, we believe we have demonstrated our ability to leverage our T-cell technology platform into other disease areas. We also believe the platform could be leveraged even further to other autoimmune diseases.
Clinical Development Update
Upcoming potential development and regulatory milestones include:
Financial Results for the Year Ended December 31, 2014
For the year ended December 31, 2014, Opexa reported a net loss of $15.1 million, or $0.54 per share, compared to a net loss of $16.7 million, or $1.25 per share, for 2013. Research and development expense was $12.1 million, an increase of 32.0% compared to $9.2 million in 2013. The increase in expense is primarily due to increases in staff and associated employee compensation expenses, increases in the cost of supplies used both in laboratory and product manufacturing operations and increased clinical investigator costs associated with increased enrollment of patients in the Abili-T clinical study.
General and administrative expense was $3.83 million, a 4.4% increase compared to $3.7 million in 2013. The increase in expense is due to a modest increase in stock compensation expense and an increase in the use of professional services, and was partially offset by lower NASDAQ listing fees.
As of December 31, 2014, Opexa had cash and cash equivalents of $9.9 million compared to $23.6 million as of December 31, 2013. The Companys monthly burn rate for the year ending December 31, 2014 was approximately $1.2 million. Based on the current activities, Opexa believes it has sufficient liquidity to support its clinical activities for the Abili-T trial, as well as preclinical development activities for OPX-212 in NMO (with an expected IND submission by mid-2015) and general operations of the Company, into the fourth quarter of 2015.
For additional information please see Opexas Annual Report on Form 10-K filed today with the SEC.
See the article here:
Opexa Therapeutics Reports Year End 2014 Financial Results and Provides Corporate Update
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