Mast Therapeutics reports net loss of $5.7 million for fourth quarter 2013

Mast Therapeutics, Inc. (NYSE MKT: MSTX) today reported financial results for the fourth quarter and year ended December 31, 2013.

"2013 was a year of great progress for Mast as we delivered on our operational goal of opening 40 clinical sites in the U.S. for EPIC, our pivotal Phase 3 study of MST-188 in sickle cell disease," said Brian M. Culley, Chief Executive Officer. "Already in 2014, we've achieved numerous operational and strategic milestones.  First, we initiated ex-U.S. enrollment for EPIC.  Second, we initiated our Phase 2 study of MST-188 in combination with recombinant tissue plasminogen activator in patients with acute limb ischemia. Third, we announced positive nonclinical data in heart failure, which suggests MST-188 provides a new mechanistic approach in an area of significant unmet need and commercial opportunity.  Fourth, we added another clinical-stage asset in AIR001 as a result of our February acquisition of Aires Pharmaceuticals. We look forward to progressing our pipeline across all of our programs and building upon last year's achievements in 2014, including having a total of 70 EPIC study sites open globally by year-end and announcing our clinical development plans for MST-188 in heart failure."

Fourth Quarter 2013 Operating Results

The Company's net loss for the fourth quarter of 2013 was $5.7 million, or $0.06 per share (basic and diluted), compared to a net loss of $4.0 million, or $0.08 per share (basic and diluted), for the same period in 2012.

Research and development (R&D) expenses for the fourth quarter of 2013 were $3.5 million, an increase of $1.4 million, or 67%, compared to $2.1 million for the same period in 2012. The increase was primarily due to increases of $1.2 million in external clinical study fees and expenses related primarily to EPIC, the Company's phase 3 study of MST-188 in sickle cell disease, and $0.2 million in personnel expenses.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2013 were $2.1 million, an increase of $0.3 million, or 20%, compared to $1.8 million for the same period in 2012. The increase resulted primarily from an increase in personnel costs and consulting fees.

Year-to-Date Operating Results

The Company's net loss for the year ended December 31, 2013 was $21.5 million, or $0.28 per share (basic and diluted), compared to a net loss of $15.6 million, or $0.33 per share (basic and diluted), for the same period in 2012.

R&D expenses for the year ended December 31, 2013 were $12.9 million, an increase of $4.8 million, or 60%, compared to $8.1 million for the same period in 2012. The increase was primarily due to increases of $6.2 million in external clinical study fees and expenses, $0.4 million in personnel costs and $0.1 million in share-based compensation expense, offset by a $1.9 million decrease in external nonclinical study fees and expenses.  The increase in external clinical study fees and expenses was primarily related to EPIC and the thorough QT/QTc study of MST-188.  The decrease in external nonclinical study fees and expenses resulted primarily from a decrease in research-related manufacturing activities for ANX-514, which the Company discontinued in 2012.

SG&A expenses for the year ended December 31, 2013 were $8.5 million, an increase of $1.0 million, or 13%, compared to $7.5 million for the same period in 2012. The increase resulted primarily from an increase in consulting fees and legal expenses.

Balance Sheet Highlights

As of December 31, 2013, the Company had cash, cash equivalents and investment securities totaling $44.4 million. Stockholders' equity amounted to $47.8 million as of December 31, 2013.