SAN DIEGO, Nov. 12, 2015 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, heart failure and stroke, today reported financial results for the quarter ended September 30, 2015.
“During the third quarter, we continued to make significant progress with our clinical development of vepoloxamer,” stated Brian M. Culley, Chief Executive Officer. “We recently surpassed the 80% enrollment mark in our Phase 3 ‘EPIC’ study in sickle cell disease, we enrolled the first patient in our open-label, repeat-exposure EPIC-extension study, and we initiated a Phase 2 study of vepoloxamer in chronic heart failure with a new formulation.”
“Additionally, the two Phase 2a studies of AIR001 in patients with heart failure with preserved ejection fraction (HFpEF) continue to enroll patients and we look forward to sharing interim and complete data from those clinical studies in coming months,” continued Mr. Culley.
Third Quarter 2015 Operating Results
The Company’s net loss for the third quarter of 2015 was $9.9 million, or $0.06 per share (basic and diluted), compared to a net loss of $7.9 million, or $0.06 per share (basic and diluted), for the same period in 2014.
Research and development (R&D) expenses for the third quarter of 2015 were $7.3 million, an increase of $1.9 million, or 36%, compared to $5.4 million for the same period in 2014. The increase was due primarily to increases of $1.8 million in external nonclinical study fees and expenses and a $0.2 million in external clinical study fees and expenses, offset by a $0.1 million decrease in personnel costs and share-based compensation expense. The $1.8 million increase in external nonclinical study fees and expenses was due primarily to an increase in research-related manufacturing costs for vepoloxamer.
Selling, general and administrative (SG&A) expenses of $2.5 million for the third quarter of 2015 were consistent with the same period in 2014.
Year-to-Date Financial Results
The Company’s net loss for the nine months ended September 30, 2015 was $29.7 million, or $0.18 per share (basic and diluted), compared to a net loss of $21.4 million, or $0.19 per share (basic and diluted), for the same period in 2014.
R&D expenses for the nine months ended September 30, 2015 were $21.1 million, an increase of $6.6 million, or 46%, compared to $14.5 million for the same period in 2014. The increase was due primarily to a $4.1 million increase in external nonclinical study fees and expenses, a $2.2 million increase in external clinical study fees and expenses and a $0.2 million increase in personnel expenses.
The $4.1 million increase in external nonclinical study fees and expenses was due primarily to a $3.8 million increase in research-related manufacturing costs for vepoloxamer and a $0.3 million increase in research-related manufacturing costs for AIR001. The $2.2 million increase in external clinical study fees and expenses was due primarily to increases of $2.7 million in EPIC study costs and $0.4 million in costs for our Phase 2 study of vepoloxamer in heart failure, offset by decreases of $0.5 million in AIR001 clinical study costs and $0.5 million in costs for the discontinued Phase 2 study of vepoloxamer in acute limb ischemia.
SG&A expenses for the nine months ended September 30, 2015 were $8.4 million, an increase of $1.3 million, or 19%, compared to $7.1 million for the same period in 2014. This increase was due primarily to a $0.7 million increase in personnel costs and a $0.5 million increase in professional and consulting fees.
The Company recognized a $0.5 million bargain purchase gain during the nine months ended September 30, 2014 associated with its acquisition of Aires, which was included in other income.
Balance Sheet Highlights
As of September 30, 2015, the Company had cash, cash equivalents and investment securities totaling $49.9 million. Stockholders’ equity amounted to $33.5 million as of September 30, 2015.
Investor Conference Call
The Company will hold a conference call today, November 12, 2015, at 4:30 p.m. ET / 1:30 p.m. PT to discuss its financial results for the third quarter of 2015 and provide a corporate update. Interested parties may access the conference call by dialing (855) 239-3120 from the U.S. and (412) 542-4127 from outside the U.S. and should request the Mast Therapeutics, Inc. Corporate Update Call. A live webcast of the conference call will be available online from the Investors section of Mast’s website at http://www.masttherapeutics.com/investors/events/. Replays of the webcast will be available on the Company’s website for 30 days and a telephone replay will be available through November 18, 2015 by dialing (877) 344-7529 from the U.S. and (412) 317-0088 from outside the U.S. and entering replay access code 10075708.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is leveraging its MAST platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop vepoloxamer (MST-188), its lead product candidate, for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes. The Company is also developing AIR001, a sodium nitrite solution for inhalation via nebulizer, for the treatment of heart failure with preserved ejection fraction (HFpEF).
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