SAN DIEGO, Oct. 31, 2014 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, today reported financial results for the quarter ended September 30, 2014.
Brian M. Culley, the Company's Chief Executive Officer, said: "The third quarter was productive for Mast. Consistent with prior guidance, our 388-patient pivotal Phase 3 study of MST-188 for sickle cell disease is on track to complete enrollment by the end of next year. We now have opened 50 study sites in the U.S. and more than ten study sites in six countries outside of the U.S."
Mr. Culley continued: "We are further encouraged by the increased attention sickle cell disease is receiving, as evidenced by the FDA's recent press release highlighting its commitment to encouraging development of new SCD treatments as an agency priority and growing attendance at the 3rd Annual Sickle Cell Disease Drug Development Conference, which we hosted during National Sickle Cell Awareness Month in September. We are proud to be a leader in this field with the most advanced new drug in development for patients with sickle cell disease."
"During the quarter, we also announced positive preliminary data from a Phase 2 study of AIR001, which we believe support further clinical development in pulmonary hypertension, and our plans to support multiple, institution-sponsored studies of AIR001 in PH associated with left heart disease."
Upcoming News and Events
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Phase 2 Study (heart failure): submit protocol to FDA
Q4 2014
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Nonclinical Study (heart failure): data
Q1 2015
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Nonclinical Study (embolic stroke): data
Q2 2015
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Phase 2 Study (heart failure): initiate enrollment
1H 2015
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EPIC Extension Study (repeat exposure): initiate enrollment
1H 2015
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Phase 2a Study of AIR001 (WHO Group 2 PH): preliminary data
2H 2015
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Phase 2 Study (heart failure): interim safety analysis
2H 2015
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EPIC Study: complete enrollment
Q4 2015
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EPIC Study: top-line data
Q1 2016
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Phase 2 Study (acute limb ischemia): complete enrollment
2H 2016
Third Quarter 2014 Financial Results
The Company's net loss for the third quarter of 2014 was $7.9 million, or $0.06 per share (basic and diluted), compared to a net loss of $5.3 million, or $0.05 per share (basic and diluted), for the same period in 2013.
Research and development expenses for the third quarter of 2014 were $5.4 million, an increase of $2.3 million, or 74%, compared to $3.1 million for the same period in 2013. The increase was primarily due to a $1.6 million increase in external clinical study fees and expenses, and a $0.4 million increase in personnel costs.
The $1.6 million increase in external clinical study fees and expenses was due primarily to an increase of $1.1 million related to the EPIC study, an increase of $0.3 million related to our Phase 2 study of MST-188 in acute limb ischemia (ALI), and an increase of $0.1 million related to the wind-down of the phase 2 studies of AIR001 in pulmonary arterial hypertension (PAH). The increase in personnel costs resulted primarily from severance expenses related to the departure of Dr. Vetticaden, the Company's former Chief Medical Officer.
Selling, general and administrative expenses for the third quarter of 2014 were $2.5 million, an increase of $0.3 million, or 14%, compared to $2.2 million for the same period in 2013. The increase resulted primarily from an increase in personnel costs.
Year-to-Date Financial Results
The Company's net loss for the nine months ended September 30, 2014 was $21.4 million, or $0.19 per share (basic and diluted), compared to a net loss of $15.8 million, or $0.23 per share (basic and diluted), for the same period in 2013.
Research and development expenses for the nine months ended September 30, 2014 were $14.5 million, an increase of $5.1 million, or 55%, compared to $9.4 million for the same period in 2013. The increase was primarily due to a $2.7 million increase in external clinical study fees and expenses, a $1.2 million increase in external nonclinical study fees and expenses, and a $1.0 million increase in personnel costs.
The $2.7 million increase in external clinical study fees and expenses was due primarily to an increase of $2.7 million related to the EPIC study, an increase of $1.0 million related to our Phase 2 study of MST-188 in ALI, and an increase of $0.8 million related to the wind-down of the AIR001 studies in PAH, offset by a decrease of $1.8 million related to the thorough QT/QTc clinical study of MST-188 that we completed in 2013. The $1.2 million increase in external nonclinical study fees and expenses is primarily due to an increase of $0.9 million in research-related manufacturing costs for MST-188 and an increase of $0.3 million for research-related manufacturing costs for the wind-down of the AIR001 studies in PAH. The increase in personnel costs resulted primarily from additional clinical and research-related manufacturing staff hired after the first half of 2013 and severance expenses related to the departure of Dr. Vetticaden.
Selling, general and administrative expenses for the nine months ended September 30, 2014 were $7.1 million, an increase of $0.7 million, or 11%, compared to $6.4 million for the same period in 2013. The increase resulted primarily from an increase in personnel costs and consulting expenses.
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, 2014, the Company had cash, cash equivalents and investment securities totaling $43.1 million. Stockholders' equity amounted to $45.2 million as of September 30, 2014.
