Stock Update (NYSEMKT:MSTX): Mast Therapeutics Inc Reports Fourth Quarter And Full Year 2015 Financial Results


Mast Therapeutics Inc (NYSEMKT:MSTX), a biopharmaceutical company developing novel, clinical-stage therapies for sickle cell disease and heart failure, today reported financial results for the fourth quarter and year ended December 31, 2015.

“Last month we announced that we had completed patient enrollment in our Phase 3 study of vepoloxamer in sickle cell crisis, known as the EPIC study. The study was conducted in 14 countries at more than 75 sites and is the largest placebo-controlled study in sickle cell disease ever concluded. It was a monumental effort to finish enrollment as quickly as possible and I commend the clinical investigators, the patients, and their families for this important achievement,” stated Brian M. Culley, Chief Executive Officer. “Vepoloxamer remains the most clinically-advanced new drug in development for sickle cell disease and we look forward to seeing the top-line results of the EPIC study in the second quarter of 2016.”

“We also recently announced positive data from a Phase 2a study of AIR001 in patients with heart failure with preserved ejection fraction conducted at Mayo Clinic,” continued Mr. Culley. “In this blinded and placebo-controlled study, AIR001 showed a statistically significant improvement in pulmonary capillary wedge pressure during exercise, the pre-specified primary endpoint, and attenuated other hemodynamic derangements of cardiac failure that occur during exercise in HFpEF patients. We look forward to initiation of the next Phase 2 study of AIR001 in the third quarter of this year, a 100-patient multi-center trial to be conducted at the premier clinical centers that make up the Heart Failure Clinical Research Network.”

Fourth Quarter 2015 Operating Results

The Company’s net loss for the fourth quarter of 2015 was $10.2 million, or $0.06 per share (basic and diluted), compared to a net loss of $7.3 million, or $0.05 per share (basic and diluted), for the same period in 2014.

Research and development (R&D) expenses for the fourth quarter of 2015 were $7.2 million, an increase of $2.3 million, or 45%, compared to $4.9 million for the same period in 2014. The increase was due mainly to increases of $0.9 million in external nonclinical study fees and expenses related primarily to research-related manufacturing costs for vepoloxamer ($0.4 million) and nonclinical toxicology studies of vepoloxamer to support a vepoloxamer NDA submission ($0.4 million), $0.9 million in external clinical study fees and expenses related primarily to EPIC study costs ($0.5 million) and costs for the Phase 2 study of vepoloxamer in heart failure ($0.4 million), and $0.4 million in personnel expenses.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2015 were $2.5 million, an increase of $0.1 million, or 5%, compared to $2.4 million for the same period in 2014.

Year-to-Date Operating Results

The Company’s net loss for the year ended December 31, 2015 was $39.8 million, or $0.25 per share (basic and diluted), compared to a net loss of $28.7 million, or $0.23 per share (basic and diluted), for the same period in 2014.

R&D expenses for the year ended December 31, 2015 were $28.3 million, an increase of $8.9 million, or 45%, compared to $19.4 million for the same period in 2014. The increase was due to increases of  $5.1 million in external nonclinical study fees and expenses, $2.9 million in external clinical study fees and expenses, $0.7 million in personnel costs and $0.2 million in share-based compensation expense.  The increase in external nonclinical study fees and expenses resulted primarily from research-related manufacturing costs for vepoloxamer ($2.9 million), nonclinical toxicology studies of vepoloxamer to support a vepoloxamer NDA submission ($1.8 million) and consulting fees for NDA-readiness activities related to vepoloxamer ($0.4 million).  The increase in external clinical study fees and expenses was related primarily to increases in EPIC study costs ($3.3 million) and the Phase 2 study of vepoloxamer in heart failure  ($0.9 million), offset by decreases in costs for the discontinued Phase 2 study of vepoloxamer in acute limb ischemia ($0.8 million) and AIR001 clinical study expenses ($0.5 million).  The increase in personnel costs resulted primarily from additional regulatory, clinical operations and research-related manufacturing staff hired in 2015.

SG&A expenses for the year ended December 31, 2015 were $11.0 million, an increase of $1.5 million, or 16%, compared to $9.5 million for the same period in 2014. The increase resulted primarily from increases in consulting expenses and personnel costs. (Original Source)

Shares of Mast Therapeutics closed last Friday at $0.28. MSTX has a 1-year high of $0.60 and a 1-year low of $0.21. The stock’s 50-day moving average is $0.32 and its 200-day moving average is $0.41.

On the ratings front, Mast Therapeutics has been the subject of a number of recent research reports. In a report issued on February 23, Maxim Group analyst Jason McCarthy reiterated a Buy rating on MSTX, with a price target of $5, which implies an upside of 1701.8% from current levels. Separately, on February 1, Canaccord Genuity’s John Newman reiterated a Buy rating on the stock and has a price target of $3.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and John Newman have a total average return of -11.9% and -18.7% respectively. McCarthy has a success rate of 30.7% and is ranked #3593 out of 3724 analysts, while Newman has a success rate of 22.6% and is ranked #3717.

Mast Therapeutics Inc is a biopharmaceutical company. The Company is engaged in developing novel therapies for serious or life-threatening diseases with unmet needs. Its pipeline includes MST-188 development programs in adjunctive thrombolytic therapy.