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Acasti Announces Fourth Quarter And Fiscal Year Results

Stocks in this article: ACST APO

The year-over-year decline in adjusted EBITDA was driven by the higher R&D expenses described above. 

The higher net loss over the prior year was largely due to expense increases related to depreciation and amortization, stock based compensation and R&D.  

"Over the past year, we continued to strengthen our business, and focus our efforts on moving closer to securing regulatory approval for our investigational new drug candidate, CaPre®," said Pierre Lemieux, Acasti's Chief Operating Officer. "We actively advanced our research and clinical development program, secured a manufacturing agreement for CaPre® clinical material, successfully completed a major financing and defended and strengthened our intellectual property. These successes are a testimony to our commitment to lay the groundwork for future growth and create sustained shareholder value by further positioning Acasti as a leader in pharmaceutical grade omega-3 phospholipids. There remain a number of important milestones ahead. However, with the encouraging results seen to date, a strong team, a solid balance sheet and a firm drive to succeed, we are well positioned to seize the opportunities before us."

Clinical Trials

Phase II TRIFECTA Trial

The number of targeted patients evaluable as per protocol has been reached. Acasti is currently evaluating the efficacy and safety of CaPre® for the treatment of patients with mild to severe hypertriglyceridemia, which is the primary objective of the study. The secondary objective of evaluating if statistically significant efficacy was reached in patient populations with mild to moderate (triglyceride levels ranging from 200 to 499 mg/dL) and severe hypertriglyceridemia (triglyceride levels over 500 mg/dL) will also be assessed separately. Based on patient information currently available, the Corporation does not believe the sample size is large enough to conclude the efficacy of CaPre in treating severe hypertriglyceridemia as part of the TRIFECTA trial. Based on literature, Acasti does not expect the FDA to request efficacy data on patients with severe hypertriglyceridemia before granting permission to conduct a Phase III trial. Acasti is targeting trial completion by the end of the second quarter of calendar 2014 and results will be available at a future date yet to be determined.

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