Acasti Pharma Inc. reported consolidated earnings results for the fourth quarter and year ended February 28, 2013. For the year, the company reported revenues from sale of CAD 724,196 against CAD 10,415 a year ago. Loss from operating activities was CAD 6,979,733 against CAD 6,512,842 a year ago. Net loss and total comprehensive loss was CAD 6,892,360 or CAD 0.09 per basic and diluted share against CAD 6,500,933 or CAD 0.10 per basic and diluted share a year ago. Net cash used in operating activities was CAD 2,548,892 against CAD 5,614,921 a year ago. Acquisition of intangible assets was CAD 103,068. Adjusted LBITDA was CAD 4,350,000 against CAD 4,481,000 for the prior year. For the quarter, the company reported revenues of CAD 49,000 compared to CAD 10,000 during the quarter ended February 29, 2012. Adjusted LBITDA was CAD 1,361,000 versus CAD 857,000 for the quarter ended February 29, 2012. Net loss was CAD 1,953,000 or CAD 0.03 per share versus CAD 1,547,000 or CAD 0.02 per share in the prior-year quarter. Sales of Onemia(TM) in the fourth quarter of fiscal 2013 were down from levels seen in the prior two quarters, largely due to a late third quarter purchase by a distributor, which resulted in lower fourth quarter sales. The company continues to make good progress on its two Phase II clinical trials, designed to evaluate the effect of different daily doses of CaPre(R) on patients with high to very high triglyceride levels. Patient recruitment for the open-label, dose ranging study (COLT) has now been completed and a final report is projected for this summer. Results for the double blind, placebo controlled study (TRIFECTA) are expected to be available during the first half of 2014.

Acasti Pharma Inc. announced encouraging preliminary clinical data of its "Randomized, Open-Label, Dose-Ranging, Multi-Center Trial to assess the Safety and efficacy of NKPL66 (CaPre®) in the treatment of mild-to-high hypertriglyceridemia" (Open-label). In the course of planning the strategy of its phase III clinical development with CaPre®, Acasti examined triglycerides data from its Open-label clinical trial. Data from 157 patients who have completed four weeks of treatment with 0.5, 1, 2 or 4 grams of CaPre® per day were assessed and CaPre® achieved a clinically important and statistically significant triglyceride reduction of up to 23% (p < 0.05) as compared to standard of care, after only a 4-week treatment. Moreover, a noteworthy trend indicating a dose-response relationship versus standard of care as well as clinically and statistically significant effects of doubling the doses of CaPre® were observed. It should also be noted that the study assesses the effectiveness of CaPre® in a real-life, routine - clinical setting since the standard of care may be any treatment the treating physicians considered as appropriate and included life-style modification as well as lipid modifying agents such as statins and fibrates, that most of the patients analysed (i.e. 86%) had baseline triglycerides between 200 and 500mg/dl (2.28 to 5.7 mmol/L) and that no serious adverse events were reported. To date, the results of this preliminary analysis suggest that CaPre® is safe and effective for the treatment of patients with triglyceride levels ranging from 200 to 500 mg/dL.

Acasti Pharma Inc. Presents at 25th Annual ROTH Conference, Mar-19-2013 08:00 AM. Venue: The Ritz-Carlton, 1 Ritz Carlton Drive, Dana Point, Laguna Niguel, California, United States.