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Acasti Pharma awaiting business review outcome after CaPre drug trial disappointment

TRILOGY 2 study on CaPre did not meet its primary endpoint CaPre was a krill-oil derived prescription drug designed to treat hypertriglyceridemia What Acasti Pharma does: Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) had been developing a krill-oil derived prescription drug called CaPre to treat hypertriglyceridemia (high levels of triglycerides in the blood), which is known to contribute to heart disease. However, in August last year, the company revealed that a TRILOGY 2 study on CaPre had not met its primary endpoint and said it would not file a New Drug Application with the US Food and Drug Administration. The group said it did not plan to conduct additional clinical trials for CaPre.  The company said in November, however, that it was still moving forward with analysis of its TRILOGY 2 Phase 3 trials of the drug CaPre in patients with severe hypertriglyceridemia. Acasti had emphasized that along with its clinical advisors, it plans to “complete the full data analyses” as contemplated in the Statistical Analysis Plan for TRILOGY 2, including the secondary and exploratory endpoints, and “the pooling of the data from TRILOGY 1 and 2.” Topline results from its Phase 3 TRILOGY 2 trial of CaPre saw a 30.4% average reduction in triglyceride levels among all patients receiving the drug, as compared to 30.5% in TRILOGY 1, and a 17.9% median reduction in triglyceride levels among patients receiving placebo at 12 weeks as compared to 27.5% in TRILOGY 1. In September, Acasti engaged Oppenheimer & Company Inc. to act as its financial advisor to assist in a business review aimed at enhancing shareholder value, the outcome of which is still being awaited. Potential options could include a merger, business combination or other strategic combination, the group has said, adding that there could be no assurance of a successful outcome. How is it doing: Acasti posted its fiscal third-quarter results to end-December 2020 on February 9, 2021.  The biopharma group said it believes it has enough cash to fund it through the review process, or at least for the next 12 months. As of the end of 2020, the company had cash of C$26.5 million compared to C$14.2 million at the end of March 2020. In the third quarter, research and development (R&D) expenses before depreciation, amortization and stock-based compensation expenses came in at C$620,000 compared to C$3.2 million for the three months ended December 31, 2019, mainly due to the reduction in research contracts and R&D activities, as well as a reduction in headcount. The net loss was C$3.2 million compared to a net loss of $12.1 million for the three months to December 31, 2019. Acasti’s second-quarter results, released in November last year, showed a net loss of US$6.1 million, or $0.06 per share, for the three months ended September 30, down from a loss of $21.2 million, $0.25 per share, in the same period of 2019. In September last year, Acasti said it had a hired seasoned executive in the healthcare and financial sectors, Brian D. Ford to be its chief financial officer. With over 30 years’ experience, the company noted that Ford had been responsible for developing business recovery strategies, negotiating M&A transactions, as well as managing quarterly and yearly accounting reports, Most recently, he was chief financial officer and senior business advisor at a private group of Ontario based medical clinics, including the largest chronic pain management practice in Canada, it added. Inflection points: Outcome of business review Update on final TRILOGY data What the boss says: In a statement with November’s second-quarter results, Acasti CEO Jan D’Alvise said: “We remain committed to maximizing value for our shareholders, and as previously disclosed, we are actively exploring and evaluating a range of strategic options. We have also taken a number of proactive steps to preserve our cash by reducing staff, discontinuing all commercialization activities and putting R&D activities on hold. This has resulted in certain one-time and non-cash charges as reflected in our financial statements this quarter.” He added: “While we continue to pursue strategic alternatives, we plan to complete the full data analyses for TRILOGY as contemplated in the Statistical Analysis Plan, including the pooling of the data from TRILOGY 1 and 2. As previously disclosed, we plan to provide an update on the final TRILOGY data when feasible.” Contact the author at jon.hopkins@proactiveinvestors.com

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