Acasti Pharma Provides Business Update for the Second Quarter of Fiscal 2021

LAVAL, Quebec, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST) today provided a business update and announced its operating and financial results for the second quarter of fiscal 2021 ended September 30, 2020.

Recent Events:

TRILOGY 1 & 2 Topline Results. The Company’s two Phase 3 clinical trials, designated as TRILOGY 1 & 2, were designed to evaluate the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia. The top-line results were announced on January 13, 2020 and August 31, 2020 respectively, and neither TRILOGY 1 nor TRILOGY 2 independently reached statistical significance, and therefore they did not meet their primary endpoint for lowering triglycerides. Although the triglyceride reduction in the CaPre arm was one of the largest seen amongst previously conducted triglyceride reduction studies, the Company will not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe hypertriglyceridemia and does not plan to conduct additional clinical trials for CaPre.

Engaged Oppenheimer & Co. Inc. to Assist in Strategic Review. On September 29, 2020, the Company announced that it had engaged Oppenheimer & Co. Inc. as its financial advisor to assist in the strategic review process. Potential strategic alternatives that may be explored or evaluated as part of this review include, but are not limited to, a merger, business combination or other strategic transaction involving Acasti and/or CaPre. There is no defined timeline for completion of the review process.

Reduction in Headcount and Discontinuation of Substantially all Commercial and R&D Activities. The Company initiated a plan in September 2020 to reduce personnel and expenses to preserve cash and further reduce its operations consistent with the decision to discontinue substantially all commercialization and research and development activities. The Company expects to devote significant time and resources to identifying and evaluating strategic alternatives, however, there can be no assurance that such activities will result in any agreements or transactions that will enhance shareholder value.