Acasti Pharma Inc. (NASDAQ:ACST) has announced its second-quarter fiscal 2021 financial and operational results and also provided corporate updates.
Acasti’s TRILOGY 1&2 trials fail to meet the primary endpoint
Recently the company reported results of two Phase 3 clinical studies, TRILOGY 1&2, designed to evaluate the safety, tolerability, and efficacy of CaPre in hypertriglyceridemia patients. The company reported the topline trial results, which didn’t reach statistical significance and thus failed to meet the primary endpoint of triglycerides lowering. Interestingly the triglyceride-lowering in the CaPre arm was the highest reported compared to previous triglyceride reduction trials. But Acasti didn’t file an NDA for severe hypertriglyceridemia patients, and it is not planning to carry more CaPre clinical trials.
On September 29, 2020, Acasti announced the engagement of Oppenheimer &Co. Inc. as a strategic advisor to help the company in its strategic review process. The Advisor will consider possible strategic alternatives as part of the review, including but not limited to a business combination, mergers, or any strategic transaction that will involve Acasti or/and Capre.
Acasti considering various options to preserve cash
Among the initiatives the company adapted to reduced expenses and preserve cash is the reduction of headcount. Equally, the company resorted to discontinuing almost all commercialization and R&D activities as part of expense reduction and cash preservation. Acasti plans to commit significant resources and time in identifying and assessing strategic alternatives. Still, there is no assurance that it will enter transactions or agreements that will enhance shareholder value.
The company’s CEO, Jan D’Alvise, said that Acasti remains committed to optimizing shareholder value and, as indicated before it is exploring and evaluating several strategic options. D’Alvise said that the company had already taken proactive steps to reduce expenses and preserve cash by lowering bits headcount, discontinuing commercialization activities, and halting R&D activities. The moves resulted in some one-time and non-cash charges in Q2 2021. He added that the company plans to complete TRILOGY data analyses, which include pooling TRILOGY 1&2 data. The company ended the quarter with $11.6 million in cash and cash equivalents.