“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.
Acasti Pharma 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.”
This is probably the single most dreaded press release any biotech or pharma company could fear to announce.
But that doesn’t mean that the show is over. This time, the science simply didn’t turn out as the company had planned, as both of their two Phase III clinical trials flopped.
The trials designated as TRILOGY 1 & 2, were designed to evaluate the efficacy, safety, and tolerability of CaPre in patients with severe hypertriglyceridemia.
Acasti’s lead product candidate was CaPre (omega-3 phospholipid), intended for the treatment of severe hypertriglyceridemia, a condition characterized by abnormally high levels of triglycerides in the bloodstream.
According to the company, Omega-3 fatty acids have extensive clinical evidence of safety and efficacy in lowering triglycerides in patients with hypertriglyceridemia.
Market research conducted by the company suggests there is an urgent market need for an effective, safe, and well-absorbing omega-3 therapeutic with a positive impact on the major lipids associated with cardiovascular disease risk.
However, that’s all now history as the company needs to pivot into something else.
They’ve cut headcount and seized all commercial and R&D activity.
Cash is low, the stock has been killed, shareholders are furious, and the management needs to find a new direction by merging, through a reverse takeover (RTO), or any other strategic transaction. All while Nasdaq is breathing down their necks, threatening with a delisting.
They’ve got until May 10, 2021, or until the cash runs out.
Acasti Pharma’s Latest Price Action
January 13, 2020 – TRILOGY 1 Press Release –“Both the placebo and CaPre study groups experienced significant reductions in triglycerides within the first four weeks from baseline, and even though the difference at 12 and 26 weeks was in favor of CaPre, due to the unexpectedly large placebo response, TRILOGY 1 did not reach statistical significance.”
August 31, 2020 – TRILOGY 2 Press Release – “The unadjusted, placebo corrected triglyceride reduction of 12.4% achieved a “p” value of 0.19, which was not statistically significant, and therefore the TRILOGY 2 study did not meet its primary endpoint.”
Although the triglyceride reduction in the CaPre arm was one of the largest seen amongst previously conducted triglyceride reduction studies, it wasn’t enough to push forward.
The stock is now over -90% down from its year-to-date (YTD) trading value.
There are presently around $1 million, or 3.12% of $ACST’s stock, in the hands of institutional investors. The top three institutional holders are:
- RENAISSANCE TECHNOLOGIES LLC with ownership of 962,593;
- TWO SIGMA ADVISERS, LP, holding 364,400 shares of the stock; and
- OXFORD ASSET MANAGEMENT LLP, currently with $65000.00 in ACST stock.
As of June 2020, Acasti Pharma had cash of $12M and no debt.
Importantly, its cash burn was $21M over the previous twelve months. That means it had a cash runway of around 7 months as of June 2020.
It is not uncommon that biotech stocks like this resurrect, it’s rare, but it happens. Especially when the company was so close. Acasti Pharma (NASDAQ: $ACST) was really on to something, both in terms of market need and product.
It’s not over until the fat lady sings.