Acasti Pharma ACST Stock News

Acasti Pharma Inc (NASDAQ: ACST) is having an incredibly strong start to the trading session this morning, trading on gains of more than 18% just after the opening bell. The gains come after the company provided a fiscal year-end update, showing tremendous progress with regard to its key initiatives. Moreover, the company also announced a notice of allowance. Here’s what’s going on:

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ACST Stock Gains On Fiscal Year End Update

Acasti Pharma announced a fiscal-year end corporate update, providing key details with regard to its progress. Part of the update was the company’s financial results for the fiscal year.

In the report, ACST said that it had $34.4 million in cash, cash equivalents and market securities at the close of the year on March 31, 2019. The company said that as clinical activities start to decelerate, this should be enough funds to get it past the completion of its ongoing Phase 3 trials.

The funding is also expected to be enough for the company to continue to work on its NDA for CaPre, an application that is expected to be submitted mid-next year should the Phase 3 data prove to be positive.

ACST also informed investors that it is currently in talks with major pharma companies in key countries around the world. The goal of the talks is to find commercialization partnerships surrounding the potential commercial launch of CaPre. It is expected that these discussions will gain further momentum once the Phase 3 results are announced.

While the company’s current cash runway will get it past its Phase 3 results, Acasti Pharma said that its management is exploring several strategic, non-dilutive funding options to extend this runway.

In a statement, Jan D’Alvise, President and CEO at ACST, had the following to offer:

Fiscal 2019 was an eventful year for the Company as we achieved several key milestones related to our ongoing Phase 3 clinical trials, which remain on schedule and within budget. We recently announced that we had achieved 100% patient randomization in both TRILOGY clinical studies, and more than 60% of patients have now completed the trial.

As a result, we remain on track to report topline results for our primary endpoint of lowering triglycerides for TRILOGY 1 in December 2019, and for TRILOGY 2 in January 2020. In addition to our preliminary topline data, we will seek to present the full data set, which will include results for our key secondary and exploratory endpoints of interest such as LDL-C, VLDL, HDL-C and HbA1c, as a late breaker presentation at the American College of Cardiology meeting at the end of March 2020.

Progress In China

In a separate press release issued this morning, ACST said that it received a Notice of Allowance for its second patent to be awarded in the People’s Republic of China. The new patent will expand existing coverage and will remain valid through 2030.

In the release, the company said that the patent relates to concentrated therapeutic omega-3 phospholipid compositions. In particular, it covers certain methods for the treatment and prevention of cardiovascular diseases, metabolic syndrome, inflammation, neurodevelopmental and neurodegenerative diseases.

In a statement, Brian Groch, Chief Commercial Officer at Acasti Pharma, had the following to offer:

China represents an important market for Acasti, given the high prevalence of hypertriglyceridemia and the need for an effective, safe and efficiently absorbed drug for the treatment of cardiometabolic related diseases. The timing of this patent is ideal as we near completion of the TRILOGY Phase 3 clinical trials for CaPre and prepare for commercialization. This patent broadens our previously allowed claims in China, and provides us with solid, long-term protection there. This patent also builds upon similar patents we have been awarded around the world.

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What Do You Think?

What are your thoughts on ACST stock and the company’s progress over the past year? Join the discussion in the comments below!

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