Acasti Pharma Inc. (NASDAQ:ACST) Q3 2023 Earnings Call Transcript

Prashant Kohli: Hi! Sure Jan. Hi Oren! Hey, you know as Jan mentioned, our strategy is multipronged to prime the market. You know obviously you know having a prime key opinion leader is very credible. Helping us in that process is very important, and then we believe we have a really robust scientific advisory board, prominent neural intensiveness from University of Texas in Houston, the largest neurocritical care site in the country with 75 neurocritical care beds. Barrow neuroscience, again, you know very prestigious, very prominent site as well, center as well, and really helping, you know using their systems to help you know recruit sites, high volume sites. You know really excited that local PIs at those sites is a big part of our strategy of priming the market.

The second part of it is, you know as part of conducting the actual study, having these high volume sites, both comprehensive and advanced stroke center is a combination of them. You know having them to gain experience, work and experience with GTX-104 versus oral, see the benefits of that. You know we strongly believe that will provide a great impetus when our product hopefully does get approved and launched, that they will become the early adopters. And in this market, as we have gotten closer to understanding the buying center if you will, you know with the P&T committee of a hospital, clinical champion and it’s a multi stakeholder decisions process. We believe that having winds behind our sale with having the earlier adopters, the key opinion leaders, the top leaders helping present at medical congress, we’ve identified a handful of those where in the intensive it’s the neurosurgeons, even the neuroscience nurses come together and having those thought leaders talk about our program, you know are all things that would really help drive product uptick.

And the last piece and the least is €“ last but not the least I mean is medical communication. Jan mentioned publication strategy, collecting pharmacoeconomic data and then being able to you know publish those in peer review journals is also prime to getting the market geared for the product and hopefully you know a solid uptick once it’s on the markets.

Oren Livnat: All right. And lastly if I may, I apologize for taking so much time. But on 101, are you still expecting with this full critical report in first half, the I guess you call it an exploratory pharmacodynamic €œefficacy€ look and will you share that with us?

A – Jan D’Alvise: Yeah, I’m going to turn that over to Pierre. Pierre, can you respond on that, because I’m not sure what this does

Pierre Lemieux : Yes, can you hear me?

Jan D’Alvise: Yeah.

Pierre Lemieux: Right. Hi Oren! Thank you for the question. Yeah, regarding GTX-101, we’re still planning together the final clinical report in May. But as you know we’ve announced the data, but now it’s a question of finalizing the report with all the bells and the whistles that €“ and QC-ing the report. So in terms of the €“ I think the PK data were reported and there were €“ we were comfortable to provide this update before Christmas. Regarding the PD, the pharmacodynamics, it’s a bit more complicated. Honestly, it was not a primary endpoint of this study. We’ve looked into some, I would say attempt to look at some micro dynamics, so using some bond free assessment. But we’ll be able to you know report a bit of that piece of data, but it’s €“ you know, I won’t €“ how can I say this €“ we’ve done this to really find the multiple ascending dose study, which will be the next step.

So I mean we’ll be sharing once we have the final report. What we believe is really I would say, relevant with the preparation of the multiple ascending dose. But it’s still part of the plan to communicate that information in due time, yes.