BioXcel Therapeutics Inc Q4 2020 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : I have a couple. So at your recent key opinion leader event, it seemed like there was a consistent theme that the real opportunity for 501 seems to be an at-home use setting. At least initially, your product will be used in a caregiver setting. So specifically, what steps do you need to take to bring the product home from a regulatory perspective? How soon after approval in the first indication might you be able to achieve that goal? And would that meaningfully change your commercial infrastructure needs? That's the first question. The second one is given the recent developments in the dementia-related psychosis space, do you have any specific plans with respect to the potential use of 501 in the DRP setting, either on an episodic or sub-chronic basis?

Question: Jin Law - UBS Investment Bank, Research Division - Analyst : This is Rich calling in for Colin. A couple of questions from us. So I want to get some more clarity regarding the 40-mcg dose at the -- for dementia, especially how that relates to at-home setting. Would that be included in the pivotal Phase III trial only if you're able to get into the at-home setting now? Or would that be sort of a separate study in the future? And then another question from us is that regarding the 65-year, older patients for schizophrenia and bipolar disorder. What is the expected label scenario for that? Would there be a warning regarding that population? Or would there be any usage difference in terms of the dose level or the frequency? Yes. So I just want to get some idea on that.

Question: Jin Law - UBS Investment Bank, Research Division - Analyst : Yes. So just kind of another follow-up on that. So your 40 mcg data may come after your initiation of the Phase III. I just want to see like how that timing is going to influence what those are you going to be including in the Phase III. Are you going to be doing 3 doses? Or are you going to do 2 and maybe add the 40 later on?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : So as 501 gets closer and closer to the market, and as you think about expanding your franchise and agitation especially as you go into some chronic settings, how are you thinking about the potential for tachyphylaxis and/or tolerance of Dex? While we know that IV Dex is a very different dosing ballgame versus something worked on. But are you aware of any limiting maximum number of doses of the Dex spin per month or per year to treat episodes of agitation on an acute basis?