BioXcel Therapeutics Inc To Discuss TRANQUILITY II Top-Line Results Call Transcript

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

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Congrats on the data. You certainly kept us all waiting. I'll give you my sort of my question and follow-up upfront. So I just wanted to touch on the 483. Can you talk about what gives you comfort that the findings won't impact your ability to seek approval on this data set? And then can you talk about if there's any other sites being inspected and why the inspection of the sort of the [named] site is still showing as open? And then maybe just as a follow-on point [to that], is the site, which is the focus of the 483 a major participant in TRANQUILITY III?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : That's really helpful. And just why it's still being considered as open?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : Okay. Great. This has been really helpful. And congrats again, guys, really great positive top line.

Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst : I wanted to get a sense of if you have an idea why you didn't see separation from placebo at 30 minutes? And then also, if you have any thoughts on what drove the outperformance in the placebo arm?

Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst : Got it. That's helpful. And one more, if I can. How should we think about the amount of data that you think is necessary to move forward with an sNDA in Alzheimer's given today's readout as well as upcoming TRANQUILITY III? And when could we get an update on your FDA interaction?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : So what's the earliest you can announce the results of an independent audit of the data? And do the audit results (inaudible) your ability to request interaction with the FDA to file? Asked another way, I guess, how confident are you in your ability to interact with the FDA in the second half on a potential path for NDA submission? And then I have a follow-up.

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : Got it. And then if we look at the trial results on the episodes, you had 443 episodes for 149 patients over a roughly 3-month period. That translates to about 3 episodes per patient in a 3-month period or about 1 episode a month. How does the frequency validation episodes compare to the number of episodes per month in the real world? And what average number of episodes per patient per year drive your multibillion-dollar market assessment? Unidentified Company Representative So maybe I would ask (inaudible). Unidentified Company Representative Yes. I'll jump in on this one because what we've seen in market research is that mild Alzheimer's dementia patients, on average, have about 3.4 episodes per month. Those with moderate Alzheimer's dementia who have agitation average about 10 episodes per month. So what you're seeing in a clinical trial may be very different than what we see in the real world.

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : I have 2. Were you surprised at all by one site contributing 40% of patients and what drove that still distributing on enrollment? And second, on the adverse events of special interest, how confident are you that the FDA's potential assessment of this benefit would utilize the same 24-hour cutoff period for events to be not attributed to the study drug?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : And how would the 40% enrollment at one site? What drove that distribution? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : And I'll sneak one in. So assuming that you are in a scenario where an sNDA is allowable based on TRANQUILITY II data, what then happens to your ongoing TRANQUILITY III trial? Or what would that be considered?