BioXcel Therapeutics Inc Corporate Analyst Meeting Transcript

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

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : Thanks. Thank you and thank you, everyone, for being here and tuning into the webcast. We do have a mic going around, so please feel free to raise your hands to ask a question. Don't be shy. Thank you also to the distinguished panel -- panelists here. I'm going to kick it off with the one kind of big picture question. We've heard a lot about why 501 or Dex in its format that BioXcel is trying to commercialize eventually is good. But is there anything in Precedex as a molecule itself or this formulation that might want you to not make this -- not use this product in the patient indication that you might be going after?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : Actually, a couple of questions here for Dr. Fava because he has to leave. But you mentioned that a large percentage of patients already experience delirium when they're in the ICU. So what prevents use of IV Dex? Because it should be relatively simple to use in that setting. But you mentioned that a large percentage of patients already experience delirium when they're in the ICU. So what prevents use of IV Dex? Because it should be relatively simple to use in that setting. What would make a sublingual formulation (inaudible)?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : And given you are so much in the know on use of Dex, it doesn't take too much convincing for you. But what do you think needs to happen for wider practices to adopt Dex?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : And this was something that I was planning to ask last -- but given you have limited time, I'm going to ask you upfront anyway. Payers and pricing are in the public eye for better or worse. How do you think that might influence the use of Dex in like -- in the ICU setting if there is a new branded product approved there?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : If you have any questions for Dr. Fava, please raise your hands. I'll ask a general question now. Let's start with Dr. Petrakis because we've seen Dex. We've seen the label for IV Dex. Now granted that could be a very different situation, but how do you see the potential for Dex to have any kind of drug-drug interactions? Especially given that patients in either the opioid use withdrawal indications or the others that are already on various other "drugs'? Ismene Petrakis So I don't know. Are you saying specifically about the IV formulation or just in general?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : For Dr. Preskorn, you mentioned the vignettes there which involving bourbon, how would alcohol infractions and things like that -- any special studies that might need to be done there with this formulation? without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. MAY 22, 2019 / 12:30PM, BTAI.OQ - BioXcel Therapeutics Inc Corporate Analyst Meeting

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : I'll move on to a specific question on dementia here. Now these product, 501, is going to be a rescue treatment for the most part. But we are aware of other drugs in development for dementia that is psychosis or treating agitation. How do you think that SQ treatment -- or the landscape for SQ treatment might change if other drugs are approved more as chronic treatment?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : So I'm going to ask almost a few investor-type questions and make our lives easier here from a modeling perspective. So if you go at each of these indications and you look at the patient profile here, how many times do you think an average patient might need to use this film in, let's say, the schizophrenia, bipolar disorder setting or dementia or in opioid use withdrawal in a given year? Any averages or medians you might [care to share there]?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : And Dr. Preskorn, you brought up an interesting point. You said potentially making use. If you look at again, the intravenous label that's out there for the approved Precedex, there is -- I think they used the word tolerance for dexmedetomidine. Is there any potential to develop a tolerance for this drug if used in a different formulation?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : And then moving on to the setting of use. For the most part, again, this is probably going to be used where a care provider is present. What about the potential for a film of Dex to be allowed for at-home use? And how do you see that evolving? Are there any roadblocks that you might see in getting that in the homes? without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. MAY 22, 2019 / 12:30PM, BTAI.OQ - BioXcel Therapeutics Inc Corporate Analyst Meeting

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : On the opioid withdrawal side, clearly, this is not a new mechanism of action, as you mentioned. So what might you consider might be the biggest hook for the use of a film in that setting? Ismene Petrakis So first of all, it's the action of the medication that causes left leg hypertension, for example, like clonidine and more effective, that would all be a big [sell]. I mean film is quite appealing in this population. So the * SUBOXONE or buprenorphine that's the way it's given. It's in a film preparation. And if people feel nauseous, they aren't going to swallow pills. Like you mentioned, with the geriatric patients, that might be -- a flushed IV is unlikely to be used in these settings. First of all, most people, they may not need it. Second of all, if you're talking about an IV drug user, they may have limited access to a vein. So a medication that can be administered in another route is a real plus.

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : Yes. Is there anything that you see that the agency might raise its eyebrows on? without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. MAY 22, 2019 / 12:30PM, BTAI.OQ - BioXcel Therapeutics Inc Corporate Analyst Meeting

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : So a risk-benefit ratio. So we have a good sense of what the competitive landscape is on the withdrawal symptoms side, but if you look at agitation as such that there aren't really a whole lot of treatments out there, Dr. Grossberg, you mentioned you might add a pipeline slide. But are you aware of any other products that might go head-to-head versus a 501 film on the agitation side that might be making it to the market around the same time or a little after?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : And then just delving a little bit into the detail BioXcel has on the product so far. We are heading into a Phase II here in schizophrenia and bipolar disorder indication. But given what you've seen so far, what would you say would be the most impressive or not characteristics of the data that are out there that have been generated by the company on the 501 film specifically or in the bridging studies?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : Do we have a formulation question on peanut butter here? without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. MAY 22, 2019 / 12:30PM, BTAI.OQ - BioXcel Therapeutics Inc Corporate Analyst Meeting

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : So clearly, I mean, it can be you'd have it in a wide variety of indications, not just the ones that you are speaking on today. So if you were look at other indications that something like this might be useful for a neuro setting, what would those be?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : We're almost out of time here, so speed in [absorption]. You touched upon data [and the base]. But for products like 501, especially if it's used in [GI] setting, do you think it would be reimbursed as a pharmacy benefit or procedure benefit? And would that make any difference in potential [to be used]?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Limited, Research Division - Analyst : With that, I would turn it back to Vimal.