BioXcel Therapeutics Inc To Host Investor Call Transcript

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

Question: Raghuram Selvaraju - H C Wainwright & Co LLC (Pre-Merger) - Analyst : Thanks very much for taking my questions, and congratulations on this data. Very important landmark development for the company. Just wanted to ask about what your current thinking is regarding the FDA stance with. respect to the at-home setting, particularly as the agency looks at ease of use in the. at-home context. If you can highlight for us any practicable differences with respect to at-home administration. of this product versus the institutional setting.

Question: Raghuram Selvaraju - H C Wainwright & Co LLC (Pre-Merger) - Analyst : Thanks so much. And then maybe can you comment at this juncture on, based on the strength of the data so far, based on existing familiarity with the 120-microgram dose, how are you thinking about commercialization. options at this point in time? And have there been any developments in your thinking on that front as you look at the. U.S. market, in particular in the context of the previous commercial history with BXCL501?

Question: Raghuram Selvaraju - H C Wainwright & Co LLC (Pre-Merger) - Analyst : Great. And then lastly, I just wanted to ask about, as you are thinking about future indications. for 501 beyond the schizophrenia and bipolar disorder context, and especially within the. context of treatment of acute agitation episodes in patients with dementia, maybe you can. comment for us on not only the ramifications for future development coming from the SERENITY. At-Home Study and being able to define safety in this at-home population and what implications. that might have for the future clinical development path of this asset in the dementia population. with acute agitation, but also the FDA's stance as it has pertained so far to EGALMI. and the EGALMI-BXCL501 in the nEURpsychiatric setting and how that provides a potential. template for the cost-effective development of 501 in the future in dementia patients.

Question: Raghuram Selvaraju - H C Wainwright & Co LLC (Pre-Merger) - Analyst : Thank you so much and congratulations again.

Question: Sumant Kulkarni - Canaccord Genuity Corp - Analyst : Good morning. Nice to see the data, and thanks for taking our questions. I have three questions, two for the company and one for Dr. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 27, 2025 / 12:00PM, BTAI.OQ - BioXcel Therapeutics Inc To Host Investor Call Crystal. I'll start with the one for Dr. Crystal first. In real-world use cases, at what point in an agitation episode do you think it would. be optimal for a patient to use this product, and what percentage of agitated patients that. present themselves to you would you prescribe this product for?

Question: Sumant Kulkarni - Canaccord Genuity Corp - Analyst : Thanks for that perspective. So now for the company, how closely do these data conform to the alignment that you've. reached with the FDA, and what do they mean for your confidence to get a supplemental. new drug application for at-home use approved by the FDA? And second, we see the percentage of adverse events involving somnolence go down over repeat. dosing. Why do you think that happens, and do you have any initial thoughts on how efficacy. might trend with repeat dosing?

Question: Samir Devani - RX Securities Ltd - Analyst : Hi guys, thanks for taking my questions. Congratulations on the strong safety data set. I guess I've got maybe 3 questions. Just we've given us the average number of. Episodes. I'm just wondering what was the maximum number of repeat doses that occurred and is there any concern about potential misuse or abuse? That's the first question. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 27, 2025 / 12:00PM, BTAI.OQ - BioXcel Therapeutics Inc To Host Investor Call

Question: Samir Devani - RX Securities Ltd - Analyst : That's great. And sorry. Did any patient try to cut the dose in half?

Question: Samir Devani - RX Securities Ltd - Analyst : Okay. And then maybe a question for Dr. Kristol. Just in terms of trying to assess the sort of real-world uptake, I'm just trying to think. about factors that may influence that uptake. And I guess things like driving restrictions, would that be a potential factor that would. influence uptake? And what other factors could you consider?

Question: Samir Devani - RX Securities Ltd - Analyst : Okay, that's great. And then just one final question for the company. Obviously, I appreciate that you're assessing your options, commercial options from here, but just maybe to give us a flavor of what might be required. What sort of infrastructure do you perceive being required to market this in the U.S.?

Question: Samir Devani - RX Securities Ltd - Analyst : That's great, thanks very much.

Question: Alec Stranahan - Bofa Merrill Lynch Asset Holdings Inc - Analyst : Hey, guys. Thanks for the data, and thanks for the questions. Just a couple from me. I guess first, looking to the efficacy readouts later this year, I know you looked at CGII. and SERENITY three Part one, which actually showed us that significant improvement over placebo. Curious whether you'd expect an even larger separation here in SERENITY at home, given. the higher dose, and any, I guess, similarities, or is SERENITY three maybe not the best comparator. for what we should expect in the next readout? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 27, 2025 / 12:00PM, BTAI.OQ - BioXcel Therapeutics Inc To Host Investor Call Out.

Question: Alec Stranahan - Bofa Merrill Lynch Asset Holdings Inc - Analyst : Okay. Okay, that's helpful. And then one more on somnolence. It looks like the placebo rate was actually, you know, meaningfully higher than in SERENITY. one and two, in SERENITY at home. Do you think this is a difference in how, you know, it was reported between the two. studies, or maybe more due to patient characteristics in the at-home versus institutional setting?

Question: Alec Stranahan - Bofa Merrill Lynch Asset Holdings Inc - Analyst : Okay, got it. Thank you so much.

Question: Sumant Kulkarni - Canaccord Genuity Corp - Analyst : Thanks for the follow-up. I have two. So in your latest 10Q, you revealed that you are running a 30-patient informant-tied trial. to evaluate correlation between patient information measures and the PEC score. Is there a way you could handicap the chance of seeing what might be considered an intuitive. result on that trial?

Question: Sumant Kulkarni - Canaccord Genuity Corp - Analyst : And the last one is actually a bit of a bigger picture, almost strategy-like question. Given how much artificial intelligence appears to be intertwined in the company's DNA, with this data set, do you expect to use your engine to generate any, maybe, counterintuitive results or anything like that, or anything that might generate new. intellectual property?