BioXcel Therapeutics Inc Q3 2023 Earnings Call Transcript

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

Question: Greg Harrison - Bank of America - Analyst : Good morning, guys. Thanks for the update. And for taking the question with respect to the 100 patient trial, can you give us some more color on the TRANQUILITY development strategy as of going for a broad label initially? And then what are the criteria for success in this trial and what would a positive trial look like?

Question: Greg Harrison - Bank of America - Analyst : Got it. And can you clarify whether you're able to use all of the data collected from TRANQUILITY II as part of their package.

Question: Greg Harrison - Bank of America - Analyst : Great.Thanks for taking the questions.

Question: Rag Selvaraju - H.C. Wainwright - Analyst : Hi. Thanks for taking my questions. I was wondering, first of all, if you could provide us with some additional context and clarity on what you expect to be the ultimate path forward for fiber I in chronic agitation and within what time line you expect to pursue this? And if we should be thinking about this as being something that you would look to target formally once you have and approval of the label in Alzheimer's associated acute agitation.

Question: Rag Selvaraju - H.C. Wainwright - Analyst : Okay. And then secondly, with respect to the Opioid Use disorder indication, do you have any additional information you can provide to us regarding the potential size of this market opportunity and maybe give us a sense of how you would expect 501 to potentially be deployed if it were to be approved on.

Question: Rag Selvaraju - H.C. Wainwright - Analyst : And lastly, if you can maybe comment on, you know, obviously, there's been some recent data that looks pretty positive for OnkosXcel. So can you give us a sense of, you know, on a qualitative basis and to what extent the availability of this clinical data might make it easier for you to either identify some kind of strategic partnership for seven oh one or indeed consummate spin out of OnkosXcel sell into a separate entity.

Question: Rag Selvaraju - H.C. Wainwright - Analyst : Thank you.

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : Good morning. Thanks for taking my questions and all the updates. So on your alignment with the FDA, did you specifically ask the agency about your ability to file on the basis of the TRANQUILITY II trial alone and asked another way, I guess, why did the company not choose to go with a more limited sNDA initially with the potential to expand the label further at some time? Or was that not possible because you're still interested establish a safety profile and order patiets?

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : Got it. And then is there a specific limit to the number of episodes that you can treat the four week period in this new trial to be considered an acute treatment? And how confident are you that the new at-home trial will not end up in a TRANQUILITY III like outcome where AD agitation is not really acute, chronic.

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : And then the last question before I jump back in the queue, is on the 73 program you now are allowed to go home with a 1,000 microgram dose. Could you just give us some color on what led did that and the discussions with the FDA around that, given it's higher than what you had contemplated in the past?

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : Thank you.

Question: Colin Bristow - UBS - Analyst : Good morning and thanks for the update, mainly just a point of clarification on the path forward in Alzheimer's agitation. I think I heard you say the company believes the TRANQUILITY II data can be used, but what did FDA specifically say about the miscibility of the data? Or will this still remain a review issue? And then on the additional study. Can you just know from the time lines of properties we're going to this is looking to be sort of 2025 readout and then certainly on the cash runway. And then on the cash runway, you're locked in Q2 you said your cash will get into mid '24. You've maintained that language. Is that simply because the updated agreement is finalized. More detail would be really helpful. Thanks.

Question: Colin Bristow - UBS - Analyst : Very helpful. Thank you.

Question: Robyn Karnauskas - Truist Securities - Analyst : Good morning and thanks for taking my questions. And I guess starting with the first one, I think before you said like the FDA like to up the dose in half for these asthma trials in what kind of conversations did you have that using the 60 milligram for and 60 microgram for the for the for the asthma setting for TRANQUILITY. Second question is at home. Can you update us on your thoughts on the number of potential doses that are in the market are episodes that you're going for at home and in the hospital setting or assisted living setting, like what is now the number that we should be thinking about? And then I have a follow-up.

Question: Robyn Karnauskas - Truist Securities - Analyst : Yes. I mentioned before you talked about how the FDA always wants to cut the dose when they go at home. And that's what you did with serenity and lower and what gives you confidence that you're using it and we wanted to have a high dose for and your trial that you did in this low data centers. And as you know, in our assisted living TRANQUILITY II program, we tested two doses, 40 micrograms and 60 micrograms. 60 microgram was statistically significant and it was well tolerated and we have a very clear safety profile established. And in TRANQUILITY I also, we had the data for the 60 microgram. So that does we want to test in a home setting because it's clearly establish data efficacy and safety profile to drug. Rob would like to add anything? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 14, 2023 / 1:00PM, BTAI.OQ - Q3 2023 BioXcel Therapeutics Inc Earnings Call

Question: Robyn Karnauskas - Truist Securities - Analyst : Would you get other variations like patients that are not completely diagnose a lot of patients are seem to have Alzheimer's, but maybe they have other kinds of dementia with that is something I read in your press release like assumed Alzheimer's that that might be upside to the opportunity. And then on the financing question, maybe talk a little bit about how you're thinking about Pryor, focusing on future development for Serenity once you get the final minutes back versus TRANQUILITY versus, say, monetizing 701 like I guess you have to prioritize one given your cash position. How are you thinking about?

Question: Robyn Karnauskas - Truist Securities - Analyst : Great. Thank you.

Question: Graig Suvannavejh - Mizuho Securities USA - Analyst : Thanks for taking my questions. And a couple if I could. Just with respect to the comments around long-term safety requirements, I'm just wondering in support have an sNDA in the AD agitation setting, what is your current expectation or and what you'll need? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 14, 2023 / 1:00PM, BTAI.OQ - Q3 2023 BioXcel Therapeutics Inc Earnings Call I guess, and the question is beyond the 100 patient four week study, is there a current thinking that you will need additional long-term safety in order to support and sNDA momentum. A follow-up question, if I could. Just on the current OpEx. I think it came in significantly higher than we were expecting. And given the current turnover, wondering how we should anticipate OpEx to evolve in the fourth quarter and the first half of next year thing.

Question: Graig Suvannavejh - Mizuho Securities USA - Analyst : Great. And if I could ask maybe just one follow-on J code. How how should we expect that how that might impact the trajectory of account sales.

Question: Graig Suvannavejh - Mizuho Securities USA - Analyst : Thank you.

Question: Corinne Jenkins - Goldman Sachs - Analyst : I guess just a couple from us. When do you anticipate that you're going to be able to finalize these protocols and initiate the at-home study for TRANQUILITY? And based on one of your prior answers, will these all be new trial sites that you need to enroll? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 14, 2023 / 1:00PM, BTAI.OQ - Q3 2023 BioXcel Therapeutics Inc Earnings Call And then, on the TRANQUILITY point, you guided, I think, for 100 patients in that study, but it comes that you've yet to determine the primary endpoint that you'll be evaluating. So how did you come up with that guidance number of fusions required and could it evolve as you determine that critical?

Question: Corinne Jenkins - Goldman Sachs - Analyst : Okay. And then as you think about this extended agreement with Oaktree and QIA., how do you think about are we taking on additional debt versus and taking capital through the equity merger?

Question: Corinne Jenkins - Goldman Sachs - Analyst : Yes. Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 14, 2023 / 1:00PM, BTAI.OQ - Q3 2023 BioXcel Therapeutics Inc Earnings Call

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : You have to so you mentioned it's easier to conduct a trial at home because of the lack of I think you used the term helicopter in the CRO, but would the burden of ensuring safety in the patient at home not be greater relative to a more marked monitored setting and how real time will feed back to the company be based on safety based events in the new Phase 3 trial.

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : And then we understand that the FDA could only opine on the data that you have in hand with TRANQUILITY II as part of a review, but did did the agency specifically say that only this one additional trial would be required to submit an sNDA or you won't require more efficacy trials.

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : And last one, I'll squeeze one in is this trial going to have a Part one In part two like SERENITY trial?

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : Thanks for the clarification.