BioXcel Therapeutics Inc Q4 2023 Earnings Call Transcript

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

Question: Greg Harrison - Bank of America - Analyst : Hey, good morning guys. Thanks for taking my questions. So after your recent FDA meetings, it seems you have more clarity for the TRANQUILITY programs. Would you say now you have two separate path to SNDA and Alzheimer's one in the CARE study and one at-home? And then how are you thinking about funding the program and the company as a whole as you get closer to the end of your cash runway is, are there any specific avenues that you're exploring? Thanks

Question: Greg Harrison - Bank of America - Analyst : Great. Thanks again.

Question: Robyn Karnauskas - Truist Securities - Analyst : Thank you for taking my questions. So I have two to after the recent meetings with the FDA, you've chosen the 120 milligram dose that and does that mean that would allow for expansion and at-home setting as a follow for that? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 12, 2024 / 12:00PM, BTAI.OQ - Q4 2023 BioXcel Therapeutics Inc Earnings Call

Question: Robyn Karnauskas - Truist Securities - Analyst : And following up on that a little bit. So you'll give them a minute. Have you spoken to the FDA clearly about that dose and you'll give them a little later point.

Question: Robyn Karnauskas - Truist Securities - Analyst : Okay. Then last question, sorry for three that's bad, like funding the program like Vimal, like how do you think about you have a lot going on you talked about like give a lot of options. How do we think about and this assay, you know, you have to find a lot of these programs are giving you feedback title How do investors think about the FastClick? What actually how do you think about the options on the table for you?

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

Question: Graig Suvannavejh - Mizuho Securities - Analyst : Hey, good morning. Thanks for taking my questions and for the clarity on two, please for me, I don't know if the first one was already asked. My apologies just on the on TRANQUILITY at-home or just the TRANQUILITY program overall that pivots to needing to collect and now efficacy data, can you tell us kind of what changed versus a previous plan just to focus on study on safety. And then secondly, while I realize that you've got to figure out the financing for the company on a go forward basis, I'm just trying to get a sense of whether you can provide us clarity around how much you think it might take to get to complete TRANQUILITY at home in order to be able to get it in a position to be able to file an SNDA. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 12, 2024 / 12:00PM, BTAI.OQ - Q4 2023 BioXcel Therapeutics Inc Earnings Call And similarly, what you think that total cost would be for completing the SERENITY program, it's just important just to in light of your current cash just to for investors to know what more funds you need to get to really the next revenue inflection point. Thank you.

Question: Graig Suvannavejh - Mizuho Securities - Analyst : Okay. Thank you vimal.

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : Morning. Thanks for taking my question. So you mentioned in your prepared remarks that for labelling purposes, the limitation of use is over a 24 to 48-hour period and you need to generate more data over three months. And when you're doing so what's the risk that you might find that agitation is not necessarily episodic? And in that case, you still think you might pursue Fiber One as a rescue therapy.

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : And then my follow-up is a financial question, what do all the latest updates mean with respect to your ability to be in line with the covenants associated with the prior financing? Or will you need to reverse those again?

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

Question: Ram Selvaraju - H.C. Wainwright - Analyst : Thanks very much for taking my questions. Can you hear me?

Question: Ram Selvaraju - H.C. Wainwright - Analyst : Okay. So I just wanted to see if you could offer some clarity whether quantitative or qualitative regarding the paused study and how much data from that study that was collected before it's paused. You expect it to be usable in furtherance of the development plans for 501.

Question: Ram Selvaraju - H.C. Wainwright - Analyst : With respect to whatever information was collected on the activity profile, is any of that information likely to be useful in potentially offsetting future development costs? Or I'm just trying to ascertain to what extent you have to recapitulate anything if indeed you do.

Question: Ram Selvaraju - H.C. Wainwright - Analyst : Okay. And then just really quickly, do you have any updates on your plans for [OncoSec Cellectis] this time? Thank you.

Question: Ram Selvaraju - H.C. Wainwright - Analyst : Thank you very much.

Question: Colin Bristow - UBS - Analyst : Hey, Good morning guys. And thanks for the updates on where you put it sort of piggybacking on a few of the questions that would be nice. Firstly, on the TRANQUILITY program, can you give us any indication on onset atrial size or perhaps what you see sort of timing. It feels like this is now going to be a back half initiation. So is it reasonable for us to assume that we'll probably see data in the back half of '25. And secondly, on the existing agile launch, sales are down sequentially now acknowledging there's no sales effort to prove the surprised you can tell us why sales are not at least staying flat. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 12, 2024 / 12:00PM, BTAI.OQ - Q4 2023 BioXcel Therapeutics Inc Earnings Call And then just a point of clarification on the credit agreement. Are you again acknowledging you didn't satisfy one of the requirements. Is it reasonable to expect that we'll get an update shortly after you cement things with FDA? Thank you.

Question: Colin Bristow - UBS - Analyst : Great. Thanks. And then on the credit.

Question: Colin Bristow - UBS - Analyst : Thank you. That's helpful.

Question: Samir Devani - Rx Securities - Analyst : Hi, guys. Thanks for taking my questions. I've got just a couple and so I just want to make sure I understand the TRANQUILITY program strategy correctly for is it now the plan to do to get the label expanded further in care facilities and then do the subsequent OUTCOMES trial. And if that's the case, what's the marketing strategy in that scenario? And then the second question is just on and maybe this is for Richard, as OpEx is significantly lower in the quarter than I had. I'm just wondering if Q4 is a good run rate for Q1? Thanks very much. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 12, 2024 / 12:00PM, BTAI.OQ - Q4 2023 BioXcel Therapeutics Inc Earnings Call

Question: Samir Devani - Rx Securities - Analyst : That's great. Thanks very much.

Question: Sumant Kulkarni - Canaccord Genuity - Analyst : Thanks for taking the follow-up. So this might be somewhat of a premature question, but it's still an important one, I think both from a financial modelling perspective, what are your latest thoughts about eventual commercial pricing of Fibre One in the Alzheimer's agitation setting, as it appears that the product might be under-priced currently given the potential value intuitive?