BioXcel Therapeutics Inc Q3 2024 Earnings Call Transcript

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

Question: Alec Stranahan - BofA Securities, Inc. - Analyst : Okay, great. Hey guys, thanks for taking our questions. Just two quick ones from us. I guess first, how has the launch of the SERENITY study gone so far? Maybe walk us through the process of getting the first patient on the study and whether you expect the rate of enrollment could be similar or maybe accelerate for the other 200 or so patients on the study? And then I've got a follow-up. Vincent O'Neill - BioXcel Therapeutics Inc - Executive Vice President, Chief of Product Development and Medical Officer Sure. Good morning, Alec. This is Vince here. So I'll start that and then I'll hand over to Rob to give a bit more detail if he feels I'm missing anything. So essentially, as you know, the study has kicked off, the first patient randomized relatively recently. We're in the ramp up phase right now. That will be totally typical for a study like this. I will mention we're coming into the holiday season, so that would typically involve a little bit of a slowdown at the sites, but then we would typically see a rebound in the January timeframe. So this is our approach to the study and what we've seen so far is absolutely standard. I'll just mention lastly, we have a large number of sites, so 200 patients and I think the final number is 26 active sites. So that's a large number of sites for the number of patients or target enrollments. So we're very comfortable with the timeline and I'll just state it again, anticipated nine to 12 months. Anything to add to that, Rob?

Question: Alec Stranahan - BofA Securities, Inc. - Analyst : Okay, that makes sense. And then on the randomization, could you just remind us if rescue medications are allowed, especially thinking about the placebo arm and whether this might actually be a helpful data point that you may be measuring over the 12-week study period? Thanks.

Question: Alec Stranahan - BofA Securities, Inc. - Analyst : Got it. Thanks for the color.

Question: Graig Suvannavejh - Mizuho Securities USA LLC - Analyst : Hey, good morning. Thanks for taking my questions. I've got two; first, just I might have missed this earlier, but on the TRANQUILITY trial protocol, what was the specific feedback that you got from FDA? If you could provide any color on that? And then secondly, was just hoping if you could provide an update on where you are with the cash runway and optionality or options that you are considering with regards to funding the company? Thanks. Vincent O'Neill - BioXcel Therapeutics Inc - Executive Vice President, Chief of Product Development and Medical Officer Sure. Good morning, Greg. This is Vince. I'll take the first part of that question. So, I mean, we don't typically give blow-by-blow details of FDA comments. What I can say, though, very comfortable in saying this, the feedback was direct, actionable, and really very concise. So, we're actually very happy with the feedback we received. Did you want to handle second part, Rich?

Question: Graig Suvannavejh - Mizuho Securities USA LLC - Analyst : Thank you very much. That's very good. 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, 2024 / 1:00PM, BTAI.OQ - Q3 2024 BioXcel Therapeutics Inc Earnings Call

Question: Graig Suvannavejh - Mizuho Securities USA LLC - Analyst : Maybe just a follow-up here with the trial underway of sorts. Can you provide color as to whether the current financing or cash to have is efficient to take the trial to completion again my apologies if I made [mistake] before?

Question: Sumant Kulkarni - Canaccord Genuity LLC - Analyst : Good morning. Thanks for taking my questions. I have two: one financial and one trial related. The financial one is how would you characterize your latest negotiations with your large investors on your ability to keep financial covenants at bay? And second, how important is the successful completion of SERENITY At-Home to the company in terms of that trial's ability to potentially unlock partnership opportunities for the larger at-home agitation market?

Question: Samir Devani - Canaccord Genuity LLC - Analyst : Hi, guys. Thanks for taking my questions. I guess the first one is just on, I think last time we spoke, you mentioned that the TRANQUILITY In-Care trial would have a cohort of 20 patients in the At-Home setting. So I just wanted to confirm following the FDA feedback whether that was still the case. I guess that's question one. Vincent O'Neill - BioXcel Therapeutics Inc - Executive Vice President, Chief of Product Development and Medical Officer Yes, hi there. This is Vince here. So yes, at the end of the day after discussion internally, we took that pilot out of the protocol. So currently that's not part.

Question: Samir Devani - Canaccord Genuity LLC - Analyst : Great, and maybe if I could just sneak one more in. In terms of the stock write-down, could you just confirm that, or give us an indication of what sort of inventory you're still holding and what may be at risk going forward, thanks.

Question: Samir Devani - Canaccord Genuity LLC - Analyst : Thanks, Richard.