BioXcel Therapeutics Inc Q4 2021 Earnings Call Transcript

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

Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst : So now that the 501 PDUFA is right around the corner, are you in label discussions currently? And how would you characterize them so far?

Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst : Got it. And then if I could hit on a different topic. What is the status of any discussions with partners to commercialize 501 in the EU? And what attributes are you looking for in a future partner?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : I have 3. I'll start with one on the TRANQUILITY trial. We saw ClinicalTrials.gov had an update posted as of yesterday on one of the Phase III trials that has a primary and study completion date of December 2022 and for a maximum of 28 doses over 12 weeks. Could you confirm the maximum number of doses, which appears to be more than what we thought it might be? And given the update was just posted yesterday in light of your Omicron comments, does that December '22 completion date reflect your latest expectations now that the Omicron seems to be behind us? That's my 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. MARCH 10, 2022 / 1:30PM, BTAI.OQ - Q4 2021 BioXcel Therapeutics Inc Earnings Call

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : Got it. And my second question, you cited a market research survey that you conducted. I want to focus a little bit on the -- a little bit of the glass that is not full, which is the 17% survey participants that did not seem to have a positive response on 501. What were the key points that those participants saw in being impediments to their use of the product? And on the 40% prescribing, what delivery setting was assumed?

Question: Sumant Satchidanand Kulkarni - Canaccord Genuity Corp., Research Division - Analyst : How about the prescribing setting? And then I'll ask my last question, too, which is 701, what are your latest plans to ascertain single-agent activity?

Question: Colin Nigel Bristow - UBS Investment Bank, Research Division - Analyst : I wanted to push you guys on something. So it sounds like you do not yet have a label in hand. I was just wondering, has FDA set an expectation specifically of when this label will arrive? And then just secondly, as we think about the post-approval setting, is it reasonable to expect some sort of launch guidance? And if so, what metrics do you anticipate giving us?

Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst : I just have a follow-up on some of them that you already answered. So with respect to the study in Alzheimer's, the 2 Phase III studies, could you provide some clarity on how we should think about like the number of patients that might actually benefit from the higher dose between the 2 different settings?

Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst : Yes, definitely. And then a question on the MDD program. I was wondering, like is there a specific subset of population from the 27 million cases that might actually benefit from this adjunct treatment?