Vimal Mehta: This is Vimal. As Vince indicated, TRANQUILITY In-Care trial is very similar to the TRANQUILITY II trial where we had the positive data. We are trying to have another well-controlled Phase 3 trial for confirmation of efficacy and safety. So we expect the trial cost to be very similar to the TRANQUILITY. So we have very good idea about what the per patient cost is. And in terms of timelines, it will be pretty much similar. While when we think of the SERENITY At-Home, it’s much smaller number of patients, almost 100 patients. So that recruitment is much faster, what we have observed in our previous three trials, SERENITY I, II and III, and cost is much lower, almost 50% of what it would be in a TRANQUILITY. So we are trying to look at both, opportunity and – as you know, with SERENITY, we can be potentially – if we can complete the trial, file an sNDA in 2025.
And it’s very synergistic because we already have the commercial product. So I would say that we have very good handle. And based on our current cash which was reported at $74 million, we are laying out what the trial cost is and what the capital requirement is and how to finance the trials. And previously answered, then we prioritize or we use a step-wise approach.
Sumant Kulkarni: I’ll ask my second and third questions in one shot here. So in TRANQUILITY In-Care, what’s a general target percentage of patients you expect to enroll that might already be on Rexulti as a chronic treatment for agitation in Alzheimer’s? And going back to cost, do you think that the operating expense base at the company as it stands currently is optimized relative to the things you need to execute on?
Vincent O’Neill: On Rexulti, I’ll ask my colleague, Dr. Risinger, to come in here. I don’t think we exclude or…
Robert Risinger: We do not exclude patients who are on Rexulti or any other antipsychotic, and I’ll point back to the TRANQUILITY II data, which demonstrated about 50% of patients are on concomitant antipsychotics.
Vincent O’Neill: And your last question, Sumant, I’m sorry, I can ask you to repeat it?
Sumant Kulkarni: Do you think the operating expense base at the company as it stands currently is optimized relative to all the things that you need to execute on in the near to midterm here?
Richard Steinhart: It’s Richard. The answer is we continue to evaluate the operating overhead and we continue to look at ways to make it more efficient and optimize it. So that’s an ongoing process here.
Operator: Our next question is from Samir Devani with Rx Securities.
Samir Devani: I just wanted to come back to the comment about the 12-month safety study that would be required for the TRANQUILITY In-Care study. I just want to confirm that would be required before you make the sNDA. And also, now that you’ve essentially completed these discussions with the FDA, what’s the trigger left now to initiate that trial?
Vincent O’Neill: This is Vince. So I think as we’ve said, we will go to the FDA and discuss not the need, of course, for long-term safety. That’s clear. But the details, and that will fundamentally be around the data that we collect in the study. So it’s going to be a protocol discussion, which of course is typically why we go and discuss things with the FDA. In terms of the requirements – I think your question was going to be around the numbers and requirements. Those are obviously set by ICH guidelines, so 300 at six months and 100 at one year. We would need the long-term safety data to support an sNDA submission.
Vimal Mehta: Samir, to answer your question when do we expect to initiate the study, as Vince mentioned, now we are sharing the protocol with the FDA and giving it to the CROs for site selection. And once we have the financing in place up to the data readout, we will initiate the study. We are getting the technical readiness.
Operator: We have reached the end of our question-and-answer session. I would like to turn the call back over to management for closing remarks.
Vimal Mehta: Thank you, everyone, for joining us today and for your continued interest in BioXcel Therapeutics. Have a great day.
Operator: Thank you. This will conclude today’s conference. You may disconnect your lines at this time and thank you for your participation.
