Corinne Jenkins: Okay. And then, as you think about this extended agreement with Oaktree and QIA, how do you think about a way taking on additional debt versus seeking capital through the equity market?
Vimal Mehta: I think always it’s a delicate balance, based on the business need, your current cash position, the options you have at your disposal. Good news is that we have both equity as well as potential debt option in addition to, as I mentioned previously, partnering, which can be outside the U.S. for Alzheimer’s-related agitation, because this opportunity in U.S. and outside is really large. In addition, as we mentioned that we have started now more concerted efforts for the OnkosXcel. So, we leverage these assets to develop our financing strategy that is create best value for our shareholders.
Corinne Jenkins: Okay, thanks.
Operator: Thank you. Our next questions come from the line of Sumant Kulkarni with Canaccord Genuity. Please proceed with your questions.
Sumant Kulkarni: Thanks for the follow-up. I have two. So, you mentioned it’s easier to conduct a trial at home because of the lack of, I think you used the term, helicoptering in a CRO. But would the burden of ensuring safety in older patients at home not be greater relative to a more monitored setting? And how real-time will feedback to the company be based on safety-based events in the new Phase 3 trial?
Vimal Mehta: So, ALF setting, as you know, is a non-medical setting where we have conducted TRANQUILITY I and II. So, the only reason you have to helicopter in a CRO is to measure the efficacy like PEC measurement and safety profile we now have in elderly patients in TRANQUILITY I and II, and we will be evaluating now in the home setting. So, safety will be measured as for any other drug, like you know, that is being tested in a home setting. And then, in terms of the efficacy, it will be more collecting the efficacy data, whether there was agitation, did the patient feel calm, given more by a caregiver. And we are developing the protocol and how we will measure that. But safety is — because we have now established 60 microgram efficacy in an ALF and that was primarily the reason to come up with the design in a home setting to expand the patient access to this drug to the patient population if we get approved.
Sumant Kulkarni: 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 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?
Vimal Mehta: I think this is our alignment, and this is a recommendation of the FDA that it is 100 patient home setting trial with efficacy assessment, as well as collecting the — safety assessment and collecting the efficacy using a caregiver, because that is the best possible design executable in a home setting. So that’s our clear understanding and company believes that there will be one more trial that we have outlined today will be required for potential submission of the sNDA.
Sumant Kulkarni: And last one, I’ll squeeze one in. Is this trial going to have a part one and part two like SERENITY III?
Vimal Mehta: No. This will not have part one and part two, because as you know, 60 micrograms efficacy has been established, we believe, in TRANQUILITY I and then further confirmed in our TRANQUILITY II trial. So, in SERENITY, we were trying to determine a lower dose than the approved dose and trying to see it will be efficacious and safe. That’s part of the reason it was designed as a two-part study. In TRANQUILITY, there was no need to design that as a two-part study.
Sumant Kulkarni: Thanks for the clarification.
Operator: Thank you. We have reached the end of our question-and-answer session. I would now like to turn the floor back over to Dr. Mehta 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 does conclude today’s teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.
