Richard Steinhart: Sure, Colin, thanks. It’s Richard. So, we’ve done a couple of things here, Colin, that make it attractive to us. We moved out the revenue covenants that would have started to impact our cash flow early next year for about a year. So that saves us some significant cash payments that may have been required under the original deal. And as Vimal said, the new covenants and the new revenue targets really align with our reprioritization in our new budgets. So, it gives us a lot more flexibility in terms of operation for us. And we renegotiated the tranches that may allow us to take down additional capital over the next few months.
Colin Bristow: Very helpful. Thank you.
Operator: Thank you. Our next questions come from the line of Robyn Karnauskas with Truist. Please proceed with your questions.
Robyn Karnauskas: Good morning, and thank you for my questions. I guess starting with the first one, so I think before you said like the FDA likes to cut the dose in half for these at-home trials. What kind of conversations did you have about using the 60 milligrams for — 60 microgram for the at-home setting for TRANQUILITY? Second question is, at-home, can you update us on your thoughts on the number of potential doses that are in the market or episodes now that you’re going for at home and in the hospital setting or assisted living setting? Like, what is now the number that we should be thinking about? And then, I have a follow-up.
Vimal Mehta: So, I’m just trying to understand, Robyn, your first question. Your first question is about the dose being used in the Alzheimer’s-related agitation, 60 microgram in a home setting? I just want to make sure that I understood.
Robyn Karnauskas: Yeah. I mean, I think before you talked about how the FDA always wants to cut the dose when they go at home, and that’s what you did with SERENITY, it was a little lower. And what gives you confidence that you’re using 60 microgram, which is the high dose for your trial that you did in assisted living?
Vimal Mehta: As you know, in our assisted living TRANQUILITY II program, we tested two doses, 40 microgram and 60 microgram. 60 microgram was statistically significant, and it was well tolerated, and we have a very clear safety profile established. And in TRANQUILITY I also we had the data for the 60 microgram. So that’s the dose we want to test in a home setting, because it’s clearly established the efficacy and the safety profile through two trials. Rob, you like to add anything on it?
Rob Risinger: Yeah. No, the FDA felt that 60 microgram had efficacy as demonstrated in TRANQUILITY II, and therefore, that’s the dose to test at home. The safety profile of 60 was consistent with being able to be dosed at home. And so, we believe a successful at-home trial will be demonstrating safety consistent with what we’ve shown in the TRANQUILITY II study.
Vimal Mehta: In terms of the number of episodes, we continue because there is no drug approved. We are — we believe one of the leaders in acute treatment of agitation, in Alzheimer’s-related agitation. So, we continue to do a lot of work internally to understand the opportunity. I will invite Matt to provide a little color what our understanding is on the number of episodes.
Matt Wiley: Sure, good morning, Robyn. As Vimal said earlier, better than 80% of patients with Alzheimer’s dementia are in an at-home setting. This is where the unmet need is potentially the greatest. Antipsychotics are not typically used in this population due to the side effects, and benzodiazepines are not an optimal choice. So, typically what’s used for these patients is some type of soothing technique. And these are relatively ineffective. And so, we believe that the opportunity is tremendous. What we’ve seen in our market research is that, on average, the number of episodes per month for these patients in the at-home setting is six. So, the opportunity out there is pretty tremendous.
Robyn Karnauskas: Would you get other reasons like patients that are not completely diagnosed, a lot of patients seem to have Alzheimer’s, but maybe they have other kinds of dementia? Would that be something that reads in your press release, like assumed Alzheimer’s that might be upside to the opportunity? And then, on the financing question, Vimal, maybe talk a little bit about how you’re thinking about prioritizing future development for SERENITY once you get the final minutes back versus TRANQUILITY versus, say, monetizing 701? Like, I guess you have to prioritize one given your cash position, how are you thinking about that?
Vimal Mehta: Regarding the prioritization, I think good news is that we have full clarity on both programs and from our two recent FDA meetings. So, we have both options at our disposal to bring this drug into the home setting. TRANQUILITY conceding a very large opportunity. It makes sense to prioritize TRANQUILITY program and that is the meeting we had in October and we are more advanced in our protocol development and like taking next steps forward with the TRANQUILITY program. Coming back related to your question about the financing, we believe that we are blessed that we have multiple options for financing. In addition to equity financing, we recently were able to revise our terms with our strategic partner to build financial flexibility.
In addition, we have opportunity to be able to partner 501 program. Now, we have a full clarity in the Alzheimer’s agitation ex U.S. That opportunity we have not explored because right now we were waiting for clarity on these two programs. And in addition, as you mentioned, and Vince also mentioned that we are focusing on monetization of OnkosXcel. So, depending on the business need, we can leverage one of these options to us to extend our cash runway and get to the clinical — meaningful clinical milestones for the TRANQUILITY program followed by the SERENITY program.
Matt Wiley: And, Robyn, this is Matt. I’ll just take on your question about the potential label for presumed Alzheimer’s dementia. And of course, these are things that we will test in the market to see how the market will react to them. But my initial reaction is that payers who might otherwise have a prior authorization due to a confirmed diagnosis might not be able to leverage a prior authorization in that way. That’s number one. Number two is that what we saw in our market research on episodes, one of the things we did collect is the number of episodes per month prior to the definitive diagnosis of Alzheimer’s dementia, and that was three per month. So, we do know that agitation exists prior to and may actually lead to the definitive diagnosis.
