So, we thought this is the best case scenario that we conduct a study in a home setting and get the best possible label we can in this patient population, whereas you know there are no drugs approved and, to our knowledge, no drugs under development also for acute treatment of agitation. So, we have a very unique position.
Sumant Kulkarni: Got it. And then, is there a specific limit to the number of episodes that you can treat per four week period in this new trial to be considered an acute treatment? And how confident are you that the new at-home trial will not end up in a TRANQUILITY III-like outcome where AD agitation is not really acute but chronic?
Vimal Mehta: We are not aware of any guidelines like migraine, where you have 15 episodes and it’s acute, and after 15, it’s considered as chronic. Those are the paths we will be working with the FDA what is the definition of acute and episodic. But as Rob said, we are developing a protocol and he will be providing you the details that what our inclusion criteria will be for a acute episodic treatment. And we will be discussing more on this one, but to answer your question, there is not a clear guideline set up or a path about that, or there’s no literature information which defines that if you have X number of episodes, it’s acute, and if you have Y number of episodes, it’s chronic.
Sumant Kulkarni: Got it. And then my last question before I jump back in the queue is, on the SERENITY III program, you now are allowed to go home with a 120-microgram dose. Could you just give us some color on what led to that and the discussions with the FDA around that, given it’s higher than what you had contemplated in the past?
Vimal Mehta: Yes. So, when we had meeting on the SERENITY III program, we had multiple choices for the doses. As you know, 120 microgram is already approved dose for IGALMI. And now, company estimate that it has been given to at least more than 10,000 people which is 120 and higher doses 180, and there is a lot of data generated which provides the confidence to the company as well as to the agency that this could be a dose we should evaluate in a home setting. We also had a choice to evaluate 80, where you understand and know that we had done PKPT modeling based on our 60-microgram dose and we could have chosen the 80-microgram dose. Those flexibility exists. The reason we are choosing 120, already a lot of safety data on 120.
Efficacy is already established. We need to evaluate primarily the safety in a home setting. And that will allow us to capture about 23 million episodes that happen in a home setting and extend it beyond the 16 million episode that’s in the hospital. So, it was very synergistic, same dose that’s given in a hospital setting if it can go in a home setting, and if patients in a home setting need any more, like, medications, they can always get 180 in the hospital. So, it’s very, very synergistic, and that’s part of the reason we have chosen 120 for evaluating in a home setting.
Sumant Kulkarni: Thank you.
Operator: Thank you. Our next questions come from the line of Colin Bristow with UBS. Please proceed with your questions.
Colin Bristow: Hey, good morning, and thanks for the update. Maybe just a point of clarification on the path forward in Alzheimer’s agitation. I think I heard you say the company believes the TRANQUILITY II data can be used, but what did FDA specifically say about the submissibility of the data, or will this still remain a review issue? And then, on the additional study, can you — it just feels like from the timelines of prior studies, we’re going to — this is looking to be a sort of 2025 readout. And then certainly on the cash runway, your last — in Q2, you said your cash will get you to mid-’24. You’ve maintained that language. Is that simply because the updated agreement isn’t finalized? Just more detail would be really helpful. Thanks.
Vimal Mehta: Sure, Colin. This is Vimal. Coming back to your question about the specifically about the TRANQUILITY II data, we have no reason to believe or we have not any discussion which tells that TRANQUILITY data is not usable. As you know, once you do submission of your sNDA, FDA does its assessment and that will continue to be the case for any sNDA. In terms of our discussion, we have no reason to believe that, and as we said, company believes this data is usable based on our own assessment as well as on the independent audit that was recently concluded. Your second question was what about the additional studies when the readout will be there. As you notice that we have about 100 patient study to conduct. It’s in a home setting.
We are developing the protocol. We are designing how many sites will be required to conduct the study. Only thing I can mention here is that conducting a trial in home setting is going to be a lot more easy than conducting a trial like a TRANQUILITY II and III. The reason for that is in TRANQUILITY II and III, you have to helicopter in the CRO to make the assessment for the efficacy. Here, as we mentioned, we are trying to evaluate the safety and will continue to collect caregiver assessment of the efficacy. So, these trials we expect are going to be relatively easier in that setting, but we have not done a trial in a home setting. So, we are very diligently working with our CRO, defining the protocol, getting the alignment on the protocol, and very soon we will be able to come back and say when we plan to initiate the trial, when the first patient will be dose, when recruitment will be completed, and how long will it take, and when the value inflection catalyst will be there for the Alzheimer’s-related agitation program.
Third question is related to the Oaktree. Recently, we had concluded a binding term sheet with Oaktree and Qatar Investment Authority. We are very grateful that they are very supportive. They have belief in BXCL501 drug and — like us, like we believe in it. And now having a very clear path for Alzheimer’s-related agitation and also a path for expanding the label for IGALMI in a home setting with SERENITY III program, we both, and based on our recent reprioritization of our commercial efforts and in the organization, this agreement or terms needed to be amended. We are very pleased to report today, they have been agreed upon under the binding term sheet, which will be documented very soon. And I will pass it on to Richard so that he can outline what is the value for the organization and why this was needed.
