BioXcel Therapeutics, Inc. (BTAI) Earnings Call Transcript & Summary

Okay. Good afternoon, everyone, and welcome to the 4:40 p.m. session here on day 2 at the Goldman Sachs Global Healthcare Conference. My name is Graig Suvannavejh. I cover U.S. and European biopharma names here at the firm. It's my great pleasure to be hosting BioXcel Therapeutics in a fireside chat. And with that, joining from the company are CEO, Vimal Mehta; and Chief Commercialization Officer; William Kane. Gentlemen, it's good to see you both, and welcome.

Thank you, Graig.

Thank you, Graig.

Okay, very well. Well, my sense is there's probably a number of investors who may be joining us who might be new to the story or picking the story back up again.

And so with that, perhaps just to level set, why don't we start off with a high level introduction into the BioXcel story. Can you give us a sense of what your key areas of focus are and what would you say are your kind of key areas of expertise that make you think that you're differentiated from other companies?

Graig, thank you very much for hosting us. Good afternoon, everyone. Thank you for joining this session. I'm Vimal Mehta, I'm CEO and Co-Founder of BioXcel Therapeutics. Very pleased to be here to provide some update on BioXcel Therapeutics, exciting progress we have made in the last several months. BioXcel Therapeutics is a clinical stage biopharmaceutical company utilizing artificial intelligence-based platform to identify transformative medicines in neuroscience and immuno-oncology. Before I begin, I just want to mention that we will be making forward-looking statement. And today, joining me on this call is Will Kane, who is our Chief Commercial Officer. In terms of key updates about our story, we got an acceptance of our NDA last month. That has been a big news for the company because that NDA acceptance and starting the program in first in human, it was a 2.5-year journey, and that was achieved quite efficiently over the 2.5-year period. So we are very excited and looking forward to now working with FDA through the approval process. Our PDUFA date for our first indication -- 2 indications, which is agitation resulting from schizophrenia and bipolar, is January 5. Our product is BXCL501. It's orally available sublingual thin film for treatment of agitation. We believe there has been a big innovation gap for almost a decade. No new drug has come in this space. What is being used is physical sustaining or chemical sustaining. So we are trying to bring a real drug which is targeting a central mechanism, we believe, of the agitation. And it will be applicable across multiple disease states. So that's our first 2 indications, and PDUFA date is January 5. And we are preparing for commercial readiness, and we're going to, in a while, talk about it. My colleague, Will, will describe what commercial readiness we have done. The second part of our strategy is to expand the indication. So we recently got -- for schizophrenia and bipolar, we have a Fast Track designation. For dementia-related agitation, we got Breakthrough Therapy designation, which was based on our current data we presented from TRANQUILITY trial, which was dose-dependent responses and we saw statistical significance even with smaller number of patients. The drug is really effective, and it was well tolerated. So using that data, we are now preparing to engage FDA for our end of Phase II meeting and double up our pivotal trial registration program. So we expect that the trial sizes will be some -- will be something like SERENITY, and it will be more close to the TRANQUILITY, the way we conducted that TRANQUILITY trial. So we are super excited in expanding to another indication, which is a very large market. There are about 6 million Alzheimer's patient, 30 million globally, and this population is going to double by 2050. And in U.S., it's expected, it will be 12 million by 2040 according to the Alzheimer's Association. And almost 70% of the patient experience agitation. So that's almost 100 million episodes a year. So it's a very, very large opportunity, and we are laser-focused in ensuring that we can move the drug with the NDA process to get to the approval and then focus on dementia Phase III trial. In addition to that, for 501, we have a strategy where we are doing a geographical expansion also besides the indication expansion. So we are preparing currently our application for filing MAA for Europe, market authorization application, and that is expected to be filed in second half of this year. So that is the second part of the value creation pillar for valuing -- increasing the value of our Neuroscience franchise. And the third is expanding into the medical settings, which we're already doing in dementia, where we conducted our trial outside the institutional setting in the assisted living centers. So those are the 3 key drivers for 501 we continue to use. And Graig asked, what is your differentiation? I do believe, and we believe that we are the only company that has built a capability from AI all the way to drug discovery development and now added the commercialization. So we have medical affairs and commercialization teams started building last year when Will Kane, who is Chief Commercial Officer; and Reina Benabou, who is Chief Development Officer, that joined us last summer. So we have built a whole team from AI on the way to commercialization. We are using the AI platform to develop sustainable pipeline outside 501, which is 502, 503. And that's the overall strategy of the company to become a neuroscience company, and that's what we're trying to do and keeping in focus. In addition to that, we wanted to prove our AI platform. So we had also started a program in immuno-oncology, where we are very well differentiated, and we are focusing only on innate immunity. And we believe we have the most advanced oral activator of innate immunity, BXCL701, which currently is going through 2 Phase II trials, in which we are trying to fill the gap wherever checkpoint inhibitors are not working. So we are focusing on cold tumors, which is aggressive forms of the prostate cancer adeno CRPC as well as in neuroendocrine patients. That's our company-sponsored trial. We expect the data readout by the end of this year. And for second trial, which is being conducted by our partner, MD Anderson, which is for heart tumors, which are either refractory or treatment line. So those are the 2 patient types we are working on. Mechanism for our both drugs is very unique. 501 is selective alpha-2 adrenergic agonist. And for 701, it's a DPP8 and 9 inhibitor. So AI platform helps identify these unique mechanisms. And with 501, we are trying to prove business models that we can bring a drug from starting a program and all the way to the market, approval within a 4- to 5-year window. That's what we are trying to achieve at BioXcel Therapeutics. And just a few things about the BXCL501 program, we have, to date, conducted 7 clinical trials we have those 800 patients. So we have built a very solid clinical backbone to build on additional indication and expand on the potential of BXCL501. In parallel, Will and his team are adopting a similar kind of a strategy when they are developing the commercial strategy that land and expand with our first -- two indication we land and then how do we expand everything, commercialization, pricing strategy, everything is designed according to that. So that's a kind of a quick overall summary of BioXcel Therapeutics.

That was very thorough, and I kind of feel that we can wrap up our fireside chat. With that said, maybe we can start with just BXCL501, and there was a lot to kind of unpack there. But with that said, can we go to the actual drug itself and how did you come to choose this drug, and it is being developed in a sublingual formulation. So can you just talk to us how you think about your drug and focusing on agitation, and different applications of the drug in different agitation-related conditions. Is there -- as you talk about this, should we be thinking of the potential of other formulations of your drug in different instances? But let's focus first on 501 and what makes you think it's a unique drug for agitation?

So it's a completely novel mechanism that we are trying to prove for treatment of the agitation. This drug originally was used in a surgical unit as an IV drug in a surgical unit as a sedative anesthetic. What have we done? What AI platform allowed us to do? We have identified this drug and the mechanism can be used for treatment of the agitation. It has not been used for agitation. It was a sedative anesthetic. It was the IV drug. We converted this into a sublingual thin film, which is proprietary. We are doing a micro deposition. So that is the second part of the innovation. And then the third piece, which is equally important, we are taking advantage of the low-dose pharmacology. We are not using the therapeutic doses that are being used for as a sedative anesthetic. So I think new indication, new formulation and a low-dose pharmacology gives us a very unique advantage, we are taking advantage of the safety database for the drug because it has been in the marketplace for a long time. But at the same time, we're completely exploring the new biology and addressing a very large unmet need where there has been no innovation for last decade, at least in the schizophrenia and bipolar. And if you start thinking of Alzheimer's and dementia, it has been 2 decades that nothing has been approved and current therapies that have been used are all black box warning.

Thank you very much. I was going to just talk about the different indications that you're looking to apply 501 in terms of treatment of patients and your lead indication is schizophrenia and bipolar agitation. You've got an NDA that's already been filed. And with that said, you're in a precommercialization plans. And I know we've got Will there, who can talk about that. But can you summarize for the audience, the strength of the data that you saw and perhaps provide a perspective of where you think with particularly a sublingual formulation, how this is going to fit for agitated patients?

At a high level, we believe this drug can be in medical practice changing because currently, 501 is as close to the guidelines that have been generated to treat the agitation. With that, I will pass it on to Will, so he can describe the key features, commercial value feature, which are driven based on our Phase III trial.

Sure. Thanks, Vimal. So the data from SERENITY I and II, I think, really a solid platform to consider the potential commercially of 501. So based on the data sets in 2 distinct patient populations, schizophrenia and bipolar disorder, both of whom experience agitation on a regular basis. We saw a rapid onset of action. So in both trials, consistently superiority to placebo by 20 minutes, good duration of effect out to 8 hours, a well-characterized tolerability profile. Obviously, no black box anticipated, given this is a reformulation of dexmedetomidine, a low rate of adverse events overall and even on the somnolence front, the somnolence that was reported in the trial was considered mild. Drowsiness, they may -- patients may have fallen asleep, but that was only reported in 1 out of 5 patients. So there's a lot from the data sets that we think will be helpful in positioning 501 in the marketplace, should we receive approval next January. Graig, specifically to the question of the sublingual formulation, actually, we refer to it as an orally dissolving film because while the trials were conducted by placing the film under the tongue, subsequent PK work has established that the film can be placed right behind the lower lip. So it doesn't need to go under the tongue or behind the teeth. And that, we think it will be particularly important because in market research, getting a film under the tongue could prove a little challenging. So being able to pull out the lower lip and put it behind that location, we think will be very helpful. Not just initially in the schizophrenia and bipolar disorder patient populations, but subsequently in the dementia population, right, where when we hopefully get to commercialize an indication there in agitation associated with dementia, having an orally dissolving film that you can put right behind the lower lip could be helpful. Relative to other formulations, obviously, as Vimal pointed out, treatment guidelines do recommend oral treatments before injectables. Injectables tend to be first line right now in emergency departments. That's a large measure because the current orals are formulations of the existing antipsychotics and benzodiazepines, and they just -- they take too long. Their onset isn't as fast as the injectables. So now 501 with onset by 20 minutes is arguably on par with the injectables without the need for physical restraint and without the need for monitoring, et cetera, after injection. Plus the film has a mucoadhesive. And so in this patient population, in particular, a psychotic patient or a manic patient, an oral tablet or a liquid could be cheeked or spit out, et cetera. But when the film is placed, it adheres and then the drug starts to be absorbed directly through your own mucosa. So -- and again, in market research, feedback has been positive about that feature of the formulation as well.

That's a great overview of kind of the product. Where do you intend to capture patients? My sense is that this is an ER situation, you've got agitated patients who, at least on the initial patient population will be schizophrenic or suffer from bipolar disease. How are those patients being treated now? And is it mainly the injectables? And with your orally-dissolving film, just walk us through how you intend to be able to capture these patients? And is there more of an opportunity at least in this initial ER setting that you can go beyond that?

Sure. So first, the current standard of care, if you will, are on the antipsychotics and benzodiazepines, the first antipsychotic, HALDOL, was launched back in 1967. So this is -- there's been a long time where the market and clinicians have relied on these 2 classes of drugs to help with patients experiencing agitation. You're right, in the emergency department setting, clinicians rely on the intramuscular injection formulations, primarily because of their onset of action. And so that's, again, where 501 could easily compete. In the inpatient setting, obviously, orals are used more frequently. So having an oral formulation of 501 allows us to position the drug for use in that treatment setting as well. And so there's opportunity in multiple settings just within the hospital itself. We intend to primarily focus on the emergency department, that's when many patients -- where many patients present when agitated. As we've talked about, of the 9 million-or-so patients in the U.S. with schizophrenia and bipolar disorder, about 1/3 of them are 3 million experiencing -- experience agitation and they can experience on average, about 12-or-so episodes per year. Many times, those episodes escalate to the point where they arrive in the emergency department. And that seems to be a viable place to begin our journey, if you will, for launching 501, also a reflection of the clinical data set that has been submitted in the NDA. Subsequently though, obviously, patients do get agitated outside the hospital. And in many instances, either they may miss doses of their antipsychotic, et cetera, and there's the opportunity to help them in other community-based settings, if you will, over time, some of the benefits there is that if we can potentially work to prevent or reduce the frequency of visits to the emergency department, that obviously has not only a clinical but a potential economic benefit as well. And so our long-range view is to land, if you will, in the hospital setting based on the data sets and then to build that over time so that we enable ourselves to help patients across multiple treatment settings, inpatient and community-based.

With the -- with your NDA already filed and accepted and with the PDUFA date now officially out there, a lot of focus, at least based on the conversations that I have are really about -- from a commercialization perspective, is this company -- does it -- is it where it needs to be? And for a hospital-based product, there's blocking and tackling that's probably separate or unique versus other drugs. So Will, maybe this question is best suited for you in terms of how is BioXcel preparing itself optimally or how is it preparing itself for an optimal launch? Maybe that's a better way of putting it, what are the things that you need to do? Where are you today? And what's still left to do?

Sure. So first, we're in a very solid position relative to our launch preparation. As Vimal mentioned, I joined about a year ago, as did Reina Benabou, who leads clinical development overall, including medical affairs. I'm fortunate that I was able to recruit very strong leaders on the commercial leadership team, people that I've worked with previously and who have experience, not only in the CNS area, but also in hospital launches. And so we are in a good position. We've done a lot of the work necessary to build our commercial infrastructure, commercial infrastructure that while it will support the initial launch, can certainly be leveraged in order to support future launches as well. We've done a solid amount of market research to understand the need, the opportunity, et cetera. And that all underscores the fact that there is significant unmet need, that the profile of 501 is very well received. And folks envision a place for it in the treatment options that they have to offer. Our MSLs are in field. They deployed in March, and so they're beginning the interactions with clinicians and with hospital pharmacy directors and payers in order to begin that first initial feedback process will field our commercial market account managers. In the third quarter, they'll have more directed conversations with payers and hospital pharmacists relative to access on their formularies, to understand the process, to understand the economics and the price points, et cetera. Sales leadership is being recruited now to be onboard third quarter. And then as we've said, we plan to build our own sales force in the fourth quarter in order to be ready for a PDUFA in the beginning of 2022. So all things are in place. We continue to advance them steadily. And I've been part of many, many launches, and hospitals certainly do present different challenges, but also different opportunities. And in this instance, I think we're really well positioned. And we know what we need to do, and we'll work towards that optimal launch that you speak of, Graig.

How are you currently thinking about pricing? And while I think it's fair to assume that you won't announce pricing until you actually see an approved product and labeling. But with that said, are there ways that you're thinking about pricing now? And how informed has that been by your interactions and any market research you've had either with KOLs and/or payers?

Sure. So you're correct. We obviously wouldn't announce our price until after receipt of the label and approval, so we can ensure that our price is reflective of the value that we think 501 brings. First, we take a long-range view to the pricing of 501, not just for the initial indications. But obviously, more importantly, to the broader runway of indications that we could potentially produce, particularly in the dementia marketplace, given the unmet need. That's a very large market opportunity, one that will grow rapidly over the next couple of decades, one in which agitation is highly frequent and only increases as patients progress through the disease state. So we want to ensure that we ensure value, not just for today, but for tomorrow as well. So we're taking a long-range view to how we price 501 at the WAC level, if you will, the wholesale acquisition level or the gross price level. And then we'll advance our thinking on differential pricing by site of the care. Hospitals being more price sensitive, we'll work to understand the price points that will allow us to access the formulary acceptance that we need to drive adoption out of the gate and to continue to build that over time, while protecting the value on the outpatient side when we hopefully, ultimately get there.

With that in mind, as I think about what potentially could be next. Again, Vimal, you did a very nice job providing a high level of the many different areas and potential indications. Your next indication is dementia-related agitation. And with that in mind, certainly, a larger patient population, one that, from my perspective, is likely to have an equally high unmet medical need. And the timing is such that, obviously, we have news of an approval of an Alzheimer's drug in -- from Biogen. But with that said, can you just remind us how you're seeing the potential opportunity in agitation and where 501 could fit in treating those patients?

Current approval by the FDA is very encouraging because there have been an innovation gap for a long time in this area, and these patients are in need for -- it's a very high unmet need, so they are in need for medication. So I think it's really good for a product like BXCL501. As I indicated, that 70% of the patient experience agitation, and agitation frequency can change as the disease progresses. So disease progression or stopping or impacting that is important. But at the same time, treatment of these symptoms like agitation is extremely important because it can be very debilitating, both for the patients as well as for the caregiver. And a lot of patients move from the home care to the assisted living and nursing homes because families can't manage their agitation episodes. So we see this as a very large market opportunity. We are encouraged and -- with this approval as well as we are very encouraged with our interaction that FDA has granted us Breakthrough Therapy designation, so that we can facilitate the development of this program. We are excited and we are looking forward to initiating our registration Phase III program in second half of this year and complementing if we get approval with the schizophrenia and bipolar with another sNDA.

Two initial questions, if I could, just on the dementia-related agitation opportunity. You're obviously moving forward into a registrational program beginning in the second half of this year. It's probably important just to level set for our audience what were the data that gave you the comfort to go ahead and move into a registrational program. There was, I think, an initial market reaction when you announced the data that perhaps was reflective of some outstanding questions around the data that you did end up sharing, but maybe could you provide that data set? And how you think that data does support moving into a registrational study or program?

Sure. So TRANQUILITY trial was the trial that we were conducting on the dementia patient using 501 and it was a dose escalation trial, and we were testing different doses. We started with 30, and we started escalating to 60 and 90. We deliberately use lower doses because it's well known that the PK for the elderly patient for this drug can be different. So it's suggested in the label that one should use half the dose. We had 120 in our schizophrenia and bipolar, and we had 180 in -- as the highest dose in its schizophrenia and bipolar. So half of that would be 60 and 90. So we wanted to start with 30 just so that we can escalate and understand. So we did the 30 cohort, then we did the 60, and then we moved to 90. All of this was happening during the peak of pandemic, like all last year in 2020. We started the trial in January, and we announced the data in January 2021. So access to the centers was not easy to get for the elderly patient. So we had to make choices, where are we going to put our resources. So we decided to put out more resources in terms of recruiting the patient on 30 and 60, and that was the right thing to do. And we achieved a statistical significance, and we saw the good tolerability with both the doses. So that gave us a very good framework that we can use this drug in assisted living centers, nursing home and ultimately be taken into the home care setting. So with that, thing in mind, we also started a cohort because now we -- at the time we had the data in our hand, a 40-microgram dose cohort. So it builds the optionality in our arsenal, how do we choose the doses and what doses we take it in the Phase III registration trial. And if we need to expand the label in the home care setting, what doses we can use. So that's the kind of overall summary. 90 -- we never put in too much emphasis on the 90 microgram because we thought that the lower doses are better efficacy. With the lower doses, it's much, much better to move the drug in that medical setting we want to treat these patients. So that's kind of a brief summary of how TRANQUILITY unfolded. And we were very pleased that all the data when we shared with the FDA, they granted us the Breakthrough Therapy designation. So it overall has worked out very well for us, like what we wanted to achieve with the program.

Okay. And could you update us, have you had your end of Phase II meeting yet with the FDA?

We have announced that it is expected in the Q2, so any time in this month period. And then once we have the meeting, we will get all the parameters aligned about the size of the trial, primary endpoint, 1 or 2 trials, and then we will prepare to initiate the registration trial.

And while -- it's understood that, obviously, you won't be able to formally announce what that Phase III registrational or program looks like, especially in advance of not having an end of Phase II meeting yet with the FDA. But can you contextualize for the audience what you think a phase or a registrational program looks like? Is it a number of studies? How large are these studies? Just -- and maybe you can't speak to the exact number, but how should we be thinking about that registrational program in broad strokes?

The way we think about this program, it will be as close to the TRANQUILITY program, like the way we conducted that trial. In terms of the size of the trial, we plan to take 2 doses. So it will be 2 doses and a placebo. If the FDA agrees to one trial, we expect the trial size can be 300 to 400 patient. That's sufficient based on our effect size, what we saw in TRANQUILITY, from achieving the efficacy. And if FDA wants 2 trials, then we will have the 2 trials there. Or it could be one trial with some safety database that need to be built. So all those things need to be worked out with the FDA. And we have the Breakthrough Therapy designation that allows us more interaction with the FDA to make sure we can optimize our registration program. Those are the key elements in terms of the endpoint, we have [indiscernible] agitation scale, CGI and ACES. So we expect one of those scales to be primary and second endpoint and have CGI and ACES as exploratory endpoints, like we had in our SERENITY trial. So it will be more or less like a SERENITY program. It's a 2-hour endpoint. It is a 1-week follow-up. So we expect a lot of elements of our Phase III trial from the SERENITY, but it's a dementia patient, so TRANQUILITY, it will mirror the TRANQUILITY. So that's how we think about our registration trial.

Maybe move just maybe quickly to the next indications. I know you touched upon it earlier, opioid withdrawal and delirium. I do think that you recently announced perhaps disappointing data in opioid withdrawal. Just remind us kind of how you're thinking about that opportunity at this point in time? And then also with delirium, I believe that you recently had some COVID-related operational challenges, and you may have touched upon this earlier, but could you just remind us how we should be thinking about these 2 next indications relative to obviously, schizophrenia and dementia-related agitation?

As you mentioned, we have established the efficacy of this drug in schizophrenia, bipolar and dementia, and now we are exploring in opioid withdrawal and delirium. Opioid withdrawal is different. It's not agitation. It's more addiction, and we are trying to help patients go through a 5- to 7-day period where there is a opioid withdrawal symptom, so that they don't -- they are not on the opioid during that 5 to 7 days, so they can get off the opioid. We conducted a trial. It was a dose escalation trial. For the first time we dosed the patient, which was dosed 2 times a day, the film for 7 days, 7 to 10 days. And that was the dosing regime. That was a primary endpoint. We achieved the primary endpoint in terms of the safety. Now we have the doses, 180 and 240, where with the retention -- in opioid withdrawal, retention is the most -- one of the most important parameters because if you cannot retain the patient, that means they are not going to get off the opioid. So we saw higher retention, where we didn't -- could not separate the COWS and SOWS was very fundamental. We were trying to stabilize these patients and most of our patients were fentanyl -- had fentanyl. So with morphine, even with higher doses, these patients could not be stabilized. So we did not get the baseline to be able to separate on the efficacy. If for future, we want to do any trial, it will not have any morphine stabilization. What we are trying to understand is what is the market evolution. There has been a drug, which is much, much weaker agonist that has been approved for prescription-based opioid. We want to capture the broader opportunity, which include the fentanyl. So we are trying to figure out if we go for that without any stabilization, can 180 to 240 doses can help us achieve the efficacy both on the COWS and SOWS, which are needed for the registration trial. So we're working, doing some post hoc analysis with our experts, working with them and trying to figure out how the market evolution is and what is the right trial to capture that market officially. So that's where we are with the opioid withdrawal. One of the biggest win from the opioid withdrawal was we have demonstrated the BXCL501 can be given 2 times a day for almost like 7 to 10 days. So this was more or less a subchronic dosing, from acute to sub chronic and then transitioned to like in the home settings and ALFs and others. So it's a journey for the compound. Regarding the delirium, it's a large opportunity. It's very strategic. There has been a proof of concept in an ICU where you can -- haloperidol refractory patients given the IV Dex, the original form of the drug, they were -- agitation was controlled, even all the reflective patients. So that was the right setting to prove that, okay, 501, what doses will be needed to treat the agitation? But we were doing this in February time frame. We opened 1 or 2 sites. We saw the challenges in recruiting the patient and finding the patient, who'll be delirious and agitated, with our trial will be too slow. So we voluntary paused it, we're reevaluating what is the right medical setting where we can get the recruitment rate and prove the value of the drug. So that's where we are with the delirium. But strategically, it makes a lot of sense because we are building our sales infrastructure for the institutional setting and all delirium patients, about 4 million of them exist in the medical ward, surgical units, ER, in the hospital settings.

We've got just maybe 2 minutes left in our fireside. So I did want to touch upon very briefly, you have in the past, at least spoken into products beyond 501 in the agitation setting, how much of a priority are those alternative formulations and delivery devices for agitation relative to another interesting program you have with 701, which you alluded to is on the oncology side of things? So how are you prioritizing beyond which we've just spoken about in terms of 501?

Great question. Strategically, we are building a company, which is AI to commercialization in neuroscience for BioXcel Therapeutics. 701 asset is looking extremely exciting. It's a new mechanism, it's oral innate immunity activator. So once we get the data in the second half of this year, we'll look for strategic options, either a partnering or divestment or whatever will help maximize the value for that asset. We think by bringing a focus for that asset, we will be able to leverage and expand the market potential what 701 can do. In terms of our Neuroscience pipeline, we have identified 502, 503 which are our new assets using the AI platform. Sometimes, when we host the R&D Day, we will lay out our strategy. We are focusing on stress-related access, where we are looking at other symptoms besides agitation, agitation is just one. And also, we are evolving our AI platform more focused on neuroscience, the next -- like an evolution of the platform. So we will provide all of those updates that how we are building a sustainable pipeline outside 501. So those efforts, that's how we prioritize and keep the focus within the business units.

Can you remind us just quickly on your cash position and what your projected cash runway is? And if you could also just summarize, there's been a lot to digest from this fireside chat, and there's a lot going on, but in terms of next catalyst over the next 6 to 12 months?

So as of March 31, our cash position was $194 million. Our bond rate for the previous 3 quarters was about $25 million. So we have projected that our cash position is good well into 2022. So we will be able to achieve a lot of milestones that are planned. And these are the milestones that we expect, first milestone will be initiation of the Phase III trial for the dementia program. And focusing on that, it's a very large market opportunity, filing of our MAA application in the second half of this year. And then third, working with the FDA to get an approval by early next year for our NDA. And in addition, we will have the data, Phase II data readout for 701 program in the second half of this year. So we have very exciting second half of this year from multiple fronts. And we are looking forward to providing more updates on that.

And Vimal, maybe a last question for you that's a bit more strategic and looking into the -- into your crystal ball, but if we were to be doing this fireside chat 5 years from now in 2026, and hopefully, we would be doing this in Southern California and in person, what do you think BioXcel will look like? What do you hope it will look like?

One of the leaders in neuroscience space, particularly in the neuropsychiatric, and continue to assess where else our AI platform can make difference. What kind of problems can we crack? Using AI, we were able to crack agitation. That's our first proof of concept, what other things we can. And there is so much need. And as you might have heard that neuroscience is the next oncology, and we see so much unmet medical need. And with the support of the FDA, we will be able to initiate new programs. And I see a lot of opportunities in the neuro rare diseases. So down the road in 5 years, we will be able to unfold and see where we can make the impact using our platform and the capability we have built from AI all the way to commercialize.

Well, thank you very much. That was a great picture of what the company could look like. And with that, I want to thank you for being on this fireside chat with me. And I do want to thank the audience for those of you who have dialed into the webcast for joining. I wish you a good rest of your day and a good rest of our Goldman Sachs Healthcare Conference. Take care.

Thank you for hosting us.