Hello, everyone, and welcome to this latest in the Series of H.C. Wainwright @Home Company Discussions. My name is Ram Salvaraju. I'm a Senior Equity Research Analyst here in Wainwright's Equity Research Department and a Managing Director at the firm. I am joined by Vimal Mehta, Chief Executive Officer, Co-Founder, and Board Member at BioXcel Therapeutics, and Dusan Kostic, who is Senior Vice President of Clinical and Medical Affairs. BioXcel Therapeutics is a publicly traded company listed on the NASDAQ under the ticker symbol BTAI. We cover BioXcel with a Buy Rating and 12-month price target of $8 per share. Gentlemen, Dusan, Vimal, it's a pleasure to have you with us.
Thank you, Ram.
I think the most appropriate place to start is to just give our audience a very brief overview of the fact that BioXcel Therapeutics is a commercially validated, clinically and regulatory validated company that historically has focused on AI-driven drug reinnovation and has successfully brought to market a drug under the trade name IGALMI, which is a sublingual formulation of dexmedetomidine for treatment of acute agitation in the neuropsychiatric context. Now, this asset is currently the subject of an ongoing Pivotal Phase III trial, the SERENITY At-Home trial, which is rapidly approaching top-line data. Perhaps, Vimal, you could start by briefly describing the design of this trial and its primary objective.
Certainly. Good afternoon, everyone. Thank you for joining, and Ram, we want to thank you for hosting us today. It's a very fortunate time. We are getting ready, as you mentioned, for the release of the top-line data from the Pivotal Phase III trial related to schizophrenia and bipolar, which is being studied this time, 501 in the home setting. We are very excited. In terms of the trial design, it's about a 200-patient trial. Safety is the primary endpoint, and 100 patients are on the drug, and it is a placebo. We also have efficacy as an exploratory endpoint, where we are looking for repeat dosing, like the patient gets the benefit over a 12-week period. It's a 12-week study. It's on track to announce shortly, as we mentioned in our previous communication this month. We are diligently working, and we are on track.
Dusan, would you like to elaborate on the design and the patient populations?
Yes, absolutely. It is, as Vimal said, a 12-week trial. The patients are randomized, about 100 per arm, to placebo or to the BXCL501, 120 mcg. The efficacy is expected to be the same as in the inpatient setting, as the approved product, IGALMI. We are not required really to show formally efficacy. That is why the safety is the primary objective, as measured by the frequency of adverse events. The patients are staying in the trial for 12 weeks, and they are taking the product or placebo whenever they feel that they need to take something for their agitation.
As I recall, this trial has already successfully passed two Data Safety Monitoring Board reviews. As discussed, the top-line data will become available probably later this month. In addition, I wanted to ask about specifically what you are anticipating from a safety perspective, because as I understand, the 120 mcg dose of IGALMI, also known as BXCL501, has been extensively characterized already and is the basis for the approval that has already been granted in Institutional setting. Isn't that correct?
Yes, that is absolutely correct. The FDA just thought that because the original studies were done in Institutional setting, they just wanted to see that the safety is not going to be different when the patients take it at home. That is why the primary objective of the study is safety. What we are expecting to see is sort of a comparable safety profile to what we have seen in Institutional setting. Basically, we are also expecting not to see any—the bar that we are setting is around the serious drug-related serious adverse events, any syncopes, falls, and again, that internal comparability to what we have seen in the Institutional setting.
For avoidance of all doubt, in the context of Institutional setting, this drug has had a very favorable safety and tolerability profile. Clearly, it is based on a well-known existing active pharmaceutical ingredient, but which you are using in a novel formulation. The sublingual administration makes it highly convenient, also because of the dosage level that you are employing here, 120 mcg. In effect, you are administering a very low dose of this active pharmaceutical ingredient relative to the way it has historically been deployed as a short-acting sedative. In all likelihood, based on the existing real-world experience, as well as prior clinical development experience, along with what has been seen so far in the SERENITY At-Home trial, you should have very high confidence in the safety and tolerability, looking very benign.
Yes, we are confident, but we're waiting to see data. You are right, and most of the adverse events that we have seen in Institutional setting are really directly connected to the pharmacodynamic effects of the drug, to the expected effects. The most common adverse event was just somnolence, which means patients were feeling sleepy. That's like 22% of the patients on the 120 mcg dose. I should also preface that by saying that even those patients who were feeling sleepy, they could all be easily awakened and evaluated at that point. None of them were asleep to the point where they could not be aroused. That was the most common adverse event, and it is directly linked to the mechanism of action of the drug. Everything else was at a fairly much lower frequency.
As, Ram, you said, this drug is already in the market. We launched it. It is not only the clinical data from SERENITY I & II, which has 750 patients. In addition, we have done PMR studies showing repeat dosing for seven days. Now, we are going to be showing over a 12-week period. I think there is a lot of data for the 120 mcg, both in the clinical setting as well as in the real world. That is the basis that we chose this dose. Now, for the first time, we are not aware that ever a trial was conducted for agitated patients in a home setting in the U.S. We are very excited about our upcoming data readout and share the data with the street.
Now, I just want to revisit some aspects of the clinical trial enrollment process and the total number of clinical sites that have been used. As I recall, there have been roughly 22 clinical sites involved here, and none of them were responsible for enrollment of more than, I think, 10%-11% of the participants. Is that correct?
That is absolutely correct. 22 sites actually enrolled patients. We did have an operational limit on each site not to enroll more than 30 patients. None of the sites even reached those 30 patients. We were trying to be as evenly spaced as we could. Yes, none of the sites enrolled more than 11% of the patients.
In terms of the balance between patients diagnosed with bipolar disorder versus patients diagnosed with schizophrenia, what did that look like in this SERENITY At-Home trial?
I think they are pretty well balanced. We are waiting for the data log to make sure. I cannot give you exact percentages, but they were pretty well balanced.
Maybe, Dusan, you can give us a brief overview of the key exploratory efficacy endpoints in this trial, how those compare to the primary efficacy endpoint of PEG score that was used in SERENITY I & II, what the specific relevance is of these efficacy endpoints in the At-Home setting, and if you are anticipating observation of clinically meaningful impact on these endpoints, given taking into account the fact that they are classified as exploratory within the context of the SERENITY At-Home trial.
Yes, right. As you mentioned, the PEG was used in the previous trials in Institutional setting. PEG is well-defined regulatory endpoints that resulted in approval of at least three medications for use in agitation in Institutional setting: two antipsychotics, injectables, and IGALMI. That is something for which you need a trained rater. When you are administering a product at home in a study, you do not have a trained rater there. We had to come with some patient-reported outcome that would at least indicate whether the patients are deriving benefit or not to some degree. FDA agreed that it's impossible to really precisely measure any effects at home because there are no measures that have been validated, and there are no trained raters. That is part of the reason why these outcome measures are exploratory.
In consultations with the FDA and doing some qualitative research, we use the modified CGI. Normally, CGI, Clinical Global Impression Scale, has seven points. Because these are being administered by patients and caregivers as opposed to clinicians, we reduce that number to four points: 0, 1, 2, and 3, meaning no agitation, mild, moderate, or severe. FDA agreed that that would probably be more appropriate than using a full seven-point scale. We are using these modified CGI scales. We are asking patients when they experience agitation before they take the product to evaluate their level of agitation and to record it. Then two hours after taking the product, to again evaluate their level of agitation and record it. That way, we will have some idea about the benefits. These are patient-reported outcomes. They are not formally validated. There is no really formal statistical analysis that FDA required.
For all of those reasons, these are really exploratory endpoints just to help us define the trends, how patients are benefiting from the product, and to some degree, more importantly, whether the patients continue to experience benefit, whether they take one, two, or three doses, or whether they take 10 or 12 doses, and whether they take it in the first month or in the first, second, and third month. That is something that FDA was to some degree interested in, to see that the benefit does not go away with repeated administration. We have, as Vimal mentioned, already demonstrated that in a control setting for up to seven episodes in seven days. Now we are extending that to 12 weeks.
We are doing it with this relatively crude, to some degree, instrument that's patient-reported, but we are hoping to see trends of benefit that are not diminishing between the first few episodes and the last few episodes.
In terms of the likelihood of any preferential response between patients with schizophrenia and patients with bipolar disorder, maybe you can remind us of how the drug previously behaved in SERENITY I and II, how equivalent the clinical impact was in patients with schizophrenia versus patients with bipolar disorder, and if you are expecting to see a similar profile in the At-Home setting.
Yes, we have not really seen any differences between schizophrenia and bipolar in the SERENITY I and the SERENITY II. There was some difference with the 120 with the lower dose in terms of whether you would see the first separation, a statistically significant separation for placebo in 20 minutes or in 30 minutes. Other than that, looking at later time points, there was really no difference in the effects between schizophrenia and placebo. There was really no difference in adverse events. We don't really expect to see that in this trial, but we will be evaluating them separately as well.
Now, maybe shifting to the regulatory process, again, assuming pivotal clinical trial results that are in line with your expectations, maybe you can summarize the regulatory process. I understand, based on your most recent press release, that you are expecting to meet with the FDA also later this month. Maybe give us a sense of what you are hoping to take away from that regulatory interaction and how that is going to set the stage for the regulatory submission process and the timeline to achieve expansion of the label for BXCL501 into the At-Home setting within neuropsychiatry for treatment of acute agitation.
The questions that we wanted FDA to answer are mainly operational. They mainly had to do with the format and the content of the sNDA application. We also wanted to just reconfirm our understanding from our meeting with them last year that what we are doing in terms of clinical program is sufficient for filing of an sNDA. Those are the main points that we asked FDA for answers, and that's what we are hoping to get from them so that we are completely ready to start working on the sNDA as soon as we have the data in hand.
Ram, regarding your timing, we have already started working on the sNDA. Non-clinical sections have been already created. Once we have this data that we are expecting this month and is positive, we will be ready to write the CSRs as well as put the CMC package and will be ready to submit. Regarding the FDA meeting that's scheduled for next week on August 20th, we are expecting the preliminary responses prior to that meeting, and we will update the street on our update on the FDA.
We are moving two paths of getting to the data readout and being able to submit sNDA as fast as we can together, and they will coincide when data readout has happened and then once we have created the CSR. That's the kind of a part of the process. In terms of timeline, it takes about four to six months to prepare the package. Since this is the sNDA, it will be shorter than that. That's what we are hoping to achieve.
Maybe we can turn our attention now to the At-Home setting opportunity, how that differs from Institutional setting, and in particular, what kind of market opportunity in terms of size this would represent for BXCL501/IGALMI. Maybe you can just elaborate for us on how much larger the At-Home setting opportunity looks to be than the Institutional setting and what kinds of dynamics might drive market adoption, market uptake in this context relative to the Institutional setting.
There are three actually factors that would make this opportunity much larger than Institutional setting. One is that in Institutional setting, there are entrenched and approved treatments. They are not very pleasant treatments for patients. They are mainly injectable antipsychotics, but they do exist, and they are entrenched, while there is absolutely nothing approved for the outpatient setting for this treatment. That's one thing. Obviously, payers are a different issue. We are outpatient. We are talking retail market. Inpatient, we are talking mainly DRGs, which is problematic in itself. Regarding the size itself, we had said previously that the size of the inpatient market is around 16 million episodes per year and the outpatient market around 23 million.
It should be kept in mind that those 23 million episodes were calculated based on claims data, and claims data are to some degree unreliable because there are really few claim codes, and because there is nothing approved, there are many episodes that would not result in a claim. However, when you calculate those 23 million episodes per 1.6 million patients, you come to about 1.2 episodes per month per patient. We have market research that shows that that number is closer to three episodes per month per patient, which means a much bigger market. We also have a published scientific paper on almost 600 patients that indicates that the number of episodes patients are experiencing is actually around four episodes per month per patient. Again, a much bigger market.
We have right now a large number of episodes that we evaluated in our trial and that we reported in our trial. When you calculate that per month and per patient, it comes much closer to those market research and published survey numbers than they did to the original claims numbers. Even though we have the number of 23 million out there for a while, we do feel that the market opportunity is much larger.
Would it be reasonable just to try to quantify this a little bit further, to say that it's plausible that the At-Home setting market in terms of total number of agitation episodes occurring per year could be as much as three to four times as large as the institutional market, or is the difference even bigger than that?
If you put together the numbers as I just outlined and do the calculation, then you could probably say that.
Okay. With respect to deploying the drug in the At-Home setting, do you anticipate, you mentioned earlier some of the structural challenges associated with market uptake and market access reimbursement in Institutional setting, are there any different potential barriers to uptake that might exist in the At-Home setting, or is it just a clear highway, as it were, if you were to obtain regulatory approval for 501 in this context?
We're not aware at this point. I mean, obviously, the next step for us is going to be, once we have the data in hand, we will start talking to the payers, and then we will see what the barriers are, what the market access issues are, and so on. We assume that it's going to be much easier than in Institutional setting.
Our thinking is around that kind of in terms of home market, we are looking at there may be pricing flexibility. We put out a deck very recently on Monday, commercial deck. It has some of the parameters defined. If you think about all the neuropsych drugs, they are priced between $1,400 - $1,800 per month, including REXULTI. We are thinking that we may have a pricing flexibility, how we go about talking to the payers, and we may price it per prescription.
We may come up with a packaging in which a certain number of films are there based on their per month what is required and price for that package. We are looking at a different model compared to what the film was for Institutional setting where it was $105 and the box of 10 was $1,050. Because there, film is dispensed individually, and it's sold to the institution. Here, this will be sold to the patient. We are coming up with those as we get the data, and we will, as Dusan said, start the payer research very soon.
Just to turn attention to other treatments that are sometimes used to address agitation, my understanding is that REXULTI, brexpiprazole, is an atypical antipsychotic that is the sole agent with a label for chronic agitation but is not expressly indicated for use in acute agitation. Do you see any potential competitive applicability of REXULTI in the acute agitation context as and when BXCL501 gets to market, or do you anticipate that 501 is effectively going to be positioned in a fully distinct niche?
First, to be more specific, REXULTI is approved for agitation associated with Alzheimer's disease. Now we are switching from bipolar, schizophrenia to Alzheimer's agitation, which is fine, just to be clear. It's not only that REXULTI is specifically labeled for chronic use, it's also specifically labeled as not being appropriate for episodic use as needed. If you read its label, it specifically says that in its limitation of use. We do not see it as a direct competitor. REXULTI, as well as some of the other products right now, is approved. There are some other products right now that are being studied for chronic treatment of agitation. All of these products have an outcome measure of number of episodes. They are reducing the frequency of episodes, but they are not really preventing.
If you look at the clinical data, they are reducing the number of episodes, but they are not preventing those episodes. When these episodes occur, they are not indicated to treat those occurring episodes. That's where we would see our product coming in, if approved, to treat the breakthrough episodes that occur despite the chronic treatment with some of these other agents.
I just want to clarify that what we are talking is for Alzheimer's agitation. There is no drug approved in the home setting for schizophrenia, bipolar, by FDA. Ram, coming back to your question, we will have our own niche market to go after, which we believe is much larger than originally. We mentioned about 23 million episodes. I just wanted to clarify that there's no drug approved in the home setting.
Yeah, no, that's very clear. This provides an interesting segue into what may effectively be the next market opportunity for BXCL501, which, Dusan, as you said, is agitation in the Alzheimer's, in the dementia-related patient population, which is completely distinct from the neuropsychiatric context in which the drug is currently being positioned. Maybe we can talk a little bit about that. As you said, REXULTI is approved to treat chronic agitation, not episodic agitation in the Alzheimer's patient population. You have already looked at the feasibility of positioning 501 in the dementia-related acute agitation context.
Maybe talk a little bit about what your historical work has been in this area and how you are looking to position the product in this domain, and in particular, maybe highlight for us how you are differentiating the use of the product in dementia-related acute agitation versus neuropsychiatrically related acute agitation, with the special emphasis on the dosage that you are planning to apply in the dementia context.
Yes, so we had one Phase I/II study, TRANQUILITY I, some time ago, and based on that, we got breakthrough designation from the FDA. We started with Phase III study, TRANQUILITY II, that was done mainly in patients with milder forms of Alzheimer's that are living in the facilities of assisted daily living. We completed that study and had positive results from that study with a 60 mcg dose separated from placebo and having a safety tolerability profile that was basically comparable to what we had seen in patients with bipolar and schizophrenia. Those were promising results for the Phase III study. Based on that, we went to the FDA. The FDA saw the results of that study as well, and we discussed our path forward. They told us that we needed to do a second efficacy confirmatory trial.
As normal, you would need two efficacy trials to move forward with an application. We discussed the protocol with them. We wrote the protocol. The second study would involve not only these milder patients, but would involve also more severe patients. All of these patients would be in some sort of an in-care setting. It would be facilities of assisted daily living. It would be memory care centers. It would be nursing homes. Those are basically facilities where there are caregivers available who are professional healthcare professionals who can actually measure the efficacy aspect again, because we need to use this gold standard of a regulatory measure. That's why we need to do the second study in the in-care setting as well. Hopefully, if everything goes well with the in-care setting, we can move.
The next step would be to move for the home setting, where we would have to do then only, most likely, we would have to do only a safety study. Right now, probably there are more patients who are living at home in terms of market. At the same time, patients who are living in the in-care facilities are experiencing a greater number of episodes per patient. It's about in terms of episodes, it's about 50-50. Just to mention that even though we would be looking for the first approval in the in-care facilities, that's not the same as the institutional facilities for bipolar and schizophrenia. These in-care facilities for Alzheimer's patients, the market would be retail.
We wouldn't be in this situation where we have to get on the specific institutional formularies and where using our product would potentially take away from the total amount of reimbursement that the institution is getting. This would be a retail market from that perspective. In terms of where we would fit, all of our studies, all of Phase III studies are done on the background of existing therapies. Even though REXULTI is the only one that's approved, patients are frequently on other antipsychotics or other agents that are used for chronic treatment of agitation, for chronic reduction in episode frequency. All of our trials are done on the background of those. The episodes that we are seeing and that we are treating are actually breakthrough episodes that are happening on top of the treatment that's already there. Your last question, I think, was around the dosing.
We did a number of pharmacokinetic studies, and we found out that patients with Alzheimer's disease actually have higher exposure to the product than patients in bipolar or schizophrenia space. This is why, coupled with general greater sensitivity of older patients to pharmaceutical products, we reduced the dose that we studied to 60 mcg. We actually tried both 40 mcg and 60mcg in the first TRANQUILITY In-Care trial, in the Phase III study. Forty mcg did not separate from placebo. , 60 mcg did. The next Phase III study will be done with 60 mcg.
In terms of how you characterize the 60 mcg dose profile versus the 120 mcg dose profile, my understanding is that historically, your experience with dose-ranging studies using BXCL501 has indicated a relatively predictable dose response curve, and that the 60 mcg dose has clearly demonstrated clinically meaningful impact and activity already, specifically in the context of the dementia-related acute agitation indication in which you expect to position it. Maybe give us a little bit more flavor regarding the 60 mcg versus the 120 mcg and some of the key characteristics of the 60 mcg dose that might make it particularly well suited for applicability in the dementia-related agitation population.
Your specifier was absolutely correct. The 60 mcg dose, we had positive data in Alzheimer's population. We actually do not have positive data with 60 mcg in bipolar schizophrenia population. As I mentioned before, it's really due to the pharmacokinetic profile of the drug. That 60 mcg dose in Alzheimer's patients maybe corresponds to 100mcg-120 mcg dose in schizophrenia bipolar patients. From that perspective, you would expect the profile to be very similar to the profile of a 120 mcg dose in younger bipolar schizophrenia patients. There is really nothing, you know, magical, very different in the 60 mcg dosing range. It's just that the patients are different, and those patients seem to be having a greater exposure. Pharmacokinetics is different. You are pretty much looking at the similar exposures in these Alzheimer's patients with 60 mcg, as with bipolar schizophrenia patients with 120 mcg.
You would expect the same frequency of the same, you know, the same degree of comparable efficacy and again, comparable tolerability. As I said, we have actually seen a relatively comparable tolerability in Phase III Alzheimer's trial with 60 mcg, as we did with 120 mcg in our pivotal trials.
Thanks. That's very helpful. I just wanted to recap, you know, one thing that I think you alluded to earlier, that in effect, the sequence of clinical development and regulatory interaction that has taken place so far with IGALMI/BXCL501, positioning the drug first in Institutional setting and then moving to the At-Home setting, effectively represents a good precedent case, a good template, as it were, for the development of the drug in the dementia-related acute agitation context. Because, as you mentioned before, there are two distinct target market contexts here. One is the long-term care, the in-care facility segment, and the other would effectively be the At-Home segment. Is that an accurate rendition of the situation?
Yes, and that is to a large degree driven by operational inability to really effectively measure the effects on agitation or the degree of agitation at home. You really need some sort of a trained rater to do that, and you cannot really do that at home unless you want to somehow helicopter raters in every time an episode happens, which would be really prohibitively expensive. You can do it in institutions. You can organize it like that. When you look at the other drugs that have been, as I mentioned, there are two or three, there are actually three injectable antipsychotics that are approved for obviously emergency room use for agitation. They have all been measured in the institution. That is why also probably to some degree, there is nothing that has ever been approved at home. This way, you measure it correctly.
You do everything that you can in a scientific way in a controlled setting, and then you move it to home just to show that at home, patients can take it and that they can take it safely. It is a pretty good pathway. It is a pathway that we are taking now with bipolar schizophrenia, and it is a pathway that we are planning to take in the future with Alzheimer's.
Just again to revisit one aspect, which is the total number of acute agitation episodes when you look at both the neuropsychiatric context as well as the dementia-related context. Could you maybe give us some sense of what your market research has revealed so far with respect to that number? I know we previously talked about the 16 million episodes in Institutional setting, the 23 million or likely significantly more based on claims data, based on what we expect to be the situation with regard to unreported episodes. What about if you add to that the dementia-related acute agitation episodes that occur each year? Are we talking about potentially a number as high as 100 million a year? Maybe just give us some context around that.
That number can be as high as 140 million- 150 million with current estimate. $16 million, as you said, in Institutional setting, $23 million, which is much bigger as we outline in our commercial deck this week. And in Alzheimer’s itself , our estimate is $100 million episodes. You're talking about 140 million- 150 million episodes without taking into account the new research that has come from the schizophrenia market.
Great. That's very helpful. Broadly speaking, when you look at the At-Home setting, whether it's within the context of dementia or in the context of neuropsych, how does this fit into BioXcel Therapeutics' own commercialization strategy? What are you thinking about in terms of potential strategic scenarios regarding how best to optimize the value of the drug in that At-Home context, in particular, of course, within the U.S. market? What might be some approaches you could take to maximize the value of the drug, but also maximize at the same time capital efficiency and cost effectiveness?
Great question, Ram. That is the next question we are thinking and addressing or need to address. That, how are we going to commercialize this product in the home market as we get that data readout this month and we put an sNDA package? That is the next natural step. There are a couple of options. We know how to build this infrastructure. We have done it for Institutional setting. If you will see our deck that we laid out, it's not a heavy lift. It's a 50 - 70 people sales force, but there may be some DTC required depending on what we are learning that this is a big market.
In that scenario, we could benefit a lot by having a strategic partner who already has a footprint and a stronger balance sheet so that we can bring this medication to a more number of patients, and as you said, in a capital-efficient manner. Currently, BioXcel is a small organization with 30 people, and we are keeping the strength of the organization in clinical development and regulatory approval. That's where we have proven ourselves. Those are the choices we'll make with our board. What is the optimal way of maximizing the value of this asset, which is a really large opportunity for our shareholders? Everything is on the table, and we are looking at all strategic options.
When you think about the costs associated with getting BXCL501 to market in the At-Home setting, in the neuropsych domain, and in both the in-care, long-term care context, as well as the At-Home setting in dementia, maybe contextualize for us a little bit, how much additional capital would be required in order to complete clinical development in those settings?
We haven't given any guidance what the cost of our trials is. Per patient costs are pretty manageable because this is an acute treatment, and you can measure it. Now it's even lower when you are doing this in a home setting because you don't need the in-care or the infrastructure. I would say these are quite cost-efficient trials, particularly the SERENITY At-Home trial, because it did not have any much efficacy component. It was primarily a safety. If we move to the Alzheimer's trial, trial costs can double there compared to our current trial in terms of the per patient cost. The reason is because there we are measuring the efficacy in those in-care, and you need to send or have the trained raters who will do the PEG measurement.
Overall, if you look at it in the context of the neuropsych or in the context of the development, we feel our trials are a lot more cost-efficient. Current focus continues to be on SERENITY, announcing the data readout, filing the sNDA, coming up with a commercial strategy. Once all of that is streamlined, now, as I mentioned, we have a small team who was completely focused on execution for this SERENITY At-Home trial. Now we will be able to move those resources when we get ready to initiate Phase III, what we call as a TRANQUILITY In-Care trial, which Dusan already mentioned. We have an alignment with the FDA in terms of the protocol. We are currently in the process of evaluating CROs, and we will be able to freeze that very shortly if we choose to initiate that trial.
Just correct me if I'm wrong here, you ended the second quarter with roughly $18.6 million. You indicated in your most recent press release that you brought in, after that time point, as of the end of June, roughly $11.5 million in gross proceeds from ATM-based stock sales and another, if I remember correctly, $3.6 million from warrant exercises. I just wanted to ask for some additional contextualization and granularity with respect to how you're feeling about your balance sheet strength and to what extent you feel that the company is adequately resourced to address the near-term objectives for BXCL501, in particular, the completion of the SERENITY At-Home trial, which is entering data analysis right now, as well as the assembly of the sNDA, the submission of the sNDA, and the period between sNDA submission and hopefully acceptance, and the ultimate FDA approval decision.
That's correct. The numbers you outlined are the right numbers, which we reported this week. In terms of how far it can take us, we obviously comfortably can announce the data readout, which is expected this month, plus do the construction or preparation of the sNDA and get it ready to file. Those are the two key focus with the capital we have in hand, and that's where we think is a near-term, as you mentioned, value driver for the company. We will continue to explore opportunities to make sure that we can, like, you know, if we need to go to the approval as well as initiate the Alzheimer's trial, we have a path developed to be able to achieve those goals. This is work in progress.
Right now, focus is on two things: announcing the SERENITY At-Home data, as you said, it is in the database log and analysis stage, and then prepare for the FDA meeting and stay tuned. We'll be ready to provide the update very shortly on both ends.
Great. Let me just ask two more quick questions as we are now winding down on time. Firstly, I wanted to ask about your broader strategic vision for the company. You mentioned previously that there are a number of different scenarios that could be envisaged with respect to optimizing the value of BXCL501 in as capital-efficient and cost-effective a manner as possible, maybe taking advantage of already existing established commercial infrastructure that might be the responsibility of a third party that you could work with in order to introduce the product in as optimized a manner as possible for the U.S. market. Maybe give us a broader spectrum view of how you see the company being optimally positioned to unlock value for shareholders.
Great question. In terms of unlocking the value, getting to the SERENITY At-Home data, top-line data, and trial being positive, filing the sNDA, that's a very near-term goal in terms of unlocking the value and developing a path for commercialization, which is equally important. We have some time for it, another 16- 18 months by the time drug will get approved. We will be developing this strategy for that. In terms of clinical development and approval, we believe Alzheimer's agitation is again a low-hanging fruit. We already have one Phase I/II study. We got the breakthrough therapy designation, and then we have one Phase III study. We just need to conduct another Phase III study. That will be a big value driver because market opportunity is so huge, and we are very uniquely positioned to treat acute treatment of agitation.
I think having those two areas, schizophrenia, Institutional setting plus home setting locked in with our product, and then being able to expand into a new indication, which is Alzheimer's agitation. In addition, as you are aware, there can be chronic application for this product because of the central mechanism. There are some ISTs being run to find the clinical signal. If those clinical signals are positive, there could be an opportunity to expand its use into the chronic application. I think for a small company like us, we have a very major product in our hand, and our goal is as much as we can handle, we will handle ourselves. If we need help, we'll bring the external help.
You know, I also wanted to just briefly touch upon two other aspects which frankly are quite underappreciated right now in the context of the broader BioXcel story. Firstly, while we can clearly see evidence that BXCL501 is a pipeline and a single product just based on applicability within the neuropsych context and the dementia context from the perspective of acute agitation, there are a number of other indications in which this product candidate can be explored, can be leveraged. Vimal, you alluded to some of this, you know, which you can effectively establish the validity of through investigator-initiated trials. I wanted to maybe explore with you the rest of the AI-driven engine at BioXcel .
Ultimately, as you look to the longer-term future, past the point when BXCL501 is an established commercial franchise, how you could conceivably generate even more value for shareholders as you look to leverage the AI-driven engine that was the origin of BioXcel Therapeutics in order to identify, optimize, and advance even more drug reinnovation and drug repurposing opportunities.
Ram, we would love to be in that situation because that's in our DNA. As you know, our ticker symbol, we have BTAI. AI was coming from the augmented intelligence or artificial intelligence. As all of you know, we became a public company in 2018 with a very different pathway than the way we were in public. We were supported by the public investors directly without having much venture capital or crossover funding. Everybody was very excited that there could be a platform or a mechanism to bring these drugs to the market space faster. That's exactly what we tried to do. Our drug 501, which became IGALMI, first in human to all the way to approval, it was a 3.5 year.
We really have proven that you can use AI and our expertise to identify the drug, take the drugs which have been there, use their mechanism to write a new story on them. We were very fortunate that we got the approval from the FDA. It proved the concept. Now we are in a phase where it was land, which we landed with IGALMI and then expand. We're expanding into the home setting, and then we are expanding into new indications. We do have an AI engine producing additional pipeline candidates like 502, 503. 502 is a candidate which was a drug, again, failed. It was a Pfizer medication, Alzheimer drug in which I think a lot of capital has gone in. It failed for Alzheimer's for cognition. Using AI and our expertise, we identified that using secondary endpoint that we can use this for treatment of chronic agitation.
Drug is given three times a day. We are adding a metabolic stabilizer to change its PK profile so it can be given once a day. We had to pause the program at that point because we did not have the resources. We needed to bring all our resources to the SERENITY At-Home trial. We would love to be in that situation where we can take advantage of our experience, our platform, our team, integration with data scientists, which is under one roof, to be able to come up with more candidates and unlock more shareholder value.
Of course, I would be remiss if I did not remind our institutional investor audience who are hopefully listening here today that, in fact, you also tried your hand at oncology-focused drug development and established a subsidiary called OnkosXcel Therapeutics for the development of a drug candidate aimed at addressing several solid tumor types. Ultimately, that still represents a potential future way to unlock further value, a potential future value driver, although that's not obviously the focus of BioXcel at this point in time. Are there any other items that you wanted to address with our institutional investor clientele? Points to note regarding BioXcel that you think they would be well advised to take into consideration?
I think a lot has been discussed in this fireside chat. I would like to give a message that the company decided to extremely focus on the clinical trial and execute well because that's our strength and that's what got us the approval. It's straight-shot approval within 3.5 years. We have gone back to our roots, and that's exactly what we are doing with this upcoming data readout that's scheduled this month in terms of that clinical execution as well as working in collaboration with the FDA to see how we can bring this drug into the marketplace. Please stay tuned. We will be providing you updates both on the clinical trial and showing you the data once we unblind the data as well as our interaction with the FDA to file sNDA.
Those are our short-term focus, and they are the biggest driver in a very short term while we have opportunities to unlock the value long term.
Really want to thank both of you, gentlemen, for taking the time today to walk us through the BioXcel Therapeutics story. Certainly a very exciting time for your company, and we look ahead with great anticipation to the top-line readout from the SERENITY At-Home trial as well as your interaction with the FDA scheduled for later this month. Once again, thank you very much, gentlemen, and thank you to our institutional investor audience for taking the time to listen in.
Thanks.