Good morning and welcome to the BioXcel Therapeutics SERENITY At-Home Phase III Top Line Results Conference Call. At this time, all participants are in a listen-only mode. If during the conference you require operator assistance, please press star zero on your telephone keypad. After the presentation, there will be a question and answer session. If you would like to register a question, you may press star one on your telephone keypad. Just to remind everyone, certain matters discussed in today's conference call and/or answers that may be given to questions asked are forward-looking statements that are subject to risks and uncertainties related to future events and/or the future financial or business performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements.
Risk factors that may affect future results are detailed in the company's quarterly report on Form 10-Q for the quarterly period ended June 30th, 2025, which can be found at www.bioxceltherapeutics.com or on www.sec.gov. As a reminder, today's conference is being recorded. Joining us today on today's call are Dr. Vimal Mehta, Chief Executive Officer; Richard Steinhart, Senior Vice President and Chief Financial Officer; Frank Yocca, Chief Scientific Officer; Dusan Kostic, Vice President, Medical Affairs Strategy; and Dr. Matt Mandel, Vice President, Clinical Development. We will also be joined for Q&A by Dr. John Krystal, Robert L. McNeill, Jr. Professor of Translational Research and Professor of Psychiatry, Neuroscience, and Psychology at the Yale School of Medicine. It is now my pleasure to turn the call over to Dr. Mehta, the CEO and founder of BioXcel Therapeutics.
Thank you, operator. Welcome, everyone, and thank you for joining our call today to discuss the results of our SERENITY At-Home Pivotal Phase III safety trial. The 120mcg do se of BXCL501 was well tolerated in patients with episodes of agitation in the outpatient setting and met the primary objective. This outcome was observed across repeat dosing and through the duration of the trial. We are extremely pleased to share our trial outcome, which we believe represents a significant milestone in bringing a new treatment option for home setting in the bipolar disorders or schizophrenia-related agitation. Agitation associated with bipolar disorders or schizophrenia is a debilitating condition for patients and threatening for healthcare providers. Current treatment approaches are suboptimal, and there is no FDA-approved therapy in the home setting. Most episodes of agitation occur at home and may escalate to the severity that requires emergency room visits.
The early intervention in the home setting may potentially prevent escalation of symptoms, reducing the visits, hospitalizations, and use of emergency interventions. Our initial estimate of 23 million agitation episodes at home was driven by claims data, which we believe are likely underreporting the incidents. Our market research, as well as a published patient survey, suggests an average frequency of three to four episodes per month, representing a larger market opportunity. We believe patients experience an estimated 57 million- 77 million agitation episodes in the home setting annually in the United States. The number of episodes observed in our at-home trial is in line with the frequency of agitation episodes. With today's positive data, I want to take a step back and look at our holistic SERENITY program.
We observed favorable and consistent efficacy and safety data across two SERENITY trials, SERENITY II and II, which resulted in approval of IGALMI at the 120 mcg and 180 mcg dose in medically supervised settings. To support the potential label expansion for home use, we conducted the SERENITY At-Home Pivotal Phase III trial. We are pleased with the results obtained today and preparing for the sNDA package for plan submission in Q1 2026. As a reminder, the focus for expansion of the IGALMI label is on the 120mcg dose, the lowest approved and marketed dose. With that, I will now like to turn the call over to Matt.
Thank you, Vim. Good morning, everybody. There are no FDA-approved therapies for agitation associated with bipolar disorders or schizophrenia in the at-home setting, and the SERENITY At-Home trial is a pivotal step on the journey to bring new treatments to an unmet need with a label expansion of IGALMI. As a reminder, IGALMI is FDA-approved at 120 mcg and 180 mcg for the acute treatment of agitation in these populations, sublingual or buccal, with use today occurring under healthcare supervision. Our At-Home study evaluated the approved 120mcg dose. Across this study, we acquired data on 2,628 agitation events with more than 2,400 treated episodes. On average, patients treated 11.6 episodes. Patients self-administered all doses successfully, indicating that though they were experiencing agitation, they can reliably administer the film. Agitation is unpleasant for patients, and they're motivated to treat it.
BXCL501 was well tolerated across multiple administrations throughout the duration of the trial, with no drug-related serious adverse events, no excessive sedation, and no falls. The overall adverse event profile was remarkably consistent with the approved IGALMI label. Additionally, patients experienced consistent benefits with repeat dosing throughout the study. Adults with schizophrenia or bipolar disorder living at home were randomized one to one to take BXCL501 120 mcg or a matching placebo. The primary objective was to describe the safety and tolerability of use when needed over a period of 12 weeks, with an exploratory assessment of continued benefit. Patients with and without reliable informants, like family members, were enrolled. By design, the study captured safety data in the context of outpatient use to reflect common strategies that patients use to treat their agitation.
Patients were allowed to employ alternative interventions, which commonly include other medications, meditation, exercise, alcohol, or cannabis. This was a rigorous outpatient study, which required multiple contacts every week for investigators to monitor patient safety and record episodes. Enrollment included eligibility reviews to ensure each patient met all inclusion and no exclusion criteria. Adults aged 18 to 75 were enrolled with schizophrenia or schizoaffective disorder or bipolar I or II. All were on stable psychotropic regimens for at least 30 days and experienced three or more agitation episodes in the prior three months. Patients were excluded if they had unstable medical illness, had moderate or greater substance abuse, or agitation driven primarily by acute intoxication. Baseline characteristics were balanced between treatment and placebo. The mean age was approximately 47 years old in both groups, with sex, race, and ethnicity evenly matched. Diagnoses were evenly split between schizophrenia and bipolar disorder.
About 20% of patients had an informant or caregiver. The average time since diagnosis was approximately 17 years, which reflects the fact that these patients are familiar with agitation and how they treat it. This study captured 2,437 agitation episodes experienced by 208 patients. 81% of those patients completed the full 12 weeks. On average, patients experienced 11.7 treated episodes each, and each patient was able to successfully self-administer the film. Overall, BXCL501 was well tolerated in the at-home setting. Importantly, there were no discontinuations due to drug-related adverse events or tolerability. The adverse event profile was consistent with the approved IGALMI label, with no new or unexpected treatment emergent adverse events identified. There were no drug-related serious adverse events, with no falls or syncope events in the BXCL501 arm. All treatment emergent adverse events were mild to moderate in severity. The drug was well tolerated across the 12-week period.
Somnolence was the most common adverse event at 22% overall incidence in the single-dose pivotal SERENITY I and II trials, which formed the basis of our label. As predicted in this outpatient study, somnolence was once again the most common adverse event, with overall incidence of 22%, which matches the incidence in SERENITY I and II. With repeated dosing, as shown in the last two columns, there was an even lower incidence of somnolence. This held true for the incidence of other TEAEs, as incidence for first dose was comparable to the single-dose SERENITY I and II trials. The adverse event incidence remained low with repeated dosing. This table shows treatment- emergent adverse events broken out by number of doses. The columns show adverse events over doses 1 to 3, 4 to 12, and 13 or greater. The incidence of adverse events does not increase with increasing use.
For example, somnolence being the most common adverse event does not increase, but actually appears to decrease with repeat use. In fact, most treatment- emergent adverse events, the incidence of those tends to decrease over repeated dosing. As you can see, when broken down by study week from the first four to the last four weeks, and as reflected in this table, the incidence of TEAEs did not increase over the three-month trial period. Somnolence, paresthesia, dizziness, and dry mouth all showed a similar pattern of reduced incidence over time. Data from more than 2,400 episodes includes patient and informant assessments of agitation. Our exploration of this data demonstrated that BXCL501 was well tolerated and provided continued effect and consistent benefit across repeat dosing over the 12-week trial. Complete analyses of the full dataset are ongoing. In summary, BXCL501 was well tolerated with multiple repeated dosing across the trial.
Outpatients successfully self-administered the film as needed for agitation at home. There were no discontinuations for tolerability, and the incidence of AEs were remarkably consistent with the current label. While we have focused on analyzing this large safety database, we look forward to presenting the full dataset, including exploratory endpoints, in the near future. Now I'll turn it back to Vimal.
Thank you, Matt. As our next steps, we will share our data. It's a lot of data on over 2,400 episodes that we have collected that were treated in multiple scientific presentations. We have already started compiling the sNDA for it's a work in progress, and we plan to submit it in Q1 of 2026. In parallel, we are developing our commercial strategy. If this drug is approved, how are we going to bring this medicine to millions of patients who are in high unmet need in the home setting? Thank you all for joining us today and for your continued interest. The results we have shared mark an important step forward in our commitment to patients, family members, and advancing a label expansion for BXCL501 in the home setting.
We remain focused on the path to the sNDA submission and look forward to keeping you updated as we move ahead. Thank you again.
Operator, thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, for your first questions. Our first questions come from the line of Elemer Piros with Lucid Capital Markets. Please proceed with your questions.
Yes, good morning. Congratulations. My first question is regarding your observation of the number of episodes per month. I think the previous reference of one to two episodes came from Symphonic Claims. How reliable were those estimates in your view? The current observation of three to four episodes per month, is that congruent with your previous post-marketing study that you conducted?
Yes, hi, thank you for the question. We do feel that the estimate based on the claims data is actually underestimating the number of episodes, mainly because there is nothing approved by the FDA. For the claim for something to be in the claims, there needs to be either prescription or a contact with a healthcare provider. We thought that the more appropriate and more accurate measurement was done in market research. We did a market research with about 80 patients, and they indicated that they are experiencing about three episodes per month. There is also a patient survey published in a medical journal that looked at about 500 or 600 patients, and they also indicated that their average number of episodes per month is actually closer to four, somewhere between three and four, but closer to four.
The number of episodes that we are seeing in our study is fully in line with that three to four number.
Thank you, Dusan. The second question is about your preliminary assessment of the efficacy of the drug. I think you used the modified CGI or Global Impression of Severity scale. If you could tell us a little bit more of how it's done, what does this scale look like, and how does it compare to when a physician assesses the efficacy in the office?
Yes, sure. We couldn't really send the trained raters to patients' homes when they had episodes. We couldn't really use the same instrument that we used in our original SERENITY trials, which does require a trained rater, a healthcare professional. We were looking at what to do. We did some qualitative interviews, and also in discussions with the FDA and with the patient groups, we realized that a simple scale on a scale from zero to three would be most appropriate for use in this patient population. We are talking about zero being no agitation, then one being mild, two moderate, and three severe.
Patients would basically just evaluate and assess and say, my agitation was, let's say, severe or moderate at the beginning of the episode, and two hours later it was, you know, it either stayed the same, got worse, or it became mild, or there was no more agitation. That was the scale. How it compares, obviously, it's not a trained rater. A trained rater would probably give a better assessment. What's also very important, the scale, the PEC scale that was used for initial approval goes from five to 35. It's very granular. It has five items. It's much more precise for assessment than this scale, which is not that granular.
My last question here is, there were discontinuations, and you mentioned that those were not due to treatment-related or adverse events. What were some of the examples for discontinuation?
As usual in this patient population, and by the way, this rate of discontinuation is really good for this patient population over three months. As I said, as usual, the most common reason for discontinuation from the trial is lack of follow-up. The patient moved, did not show up at the site, and so on. That's the most common reason. There was a number of reasons which encompassed one or two patients only, or three, like three patients got pregnant, some patients didn't follow the protocol, and so on. There were no discontinuations for any drug-related events, be it tolerability or efficacy.
Thank you. I'll get back onto the queue, but maybe a follow-up if we have time to the physicians on the call. What are some of the off-label alternatives? Obviously, there is nothing approved at the end of your at-home setting. If they could explain or explore that topic. Thank you.
Yes. Essentially, the options out there are antipsychotics or benzodiazepines, both of which, you know, have their downsides, if you will. You know, nothing approved, as we have previously stated.
Thank you so much.
Thank you. Our next question has come from the line of Ram Selvaraju with H.C. Wainwright. Please proceed with your questions.
Thanks very much for taking my questions, and congratulations on this data. Very important landmark development for the company. I just wanted to ask about what your current thinking is regarding the FDA stance with respect to the at-home setting, particularly as the agency looks at ease of use in the at-home context. If you can highlight for us any practicable differences with respect to at-home administration of this product versus the institutional setting.
Good morning, Ram. We announced very recently, I believe on August 16, that we got an alignment with the FDA. We had a planned meeting with the FDA for August 20th. We received our preliminary meeting comments, and when we looked at that, our goal was to get an alignment on content and format, what is needed to submit an sNDA. We ultimately decided that this meeting is not required anymore, and the meeting minutes we received become the official record. In terms of what is needed for the sNDA, this phase III trial, which we announced the results at home, is paramount and critical, and we are very pleased with the results we have received in terms of the tolerability for the drug that we announced. We will analyze all this data and submit to the FDA.
In addition to that CMC package, there is one difference between the in-care setting and the home setting. In terms of the pouch which holds the film, it is child proof, so patients have to cut it in the home setting, and you saw that we recorded more than 2,400 episodes where patients self-administered the drug. That is very encouraging. Third is the non-clinical section, which we have already written up for the sNDA, and once CSR is ready, and some of the data for the CMC that we will put together, we will submit the sNDA package to the FDA.
Thank you very much. Can you comment at this juncture, based on the strength of the data so far and existing familiarity with the 120 mcg dose, how you are thinking about commercialization options at this point in time? Have there been any developments in your thinking on that front as you look at the U.S. market, particularly in the context of the previous commercial history with BXCL501 ?
We have been focused on completing this phase III trial. Now this trial has been completed, and we are very pleased with the results we have received. Our next focus is sNDA submission, as I mentioned, and then develop our commercialization strategy, which can be a multi-prong strategy, which could include working with some strategy partners who may have established footprint to 50/50 relationship to self-be doing the commercialization. At this point in time, we are keeping all options open, and as we progress, we will update that which is the most optimal option. As you saw, the number of episodes in the home setting is large. Plus, we have a drug already approved in the institutional setting. We want to make sure we have the right kind of a footprint to bring this medicine to as many number of patients as efficiently we can.
Great. Lastly, I just wanted to ask about, as you're thinking about future indications for BiBXCL501 , beyond the schizophrenia and bipolar disorder context, and especially within the context of treatment of acute agitation episodes in patients with dementia, maybe you can comment for us on not only the ramifications for future development coming from the SERENITY At-Home trial and being able to define safety in this at-home population and what implications that might have for the future clinical development path of this asset in the dementia population with acute agitation, but also the FDA stance as it has pertained so far to BXCL501 , in the neuropsychiatric setting and how that provides a potential template for the cost-effective development of BXCL501 , in the future in dementia patients.
Alzheimer's agitation, as we all know, is a very large unmet medical need. Our estimate there is even bigger than the schizophrenia bipolar, almost more than 100 million episodes, what we know today are our estimates. Already in that program, we have one positive phase III trial demonstrating the safety and efficacy for 60 mcg dose. That's extremely encouraging. We have alignment with the FDA to initiate a second confirmatory phase III trial using the 60 mcg dose. We have a protocol agreed. It will be a 150-patient trial with 75 patients in each arm. The only difference compared to our previous TRANQUILITY phase III trial is that we will be using all kinds of Alzheimer's patients. In our previous TRANQUILITY trial, two trials, we had patients who live in the assisted living facility. Now it will encompass assisted living facilities, memory care centers, as well as nursing homes.
This will include all kinds of spectrum of agitation, whether it's mild, moderate, or severe. Since we have demonstrated one positive phase III study, we are ready to go and start our second phase III study. We are currently evaluating our CRO choice, and we have the protocol in alignment. Now, having completed the SERENITY At-Home trial, we will have internal resources available to be able to initiate that trial. It's a very exciting program. It's a large opportunity. Considering that we have already demonstrated now safety in a home setting for the first time, until now, all our trials, which are over 10 trials, were conducted in the institutional setting. It's a very major milestone for a drug that was sitting in an ICU unit, and then we brought it to the institutional care, and now it's going in the home setting.
It's a very major step, and safety data is extremely encouraging. We are very much encouraged. The initial next phase III trial will be in the in-care setting, like as I mentioned, ALF, nursing home, or memory care. Once we demonstrate the phase III data, then we will conduct a similar kind of a home setting trial in Alzheimer's agitation, which will be again, we'll get an alignment with the FDA. It will be a safety trial so that we can cover patients who live in the home setting and patients who live in the in-care. All of us know most of the biggest reason for Alzheimer's patients to go in the nursing home or ALF is agitation, not their underlying disease, Alzheimer's. It's a very major step, the data we received today, to have conversations with the FDA.
Thank you so much, and congratulations again.
Thank you, Ram.
Thank you. Our next questions come from the line of Gregg Moskowitz with Mizuho Securities. Please proceed with your questions.
Hi, good morning. Thank you for taking my questions and congratulations on the data for this at-home study. My question really has to do more about the company and where it currently stands with regards now having the data in hand, what kind of options the data open up for the company, especially in light of where the company is currently with respect to its cash balance, current OpEx spend. Could you give us a sense of what kind of financial options or opportunities this might open up for the company, given I believe your cash levels may currently be supportive of a runway through maybe the balance of the year, but maybe not beyond.
If you're looking at a filing in terms of the first quarter of next year and on the assumption there's a 10-month review for that sNDA, just can you give us a sense, Vimal, of kind of the strategy around financing the company? Thanks.
Hi, good morning, Gregg. That's a very good question, and we continue to evaluate various options. Having this data, positive data, opens up multiple optionality for the company in terms of bringing this medication to the patients. That could include strategic partnering, that could include royalty deals, that could include financing. All options open up. We are very pleased that we have multiple options, and we will work in the interest of our shareholders to maximize the value, the option that will deliver the value. Today, we are very excited that we have this data, and we are on the journey to bring our current drug, IGALMI, and expand its label in the home setting. I would say that it's a very exciting day for the company to have all these options opened up, and we will provide the street update as we move along.
We will be very pragmatic about it, what makes sense to maximize the value for all shareholders.
Just as a follow-up, if I could, just on this topic, you've got the data in hand. It seems to me that the next key event for the company will be the submission of the sNDA. I don't recall any other data events throughout the balance of this year. With that in mind, third quarter results typically get announced by the company in November. I'm wondering if we should be expecting or planning an update from the company before you next announce third quarter results.
I don't think, Gregg, I will be in a position today to announce what updates we can provide. We will be working and have been working on multiple options, and they are in front of us, and we will decide what makes most sense.
Thank you very much, and congratulations again on the data.
Thank you, Gregg.
Thank you. Our next questions come from the line of Sumant Kul karni with Canaccord Genuity. Please proceed with your questions.
Good morning. Nice to see these data, and thanks for taking our questions. I have three questions, two for the company and one for Dr. Krystal. I'll start with the one for Dr. Krystal first. In real-world use cases, at what point in an agitation episode do you think it would be optimal for a patient to use this product, and what percentage of agitated patients that present themselves to you would you prescribe this product for?
Sumant, we are just checking if there is any technical difficulty. I want to see if Dr. Krystal is on the call.
Sure. Can you hear me now?
John, your line is now live, yes.
Okay, great. Sorry. All right. I apologize for the technical glitch there. First, I think it's important to take a step back and say that agitated behavior is among the most disruptive kinds of behaviors that can happen in home. It not only motivates patients to seek higher levels of care, such as emergency rooms and inpatient hospitalization, but it can profoundly undermine the relationship of patients and their caregivers and actually destabilize home living situations as caregivers feel threatened or frightened about managing these challenging clinical situations. Sometimes this can lead patients to have to leave their current living session and find other places to live. It's a very high-priority issue. The question about the optimal timing of dosing in episodes of agitation is an important one because obviously the goal is to prevent these blow-ups from occurring at home, which can have such negative consequences.
As patients are experiencing rising distress and feeling themselves become agitated at the early stage is when you want people to be intervening to stave off these episodes of agitation if possible. It's my sense that patients can monitor themselves and caregivers can provide constructive feedback. One of the nice things about IGALMI, given its tolerability and safety profile, is that it's an intervention that's likely to be used. Adjunctive antipsychotics, when used for agitation, and sometimes even the benzodiazepines carry with them certain side effects that patients sometimes find unpleasant and making them less interested in taking these extra pills when they're experiencing an episode of agitation. I think that's really an opportunity for IGALMI to be utilized in these episodes of agitation. The question about what % of patients would it be prescribed for, I think it's really a difficult question to answer precisely.
Clearly, those patients who are having meaningful, clinically meaningful episodes of agitation at home would be great candidates for it. I think it's very promising and something I would consider for my patients that are experiencing those episodes.
Thank you for that perspective. For the company, how closely do these data conform to the alignment that you reached with the FDA? What do they mean for your confidence to get a supplemental new drug application for at-home use approved by the FDA? We see the percentage of adverse events involving somnolence go down over repeat dosing. Why do you think that happens? Do you have any initial thoughts on how efficacy might trend with repeat dosing?
Yes, thank you. We had an agreement with the FDA about the protocol. Any comments that they made on the protocol we incorporated before starting the study. We are fairly comfortable that we are answering all the questions that the FDA has asked and that the results of this trial will, as planned, form the backbone of our sNDA preparation and submission. Regarding the question of the loss of efficacy because the tolerability got better, one of the questions that we asked for this study was to look at the exploratory analysis regarding the effectiveness of BioXcel Therapeutics. Certainly an important question was, does the benefit that patients are experiencing continue over time and with repeat dosing? As we said before, the FDA was very comfortable with the efficacy of 120 mcgs, but that was determined with a single dose.
We wanted to follow how this benefit behaves with repeat dosing. As we announced in the press release, the benefit, the reduction in symptoms that we see with BXCL501, persisted throughout the studies, throughout the repeat dosing. We do not see any attenuation of benefit with a higher number of doses. You can say we do not really see any tachyphylaxis. This is similar to our post-marketing commitment study that we did with a higher dose in an inpatient setting where we administered up to seven doses and where we saw no tachyphylaxis or tolerance over seven days. Up to seven doses, we now extended this to a much higher number of doses and to a much longer time period. We feel that we have answered that question at this point. Of course, we will be doing an additional analysis, but the data are pretty clear at this point.
Got it. Thanks.
Thank you. Our next questions come from the line of Samir Devani with Rx Securities. Please proceed with your question.
Hi guys, thanks for taking my questions. Congratulations on the strong safety data set. I guess I've got maybe three questions. Just, you've given us the average number of episodes. I'm just wondering what was the maximum number of repeat doses that occurred, and is there any concern about potential misuse or abuse? That's the first question.
Yeah, we don't, I mean, there was a wide number, but we don't really, we haven't really looked at the number and the density of doses. I mean, as I said, it's 2,400 doses. Our primary objective was to look at the safety and be able to provide everybody and to announce the top line data for the primary objective. These additional measures of the distribution of dosing, the density, whether people were taking it day by day or over a longer time period, we haven't really analyzed those data. The patients were allowed to take one dose in 12 hours, no more than that. To date, we don't really have any evidence of any abuse potential. The drug is not scheduled. Patients were taking it as needed.
We don't really have any indication of any abuse potential, but at the same time, we don't also have any information on the distribution of dosing at this point. This data will be coming up shortly when our statisticians have had some time to catch a breath.
That's great.
And sorry.
Did any patient try to cut the dose in half?
Not that we are aware of. We don't know.
Okay. Maybe a question for Dr. Krystal, just in terms of trying to assess the sort of real-world uptake. I'm just trying to think about factors that may influence that uptake. I guess things like driving restrictions, would that be a potential factor that would influence uptake? What other factors could you consider?
Sure. Obviously, in terms of driving restrictions, the major issue there is the sedating effects of the drug. On the other hand, the data that we've reviewed are for patients with psychotic disorders who are agitated, who I would suggest are not a group of people we want driving anyway. I think my guess is that the sedation, to the extent that it occurs, is probably contributing to some of the benefit that some of these patients are getting from IGALMI. I think in terms of real-world impact, when you are in an agitated state and need to calm down quickly, safely, and tolerably, I think IGALMI can be a real value there to fill that need. Because it's relatively short-acting and it's relatively well tolerated, I don't see it as having a negative impact on lifestyle, generally speaking.
That's great. Just one final question for the company. Obviously, I appreciate that you're assessing your options, commercial options from here, but just maybe to give us a flavor of what might be required, what sort of infrastructure do you perceive being required to market this in the U.S.?
We have done an initial assessment. As everyone knows, we are a commercial group. We launched IGALMI in the institutional setting, so we have a lot of inherent knowledge. While we were preparing what would be required for a home setting, our initial estimate, and it's in our deck that we posted about the commercial opportunity sometime in mid-August, it will be about an initial 50- 70 sales reps that will be required to go to the market to initiate and launch the drug. As we learn more, then we will expand. Initially, that would have provided a good coverage to get this product out. There is some benefit of the product being in the marketplace. Our brand is there. Patients have the experience, as well as the physicians and the family members.
Sometimes we have seen currently patients come back and say, "I want IGALMI." I think the brand is building. With this data, and then upon getting approval, when we get that from the FDA, between now and then, we'll develop a strong commercialization strategy. Unmet need is so huge, much larger than we originally thought. It will make perfect sense to have a strong commercialization strategy that can bring this medicine to those patients.
That's great. Thanks very much.
Thanks, Samir.
Thank you. Our next questions come from the line of Alec Stranahan with Bank of America. Please proceed with your questions.
Hey guys, great to see the data and thanks for the questions. Just a couple from me. I guess first looking to the efficacy readouts later this year, I know you looked at CGI-I and SERENITY III Part 1, which actually showed a significant improvement over placebo. Curious whether you'd expect an even larger separation here in SERENITY At-Home, given the higher dose. You know, any similarities or is SERENITY III maybe not the best comparator for what we should expect in the next readout?
Yes, thank you for the question. Definitely I think SERENITY At-Home trial Part 1 is not a good comparator, not only because it used a lower dose, but also because it was done in the in-care setting. All the ratings were done by trained clinicians. Even though Clinical Global Impression, CGI, sort of sounds the same, it should be noted that the one that we are using in this trial at home has M in front of it for modified. It has only basically three intervals for anchor points from zero to three, while the clinician-rated scale has seven. In addition to that, the clinician-rated scale is basically based on the observations and the experience of trained healthcare professionals, while the modified CGI that was used in this trial is being assessed by patients themselves. It is more sort of a patient-reported outcome.
It would be very, very difficult to compare across the trials for that reason.
I would like to add in this trial there is a 20% cohort of informants also. We had agreed with the FDA that patients alone, as well as patients who live with their caregivers, so about 20% patients have the informant. They also made the assessment. When we have done full analysis, Alec, we will have the data from patient assessment as well as from the informant. That was designed so that we can get data from both sources for this MCGI scale.
Okay, that's helpful. One more on somnolence. It looks like the placebo rate was actually meaningfully higher than in SERENITY I and II in the SERENITY At-Home trial. Do you think this is a difference in how it was reported between the two studies, or maybe more due to patient characteristics in the at-home versus institutional setting? I guess.
Yeah, thanks. I don't think that's because of the way it was reported. I think it's more because this was a pragmatic study. As Matt mentioned in the design section, the patients were really allowed to use all sorts of other coping mechanisms, including alcohol, cannabis, meditation, and so on. That's probably one of the reasons why you see a higher rate of somnolence in the patient group. Also, we talked to some of the experts in the field, and they say that the fact that somnolence is mentioned as a potential adverse event on the case report form may have contributed to that because patients may have expected it, and then it goes down quite a bit with repeated dosing when probably they realize they are not experiencing it anymore. Those are the two factors that are possible. Of course, it's all a matter of speculation at this point.
It's really not, we don't feel it's the matter of how the adverse events are reported.
Okay, got it. Thank you so much.
Thank you. Our next questions come from the line of Elemer Piros with Lucid Capital Markets. Please proceed with your questions.
Yes, just a quick follow-up, please. In the exclusion criteria, I didn't see that you listed anything regarding cardiovascular background or limitation. Is that the case? If you could comment on that, please.
Yeah, there was an exclusion for patients with any unstable medical illnesses. Among those would include the cardiovascular as well.
Okay, thank you. Thanks for clarifying.
Thank you. Our next questions come from the line of Sumant Kulkarni with Canaccord Genuity. Please proceed with your questions.
Thanks for the follow-up. I have two. In your latest 10-Q, you revealed that you're running a 30-patient informant-tied trial to evaluate correlation between patient information measures and the PEC score. Is there a way you could handicap the chance of seeing what might be considered an intuitive result on that trial?
That trial is done. It's an open-label trial. We have already recruited more than 80% of the patients. In that trial, design is very simple that these patients are recruited with the informant, and then patient reports, trained data reports, PEC measurement before and after taking IGALMI. Then a patient reports how they feel, like you know, with the NCGI and an informant. We have done, it's an open-label trial, 80% recruitment. We are trying to look for the correlation between the PEC and NCGIS because, as you know, NCGIS is an exploratory endpoint. FDA agreed that 120 mcg has a well-established efficacy and safety. We demonstrated the safety in our home trial today. Also, initial data is quite encouraging. What we have seen using the patient reported how they feel benefit from this drug.
This is a kind of saying the correlation study that we are performing for the measurements we have done in the current trial.
My last one is actually a bit of a bigger picture, almost strategy-like question. Given how much artificial intelligence appears to be intertwined in the company's DNA, with this data set, do you expect to use your engine to generate any maybe counterintuitive results or anything like that, or anything that might generate new intellectual property?
Great question. Once our team, while this trial was going on, our AI team helped us identify various sites where the patient flow can happen. AI was used there, and they've been building models using what unblinded data, what we were collecting. Now data has been unblinded. They will be in a position to look for and do some analysis, which normally is outside the current method normally used. We'll continue to do that. Plus, we will try to see if AI provides us any additional insight, both from understanding the patient population, our safety results, our efficacy results. We will update once we had a chance to do those analysis.
Thank you.
Thank you. I'm showing no further questions at this time. I would now like to hand the call back over to management for any closing comments.
Thank you very much for joining us today. It's a very exciting day. We are very excited to move forward this drug for the submission of our s NDA. Have a great day.
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.