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BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q2 2023 Earnings Convention Name August 14, 2023 8:00 AM ET
Firm Members
Vimal Mehta – Founder & CEO
Richard Steinhart – SVP & CFO
Matt Wiley – SVP & Chief Business Officer
Robert Risinger – Chief Medical Officer, Neuroscience
Frank Yocca – Chief Scientific Officer
Convention Name Members
Gregory Harrison – Financial institution of America
Colin Bristow – UBS
Sumant Kulkarni – Canaccord
Raghuram Selvaraju – H.C. Wainwright
Yatin Suneja – Guggenheim Securities
Samir Devani – Rx Securities
Kambiz Yazdi – Jefferies
Operator
Good morning, and welcome to BioXcel Therapeutics’ Second Quarter 2023 Monetary Outcomes Convention Name. Presently, all members are in a listen-only mode. [Operator Instructions] After the audio system’ presentation, there will likely be a question-and-answer session. [Operator Instructions]
Simply to remind everybody, sure issues mentioned in right now’s convention name and/or solutions which may be given to questions requested are forward-looking statements which can be topic to dangers and uncertainties associated to future occasions and/or the longer term monetary or enterprise efficiency of the corporate. Precise outcomes may differ materially from these anticipated in these forward-looking statements.
Danger components which will have an effect on future outcomes are detailed within the firm’s annual report on Type 10-Q for the quarter ended March 31, 2023, which could be discovered at www.bioxceltheapeutics.com, or on www.sec.gov, and which will likely be up to date in its quarterly report on Type 10-Q for the quarter ended June 30, 2023. As a reminder, right now’s convention is being recorded.
Becoming a member of us on right now’s name are Dr. Vimal Mehta, Chief Government Officer; Richard Steinhart, Chief Monetary Officer; Matt Wiley, Chief Business Officer; Dr. Rob Risinger, Chief Medical Officer of Neuroscience; Dr. Vince O’Neill, Chief R&D Officer of OnkosXcel Therapeutics; and Dr. Frank Yocca, Chief Scientific Officer.
It’s now my pleasure to show the decision over to Dr. Mehta, the CEO and Founding father of BioXcel Therapeutics. Please go forward.
Vimal Mehta
Thanks, operator. Welcome, everybody and thanks for becoming a member of our name right now. Earlier than we start, I first wish to say that the corporate was dismayed and pissed off by our current discovery of sure investigator misconduct that occurred throughout our TRANQUILITY II trial. This summer season has not progressed as we had anticipated and we plan to make important modifications to our whole enterprise construction. Whereas I am deeply disenchanted, I am extra decided than ever to proceed growing our drug candidates and put BioXcel Therapeutics again ready to perform its core mission.
Now I’ll begin by protecting our strategic reprioritization and the way it’s designed to place us for fulfillment going ahead. As well as, I’ll share as a lot info as I can concerning the standing of our TRANQUILITY program in Alzheimer’s related agitation. Six years in the past, we based BioXcel Therapeutics with a transparent mission to construct a uniquely disruptive biopharmaceutical mannequin utilizing AI approaches to carry transformative medicines to sufferers. We imagine, now we have fulfilled this mission with the approval and launch of IGALMI and with our packages within the late-stage of scientific growth.
We at the moment are taking the mandatory steps throughout the enterprise to strengthen our capacity to advance our land and expense technique. Particularly, we’re taking clear, well-defined and decisive actions in three areas. First, let’s talk about our industrial reprioritization. We landed with IGALMI’s approval within the institutional setting.
We at the moment are shifting assets to the broaden facet (ph) of our market technique into what we imagine is a doubtlessly extra promising retail pharmacy and outpatient setting. This shift is essentially attributable to the truth that the hospital setting proved to be tougher to penetrate than we initially anticipated, significantly in a difficult post-COVID surroundings. Regardless of these challenges, nevertheless, we stay dedicated to creating IGALMI accessible to sufferers within the institutional setting.
We started deploying a contracting effort with giant hospitals, well being care programs and built-in supply community previous to our reprioritization and have been happy to see it obtain some preliminary success, with elevated demand for current hospital clients and enormous well being programs. The truth is, our Q2 revenues doubled from Q1 largely attributable to this contracting technique. Due to this fact, we’ll now broadly undertake it.
As a part of this motion, we plan to cut back our whole workforce from roughly 190 to 80 staff over the subsequent a number of months. Nearly all of these reductions will likely be within the industrial group to assist us construct in direction of potential label expansions and to help IGALMI, we’ll preserve a core 12 member group from market entry, industrial operations, gross sales and commerce features.
This resolution to cut back our workforce was extraordinarily troublesome for the administration group and the Board, however was necessitated by quite a lot of market and enterprise components. I am grateful to all of our staff who made many contributions to our firm. We’re dedicated to offering help to these impacted as they transition from the corporate.
The second a part of our enterprise transformation includes shifting our growth focus to excessive potential agitation market alternatives for BXCL501 in bipolar issues, schizophrenia and Alzheimer’s dementia. We firmly imagine this drug has the potential to have a optimistic influence on sufferers and caregivers and handle a big unmet medical want.
For instance, 23 million episodes of bipolar schizophrenia-related agitation happen yearly within the U.S. within the at-home setting. As well as, 100 million Alzheimer’s associated agitation episodes happen yearly within the U.S. Importantly, greater than 80% of those sufferers are in an agitation setting and episode right here characterize greater than half of the entire episode quantity. We’re motivated to develop 501 to deal with the wants of those sufferers.
Now we have developed a complete plan for our TRANQUILITY program in Alzheimer’s-associated agitation. In June, we introduced optimistic top-line information from TRANQUILITY II. This was a uniquely complicated trial requiring mobilization of scientific group, each time an agitation episode occurred. We had been happy that our high line information confirmed that we met our major endpoint with the 60-megagram dose, with 501 demonstrating a statistically important 39% larger discount in PEC rating from baseline in comparison with placebo at 2 hours.
We additionally met a key secondary endpoint with a statistically important discount in agitation signs versus placebo, as measured by PEC rating change from baseline at 1 hour with 60 micro gram (ph) dose. 501 was properly tolerated, with no drug associated severe opposed occasions over trial period. As we disclosed in an 8-Okay submitting, there have been points associated to a principal investigator at a TRANQUILITY II scientific aspect. They conduct by this PI was unacceptable and intensely unlucky. We’re investigating the difficulty and, for instance, have already initiated an audited by an impartial third-party of the information from the PI’s scientific aspect.
As well as, now we have requested a gathering with the FDA to debate our whole TRANQUILITY program. This can embrace each TRANQUILITY II, TRANQUILITY III scientific trials, the information audit and the information bundle which may be required to help submission of an sNDA looking for approval of 501 for the acute therapy of agitation in delicate to average dementia sufferers with possible Alzheimer’s illness. We hope to have an replace on the TRANQUILITY program, together with the audit and FDA assembly by the top of the yr.
Concerning TRANQUILITY III, we paused enrollment after early trial information confirmed a a lot greater background frequency of agitation episode than initially anticipated. It seems that this affected person inhabitants could also be higher suited to a persistent therapy of agitation, whereas our focus is on growing 501 as acute therapy of Alzheimer’s agitation. As a reminder, now we have breakthrough remedy designation for the acute therapy of agitation related to dementia.
In parallel, we’re advancing our SERENITY program for the at-home acute therapy of agitation related to bipolar issues or schizophrenia. In Could, we reported high line outcomes from SERENITY Half I. We evaluated sufferers in Half 1 in a monitored medical setting as surrogates for the at-home setting. The trial assessed the protection and efficacy of 60-microgram dose of BXCL501, which is half of the bottom accredited dose of IGALMI utilizing the identical major and secondary endpoint as within the SERENITY I [indiscernible].
Whereas we imagine the information suggests the potential for 501 to be efficient in a monitored medical settling with 60 micro gram dose, we didn’t meet the first endpoint of imply change in PEC rating at 2 hours. Nevertheless, the 60 micro gram dose was properly tolerated and demonstrated favorable security outcomes, together with proportionately fewer opposed occasions in comparison with these noticed throughout SERENITY I and II, which evaluated the accredited 120 microgram or 180 microgram doses. We imagine these security outcomes help the potential for at-home use.
We at the moment are conducting SERENITY III Half 2. It’s a 12-week research to guage the protection of a 60 microgram dose of BXCL501, with an non-compulsory 60 microgram dose. To determine a dose to doubtlessly present an optimum steadiness between the protection and efficacy within the at-home inhabitants, we carried out pharmacokinetic and pharmacodynamic modeling that prompt that use of an 80 microgram dose of BXCL501 may present this steadiness. We imagine the analysis of an 80 microgram dose is additional supported by our earlier scientific expertise with this dose throughout our Section Ib trial in schizophrenia sufferers with agitation.
We plan to satisfy with the FDA to debate the 80 microgram dose and a protocol modification to the continuing SERENITY III Half II research. The first goal of half 2 is to explain the incidence of therapy emergent opposed occasions, the first endpoint is a comparability of significant opposed occasions and therapy emergent opposed occasions as in comparison with placebo and the secondary endpoints embrace plenty of efficacy assessments.
Turning to our main depressive dysfunction program, we reported optimistic high line outcomes from the Section Ib a number of ascending dose trial in Could. As a part of our reprioritization effort, we’ll pause this program. To reinforce our scientific growth group, Dr. Vince O’Neill, who’s presently serving as Head of R&D for OnkosXcel will play a broader function in our neuroscience growth.
Vince has been with the corporate for the reason that IPO in 2018, and has been — has in depth pharmaceutical scientific growth expertise. Vince performed an instrumental function in SERENITY I and II trials, together with our Chief Medical Officer, Dr. Rob Risinger, that resulted within the approval of IGALMI and the profitable human proof-of-concept trials for 701 in our oncology program.
Dusan Kostic, our Head of Medical Affairs will play an necessary function in growing scientific and medical methods of 501 to help commercialization of any potential indications. He has greater than twenty years of pharmaceutical business expertise in neuroscience. This contains scientific growth and commercialization of main medication, akin to Abilify, INVEGA, Abilify Maintena and Rexulti. Now we have additionally initiated a search to broaden our Board of Administrators to strengthen scientific growth experience.
The third a part of our enterprise transformation includes prioritizing AI-driven innovation to strengthen our neuroscience scientific expertise. Our distinctive integration of knowledge science scientific experience and commercialization offers us a robust and distinct aggressive benefit in constructing a sturdy R&D pipeline. We’re really enthusiastic about our scientific initiatives and pipeline candidates, together with BXCL502.
We stay up for highlighting these developments at an R&D occasion we plan to host later this yr. We additionally plan to highlight our next-generation AI platform capabilities to determine and reinnovating late-stage drug candidates and introduce BXCL503 and 504.
In abstract, this can be a difficult but transformative interval for our firm. We’re taking swift and decisive steps with the objective of placing the corporate in the absolute best place for future success. Now we have acquired curiosity from potential company companions. Nevertheless, it’s far too early to know what if any type such a transaction may take. We’re enthusiastic about our objectives and stay dedicated to delivering long-term worth to shareholders.
Now, I’ll flip the decision over to Wealthy, who will talk about our second quarter monetary outcomes.
Richard Steinhart
Thanks, Vimal. Our second quarter 2023 monetary outcomes are as follows. Web income of IGALMI was roughly $457,000 for the quarter. Analysis and growth bills had been $27 million for the second quarter of 2023 in comparison with $17.9 million for a similar interval in 2022. The elevated bills had been primarily attributable to elevated scientific trial bills for SERENITY III and TRANQUILITY II.
Promoting, basic and administrative bills had been $25.9 million for the second quarter of 2023 in comparison with $18.4 million for a similar interval in 2022. The elevated bills had been primarily attributable to a rise in personnel and associated prices to help the commercialization of IGALMI. BioXcel Therapeutics had a $53.5 million loss for the second quarter of 2023 in comparison with a internet lack of $37.7 million for a similar interval in 2022. The loss for the quarter included roughly $6.1 million in non-cash stock-based compensation.
Money and money equivalents totaled $127.5 million as of June 30, 2023. As famous, the corporate is endeavor a strategic reprioritization that features a discount within the workforce of greater than 50%, which is anticipated to cut back bills considerably. Within the absence of extra capital changing into accessible, the corporate below the strategic financing agreements or in any other case, the corporate estimates that its present money and money equivalents will final via mid-2024.
The corporate’s beforehand disclosed money runway projection assumed the complete utilization of its strategic financing agreements of $155 million with Oaktree Fund Administration and Qatar Funding Authority. Based mostly on current occasions, the corporate will not be prone to be ready to satisfy the milestones required to entry the extra capital below the financing agreements. The corporate is exploring a number of methods to increase its money runway and is already in discussions with its strategic financing companions to amend the agreements. Profitable modification of those agreements may lengthen the corporate’s money runway.
Lastly, almost about OnkosXcel, we’re presently analyzing strategic options, together with strategic partnerships or financing.
Now I might like to show the decision again to Vimal.
Vimal Mehta
Thanks, Wealthy. We might now wish to open the decision for questions. Operator?
Query-and-Reply Session
Operator
Presently, we will likely be conducting a question-and-answer session. [Operator Instructions] Our first query right now comes from Greg Harrison of Financial institution of America. Please proceed together with your query.
Gregory Harrison
Hey. Good morning. Thanks for taking the query. How are you fascinated about the outlook for the corporate with this restructuring and the way do you assume buyers ought to take into consideration the story at this level?
Vimal Mehta
Good morning, Greg. That is Vimal. I am very excited concerning the outlook for our enterprise. As I shared earlier, we’re laser targeted on the at-home alternatives for BXCL501. Particularly, the 2 worth drivers for 501 are SERENITY program for schizophrenia and bipolar related agitation and our TRANQUILITY program for Alzheimer’s agitation. We landed IGALMI within the institutional setting and we at the moment are shifting assets to broaden right into a doubtlessly extra promising retail pharmacy and outpatient setting. We additionally stay up for highlighting our pipeline with BXCL502 replace at R&D Day by the top of this yr.
Gregory Harrison
Bought it. That is useful. And another, if I can. Might you give us some extra coloration on why you made the choice to shift focus to the at-home setting and away from institutional medical setting?
Vimal Mehta
We’re shifting our focus from the institutional setting to the retail/at-home market as a result of market and enterprise components we shared in our name. The hospital setting was tougher to penetrate than initially anticipated, significantly in a difficult post-COVID surroundings. You will need to word that we’ll proceed to make IGALMI accessible to our hospital clients via a extra focused contracting effort and small core group. We’re dedicated to bringing IGALMI to present and future sufferers and their households for present indication and for brand new indications.
Gregory Harrison
Thanks for taking the query.
Operator
The subsequent query is from Colin Bristow of UBS. Please proceed together with your query.
Colin Bristow
Thanks. Good morning. And I simply needed to go on properly performed on this reprioritization. You made powerful choices, however I believe they needed to be performed. And perhaps first query and simply form of pigging again off of the issues, may you define the way you see the market alternative for IGALMI now that you simply’re shifting the main target to at-home setting? And the way ought to we take into consideration that particularly from a market alternative viewpoint?
After which secondly, I believe that is the most typical query we’re getting from buyers is simply updates on the timing of first the exterior order. I believe I heard you mentioned by the top of the yr, however any extra coloration you can provide with the place you might be on this course of can be nice. After which on the second a part of that’s simply timing relating to suggestions from FDA. I do know you’ve got requested a gathering, however when do you count on this to happen and have you ever had any kind of interactions or suggestions round this information concern? Thanks.
Vimal Mehta
Good morning, Colin. Concerning your query concerning the TRANQUILITY program replace, as I acknowledged in my earlier remarks that we count on to have replace or hope to have the replace by the top of the yr. Impartial audit is in progress. Now we have requested a gathering. As soon as now we have the assembly, we may have a readability what’s the information bundle required to file an sNDA and can be a great time to offer an replace on the TRANQUILITY program.
I simply would admire, should you can come again to your first query that you simply had requested in order that we will handle that.
Matt Wiley
Good morning, Colin. It is Matt. How are you?
Colin Bristow
Yeah. In order you might be checking, [Multiple Speakers]
Matt Wiley
I did. Yeah. So the query concerning the market alternative switching from the hospital setting to the at-home setting. Needless to say there are 23 million episodes within the at-home setting. One of many issues that we accounted for in our fashions as properly is that we might seize most of the sufferers that wind up within the emergency division within the at-home setting as properly. And given the market analysis that we have performed. We acknowledge the unmet want within the residence setting is kind of important. It is underrecognized and underdiagnosed, however the sufferers actually see worth right here. They usually indicated that each they and their caregivers would use this product profile for BXCL501 in 80% of their episodes. So we really feel that the market circumstances for the at-home setting is kind of favorable and we stay up for bringing the drug to these sufferers.
Colin Bristow
Nice. Thanks.
Operator
The subsequent query is from Sumant Kulkarni of Canaccord. Please proceed together with your query.
Sumant Kulkarni
Good morning. Thanks for taking my questions. So in your breakthrough remedy designation standing, how precisely does the FDA outlined acute therapy of agitation by way of variety of episodes or cases of movie utilization per thirty days? Alongside these traces, do you assume the present pricing of $105 per movie is suitable on a strategic misstep for the comfort of at-home use? I am asking due to two components. First, even one had been to hit the annual specialty tier of roughly $10,000 per yr for pricing on a gross foundation, that might translate to a affected person utilizing 100 movies a yr, and makers of persistent therapies of agitation take pleasure in considerably greater market caps or buyout values however pricing assumptions there a lot greater as properly.
Matt Wiley
So let me — I am going to handle the value query and the variety of episodes. In the beginning, we did conduct analysis once we established our launch value in each bipolar schizophrenia within the at-home setting and in addition in ADA. And what we discovered is that for episodic therapy there was urge for food available in the market for that value level. Definitely, what we see is the amount of episodes within the delicate Alzheimer’s dementia sufferers is roughly three a month and that may escalate additional as they change into extra average. However we additionally acknowledge that 81% of the ADA [indiscernible] are both in an at-home setting or an ALF setting, which is nice one (ph) at-home setting, and characterize over 50% of the entire quantity of agitation episodes. And that does not preclude 501 from being utilized in episodic breakthrough episodes to breakthrough in different places as properly.
Sumant Kulkarni
Bought it. After which does your new money runway embrace the potential to redo TRANQUILITY II in case the FDA says you won’t be able to file on simply what you might have presently?
Vimal Mehta
Sumant, we aren’t speculating on that. We’re doing an audit and we wish to meet with the FDA and get the suggestions, then we can touch upon it.
Sumant Kulkarni
Thanks.
Operator
The subsequent query comes from Ram Selvaraju of H.C. Wainwright. Please proceed together with your query.
Raghuram Selvaraju
Hello. Thanks a lot for taking my query. I simply needed to revert again to the formulary wins that you simply had beforehand introduced that you simply had been beforehand engaged in pursuing within the institutional setting and needed to ask how that’s affected, if in any respect, by your reprioritization right here into the at-home setting. To what extent may we doubtlessly count on you to have the ability to capitalize on the formulary wins which have already occurred within the institutional setting and alongside what trajectory? And likewise should you may remark in any respect on the way you count on promotional actions to be totally different within the at-home context versus the institutional context. Thanks.
Matt Wiley
Certain. So to start with, we reported out that we had over 185 formulary wins, [indiscernible] wins up to now. We’re nonetheless accumulating these wins at a win charge of over 65%. The truth is, we had three wins on Friday. And so we might count on that the 650 or so hospitals which can be nonetheless scheduled to vote will proceed with that course of. And assuming that we proceed to accrue these hospitals, we’ll attain out to them via medical affairs actions, via market entry actions, contracting and definitely help them of commerce and distribution to make sure that they will entry the drug and put it to use.
The medical affairs help will clearly be actually necessary in serving to them decide find out how to develop protocols and pathways, in order that planning is in place as properly. The promotional actions for the at-home market is a little bit bit totally different since you are educating physicians and sufferers on the identical time. As you recognize, sufferers could be motivated to ask for prescribed drugs, so that might be a part of the plan as properly, after which via sampling and contracting with PBMs. And these are actions that the contract with PBMs and state Medicaid, these are actions which may be achieved previous to even FDA approval, contemplating now we have a drug available on the market right now. So these are actions that we’re planning out to get forward of that potential approval and extra to return on the precise market entry technique in months to return.
Raghuram Selvaraju
Thanks.
Operator
The subsequent query is from Yatin Suneja of Guggenheim Companions. Please proceed together with your query.
Yatin Suneja
Hey, guys. Thanks for taking my query. Possibly first query is on the Alzheimer’s illness agitation. I perceive you’ll meet with the FDA and attempt to get their suggestions on TRANQUILITY II and I. Are you able to simply speak about what typically is the ICS pointers for a sign like this? What kind of publicity, period of publicity is required from a regulatory perspective for a illness that impacts tens of millions of individuals? As a result of it looks like you had been kind of stopping TRANQUILITY II. It is nonetheless not clear to me, if can TRANQUILITY I and II mixed is sufficient so that you can get an approval. In order that’s one. Mainly simply assist me perceive the trail ahead for Alzheimer’s illness agitation as you perceive.
The second is, it looks like on the R&D day, you are going to discuss a little bit bit concerning the 502. Simply curious, perhaps should you can spotlight a little bit bit there. After which by way of the money runway, perhaps assist us perceive how ought to we mannequin it going ahead? The place precisely are you chopping value? How most of the gross sales rep you are still going to have? In order that’s these three questions. Thanks.
Vimal Mehta
Thanks, Yatin. First query relating to the TRANQUILITY program, Rob will reply like what our plans are.
Robert Risinger
Yeah. So let me be clear that we paused the trial as a result of the early information in TRANQUILITY III indicated that the affected person inhabitants could also be higher suited to persistent versus episodic remedy. And as you recognize, our focus is on the episodic therapy in keeping with our breakthrough remedy designation by FDA for episodic therapy. Now we have determined to pause the trial to be able to talk about this concern with the FDA at an upcoming assembly and we’ll be capable to present extra steerage on that after that assembly happens. We do count on at that assembly to debate each the auditing and the TRANQUILITY II outcomes. And at that time, we’ll be capable to present extra steerage on the finish of the yr with regard to what will likely be vital for submitting an sNDA bundle.
Vimal Mehta
Yatin, relating to your second query, I’ll go it on to Rob — go it on to Frank for 502.
Frank Yocca
Hello, Yatin. That is Frank Yocca. I am enthusiastic about our rising pipeline growth candidates, particularly BXCL502. We actually are wanting ahead to an upcoming R&D Day the place we’ll current our progress with this molecule, significantly its growth, but additionally talk about some distinctive indications of curiosity. Secondly, we’ll talk about our next-generation AI platform. This has advanced significantly. From the primary time we did our R&D Day two years in the past, the capabilities are — have been enhanced for figuring out and reinnovating late-stage alternatives. And we’ll additionally talk about some candidates for extra pipeline entries, akin to BXCL503 and 504. So will probably be a really fascinating day.
Vimal Mehta
So relating to your third query, Yatin, associated to the money runway, Richard will reply.
Richard Steinhart
Certain, Yatin. So the reprioritization that we’re engaged on now will lengthen the money runway by lowering our burn considerably. And we’re additionally engaged on numerous different choices to increase the money runway, which incorporates working with our strategic companion. As we mentioned, the objective is to get the corporate to about an $80 million go-forward annualized burn charge and that is what we’re working in direction of. By way of market, we’ll scale back that the market entry group will likely be a core group of market entry groups to work via the industrial sector.
Operator
The subsequent query is from Graig Suvannavejh of Mizuho Securities. Please proceed together with your query.
Unidentified Participant
Good morning. That is Richard on for Graig Suvannavejh from Mizuho. So simply two questions from me. One, simply following up from the money query, how do you count on the break up between R&D and SG&A going ahead? After which two, for the IGALMI alternative and gross sales, how ought to we be shifting that on a go-forward foundation now that your major focus is on at-home setting? Thanks.
Richard Steinhart
So by way of the commercialization, it should be a small core group of a few dozen folks. So that can scale back our SG&A bills fairly dramatically shifting ahead. Our R&D bills ought to go down. Keep in mind, within the first half of the yr, we had SERENITY III and TRANQUILITY II totally applied and that is what induced the rise in bills within the first half of 2023.
Matt Wiley
And Richard, relating to your second query on modeling. We have by no means supplied steerage on IGALMI gross sales. And so I believe the best way to consider that is by lowering our headcount in industrial to 12, it limits our capacity to exit and prospect the best way that we had in focusing on the 1,700 hospitals. Nevertheless, we’ll proceed to help via contracting efforts and thru commerce and distribution on each our current clients and those who select to return on-line and approve IGALMI via formulary, we’ll help them in the identical means. So which will enable you, however I am unable to give steerage past that.
Operator
The subsequent query is from Robyn Karnauskas of Truist Securities. Please proceed together with your query.
Unidentified Participant
Hello. That is Alex on for Robyn. Are you able to remind us what the approximate market alternative is, the breakdown for dementia setting between assisted dwelling facility versus nursing residence and what are the gating components to IGALMI uptake on the assisted dwelling facility?
Matt Wiley
In order I believe we have communicated beforehand with the 100 million episodes whole, about an 80% of the sufferers with Alzheimer’s dimension, I discussed this earlier within the name, are in both the at-home setting or the ALF setting. And I haven’t got a selected breakdown for you right here, however actually one thing I can talk later as we get nearer to market entry disclosure. Higher than 50% of the episodes are in these settings. And we really feel that, that enables us to cost the drug as an episodic drug versus pricing it as a persistent drug and definitely can be utilized episodically in any setting. So we predict that the TAM nonetheless holds at 100 million episodes.
Operator
The subsequent query is from Corinne Jenkins of Goldman Sachs. Please proceed together with your query.
Unidentified Participant
Hello. That is [indiscernible] on for Corinne Jenkins. So first, what do you view as your finest choices to additional lengthen runway past mid-2024? After which second query is, if the FDA requires a further research, the place they’ve the beginning — will now we have form of the identical trial with the identical inhabitants in TRANQUILITY II?
Vimal Mehta
Hello. That is Vimal. Concerning our money runway expense, as Richard has already outlined, our money runway in mid of 2024. And that is clearly predicated on what scientific trials we will likely be executing on. By way of our choices to increase that money runway, now we have a number of alternatives. One is working with our strategic companion, which Richard has already outlined, who’re our financing companions. There’s an curiosity growing in these packages by different company companions. We’re wanting into that. And as well as, now we have some core belongings that we will monetize and capitalize to increase our money runway. So excellent news is that now we have a number of alternatives to increase our money runway and obtain significant scientific milestones.
Robert Risinger
So let me deal with if the FDA has to do one other research, at this level, it is untimely to debate whether or not one other research is required. However by way of whether or not that research can be ALF or simply at-home, once more, we actually make that call upon session with the FDA, and we’ll be offering that replace later this yr.
Vimal Mehta
I believe I might identical to so as to add on high of what Rob mentioned, we’re a pioneer in growing episodic treatment to deal with agitation. We’re studying from the information, from the indicators, from the scientific outcomes that we’re observing. We by no means or FDA by no means anticipated that we’ll have so many episodes noticed within the nursing houses setting. So we’re taking that info again to the FDA and designing a program what makes most sense. Does it make sense to have ALF in residence setting as an episodic and no matter is required to place collectively that bundle. And wouldn’t it make sense to return in a while and consider the nursing residence as a extra persistent choice? As a result of I might wish to remind everybody our Breakthrough Remedy designation is in for acute therapy of agitation and we imagine mild-to-moderate possible Alzheimer’s illness inhabitants is a related one up to now what now we have noticed.
Unidentified Participant
Okay. Thanks.
Operator
The subsequent query is from Samir Devani of Rx Securities. Please proceed together with your query.
Samir Devani
Yeah. Hello, guys. Thanks for taking my questions. It should have been requested already, however I’ve received a pair. I assume the massive query for me is it real looking for you guys to market on to the generalist physicians for the at-home setting? Is not that basically extra the area of massive pharma? And is it — have you considered simply doing a partnership deal round IGALMI to deal with that and scale back the money burn? After which I assume the second query is simply actually out of curiosity, what number of agitation episodes had been you seeing in TRANQUILITY III within the nursing residence setting? Thanks very a lot.
Matt Wiley
I am going to take the primary query. Good morning. So once we take into consideration the at-home setting for bipolar and schizophrenia, there are roughly 7,000 to eight,000 psychiatrists that both diagnose or actively handle the therapeutic therapies for these sufferers. So we really feel that we might be very properly positioned to entry that market. Because it pertains to Alzheimer’s dementia agitation, these sufferers are managed from a high line perspective by about 65,000 physicians in the USA, about 30,000 of these can be of curiosity to us. These 30,000 are moreover making the prognosis and therapy analysis for these sufferers.
Now of these, there are someplace between 3,000 to 4,000 which can be specialists of curiosity. However the major care alternative or the generalist alternative, as you described, we might both need to companion with a CSO, a possible partnership with a bigger pharmaceutical firm or permutations of all three of these. And in order that market entry technique has not but clearly outlined, however we’re working via these issues or these potential alternatives, I assume, presently.
Vimal Mehta
So Samir, relating to what number of episodes we noticed. I’ll let Rob reply that.
Robert Risinger
So there are sufferers persevering with within the trial at this level and so they proceed to have episodes. So the quantity is accruing. It is laborious to say it on a given day. So I believe one of the best ways to explain it will be to say it is common. And it’s larger on a person foundation than what we reported in our TRANQUILITY II outcomes. And that is precisely why we’re discussing it with the FDA in order that now we have a transparent path ahead for episodic therapy of acute episodes and we’ll have that steerage on the finish of the yr.
Samir Devani
Thanks very a lot.
Operator
The subsequent query is from Kambiz Yazdi of Jefferies. Please proceed together with your query.
Kambiz Yazdi
Good morning, group. What are the proposed options which can be going to be within the protocol modification for SERENITY III Half 2? What are the form of the important thing secondary efficacy assessments that will likely be beneficial? After which perhaps in your [indiscernible] financing partnerships, what modifications your credit score settlement and [indiscernible] would allow you to entry capital or earlier and be enticing to your companions? Thanks.
Robert Risinger
So we’re finalizing that amended protocol. The secondary measures need to do with quite a lot of totally different, we’ll name them views on efficacy. And as soon as now we have the assembly with the FDA, I believe will probably be a lot simpler to explain your entire research and the main points.
Vimal Mehta
So Kambiz, did it reply your query? As a result of what we’re saying is now, now we have chosen dose 80 micrograms primarily based on our pharmacokinetic/pharmacodynamic modeling as we had been anticipating. And now it is a matter of modifying protocol submitting to the FDA after which we will likely be ready to provoke the research. As Robert mentioned, the first is security after which efficacy developments as we measure over a 12-week interval. So that is what would be the consequence we will likely be wanting from that point.
Kambiz Yazdi
Yeah. Thanks, Vimal.
Vimal Mehta
Concerning your subsequent query, modification on the credit score settlement. As Richard has talked about that we’re in energetic discussions. And as we make progress, we’ll present an replace.
Kambiz Yazdi
Thanks very a lot. Recognize it.
Operator
There aren’t any extra questions presently. I might like to show the decision again over to Dr. Mehta for closing remarks.
Vimal Mehta
Thanks, everybody for becoming a member of us right now. We’re enthusiastic about our path ahead via this strategic reprioritization and stay up for sharing updates on our progress. Thanks in your continued curiosity in BioXcel Therapeutics and have an incredible day.
Operator
This concludes right now’s convention. It’s possible you’ll disconnect your traces presently. Thanks in your participation.
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