Good morning, welcome to the BioXcel Therapeutics second quarter 2023 financial 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 annual report on Form 10-Q for the quarter ended March 31, 2023, which can be found at www.bioxceltherapeutics.com or on www.sec.gov, and which will be updated in its quarterly report on Form 10-Q for the quarter ended June 30, 2023. As a reminder, today's conference is being recorded. Joining us on today's call are Dr. Vimal Mehta, Chief Executive Officer, Richard Steinhart, Chief Financial Officer, Matt Wiley, Chief Commercial 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 is now my pleasure to turn the call over to Dr. Mehta, the CEO and founder of BioXcel Therapeutics. Please go ahead. Thank you, operator. Welcome, everyone, and thank you for joining our call today. Before we begin, I first want to say that the company was dismayed and frustrated by our recent discovery of certain investigator misconduct that occurred during our TRANQUILITY II trial. This summer has not progressed as we had anticipated, and we plan to make significant changes to our entire business structure. While I'm deeply disappointed, I am more determined than ever to continue developing our drug candidates and put BioXcel Therapeutics back in a position to accomplish its core mission. I will start by covering our strategic reprioritization and how it is designed to position us for success going forward. In addition, I will share as much information as I can about the status of our TRANQUILITY program in Alzheimer's associated agitation. Six years ago, we founded BioXcel Therapeutics with a clear mission: to build a uniquely disruptive biopharmaceutical model using AI approaches to bring transformative medicines to patients. We believe we have fulfilled this mission with the approval and launch of IGALMI and with our programs in the late stage of clinical development. We are now taking the necessary steps across the business to strengthen our ability to advance our land and expand strategy. Specifically, we are taking clear, well-defined, and decisive actions in 3 areas. First, let's discuss our commercial reprioritization. We landed with IGALMI's approval in the institutional setting. We are now shifting resources to the expand aspect of our market strategy into what we believe is a potentially more promising retail pharmacy and outpatient setting. This shift is largely due to the fact that the hospital setting proved to be more difficult to penetrate than we originally anticipated, particularly in a challenging post-COVID environment. Despite these challenges, however, we remain committed to making IGALMI available to patients in the institutional setting. We began deploying a contracting effort with large hospitals, healthcare systems, and integrated delivery networks prior to our reprioritization and have been pleased to see it achieve some initial success with increased demand from existing hospital customers and large health systems. In fact, our Q2 revenues doubled from Q1, largely due to this contracting strategy. Therefore, we will now broadly adopt it. As part of this action, we plan to reduce our total workforce from approximately 190 to 80 employees over the next several months. The majority of these reductions will be in the commercial organization. To help us build toward potential label expansions and to support IGALMI, we will maintain a core 12-member team from market access, commercial operations, sales, and trade functions. This decision to reduce our workforce was extremely difficult for the management team and the board, but was necessitated by a variety of market and business factors. I'm grateful to all of our employees who made many contributions to our company. We are committed to providing support to those impacted as they transition from the company. The second part of our business transformation involves shifting our development focus to high potential agitation market opportunities for BXCL501 in bipolar disorders, schizophrenia, and Alzheimer's dementia. We firmly believe this drug has the potential to have a positive impact on patients and caregivers, and address a significant unmet medical need. For example, 23 million episodes of bipolar and schizophrenia-related agitation occur annually in the U.S., in the at-home setting. 100 million Alzheimer's-related agitation episodes occur every year in the U.S. Importantly, more than 80% of these patients are in a residential setting, and episodes here represent more than half of the total episode volume. We are motivated to develop five oh one to address the needs of these patients. We have developed a comprehensive plan for our TRANQUILITY program in Alzheimer's-associated agitation. In June, we announced positive top-line data from TRANQUILITY II. This was a uniquely complex trial, requiring mobilization of clinical teams whenever an agitation episode occurred. We were pleased that our top-line data showed that we met our primary endpoint with the 60 mcg dose, with BXCL501 demonstrating a statistically significant 39% greater reduction in PEC score from baseline compared to placebo at 2 hours. We also met a key secondary endpoint with a statistically significant reduction in agitation symptoms versus placebo, as measured by PEC score change from baseline at 1 hour with 60 mcg dose. BXCL501 was well-tolerated, with no drug-related serious adverse events over trial duration. As we disclosed in an 8-K filing, there were issues related to a principal investigator at a TRANQUILITY II clinical site. The conduct by this PI was unacceptable and extremely unfortunate. We are investigating the issue and, for example, have already initiated an audit by an independent third party of the data from the PI's clinical site. In addition, we have requested a meeting with the FDA to discuss our entire TRANQUILITY program. This will include both TRANQUILITY II, TRANQUILITY III clinical trials, the data audit, and the data package that may be required to support submission of an sNDA seeking approval of BXCL501 for the acute treatment of agitation in mild to moderate dementia patients with probable Alzheimer's disease. We hope to have an update on the TRANQUILITY program, including the audit and FDA meeting, by the end of the year. Regarding TRANQUILITY III, we paused enrollment after early trial data showed a much higher background frequency of agitation episodes than originally expected. It appears that this patient population may be better suited for a chronic treatment of agitation, while our focus is on developing BXCL501 as acute treatment of Alzheimer's agitation. As a reminder, we have Breakthrough Therapy Designation for the acute treatment of agitation associated with dementia. In parallel, we are advancing our SERENITY program for the at-home acute treatment of agitation associated with bipolar disorders or schizophrenia. In May, we reported top-line results from SERENITY III Part 1. We evaluated patients in Part 1 in a monitored medical setting as surrogates for the at-home setting. The trial assessed the safety and efficacy of 60 mcg dose of BXCL501, which is half of the lowest approved dose of IGALMI, using the same primary and secondary endpoint as in the SERENITY I and II. While we believe the data suggests the potential for BXCL501 to be effective in a monitored medical setting with 60 mcg dose, we did not meet the primary endpoint of mean change in PEC score at 2 hours. However, the 60 mcg dose was well-tolerated and demonstrated favorable safety results, including proportionately fewer, fewer adverse events compared to those observed during SERENITY I and II, which evaluated the approved 120 mcg or 180 mcg doses. We believe these safety results support the potential for at-home use. We are now conducting SERENITY III Part 2. It is a 12-week study to evaluate the safety of a 60 mcg dose of BXCL501 with an optional 60 mcg dose. To identify a dose to potentially provide an optimal balance between the safety and efficacy in the at-home population, we performed pharmacokinetic and pharmacodynamic modeling that suggested that use of an 80 mcg dose of BXCL501 could provide this balance.... We believe the evaluation of an 80 mcg dose is further supported by our previous clinical experience with this dose during our Phase Ib trial in schizophrenia patients with agitation. We plan to meet with the FDA to discuss the 80 mcg dose and a protocol amendment to the ongoing SERENITY III Part 2 study. The primary objective of Part 2 is to describe the incidence of Treatment-Emergent Adverse Events. The primary endpoint is a comparison of serious adverse events and Treatment-Emergent Adverse Events as compared to placebo. The secondary endpoints include a number of efficacy assessments. Turning to our major depressive disorder program, we reported positive top-line results from the Phase Ib multiple ascending dose trial in May. As part of our reprioritization effort, we will pause this program. To augment our clinical development team, Dr. Vince O'Neill, who is currently serving as Head of R&D for OnkosXcel, will play a broader role in our neuroscience development. Vince has been with the company since the IPO in 2018, and has extensive pharmaceutical clinical development experience. Vince played an instrumental role in SERENITY I and II trials, along with our Chief Medical Officer, Dr. Rob Risinger, that resulted in the approval of IGALMI and the successful human proof-of-concept trials for Seven oh one in our oncology program. Dusan Kostic, our Head of Medical Affairs, will play an important role in developing clinical and medical strategies of Five oh one to support commercialization of any potential indications. He has more than 2 decades of pharmaceutical industry experience in neuroscience. This includes clinical development and commercialization of leading drugs such as Abilify, Invega, Abilify Maintena, and Rexulti. We have also initiated a search to expand our board of directors to strengthen clinical development expertise. The third part of our business transformation involves prioritizing AI-driven innovation to strengthen our neuroscience clinical development. Our unique integration of data science, clinical expertise, and commercialization gives us a powerful and distinct competitive advantage in building a robust R&D pipeline. We are truly excited about our clinical development initiative and pipeline candidates, including BXCL502. We look forward to highlighting these developments at an R&D event we plan to host later this year. We also plan to spotlight our next generation AI platform capabilities for identifying and re-innovating late-stage drug candidates and introduce BXCL503 and 504. In summary, this is challenging, yet transformative period for our company. We are taking swift and decisive steps with the goal of putting the company in the best possible position for future success. We have received interest from potential corporate partners. However, it is far too early to know what, if any, form such a transaction could take. We are passionate about our goals and remain committed to delivering long-term value to shareholders. I will turn the call over to Rich, who will discuss our second quarter financial results. Thank you, Vimal. Thank you, Vimal. Our second quarter 2023 financial results are as follows: Net revenue of IGALMI was approximately $457,000 for the quarter. Research and development expenses were $27 million for the second quarter of 2023, compared to $17.9 million for the same period in 2022. The increased expenses were primarily attributable to increased clinical trial expenses for SERENITY III and TRANQUILITY II. Selling, General and Administrative expenses were $25.9 million for the second quarter of 2023, compared to $18.4 million for the same period in 2022. The increased expenses were primarily attributable to an increase in personnel and related costs to support the commercialization of IGALMI. BioXcel Therapeutics had a $53.5 million loss for the second quarter of 2023, compared to a net loss of $37.7 million for the same period in 2022. The loss for the quarter included approximately $6.1 million in non-cash stock-based compensation. Cash and cash equivalents totaled $127.5 million as of June 30th, 2023. As noted, the company is undertaking a strategic reprioritization that includes a reduction in the workforce of more than 50%, which is expected to reduce expenses significantly. In the absence of additional capital becoming available, the company, under the strategic financing agreements or otherwise, the company estimates that its current cash and cash equivalents will last through mid-2024. The company's previously disclosed cash runway projection assumed a full utilization of its strategic financing agreements of $155 million with Oaktree Fund Administration and Qatar Investment Authority. Based on recent events, the company is not likely to be in a position to meet the milestones required to access the additional capital under the financing agreements. The company is exploring multiple ways to extend its cash runway and is already in discussions with its strategic financing partners to amend the agreements. Successful modification of these agreements could extend the company's cash runway. Finally, with regards to OnkosXcel, we are currently examining strategic alternatives, including, strategic partnerships or financing. Now I'd like to turn the call back to Vimal. Thank you, Rich. We would now like to open the call for questions. Operator? At this time, we will 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. Our first question today comes from Greg Harrison of Bank of America. Please proceed with your question. Hey, good morning. Thanks for taking the question. How are you thinking about the outlook for the company with this restructuring? How do you think investors should think about the story at this point? Good morning, Greg. This is Vimal. I'm very excited about the outlook for our business. As I shared earlier, we are laser-focused on the at-home opportunities for BXCL501. Specifically, the 2 value drivers for 501 are SERENITY program for schizophrenia and bipolar associated agitation, and our TRANQUILITY program for Alzheimer's agitation. We landed with IGALMI in the institutional setting. We are now shifting resources to expand into a potentially more promising retail pharmacy and outpatient setting. We also look forward to highlighting our pipeline with BXCL502 update at R&D Day by the end of this year. Got it. That, that's helpful. One more, if I can: Could you give us some more color on why you made the decision to shift focus to the at-home setting and away from institutional medical settings? We are shifting our focus from the institution setting to the retail slash at-home market due to the market and business factors we shared in our call. The hospital setting was more difficult to penetrate than originally anticipated, particularly in a challenging post-COVID environment. It is important to note that we will continue to make IGALMI available to our hospital customers through a more targeted contracting effort and small core team. We are committed to bringing IGALMI to current and future patients and their families for current indication and for new indications. Great. Thank you for taking the question. The next question is from Colin Bristow of UBS. Please proceed with your question. Hey, good morning. I just wanted to pass on, well done on this reprioritization. You made tough decisions, but I think they had to be done. Maybe first question, and just kind of piggyback off the prior one, could you outline how you see the market opportunity for IGAL- for IGALMI now that you're shifting the focus to the at-home setting? You know, how should we think about that, you know, specifically from a market opportunity point of view? Then secondly, and I think this is the most common question we're getting from investors, is just updates on the timing of, firstly, external audit. I think I heard you say by the end of the year, but any more color you can give with where you are in this process would be great. Then, you know, on the second part of that is just timing, regarding feedback from FDA. I know you've requested a meeting, but, when do you expect this to occur? Have you had any sort of interactions or feedback around this data issue? Thank you. Good morning, Colin. Regarding your question about the TRANQUILITY program update, as I stated in my earlier remarks, that we expect to have updates or hope to have the update by the end of the year. Independent audit is in progress. We have requested a meeting. Once we have the meeting, we will have a clarity, what is the data package required to file an sNDA, and that will be a good time to provide an update on the TRANQUILITY program. I just would appreciate if you can come back to your first question that you had asked so that we can address that. Yeah, I think. My first question was- Good morning, Colin, it's Matt. How are you? Yeah, the question- I was just checking you, you heard it, right? I did. Yeah. The, the question about the market opportunity switching from the, the hospital setting to the at-home setting. You know, keep in mind that there are 23 million episodes in the at-home setting. One of the things that we accounted for in our models as well is that we would capture many of the patients that wind up in the emergency department in the at-home setting as well. Given the market research that we've conducted, we recognize the unmet need in the home setting is quite significant. It's, it's underrecognized and underdiagnosed, but the patients certainly see value here. They indicated that both they and their caregivers would use this product profile for BXCL501 in 80% of their episodes. we feel that the market conditions for the at-home setting is, is quite, quite favorable, and we look forward to bringing the drug to those patients. Great. Thank you. The next question is from Sumant Kulkarni of Canaccord. Please proceed with your question. Morning. Thanks for taking my question. So per your Breakthrough Therapy Designation status, how exactly does the FDA define acute treatment of agitation in terms of number of episodes or instances of film usage per month? Along those lines, do you think the current pricing of $105 per film is appropriate or a strategic misstep for the convenience of at-home use? I'm asking because of two factors. First, even one way to hit the annual specialty tier of roughly $10,000 per year for pricing on a gross basis, that would translate to a patient using 100 films a year. Makers of chronic treatments of agitation enjoyed significantly higher market caps or buyout values, but pricing assumptions, they were much higher as well. Let me, I'll address the price question and the number of episodes. You know, first and foremost, we did conduct research when we established our launch price in both bipolar schizophrenia in the at-home setting and also in ADA. What we found is that for episodic treatment, there was appetite in the market for that price point. Certainly, what we see is that the volume of episodes in the mild Alzheimer's dementia patients is roughly 3 a month, and that can escalate further as they become more moderate. We also recognize that 81% of the ADA are either in an at-home setting or an ALF setting, which is akin to an at-home setting, and represent over 50% of the total volume of agitation episodes. That doesn't preclude 501 from being used in episodic breakthrough episodes, episodic breakthrough, in other locations as well. Got it. Does your new cash runway include the potential to redo TRANQUILITY II in case the FDA says you will not be able to file on just what you have currently? Sumant, we are not speculating on that. We are doing an audit, and we want to meet with the FDA and get the feedback, then we will be able to comment on it. Thanks a lot. Thank you. The next question comes from Ram Selvaraju of H.C. Wainwright. Please proceed with your question. Hi, thanks so much for taking my question. I just wanted to revert back to the formulary wins that you had previously announced, that you were previously engaged in pursuing in the institutional setting. Wanted to ask how that is affected, if at all, by your reprioritization here into the at-home setting. To what extent could we potentially expect you to be able to capitalize on the formulary wins that have already happened in the institutional setting, and along what trajectory? Also, if you could comment at all on how you expect promotional activities to be different in the at-home context versus the institutional context. Thank you. Sure. You know, first of all, we reported out that we had over 185 formulary wins, P&T wins to date. We're still accumulating those wins at a win rate of over 65%. In fact, we had three wins on Friday. We would expect that the 650 or so hospitals are still scheduled to vote. We'll continue with that process. Assuming that we continue to accrue these hospitals, we will reach out to them through medical affairs activities, through market access activities, contracting, and certainly support them with trade and distribution to ensure that they can access the drug and utilize it. The medical affairs support will obviously be really important in helping them determine how to develop protocols and pathways, so that planning is in place as well. The promotional activities for the at-home market is a little bit different because you are educating physicians and patients at the same time. As you know, patients can be motivated to ask for prescription drugs, so that would be part of the plan as well, and then through sampling and contracting with PBMs. These are activities that the contract with PBMs and state Medicaid, those are activities that may be accomplished prior to even FDA approval, considering we have a drug on the market today. Those are activities that we're planning out to get ahead of that potential approval, and more to come on the actual market entry strategy in months to come. Thank you. The next question is from Yatin Suneja of Guggenheim Partners. Please proceed with your question. Hey, guys. Thank you for taking my question. I mean, the first question is on the Alzheimer's disease agitation. I understand you will meet with the FDA and try to get their feedback on TRANQUILITY II and I. Can you just talk about what generally is the ICF guidelines for an indication like this? What sort of exposure, duration of exposure is needed from a regulatory perspective for a disease that affects millions of people? Because it seems like you are sort of stopping TRANQUILITY II. It's still not clear to me if TRANQUILITY I and II combined is enough for you to get an approval. That's 1. Basically, just help me understand the path forward for Alzheimer's disease agitation as you understand. The second is, it seems like on the R&D day, you're gonna talk a little bit about the BXCL502. Just curious, you know, maybe if you can highlight a little bit there. You know, in terms of the cash runway, maybe help us understand, how should we model it going forward? Where exactly are you cutting costs? You know, how many of the sales rep, you're still going to have? Yeah, so these three questions. Thanks. Thank you, Yatin. First question regarding the TRANQUILITY program. Rob, Rob will answer, like, what our plans are. Yeah. So let, let me be clear that, that we paused the trial because the early data in TRANQUILITY III indicated that the patient population may be better suited for chronic as opposed to episodic therapy. As you know, our focus is on the episodic treatment, in line with our Breakthrough Therapy Designation by FDA for episodic treatment. We have decided to pause the trial in order to discuss this issue with the FDA at an upcoming meeting, and we'll be able to provide more guidance on that once that meeting occurs. We do expect, at that meeting, to discuss both the auditing and the TRANQUILITY II results, and at that point, we'll be able to provide more guidance at the end of the year with regard to what will be necessary for filing an sNDA package. Yati, regarding your second question, I will pass it on to Rob, pass it on to Frank for BXCL502. Hi, Yati, this is Frank Yocca. I'm excited about our emerging pipeline development candidates, especially BXCL502. We really are looking forward to an upcoming R&D day, where we'll present our progress with this molecule, particular its development, but also, discuss some, some unique indications of interest. Secondly, we will discuss our next generation A.I. platform. This has evolved considerably from the first time we did our R&D day two years ago. The capabilities have been enhanced for identifying and reinnovating late-stage opportunities. We'll also discuss some candidates for additional pipeline entries such as BXCL503 and 504. It'll be a very interesting day. Regarding your third question, Yatin, related to the cash runway, Richard will address. Sure, Yatin. The reprioritization that we're working on now will extend the cash runway by reducing our burn significantly. We're also working on various other options to extend the cash runway, which includes working with our strategic partner. You know, as we said, the goal is to get, is to get the company to about an $80 million go-forward annualized burn rate. That's what we're working towards. In terms of the market, we'll reduce that. The market access team will be a core group of market access teams to work through the commercial sector. The next question is from, Graig Suvannavejh of Mizuho Securities. Please proceed with your question. Good morning. This is Richard on for Graig Suvannavejh at Mizuho. Just 2 questions from me is, 1, just following up from the crash one-night question. How do you expect the split between R&D and SG&A going forward? Then 2, for the IGALMI opportunity in sales, how should we be modeling that on a go-forward basis, now that your primary focus is on the at-home setting? Thank you. In terms of the commercialization, it's gonna be a small core team of about 12 people. That will reduce our SG&A expenses pretty dramatically, you know, moving forward. Our R&D expenses should go down. Remember, in the first half of the year, we had SERENITY III and TRANQUILITY II fully implemented, and that's what caused the increase in expenses in the first half of 2023. Richard, regarding your, your second question on modeling, we, we've never provided guidance on IGALMI sales. I think the way to think about this is by reducing our headcount in commercial to 12, it limits our ability to go out and prospect the way that we had in targeting the 1,700 hospitals. However, we will continue to support through contracting efforts and through trade and distribution on both our existing customers and those that choose to come online and approve IGALMI through formulary. We will support them in the same way. That may help you, but I can't give guidance beyond that. The next question is from Robin Karnauskas of Truist Securities. Please proceed with your question. Hi, this is Alex, one for Robin. Can you remind us what the approximate market opportunity is? The breakdown for dementia setting, between Assisted Living Facility versus nursing home? What are the getting factors to a growing uptake on the Assisted Living Facility? The, you know, as, as I think we've communicated, previously, with there are 100 million episodes total, better than 80% of the patients with Alzheimer's dementia, I, I mentioned this earlier in the call, are in either the at-home setting or the ALF setting. I don't have a specific breakdown for you here, but certainly something I can communicate later as we get closer to a market entry disclosure. Better than 50% of the episodes are in those settings, and we feel that that allows us to price the drug as an episodic drug, as opposed to pricing it as a chronic drug. Certainly can be used episodically in any setting. We think that the TAM still holds at 100 million episodes. The next question is from Corinne Jenkins of Goldman Sachs. Please proceed with your question. Hi, this is Omahri on for Corinne Jenkins. First, what do you view as your best options to further extend runway beyond mid-2024? Second question is, if the FDA requires an additional study, will they have to start which episodic leading trial with the same population in Tranquility II? Hi, this is Vimal. Regarding our cash runway extension, as Richard has already outlined, our cash runway is mid of 2024, and that's obviously predicated on what clinical trials we will be executing on. In terms of our options to extend that cash runway, we have multiple opportunities. One is working with our strategic partner, which Richard has already outlined, who are our financing partners. There is interest developing in these programs by other corporate partners. We are looking into that, and in addition, we have some core assets that we can monetize and capitalize to extend our cash runway. Good news is that we have multiple opportunities to extend our cash runway and achieve meaningful clinical milestones. Let me handle it. If, if the FDA has to another study, at this point, it's, it's premature to discuss whether another study is required. But in terms of whether that study would be ALF or just at home, again, we'd certainly make that decision upon consultation with the FDA, and we'll be providing that update later this year. I think I'd just like to add on top of what Rob said, we are a pioneer in developing a episodic medication to treat agitation. We are learning from the data, from the science, from the clinical outcomes that we are observing. We never, or FDA, never expected that we will have so many episodes observed in the nursing home setting. We are taking that information back to the FDA and designing a program, what makes most sense. Does it make sense to have ALF and home setting as a episodic and whatever is needed to put together that package? Would it make sense to go back later on and evaluate the nursing home as a more chronic option? Because I'd like to remind everyone, our Breakthrough Therapy Designation is in for acute treatment of agitation, and we believe mild to moderate probable Alzheimer's disease population is a relevant one so far what we have observed. Okay, thank you. The next question is from Samir Devani of Rx Securities. Please proceed with your question. Yeah. Hi, guys. Thanks for taking my questions. Most have been asked already, but I've got a couple. I, I guess the, the big question for me is, is it realistic for you guys to market directly to the generalist physicians for the at mar- at-home setting? Isn't that really more the domain of big pharma? Does it... Have you thought about just doing a partnership deal around IGALMI to address that and reduce the cash burn? Then I guess the second question is just really out of interest, how many, how many agitation episodes were you seeing in TRANQUILITY III in the nursing home setting? Thanks very much. I'll, I'll take the first question. Good morning. When we think about the at-home setting for bipolar and schizophrenia, there are roughly 78,000 psychiatrists that either diagnose or actively manage the therapeutic treatments for those patients. We feel that we would be very well positioned to access that market. It relates to Alzheimer's, dementia, agitation, these patients are managed from a top-line perspective by about 65,000 physicians in the United States. About 30,000 of those would be of interest to us. Those 30,000 are additionally making the diagnosis, diagnosis and treatment evaluation for these patients. Of those, there are somewhere between 3,000-4,000 that are specialists of interest. The primary care opportunity or the generalist opportunity, as you described, we would either have to partner with a CSO, a potential partnership with a larger pharmaceutical company, or permutations of all three of those. That market entry strategy is not yet clearly defined, but we're working through those, those problems or those, those potential opportunities, I guess, at this time. For me, regarding, how many episodes we observed, I will let Rob answer that. Yeah. There are patients continuing in the trial at this point, and they continue to have episodes, so the number is accruing. It's hard to say it on a given day, so I, I think the best way to describe it would be to say it's regular, and it is greater on an individual basis than what we reported in our TRANQUILITY II results. This is exactly why we're discussing it with the FDA, so that we have a clear path forward for episodic treatment of acute episodes. We'll, we'll have that guidance at the end of the year. Thanks very much. The next question is from Kambiz Yazdi of Jefferies. Please proceed with your question. Good morning, team. What are the proposed features that are going to be in the protocol amendment for SERENITY III Part 2? What are the kind of the key secondary efficacy assessments that would be valuable? Then maybe on your strategic financing partnerships, what modifications to your credit agreement and RFA would enable you to access capital earlier and be attractive to your partners? Thank you. We are finalizing that amended protocol. The secondary measures have to do with a variety of different, we'll call them, perspectives on efficacy. Once we have the meeting with the FDA, I think it, it will be much easier to describe the entire study and the details. Kambiz, did it answer your question? Because, what we are saying is, now we have selected a dose 80 mcg, based on our pharmacokinetic pharmacodynamic modeling, as we were expecting, and now it's a matter of modifying, protocol, submitting to the FDA, and then we will be in a position to initiate the study. As Rob has said, the primary is safety and then efficacy trends as we measure the over a 12-week period. That's what will be the outcome we will be looking from that trial. Yes. Thank you, Vimal. Regarding your next question, modification on the credit agreement. As Richard has mentioned, that we are in active discussions, and as we make progress, we'll provide an update. Thank you very much. Appreciate it. There are no additional questions at this time. I'd like to turn the call back over to Dr. Mehta for closing remarks. Thank you, everyone, for joining us today. We are excited about our path forward through this strategic reprioritization and look forward to sharing updates on our progress. Thank you for your continued interest in BioXcel Therapeutics, and have a great day. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.