BTAI (2020 - Q2)

Hello, and welcome to the BioXcel Therapeutics Second Quarter 2020 Financial Results Conference Call. At this time all participants are in a listen-only mode. [Operator Instructions] A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It’s now my pleasure to turn the call over to Vimal Mehta, CEO. Please go ahead. Vimal Me

Thank you, operator, good morning everyone and thank you for joining our conference call to discuss BioXcel Therapeutics financial results and business highlights for the second quarter 2020. We appreciate everyone’s time and attention. Joining me on the call today are Vince O'Neill, Chief Medical Officer; Will Kane, Chief Commercial Officer; Reina Benabou, Chief Development Officer; and Rob Risinger, Senior Vice President of Clinical Development. Our CFO, Richard Steinhart, is currently on medical leave and he is unable to join us today. In his absence our Controller, Michael Stanton, will be reviewing the financial results on today’s call. Months in COVID-19 is still creating uncertainty in the world and continues to affect each and every one of us. Healthcare workers will forever be our heroes as they remain committed to protecting our lives and halting the spread of the virus. In accordance with the U.S. CDC and State of Connecticut earlier – earlier this year, we implemented a work-from-home policy for all employees. We have been monitoring the impact of the pandemic in order to determine the best practice for continuing operations while mitigating this. At the end of the second quarter, we initiated our return to work plan, slowly bringing a limited number of staff back to the office and implementing the strict rules to protect our employees. Except for challenges in accessing elderly care facilities, we are fortunate that we have not experienced any significant delays to our ongoing or planned clinical trial. However, we continue to closely monitor the situation and provide updates as needed. As many of you know, this is one of the most exciting times in BioXcel’s history from positive results in two pivotal Phase 3 trials of BXCL501 to a very successful follow on offering. We cannot tell you how pleased we are with our progress. We remain committed to and on track with our commercial, clinical and development plans as we advance the investigation of our two candidates: BXCL501 and BXCL701. I will be starting off with our lead neuroscience clinical candidate BXCL501. As a reminder, 501 is a proprietary thin film formulation of dexmedetomidine, or Dex, for the treatment of acute agitation. We were ecstatic last month to announce positive top-line results from both SERENITY Phase 3 trials of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder, achieving the primary, secondary and exploratory endpoint. I would like to quickly recap those results, which we also reviewed in greater detail during a conference call last month. As you may recall, these two SERENITY studies were similarly designed as double-blind placebo-controlled parallel group trials with a total of 759 patients, 18 to 75 years of age. In each trial, patients were randomized to 1 of 3 arms receiving a film of either 120 microgram, 180 micrograms or a matching placebo. The primary objective of the trials was to determine the effect on agitation at two hours using the PAN's Excitatory Component scale, or PEC, a validated means to quantify the degree of agitation. The key secondary end point was the earliest time at which an effect on agitation was apparent by the change from baseline impact total score. Both trials demonstrated highly statistically significant and clinically meaningful improvement in PEC score and demonstrated statistically significant improvement in PEC score as early as 20 minutes after treatment. BXCL501’s rapid onset is an extremely important benefit for both the caregiver and patient. To further confirm the primary, our exploratory endpoints also demonstrated highly statistically significant and clinically meaningful reductions in agitation measures with durable reductions in agitation lasting at least four hours. In terms of BXCL501 safety profile, it was well tolerated with no serious adverse events. We could not be happier with the outcome of SERENITY I and II. These encouraging data represents an important milestone for patients with schizophrenia and bipolar disorder as well as their caregivers. We have a pre-NDA meeting scheduled with the FDA in October and look forward to submitting an NDA expected in the first quarter of 2021. In preparation for a potential approval by the FDA and the commercialization of BHCL501, we have built out our management team and have hired Will Kane as Chief Commercial Officer former Head of the U.S. General Medicine business unit at Allergan, and Dr. Reina Benabou as Chief Development Officer, former Chief Medical Officer of Cognivue. Both hires have extensive experience in bringing neuroscience products to market and will be integral in developing our prelaunch plan and go-to-market strategy. Will and Reina’s focus over the next 12 months is to develop the infrastructure needed, including building and hiring the medical affairs team, the managed markets team and the sales force. We will be well prepared for a potential product launch by 2022. Furthermore, these strong results from the SERENITY trials highlight BXCL501’s beneficial mechanism of action in helping to reduce agitation despite the underlying neuropsychiatric disease. This is in turn opens the candidate's potential to being an effective treatment for a variety of conditions ranging from acute to chronic agitation. And as you know, we are already well underway investigating BXCL501 in patients suffering from dementia and opioid withdrawal symptoms and are preparing to initiate a Phase II trial for the treatment of delirium later this year. Moving to TRANQUILITY, our Phase Ib/II trial for the acute treatment of agitation in dementia, this proof-of0concept trial is an adaptive design, intended to identify the most effective and tolerable dose or doses in this elderly patient population using three exploratory efficacy endpoints: PEC, Pittsburgh Agitation Scale and a modified version of the Cohen-Mansfield Agitation Inventory. We have currently finished dosing the first two arms of the trial, 30 microgram and 60 micrograms in a total of 30 patients. After reviewing the safety and tolerability data, we are now initiating the next dose 90 microgram. Please note, we are evaluated lower doses than previously tested in schizophrenia and bipolar patients because these elderly individuals may be intrinsically more sensitive to Dex, the active ingredient in BXCL501. Once we have identified the optimum dose for this patient population, we plan to advance the program into late stage development in consultation with the FDA. Recall that the FDA granted fast-track status to the development of BXCL501in dementia. Based on findings from the 90 microgram cohort, the company will report top-line results expected in the fourth quarter of 2020, or if needed, proceed to an additional dose cohort. With no FDA approved therapies to treat agitation in dementia and off-label drugs having a black box warning for the elderly, a treatment is desperately needed for this large patient population, especially given that they are at a significant risk of falling and injuring themselves when having an agitation episode. After reviewing the SERENITY results, we are confident that BXCL501's significant coming response shown in schizophrenia and bipolar patient will be repeated in dementia, since 501's mechanism of action seems to directly target agitation regardless of the underlying condition. With this patient population among the highest at risk for COVID-19, we are making sure we are taking all precautionary measures to guarantee that both the patients and caregivers remain healthy by reducing the risk of potential exposure. This past quarter, we announced that first patient has been enrolled in the Phase Ib/II RELEASE trial for the treatment of opioid withdrawal symptoms. And we are already and currently enrolling the third dose cohort of 90 microgram. This is our fourth indication to enter the clinic for BXCL501, again, highlighting the potential versatility of this candidate across vastly different conditions. In addition, for the first time, this candidate will be used as a sub-chronic treatment with ascending dose cohort of 501 being administered twice daily, 12 hours apart for 10 days. We are looking forward to reporting top line results from the RELEASE trial in the first quarter of 2021. Managing addiction has been a major challenge, and this crisis has only been exacerbated by the COVID-19 pandemic. The symptoms associated with opioid withdrawal are extremely debilitating and uncomfortable that makes breaking this addiction very difficult, often resulting in relapse and continued drug abuse. With accidental drug overdose as the number one cause of death in the U.S. for individuals under the age of 50 years old, a new treatment option is needed that helps alleviate withdrawal symptoms in order to assist in breaking the cycle of addiction. We believe BXCL501 has the potential to provide relief from debilitating opioid withdrawal symptoms, diminishing the arch to relapse in hopes of helping the individual on their path to recovery. In addition, we plan to initiate a Phase II trial in patients with agitation associated with delirium with and without COVID-19 this year. We believe our compassionate use program initiated last month at Massachusetts General Hospital, which provide BXCL501 to critically-ill COVID-19 patients in the ICU suffering from delirium and agitation will be symbiotic with our plans to pursue delirium as an additional indication with BXCL501. To wrap up, this quarter's neuroscience highlight, we received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application related to 501. The patent is expected to cover film formulations containing Dex and method of treating agitation using such film formulations in strengthening our intellectual property position and providing additional value for our stakeholders. The pattern, which is to be issued in the third quarter of 2020, is expected to extend IP protection until 2039. Now that we have shown 501's effectiveness in two indications, we are excited to explore all of the potential opportunities ranging from acute to chronic use in hopes of expanding the market value. We truly believe that BXCL501 will offer a safe, effective and easy-to-administer therapy for the millions of individuals that suffer from agitation in the U.S. and around the world, regardless of the underlying diagnosis. We are focused on continuing to validate 501's success across conditions marked by agitation and look forward to exploring numerous potential indications such as alcohol withdrawal, PTSD, traumatic brain injury and phobias. Now I would like to turn the conversation to our immuno-oncology clinical candidate, BXCL701, our orally available systemic innate immunity activator designed with a dual mechanism of action. Starting off, the Phase II efficacy portion of the Phase Ib/II trial of BXCL701 in combination with KEYTRUDA for Treatment-emergent Neuroendocrine Prostate Cancer, or TNEPC, is progressing on track, approximately 30 eligible men with TNEPC will receive 0.3 milligram of BXCL701 twice daily on days one to 14 of each 21-day cycle, plus 200-milligram of KEYTRUDA, administered intravenously on day one and then every 21 days. This split dose totaling 0.6 mg per day, the recommended dose when used in combination with KEYTRUDA, is based on results from the Phase Ib safety lead-in, which showed on-target side effects consistent with cytokine activation. In addition, based on preliminary evidence of activity in the Phase Ib safety portion of the trial, we recently initiated a separate cohort forecasted resistant prostate cancer patients who have failed taxane-based chemotherapy and up to two lines of second generation androgen pathway blockers. This cohort is expected to run concurrently to the tNEPC cohort. Initial efficacy data from this trial are expected to be reported later this year. BXCL701 was designed to generate an adaptive immune response, causing tumors to be more reactive to immunotherapies, including KEYTRUDA. Our preliminary clinical biomarker data showed dose- and time-dependent changes in circulating IL-18 concentrations from baseline. This is consistent with our understanding of the MOA of BXCL501 as IL-18 is a multifunctional cytokine that serves as a bridge between innate and adaptive immunity. We believe this candidate has the potential to be an effective treatment for patients in these subpopulations of prostate cancer. We are also progressing the clinical evaluation of BXCL701 via the open-label Phase II basket trial conducted at the MD Anderson Cancer Center. This study is evaluating the combination of BXCL501 and KEYTRUDA in patients with advanced solid cancer and consists of two arms: checkpoint naïve patients and patients who are refractory to checkpoint therapy. In June, the safety portion of the trial was complete. And recently, the trial met the efficacy bar in both arms, allowing the study to proceed to completion. We look forward to presenting initial data at a scientific conference later this year. Furthermore, the combination trial of BXCL701, bempeg from Nektar and avelumab from Pfizer and Merck KGaA in second-line pancreatic cancer, will start following the completion of Nektar and Pfizer Phase Ib safety study of bempeg and avelumab and the outcome of that trial. We are also further exploring compelling combination with BXCL501 in additional indications with high unmet needs. In July, we raised gross proceeds of approximately $200 million in a public offering, which helped to significantly strengthen our balance sheet. This cash, together with our current result, provide BioXcel a cash runway well into 2022 to fund key clinical regulatory, operational and commercial activities. With that, I would like to turn the call over to our Controller, Michael Stanton. Michael?

Thanks, Vimal. Once again, thank you all for joining us this morning, and a special welcome to our shareholders. BTI reported a net loss of $21.4 million for the second quarter of 2020 compared to a net loss of $8.5 million for the same period in 2019. The second quarter 2020 results include approximately $2 million in noncash stock-based compensation compared to $1 million for the same period in 2019. Research and development expenses were $17.9 million for the second quarter of 2020 compared to $6.5 million for the same period in 2019. The increase was primarily due to increases in clinical trial activity. General and administrative expenses were $3.5 million for the second quarter of 2020 as compared to $2.1 million for the same period in 2019. The increase was primarily due to salaries, noncash compensation costs and professional fees. Total operating expenses for the second quarter of 2020 were approximately $21.4 million compared to total operating expenses of approximately $8.6 million for the same period in 2019. As of June 30, 2020, cash and cash equivalents totaled approximately $65.5 million. This does not include the $187.5 million in net proceeds generated from our equity offering that closed on July 31, 2020. That concludes the financial review of our second quarter. Now I would like to turn the call back to Vimal for any further comments.

Thanks, Michael. We would now like to open the call to questions. Operator?

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question today is coming from Geoff Meacham from Bank of America. Your line is live.

Okay, great. Thanks guys for the question and congrats on the progress. I just had a couple. So when you just, as it relates to the SERENITY studies, I know you guys have a time to dig through that. Is there any data in the elderly population in that study that that could be helpful just as a read-through to the dementia study and just more specifically asking on optimal dosing and moving up on that? And then I have one followup.

Thanks Geoff for the question. We – as you said, we've been digging through the data. And what – wherever we are with the analysis, Rob will provide you some perspective on it.

Yeah. So we've looked at in both trials, the overall AEs for patients aged 65 through 75 that were dose both with 120 or 180 micrograms, and there was no different AEs than the younger patients, really no difference in the profile and also say there were no SAEs in this population or any patients in these trials.

Okay, that's helpful. And then, just as it relates to TRANQUILITY and the dosing. If you assume that, maybe one of the lower doses is what's move forward in Phase III. I know you guys are planning on having several doses available. But if you had an even lower one available for dementia. Just give us a sense for maybe how you think about that commercially from a – pricing and sort of reimbursement access perspective?

Sure. Good morning, Geoff. This is Will. So I think obviously we'll wait to see the data and how that plays out relative to the optimal dose for that population. I think it will give us an opportunity then to think through pricing potentially by indication or by dose strength. Again we'll have to wait and see how that plays out. And then, as you can appreciate for the geriatric dementia population, the Alzheimer's population, that is mostly a Medicare Part D populations. So that would involve interactions with those PDPs and pay organizations. But I think it would give us a strong position given the lack of approved treatments for acute agitation in dementia, Alzheimer's, et cetera. So I think it would serve as well or – it wouldn't anyway hamper us in terms of launching the product if the dosing were different.

Okay, great. Thanks a lot guys. I appreciate it.

Thanks, Geoff.

Thank you. Our next question today is coming from Robyn Karnauskas from Truist Securities. Your line is now live.

Hi guys. thanks for taking my questions and congratulations. Okay. I have a few. Let me just start with dementia. So you said you've dose up to 60 in the Phase III trial for schizophrenia, you didn't see a stat big benefit there. And if I recall the IV dose for – in dementia was sort of overlapping, as far as PK/PD with the other indications are going after. Like, do you have any sense of whether or not, I mean – it's double-blinded, but is there any sort of rule given the adaptive trial design that you've have not seen efficacy or see efficacy at that time point over that bar is. Just trying to get a sense of – if you have any sense yet of how high you could go. And then the next question would be, so you mentioned that you're going after 90 and if that bet take you into the fourth quarter. What happens if you go even higher, and what is the bar for going even higher above 90? Could that push you into first quarter. Just trying to get a sense on timelines? Thanks.

Great question. Let me address with your second question about the timeline. I think these cohorts generally won't take too long to complete, if COVID-19 situation does not impact our access to their dearly care center. That can become challenging, if cohort go without any like COVID-19 delays, and we can complete it pretty quickly. So depending on, as you indicated once 90 is completed, do we choose to go further to 120 or 105, whatever dose we will choose, data will guide us. So could it go to Q1? It's very hard to predict, but our goal is – that as soon as we can complete these recruitment and move the program forward. So it's hard to predict at this time, as we have indicated in our press release also. I will pass it on to Rob, regarding the other aspect of the question, which is related to what activity we saw in SERENITY with a lower doses. Rob?

Sure. So we designed the SERENITY trials in the development around agitation and schizophrenia and bipolar, based on our Phase II trial, that Phase II trial was a dose ranging trial. And as you're pointing out, we saw efficacy at a range of doses, it was really remarkably dose responsive. Now this was obviously patients with schizophrenia and we found some efficacy actually at 60 micrograms in that Phase II trial. We chose to take the higher doses into the Serenity trials because they prove to be greater proportion of response, a greater magnitude of response, and maybe slightly faster in terms of their efficacy. So we have a lot of things to consider. But the point is that in patients who are much younger, realize patients with schizophrenia, we showed efficacy at doses of 60 micrograms. And that's why we're testing lower doses in patients with dementia. We know that the IV formulation is labeled to use about half the dose in the elderly. So we actually have a plethora of data to design these trials, and we're using the exact same approach that we've used to generate the pivotal trials that were robustly positive. We're doing the same thing with dementia.

And Robyn, I like to add also. This is Vimal. Even if you remember in our Phase II schizophrenia trial, 80 was statistically significant. So we start seeing activity with a lower dosing and in schizophrenia and bipolar considering the nature of the patient, then you optimize the dose where you start seeing maximum number of response. So that's why we had dose escalated to 120 and 180 there.

Great. Just a quick follow-up, just want to be clear. But I know that yet to start lower for IV, but from what I understood from our conversations is that, the IV-PK look somewhat similar. So we don't really know if that's actually needed for going forward. I just was asking what is in the protocol, the bar for going even higher, higher than 90, because 90 you could argue that 90, you might have – it could be a better chance. If it's IV, it looks exactly the same, as far as PK-PD with these older patients than with the younger patients, sort of – as you're sort of alluding to in the schizophrenia trial, then you may need to go 90, you may need to go higher, if you want to have better efficacy. So what is that bar, just – clear as to the allowance for you to go higher? And then...

Robyn, just – there is no bar for us to escalate.

Okay. I think if you have to be safe, right. You have to have like, then...

Okay. Safety is the bar. If you, of course – we're not going to do anything unsafe. So safety is the bar.

Okay. And then color-wise, anymore clarity, I know you can't predict timing. But have you seen any increase in enrollment, as COVID sort of – shifted like from the beginning of the trial to the end. Has the COVID impact changed or for example, are you enrolling patients faster, as COVID cases come down in certain parts of the country. Anymore – just – I know you can't give specifics, but just any type of color that would help us feel more comfortable that there couldn't be slowing again potentially?

We do see our enrollment when there are no impact with the COVID-19, no shutdowns by those state or by the federal level to get access to these facilities. We do see trials do go quite fast. If there is no disruption.

Okay, perfect. Thanks for taking my questions.

Thank you, Robyn.

Thank you. Our next question today is coming from Yatin Suneja from Guggenheim Partners. Your line is now live.

Hey, guys. Thank you for taking my questions. Just a couple from me also. With regard to the safety consideration. Could you maybe talk about how this older patient. Are they even – are they also more sensitive on the safety side. And then with regard to the change in blood pressure or drop in heart rate. What might be acceptable, like how much drop in heart rate would you anticipate given that you saw that in your earlier trials in schizophrenia? And then I have a follow-up.

Yeah. So we're looking at overall safety, as we continue to escalate the dose and we're particularly, we know that in the elderly and safety of anything with respect to cardiovascular changes can result and for example falls or syncope, where people – if you will pass out and so that's one of the key safety measurements that we're monitoring closely. And so that's what we're – those are the kinds of events that we're monitoring. But we continue to escalate.

Got it. And then in terms of– can you just comment also on like how many centers? Is it – this consider more of a caregiver setting. Like who is giving a consent. And then, who is, our patients able to take the films themselves or is it caregiver that is providing the film to them?

Yes, we haven't – entirely disclosed that. So, it's that typical care center for – where many patients with dementia are residing.

Okay, that's all I had. Thanks.

Thanks, Yatin.

Thank you. Our next question today is coming from Sumant Kulkarni from Canaccord. Your line is now live.

Good morning. Thanks for taking my questions. I have two, the first one is very specific. Could you please put the data in your May 2019 poster from ASCP into a quantitative context for investors from bridging from an intravenous dose in Alzheimer's patients to a safe and effective dose for the film for agitation and dementia? That's the first question. The second one is, in the agitation and geriatric dementia setting, clearly, there's a risk-benefit profile that must be considered. What I mean is the risk of someone agitated versus not being treated, even if the treatment has some side effects. How might you be specifically able to address this aspect when you go to the FDA, for example for approval?

Yes, the range of plasma concentrations with the IV, kind of proof of concept trials, that produce now a RASS score of minus one. Now, realize that you can treat agitation with the RASS score of zero, but the range that produced a RASS score of minus one was between 100 and 300 picogram per mL. And so, we know we can achieve that with our sublingual proprietary formulation. With respect to the safety, the risk benefit profile, we know that agitation patients, especially with dementia and agitation, have a number of risks just from the condition. Those risks include physical harm to themselves. They include falls. They include accidents and falls. So we are – obviously, these are also things that we're monitoring closely. And this is a placebo-controlled trial as most of our trials will be. So we'll have comparator datas what I'm suggesting.

Got it. And just a follow-up to that. What are some of the specific quantitative parameters you set – you're setting as hurdles on the safety when you move to the next cohort.

Because these are – this is a proof-of-concept trial, if you will, or dose ranging. We're looking for any safety signals that would prevent us from testing higher doses.

And that mean, Sumant, that if there is a syncope or there is a syncope and a risk of fall, so those are the key parameters that we monitor for the safety. Obviously, you monitor all the blood pressure and heart rate those changes. But I think key factor from a dose escalation perspective is whether there is any syncope or whether there is any syncope and a fall.

Got it. Thanks.

Thank you. [Operator Instructions] Our next question today is coming from Do Kim from BMO Capital Markets. Your line is now live.

Hi, this is Jameson on for Do. Thanks for taking the questions and congrats on the progress. One on the delirium program. Given that you have all that additional data from SERENITY, the MGH study, plus the data of IV dexmed, do you think there's a potential for an accelerated path? Or do you still anticipate running the Phase III? Thanks.

So you’re right. If it is COVID-19 patients, there could be some accelerated path including emergency use authorization. But I think that market is like, you know, that need is sporadic and that market is unpredictable where we are focusing from a commercial opportunity, ICU-based delirium for our first trial, because that's a very well established situation agitation for the delirium patient. So I'm going to pass it onto Reina, she can put a little more color, the hyperactive delirium patient and what they experienced in terms of agitation.

Yes. So agitation in delirium in several places in the hospital is the reason for higher mortality or outcomes et cetera. So – and there is a lofty track record of IV Dex in successful management of delirium. So – and keeping our data with the film, I have no doubt that we can certainly pursue and really increase the outcomes of those patients with delirium in several settings.

Great. Thanks. Congrats on the progress, looking forward to the TRANQUILITY readouts.

Thank you.

Thank you. Our next question today is coming from Ram Selvaraju from H.C. Wainwright. Your line is now live.

Thanks very much for taking my question. So, firstly, on the TRANQUILITY program, I had two clarificatory points. Firstly, if you have great efficacy with the 90 microgram dose, just if you look at the efficacy profile and assuming that the safety is all clear, what exactly would be your incentive to pursue higher doses? In other words, the 90 microgram doses looking very potent and looks like it would give you a high degree of statistical significance. What would be your specific incentive for looking at higher doses? And then secondly, can you comment on medications that are excluded in the TRANQUILITY study, in particular, those that are known to be associated with high-risk of falls in this population. And in particular, I'd be interested to know whether NUEDEXTA and NUPLAZID are excluded medications. Thank you.

The only medications right now that are really excluded would be medications that would increase blood pressure, like pressers for example. We have intentionally tried to include patients who are on a range of other medications. We know that the population is treated with polypharmacy unfortunately. And so we're trying to test this as safely as possible, but nonetheless, and as generalizable a population as is feasible. So the exclusions right now have to do with pressers things that that might alter blood pressure in a negative way.

Okay, thank you. That's helpful. Now, in addition, I wanted to ask about opioid withdrawal efficacy endpoints, which efficacy endpoints you anticipate are likely to be most applicable in that context. And also if you could enumerate what the potential advantages of a drug like 501 might be in that indication versus, for example, Lucemyra or lofexidine.

We are using the COWS, the clinical opiate withdrawal scale, and the SOWS, the subjective opiate withdrawal scale of Gossop. This is the registrational endpoint that the FDA accepts, for example, to demonstrate efficacy, to treat opiate withdrawal symptoms. We believe that BXCL501 has both robust effects in terms of treating opiate withdrawal symptoms. We believe it is rapid. We believe it is also – should have a magnitude of effects likely greater than Lucemyra. Now, this is based upon our IV proof-of-concept trial in patients undergoing withdrawal. And that is also based on preclinical data showing the selective and highly potent agonism relative to Lucemyra.

And Ram, I do want to address your initial question. If we win 90 microgram, we see great efficacy, do we have any incentive to go forward? I think what we are really trying to achieve there is a sweet spot of effectiveness and the tolerability and also the coverage. We are here not just treating Alzheimer's dementia patients, we are having all kinds of dementia patients and we want to see what dose is working in what kind of patients, so that we can get a good handle and then we can choose for our late-stage development right kind of a dementia population where we see optimal efficacy as well as safety.

Okay, great. And then just a couple more I was wondering if you could provide us with an update on the COVID-19 associated delirium compassionate use program? And if you are seeing any additional interest, any demand from hospitals beyond MGH in that context? And then if you could provide us with your sort of updated perspective on potential lifestyle indications as it were in the long run with regard to 501? I mean, we've talked previously on other calls about phobias. I was just wondering if you had any thoughts about conditions like PTSD, middle-of-the-night awakening, things like that, where a calming agent like this might potentially be applicable, of course, in the very, very long run after you get through all of these initial indications. Thank you.

That's right. That's right. As you mentioned, these are quite a bit of potential with 501 to expand and capture the market opportunity. Delirium MGH is a MGA study, and they will provide the update. If they provide us update, then we will provide. But what that has done coming to your question created interest with a lot of key opinion leaders who are the leaders in this field. And we are working with them to design our Phase II trial in delirium. So that trial or that visibility like in our interests and FDA’s support to use it for a compassionate use has been helpful and we have speeded up our government for delirium agitation. I will pass it on to Rob and Reina to talk about more broadly about like how they are thinking about PTSD, alcohol withdrawal, or phobias, there quite a bit of opportunity. So Rob and Reina?

And TBI, I mean, phobia, for example, people think of phobias like a fear of flying or a fear of heights. Phobia is actually have a certain amount of background anxiety as well. It does affect their lives. And there is a thing called agoraphobia, which limits people's ability to even leave their home. So it's hard for them to be employed often. They can't leave the house. There is potential application across a number of these anxiety disorders as well as PTSD, a huge and continuing problem for patients, not just military, but many, many patients develop PTSD from accidents and trauma. There – again, there's an evidence that dexmedetomidine may have beneficial effects in traumatic brain injury patients, not just in the acute trauma and treating with delirium, there's evidence of that, but there is also potential evidence of long-term recovery. They have, for example, sleep wake disturbances. It's a classic symptom, almost every patient has that. And obviously, dexmedetomidine can potentially improve sleep as a biomimetic sleep. So it augments sleep in a very specific way that is unique very different than benzodiazepines or other sleep agents. So I'll let Dr. Benabou speak to others.

So thank you very much, Rob. So, honestly, I think we add value in patients' lives if we can either prevent, predict, or – and optimize a disease state. So, there's a lot that we can do in terms of lifestyle on a daily basis as well. So – and 501 has clearly demonstrated a reliable, consisting, excellent efficacy and safety profile that is due to his central mechanism of action. So we're confident that we also make a difference in all those other indications, as Rob mentioned.

And I would like to also that at some point we will engage the FDA in a conversation where we can seek that there will be opportunity for a broader agitation label if we can prove our drug is working through a central mechanism after having the efficacy in couple of these indications, so there a quite a bit of a strategy that is needed to do the lifecycle management and capture the full potential of this drug. And I think good news is that we have both clinical team and commercial team and our medical team they're working very closely how to prioritize them and what strategy to use to expand the potential of 501.

Thank you.

Thanks, Ram.

Thank you. We have reached the end of our question-and-answer session. I'd like to turn the floor back over to management for any further or closing comments.

Thank you again for joining our call today. I'm extremely proud of BioXcel's tremendous growth on both the clinical and corporate fronts, and we remain focused on continuing this momentum for the remainder of 2020 and beyond. Have a great day, and please reach out to us if you have any additional questions. Thank you.

Thank you. And that does conclude today’s teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.