Good morning, and welcome to the BioXcel Therap eutics first quarter 2021 financial results conference call. At this time, all participants are on 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 future financial performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. The risk factors that may affect results are detailed in the company's most recent public filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarterly period ended March 31st, 2021, which can be found on its website at www.bioxceltherapeutics.com or on www.sec.gov. 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, Will Kane, Chief Commercial Officer, Vincent O'Neill, Chief Medical Officer, Frank Yocca, Chief Development Officer, and Reina Benabou, Chief Development Officer. It is now my pleasure to turn the call over to Dr. Mehta, the CEO of BioXcel. Thank you, sir. Please go ahead. Thank you, operator. Good morning, everyone, thank you for joining our conference call to discuss BioXcel Therapeutics financial results and business highlights for the first quarter of 2021. We appreciate everyone's time and attention. This quarter, we have remained committed to accomplishing our long-term goals for our neuroscience candidate, BXCL501, with an emphasis on advancing our dementia development program as well as building the commercial readiness infrastructure needed to support the potential launch of our first two indications. Starting off with dementia, we are very pleased with the tremendous advancement we have made with this indication, from successful data readout to the receipt of breakthrough therapy designation from the FDA. In first quarter, we announced positive data from the TRANQUILITY study, our phase Ib/II trial for the acute treatment of agitation associated with dementia, which included patients with Alzheimer's disease. To summarize, 501 was well-tolerated, with statistically significant reductions in agitation achieved at two hours post-dose with both 30 μg and 60 μg cohort as measured by primary and secondary endpoint. Also, the supplemental 40 μg dose cohort study was initiated and is progressing well. These results aim to provide development paths to a pivotal program and provide a strong foundation for our broad dementia development strategy. We are highly encouraged by 501's potential in dementia. We believe it has broad applicability in treating not just acute agitation, but the full spectrum of agitation across care settings. Supported by the TRANQUILITY results, we received FDA breakthrough therapy designation for BXCL501 for the acute treatment of agitation associated with dementia. Another win for this indication. This designation highlights the need for alternative treatment options for this underserved patient population and potentially offers an expedited development and regulatory review for 501. With our end of phase II meeting with the FDA in the near future, we look forward to discussing our registrational development strategy for dementia, solidifying the trial design, as well as initiating the late-stage program in the second half of this year. Approximately 6 million individuals in the U.S. are living with dementia, and of that, 70% experience agitation episodes. This market is a huge opportunity that is largely untapped. Following decades of research, there are still no safe and effective treatments that directly target agitation commonly seen with the dementia patient, including Alzheimer's patients. We are thrilled by the potential to be the first company to develop a therapy designed to address the significant patient and caregiver need. In parallel, we are making great strides with commercial readiness initiatives in hopes of bringing the first treatment to specifically address schizophrenia and bipolar disorders related agitation to the U.S. market. Back in March, we announced that we have completed the submission of our NDA application to the FDA, supported by positive data from the pivotal SERENITY studies reported last July. This is our first NDA for our neuroscience program, and we expect a response from the FDA this month regarding the submission. On the commercialization front, we are continuing to advance our preparations for commercial readiness. These initiatives have included making key hires for both commercial and medical teams. In March, we deployed our medical science liaison and medical managed care team. Additionally, we are completing the design of our sales force site and structure. If approved, we are confident we would be ready for a commercial launch of BXCL501. Importantly, the infrastructure we are building to support the potential commercialization of BXCL501 for acute treatment of agitation associated with schizophrenia and bipolar disorders one and two will be crucial foundation to launching additional potential follow-on indications, paving the way for our neuroscience business. Recently, in tandem with Mental Health Awareness Month, we launched an education campaign on agitation in neuropsychiatric diseases such as schizophrenia and bipolar disorders, called Boiling Point. This campaign intends to shed light on the importance of prompt and cooperative de-escalation in the acute treatment of agitation. Our interactive website at partnersincalm.com aims to educate healthcare providers. Importantly, our strategy for commercializing 501 for the treatment of schizophrenia and bipolar disorders includes agitation associated with dementia, as well as other possible indications. We have already benefited broadly from the market research, payer, and advisory board meetings we have held with a deeper understanding of the agitation treatment landscape. We will continue identifying key learnings and insights as we roll our commercial plan for schizophrenia and bipolar disorder that will help lay the foundation for the much larger dementia opportunity. With the preparations for U.S. commercialization on track, we are excited to announce that our strategic plans for geographic market expansion in Europe are also underway. Utilizing our NDA package, we expect to file a marketing authorization application with the European Medicines Agency for the treatment of acute agitation associated with schizophrenia and bipolar disorders one and two in the second half of this year. We are committed to delivering transformative neuroscience medicines to the global population through regulatory expansion opportunities and potential strategic partnerships to help commercialize 501 in Europe. Adding to our geographic expansion strategy, we recently strengthened our BXCL501 IP portfolio with the issuance of two Japanese patents. The first covers method of treating agitation, which will expire no earlier than 2037, the second is directed to film design, which will expire no earlier than 2041. All these achievements serve as foundational building blocks for expanding our global footprint. While we continue to prioritize our dementia and schizophrenia bipolar programs, we believe that 501's differentiated mechanism of action has the potential to treat a wide spectrum of agitation across neuropsychiatric and neurological disorders. We are confident this candidate has the potential to be used across an array of treatment settings where there are large unmet needs. Recently, we reported data from the RELEASE study, our phase Ib/II trial of BXCL501 for the treatment of opioid withdrawal symptoms. This trial marked our first time testing 501 as a subchronic treatment, twice-daily dosing over one week. We were encouraged that we met the primary safety endpoint and were able to identify a dose range that was generally well-tolerated and resulted in numerical improvements in retention in this difficult-to-treat fentanyl-enriched patient population. According to the latest estimate from the CDC, synthetic opioid fatalities rose by an unprecedented 55% during the 12 months ending in September 2020. The growing use of fentanyl is becoming a significant national health crisis. Based on these statistics, we believe there is an important need for new treatment options to help address this mounting crisis. We will continue to analyze these results in collaboration with our highly distinguished advisors regarding potential next steps for this important condition. The RELEASE data also supports further investigation of different dosing regimens across additional indications and treatment settings. As you can see, we have laid a robust clinical foundation for our BXCL501 program, conducting a total of seven clinical trials in over 800 subjects across a range of diseases in just over two and a half years. We have now demonstrated the potential for robust treatment effect for alleviating acute agitation in three distinct indications: schizophrenia, bipolar disorder, and dementia. We have made significant progress on our strategic initiatives in building an integrated organization encompassing artificial intelligence, research and development, medical and commercial capabilities to deliver innovative medicines to patients. At BioXcel, we are passionate about the potential to bring novel treatments in neuroscience and immuno-oncology to the millions of patients who lack effective and tolerable options, while also creating value for our shareholders. Now, I would like to turn the conversation to our immuno-oncology clinical candidate, BXCL701. It is an oral immunomodulator designed to stimulate both innate and adaptive immune systems, potentially turning cold tumors to hot. 701 is designed to be a potent inhibitor of DPP-8 and DPP- 9 that may activate inflammasomes, resulting in the release of pro-inflammatory cytokines in the tumor microenvironment. As you know, despite checkpoint inhibitor therapy undoubted success, many patients do not respond to them, particularly cold tumors, such as aggressive form of prostate cancer. We are excited about BXCL501's novel mechanism of action to combine with a checkpoint inhibitor and are encouraged by our IO program to date. We believe BXCL701 is the most advanced orally available innate immunity activator in development that has been optimized for dosing in combination with KEYTRUDA. 701 is currently being evaluated in two combination trials with KEYTRUDA for the treatment of several advanced cancer types, both cold and hot tumors. In our ongoing open-label phase Ib/II trial in aggressive forms of prostate cancer, we are pleased that the adenocarcinoma cohort has met its efficacy bar to move to stage two. The trial will now continue to full enrollment and updated efficacy data are expected to be reported this year. This is a giant step for 701, as this candidate is showing early promise in cold tumors by potentially making the cancer more recognizable to checkpoint inhibitors. If successful, this innate immune inhibitor could be transformative to the immuno-oncology field. Finally, the company has strong cash position of $194 million to achieve our key milestones. With that, I would like to turn the call over to our CFO, Richard Steinhart. Richard? Thank you, Vimal. We reported a net loss of $26.4 million for the first quarter of 2021, compared to a net loss of $14.9 million for the same period in 2020. Research and development expenses were $14.7 million during the first quarter of 2021, as compared to $12.4 million for the same period in 2020. The higher expenses were primarily attributable to an increase in personnel and related costs necessary to enlarge our development and medical teams. In addition, we experienced increased professional fees in conjunction with higher consulting fees and CMC costs related to BXCL501, as well as increased costs related to our RELEASE clinical trial. These increases were offset in part by a decrease in SERENITY I and II clinical trial costs. General and administrative expenses were $11.6 million for the first quarter of 2021, as compared to $2.6 million for the same period in 2020. The increase was primarily due to higher personnel-related costs, as well as costs related to our expansion in preparation of the potential launch of BXCL501 in the U.S., and increased legal, professional fees, and insurance costs. The first quarter of 2021 results include approximately $5.6 million in non-cash stock-based compensation costs, compared to non-cash stock-based compensation costs of $776,000 for the same period in 2020. As of March 31st, again, our cash and cash equivalents totaled approximately $194 million. I'd like to turn the call back to Vimal for any further comments. Thanks, Richard. We would now like to open the call for questions. Operator? Thank you. The floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad at this time. A confirmation tone will indicate your line is in the question queue. If you would like to remove your question from the queue, please press star two. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that is star one to register a question at this time. We do ask that you please limit yourself to one question and one to two follow-up questions. Our first question today is coming from Geoff Meacham of Bank of America. Please go ahead. Hey, guys. This is Greg Harrison on for Geoff. Thanks for taking the question. As you look forward to a pivotal trial in dementia, what are your preferred characteristics you'd target in your end of phase II meeting with the FDA? Just wondering if you'd be able to potentially run a smaller trial given the existing safety track record of 501 and get the indication added to the label center. Greg, thanks for the question. This is Vimal. We are having a planning meeting with the FDA to get alignment on the things you exactly mentioned, the clinical trial design and what is the size of the trial needed and what is the size of the safety database needed. We will get the clarity on all of that soon once we have a meeting with the FDA. As you know, in TRANQUILITY, we use ALF setting, and we are trying to see that what we want to do in phase III is close to what we have done in TRANQUILITY. Got it. Very helpful. Thanks. Thank you. Our next question is coming from Graig Suvannavejh of Goldman Sachs. Please go ahead. Hi, team. Thanks for taking the question. This is Anna on for Graig Suvannavejh. Just one quick question from us. Could you provide a little bit more color on the Placidity enrollment and the burden of COVID-19? Just a little color would be helpful. Thanks. We initiated the sites in Q1, and after opening couple of sites, we realized that there were operational difficulties in enrolling the patients and opening additional sites. We decided to voluntarily pause enrollment until we assess what is the optimal step to take to initiate the trial. Great. Thanks. Do you expect that the timelines would be slightly delayed in terms of getting first signs or first signals of data? Once we have assessed what the operational challenges are and how we're going to overcome, then we will be able to provide a guidance on the timeline. Great. Thanks so much. Thank you. Our next question is comi ng from Brian Mills of Jefferies. Please go ahead. Hi, thanks for taking our questions. I was wondering if you could talk a little bit about the 501 commercial launch preparations. Have you encountered any logistical challenges due to COVID, and when do you expect to hold meetings with P&T committee? Thanks. Sure. Thanks, Brian. This is Will Kane. I'll address your question. Our preparation for the launch is ongoing, and we're making steady progress. Everything is coming together. We've completed a good chunk of market research to help inform us. The product does receive positive reviews by hospital-based clinicians as well as pharmacy directors. We consider that a positive signal relative to the receptivity to 501. They also clearly recognize the unmet need, particularly in the patients who are treating in the hospital setting. As I said, the profile does motivate them. We don't anticipate at the current time impacts of COVID simply because we're a ways away from the launch. That's going to require tracking over the next several months. As you know, our base case plan is a launch in Q1 of 2022. We will plan for that, continue to assess the opportunity to access hospitals to achieve our goal when we build our sales force. The goal is to obviously engage and to partner with local advocates in hospitals that are high priority for us, so that they can be spokespeople, if you will, in front of the P&T committees to initiate the process and ultimately achieve formulary access for the product. Great. That's helpful. Thank you. Thank you. Our next question is coming from Robyn Karnauskas of Truist Securities. Please go ahead. Hi, guys. Good morning. Thanks for taking the question. I guess one for Will. You said you talked about the structure for the sales force and for marketing of the drug. Do you have any updated thoughts on either feedback from, you mentioned payers. What kind of feedback are you getting from the payers, and any updated thoughts on the structure of your sales force? Then just as a follow-up, can you just give an update on enrollment of the PTSD and delirium trials? Thank you. Sure. Hi, Robyn. Thanks for the questions. I'll obviously start. As it relates to feedback, if you will, from payers, we have, as I said, done some market research with both payers, but more importantly with hospital-based P&T committee members such as pharmacy directors. As I said, the profile of the drug is very well received. They recognize the unmet need, as I stated previously. Hospitals are a more price-sensitive segment of the market. We're looking to understand what level of discounting, if you will, off a WAC price may be necessary to achieve the formulary access that we are shooting for, which is broad-based, because the product has applicability across a spectrum of patients with agitation associated with schizophrenia and bipolar disorder. What I would say is feedback so far has been positive. We have more work to do, certainly on the pricing front, as we get closer, which we will continue to do, and as we engage more and more P&T committee members directly through both the medical managed care team and then ultimately when we field an account management team in the second half of this year, which is on schedule. In terms of the structure of the field force, I guess I'm pleased to say that as we continue the analysis to finalize the size and structure, it is pretty much on par with what the initial thinking was, 75-100 representatives. Probably closer to 75, as we think through the process. We have already identified high potential hospitals that would constitute the core. As we indicated previously, that's about 1,500 or so. The next step is to continue to profile them to understand things like P&T scheduling processes, who the local advocates are, et cetera, to help us prepare for engagement with them. Robyn, this is Vimal. Regarding the update on the PTSD, as you know, that is a trial we are conducting with Yale and VA. It's an IST. They are working towards the goal of initiating the trial. As we get update that they have initiated, we will be in a position to communicate. For the delirium, which I mentioned, the PLACIDITY, we had some operational challenges in the ICUs in the current environment to enroll patients as well as to be able to open additional sites. We have voluntarily paused delirium, and we continue to be focused on our three priority indications, schizophrenia, bipolar, and dementia. Thank you. Our next question is coming from Ram Selvaraju of H.C. Wainwright. Please go ahead. Hi, thanks very much for taking my questions. Can you hear me? Yes, we can hear you. Firstly, with respect to the European perspective on 501, can you perhaps elaborate on what you consider to be the most optimal and effective way to commercialize the drug if you anticipate establishing your own commercial infrastructure in Europe, or if you're going to seek a partner? If you are going to seek a partner, can you give us a sense of what you think is likely to be the optimal timing for that, either ahead of or post-approval? Thanks. Ram, thanks for the question. We are very pleased that our recent interactions with the agency in Europe were positive, and they gave us good feedback, and we were encouraged that we can use the NDA package to file in Europe. Having said that, which we are planning to file in second half of this year, our strategy as a company is to launch this product in U.S. ourselves and seek a partner in Europe. With this filing, once we get this filing, it definitely creates more interest because now there is a definitive path to the regulatory approval. We'll continue to explore the opportunity to find the relevant partners. We obviously get approached by some partners and see who has the relevant capabilities, not only for schizophrenia and bipolar, for our other upcoming indications, including dementia. Okay, just a quick follow-up on the delirium side of things. Are you envisioning the possibility of conducting a new study somewhat along the lines of PLACIDITY, but that doesn't involve focusing on COVID-19 patients exhibiting acute delirium, rather patients who are exhibiting delirium in the post-surgical setting? Do you think that it would be feasible to conduct such a study without running into the same logistical problems that you previously had? There are four settings for delirium. ICU, post-operative setting, medical wards, and ER. We have a choice to make that in any of those settings, trial can be conducted. We chose ICU for very fundamental reason. There was a data available with IV dex about a proof of concept that when dex was used, all patient responded who were refractory to haloperidol. That was the rationale to choose the ICU. Considering the operational difficulties, medical wards can be another very viable option. Thank you. Thank you. Our next question is coming from Yatin Suneja of Guggenheim Partners. Please go ahead. Good morning, guys. Thank you for taking my question. With regard to the potential dementia-related agitation study, is there a thought of going after dementia, or could you narrow it to a particular dementia subset like, let's say, Alzheimer's? Just wanted to get a sense, the learning that you might be applying from what happened at Acadia. Yes, thanks for the question. In our TRANQUILITY trial, our majority of the patients were Alzheimer's patients. If you look at it, they were about 85% or more. Then second largest was vascular dementia. When we looked at the data, we did not see, like in our subgroup analysis, much difference between the two types of dementia population. The third was FTD. We did not have Parkinson's patients as well as Lewy Body. We are already narrow in terms of our dementia subpopulation. What you mentioned, what learnings can we have? We learn from that, then we will have a conversation with the FDA. What is the most optimal path to get to the sNDA? Is it the dementia with Alzheimer's as the major subtype and some of the other dementia, which I mentioned, or it's only Alzheimer's? Those things need to be discussed with FDA. Got it. Just one question on 701. Could you maybe talk about what you need to see in stage two for you to move into, let's say, pivotal development? How much data are we going to be expecting later this year? Thank you. Vin, do you want to take that question? Sure, I'll take that. Thanks, Vimal. As you may recall, the study is divided into stage one and stage two. 15 patients in stage one, and then a further 13 patients in stage two, 28 patients in total. We'd previously said that we're aiming to see a composite response rate, around 20%. Given that this is an end-stage patient population, we think that's compelling. Were we to see that, then the next step would be actually to expand out this study, and continue to run the trial, essentially to accrue more patients and get a more precise handle on what that response rate is. Hopefully that answers your question. Thank you. Thank you. Our next question is coming from Colin Bristow of UBS. Please go ahead. Well, hey, guys. This is Rich calling in for Colin. A couple of questions from us. We only saw the MD Anderson Cancer Center basket study presentation at the upcoming ASCO, and I believe you guys mentioned that you would present the prostate cancer in mid-year. Seems to be delayed now. Just any reason for that? Also a follow-up question on, you mentioned the cash position after Q1 at $194 million. When do you expect to do another raise to support commercialization of 501? Thank you. You are right that regarding ASCO, our investigator at MD Anderson is going to present the data that is related to the hot tumors, like either refractory or treatment naive patient. We have indicated that we will plan to announce the data mid-year sometime with the prostate. Where are we are with the trial, where we have moved to the stage two. We feel good and confident that trial enrollment is progressing well. These are open label trial. We want to accumulate sufficient number of patients and see responses over a period of time. We believe that there's no material change in our guidance when we will be ready to share the data on the 701 trial. Regarding your question, do you have any question, or does it address your 701 question? Yeah, that answers it. Thank you. Okay. As we indicated, cash position is under $194 million. Our past three quarters, if you look at it, our burn rate has been in the order of about $25 million per quarter. This cash position gives us a very strong position to achieve the key milestones that we want to achieve that we have highlighted today. We feel currently we are in a good position, as far as our cash is concerned. Thank you. Our next question is coming from Sumant Kulkarni of Canaccord. Please go ahead. Morning. Thanks for taking my questions. I have a couple. First, we know you said you expect potential acceptance of your 501 NDA this month, and we're right at the 60-day mark since your press release. Could you characterize any new interactions with the FDA that you might have specifically had on this NDA after submission? The second question is, what are the latest levers you have for non-dilutive funding? Do you have any preference for geography, U.S. versus Japan? Or perhaps royalty deals in the U.S.? Sumant, you are right that we have completed the 60-day cycle with the FDA. The questions FDA has asked us prior to the 60-day, all of those questions were addressed. We expect to hear from the FDA on the now 74th day, when we will potentially learn about the acceptance as well as about the PDUFA date. Your second question is about the non-dilutive financing. Considering we are filing our MAA with EMA, so Europe will be the first priority. As you notice that we got two additional patents issued in Japan, that's a real market opportunity. We will continue to evaluate, and we will schedule that as the next priority to the Europe. Sometimes when you are seeking these partnerships, you do find partners who may be interested in both geographies. It's very difficult to predict, but I think we are making progress on both fronts outside U.S. Got it. Thanks. Thank you. Our next question is coming from Samir Devani of Rx Securities. Please go ahead. Yeah. Hi. Thanks for taking my questions. I just want to confirm, you mentioned you're using the NDA package for the European filing, but is there any other data that you may need ahead of that submission? That's, I guess, the first question. Thanks. Samir, thanks for asking the question. That was our question when we had meeting with the agency, and now we believe we have the alignment that we don't need to generate any additional data than what we already have in our NDA package to submit the MAA application. Okay, that's great. Just one follow-up, just on the PLACIDITY and delirium opportunity. I'm just wondering if you can maybe just remind us of why docs would not prefer in that setting to use sort of IV dex rather than the film. Thanks very much. That's a very relevant question, Samir. As you know, IV dex is only available in a surgical suite currently, and also it involves some sort of titration and other difficulties that are associated in administering IV dex to treat the agitation. What we have learned is there are settings, like medical ward and other settings, where there could be opportunity for a 501. That's part of the reason we feel that it is across an institutional setting. There are certain places, like particularly in medical wards and all that, it's a big burden to be able to put a IV line and do the titration with IV dex. Our research indicates that delirium opportunity in medical wards and some of the other places in the institution can be very relevant for the film. Great. Thanks. Thank you. Our next question is coming from Anita Dushyanth of Berenberg Capital Markets. Please go ahead. Hi, good morning. Thanks for taking my question. Just a couple here. Can you talk about the enrollment rate in the TRANQUILITY expansion study? Also, sorry if I missed this one, were you able to mention what the size of the sales force is for the commercialization of the 501? In terms of the enrollment in the supplemental cohort of 40 µg, enrollment is progressing well. We expect that we will be able to complete that enrollment and have our data in our hand to make decisions for our phase III program. Regarding the sales force, Will has mentioned that our range is 75-100, but more or less the sizing work that is being don e for priority hospitals about 1,500, it may be more or less 75. Great. Thank you. Thank you. We're showing no additional questions in queue at this time. I'd like to turn the floor back over to management for any additional or closing comments. Thank you, operator. Our number one goal as a company is to deliver transformative medicines to patients in need, and we are confident this can become a reality in the near future. Thank you all for joining our call today. Gentlemen, thank you for your participation. You may disconnect your lines at this time. Have a wonderful day.