Good morning, and welcome to the BioXcel Therapeutics Q2 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. During the conference, if 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 can 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 relating to future events and/or the 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 to U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarterly period ended June 30th, 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, Dr. Vincent O'Neill, Chief Medical Officer, Dr. Frank Yocca, Chief Scientific Officer, and Dr. Rob Risinger, Senior Vice President of Clinical Development. It is now my pleasure to turn the call over to Dr. Mehta, CEO of BioXcel. Thank you, sir. Please go ahead. Thank you, operator. Welcome, everyone, and thank you for joining our call today. We had a very exciting and productive Q2 as we continue to execute on our key initiatives that we believe will deliver long-term value to patients, healthcare providers, and our shareholders. As many of you are familiar, we are a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. Our two most advanced programs are BXCL501, our neuroscience investigational candidate that is being developed for the treatment of agitation, and BXCL701, our immuno-oncology investigational candidate, which is being developed for the treatment of aggressive forms of prostate cancer and advanced solid tumors. I will begin today's call with an overview of the progress we have made with our neuroscience program and plans to expand into additional neuropsychiatric disorders. In just over two and a half years, we were able to go from conducting our first in human trial, BXCL501, to receiving FDA acceptance of our NDA filing for the treatment of acute agitation associated with schizophrenia and bipolar disorders 1 and 2. Thanks to the hard work of the entire BioXcel team, we were able to successfully conduct a total of seven clinical trials in over 800 patients across a range of disorders, laying a robust clinical foundation for our BXCL501 program. This is in alignment with our three-pillar growth strategy for our neuroscience franchise, which is designed to expand follow-on indications, including dementia, across multiple treatment settings and our global reach. I'm pleased to report that we continue to successfully execute on these key initiatives and have made important progress across our clinical, regulatory, and commercial objectives for our lead program, BXCL501. With regards to clinical progress, we continue to advance our plans for expanding the use of BXCL 501 into additional indications. We remain on track to commence a phase III program of BXCL501 for the acute treatment of agitation associated with dementia in the Q4 of this year, which has been granted breakthrough therapy designation by the FDA. Agitation associated with dementia, including Alzheimer's disease, is a significant market opportunity as the need for better treatment options is immense. We also plan to report top-line data from our ongoing 40 microgram dose phase II TRANQUILITY trial of BXCL501 in patients with dementia during the Q4 of 2021. In May, we received FDA acceptance for the filing of our NDA for BXCL501 with a PDUFA action date of January 5th, 2022, for the acute treatment of agitation associated with schizophrenia and bipolar disorder. This acceptance marks important progress towards our goal of providing a new treatment option for the millions of patients struggling with acute agitation. If approved, this would be the first major medical advancement for this huge indication in almost a decade. In addition, we initiated a pediatric study for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorder. While the FDA reviews our application, we are executing on our comprehensive commercial readiness strategy to ensure that if we receive FDA approval, we are well-positioned to bring BXCL501 to patients and healthcare providers across the U.S. Our key initiatives in the last quarter included the deployment of our medical science liaison and medical management care teams who are continuing to engage in scientific and medical-to-medical exchange with the healthcare professionals and care, respectively, to provide key insights to support commercial strategy. In May, data from the SERENITY phase III trials were presented at the American Psychiatric Association Annual Meeting and at the International Society for Bipolar Disorders Global Conference, and additional data will be presented at leading medical conferences during the second half of this year. In late June, we held a commercial day where our teams shared market insights, commercial opportunity, and highlighting launch readiness plan. In preparation for go-to-market strategy, we have augmented commercial teams with several key hires and are further refining the designs of our sales force and market access strategy. We are advancing our strategic initiative for geographic expansion. Our plans are underway for a Marketing Authorisation Application to the European Medicines Agency of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders 1 and 2. We believe the European market represents a sizable opportunity similar to the U.S., which we estimate is nine million patients and approximately 40 million agitation episodes per year. All of this work will serve as a solid foundation for the commercial launch of additional follow-on indications, paving the way for further growth opportunities in our neuroscience business. We remain confident in BXCL501 potential across multiple indications where there is a significant need for new innovative treatment options. We continue to leverage our AI technology and our proprietary clinical data to strategically expand market opportunities across a broad spectrum of neuropsychiatric disorders, where BXCL501 can become a valuable therapeutic option. In the fall of this year, we plan to host an R&D day to provide an update on our BXCL501 program, pipeline within a product, and additional neuroscience pipeline candidates. We look forward to providing more information in the coming weeks. Looking beyond our neuroscience program, our phase I-B/II study for castration-resistant prostate cancer with BXCL701 is nearing completion, and a more complete efficacy update on the phase II portion of the trial is expected in the Q3 of this year. Based on these results, we plan to design our next phase of the CRPC program and leverage BXCL701 novel mechanism within our immuno-oncology pipeline. As we move into the second half of this year, we look forward to further building on the important progress we have discussed today and continue to drive forward sustainable growth strategies for our business. Now, I would like to turn the call over to Richard, who will give a financial update. Thank you, Vimal Mehta. I'd now like to review our financial results for the Q2 2021. Research and development expenses were $13.5 million during the Q2 of 2021, as compared to $17.9 million for the same period in 2020. Decreased expenses were primarily attributable to a reduction in clinical trial costs related to our SERENITY trials. These amounts were offset in part by an increase in personnel and related costs necessary to enlarge our development and medical teams. In addition, we experienced increased professional fees related primarily to toxicology studies, as well as increased regulatory and consulting fees, all related to BXCL501. General and administrative expenses were $14.1 million for the Q2 of 2021, as compared to $3.5 million for the same period in 2020. The increase was primarily due to the overall growth of the company, including higher personnel costs and stock-based compensation. In addition, we experienced increased costs related to legal, professional, and insurance fees and expenses related to the potential commercial launch of BXCL501 in the U.S. The company reported a net loss of $27.6 million for the Q2 of 2021, compared to a net loss of $21.4 million for the same period in 2020. The Q2 of 2021 results include approximately $6.8 million in non-cash stock-based compensation costs, compared to non-cash stock-based compensation of $2 million for the same period in 2020. As of June 30th, 2021, cash and cash equivalents totaled approximately $273.1 million. Now I'd like to turn the call back to Vimal for any further comments. Vimal? Thanks, Richard. We would now like to open the call for questions. Operator? Thank you. We will now be conducting the 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 has been questioned queued. You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star two. One moment please while we poll for your questions. Our first question comes from the line of Jeff Harrison with Bank of America. Please proceed with your question. Hey, this is Greg Harrison on for Jeff. Thanks for taking our question. Looking to the upcoming readout of BXCL 701, what sort of efficacy profile would you expect to see that would give you confidence both in moving the program forward through the clinic as well as in the commercial potential of the asset? Thank you, Greg, for the question. I'll return this question to Will. Thanks, Vimal. As you've previously said elsewhere, we're looking really for a 20% response rate, roughly. That would probably be very relevant for adenocarcinoma CRPC and arguably a slightly lower response rate. Mid-teens may be relevant in NEPC. I say that based on the fact that both of these flavors of castrate-resistant disease are essentially unmet medical needs. Bear in mind our patient population have failed three lines of systemic therapy. That's helpful. Thanks. Sure. Thank you. Our next question comes from the line of Ram Selvaraju with H.C. Wainwright. Please proceed with your question. Hi. Thanks so much for taking my question. Can you give us an update on the availability of what you deem to be qualified sales personnel to enable you to appropriately support the BXCL501 launch? Relative to Vimal's comments earlier on the call regarding the European opportunity and opportunities in other ex-U.S. territories for BXCL501, can you perhaps give us an overview of your partnering strategy, your overall commercial outreach strategy as it pertains to those regions, and in particular, enumerate for us which territories beyond the U.S. and Europe might potentially be the most pertinent commercial opportunities for BXCL501 Thanks, Ram. I will just take on the first question about from the partnering. As we have indicated that we plan to find a partner in Europe for co-development and co-commercialization of BXCL501. As I mentioned that we are plans are underway to file an MAA. Things are progressing well on both fronts. With that, I will pass you on to Will to answer your first part of the question. Will? Thank you, Vimal. Good Good morning, Ram. Relative to the build-out of the sales force, as we've indicated, our timing is to hire sales leadership in the Q3 and then plan for hiring the sales force in the Q4, obviously dependent upon the progression of the NDA review and labeling negotiations. I'm happy to report that we recently hired our head of sales, VP of sales, who brings with him significant and substantive experience in the hospital setting, and clearly a large network of individuals that he has already reached out to. We feel from that perspective, we're in a very good position. Plus, we have a solid plan in place with a recruiting firm in order to access top talent, and that's what we'll be initiating after we bring on the sales leadership team to begin that process. I think we're right on plan as we have always indicated. Okay, great. Then just with respect to Vimal's earlier comments regarding the broadening of the neuroscience pipeline, can you maybe elaborate for us what general indications or sub-indications within neuroscience you intend to focus on most? If you're going to primarily prioritize neuropsychiatry-related indications versus neurodegeneration, or if you're going to give equal weight to both. Thank you. BXCL501, as you know, is a pipeline within a product. We continue to focus on clinical execution. In terms of our additional pipelines that we are using our AI platform to identify additional pipeline candidates, our strategy is to focus on stress-related axes. Initially, we are focusing on neuropsychiatric disorders. As we move along, our platform is very much applicable to other disease areas, as you said, neurodegenerative disease. We believe that will be our next progression. Our next candidate that we plan to discuss in R&D day will be in the neuropsychiatric space. Thank you. Thank you. Our next question comes from the line of Graig Suvannavejh with Goldman Sachs. Please proceed with your question. Hi, team. This is Anna on for Graig Suvannavejh. Thanks for taking our question. Just on trials, could you please help us frame the 40 microgram data and what you expect to see and how to think about that data in the context of potentially getting a label that's for at-home use only? That's a great question. 40 microgram cohort was initiated with additional optionality in our dosing regimen. We already have 30 and 60 microgram, which were showing good efficacy as well as safety profile. We wanted to make sure that in dementia, our opportunity lies in the acute to intermittent chronic, and also it lies in ALF nursing home and in the home setting. The data from 40 microgram will inform us what is the efficacy and safety in this session. We continue to do blinded analysis of the safety in the midpoint of our 40 microgram dosing. This will also inform us what dosage to take forward in our phase III program that we plan to start in Q4 of 2021. This 40 microgram dose adds additional optionality to what we currently have at 20 and 50 micrograms. Great. Thanks so much. Thank you. Our next question comes from the line of Eddie Hickman with Guggenheim. Please proceed with your question. Hey, guys. Thanks for taking my question. This is Eddie Hickman from Guggenheim. Two from me. Are you thinking about enrollment in the dementia study? Do you think you'll need a critical percentage of patients with Alzheimer's or several types of dementia to match to real world numbers? How are you proposing to the FDA to avoid any kind of group analysis scrutiny? And then for Will, are there any recently approved drugs that are administered in a similar setting to BXCL501 that might be a good comp to back that in the commercial trend picture? Thanks. For our dementia program, we are very cognizant that what kind of analysis we will need to present to get a FDA approval. That is actually what we are working with FDA. If we have in our Alzheimer's population, which is expected to be the major population in dementia. That was almost 85% in our TRANQUILITY trial. If we have certain signal significant, would we need a broader label or we need to demonstrate it into the subtype. Having alignment with FDA, we will make a choice and make a decision, what trial or what the trial design should be to achieve those goals. Eddie, on the second question relative to any recently approved drugs that may be useful as comps. As we talked about, as we indicated on the commercial day presentation, there isn't a specific drug that we believe is a true comp for BXCL501. BXCL501 is bringing an innovative new approach to the treatment of agitation in patients where there has been one for a while. I think the more relevant way to look at it is by setting. In the hospital setting, which is where we will land, obviously, with the first indication, it is the hospital that controls formulary access, and payers usually refer to them in terms of their decisions there. Hospitals have their own processes, as we indicated, relative to timing, and advocacy needed within an institution. We're clearly aware of those, and so we'll be building a deeper understanding of those among target hospitals. With adoption in hospitals, it just tends to be a little bit slower, right? There's a little more inertia we need to work through. As we've indicated, we believe we have a paradigm-changing treatment, and a valuable new option for hospitals to consider. The feedback so far has been very favorable. We're very motivated that we'll be able to drive this steadily forward. In addition, I would just add that our medical science liaison continue to generate additional market insight. They're always bringing it back that there's the opportunity in pre-ED settings like pre-emergency department, like the other settings which are in community hospitals. It could be group homes, it could be EMS, and you might know some of the drugs are used in those settings before patients are brought in. We need to evaluate whatever we are learning from the market in shaping our commercial strategy. Once we have done complete work, it is expected in the next several months, we'll provide an update. Appreciate the conversation. Thank you. Our next question comes from the line of Sumant Kulkarni with Canaccord Genuity. Please proceed with your question. Vimal, thanks for taking my question. I have just one. We've seen the FDA become more unpredictable with pending NDAs just ahead of action dates. In that context, could you remind us as to how confident you may be about BXCL501 clear approval requirements for your sublingual film with the site inspections, so that you can receive approval in a timely fashion? When do you expect labeling discussions to begin with [compartment company]? The pre-approval inspection, we continue to do mock exercises using the third party, and our manufacturer is based in Pennsylvania. We continue to monitor that if FDA will do an on-site visit, and depending on the pandemic situation, will it be a virtual. We are prepared for both situations, plan A and plan B. About your second question, can you just please remind me what was the second part of the question? Related to the pre-approval site discussions, have labeling discussions started, or when do you expect them to start? We expect the labeling discussions to begin towards the end of this year. Thank you. Our next question comes from the line of Anita Dushyanth with Berenberg Capital Markets. Please proceed with your question. Good morning. Thanks for taking my question. Just on what you all commented earlier. I was wondering, when BXCL501 is initially introduced in the hospital setting, but there, potentially, even if it's expanded for other treatments and that's where it could be administered at home. Could you sort of describe the marketplace and opportunity for that? Thanks for the question, Anita. As we've indicated previously, our strategy is one of landing and expanding. The hospital becomes our primary start. As Vimal indicated, we cast a wide net to understand opportunities that may present itself, ultimately based on the label we receive and the ability of that label to promote in various settings. We will continue to look at that, but our base, if you will, out of the gate, will be the hospital setting. Beyond that, as we've indicated, there is significant opportunity in bipolar disorder patients in the community. Many oftentimes experience agitation at home, and that is in many ways self-treated or treated with benzodiazepines before it rises to the level where it needs to be treated in an emergency department setting. We believe, over time, there's an opportunity to help those patients. There was a study out of Europe that was conducted by Robert, which indicated that that opportunity presents itself in terms of their agitation. Relative to the dementia market, which we've indicated, that is a very large market. With currently six million Alzheimer's patients in the U.S., that's expected to double over the next 20 years. There's a high rate of agitation in those patients. They obviously are cared for across treatment settings, not only in nursing homes but assisted living facilities and obviously at home. Given the rise in the size of that population, the home setting will become increasingly important. The whole plan is to enable helping those patients with BXCL501, and that's what the clinical development plan is looking to do. From a marketing perspective and a commercial perspective, we will build accordingly to capitalize on those opportunities. Thanks. That was helpful. Just one more. Also, how do you sort of plan to allocate those resources between BXCL501 and potentially BXCL 701 in the other indications and then the early-stage BXCL 701 candidates? Strategically, we have formulated for us to continue to build our neuroscience franchise. We want BioXcel Therapeutics in five years down the road to be a leader in neuropsychiatric and neuroimmune rare diseases. That's what our vision of the company we are building. Regarding the BXCL701, now we will have data in Q3 timeframe this year. That will provide a good confidence in our human proof of concept for this mechanism. That's what exactly we are trying to prove, because it's the activator of innate immunity. We are testing it for the first time, a combination of orally available such advanced agent in combination with [capecitabine]. Once we achieve that, we will seek strategic options, what will be best in the interest of our shareholders. We continue to evaluate various options that will make sense for the business. Thanks a lot. That's helpful. Thank you. As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from the line of Samir Devani with Rx Securities. Please proceed with your question. Hi, everyone. Thanks for taking my question. Could you just remind me what the status is of the MD Anderson study with BXCL 701? Great. Thanks. Vincent. Sure. I think as we've previously announced, the two arms of the study have moved from stage one to stage two. That study will now complete or proceed to completion, I should say. Just a reminder, it's an Bayesian styled design, so a fairly small sample size, 15 approximately patients in each arm. To follow up, when would you expect for us to see any data from that study? Yeah. This is currently an IST, and obviously we're not in charge of the enrollment of the study. We would expect to see enrollment probably complete by the end of the year, approximately. Again, just to stress, we don't have direct control over the trial. That's definitely how MD Anderson has positioned the trial. Great. Thanks so much. Thank you. There are no further questions at this time. I would now like to hand the call back over to Vimal Mehta for any closing comments. Thank you everyone for joining us today. I'm looking forward to connecting with many of you at upcoming conferences and calls. In the meantime, if you have any questions, please feel free to reach out. Have a great day. Thank you. This does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time. Have a great day.