BioXcel Therapeutics, Inc.

Good morning, and welcome to the BioAccel Therapeutics third quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode. If during the conference you require operator assistance, please press star zero on your telephone keypad. After the presentation, there will be a question and answer session. If you would like to register a question, you may press star one on your telephone keypad. Just to remind everyone, Certain matters discussed in today's conference call and or answers that may be given to questions asked are forward-looking statements that are subject to risks and uncertainties related to future events and or the future financial or business performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. Risk factors that may affect future results are detailed in a company's quarterly report on Form 10Q for the quarter ended June 30th, 2022, which can be found at www.bioexcelltherapeutics.com or on www.sec.gov, which will be updated in its quarterly report on Form 10-Q for the quarter ended September 30th, 2022. As a reminder, today's conference is being recorded. Joining us on today's call are Dr. Vimal Mehta, Chief Executive Officer, Richard Steinhardt, Chief Financial Officer, Matt Wiley, Chief Commercial Officer, Dr. Rob Reisinger, Chief Medical Officer of Neuroscience, Dr. Frank Yalka, Chief Scientific Officer, and Dr. Vince O'Neill, Chief Medical Officer of Oncology. It is now my pleasure to turn the call over to Dr. Mehta, the CEO and founder of BioXcel Therapeutics. Please go ahead.

Thank you, Operator. Welcome, everyone, and thank you for joining our call today to discuss Bioexcel Therapeutics' financial performance and business highlights. The third quarter of 2022 marked a pivotal moment in the history of Bioexcel Therapeutics. In the last few months, we have transitioned to a commercial organization and successfully launched EGALMI. We have made tremendous progress across all facets of our business and are very excited for 2023 and beyond. We continue to fully execute on our land and expense strategy for lead program BXEL 501 to build our neuroscience education franchise. In that regard, we have multiple pivotal data readouts from our ongoing trials expected in the first half of 2023. We believe this will allow us to capitalize on the 15 billion agitation market opportunity. This consists of 139 million episodes in total for our first three indications, including bipolar disorders, schizophrenia, and Alzheimer's. Agitation is an underdiagnosed and underserved market. that has not seen treatment innovation in nearly a decade. Igalmi is approved by the FDA for acute treatment of agitation for schizophrenia and bipolar disorders in adults. There are approximately 16 million agitation episodes of these conditions in the U.S. annually, which are treated in the institutional medical setting. We truly believe the introduction of Egalme could drive agitation market creation in a similar fashion as the emergence and rapid growth of the depression market following the introduction of novel treatment options in the early 1990s. Egalme is a novel product with a broad label to treat the full spectrum of agitation and in schizophrenia and bipolar 1 and 2 disorders. In short, we are blazing new trails in the agitation market. We recently hosted a commercial day and clearly outlined the evolving agitation market dynamics, positive initial momentum, and launch performance matrices. A neuropsychiatric product like Egalmi with novel mechanism of action has never been launched to treat agitation in an institutional setting. Our commercial path is unprecedented with no obvious surrogates. Yet, there is a clear demand from hospitals for the pharmacoeconomic benefits and safety of healthcare professionals and patients. Within the first four months and with only 26 reps initially covering 700 target hospitals, we have already observed increasing market access, efficient targeting, and highly favorable market drivers. We recorded our first product revenue and are pleased to have extensive market reach and hundreds of formulary reviews scheduled in hospitals within a short span. Based on these factors, we made the strategic decision to expand our sales footprint across all major geographic markets. By December 1st, we will increase our sales force and deploy a total of 70 reps to cover approximately 1,700 target hospitals. We now have fully integrated commercial and medical teams with the necessary infrastructure to cover the entire U.S. agitation market to fuel our growth. To drive additional awareness and understanding of EGALMI, our medical affairs teams have been actively engaging with the medical community and P&T committee members in addition to participating in leading industry conferences across the country. EGALMI awareness and scientific validation continues. with too many scripts from our pivotal serendipity trials recently published in leading scientific journals. We believe all of these efforts will facilitate formulary approvals, our key focus that will result in demand generation. Our Chief Commercial Officer, Matt Wiley, will walk you through our launch progress to date and we'll review the launch performance matrices shortly. In addition to our launch progress, our robust clinical pipeline is advancing rapidly. We are extremely enthusiastic about our indication expansion opportunity in Alzheimer's-related agitation. With an estimated 100 million annual agitation episodes in the U.S., And no current FDA approved therapies for these patients. This represents a large and growing unmet malignant need. 501 received breakthrough therapy and fast track designations from the FDA for agitation related to dementia. We are looking forward to announcing top line data from the Tranquility 2 Pivotal Trial in first half of 2023. Also, we will be initiating the Tranquility III pivotal trial by the end of this year. We are also excited about Serenity III Pivotal Program and potentially expanding 501 for at-home use to treat agitation associated with bipolar disorders and schizophrenia. There are approximately 23 million agitation episodes of these conditions in the U.S. annually. The top line efficacy data lead out from the Serenity III pivotal trial is expected in the first half of 2023. Serenity III has many parallels with the Serenity I and II trials that form the basis for EGalmy's approval. At-home use is expected to more than double our current market opportunity with EGalmy. Truly, a pipeline within a product, BXAL 501 also continues to be evaluated as an adjunctive treatment for major depressive disorder or MDD. We have already completed multiple cohorts in our Phase 1 dose escalation trial in Healthy Volunteers and expect to report top-line results in the first half of 2023. Let me turn to Oncosexcel Therapeutics. This fully-owned subsidiary is focused on the sustained growth of companies' immuno-oncology franchise. BXEL 701, our lead program, is a systemic activator of innate immunity in development for aggressive forms of prostate cancer in combination with Keytruda. We are pleased about the promising data for 701 in small-cell neuroendocrine cancer, or SCNC, recently presented at the Prostate Cancer Foundation Scientific Retreat. Recall, there is no FDA-approved treatment in SCNC and a high mortality rate. Our data demonstrated a composite response rate of 33% for the first 15 evaluable SCNC patients and a median duration of nine months in the first five responders. We have now completed in the ongoing phase two SCNC trial and expect to present top line data in early 2023. In addition, today at CIDDI, we are presenting data on potential predictive biomarker for 701 in patients with leukemias, including acute myeloid leukemia. We also believe these biomarkers could have potential implications for solid tumors. The poster will be available on our corporate website after this call. We continue to strengthen our intellectual property portfolio. For 501 in this quarter, we had two new US patents issued, two US notices of allowance, and seven patents from foreign offices. We expect these patents will be included in FDA's approved drug products with therapeutic equivalence evaluation, which is commonly known as Orange Book. Additionally, for 701, we had eight patent allowances slash issuances received from foreign offices. In closing, Biaxial Therapeutics has had a remarkable quarter. We are developing a leadership position in the education market, have multiple upcoming data catalysts, and are well positioned for growth in 2023. I would now like to turn the call over to Matt Wiley to review our launch progress. Matt?

Thank you, Vimal, and good morning, everyone. As we reported in our commercial day a few weeks ago, we are making very good progress on our GOMI launch efforts. These efforts are continuing to pay off, and I'm pleased to share some additional updates with you today, specifically in relation to our launch performance metrics. Our market access activities are a critical component of our strategy, so I'll start with our progress with group purchasing organization, or GPO, contracting efforts. As we have mentioned in previous communications, the typical contracting timeframe with GPOs averages six to nine months. We have made steady progress and increased our access to GPOs throughout the quarter. We are now contracted with two GPOs, including the largest in the country, covering nearly 50% of the beds in our target universe. We are in ongoing negotiations with the other leading GPOs and expect to continue to improve our access in the coming weeks and months. As a reminder, the three largest GPOs represent over 90% of our target beds, so we are very happy with our achievements to date. In tandem, we continue to engage with integrated delivery networks, or IDNs, focusing on those systems that exert high control to drive further downstream utilization of Agami. We are concentrating on 59 high-value IDNs, with formulary voting currently scheduled for 21% of the targeted vets. As part of our ramp-up efforts, we've deployed a team of corporate account directors dedicated to coordinating with our sales team and driving the formulary and contracting activity. We have learned a lot about the deployment process in the last four months being in the field. In the first wave of our sales deployment, we chose 26 high volume territories covering 700 target accounts and received resoundingly positive traction. We have been able to now reach over 75% of this initial target universe and have seen significant interest and pull through as P&T committees continue to add Agami to future agendas. These positive results give us great confidence to deploy our full 70-person sales force targeting approximately 1,700 hospitals. This will equip us to build upon the strong momentum we have made since trade launch in July. We expect to deploy this team in the field by December 1st. To ensure ongoing optimization and informed deployment of our field force, We have taken a unique approach to our sales strategy by building out a database of 81 billion records spanning more than five years. With this data lake, we are able to examine and refine our targeting methodology by building a hierarchy of target hospitals informed by the location and frequency of agitation episodes. The model we have today represents the majority of agitation episodes in bipolar and schizophrenia patients and takes into account nearly 80% of the total psych vets in the United States. Turning now to marketing, we will continue to build on our peer-to-peer programs and digital marketing efforts for the balance of the year and amplify these efforts in 2023. To date, our peer-to-peer programs have engaged over 1,000 HCPs at speaker venues and conventions, and the Agalmi Now available digital campaign has yielded significant engagement with over 140,000 visits to our HCP websites. Our understanding of Egolme's value proposition in this market continues to evolve and strengthen. Just a month or so ago, new data from the American College of Emergency Physicians was released, showing that more than half of emergency room physicians have been physically assaulted, with one-third sustaining an injury. Bipolar and schizophrenia patients are much more likely to commit emergency department assaults, and the current treatment paradigm for agitated patients may be exacerbating this issue. The dynamic provides a nice tailwind for Agolme to enter the market, highlighting an additional and previously underappreciated value proposition. In summary, the market conditions and Agolme receptivity are setting us up for success in 2023 and beyond. We have nearly 50% of our targeted beds under contract with GPOs, with others in process. We have 21% of the target IDN beds scheduled to vote with nearly 41,000 target beds and an additional 15,000 Tier 2 beds in progress. Additionally, we have over 120 out of 700 target hospitals scheduled for P&T vote and nearly 350 P&T votes for Tier 2 hospitals in process. Keep in mind, this is reflective of our initial 26 territory deployments. Both the IDN and P&T scheduled votes have improved since we last reported these figures on commercial day, and we expect these votes in process will continue to climb. Additionally, we have added positive formulary wins since our last readout, and we'll provide more specific details on this metric in future calls. Now I'll turn the call over to Richard. We'll give a financial update. Richard?