BioXcel Therapeutics, Inc.

Good morning and welcome to the BioExcel Therapeutics fourth quarter and full year 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 the company's quarterly earning report on Form 10-Q for the quarter ended September 30, 2022, which can be found at www.bioexceltherapeutics.com or on www.sec.gov, and which will be updated in its annual report on Form 10-K for the year end December 31, 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. Vince O'Neill, Chief R&D Officer of Oncosexcel Therapeutics, Dr. Rob Reisinger, Chief Medical Officer of Neuroscience, and Dr. Frank Iacca, Chief Scientific Officer. It is now my pleasure to turn the call over to Dr. Mehta, the CEO and founder of BioXcel Therapeutics. Please go ahead.

Thank you, operator. Welcome, everyone, and thank you for joining our call today to discuss BioXcel Therapeutics' fourth quarter and full year 2022 financial performance and business highlights. It was exactly five years ago that BioXcel Therapeutics became a public company and And we embark on our journey with a clear mission to build a uniquely disruptive biopharmaceutical company model using artificial intelligence approaches to bring transformative medicines in neuroscience and immunology to patients. We are proud of what we have accomplished. At the same time, we are even more excited about what lies ahead. And so it is with great pride and enthusiasm that I share with you why I believe the company has never been better positioned to potentially bring new treatment options to millions of patients in areas of high unmet needs and deliver significant value to our shareholders. We are making great strides in building on our accomplishments in 2022 which was truly a transformative period for BioXcel Therapeutics as we transitioned to a commercial stage company. Last year, we received FDA approval for our first drug, Egalmi, for the acute treatment of mild, moderate, and severe forms of agitation for schizophrenia and bipolar disorders in adults. This broad label has brought a new treatment option for patients in a nascent market where there had been no innovation in nearly a decade. Most notably, using our AI platform, we advanced from IND to commercial launch in less than four years. We believe that we have introduced the first AI discovered drug for an acute neuropsychiatric condition. Today, we are building on these accomplishments and remain laser focused on accelerating our growth in 2023 and beyond. There are many reasons why we are so excited about our near-term opportunities. First, our commercial execution of EGALMI is fully underway. We believe that EGALMI's unique mechanism of action and ability to create agitation creates a commercial path in an institutional setting with no obvious analogs. To date, we have made impressive progress with our initial field force of 26 sales reps. Now, with our commercial operation fully deployed with 70 sales reps in all major markets across the U.S., we look forward to accelerating this momentum. We are pleased with the market reception of Egalme, which is supported by highly favorable market dynamics. Initial response from healthcare providers has been extremely positive. It's especially rewarding to hear about the difference Egalme is already making for patients, families, and healthcare providers. Matt will share more details about our commercial progress and launch matrix that we are excited about in his remarks that follow. Second, turning to our robust clinical pipeline, we believe the upcoming quarter may represent a watershed moment for the company. In the second quarter, we expect to announce pivotal clinical data that potentially support significant market expansion opportunities for our lead neuropsychiatric program, BXEL 501. We believe this agitation market remains underdiagnosed and underserved. It is comprised of an estimated 139 million agitation episodes per year across bipolar disorder, schizophrenia, and Alzheimer's, our three priority indications across various medical settings. Specifically, we expect to announce Data from two Phase III pivotal studies for 501 in the second quarter. These studies include Tranquility II trials and Serenity III trials. Our Tranquility program is designed to evaluate 501 for the acute treatment of Alzheimer's-related agitation. Up to 100 million agitation episodes are estimated to occur annually in this patient population in the U.S. where currently there are no approved FDA therapies. The Tranquility II trial is fully enrolled, and the data cleaning and verification process has begun. In Tranquility III, we are accelerating enrollment of patients with moderate to severe dementia in nursing homes, with first patient dosing having occurred last December. Turning to Serenity III, We built this program upon 501's demonstrated benefit for agitation associated with schizophrenia or bipolar I or II disorders in adults. The two-part pivotal trial is evaluating the safety and efficacy of a 60-microgram dose in acutely agitated bipolar I and II disorders and schizophrenia patients to support use of 501 in the at-home setting. The estimated 23 million agitation episodes occur in the US each year in this setting. With Serenity III Part I, more than 90% of patients are already enrolled with complete enrollment imminent. We plan to enter the data cleaning and validation phase shortly. Part two of the trial is expected to begin in the second quarter. In addition, we anticipate reporting top line results from our phase 1B multiple ascending dose trial for major depressive disorders in the second quarter. There are over 300 million antidepressant prescriptions filled annually in the U.S. and treatment options Options are suboptimal due to slow onset of action and incomplete response. For the first time, we are conducting chronic dosing of 501 in healthy volunteers and evaluating its safety and tolerability on a daily or twice-daily dosing basis over a seven-day period, including in combination with an antidepressant. The trial outcome is expected to inform dose selection in combination with selective serotonin or serotonin norepinephrine reuptake inhibitors in MDD patients. Beyond these three important near-term data readouts, we are advancing our research and development pipelines. We are developing BXL502 in novel serotonergic receptor antagonists as a potential therapy for chronic treatment of agitation in patients with dementia and other related neuropsychiatric conditions. I'm pleased to announce that prototype formulation has been developed and we are initiating IND enabling studies. Our advancements have continued to validate our unique AI approach in discovering novel pathways and product candidates for neuropsychiatric disorders and for neuro rare diseases. This is a new area of focus for the company. We have identified more than 10 product concepts that are being evaluated as we look to expand our neuro pipeline beyond 501 and 502. We plan to host an R&D day in the near future to outline our strategy and progress in more detail. Lastly, we are thrilled with our progress with BXCL701. It has a compelling value proposition in hard-to-treat tumors and is one of the most clinically advanced oral innate immune activators. It has demonstrated positive efficacy results in two cancer types, and CRPC, small cell neuroendocrine prostate cancer, SCNC, and adenocarcinoma, which is supported by 800-subject clinical safety database. The 701 MO is novel and has been published in a peer-reviewed journal. As presented at ESCO GU in February, BXCL701 in combination with Ketruda demonstrated a complete response rate of 25% in SCNC. This is a promising result in heavily pre-treated patients with no FDA-approved therapy. We believe the results support moving forward with a potential pivotal study for BXCL701 as a monotherapy and in combination with Ketruda in SCNC. in second half of this year pending FDA discussions. Finally, we are excited about the tremendous potential of OncoZexal Therapeutics and are actively seeking to unlock its full value for our shareholders. We expect to provide an update on this shortly. Looking back, I can proudly say that 2022 was a year of significant accomplishment for bio-excel therapeutics on all fronts. The approval and launch of Egalme validates our use of AI with positive impact on the drug discovery and development paradigm and on patients' lives. We are truly a driver of the industry change and have demonstrated that our AI-based approach can improve the probability of success, reduce development timelines, and enhance R&D economics. These accomplishments reflect the mission of the company that we set out to fulfill when we became a public company five years ago. I would now like to turn the call over to Matt Wiley to review our commercial progress and exciting launch matrices. Matt?

Thank you, Vimal, and good morning, everyone. Before I provide an update on our commercial activities, I want to reinforce Vimal's message of how proud we are of what we accomplished last year with the approval and launch of Agami. Not only did we focus on building a strong commercial organization, we took the necessary steps and investment in building an entirely new market for the treatment of agitation episodes, an area which there have been no new developments in more than a decade. It's important to understand this context as we move from launch to market development to sales acceleration later this year. Our commercial engine is running efficiently and firing on all cylinders as we move into the heart of the new year. Looking back to 2022, I can report that the fourth quarter was transformational for the commercial organization. Most importantly, we improved the volume of potential patient exposures to agami. and continue to pave the way for broader access to this meaningful treatment. We are working hard to change the lives of patients, and each one matters to us. Considering that objective, we successfully expanded the sales force of 70 representatives with full deployment commencing last December. This allowed us to expand our reach from 700 target hospitals to more than 1,700 and positioned us to fully launch Agami as we enter 2023. The new sales team members have the same depth of experience necessary to continue our launch momentum as our original team members from the original sales team last year did, with an average of 21 years of industry experience and an average of eight or more product launches. This expanded team has already begun making an impact. They've extended our reach to more than 1,100 of our target hospitals to date and are reaching over 7,000 unique healthcare providers. Interest in IGALMI continues to grow, and this increase in share of voice is expected to accelerate P&T reviews and process and formulary adoptions this year. With that in mind, I'll provide some updates on our formulary adoption progress. As you know, we launched IGALMI last year with a small team of 26 representatives. This team has secured formulary access in more than 65 total hospitals to date, with 39 of those as Tier 1 accounts and 27 as Tier 2. We also have more than 600 P&T reviews in process that should take place over the next few months. Of these, approximately 280 are Tier 1 hospitals. We are right now within that window of the typical review time of 6 to 12 months. So the original sales team has made significant progress in lining these meetings up with 46% of its original targets either approved or scheduled to vote. We expect more of these efforts to matriculate into P&T scheduled votes in the coming months. Our second hiring wave and newly deployed 44 representatives have just begun their efforts and we expect to see a meaningful uptick in formulary votes in process in the second and third quarters due to their efforts. Market research prior to launch indicate that we should expect to see a majority of P&T votes would result in formulary wins for Agami. This has been our experience to date and we continue to be pleased with the perceived value of Agalmi to hospitals, patients, and healthcare providers. We are encouraged that several hospitals and systems have already begun ordering the product to develop firsthand experience prior to full approval. We see this as a significant win. As hospitals gain experience with Agalmi, we've received positive anecdotal feedback regarding patient response, throughput, and staff safety. On this topic, we expect to launch a free trial program to qualifying hospitals later this quarter. This program is designed to facilitate early experience with Agalmi and to provide hospital and system-specific metrics they can analyze to determine their own value. We expect this program to accelerate the demand of Agalmi in de novo institutions nationwide. Turning to market access, we have now contracted with three group purchasing organizations, or GPOs, covering half of the targeted hospital beds. While we are in negotiations and discussions with the remaining two major GPOs, we have focused our attention on system-specific contracting that will help accelerate the pace of Integrated Delivery Network, or IDN, reviews and adoption to provide system-wide access to Agami. As noted in previous calls, our Corporate Account Directorate team is targeting 59 IDNs, having a total of approximately 280,000 beds in the United States. So far, we have secured formulary approval for just over 7,000 of those beds, or 2%, with more than 70,000, or 25%, anticipating a vote over the next two quarters or so. Selective contracting with these entities may further accelerate the review process with some of the remaining systems that have not yet to engage. At the same time we are beginning to gain access, we are ramping up our marketing efforts significantly to support our field teams. We are launching a new HCP-targeted advertising campaign focused on IGAMI as a collaborative approach to managing agitation in bipolar and schizophrenia patients. Based on our research, this campaign is motivating to healthcare providers and helps us position IGAMI as a positive solution for both patients and advanced practice providers, such as ER staff and nurses. We are deploying this campaign through print media, digital media, and our sales team and expect to generate more than 10.5 million impressions in the second quarter. We have also deployed a geo-targeting media effort to digitally encircle our target institutions in the U.S. This means anyone in those hospitals with a smartphone or computer may see Agalmi advertising on popular websites and applications. In addition, the marketing team deployed a large-scale peer speaker effort to provide a comprehensive presentation on Agalmi-targeted HCPs. We have also planned promotional attendance at six national conferences with more than 150 regional or local conferences this year that will further amplify our message and exposure. I'm proud of the commercial organization's tremendous progress with the launch of Agalmi to bring this important new treatment option to patients. Our early success and interest in the brand is palpable, and our field team energy continues to outpace industry norms. While there is an expected protraction to hospital launches and uptake, Market receptivity and excitement continues to grow, and the promise of this drug to patients is peerless. We are disrupting and creating a market in agitation, and our confidence in this brand could not be higher. Now, I'll turn the call over to Vince, who will provide an overview of OncoseXL's recent progress.