BioXcel Therapeutics, Inc.

Good morning and welcome to the BioAccel Therapeutics second 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'd 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 report on Form 10-Q for the quarter ended March 31st, 2021, which can be found at www.bioexceltherapeutics.com or on www.sec.gov, which will be updated in its quarterly report on Form 10-Q for the quarter ended June 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 Yacca, 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 of BioXcel Therapeutics. Please go ahead.

Thank you, operator. Welcome, everyone, and thank you for joining our call today to discuss BioXcel Therapeutics' financial performance and business highlights for the second quarter of 2022. It has been a busy but rewarding few months, and we have many exciting updates to review this morning. As you know, we are a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immunology. You have heard me discuss our five-year vision to become the premier AI-driven neuroscience company, and our progress from this past quarter across all parts of our business continues to bring us closer to this ambitious goal. Let me begin by highlighting our notable achievements across the organization. We have laid the foundation for a successful entry into the market for EGALMI. Our FDA approved acute treatment for mild, moderate, or severe agitation associated with bipolar I or II disorder or schizophrenia in adults. Our sales team has been in the field for over two months, and key commercial activities are in full swing to create awareness and drive eventual adoption. With trade launch in early July, our priority remains delivering this new treatment option to hospital systems, healthcare professionals, and patients. Our chief commercial officer, Matt Wiley, will discuss commercial progress and early feedback from the field in more detail shortly. While Egalme's trade launch marked an important milestone for the 501 program, we continue our heavy focus on our three-pillar portfolio expansion strategy for the franchise. Let me summarize our progress since last quarter. Following a successful Type B meeting with the FDA, we have further executed our strategy for our first strategic pillar, which is broadening the medical setting where 501 can be offered. On this front, I'm excited to announce our Serenity III trial for at-home use. This pivotal, double-blinded, placebo-controlled single study is designed to evaluate BXCL501 60-microgram dose for agitation associated with bipolar I or II disorder and schizophrenia, and will consist of two parts. The first part is similar to our Serenity I and II trials, which were the basis for our eGalmy approval earlier this year, and is designed to assess efficacy and safety in acutely agitated bipolar and schizophrenia patients in an institutional setting. Like Serenity 1 and 2, Serenity 3 primary efficacy endpoint is a change from baseline in PEP total score at two hours compared to placebo. The second part of Serenity 3 is designed to assess safety compared to placebo when self-administered at home. We believe Serenity 3 may be de-risked for the following reasons. First, it will utilize many of the same investigators and clinical sites as 3 and 81 and 2. Second, we have already observed dose-dependent responses in our phase 1 slash 2B study for 60, 80, 120, and 180 microgram doses. market research shows a significant number of newly identified unclaimed and untreated episodes in bipolar patients in the at-home setting. This is additive to the claims data research showing that one-third of the 25 million bipolar and schizophrenia agitation-related episodes occur outside the institutional setting. Coupled together, this is a clearly defined medical need and large market opportunity in which we have already demonstrated the efficacy and safety of Egalme. Additionally, the experience which psychiatrists will gain in the institutions with the current commercial effort will help build a strong bridge to eventual community use if approved. We expect to initiate Serenity III in the second half of 2022. Next, as part of our indication strategy, expansion strategy, we have made strides in our clinical development programs for 501. Our Tranquility Program for the acute treatment of agitation in patients with Alzheimer's disease is advancing well. Our Tranquility II Pivotal Trial is enrolling. with top-line data now expected in the first half of 2023, and we still anticipate initiating enrollment in the second half of this year for Tranquility III, our second pivotal trial in the program. With the recent approval of EGALMI and its strong initial level, we believe the Tranquility Program has been significantly de-risked. The positive efficacy, safety, and tolerability data generated today, along with breakthrough therapy designation from the FDA, provides us continued confidence in the Pivotal Tranquility Program. We look forward to progressing 501 towards a supplemental NDA for agitation in patients with Alzheimer's. Alzheimer's disease-related agitation remains a clinical area of significant and growing unmet need with an estimated 100 million episodes per year in the U.S. and no FDA-approved therapies. We are excited by the potential of 501 to play a key role in providing a much sought-after solution for Alzheimer's-associated agitation. Further to our indication expansion strategy, we are investigating the potential utility of 501 as an adjunctive treatment in major depressive disorders. Our phase one multiple ascending dose trial in healthy volunteers is progressing well, with our 30 and 60 microgram dose cohorts complete. This double-blinded placebo-controlled study includes multiple cohorts, each consisting of 18 volunteers. The 80-microgram dose escalation portion of the trial is currently underway. Data readout for this daily-dosing study is expected in the first half of 2023 and will inform our dose selection for a future proof-of-concept depression study. Over 300 million antidepressant prescriptions are filled annually in the U.S., and current treatments are limited by slow onset of action and incomplete responses. More broadly, the 60-megagram daily dosing over seven days in healthy volunteers is quite encouraging and supportive for our leading programs for at-home use. Moving on to the third and final pillar for our 501 expansion strategy, growing job geographic footprint. Given the significant near-term US market opportunity, the company has available by developing 501 for bipolar one and two and schizophrenia patients in the home setting. And as an adjunctive treatment for MDD, we have made the strategic choice to prioritize resources to execute on US strategy over ex-US. As a result, we have chosen not to file an MAA at this time. We fully intend to pursue a well-timed geographic expansion at the most appropriate and opportune time. Moving beyond 501, we are leveraging our proven AI technology to build out a sustainable R&D pipeline. As part of our efforts to build out our neuroscience franchise, we continue to advance formulation work for BXCL502, which demonstrates a novel and differentiated mechanism of action for the chronic treatment of agitation related to dementia and other neuropsychiatric conditions. Shifting to our oncology franchise, we have established Onco's Excel, a fully operational focus subsidiary to provide maximum strategic and financial flexibility and position us for sustained expansion and optimization of the franchise. We are actively seeking strategic options, including third-party investments to advance Onco's Excel and ultimately unlock significant value for our immuno-oncology franchise. Under OncoseXL, we are advancing the clinical development of BXEL 701, our leading immuno-oncology clinical candidate being developed for the treatment of aggressive forms of prostate cancer. This includes progress on our metastatic castrate-resistant prostate cancer phase two trial of 701 plus Keytruda combination therapy in patients with either small cell neuroendocrine carcinoma or adenocarcinoma phenotype. Patient enrollment in the SCNC OR is expected to be completed in the second half of this year. In addition, enrollment is advancing for our adenocarcinoma randomized trial expansion, evaluating 701 monotherapy versus 701 Keytruda combination therapy. We look forward to providing additional updates on our plans to maximize shareholder value to our oncology subsidiary later this year. On the corporate front, we have welcomed industry veteran Michael Miller to our board of directors and the BioXcel family. We are very pleased to have his strategic leadership and commercial growth experience available during this exciting time for BioExcel. Lastly, we continue to fortify our intellectual property with two new patents related to Egalme's film formulations containing dexmedimidine and methods of treating agitation using the film. In summary, we have made great progress across all aspects of our business this quarter. and are continuing our work to transform the agitation treatment landscape and other neuropsychiatric conditions. We have many exciting catalysts on the horizon and look forward to continuing our journey toward becoming the leading AI-enabled neuroscience company. Now, I would like to turn the call over to Matt Wiley, who will give an update on the IGALMI launch. Matt?

Thank you, Vimal, and good morning, everyone. I'm pleased to report our progress on three fronts this morning. Our early market access momentum, key learnings from our initial field force efforts, and our commercial strategy and execution. The market access activities are progressing very well and are on schedule. While the contracting timeframe with group purchasing organizations or GPOs can take six to nine months on average, we have been encouraged by our early engagement. There are three national GPOs that represent over 90% of the beds in our 1,700 targeted hospitals, and we are in various stages of discussions and negotiations with each. We expect to finalize the contracting process over the next few months, and we'll share our progress with you when these relationships are complete. In addition to national GPOs, we've engaged with Integrated Delivery Network Hospitals, or IDNs, to drive further downstream adoption of IGOMI. We have also executed the CMS contract and completed the federal supply schedule submission to unlock access to state and VA hospitals, respectively. We have completed the first phase of our commercial build-out and deployment of our sales personnel in the highest priority targets. To date, our field force has successfully engaged a majority of their target hospitals and has made progress in P&T formulary review discussions. Multiple hospital systems and IDNs have indicated their interest for the product and expressed an intent to review. As the P&T committees review Agami in their scheduled meetings during the second half of this year, we will provide an update with more specific metrics. We've learned a lot since the field launch 10 weeks ago. The early response to our awareness activity, sales messaging, and Agami concept, for which there is no commercial precedent, has been starkly positive and has revealed tremendous opportunity within the bipolar and schizophrenia agitation markets. Through discussions with stakeholders in target hospitals, our understanding of the value proposition of IGALMI continues to strengthen. The challenges surrounding the administration of intramuscular injections is a market dynamic that is becoming increasingly worrisome to institutional stakeholders and one which creates a market environment favorable to IGALMI. The use of physical restraint is often required to inject agitated patients and can increase both the expenses and safety risk to staff. Physical restraint can be costly and resource intensive for hospitals at approximately $1,500 per patient, which typically surpasses the reimbursement. Consequently, a novel treatment option like Agami may offer an effective solution to address these issues while potentially limiting associated expenses. Furthermore, Agitated patient outburst may result in patient, caregiver, and staff injuries, which leads to lost work time, transfers, lawsuits, and generally unsafe work environments. COVID-driven staffing pressures still exist at many of these places of care. As institutions look for ways to decrease the use of restraints and reduce injury to staff, we are observing a desire to increase the use of oral less invasive medications for managing agitation consistent with consensus guidelines. Turning now to marketing, we are deploying tactics to support the sales efforts and amplify the awareness of Agalmi. To educate healthcare providers on the core benefits of Agalmi, we have recently deployed our promotional speaker peer-to-peer program. These programs will ramp up significantly over the next two quarters to drive interest, formulary adoption, and demand. The team has also successfully launched our Agalme Now available digital campaign, which has achieved over 100,000 visits to our HCP website and garnered meaningful engagement with content in just a short period of time. Based on the positive market response to Agalme, significant process with market access, and increasingly favorable market dynamics, we are excited to begin our second phase of personal promotion and fully deploy our sales team across 70 territories over the next several months. This puts us in a strong position to take full advantage of the opportunity to treat volumes of patients. Now, I'll turn the call over to Richard, who will give a financial update.