BioXcel Therapeutics, Inc.

Good morning, and welcome to the BioAccel Therapeutics first quarter 2023 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 annual report on Forum 10-K for the year ended December 31, 2022, which can be found at www.bioexceltherapeutics.com or on www.sec.gov, and which will be updated in its quarterly report on Forum 10-Q for the quarter ended March 31, 2023. 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 Riesinger, Chief Medical Officer of Neuroscience, Dr. Vince O'Neill, Chief R&D Officer of OncosXL Therapeutics, and Dr. Frank Yaka, Chief Scientific Officer. It is now my pleasure to turn the call over to Dr. Mehta, the CEO and founder of BioXL Therapeutics, Please go ahead.

Thank you, operator. Welcome, everyone, and thank you for joining our call today to discuss BioXcel Therapeutics first quarter 2023 financial performance and business highlights. This is shaping up to be a momentous year for BioXcel Therapeutics. Our success in advancing our corporate objectives continues on an exciting trajectory. We are maturing as a commercial organization, solidifying our position as a leading innovator in a nascent education market and advancing our pipeline towards critical value-creating and business transformative milestones. We believe we are well on track to realizing our vision of becoming the leading AI-enabled neuroscience company. I have truly never been more excited than I am today for BioExcel's promising future. Now, let me highlight our commercial progress and upcoming clinical milestones. On the commercial front, we continue to execute on our launch for Egalme, approved for the acute treatment of mild, moderate, and severe forms of agitation associated with schizophrenia and bipolar disorders in adults. Integrated commercial team now fully deployed for only one full quarter. We are already seeing encouraging market traction. For example, since our last earnings call, we have more than doubled our number of formulary wins. This is opening a significant addressable market opportunity for Egalmi. I would like to emphasize that we are continuing to build a new education market because Egalme represents the first innovation for this indication in nearly a decade. While we recently celebrated the anniversary of Egalme's FDA approval in April 2022, it is still less than one year since our trade launch last July. I'm proud of the strong performance we have achieved today and the real-world utility Egalme is demonstrating. I will be sharing several inspirational anecdotes of this later on the call. On the clinical front, we are very excited for three key data readouts across our lead neuropsychiatric program, BXEL 501. These data readouts are on track and expected to enable significant potential market expansion. The overall education market remains underdiagnosed and underserved. There are an estimated 139 million education episodes occurring each year in the U.S. across our three priority indications, bipolar disorder, schizophrenia, and Alzheimer's disease. Similar large markets exist for these conditions in other geographies outside the U.S. Starting with bipolar disorder and schizophrenia, we are looking to potentially expand into the at-home setting where an estimated 23 million agitation episodes occur in the U.S. every year. Our Serenity III program is investigating BXCL501 in this important setting through a two-part study design. We anticipate announcing top-line pivotal data from Part 1 of the study this month. We also look forward to initiating Part 2 of the study this quarter. Turning to Alzheimer's disease, a very large underserved market with no approved therapies, agitation episodes are one of the primary reasons for these patients to move into long-term care facilities. Up to an estimated 100 million agitation episodes occur annually in the U.S. Our Tranquility II program continues to advance, and we are on track to report top-line data in June. In parallel, enrollment is advancing for Tranquility III. Here we are investigating 501 in patients with moderate to severe dementia in long-term care facilities. Outside of agitation, we are making strides towards unlocking BXCL501's full therapeutic potential. It has a novel mechanism of action for potential use as an adjunctive treatment for major depressive disorders. We look forward to sharing top-line results from our Phase 1b multiple ascending dose trial this month. There are over 300 million antidepressant prescriptions filled annually in the U.S. Currently available treatment options are characterized by slow onset of action and incomplete response. We believe this represents a significant market opportunity as a chronic treatment in depression and in other neuropsychiatric conditions. Turning to Oncosexcel Therapeutics, we remain excited about our subsidiary's potential. We continue to explore strategic options for this business and advance our immuno-oncology clinical pipeline. In the second half of this year, we expect to initiate our randomized Phase IIb trial, evaluating BXCL701 as monotherapy and in combination with Keytruda for small-cell neuroendocrine prostate cancer, or SCNC. This trial could serve as a potential registration study for SCNC pending our discussions with the FDA. There are an estimated 288,000 new prostate cancer patients expected in the U.S. this year with approximately 11,500 progressing to SCNC. This patient population is in dire need of treatment options as there are no approved FDA tests. To close, we have had a very productive quarter and have laid a solid foundation for many near-term exciting developments. I'm confident we will continue to meet the high expectations we have set forth for ourselves. With that, I would now like to turn the call over to Rob Isinger to provide some additional details on our three upcoming data readouts this quarter. Rob?

Thank you, Vimal. This is indeed a very exciting time for our neuroscience clinical pipeline at BioXcel Therapeutics. We are expecting three near-term data readouts across the BXCL 501 program. These will potentially help expand this novel asset outside of the institutional setting and into additional therapeutic areas of significant unmet need. Let me briefly summarize these important milestones, their clinical relevance and significance. We are on track to announce top-line data in schizophrenia and bipolar disorder from part one of our Serenity III study this month. This study will report both efficacy and safety information for a 60-microgram dose. Given the purpose of this study, we chose a lower dose to help establish a greater safety margin for at-home use. while maintaining a margin of efficacy. Dose selection was informed by our experience with the 60-microgram dose in our Phase 1b trial. Our goal is to arrest agitation episodes in its earliest stages at home. Patients at home are aware of becoming agitated and have not yet reached the magnitude requiring emergency treatment. This contrasts with the magnitude of improvements in PEC total scores in Serenity 1 and 2, which were designed for the emergency setting, where patients require rapid onset of action considering their acuity. In Part 1 of the Serenity 3 study, We have 80% power for a single 60-microgram dose to separate from placebo by one point or greater in the PEC total score, with an alpha of 0.05 or better. For potential home use, we have powered the Serenity 3 trial for a dose intended to maximize the margin of safety for broader community use. Data cleaning and verification is in progress, with expected readout this month. Part two of our Serenity III study is expected to initiate this quarter and is designed to evaluate the safety of a 60-microgram dose plus a second dose, if required, at home. Let me turn now to Tranquility II, which is evaluating 501 for the acute treatment of Alzheimer's-related agitations. in assisted living facilities and residential settings. The primary endpoint is the change in baseline PEC total scores two hours after the first dose, as in Tranquility 1, and treatment over a three-month observation period. Confirmatory measures include the Clinical Global Impression of Improvement, the Pittsburgh Agitation Scale, and Agitation Calmness Evaluation Scale. In Tranquility 1, we observed statistical significance for the primary endpoint as well as efficacy across these confirmatory measures for the 60-microgram dose. The data cleaning and verification process is underway. We expect to announce top-line data from this pivotal trial in June. Lastly, our Phase 1B Multiple Ascending Dose Trial was designed to test safety and tolerability of daily dosing of BXCL501 for seven days in healthy volunteers to inform proof-of-concept trial dose selection. In Phase 2 program, treatment in MDD patients will be evaluated with BXCL501 in combination with first initiation of of selective serotonin or serotonin norepinephrine reuptake inhibitors, SSRIs or SNRIs, respectively, in order to assess accelerating the response to an antidepressant. This study lays the foundation for combination of BXCL501 with antidepressants for MDD and for the potential chronic dosing in a variety of other neuropsychiatric conditions. We anticipate announcing top line results this month. To summarize, over the next several weeks, we expect to announce key data via three separate readouts for BXCL501 with plans intended to further unlock this asset's full therapeutic potential by demonstrating its ability to treat agitation across additional indications in additional medical settings and potential expansion into illnesses which require chronic dosing. Let me now turn the call over to Matt for an overview of our commercial progress.