BioXcel Therapeutics, Inc.

Good morning and welcome to the BioExcel Therapeutics second quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. If during the conference call you require operator assistance, please press star zero on your telephone keypad. After the formal remarks, 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 Form 10-K for the year ended December 31, 2023, which can be found at www.bioexceltherapeutics.com or on www.sec.gov, and which will be updated in its quarterly report on Form 10-Q for the quarterly period ended June 30, 2024. As a reminder, today's call is being recorded. Speaking on today's call are Dr. Vimal Mehta, Chief Executive Officer, Dr. Vince O'Neill, Chief of Product Development and Medical Officer, and Richard Steinhardt, Chief Financial Officer. They will be joined in the question and answer session by Dr. Frank Yacca, Chief Scientific Officer, Matt Wiley, Chief Commercial Officer, and Dr. Rob Reisinger, Chief Medical Officer of Neuroscience. It is now my pleasure to turn the call over to Dr. Mehta. Please go ahead.

Thank you, operator. Good morning, and thank you for joining us today. At BioXcel Therapeutics, we are focused on expanding our lead asset, BXEL501, into the home setting for bipolar and schizophrenia-related agitation and into a new indication for Alzheimer's-related agitation. We are extremely passionate and motivated to bring this much-needed therapeutic option to millions of patients who are struggling with episodes of agitation. We believe BXEL 501 offers a compelling value proposition, and we look forward to advancing the development of our two clinical programs. At this time, we are delighted to reach an important juncture with the Serenity Program as we are finalizing development plans for BXEL 501 in the at-home setting. where the majority of agitation episodes occur. We truly believe that this is a much-needed treatment option for patients, caregivers, and healthcare providers as there are no FDA-approved therapies for agitation in the home setting. The Serenity at Home trial could represent a near-term value creation opportunity to potentially expand beyond the institutional setting where Egalme is currently marketed. Our Tranquility Program plans with BXAL 501 for Alzheimer's associated agitation are also progressing. This program could address a significant unmet medical need, and we are pleased to have received breakthrough therapy designation from the FDA for this indication. We believe this program could represent a larger longer-term growth opportunity to potentially address an estimated 100 million annual episodes of Alzheimer's-associated agitation. Vince will share updates on the Tranquility and Serenity Program shortly. Turning to EGALMI, we have seen growing adoption among psychiatric care clinics and behavioral health facilities. This market segment represents a community-adjacent opportunity characterized by strong product fit and lower administrative barriers. Given our small field commercial footprint, we believe targeting this market sector positions Regalmi for continued growth and scalability. This could also serve as a bridge to the home setting to the at-home setting if approved. We believe this approach, coupled with substantial patent protection that extends to 2043, could enable us to fully realize the potential of ecology. Finally, we remain focused on strengthening our balance sheet to support our late-stage clinical trials with the goal of reaching data readouts. We are also evaluating strategic financing alternatives such as royalty monetization, on-cause Excel monetization, as well as strategic partnerships. In summary, plans for our core clinical programs are advancing, our market access strategy with Regalme is progressing, and we are pleased with growing patent portfolio. With that, I will turn the call over to Vince.

Thank you, Vimal. So as Vimal announced, we're pleased to be preparing for initiation of our Serenity at Home trial. which, as a reminder, is designed to be a double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of a 120-microgram dose of 501 over a 12-week period. The primary objective will be safety with efficacy measures as exploratory endpoints. We recently received feedback on the trial protocol from the FDA. We've completed the CMC work we believe is sufficient to support the use of childproof pouches in the home setting. and have finally defined the final statement of work in clinical site selection with our CRO, all preparing us for trial initiation. Plans for our Tranquility program are also advancing with the focus on our Tranquility in-care trial. The proposed trial design is substantially similar to Tranquility 2. As a reminder, Tranquility in Care is a double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of a 60-microgram dose of 501 over a 12-week period. The primary endpoint is expected to be the change in PEC score at two hours post-first dose. The Tranquility in Care protocol is in final form, and we're planning to submit it to the agency. Turning to our PMR study with the GALMI, We were pleased to have reported positive top-line results evaluating PRN or as needed treatment of Egalme. The study achieved its objective and demonstrated no evidence of tachyphylaxis tolerance or withdrawal with the 180 microgram dose, the highest approved dose. Although the study was not statistically powered to evaluate repeat dose efficacy, a reduction in agitation was observed for each episode occurring during the seven-day study period. and no serious adverse events were reported following treatment. I would now like to turn the call over to Rich, who will review our financial results for the second quarter.