BioXcel Therapeutics, Inc.

Good morning and welcome to the BioXL Therapeutics first 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 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 ending December 31, 2024, which can be found at 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 March 31, 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 Q&A session by Dr. Frank Yaka, 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. 2024 has been an important period of progress for bioexcel therapeutics, both at the program and corporate level. Starting with our neuroscience program, our journey with BXEL 501 is well underway to expand the market potential for our agitation portfolio into the retail setting. We are focused on potentially bringing this novel treatment option for bipolar and schizophrenia-related agitation into the home setting. We are also dedicated to expanding into a much larger indication Alzheimer's-related agitation, both in the in-care and home setting. We believe these two opportunities are unique with no known FDA-approved therapies and represent transformative value drivers for the company and our shareholders. We are pleased to be advancing the plans for both late-stage tranquility and serenity programs While Vince will discuss the details of these programs shortly, I want to point out that we believe Serenity at Home may provide us with a nearer-term opportunity to create shareholder value through a potential label expansion for the previously approved 120-microgram dose. The Tranquility in Care trial is similar in design to our positive Phase III Tranquility II trial. We see a larger long-term growth potential with this program. We believe there is a significant upside to be the first to enter this untapped market. In addition to progressing our clinical development program, we have further expanded intellectual property for our neuroscience franchise. We were recently granted two new patents in US and Japan. We believe this provides long-term protection for our assets and gives us a solid foundation from which to pursue further development of BXEL 501 and potential partnerships in key international markets. Our IP portfolio is substantial. As of April 2024, we have 30 granted or allowed patents. and more than 140 additional patent applications in prosecution. We also have eight US patents for our approved drug, Egalme, listed in the FDA's Orange Book, with two additional recently allowed patents eligible for listing, one issued by the US Patent and Trademark Office. Turning to Egalme commercialization traction, our revised and focused strategies yielding results as we increase net revenue in the Q1 2024 by 55% over the Q4 2023. This growth is being primarily driven by volume contracting, new customer acquisitions, increased utilization from existing customers, and the recently implemented permanent J code for EGALMI. We are seeing this momentum carrying forward into the second quarter with cartel volume already exceeding that of the first quarter this year. We are pleased that EGALMI is reaching a greater number of patients and healthcare providers and expect this momentum to continue. Both institutional and home setting market for bipolar and schizophrenia related agitation are symbiotic and commercially strategic. We are excited about achieving an uptick in economy utilization and having a clear development path for the home setting. Turning now to the corporate front, we are pleased to have completed the 25 million registered direct offering we recently announced. This transaction provides an important bridge to continue advancing our business strategy and clinical trial plans. We remain focused on further strengthening our balance sheet and exploring multiple financing options, including potential partnerships, to extend our cash run. We also continue to optimize operational efficiencies. To wrap up, we believe our business fundamentals are strong. We are advancing two late-stage clinical programs, strengthening intellectual property, and seeing progress with commercialization of Egalme. These accomplishments are underpinned by a compelling value proposition for driving future growth for the company. With that, I will turn it over to Vince.

Thank you, Vimal. I appreciate the opportunity to review the progress we've made with our late stage clinical development programs for 501. So since speaking with you in March, we've received the minutes from our meetings with FDA regarding the development plans for the Tranquility and Serenity programs. Based on that feedback, we have developed and announced the designs of both pivotal phase three trials. We're pleased to have clarity on development paths, which may lead to two potential SNDA submissions, both for Alzheimer's-related agitation and bipolar and schizophrenia-related agitation. As a reminder, in the Tranquility Program, we're evaluating 501 as an acute treatment for agitation associated with Alzheimer's dementia. Our Tranquility in-care trial is designed as a double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of a 60-microgram dose of 501 over a 12-week period. The primary endpoint is change in PEC score at two hours post-first dose. It's important to note that this is the same endpoint used in previous positive tranquility trials and in studies that supported the FDA approval of Egalme. In the Serenity program, we're evaluating the potential at-home use of 501 for agitation associated with bipolar disorders or schizophrenia. Our Serenity at-home trial 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 is safety, with efficacy measures as exploratory endpoints. Again, we've taken a thoughtful and deliberate approach to our trial designs with the ultimate goal of accessing the retail setting in mind and we look forward to advancing our plans. The trial protocols have now been finalized and are being shared with the FDA and our CRO is for clinical site selection. In our PMR study, we recently completed the enrollment of 22 patients with frequent episodes of agitation for bipolar disorders or schizophrenia in that open label study. It's designed to evaluate whether tolerance, tachyflaxes, or withdrawal occur following repeat dosing of the 180 microgram dose of Egalami after seven days of repeated treatment. These trial results can help address the language around limitations of use and warnings and precautions in Egalami's current label. We're performing data cleaning currently and look forward to announcing results from this PMR study shortly. I'd like to end my remarks with a few comments about our lead immune oncology asset, 701. Earlier this year, we announced the completion of patient enrollment in the safety portion of the Phase 2 trial of 701 in combination with K-TRUDA in metastatic pancreatic ductal adenocarcinoma. The trial is being led by Georgetown Lombardi Comprehensive Cancer Center. We are pleased that a late-breaking abstract was selected for presentation at the 2024 ASCO Annual Meeting and look forward to sharing the data on June the 1st with you. We have formally initiated the process for monetization of this asset. I would now like to turn the call over to Rich, who will review our financial results for the first quarter of 24. Richard.