BioXcel Therapeutics, Inc.

Good morning and welcome to the BioXL Therapeutics quarter 2021 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 performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. The risk factors that may affect results are detailed in the company's most recent public filings with the US Securities and Exchange Commission. including its quarterly report on Form 10-Q for the quarterly period ended June 30th, 2021, which can be found on its website at www.bioexceltherapeutics.com or on www.sec.gov. As a reminder, today's conference is being recorded. Joining us on today's call are Dr. Vim Ometa, Chief Executive Officer, Richard Steinhardt, Chief Financial Officer, Will Kane, Chief Commercial Officer, Dr. Vince O'Neill, Chief Medical Officer, Dr. Frank Yaka, Chief Scientific Officer, and Dr. Rob Rissinger, Senior Vice President of Clinical Development. It is now my pleasure to turn the call over to Dr. Mehta, the CEO of BioXcel. Thank you, sir. Please go ahead.

Thank you, operator. Welcome, everyone, and thank you for joining our call today. We had a very exciting and productive second quarter as we continued to execute on our key initiatives that we believe will deliver long-term value to patients, healthcare providers, and our shareholders. As many of you are familiar, we are a clinical-scale biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicine in neuroscience and immunology. Our two most advanced programs are BXL501 our neuroscience investigational candidate that is being developed for the treatment of agitation and BXCL701, our immuno-oncology investigational candidate which is being developed for the treatment of aggressive forms of prostate cancer and advanced solid tumors. I will begin today's call with an overview of the progress we have made with our neuroscience program and plans to expand into additional neuropsychiatric disorders. Over two and a half years, we were able to go from conducting our first inhuman trial with BXCL501 to receiving FDA acceptance of our NDA filing for the treatment of acute agitation associated with schizophrenia and bipolar disorders 1 and 2. Thanks to the hard work of the entire Bioexcel team, we were able to successfully conduct a total of seven clinical trials in over 800 patients across a range of disorders laying a robust clinical foundation for our 501 program. This is in alignment with our three-pillar growth strategy for our neuroscience franchise, which is designed to expand follow-on indications, including dementia, across multiple treatment settings and our global reach. I am pleased to report that we continue to successfully execute on these key initiatives and have made important progress across our clinical, regulatory, and commercial objectives for our lead program, VHDL 501. With regards to clinical progress, we continue to advance our plans for expanding the use of 501 into additional indications. We remain on track to commence a Phase C program of BXCL501 for the acute treatment of agitation associated with dementia in the fourth quarter of this year, which has been granted breakthrough therapy designation by the FDA. Agitation associated with dementia, including Alzheimer's disease, is a significant market opportunity as the need for better treatment options is immense. plan to report top line data from our ongoing 14-microgram dose phase two tranquility trials of BXL501 in patients with dementia during the fourth quarter of 2021. In May, we received FDA acceptance for the filing of our NDA for BXL501 with a PDUPA action date of January 5th, 2022 for the acute treatment of agitation associated with schizophrenia and bipolar disorder. This acceptance marks important progress towards our goal of providing a new treatment option for the millions of patients struggling with acute agitation. If approved, this would be the first major medical advancement for these two indications in almost a decade. In addition, we initiated a pediatric study for the acute treatment of agitation associated with schizophrenia and bipolar disorders. While the FDA reviews our application, we are executing on our comprehensive commercial readiness strategy to ensure that if we receive FDA approval, we are well positioned to bring BXL501 to patients and healthcare providers across the U.S. Our key initiatives in the last quarter included the deployment of our medical science liaison and medical managed care teams who are continuing to engage in scientific and medical-to-medical exchange with the healthcare professionals and peers, respectively, to provide key insights to support commercial strategy. In May, data from the Serenity Phase C trials were presented at the American Psychiatric Association annual meeting and at the International Society for Bipolar Disorders global conference and additional data will be presented at leading medical conferences during the second half of this year. In late June, we held a commercial day where our team shared market insights, commercial opportunity and highlighting launch readiness plan. In preparation for go-to-market strategy, We have augmented commercial teams with several key hires and are further defining the designs of our Salesforce and market access strategy. We are advancing our strategic initiative for geographic expansion. Our plans are underway for a marketing authorization application with the European Medicines Agency for BXCL 501 for the acute treatment of agitation. associated with schizophrenia and bipolar disorders 1 and 2. We believe the European market represents a sizable opportunity similar to the U.S., which we estimate is 9 million patients and approximately 40 million agitation episodes per year. All of this work will serve as a solid foundation for the commercial launch of additional follow-on indications paving the way for further growth opportunities in our neuroscience business. We remain confident in BXL501's potential across multiple indications where there is a significant need for new innovative treatment options. We continue to leverage our AI technology and our proprietary clinical data to strategically expand market opportunities across a broad spectrum of neuropsychiatric disorders where BXL-501 can become a valuable therapeutic option. In the fall of this year, we plan to host an R&D day to provide an update on our BXL-501 program, pipeline within a product, and additional neuroscience pipeline candidates. We look forward to providing more information in the coming weeks. Looking beyond our neuroscience program, our Phase I QB study for castrate-resistant prostate cancer with BXL501 is nearing completion, and a more complete efficacy update from the Phase II portion of the trial is expected in the third quarter of this year. Based on these results, we plan to design our next phase of the CRCC program and leverage BXL-701's novel mechanism to build our immunology franchise. As we move into the second half of this year, we look forward to further building on the important progress we have discussed today and continue to drive forward sustainable growth strategies for our business. Now, I would like to turn the call over to Richard, who will give a financial update.

Thank you, Vimal. I would now like to review our financial results for the second quarter of 2021. Research and development expenses were $13.5 million during the second quarter of 2021, as compared to $17.9 million for the same period in 2020. The decreased expenses were primarily attributable to a reduction in clinical trial costs related to our serenity trials. These amounts were offset in part by an increase in personnel and related costs necessary to enlarge our development and medical teams. In addition, we experienced increased professional fees related primarily to toxicology studies as well as increased regulatory and consulting fees all related to BXCL 501. General and administrative expenses were $14.1 million for the second quarter of 2021. as compared to $3.5 million for the same period in 2020. The increase was primarily due to the overall growth of the company, including higher personnel costs and stock-based compensation. In addition, we experienced increased costs related to legal, professional, and insurance fees, and expenses related to the potential commercial launch of BXCL 501 in the U.S. The company reported a net loss of $27.6 million for the second quarter of 2021 compared to a net loss of $21.4 million for the same period in 2020. The second quarter of 2021 results include approximately $6.8 million in non-cash stock-based compensation costs compared to non-cash stock-based compensation of $2 million for the same period in 2020. As of June 30, 2021, Cash and cash equivalents totaled approximately $273.1 million. Now I'd like to turn the call back to Vimal for any further comments. Vimal?