BioXcel Therapeutics, Inc.

Good morning and welcome to the BioAccel Therapeutics third 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 subject to risks and uncertainties related to future events and or future financial performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. Risk factors that may affect results are detailed in the company's most recent public filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10Q for the quarterly period ended September 30th, 2021, which can be found 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. Zilma Mehta, Chief Executive Officer, Richard Steinhardt, Chief Financial Officer, Vince O'Neill, Chief Medical Officer, Frank Yaka, Chief Scientific Officer, and Rob Reisinger, Senior Vice President of Clinical Development. 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. We will update you on our financial performance and business highlights for the third quarter of 2021. As you know, BioXcel Therapeutics is a clinical stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immunology. It is a very exciting time for the company, and we are pleased to report tremendous progress in our neuroscience and immunology franchise, as well as commercial and launch planning as we near our January 5th PADUFA date. We have many accomplishments to discuss today, Let's start with our most advanced program in neuroscience, BXCL501, for the acute treatment of agitation associated with schizophrenia and bipolar disorders 1 and 2. As a reminder, this is our lead investigational candidate that we doubled out from first in human trial to FDA acceptance for our NDA filing in under three years. This speed is remarkable, as we are not aware of any other AI-driven drug discovery and development company that has achieved these milestones as efficiently. We are now less than two months away from potential approval, and our commercial and launch readiness activities are advancing well. We have expanded our sales leadership, including onboarding a VP of sales and regional sales director. They have deep neuroscience expertise with multiple product launches in both institutional and outpatient settings, and experience working for startups and large companies. We are also focused on recruitment for our sales team across key territories. We are finalizing our market access and pricing strategy through evidence-based market research for 501. Through two strategic initiatives, we are continuing to educate key audiences about our innovative product with no similar launch analogs. First, we have fully launched our disease education campaign, promoting awareness around acute treatment of agitation in schizophrenia and bipolar disorder. This is a broad, multi-channel campaign that includes broadcast, and product theater presentations by key thought leaders. The campaign is designed to educate healthcare providers on the full spectrum of signs, symptoms, and levels of severity associated with agitation and the importance of prompt, non-invasive treatment for patients with schizophrenia and bipolar disorders. Second, our medical science liaison and medical medical managed care teams are actively engaged with healthcare providers at the institutional level and at conferences around the country. At several recent conferences, we had educational booths that effectively informed participants on how to assess agitation in a schizophrenia and bipolar patient and follow treatment guidelines. We will continue to actively participate at industry-leading conferences in the months ahead. Two strategic initiatives are continuously providing us with valuable insights for commercial launch while building important awareness of agitation associated with neuropsychiatric disorders. We are excited about the possibility of bringing a potential new treatment option to the millions of patients struggling with acute agitation associated with schizophrenia and bipolar disorder. Equally significant, 501 has the potential to be the first innovative product, new therapy for these indications in more than a decade. Our neuroscience franchise is growing rapidly. In fact, we believe that 501's pending approval and commercialization is just the beginning. As you will recall, we have a three-pillar portfolio extension strategy for BXCL 501. We intend to expand indications for 501, extend our geographic reach, and grow the medical settings where our treatments are offered. Let me quickly review our progress within each of these three pillars. Reflecting our indication expansion pillars, 501 represents a pipeline within a product, and we are advancing 501 across several indications. We plan to initiate a Phase III program evaluating 501 for the acute treatment of agitation in patients with Alzheimer's disease in Q4 of this year. This follows multiple meetings with the FDA and strategic considerations related to clinical, regulatory, and commercial potential. Alzheimer's disease is the most prevalent type of dementia in the U.S. For context, in Americans over 65 years old, Alzheimer's disease is expected to double over the next 20 years, increasing from 5.8 million in 2020 to 11.8 million in 2014. Up to 70% of those patients experience agitation, with an estimated 100 million episodes of agitation in the U.S. every year. We believe 501 would mark the first orally available therapy, if approved, where there are currently no FDA-approved therapies. Given the unmet medical need in this area, we intend to pursue BXCL501 in other dementia subtypes as part of our future development. Beyond dementia, we are expanding 501 into new indications, including a Phase 1b2 trial evaluating 501 as an adjunctive treatment in major depressive disorder, or MDD. a major public health burden with a high unmet need. It is estimated that 30 million or more Americans are currently on antidepressant, with 25% of those diagnosed remaining ill after starting treatment. Our team is preparing to submit an IND, and we expect to initiate a clinical trial in the first half of 2022. Second, as a part of our geographic expansion strategy, we expect to submit a marketing authorization application with the European Medicine Agency in the first half of 2022 for BXAL 501. We believe the EU represents a sizable market opportunity similar to the U.S. The third pillar of our expansion strategy is to grow the 501 franchise across multiple treatment settings as part of our land and expand strategy. 501 has the potential to move into outpatient settings, which represents another large market opportunity. We are actively pursuing the development and expansion strategy for both our current and future indications. Our AI platform continues to drive our innovation and has spurred the clinical progress of BXL501 into MDD and the discovery of BXL502. At R&D Day in September, we shared an in-depth look at how we apply this platform to accelerate our drug discovery and development efforts. We will continue to leverage our AI platform for building a sustainable R&D pipeline. We have already begun formulation and clinical development planning for BXEL 502 for the chronic treatment of agitation and dementia. 502 is designed as a monotherapy and we believe there may be a potential benefit of combining 501 and 502 as a treatment of agitation and dementia. Turning to our immuno-oncology franchise, we also made great strides progressing the BXEL 501 program. As a reminder, 501 is an orally administered systemic activator of innate immunity candidate being developed for the treatment of aggressive forms of prostate cancer and advanced solid tumors. As further evidence of 701's broad potential, in hard-to-treat tumors at ESMO in September. We presented positive interim data from our ongoing Phase 1B-2 study of BXL701 in combination with Keytruda. We demonstrated encouraging efficacy and a favorable safety profile in heavily pre-treated metastatic castrate-resistant prostate cancer patients with adenocarcinoma. Building upon these results, we also announced the expansion of our de novo and treatment-emergent small-cell neuroendocrine SCNC cohort. This is an area of high-end medical needs with no current standard of care. We expect to present additional efficacy data from the MD induction-led open-label Phase II basket trial of 701 and Keytruda for advanced solid tumors in the first half of 2022. Last week, the Journal of Immunotherapy of Cancer reported data findings suggesting 701 may enhance immunotherapy efficacy in cold tumor types such as pancreatic cancer. These findings also highlight the importance, potential importance of natural QR cells along with T cells in regulating pancreatic cancer tumor growth. These encouraging results have validated our continued efforts to identify other cancer types that could benefit from 701's novel mechanism of action. We continue to optimize the potential of our immunology franchise as we advance multiple clinical strategies. To summarize, this is a very exciting time for Bioexcel Therapeutics as we are rapidly progressing both franchises and preparing for commercial launch. We believe that we are uniquely positioned to take advantage of market opportunities in the near and long term. Now, I would like to turn the call over to Richard who will give a financial update. Richard?

Thank you, Vimal. I will now review our third quarter 2021 financial results. Research and development expenses were $11.9 million for the third quarter of 2021, as compared to $16.3 million for the same period in 2020. The decrease in expenses were primarily attributable to a reduction in our 501 clinical trial costs. These amounts were offset in part by an increase in clinical trial costs related to BXEL 701. In addition, we experienced greater professional and consulting fees, which were primarily related to the development of BXEL 501. General and administrative expenses were $14.9 million for the third quarter of 2021, compared to $8.5 million for the same period in 2020. The increase was primarily due to higher stock-based compensation and personnel costs due to continued expansion of our teams, increased marketing and commercial costs related to our preparation of the potential launch of BXEL 501 in the U.S., as well as increased insurance, legal, and professional fees. The company reported a net loss of $26.8 million for the third quarter of 2021 compared to a net loss of $24.8 million for the same period in 2020. As of September 30, 2021, cash and cash equivalents totaled approximately $252.9 million. Now I'd like to turn the call back to Vimal.