BioXcel Therapeutics, Inc.

Good morning and welcome to the BioAccel Therapeutics fourth quarter and full year 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 the 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 10-Q for the quarterly period ended September 30, 2021, as will be updated by its annual report on Form 10-K for the year ended December 31, 2021, which can be found at bioexceltherapeutics.com or on sec.gov. 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, Dr. Vince O'Neill, Chief Medical Officer, Dr. Frank Yaka, Chief Scientific Officer, Dr. Rob Reisinger, Senior Vice President of Clinical Development, and Matt Wiley, Chief Commercial Officer. It is now my pleasure to turn the call over to Dr. Mehta, the CEO of BioAccel Therapeutics. Please go ahead.

Thank you, operator. Welcome, everyone, and thank you for joining our call today to discuss biocell therapeutics, financial performance, and business highlights for the fourth quarter and the full year of 2021. We have a lot to discuss as we embark on a potentially monumental year for the company, so let's get right into it. As you know, biocell therapeutic is a clinical stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immunology. As we near our April 5th, for our lead asset, BXEL 501, I would like to reflect on the significance of 2021, a landmark year for the company with numerous achievements across neuroscience and immunology franchises. starting with BXEL 501, which is currently under FDA review for the acute treatment of agitation associated with schizophrenia and bipolar disorders 1 and 2. We kept an unprecedented journey in 2021, having regulatory submission in just under three years from first in human trials. We are not aware of any other AI-driven drug discovery and development company that has achieved this milestone as efficiently as we have. We view this impressive timeline as further validation of our AI platform and R&D capabilities. We are now less than one month away from potential approval of 501 as our first marketed drug. Since joining as our Chief Commercial Officer, Matt Wiley has led the development of an integrated commercial strategy to support our potential near and long-term commercial vision, including launch readiness activities and the build-out of our national sales force, which is progressing as planned. We are focused on hiring sales representatives with extensive experience and are finalizing our marketing materials, and market access and pricing strategies. Our medical science liaison and medical managed care teams are actively educating healthcare providers and payers on unmet market needs to disrupt the treatment paradigm for their schizophrenia and bipolar patients suffering from agitation. Our team participated in a number of emergency medicine and neuropsychiatric conferences around the country in 2021 with more events planned in the months ahead. We have also seen positive reaction in market research that reflects broad enthusiasm for our proposed brand story and message platform. In a recent study of over 150 healthcare providers. 83% had a positive impression of BXEL 501 after reviewing our blinded marketing materials and stated they would prescribe BXEL 501 for 40% of their schizophrenia and bipolar patients if approved. This prescribing intent for BXEL 501 was shown to displace current standards of care broadly including benzodiazepines, typical and atypical antipsychotics, and other prescription treatments. If approved, 501 would be the first new therapy in nearly a decade for these indications, and we are encouraged by the widespread recognition of its potential benefit to patients and caregivers. Beyond potential approval of 501, we remain committed to our three pillar portfolio expansion strategy, which includes indication expansion, extending our geographic reach, and growing the medical setting where 501 is offered. First, regarding our indication expansion strategy, 501, it presents a pipeline within a product, and we are actively pursuing new indication representing significant future growth opportunities. This past December, we initiated a phase three program evaluating 501 for the acute treatment of agitation in patients with Alzheimer's disease. This program consists of two trials, Tranquility 2 for patients in assisted living or residential facilities, and Tranquility 3 for patients in nursing homes. With an estimated 100 million episodes of agitation associated with Alzheimer's in the U.S. every year, we believe 501 has the ability to address this high unmet medical need and would mark the first approved therapy in this indication if approved. We look forward to advancing this potential novel treatment option for the growing population of Alzheimer's patients. We are also expanding 501 into new indications and have recently filed an IND for 501 as a potential adjunctive treatment in major depressive disorders. MDD remains the most common type of depression in the U.S. with approximately 27 million cases a year. There are over 300 million antidepressant prescriptions filled annually. With limitation to these treatments such as slow onset of action and incomplete responses, we believe that our own clinical data suggests BXAL 501 could be an effective treatment option for these patients. Moving to our second pillar, geographic expansion, we expect to submit a marketing authorization application with the European Medicine Agency in the first half of this year. for PXEL 501. With a sizable market opportunity similar to the U.S., we are working diligently to grow our footprint and reach more potential patients who could benefit from our novel product. As part of this strategy, we are actively seeking a partner to potentially commercialize 501s. Our third strategic pillar in our land and expense strategy We want 501 to ultimately be accessible to patients regardless of treatment setting. Rounding out our growth strategy, we continue to evaluate and pursue expansion opportunities into new settings of care for both current and future indications. As part of our strategy for a sustainable R&D pipeline and using our AI platform, we have expanded our pipeline with our newest product candidate, BXCL502. We initiated formulation for BXCL502 for the chronic treatment of agitation in dementia patients. 502 is designed to be a potent and selective antagonist for a GPCR target affecting serotonergic signaling in the cerebral cortex. It differentiated and novel mechanism. Let me now turn to our immuno-oncology franchise where we continue to make tremendous progress advancing the 501 program. As a reminder, 701 is an orally administered systemic activator of innate immunity being developed for the treatment of aggressive forms of prostate cancer and advanced solid tumors. In February, we presented positive data in both metastatic castrate-resistant prostate cancer, MCRPC, patient cohorts at ESCO-GU. BXCL701 plus Ketruda demonstrated encouraging composite response rates of 21% for adenocarcinoma patients and 33% for SCNC patients. Together, the results support 501's potential to serve as a differentiated approach for MCRPC patients and possibly extend checkpoint inhibitor therapy into hard-to-treat cancers. We also expect additional efficacy data from the MD-inversion-led open-label Phase II Buscat trial of 701 and Keytruda for advanced solid tumors in the second half of 2022 and continue to be encouraged by the potential of 701. To summarize, our AI platform continues to drive our innovation, starting with our two lead product candidates. Both have shown promising results through clinical development, including publication in prestigious journals such as JAMA and Jitsi, and we couldn't be more excited for the future of our neuro and oncology franchises. 2021 was a critical year for BioXcel Therapeutics, as we hit many key milestones on our way towards a potential first product approval. 2022 is shaping up to be a busy and exciting year as we look to build on our many recent successes. 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 fourth quarter and full year 2021 financial results. Research and development expenses were $12.5 million for the fourth quarter of 2021, compared to $11.4 million for the same period in 2020. The increased expenses were primarily attributable to increased headcount and related costs during the three-month period of 2021. Research and development expenses were $52.7 million for the full year 2021, as compared to $58 million for the same period in 2020. The decrease for the year ended December 31, 2021, was primarily attributable to decreased clinical trial expenses related to BXEL 501, which were partially offset by increased trial expenses related to BXEL 701 clinical trials. General administrative expenses were $13.6 million for the fourth quarter of 2021, as compared to $9.7 million for the same period in 2020. The increase was primarily due to increased headcount and related costs, including higher stock-based compensation, increased marketing and commercial costs related to the potential launch of BXEL 501 in the United States, as well as increased legal and professional fees and insurance costs. General and administrative expenses were $54.2 million for the full year 2021 as compared to $24.3 million for the same period in 2020. The increase for the year ended December 31, 2021, was primarily attributable to increased headcount and associated costs, including non-cash stock-based compensation. We also incurred significant commercial costs in preparation for a potential U.S. launch of BXEL 501. BioXcel Therapeutics reported a net loss of $26.1 million for the fourth quarter of 2021, compared to a net loss of $21.1 million for the same period in 2020. For the full year, BioAccel reported a net loss of $106.9 million, compared to a net loss of $82.2 million for the same period in 2020. As of December 31, 2021, cash and cash equivalents totaled approximately $233 million. Now I'd like to turn the call back to Vimal. Thank you, Richard.