Cerevel Therapeutics Holdings, Inc.

Good morning. Welcome to the Ceravel Therapeutics fourth quarter and full year 2021 financial results conference call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the Q&A portion of the call. Please note that this call may be recorded. I'll now hand the call over to Matt Calistri, Vice President of Corporate Strategy and Investor Relations.

Thank you. Good morning, everyone. We appreciate you joining us for our fourth quarter and full year 2021 earnings call. On today's call, you'll be hearing from Dr. Tony Coles, our chairperson and chief executive officer, Dr. Ray Sanchez, our chief medical officer, Dr. John Renger, our chief scientific officer, and Mark Bodenrader, our interim chief financial officer. During our call today, please refer to our press release from this morning, detailing our 2021 performance, as well as our updated corporate presentation. both of which are available on our website. I would like to remind you that we will be making forward-looking statements that reflect our current views related to, among other things, the potential attributes and benefits of our product candidates and the format and timing of our product development activities and clinical trials. We strongly encourage you to review the information that we file with the SEC regarding specific risks and uncertainties. I will now hand the call over to Dr. Tony Coles, chairperson and CEO of Ceravel, to provide an overview of our achievements and outlook.

Thanks, Matt, and good morning, everyone. Thank you all for joining us for our fourth quarter and full year 2021 business results call. Ceravel is well on its way to achieving our aspiration of becoming the premier neuroscience company. We've got the pipeline, the people, and the capital we need to transform what's possible in neuroscience. And we have seen that borne out with the two positive trial results we have recently announced in schizophrenia and anxiety. First, in June of last year, we announced positive phase 1B data in schizophrenia for Imraclidine, our M4 selective positive allosteric modulator, or PAM. We're eager to bring this potentially transformative therapy to as many patients as possible, as soon as possible, and are working aggressively and creatively to do so. Earlier this year, we shared the details of our comprehensive phase two program in schizophrenia, which we expect to initiate in the middle of this year. And just two weeks ago, we announced positive anxiety data for DERIGABAT, our selective alpha-235 gabapam. This trial demonstrated, for the first time, Proof of principle in the clinic that a compound that targets alpha-2, 3, 5 selectively and spares alpha-1 can generate anxiolytic activity and minimize the side effects that limit benzodiazepines to only episodic use. Benzodiazepines are widely known to be non-selective gabapams and have a challenging side effect profile, including sedation, withdrawal, and abuse potential. These impressive clinical results support the distinct Cerebell approach to treating neuroscience disease, an approach that is grounded in a deep understanding of neurocircuitry, is focused on targeted receptor subtype selectivity, and which is distinguished through differentiated pharmacology as illustrated on slide eight of our corporate presentation. We've grown our dynamic, innovative, and experienced team of employees, bringing forward these and the rest of our clinical programs We've almost doubled in size from 104 employees at the beginning of 2021 to 200 at the beginning of this year, with the majority, over 70%, working in research and development. Another strength of Cerebellum is our robust financial position, which we bolstered in 2021 through innovative deal-making. In April, we announced a non-dilutive financing deal for Tevapidon that secured funding for our most advanced program through NDA submission. And we raised $250 million to a follow-on offering in July after the announcement of our positive and miraculous data. As a result, we're very well capitalized to fund our operations into 2024. Now, turning to our pipeline, which is slide nine of the presentation, we'd like to highlight the depth and the breadth of the late stage programs in the Cerevel portfolio. With two important readouts already completed, We're rapidly advancing the rest of our pipeline in the hopes of addressing the unmet needs of patients suffering from not only schizophrenia and anxiety, but also epilepsy, Parkinson's, dementia-related apathy, and other neuroscience diseases. Slide 10 highlights the upcoming milestones for our lead programs. In the second half of this year, we're looking forward to Phase 2 proof-of-concept data from our ongoing trial of DERIGABAT in focal epilepsy. In the first half of 2023, we anticipate having data from our ongoing Phase 2A trial of CBL871 and dementia-related apathy. Also, in the first half of 2023, we expect to have Phase 3 tabapadon data in late-stage Parkinson's with early-stage Parkinson's data to follow later in the year. And in the first half of 2024, we expect to have data from our two recently announced Phase 2 trials of imraculidine and schizophrenia. We also have a robust early clinical and discovery pipeline that we are actively advancing, leveraging the state-of-the-art laboratories at our Cambridge Crossing facility. In sum, Cervell is in an enviable position, bringing together a strong pipeline, a talented team, and a robust financial position to advance the treatment of neuroscientific diseases. Now, let me turn the call over to Dr. Ray Sanchez, our Chief Medical Officer, to review the key updates for our lead programs.