Cerevel Therapeutics Holdings, Inc.

Good morning and welcome to the Ceravel Therapeutics Third Quarter 2022 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 will now hand the call over to Matt Calistri, Vice President of Investor Relations. Please go ahead.

Thank you. Thank you. Good morning, everyone. We appreciate you joining us for our third quarter 2022 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. Dave Cisse, our President, will join us for Q&A. During our call today, please refer to our press release from this morning detailing our Q3 2022 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 achievement and outlook.

Thanks, Matt, and good morning, everyone. Thanks for joining us for our third quarter 2022 business results call. At Ceravel, we know our aspiration is to become the premier neuroscience company. Our recent financing of $599 million puts us in a strong position, and now with more than a billion dollars of capital on our balance sheet to fuel our pipelines. Here at Ceravel, we innovate across all aspects of our business, from drug development to clinical trials to capital formation, and our strategic and creative approach to financing following positive data from a peer is a prime example of this approach. We have more than doubled our financial resources, which we expect will fund our operations into 2025. We have multiple mid- to late-stage clinical trials across four therapeutic areas, along with several planned proof-of-concept and early-stage discovery programs. By advancing a broad neuroscience portfolio that we believe is unmatched among our peers, we seek to deliver potentially transformative medicines to the millions of people living with schizophrenia, Parkinson's disease, epilepsy, dementia-related apathy, panic disorder, and Alzheimer's disease psychosis. We have confidence in our deliberate and differentiated approach to treating neuroscience diseases through which we focus on three core elements. First, targeted neurocircuitry, which is developing a deep understanding of how the brain is wired. Second, receptor subtype selectivity, which enables us to narrowly target our therapeutic interventions. And third, differentiated pharmacology, which enables us to precisely design potential therapies for the diseases we're focused on. And our progress continues. In June, we initiated our robust phase two program for imbraclidine, our novel muscarinic M4 selective positive allosteric modulator, or PAM in adults living with schizophrenia. We're all aware that the patient need in this area is tremendous. More than two million people in the US live with schizophrenia, a disease that dramatically affects families, loved ones, and entire communities. At Cerevel, we are committed to advancing our Imraclidine program on an accelerated basis to bring this potentially transformative therapy to as many individuals as possible as soon as possible. And we believe Imraclidine has tremendous potential beyond schizophrenia. By the end of this year, we plan to initiate a phase one safety, tolerability, and pharmacokinetic trial in healthy elderly volunteers to support future development of imraculidine in Alzheimer's disease psychosis, or ADP. The behavioral and psychological symptoms of Alzheimer's, such as delusions, hallucinations, and paranoia, exert an enormous toll on patients, their loved ones, and the cost of care. I'm very pleased to share that in recognition of the significant unmet need in this particular syndrome, we recently received fast-track designation from the FDA for Imraclidine for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis. We're eager to explore Imraclidine's potential in this and other conditions. Our work with Imraclidine in schizophrenia and ADP is, however, only one part of the Cerebral story. Across our pipeline, we are bringing forward therapies for other serious neurological conditions by targeting new pathways with novel approaches. DERIGABAT, our selective alpha-235 GABA-PAM, is another Serovel program with multiple potential indications. The first of these is epilepsy, the fourth most common neurological disorder. As we recognize Epilepsy Awareness Month in November, we reflect on the fact that 1 in 10 people will have a seizure in their lifetime, and 1 in 26 will develop epilepsy. We're studying dirigibat and focal epilepsy through our Phase II REALIZE trial, which is on track to read out in mid-2023. And earlier this year, we announced positive acute anxiety data for dirigibat, The DERIGABAT trial demonstrated for the first time proof of principle in the clinic that a compound targeting alpha-2, 3, 5, and sparing alpha-1 can generate anxiolytic activity and at the same time may be able to minimize the side effects that limit benzodiazepines to only episodic use. We've selected panic disorder. as an additional indication for Darigabath, as panic is the second most common anxiety disorder and can be the most debilitating. We expect to initiate a phase two proof of concept trial in 2023. Let me turn now to our most advanced program, Tavapidon, the first D1, D5 partial agonist in development for the treatment of Parkinson's disease. We believe our registration directed Phase III program has the potential to establish Tabapadon as the cornerstone of therapy across the spectrum of Parkinson's disease, the preferred monotherapy choice for the newly diagnosed patient, and the ideal adjunctive therapy to leave Adelpa as the disease progresses. Although certain of our data readout timelines in this program are under review, All three of our phase three trials in early and late stage Parkinson's disease are ongoing, along with the corresponding open label extension. So, as you can see, CeraVel is advancing with clear purpose, and our late stage pipeline has the potential to deliver important medicines to individuals living with neuroscience diseases who need and deserve new treatment options. We believe CeraVel's future is bright, driven by the strength of our pipeline and our programs and our early-stage discovery initiatives, and we remain committed to changing what is possible in neuroscience. Now, let me turn the call over to Dr. Ray Sanchez, our Chief Medical Officer, to provide some added color about our lead programs. Ray?