Cerevel Therapeutics Holdings, Inc.

Good morning, ladies and gentlemen, and welcome to the Cerebral Thyroid Explored Quarter and Full Year 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 Gillespie, Vice President of Investor Relations.

Thank you. Good morning, everyone. We appreciate you joining us for our fourth quarter and full year 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. During our call today, please refer to our press release from this morning, detailing our 2022 performance, as well as our updated corporate presentations. 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 Cerevel to provide an overview of our achievements and outlook.

Thanks, Matt. And good morning, everyone. And thank you for joining us for our fourth quarter and full year 2022 business results call. Cerevel aspires to become the premier neuroscience company, and we continue to have great momentum towards achieving that distinction. 2022 was a particularly productive and successful year as we remained steadfast and focused on our mission to transform what is possible in neuroscience. We delivered positive results in our Imrakladine blood pressure trial in December, raised $599 million in new capital at mid-year to extend our cash runway into 2025, and started the year with positive anxiety data in Derigabat, marking an important set of achievements for the organization. Let me first specifically highlight Imraqlithi, our M4 selective positive allosteric modulator, or PAM. We are especially pleased with the momentum of this program, which remains our top priority. Our robust phase two Empower program for adults living with schizophrenia is enrolling well and remains on track for a data readout in the first half of 2024. We know that the patient need in this area is tremendous. More than 2 million people in the U.S. live with schizophrenia, and the disease touches the lives of caregivers and communities at large, with patients more likely to experience homelessness, addiction, and death by suicide. We continue to prioritize this important Phase II program and the completion of the other necessary registration-enabling activities, including an open-label extension trial, in order to bring this potentially transformative medicine to patients as quickly as possible. We also proactively took an important step toward registration by conducting and concluding our ambulatory blood pressure monitoring trial early in clinical development. The positive results from this important risk-mitigating trial, which were announced in December 2022, provided clear evidence that Imracavine does not induce a sustained increase in blood pressure with chronic dosing in people living with schizophrenia. Driven by our strong belief in the differentiated advantages of a targeted, selective, informed mechanism, we are also exploring Imbraclidine for the treatment of Alzheimer's disease psychosis, a condition that affects more than 40% of people living with Alzheimer's disease. We were pleased to receive fast-track designation for Imbraclidine from the FDA for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis and we initiated a Phase I Healthy Elderly Volunteer Trial to support development in this indication at the end of last year. Our work with Imraciline and schizophrenia and ADP, however, is only one part of the Cerebell story. Across our broad pipeline, we are also advancing therapies for other serious neurological conditions by targeting new pathways with novel selective approaches, which is the central unifying thesis underlying Cerevel. As such, I'd now like to highlight Derigabat, our alpha-235 selective GABA-A receptor PAM in development for both epilepsy and panic disorder. We're currently conducting the REALIZE trial, a phase two proof-of-concept trial in focal epilepsy. Epilepsy is the fourth most common neurological disorder affecting one out of every 26 people. Our realized trial seeks to advance DERIGABAT in this important indication and address an area of tremendous unmet need for patients who need better control of their seizures. As Ray will discuss in more detail, enrollment has been affected by post-COVID headwinds that are causing clinical trial delays across the industry. Given these landscape challenges, we have announced today that we no longer expect data for this trial in 2023. As we've recently done with Tevapidon, we are conducting a thorough review of the realized sites and the clinical trial timeline and are actively implementing robust mitigation plans to complete this trial. We will provide an update on that revised timeline by mid-year. We have tremendous confidence in the potential of DERIGABAT to address important unmet medical needs, not only for epilepsy, but in the potential treatment of anxiety-related disorders, given its selectivity and its avoidance of the alpha-1 receptor subunit, which we believe is the main driver of the occurrence of side effects that plagues benzodiazepines. It was this time last year that we shared our positive top-line data from our DERIGABAT Phase 1 Healthy Volunteer Trial in a panic symptom model. These results provide strong evidence of DERIGOVAT's potential as a well-tolerated and differentiated daily maintenance treatment for anxiety-related disorders, which would be an important breakthrough in the clinical treatment of anxiety. We're enthusiastic about initiating our Phase 2 trial in panic in the second quarter of this year, and that remains on track as well. As we begin 2023, our focus is on execution and continued fiscal discipline as we head into a data-rich 2024, when we expect seven mid- to late-stage data readouts, starting with our two Phase II trials of Imraclidine for schizophrenia in the first half of next year. As of the end of 2022, we had $950 million of cash resources, which we expect will fund our operations into 2025. And we continue to look for opportunities to be creative in our ongoing efforts to maximize the value of our pipeline as we target our spending on the highest priority programs. Finally, I also want to acknowledge that our president, Abe Cisse, will be leaving Cerevel as of March 9 to pursue an exciting CEO opportunity at a private biotechnology company. I want to publicly thank Abe for his leadership and many contributions to Cerebell, and we all wish him well in his next endeavors. With that, let me now turn the call over to Dr. Ray Sanchez, our Chief Medical Officer, to provide some added color regarding our lead programs. Ray?