Cerevel Therapeutics Holdings, Inc.

Good morning and welcome to the Cerebral Therapeutic First Quarter 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.

Thank you. Good morning, everyone. We appreciate you joining us for our first quarter 2023 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 first quarter 2023 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.

Good morning, and thank you, Matt. Thank you for joining us for our first quarter 2023 business results call. This morning, we announced the appointment of Ron Renaud as the next president and CEO of Ceravel, and I am really looking forward to partnering with him as I return to where my career with Ceravel began in 2018, and that's as chairperson of the board. I have known Ron for more than a decade, and his tremendous experience and leadership will serve the organization well as it prepares for an exciting future, most notably the seven data readouts that we expect in the coming year. As I worked with the board to plan this transition and return to my role of chairperson, we knew that a smooth change in leadership required the right timing and the right successor. fundamental strength of the company made now the right time, and we know that in Ron, we have found the right successor. Ron brings deep experience in the life sciences sector, and as the former CEO of both Translate Bio and Identix Pharmaceuticals, he is truly the perfect fit to become the next CEO of Ceravel. I have great confidence in Ron's ability to lead Ceravel into its next phase as we work together to unravel the mysteries of the brain. Ron will join Cerevel at a time when we are steadfast and focused on executing our clinical trials and optimizing our cash runway with thoughtful fiscal discipline. Cerevel has a tremendous pipeline that is poised to transform what is possible in neuroscience, and we look forward to bringing new treatment options to as many patients as possible as soon as possible. Let me first review the status of our lead programs, starting with Imrakladine. our M4 selective positive allosteric modulator, or PAM. Our Imrakladine program has maintained strong momentum, and our robust Phase II Empower program for adults living with schizophrenia is enrolling well and remains on track for a data readout in the first half of 2024. At Cerevel, we're committed to advancing our Imrakladine program on an accelerated basis, and we continue to prioritize this important Phase II program and the completion of the other necessary preclinical and CMC registration enabling activities, in addition to an open-label extension trial, in order to bring this potentially transformative medicine to the people who need it. Driven by our strong belief and conviction in the differentiated advantages of a targeted, selective, infomuscarinic mechanism, we are also exploring Imraclidine for the treatment of Alzheimer's disease psychosis. We were pleased to receive FDA fast-track designation for imraculamine for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis, and we initiated a phase one healthy elderly volunteer trial to support development in ADP at the end of last year. Beyond our work with Imraclidine and schizophrenia and ADP, we are also advancing therapies for other serious neurological conditions by targeting new pathways with novel selective approaches. Derigabat, our selective alpha-235 GABA-APAM, is another Cerebral Program with multiple potential indications. The first of these is epilepsy, the fourth most common neurological disorder. Through our phase two REALIZE trial, we are studying derigabat and focal epilepsy, an area of tremendous unmet need for patients who need better control of their seizures. We announced today that we expect this program to read out mid-year 2024 as one of our seven anticipated mid to late stage data readouts next 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 selective receptor subtype profile and its avoidance of Alpha-1, the key receptor subunit, we believe, is the main driver of side effects for benzodiazepines. We will be initiating our Phase II trial in panic disorder this quarter, as planned, and look forward to providing you with future updates as that trial progresses. Turning now to Tevapidon, the first D1, D5 partial agonist in development for the treatment of Parkinson's disease, we believe our registration-directed phase three program has the potential to establish Tevapidon as the cornerstone treatment across the spectrum of Parkinson's disease therapy. We believe Tevapidon could serve as both the preferred monotherapy choice for the newly diagnosed patient and the ideal adjunctive therapy choice to levodopa as disease progresses. All three of Cerebral's phase three trials in Parkinson's disease known collectively as the TEMPO trials are ongoing along with the corresponding open label extension trial. We expect data from TEMPO 3 now in the first half of 2024 and data from TEMPO 1 and TEMPO 2 in the second half of 2024. While we remain single-mindedly focused on executing our broad range of clinical trials, we recognize the need for continued fiscal discipline. As Mark will explain in detail in a moment, we have reduced our planned 2023 operating expenses while maintaining a rigorous focus on our key priorities, specifically the data readout timelines for our lead assets, and investing in our early pipeline, where we believe there is long-term value creation potential. We will continue to monitor our expenses for additional opportunities to manage and gate spend where possible, and we will explore external business development and partnering opportunities, such as risk-sharing arrangements or ex-U.S. partnerships as appropriate. Cerevel's cash, cash equivalents, and marketable securities are expected to support our seven anticipated data readouts in 2024 and fund our operations into 2025. Importantly, we have ample cash and runway to see us through the top-line data readout of our Immaculate in Phase II program. The strong fundamentals of our business make this the ideal time to welcome Ron to the team, as we look forward to a bright future for Cerevel and the patients we seek to serve. With that, let me now turn the call over to Dr. Ray Sanchez, our Chief Medical Officer, to provide some added color about our lead programs. Ray?