Cerevel Therapeutics Holdings, Inc.

In Q&A, you can dial star one one. Music Good morning and welcome to the Sarah Bell Therapeutics second quarter 2022 financial results conference call. At this time, all participants are in 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 Corporate Strategy and Investor Relations.

Thank you. Good morning, everyone. We appreciate you joining us for our second 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 Langer, our Chief Scientific Officer, and Mark Bodenreiter, our Interim Chief Financial Officer. Dave Cesar, President, will join us for Q&A. During our call today, please refer to our press release from this morning, detailing our Q2 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 uncertainty. 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, everyone, and thank you for joining us for our second quarter 2022 business results call. At Cerevel, it's our aspiration to become the premier neuroscience company, and we are certainly well on our way to achieving this distinction. With a broad and deep pipeline of new programs, compelling early data in schizophrenia, which has led us to initiate a potentially pivotal large phase two program for imraculidine, five new data readouts expected next year, and a robust set of mid to late stage programs, that have the potential to bring transformative medicine to the millions of people living with schizophrenia, Parkinson's, epilepsy, and dementia-related apathy. And with our announced intention today to study Imraculidine in Alzheimer's disease psychosis and Derigabat in panic disorder, we have even more ways to unlock the value of our rich portfolio. We're advancing a pipeline of neuroscience programs that we believe is unmatched among our peers, with additional early stage programs that hold promise in major depressive disorder and other high unmet need conditions. For our mid to late stage programs, as we mentioned, we expect a remarkable five data readouts before the end of next year. Three phase three readouts for Tavapidon in Parkinson's disease, a Phase II readout in the RIGABAT for focal epilepsy, and a Phase II readout for CVL871 in the novel indication of dementia-related apathy. With so many near-term milestones, CERL is positioned to bring tremendous value to both our patients and shareholders over this period of time as we seek to transform what's possible in neuroscience. And following closely after the five upcoming data milestones in the first half of 2024, we expect the phase two program data readout for Imraclidine, our novel muscarinic M4 selective positive allosteric modulator, or PAM, which we're investigating in adults living with schizophrenia. We're rapidly advancing this very important program, and we have already initiated our phase two program in June, as promised. We're all well aware that the patient need in this area is tremendous. More than 2.7 million people in the U.S. alone live with schizophrenia, a disease that dramatically affects families, loved ones, and entire communities. Individuals living with schizophrenia are more likely to be unemployed, experience homelessness, and most sobering, they're 20 times more likely to die by suicide. At Cereval, we're committed to advancing this program with its innovative mechanism of action, leveraging a new potential approach for treatment in a condition that has not seen innovation in 50 years. And we're working to do this on an accelerated basis in order to bring this potentially transformative therapy to as many individuals as possible as soon as possible. The M4 pathway also holds promise for other devastating conditions, And not only are we committed to developing imraclidine to its full potential as part of a broader M4 franchise, with a second potential new therapy that acts as an agonist at targeting the M4 receptor, we have an additional opportunity to leverage the targeted selectivity of the M4 pathway. John Ringer will provide additional details on this exciting new program in just a moment. Within Rackledine, we intend to initiate a phase one trial evaluating safety, tolerability, and pharmacokinetics in healthy elderly volunteers to support future development 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 those suffering from them and their loved ones. we're eager to explore Imeraclovine's potential in ADP and ultimately other conditions. Our work with Imeraclovine in schizophrenia and ADP is only one part of the cerebral story though. Earlier this year, we announced positive anxiety data for DERIGABAT, our selective alpha-235 gabapam. The DERIGABAT trial demonstrated for the first time proof of principle in the clinic that a compound targeting alpha-235 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. Anxiety is another area of tremendous unmet need. In the first year of the COVID-19 pandemic, anxiety and depression worldwide increased by a staggering 25%, and that figure is likely higher than reported. Related to anxiety, 17 years have passed since we have seen innovation in the treatment of panic disorder. Following our evaluation of the results of our anxiety trial earlier this year, we announced today that we have selected panic disorder as an additional indication for derigabat behind epilepsy, as panic is the second most common anxiety disorder and can be the most debilitating. Ray Sanchez will have further comments more specifically in his section of the call. Cerevel 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 the future at Cerevel is bright, driven by the strength of our pipeline and our programs, and we remain committed to changing the face of neuroscience. I'll now turn the call over to Dr. Ray Sanchez, our Chief Medical Officer, to provide some added color about our lead programs.