Cerevel Therapeutics Holdings, Inc.

Good morning. Welcome to the Servil Therapeutics Second Quarter 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 will now hand the call over to Mr. Matthew Calistri, Vice President of Corporate Strategy and Investor Relations.

Thank you. Good morning, everyone. We appreciate you joining us for our second quarter 2021 results 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 Kathy Yee, our chief financial officer. Please refer to our press release from this morning detailing our Q2 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 our financial performance, future events, and industry and market conditions, as well as forward-looking statements including 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 it over to Dr. Tony Coles, Chairperson and CEO of Cerebellum, to provide an overview of our achievements and outlook.

Thanks, Matt, and good morning, everyone. Thank you for joining us. This quarter has been a pivotal one for Cerevel as we begin to deliver on our aspiration to become the premier neuroscience company. We were pleased to announce positive phase 1B top-line data for CBL231, our M4-selected PAM in schizophrenia, earlier in the quarter. The results were robust and very encouraging, and we believe this compound has the potential to truly transform schizophrenia therapy and improve quality the lives of millions of patients and their caregivers. In a moment, our Chief Medical Officer, Dr. Ray Sanchez, will review the trial results in more detail. Following our positive data readout for CVL231, we're proud to have completed a $350 million follow-on offering with approximately $328 million in net proceeds. With our continued focus on creative capital formation, including our Tevapidon risk sharing deal and redemption of our public warrants, we have now raised a total of more than $800 million as a public company. The proceeds of this most recent raise will be used to fund a comprehensive phase two program for CBL 231 and to advance several of our earlier stage programs. Together with proceeds from the redemption of our outstanding public warrants, we have strengthened our balance sheet and have the resources we need to advance our pipeline through multiple data readouts over the next three years. Specifically, we anticipate two data readouts for DERIGABAT in 2022, with data from our Phase I acute anxiety trial expected in the first half of the year and the readout from our Phase II focal epilepsy trial in the second half. Also in the second half of 2022, we expect a Phase II readout of CVL871 in dementia-related apathy, an asset for which we recently received fast-track designation from the FDA. And in 2023, we expect data from our Phase III program for tevapidon in early and late-stage Parkinson's. Finally, as I mentioned, we'll be advancing CVL231 into a comprehensive Phase II program, and we'll provide additional details on timing and design in the months ahead. So, as you can see, we have a rich late-stage pipeline that is poised to deliver a number of potential catalysts in 2022 and 2023, and we look forward to sharing those results with you as they become available. We're also showing great progress in our earlier-stage pipelines. During the second quarter, we submitted an IND for CBL354, our Kappa opioid antagonist, and we anticipate another IND submission for CBL047, our selective PDE4 inhibitor, in the fourth quarter of this year. As we enhance our discovery capabilities, we continue to leverage enabling technologies such as gene editing and artificial intelligence at our new Cambridge Crossing facility, to identify the most impactful drug targets for neuroscience diseases. I'd now like to ask Dr. Ray Sanchez, our Chief Medical Officer, to provide the latest updates on our clinical development efforts. Ray?