Cerevel Therapeutics Holdings, Inc.

Good morning, and welcome to the Sarah Bell Therapeutics Second Quarter 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 Galastri, Vice President of Investor Relations.

Thank you. Good morning, everyone. We appreciate you joining us for our second quarter 2023 earnings call. On today's call, you'll be hearing from Ron Renaud, our president and chief executive officer, Dr. Ray Sanchez, our chief medical officer, Dr. John Renger, our chief scientific officer, and Dr. Susan Altshuler, our chief financial officer. During our call today, please refer to our press release from this morning detailing our second quarter 2023 financial 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 Rob Renaud, President and CEO of Cerebel, to provide an overview of our achievements and outlook.

Good morning, everyone, and thank you for joining us for our second quarter 2023 business results call. I'm pleased to be here with all of you today as the new president and CEO of this exceptional company. In my time at Ceravel so far, I've seen immense passion and dedication from the team, and I'm incredibly enthusiastic about our science and innovation as we aim to build a world-class neuroscience company. Before getting into the specifics, let me share some of my initial observations of this organization. CeraVil is comprised of smart, energized, with deep experience in neuroscience drug, energized people with deep experience in neuroscience drug development and notable track records of success. We have an unparalleled pipeline with the potential to bring new treatments to some of the most challenging neuroscience diseases. We're also focused on discipline execution, aware that patients and loved ones are waiting for these important new treatment options. Before I joined the company, I was impressed with this enviable portfolio. Now that I've had an opportunity to work with this team and dive deep into the details of the science and the programs, I'm even more excited about all we have ahead of us. Turning to our lead programs, let me start with Imraclidine, our M4 selective positive allosteric modulator, or PAM. At Cerevel, we're exploring all aspects of the M4 muscarinic pathway as we seek to build a franchise that can address a broad range of diseases via this mechanism. Imraclidine is a highly selective for M4, and we believe it has the potential to change the way we do and treat schizophrenia, Alzheimer's disease, psychosis, and other serious mental illnesses. We announced this morning that our Imraclidine Phase II Empower program is now expected to read out in the second half of 2024, a change resulting from recent slower than expected enrollment. We are deploying measures to restore our pace of enrollment and I am personally working closely with Ray and the team on mitigation strategies. Ray will provide more details, including our go-forward approach and our reasons for confidence in our updated timing. As always, we're focused on ensuring the quality of Imraclidine data and will be thoughtful in our plans to add new sites or countries to ensure we maintain our rigorous standards. Moving now to Tevapidon, the first D1, D5 partial agonist in the development for treatment of Parkinson's disease. We believe our Registrational Phase III Tempo Program has the potential to establish Tavapadon as a backbone treatment across the spectrum of Parkinson's disease therapy. Tavapadon has the opportunity to serve as both the preferred monotherapy for newly diagnosed patients and the ideal adjunctive therapy to levodopa as the disease progresses. We expect Tempo III to be our first data readout of 2024, while data from Tempo I and Tempo II will read out in the second half of 2024. Turning now to DERIGABAT, our selective alpha-235 GABA-A PAM, currently in development for both epilepsy and panic disorder. Our phase two realized trial in focal epilepsy is designed to address an area of tremendous unmet medical need for patients who need better control of their seizures. We expect this program to be our second data readout next year, coming mid-year 2024. We also recently initiated the ADAPT trial of DERIGABAT, a Phase II proof-of-concept trial in panic disorder. We have confidence in the potential of DERIGABAT to treat anxiety-related disorders, given its selective receptor subtype profile and its avoidance of Alpha-1, the receptor subunit we believe is the main driver of side effects for benzodiazepines. On the financial front, we have a strong balance sheet that is expected to support all of our anticipated late-stage data readouts next year. Before I hand it over to Ray, I want to take a moment to welcome the newest members to the CeraVel executive team, Dr. Susan Altshuler, Chief Financial Officer, and Paul Burgess, Chief Business Development and Strategic Operations Officer. Susan brings financial management, investor relations, and business planning experience from leading biopharma companies. Paul brings deep experience in corporate development, business development, and operations, key skills during this important juncture for CeraVel. All three of us have been warmly welcomed by Cerevel senior leaders, seasoned leadership team. I'm proud of how in just seven weeks, we've come together as a new invigorated executive team. I'm energized by all that we will do together, along with all of our Cerevel colleagues to build a world-class neuroscience company with multiple commercial products. With that, I'll now turn the call over to Dr. Ray Sanchez, our chief medical officer to provide some added color about our lead programs.