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Arvinas, Inc.
2/11/2025
Good day, and thank you for standing by. Welcome to the Arvanas fourth quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker for today. Jeff Boyle, please go ahead.
Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release with our fourth quarter and full year 2024 financial results, which is available in the investors and media section of the website at arvinas.com. Joining the call today are John Houston, our Venice's Chief Executive Officer, President, and Chairperson, Noah Berkowitz, our Chief Medical Officer, Angela Cacasey, our Chief Scientific Officer, and Andrew Seck, our Chief Financial Officer. Before we begin the call, I'll remind you that today's discussion contains forward-looking statements that involve risks, uncertainties, and assumptions. These risks and uncertainties are outlined in today's press release, and in the company's recent filings with the Securities and Exchange Commission, which I urge you to read. Our actual results may differ materially from what is discussed on today's call. And now I'll turn the call over to John Houston, our CEO, President, and Chairperson.
John? Thanks, Jeff. Good morning, everyone, and thank you for joining us this morning. It's a very exciting time for us here at Arvinas as we're on the cusp of some major accomplishments that include our first phase three top line data results expected later this quarter, and first in human data from our first PROTAC targeting neurodegenerative disease. We continue progressing a robust portfolio of exciting development programs that have the potential to transform the treatment landscape across a broad range of cancers and neurodegenerative diseases. our novel approach to discovering, developing, and commercializing a new class of medicines has always been the backbone of our company, and we're pleased to provide an update this morning at such an important time for the organization. Today, I'll begin with a brief overview of our VINUS, our ProTag discovery platform, and an update on our pipeline. Noah will then provide an overview of our VetDegistrant or VetDeg clinical program, including reviewing the Phase III Vertac II trial, and also provide an update on our first neuroclinical program with ARV102, our LRRK2 degrader. Angela will provide an update from our earlier stage programs, including our BCL6 degrader, ARV393, and our KRAS G12D degrader. And finally, Andrew will provide an overview of our fourth quarter and full year 2024 financials before we open up the call for your questions. Over the course of the last year, we have made significant progress on our mission to improve the lives of patients with debilitating and life-threatening diseases. Our pipeline of proteolysis targeting chimeras, or ProTac protein degraders, have been designed to harness the body's natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Our innovative ProTac platform has enabled us to create a deep pipeline while making significant breakthroughs in targeted protein degradation. These breakthroughs include designing degraders with drug-like properties that are orally bioavailable and, when needed, able to cross the blood-brain barrier. VetDeg is the most advanced program in our pipeline, and in addition to our ongoing phase three monotherapy trial, our current development plan includes two additional phase three combination trials across the first and second line settings in metastatic breast cancer. VetDag is an oral protein degrader specifically designed to target and degrade the estrogen receptor for the treatment of patients with ER-positive, HER2-negative breast cancer. Together with Pfizer, we are developing VetDag with a goal of becoming the best-in-class ER-targeting backbone therapy, first as a monotherapy, then with multiple combination strategies. And soon, we expect to have data in hand from Vertac II, our first-ever phase three trial. Data from this Phase III clinical trial will be an important milestone for Arvinas, and we look forward to sharing top-line results later this quarter. If positive, these results will support our first new drug application and mark our potential transition to a commercial stage company. NOAA will provide an overview of the trial later in the call. Now, given how close we are to this disclosure, we will not be answering questions about trial progress, or offering additional guidance on expectations for VERITAC2 during the Q&A portion of our call. Last month, we announced updates to our clinical development plans for VET-DEG combination trials in the first and second line settings, pending emerging data and health authority feedback. In the first line, we announced that in 2025, we intend to initiate a phase three trial with VET-DEG plus Pfizer's novel investigational CDK4 inhibitor, a termocyclic. In the second line, we announced that we plan to initiate a Phase III combination trial evaluating VEPDAG with a CDK4-6 inhibitor, which we also expect to initiate in 2025. Beyond VEPDAG, we have a data-rich year ahead, and we believe there are exciting opportunities for PROTACs across oncology and neuroscience. In April, we plan to present the first in human data from ARV102, a LRRK2 degrader, which we believe will highlight the potential value our PROTAC degraders can offer to patients with neurodegenerative diseases. Additionally, in 2025, we plan to share preliminary data from our Phase 1 trial with ARV393, our BCL6 degrader, in patients with non-Hodgkin lymphomas. And finally, we are in track to file an investigational new drug application for our KRAS G12 de-degrader this year. I'll now turn the call over to Noah for an overview of the VEP-DEG and ARV-102 programs. Noah?
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