Arvinas, Inc.

welcome each and every one of you to the Arvina's first quarter 2025 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. It is now my pleasure to turn today's call over to Arvina's Vice President of Investor Relations, Jeff Boyle. Please go ahead.

Thank you, and good morning, everyone. Thanks for joining us. Earlier today, we issued a press release with our first quarter 2025 financial results, which is available in the investor and media section of our website at Arvinas.com. Joining the call today are John Houston, Arvinas' chief executive officer, president, and chairperson, Noah Berkowitz, our chief medical officer, and Andrew Saag, our chief financial officer. Our chief scientific officer, Andrew Saag, was scheduled to join us this morning, but had an unanticipated personal event and will not be able to. 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.

Thanks, Jeff. Good morning, everyone, and thank you for joining us today. As you saw in our earnings release this morning, we have reached an important moment in Arvinas' progress as a company. We recently shared the first-ever positive pivotal data for a prototype degrader, VipDegastrant, which we are moving towards filing and registration. In addition, we continue making great progress with our pipeline and shared exciting first-in-human data for ARV102, our LARC2 degrader, and excellent preclinical combination data for ARV393, our BCL6 degrader in hematology. We also recently received a safety procedure from the FDA for ARV806, our KRAS G12D degrader. We will discuss each of those items on the call today. Noel will review the clinical progress for Vebdegistrant or Vebdeg and for ARV102. He will also then review our recent preclinical combination data for ARV393 and provide an update on ARV806. Finally, Andrew will provide a financial overview, including our capital allocation priorities and updated cash runway guidance. However, before we get into our data updates, I'd like to cover three important topics up front. First, we are making excellent progress towards our filing and registrational plans for VETDEC in the second line plus ESR1 mutant breast cancer. Based on the strong data from the VRTAC2 study, we have a high conviction that VETDEC has the potential to be a best-in-class monotherapy treatment for patients in a second line ESR1 mutant setting. We are on track to submit a regulatory filing with health authorities in the coming months. We believe there is an attractive opportunity for BET diagnosis as a second-line plus ESR1 mutant treatment in metastatic breast cancer, and we will discuss this opportunity in greater detail after our ASCO presentation in June. Secondly, we have aligned with Pfizer on the removal of the two Phase III combination trials from our joint development plan that were planned for this year. The first of these trials was a combination with a CDK4-6 inhibitor in the second-line setting, And based on recent discussions with health authorities and our observations from other trials involving biomarker-selected populations, we believe ER therapies will be restricted to patients with ESR1 mutations in the second-line plus setting. With this in mind, we have removed the second-line ITT combination trial, which was planned to initiate in 2025 from our joint development plan. The second trial was the first-line combination trial with the termocyclib, Pfizer's CDK4 inhibitor, which was also planned to initiate in 2025. After reviewing the totality of emerging information, including external data results, the evolving treatment landscape in metastatic breast cancer and long-term capital allocation, we have aligned with Pfizer to remove this first-line combination study from our joint development plan as well. We and Pfizer will continue to evaluate our ongoing combination studies in the second line plus setting and generate valuable data in metastatic breast cancer to inform our path forward. In addition, Pfizer is adding a VEBDAG combo cohort to their ongoing phase one clinical trial with their investigational CAT6 inhibitor. This trial will be operationalized and funded solely by Pfizer. As these trials complete, we'll make data-driven decisions about whether further investment in each of these combinations is warranted. I look forward to sharing additional details in the coming months as our trials continue. The third major topic is our company-wide cost reduction effort. The recent challenges in the capital markets are prompting us to extend our cash runway and ensure our programs reach data milestones before additional capital is needed. An important step in this process is maximizing our efficiency and reducing our operating expenses wherever possible. We have implemented a restructuring that includes a workforce reduction of approximately one-third of the company, portfolio reprioritization, and overall cost reductions of approximately $80 million annually on a full-year run rate basis. Although difficult, the workforce reduction, which will result in streamlined operations across the entire organization, is a prudent decision that we believe will appropriately size the company for future success. We have also reprioritized our research portfolio to focus on assets that have the greatest potential to deliver the most value for patients, physicians, and shareholders. Our clinical programs ARV102 in neurodegeneration and ARV393 in hematology remain on track to deliver important clinical data later this year. Overall, these steps will result in a combination of cost savings and cost avoidance of approximately $500 million over the next three years. The net results of these actions is a change in our guidance to extend our cash runway into the second half of 2028. We believe these significant cost savings and a refined capital allocation strategy, in addition to a strong balance sheet, will allow us to advance our early development portfolio in a timely and efficient manner, as well as ensuring a financially disciplined approach to commercial readiness. Before I continue, I do want to thank all the talented employees who were directly impacted by this decision. I'm proud of the progress we have made together and want to acknowledge their contributions and commitment to discovering and developing new treatment options for patients with life-altering diseases. We wish the best for these colleagues as they transition to new opportunities. I also want to thank the employees who are continuing the journey with us at Arvinas, as each of them will be instrumental in helping us achieve the ambitious goals we have laid out for the company. I'll now turn the call over to the team to review our recent data and the details from the quarter. I'll return at the end of the call to review the milestones that we anticipate for the remainder of 2025. But for now, I'll turn the call over to Noah.