Arvinas, Inc.

Hello and welcome to the AirVenus 4Q25 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. And if you would like to withdraw your question, press star one again. Thank you. I will now turn the call over to Jeff Boyle, Head of Impressor Relations. Jeff, you may begin.

Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release with our fourth quarter and full year 2025 financial results, which is available in the investor and media section of our website at arvenis.com. Joining us on the call today, we have Randy Teal, our president and CEO, Noah Berkowitz, our chief medical officer, Angela Cacasey, our chief scientific officer, and Andrew Saik, our chief financial officer. Before we begin, 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 filing 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. A replay of this call, as well as today's press release and an updated corporate deck, will be available on the Investor and Media section of our website. And now I'll turn the call over to Randy Thiel. Randy?

Thanks, Jeff, and thank you all for joining us today. It's an honor and a privilege to lead such a talented and committed team as Arvinas enters a period where we anticipate multiple value driving milestones at the company. In addition to the team, we have a technology proven in the clinic, an exciting pipeline, and a strong balance sheet, allowing us to continue our work to make a meaningful impact for patients, their families, and our shareholders. 2025 saw meaningful progress across our pipeline and was a transformative year for the company. In addition to submitting our first new drug application, setting the stage for potentially the first-ever FDA approval of a ProTac degrader, we redefined our strategy to maximize the opportunities ahead in each of our core areas of focus. With four ongoing clinical trials across oncology and neurology, including our recently begun first-in-human trial of our PolyQ AR degrader, ARV027, we believe we have the potential to bring truly differentiated treatments to millions of underserved patients. We're entering a pivotal period at Arvinas, As we've been previewing for the past six months, 2026 will be defined by multiple data readouts and clinical advancements. We believe these milestones will validate our strategy of developing only treatments that are highly differentiated from other options. I'll summarize clinical data expectations for the year and make a few comments on corporate strategy before turning the call over to the team to walk through recent accomplishments and our forward-looking plans in more detail. Beginning with our LRK2 degrader, ARV102, I'm pleased to announce today that data from our Phase I clinical trial in patients with Parkinson's disease was accepted for an oral presentation at the Alzheimer's Disease and Parkinson's Disease Conference in March. We'll assess the ability of ARV102 to degrade LRK2 in the CSF and see how it impacts important pathway biomarkers. Rather than inhibit LRK2's kinase activity intermittently, ARV102 degrades the entire LRRK2 protein, an important consideration when thinking about its potentially differentiated profile. Turning to ARV806, our KRAS G12D ProTech potently and selectively eliminates both the on and off forms of the protein. Based on faster than expected enrollment in this trial, we now expect to make our first data disclosure for the program by the middle of 2026, and we've already submitted data from that trial for presentation at a medical congress in the coming months. This will be an important look at why we believe ARV806 has the potential to be a clearly differentiated treatment, so stay tuned for more on our disclosure plans. Next, our ProTax BCL6 degrader, ARV393, is continuing to progress well in our Phase I dose escalation trial, and we intend to share data from this trial in the second half of 2026. As announced on our last earnings call, we've already seen responses in early cohorts in patients with both B and T cell lymphomas, even at exposures below those predicted to be efficacious. We also observed robust BCL6 degradation, and the safety profile of 393 supports continued dose escalation. With respect to Depdegastrant, as you know, we are working with Pfizer to select a third party for its commercialization and potential further development. Our goal remains to make sure that if it's approved, Depdeg is launch-ready and available as a potentially best-in-class therapeutic option for patients with ER positive, HER2 negative, advanced breast cancer in the second line, ESR1 mutant setting. Our discussions to date with potential partners have been productive, and we're working to have an agreement in place before the June 5th PDUFA date. Finally, before I turn the call over to the team, I'd like to make two comments on corporate strategy. First, last year, we decided to refocus our resources on our Phase I clinical programs, which we now have four of. While we believe VETDAG has the potential to be a best-in-class therapy for patients, we think the best way for our business to create shareholder value is to focus on ARV102, ARV806, ARV393, and now ARV027. Second, we recognize the bar is high for all of our programs. We won't settle for as good as, and we hope patients don't have to choose between efficacy, safety, and tolerability. We're determined to only develop treatments that are differentiated and will be highly disciplined in moving programs forward. We believe our pipeline is producing potentially transformative treatments for patients, and we look forward to sharing what we believe will be compelling data for each of these programs as we reach milestones in the future.