11/5/2025

speaker
Operator

Thank you for standing by and welcome to our Venus third quarter 2025 earnings call. I'd like to remind everyone that this call is being recorded and that 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. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Mr. Jeff Boyle. You may begin.

speaker
Jeff Boyle
Head of Investor Relations

Good morning, everyone, and thank you for joining us. Earlier today, we issued a press release with our third 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 Huston, Arvinas' chief executive officer, president, and chairperson, Noah Berkowitz, our chief medical officer, Angela Cacasey, our chief scientific officer, and Andrew Sake, our Chief Financial Officer. Before we begin the call, I'll remind you that today's discussions contain forward-looking statements that involve risks, uncertainties, and assumptions, which are outlined in today's press release and in the company's recent filings with the U.S. 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 today's call, as well as an updated corporate deck, will be available in the Investor and Media section of our website. And now I'll turn the call over to John. John?

speaker
John Huston
Chief Executive Officer, President & Chairperson

Thanks, Jeff. Good morning, everyone, and thank you for joining us today. As highlighted in our third quarter earnings release issued earlier this morning, this has been a dynamic and productive period for Arvinas, marked by meaningful progress across both our corporate initiatives and clinical development programs. During the quarter, we announced significant developments, both in our pipeline and enhancing efficiency across our organization, all here that drive in value from our portfolio to deliver benefit to patients and value to shareholders. Our deep pipeline provides multiple opportunities for value creation as we work to address the largest areas of significant unmet need in oncology and neurology. We have entered the beginning of a data-rich period with multiple readouts from our early-stage clinical programs, including recent clinical data from ARV102, or LARP2, the greater, and preclinical data from ARV806, our KRAS G12D degrader. We also presented the first preclinical data from ARV027, our promising new clinical candidate that targets polyglutamine-expanded androgen receptor, or Poly2AR, the root cause of spinal bulbar muscular atrophy, or SBMA. In addition, we also anticipate sharing preclinical data from our DCL6 degrader, ARV393, at the ASH conference in December, and preclinical data from our new HPT1 degrader, ARV6723, later this week at the CITSE conference. NOAA will also share a promising update from our ongoing Phase I monocerity trial with ARV393 later in the call today. We have a strong track record of translating promising preclinical results into important successes in the clinic with a platform that has consistently shown its versatility and promise. We continue to build on that record with multiple ongoing and planned clinical trials in areas of high unmet need, a pipeline of high value assets, a strong research engine, and cash on hand into the second half of 2028 that gives us financial and strategic flexibility. In September, we announced that we and Pfizer will jointly select a third party for the commercialization and potential further development of VetDagastrat with the goal of rapidly bringing it to patients if approved. VetDag's new drug application is currently under review by the FDA, and the agency has issued a PDUFA action date of June 5th, 2026. Our goal is to have a partner in place before this date to make sure that VetDag, if approved, is launch ready as a potentially best-in-class therapeutic option for ER-positive, HER2-negative advanced breast cancer in the second-line ESR1 mutant setting of ARV393.

Disclaimer

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