Arvinas Inc to Discuss the Phase 1 Dose Escalation Data and Interim Data from the Phase 2 ARDENT Trial Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Tyler Van Buren - Cowen and Company, LLC - Analyst : I think earlier in the presentation, you mentioned that there is potential for approval with a greater than 25% PSA50 response rate. So can you help put that threshold in the context given the TRITON2 results? And was that from a discussion with regulators? Or how did you get there? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 17, 2022 / 1:30PM, ARVN.OQ - Arvinas Inc to Discuss the Phase 1 Dose Escalation Data and Interim Data from the Phase 2 ARDENT Trial

Question: Edward Tenthoff - Piper Sandler & Co. - Analyst : I'm really impressed by the data. I just want to confirm the numbers real quick. So it's -- before it was 12 out of 26 now it's 13 out of 28. Is that correct for the PSA50?

Question: Edward Tenthoff - Piper Sandler & Co. - Analyst : Is the same. Yes, awesome. That's really helpful. And then I just want to get a sense. I definitely see the path forward in these mutant patients and with the 878/875 mutation. What are the opportunities? Or how would you start to explore ARV-110 in earlier lines? In particular, I was in treatment, what you're saying about pre-enzalutamide or abiraterone. What would that kind of study look like?

Question: Eliana Merle - UBS Investment Bank - Analyst : Congrats on the data. I was just wondering if you could elaborate a bit on the biology behind the sensitivity in the 878 and 875 mutations. I mean I know there's some preclinical literature around how these mutations might turn enzalutamide, say, into an AR agonist, but curious your perspective on what's driving the higher response here with an AR decorator. And I guess what we right know and like, I guess, not yet now. And then just a quick follow-up to that just in terms of the prevalence of these mutations. Just I guess, what are you seeing as a prevalence in the later-line setting? You alluded that it might be higher than the literature. Just any specifics around there would be helpful. And I guess, your thoughts on how the prevalence is evolving as you move from earlier to later lines of therapy for the 878 and 875 mutations?

Question: Madhu Kumar - Goldman Sachs Group, Inc. - Analyst : So a little bit of housekeeping. The two RECIST response patients in the study, can you give us some clarity on what the duration of response was. And for the Phase 1 patient that had a RECIST response, what was the dose that was administered?

Question: Madhu Kumar - Goldman Sachs Group, Inc. - Analyst : Duration of response, please?

Question: Madhu Kumar - Goldman Sachs Group, Inc. - Analyst : Okay. I guess one big-picture question to think about, how do you think about given what you're seeing from bav that you disclosed today. How do you think about kind of follow-on AR drugs where they fit in the kind of treatment landscape in relief of bav based on today's results?

Question: Madhu Kumar - Goldman Sachs Group, Inc. - Analyst : When we think about 110 as compared to the follow-on drugs like 766, kind of the other AR degraders you have in your pipeline, where do you think each of these drugs fit in given what you now know about 110 as compared to potentially those follow-on assets? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 17, 2022 / 1:30PM, ARVN.OQ - Arvinas Inc to Discuss the Phase 1 Dose Escalation Data and Interim Data from the Phase 2 ARDENT Trial

Question: Joon Lee - Truist Securities, Inc. - Analyst : So you're doing a combination study with abiraterone, the ZYTIGA presumably because there's an overlap with target binding sight with enzalutamide. Have you looked at XTANDI versus ZYTIGA-experienced subgroups? And if so, were there any differences in the PSA50 in those subgroups?

Question: Joon Lee - Truist Securities, Inc. - Analyst : So then there's a follow-up question, sorry, which is if the binding sites are the same between XTANDI and 110, how was 110 actually working in those who progressed on XTANDI?

Question: Tazeen Ahmad - BofA Securities - Analyst : It's very clear that you've got a very strong signal on these 878/875 patients. But as it relates to 110 specifically, how are you right now thinking about the potential beyond that group of patients? And do you have any idea of what might be driving the resistance to 110.

Question: Tazeen Ahmad - BofA Securities - Analyst : Okay. And just maybe as a quick follow-up. For the NHA naive patients, you said that you're going to be studying them, are those studies at to start this year?

Question: Zegbeh Jallah - ROTH Capital Partners, LLC - Analyst : I think the first one, I just wanted to clarify, is the logistics around testing for 878 or 875, how that's done clinically. And then if you just put a dollar amount on what you think the market opportunity is in that setting? And then the last one here is just about the combo study. We're just wondering what the rationale is for the efficacy since this is not in a molecularly defined patient population? And what are you thinking about in terms of the market opportunity, again, in terms of a dollar amount since this is only with patients that have failed abiraterone?

Question: Zegbeh Jallah - ROTH Capital Partners, LLC - Analyst : And then Ron, I think the last bit was just about logistically about testing 878 and 875, just meaning new bottlenecks in the clinical path towards getting to those patients? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 17, 2022 / 1:30PM, ARVN.OQ - Arvinas Inc to Discuss the Phase 1 Dose Escalation Data and Interim Data from the Phase 2 ARDENT Trial

Question: Alethia Young - Cantor Fitzgerald & Co. - Analyst : Congrats on this interesting data. Can you talk a little bit more about kind of maybe potential sample size in the pivotal study? And kind of how kind of you're thinking about how long it might take to potentially enroll and I understand it's a little bit premature, but just anything more that you can provide about thinking about details around the specific study that's important?

Question: Bradley Canino - Stifel, Nicolaus & Company, Incorporated - Analyst : And thanks for the details around this complicated data set. In the 878/875 population, you spoke to 28 patients on slide 12 with that 46% PSA50. But that includes six patients that are less pretreated of which four had a PSA50 decline. So the first question is, could you conceivably enroll these less pretreated patients for an accelerated approval population? I see that the rucaparib trial required prior Taxane. And then second, does the inclusion of these patients benefit the PSA50 versus what would be expected in the intended accelerated approval population? Because I would think additional therapies and chemos might create those co-occurring mutations not degraded by 110. And we see a smaller PSA50 benefit there in that mix group in purple in Slide 11.

Question: Michael Schmidt - Guggenheim Securities, LLC - Analyst : I just had one more bigger picture question on the sort of the ultimate market positioning of 110 as a monotherapy in the mutation-positive patients. I guess you just mentioned, I think the initial accelerated approval study is presumably going to be some type of late line, late-stage patient population. But then, I guess, ultimately, where do you feel the best place for the monotherapy in the mutation population is? And also any thoughts on the evolving market here with the PROpel data also being presented at the conference and how it might be positioned to other emerging therapies in the first line CRPC setting?

Question: Yigal Nochomovitz - Citigroup Inc. - Analyst : I have a very specific question about the definitions in the footnote on slide 12. Just trying to understand what best PSA decline actually means. Does best mean that these PSA50 declines were confirmed with the second reading? Or does it mean that the patients only need to cross the PSA50 threshold onetime to get counted as a PSA50 responder?

Question: Etzer Darout - BMO Capital Markets Equity Research - Analyst : Great. Thank you for this update this morning. I guess you touched on this a little bit earlier. But looking back at slide 19, is it that the AR independent mechanisms are maybe more prevalent than we assume sort of earlier on in the treatment paradigm for these patients. I guess related to that, how REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 17, 2022 / 1:30PM, ARVN.OQ - Arvinas Inc to Discuss the Phase 1 Dose Escalation Data and Interim Data from the Phase 2 ARDENT Trial much of this is a consequence of NHA being used in like castration sensitive or even sort of non-metastatic settings. And then ultimately, the potential even for ARV-110 tend to be used sort of earlier in that setting in the mutation population.

Question: Mark Breidenbach - Oppenheimer & Co. Inc. - Analyst : Congrats on the data. Just wondering, especially since given the rucaparib experience and its approval on RECIST response rate, I'm wondering if you can comment on how cleanly the tumor size reductions you're seeing in the 7 RECIST evaluable patients correlates with their PSA decline. That would be helpful.